21 CFR 346.14 - Protectant active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Protectant active ingredients. 346.14 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.14 Protectant active ingredients. (a) The following active ingredients may be used as the sole protectant active...

21 CFR 346.14 - Protectant active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Protectant active ingredients. 346.14 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.14 Protectant active ingredients. (a) The following active ingredients may be used as the sole protectant active...

21 CFR 341.18 - Expectorant active ingredient.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.18 Expectorant active ingredient. The active ingredient of the...

21 CFR 335.10 - Antidiarrheal active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antidiarrheal active ingredients. 335.10 Section...) DRUGS FOR HUMAN USE ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 335.10 Antidiarrheal active ingredients. The active ingredient of the product consists of any one of the...

21 CFR 335.10 - Antidiarrheal active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antidiarrheal active ingredients. 335.10 Section...) DRUGS FOR HUMAN USE ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 335.10 Antidiarrheal active ingredients. The active ingredient of the product consists of any one of the...

21 CFR 341.18 - Expectorant active ingredient.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.18 Expectorant active ingredient. The active ingredient of the...

21 CFR 341.18 - Expectorant active ingredient.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.18 Expectorant active ingredient. The active ingredient of the...

21 CFR 335.10 - Antidiarrheal active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antidiarrheal active ingredients. 335.10 Section...) DRUGS FOR HUMAN USE ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 335.10 Antidiarrheal active ingredients. The active ingredient of the product consists of any one of the...

21 CFR 335.10 - Antidiarrheal active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antidiarrheal active ingredients. 335.10 Section...) DRUGS FOR HUMAN USE ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 335.10 Antidiarrheal active ingredients. The active ingredient of the product consists of any one of the...

21 CFR 335.10 - Antidiarrheal active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antidiarrheal active ingredients. 335.10 Section...) DRUGS FOR HUMAN USE ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 335.10 Antidiarrheal active ingredients. The active ingredient of the product consists of any one of the...

21 CFR 341.18 - Expectorant active ingredient.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...-COUNTER HUMAN USE Active Ingredients § 341.18 Expectorant active ingredient. The active ingredient of the...

21 CFR 350.10 - Antiperspirant active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antiperspirant active ingredients. 350.10 Section...) DRUGS FOR HUMAN USE ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 350.10 Antiperspirant active ingredients. The active ingredient of the product consists of any of the...

21 CFR 350.10 - Antiperspirant active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antiperspirant active ingredients. 350.10 Section...) DRUGS FOR HUMAN USE ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 350.10 Antiperspirant active ingredients. The active ingredient of the product consists of any of the...

21 CFR 350.10 - Antiperspirant active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antiperspirant active ingredients. 350.10 Section...) DRUGS FOR HUMAN USE ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 350.10 Antiperspirant active ingredients. The active ingredient of the product consists of any of the...

21 CFR 350.10 - Antiperspirant active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antiperspirant active ingredients. 350.10 Section...) DRUGS FOR HUMAN USE ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 350.10 Antiperspirant active ingredients. The active ingredient of the product consists of any of the...

21 CFR 350.10 - Antiperspirant active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antiperspirant active ingredients. 350.10 Section...) DRUGS FOR HUMAN USE ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 350.10 Antiperspirant active ingredients. The active ingredient of the product consists of any of the...

An accurate and precise representation of drug ingredients.

PubMed

Hanna, Josh; Bian, Jiang; Hogan, William R

2016-01-01

In previous work, we built the Drug Ontology (DrOn) to support comparative effectiveness research use cases. Here, we have updated our representation of ingredients to include both active ingredients (and their strengths) and excipients. Our update had three primary lines of work: 1) analysing and extracting excipients, 2) analysing and extracting strength information for active ingredients, and 3) representing the binding of active ingredients to cytochrome P450 isoenzymes as substrates and inhibitors of those enzymes. To properly differentiate between excipients and active ingredients, we conducted an ontological analysis of the roles that various ingredients, including excipients, have in drug products. We used the value specification model of the Ontology for Biomedical Investigations to represent strengths of active ingredients and then analyzed RxNorm to extract excipient and strength information and modeled them according to the results of our analysis. We also analyzed and defined dispositions of molecules used in aggregate as active ingredients to bind cytochrome P450 isoenzymes. Our analysis of excipients led to 17 new classes representing the various roles that excipients can bear. We then extracted excipients from RxNorm and added them to DrOn for branded drugs. We found excipients for 5,743 branded drugs, covering ~27% of the 21,191 branded drugs in DrOn. Our analysis of active ingredients resulted in another new class, active ingredient role. We also extracted strengths for all types of tablets, capsules, and caplets, resulting in strengths for 5,782 drug forms, covering ~41% of the 14,035 total drug forms and accounting for ~97 % of the 5,970 tablets, capsules, and caplets in DrOn. We represented binding-as-substrate and binding-as-inhibitor dispositions to two cytochrome P450 (CYP) isoenzymes (CYP2C19 and CYP2D6) and linked these dispositions to 65 compounds. It is now possible to query DrOn automatically for all drug products that contain active

21 CFR 336.10 - Antiemetic active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antiemetic active ingredients. 336.10 Section 336...) DRUGS FOR HUMAN USE ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 336.10 Antiemetic active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 347.12 - Astringent active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Astringent active ingredients. 347.12 Section 347...) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of the...

21 CFR 346.18 - Astringent active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Astringent active ingredients. 346.18 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.18 Astringent active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 355.10 - Anticaries active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Anticaries active ingredients. 355.10 Section 355...) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.10 Anticaries active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.18 - Astringent active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Astringent active ingredients. 346.18 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.18 Astringent active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 355.10 - Anticaries active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Anticaries active ingredients. 355.10 Section 355...) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.10 Anticaries active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.20 - Keratolytic active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Keratolytic active ingredients. 346.20 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.20 Keratolytic active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.12 - Vasoconstrictor active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Vasoconstrictor active ingredients. 346.12 Section...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.12 Vasoconstrictor active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 336.10 - Antiemetic active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antiemetic active ingredients. 336.10 Section 336...) DRUGS FOR HUMAN USE ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 336.10 Antiemetic active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 355.10 - Anticaries active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Anticaries active ingredients. 355.10 Section 355...) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.10 Anticaries active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.20 - Keratolytic active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Keratolytic active ingredients. 346.20 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.20 Keratolytic active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 336.10 - Antiemetic active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antiemetic active ingredients. 336.10 Section 336...) DRUGS FOR HUMAN USE ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 336.10 Antiemetic active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 355.10 - Anticaries active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Anticaries active ingredients. 355.10 Section 355...) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.10 Anticaries active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.20 - Keratolytic active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Keratolytic active ingredients. 346.20 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.20 Keratolytic active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.18 - Astringent active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Astringent active ingredients. 346.18 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.18 Astringent active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.12 - Vasoconstrictor active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Vasoconstrictor active ingredients. 346.12 Section...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.12 Vasoconstrictor active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.20 - Keratolytic active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Keratolytic active ingredients. 346.20 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.20 Keratolytic active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 347.12 - Astringent active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Astringent active ingredients. 347.12 Section 347...) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of the...

21 CFR 346.18 - Astringent active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Astringent active ingredients. 346.18 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.18 Astringent active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.12 - Vasoconstrictor active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Vasoconstrictor active ingredients. 346.12 Section...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.12 Vasoconstrictor active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.12 - Vasoconstrictor active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Vasoconstrictor active ingredients. 346.12 Section...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.12 Vasoconstrictor active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.18 - Astringent active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Astringent active ingredients. 346.18 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.18 Astringent active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 346.20 - Keratolytic active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Keratolytic active ingredients. 346.20 Section 346...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.20 Keratolytic active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 336.10 - Antiemetic active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antiemetic active ingredients. 336.10 Section 336...) DRUGS FOR HUMAN USE ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 336.10 Antiemetic active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 347.12 - Astringent active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Astringent active ingredients. 347.12 Section 347...) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of the...

21 CFR 346.12 - Vasoconstrictor active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Vasoconstrictor active ingredients. 346.12 Section...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.12 Vasoconstrictor active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 347.12 - Astringent active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Astringent active ingredients. 347.12 Section 347...) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.12 Astringent active ingredients. The active ingredient of the product consists of any one of the...

21 CFR 355.10 - Anticaries active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Anticaries active ingredients. 355.10 Section 355...) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 355.10 Anticaries active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 336.10 - Antiemetic active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antiemetic active ingredients. 336.10 Section 336...) DRUGS FOR HUMAN USE ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 336.10 Antiemetic active ingredients. The active ingredient of the product consists of any of the following when...

21 CFR 357.210 - Cholecystokinetic active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Cholecystokinetic active ingredients. 357.210 Section 357.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Cholecystokinetic Drug Products § 357.210 Cholecystokinetic active ingredients. The active ingredient of the product...

21 CFR 333.210 - Antifungal active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Antifungal Drug Products § 333.210 Antifungal active ingredients. The active ingredient of the product...

21 CFR 358.610 - Pediculicide active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Pediculicide active ingredients. 358.610 Section 358.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Pediculicide Drug Products § 358.610 Pediculicide active ingredients. The active ingredients of the product...

21 CFR 357.110 - Anthelmintic active ingredient.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Anthelmintic active ingredient. 357.110 Section 357.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Anthelmintic Drug Products § 357.110 Anthelmintic active ingredient. The active ingredient of the product is...

21 CFR 358.610 - Pediculicide active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Pediculicide active ingredients. 358.610 Section 358.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Pediculicide Drug Products § 358.610 Pediculicide active ingredients. The active ingredients of the product...

21 CFR 357.110 - Anthelmintic active ingredient.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Anthelmintic active ingredient. 357.110 Section 357.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Anthelmintic Drug Products § 357.110 Anthelmintic active ingredient. The active ingredient of the product is...

21 CFR 333.210 - Antifungal active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Antifungal Drug Products § 333.210 Antifungal active ingredients. The active ingredient of the product...

21 CFR 358.610 - Pediculicide active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Pediculicide active ingredients. 358.610 Section 358.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Pediculicide Drug Products § 358.610 Pediculicide active ingredients. The active ingredients of the product...

21 CFR 357.210 - Cholecystokinetic active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Cholecystokinetic active ingredients. 357.210 Section 357.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Cholecystokinetic Drug Products § 357.210 Cholecystokinetic active ingredients. The active ingredient of the product...

21 CFR 358.610 - Pediculicide active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Pediculicide active ingredients. 358.610 Section 358.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Pediculicide Drug Products § 358.610 Pediculicide active ingredients. The active ingredients of the product...

21 CFR 358.610 - Pediculicide active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Pediculicide active ingredients. 358.610 Section 358.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Pediculicide Drug Products § 358.610 Pediculicide active ingredients. The active ingredients of the product...

21 CFR 357.110 - Anthelmintic active ingredient.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Anthelmintic active ingredient. 357.110 Section 357.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Anthelmintic Drug Products § 357.110 Anthelmintic active ingredient. The active ingredient of the product is...

21 CFR 333.210 - Antifungal active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Antifungal Drug Products § 333.210 Antifungal active ingredients. The active ingredient of the product...

21 CFR 333.210 - Antifungal active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Antifungal Drug Products § 333.210 Antifungal active ingredients. The active ingredient of the product...

21 CFR 357.110 - Anthelmintic active ingredient.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Anthelmintic active ingredient. 357.110 Section 357.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Anthelmintic Drug Products § 357.110 Anthelmintic active ingredient. The active ingredient of the product is...

21 CFR 357.110 - Anthelmintic active ingredient.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Anthelmintic active ingredient. 357.110 Section 357.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Anthelmintic Drug Products § 357.110 Anthelmintic active ingredient. The active ingredient of the product is...

21 CFR 357.210 - Cholecystokinetic active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Cholecystokinetic active ingredients. 357.210 Section 357.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Cholecystokinetic Drug Products § 357.210 Cholecystokinetic active ingredients. The active ingredient of the product...

21 CFR 333.210 - Antifungal active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antifungal active ingredients. 333.210 Section 333.210 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Antifungal Drug Products § 333.210 Antifungal active ingredients. The active ingredient of the product...

21 CFR 333.310 - Acne active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Acne active ingredients. 333.310 Section 333.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of the...

21 CFR 333.310 - Acne active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Acne active ingredients. 333.310 Section 333.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of the...

21 CFR 333.310 - Acne active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Acne active ingredients. 333.310 Section 333.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of the...

21 CFR 340.10 - Stimulant active ingredient.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Stimulant active ingredient. 340.10 Section 340.10... FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredient § 340.10 Stimulant active ingredient. The active ingredient of the product consists of caffeine when used within the...

21 CFR 340.10 - Stimulant active ingredient.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Stimulant active ingredient. 340.10 Section 340.10... FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredient § 340.10 Stimulant active ingredient. The active ingredient of the product consists of caffeine when used within the...

21 CFR 340.10 - Stimulant active ingredient.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Stimulant active ingredient. 340.10 Section 340.10... FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredient § 340.10 Stimulant active ingredient. The active ingredient of the product consists of caffeine when used within the...

21 CFR 340.10 - Stimulant active ingredient.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Stimulant active ingredient. 340.10 Section 340.10... FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredient § 340.10 Stimulant active ingredient. The active ingredient of the product consists of caffeine when used within the...

21 CFR 346.10 - Local anesthetic active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Local anesthetic active ingredients. 346.10... (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any of...

21 CFR 346.10 - Local anesthetic active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Local anesthetic active ingredients. 346.10... (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any of...

21 CFR 346.10 - Local anesthetic active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Local anesthetic active ingredients. 346.10... (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any of...

Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

PubMed

Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

2015-01-01

Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination.

21 CFR 333.310 - Acne active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of the...

21 CFR 333.310 - Acne active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of the...

21 CFR 346.14 - Protectant active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.14... ingredient in a product if the ingredient as identified constitutes 50 percent or more by weight of the final product. In addition, the following active ingredients may be used in concentrations of less than 50...

21 CFR 332.10 - Antiflatulent active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antiflatulent active ingredients. 332.10 Section...) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.10 Antiflatulent active ingredients. Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this...

21 CFR 332.10 - Antiflatulent active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antiflatulent active ingredients. 332.10 Section...) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.10 Antiflatulent active ingredients. Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this...

21 CFR 332.10 - Antiflatulent active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antiflatulent active ingredients. 332.10 Section...) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.10 Antiflatulent active ingredients. Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this...

21 CFR 332.10 - Antiflatulent active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antiflatulent active ingredients. 332.10 Section...) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.10 Antiflatulent active ingredients. Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this...

21 CFR 332.10 - Antiflatulent active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antiflatulent active ingredients. 332.10 Section...) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.10 Antiflatulent active ingredients. Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this...

21 CFR 344.12 - Ear drying aid active ingredient.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Ear drying aid active ingredient. 344.12 Section...) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.12 Ear drying aid active ingredient. The active ingredient of the product consists of isopropyl...

21 CFR 344.10 - Earwax removal aid active ingredient.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Earwax removal aid active ingredient. 344.10... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.10 Earwax removal aid active ingredient. The active ingredient of the product consists of...

21 CFR 344.12 - Ear drying aid active ingredient.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ear drying aid active ingredient. 344.12 Section...) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.12 Ear drying aid active ingredient. The active ingredient of the product consists of isopropyl...

21 CFR 344.12 - Ear drying aid active ingredient.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Ear drying aid active ingredient. 344.12 Section...) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.12 Ear drying aid active ingredient. The active ingredient of the product consists of isopropyl...

21 CFR 344.10 - Earwax removal aid active ingredient.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Earwax removal aid active ingredient. 344.10... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.10 Earwax removal aid active ingredient. The active ingredient of the product consists of...

21 CFR 344.10 - Earwax removal aid active ingredient.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Earwax removal aid active ingredient. 344.10... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.10 Earwax removal aid active ingredient. The active ingredient of the product consists of...

21 CFR 344.12 - Ear drying aid active ingredient.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Ear drying aid active ingredient. 344.12 Section...) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.12 Ear drying aid active ingredient. The active ingredient of the product consists of isopropyl...

21 CFR 344.12 - Ear drying aid active ingredient.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Ear drying aid active ingredient. 344.12 Section...) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.12 Ear drying aid active ingredient. The active ingredient of the product consists of isopropyl...

21 CFR 344.10 - Earwax removal aid active ingredient.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Earwax removal aid active ingredient. 344.10... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.10 Earwax removal aid active ingredient. The active ingredient of the product consists of...

21 CFR 344.10 - Earwax removal aid active ingredient.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Earwax removal aid active ingredient. 344.10... (CONTINUED) DRUGS FOR HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 344.10 Earwax removal aid active ingredient. The active ingredient of the product consists of...

21 CFR 338.10 - Nighttime sleep-aid active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists of...

21 CFR 338.10 - Nighttime sleep-aid active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists of...

21 CFR 338.10 - Nighttime sleep-aid active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists of...

21 CFR 338.10 - Nighttime sleep-aid active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists of...

21 CFR 338.10 - Nighttime sleep-aid active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Nighttime sleep-aid active ingredients. 338.10... (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists of...

21 CFR 346.10 - Local anesthetic active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Local anesthetic active ingredients. 346.10 Section 346.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any of...

21 CFR 346.10 - Local anesthetic active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Local anesthetic active ingredients. 346.10 Section 346.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... § 346.10 Local anesthetic active ingredients. The active ingredient of the product consists of any of...

21 CFR 347.12 - Astringent active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Astringent active ingredients. 347.12 Section 347.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients...

21 CFR 340.10 - Stimulant active ingredient.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Stimulant active ingredient. 340.10 Section 340.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredient § 340.10...

21 CFR 358.310 - Ingrown toenail relief active ingredient.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Ingrown toenail relief active ingredient. 358.310 Section 358.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Toenail Relief Drug Products § 358.310 Ingrown toenail relief active ingredient. The active ingredient of...

21 CFR 358.310 - Ingrown toenail relief active ingredient.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Ingrown toenail relief active ingredient. 358.310 Section 358.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Toenail Relief Drug Products § 358.310 Ingrown toenail relief active ingredient. The active ingredient of...

21 CFR 358.310 - Ingrown toenail relief active ingredient.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Ingrown toenail relief active ingredient. 358.310 Section 358.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Toenail Relief Drug Products § 358.310 Ingrown toenail relief active ingredient. The active ingredient of...

21 CFR 358.310 - Ingrown toenail relief active ingredient.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Ingrown toenail relief active ingredient. 358.310 Section 358.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Toenail Relief Drug Products § 358.310 Ingrown toenail relief active ingredient. The active ingredient of...

21 CFR 358.310 - Ingrown toenail relief active ingredient.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Ingrown toenail relief active ingredient. 358.310 Section 358.310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Toenail Relief Drug Products § 358.310 Ingrown toenail relief active ingredient. The active ingredient of...

21 CFR 331.11 - Listing of specific active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Listing of specific active ingredients. 331.11... (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.11 Listing of specific active ingredients. (a) Aluminum-containing active ingredients: (1) Basic...

21 CFR 331.11 - Listing of specific active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Listing of specific active ingredients. 331.11... (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.11 Listing of specific active ingredients. (a) Aluminum-containing active ingredients: (1) Basic...

21 CFR 349.30 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 349... SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.30 Permitted combinations of active ingredients. The following combinations are permitted...

21 CFR 349.30 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 349... SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.30 Permitted combinations of active ingredients. The following combinations are permitted...

21 CFR 349.30 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 349... SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.30 Permitted combinations of active ingredients. The following combinations are permitted...

21 CFR 349.30 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 349... SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.30 Permitted combinations of active ingredients. The following combinations are permitted...

21 CFR 349.30 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Permitted combinations of active ingredients. 349... SERVICES (CONTINUED) DRUGS FOR HUMAN USE OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 349.30 Permitted combinations of active ingredients. The following combinations are permitted...

21 CFR 358.110 - Wart remover active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Wart remover active ingredients. 358.110 Section... Remover Drug Products § 358.110 Wart remover active ingredients. The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each...

21 CFR 358.110 - Wart remover active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Wart remover active ingredients. 358.110 Section... Remover Drug Products § 358.110 Wart remover active ingredients. The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each...

21 CFR 358.110 - Wart remover active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Wart remover active ingredients. 358.110 Section... Remover Drug Products § 358.110 Wart remover active ingredients. The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each...

21 CFR 358.110 - Wart remover active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Wart remover active ingredients. 358.110 Section... Remover Drug Products § 358.110 Wart remover active ingredients. The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each...

21 CFR 358.110 - Wart remover active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Wart remover active ingredients. 358.110 Section... Remover Drug Products § 358.110 Wart remover active ingredients. The product consists of any of the following active ingredients within the specified concentration and in the dosage form established for each...

21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 346.16 Section 346.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of the...

21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 346.16 Section 346.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of the...

21 CFR 331.10 - Antacid active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more of...

21 CFR 331.10 - Antacid active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more of...

21 CFR 331.10 - Antacid active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more of...

21 CFR 331.10 - Antacid active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more of...

21 CFR 331.10 - Antacid active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Antacid active ingredients. 331.10 Section 331.10... FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.10 Antacid active ingredients. (a) The active antacid ingredients of the product consist of one or more of...

21 CFR 347.10 - Skin protectant active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.10 Skin protectant active ingredients. The active ingredients of the product consist of any of the...) Aluminum hydroxide gel, 0.15 to 5 percent. (c) Calamine, 1 to 25 percent. (d) Cocoa butter, 50 to 100...

21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The active...

21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Analgesic, anesthetic, and antipruritic active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of the...

21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The active...

21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Analgesic, anesthetic, and antipruritic active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of the...

21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The active...

21 CFR 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Analgesic, anesthetic, and antipruritic active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.16 Analgesic, anesthetic, and antipruritic active ingredients. The active ingredient of the...

21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The active...

21 CFR 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. 348.10 Section 348.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Active Ingredients § 348.10 Analgesic, anesthetic, and antipruritic active ingredients. The active...

21 CFR 347.20 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 347.20 Permitted combinations of active ingredients. (a) Combinations of skin...) Combinations of skin protectant and external analgesic active ingredients. Any one (two when required to be in...

21 CFR 331.15 - Combination with nonantacid active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Combination with nonantacid active ingredients... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally...

21 CFR 331.15 - Combination with nonantacid active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Combination with nonantacid active ingredients... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally...

21 CFR 331.15 - Combination with nonantacid active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Combination with nonantacid active ingredients... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally...

21 CFR 331.15 - Combination with nonantacid active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Combination with nonantacid active ingredients... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally...

21 CFR 331.15 - Combination with nonantacid active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Combination with nonantacid active ingredients... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Active Ingredients § 331.15 Combination with nonantacid active ingredients. (a) An antacid may contain any generally...

21 CFR 341.20 - Nasal decongestant active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Nasal decongestant active ingredients. 341.20... OVER-THE-COUNTER HUMAN USE Active Ingredients § 341.20 Nasal decongestant active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits and...

21 CFR 341.20 - Nasal decongestant active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Nasal decongestant active ingredients. 341.20... OVER-THE-COUNTER HUMAN USE Active Ingredients § 341.20 Nasal decongestant active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits and...

21 CFR 341.20 - Nasal decongestant active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Nasal decongestant active ingredients. 341.20... OVER-THE-COUNTER HUMAN USE Active Ingredients § 341.20 Nasal decongestant active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits and...

21 CFR 341.20 - Nasal decongestant active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Nasal decongestant active ingredients. 341.20... OVER-THE-COUNTER HUMAN USE Active Ingredients § 341.20 Nasal decongestant active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits and...

21 CFR 352.20 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 352... INDEFINITELY] Active Ingredients § 352.20 Permitted combinations of active ingredients. The SPF of any...) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352...

21 CFR 352.20 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 352... INDEFINITELY] Active Ingredients § 352.20 Permitted combinations of active ingredients. The SPF of any...) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352...

21 CFR 352.20 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 352... INDEFINITELY] Active Ingredients § 352.20 Permitted combinations of active ingredients. The SPF of any...) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352...

21 CFR 352.20 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 352... INDEFINITELY] Active Ingredients § 352.20 Permitted combinations of active ingredients. The SPF of any...) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352...

21 CFR 352.20 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Permitted combinations of active ingredients. 352... INDEFINITELY] Active Ingredients § 352.20 Permitted combinations of active ingredients. The SPF of any...) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352...

21 CFR 347.20 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 347... Active Ingredients § 347.20 Permitted combinations of active ingredients. (a) Combinations of skin protectant active ingredients. (1) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (i...

21 CFR 347.20 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 347... Active Ingredients § 347.20 Permitted combinations of active ingredients. (a) Combinations of skin protectant active ingredients. (1) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (i...

21 CFR 347.20 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 347... Active Ingredients § 347.20 Permitted combinations of active ingredients. (a) Combinations of skin protectant active ingredients. (1) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (i...

21 CFR 347.20 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 347... Active Ingredients § 347.20 Permitted combinations of active ingredients. (a) Combinations of skin protectant active ingredients. (1) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (i...

21 CFR 333.320 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Topical Acne Drug Products § 333.320 Permitted combinations of active ingredients. (a) Resorcinol...

21 CFR 333.320 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Topical Acne Drug Products § 333.320 Permitted combinations of active ingredients. (a) Resorcinol...

21 CFR 333.320 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Topical Acne Drug Products § 333.320 Permitted combinations of active ingredients. (a) Resorcinol...

21 CFR 333.320 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 333.320 Section 333.320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... Topical Acne Drug Products § 333.320 Permitted combinations of active ingredients. (a) Resorcinol...

21 CFR 358.510 - Corn and callus remover active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Corn and callus remover active ingredients. 358... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients. The product consists of any of the following active ingredients within the specified concentrations and in the...

21 CFR 358.510 - Corn and callus remover active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Corn and callus remover active ingredients. 358... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients. The product consists of any of the following active ingredients within the specified concentrations and in the...

21 CFR 358.510 - Corn and callus remover active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Corn and callus remover active ingredients. 358... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients. The product consists of any of the following active ingredients within the specified concentrations and in the...

21 CFR 358.510 - Corn and callus remover active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Corn and callus remover active ingredients. 358... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients. The product consists of any of the following active ingredients within the specified concentrations and in the...

21 CFR 346.22 - Permitted combinations of anorectal active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of anorectal active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.22 Permitted combinations of anorectal active ingredients. (a) Any two, three, or four...

21 CFR 346.22 - Permitted combinations of anorectal active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of anorectal active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.22 Permitted combinations of anorectal active ingredients. (a) Any two, three, or four...

21 CFR 346.22 - Permitted combinations of anorectal active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of anorectal active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 346.22 Permitted combinations of anorectal active ingredients. (a) Any two, three, or four...

21 CFR 333.320 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Permitted combinations of active ingredients. 333... Topical Acne Drug Products § 333.320 Permitted combinations of active ingredients. (a) Resorcinol... of the user, the revised text is set forth as follows: § 333.320 Permitted combinations of active...

21 CFR 358.720 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Permitted combinations of active ingredients. 358... Permitted combinations of active ingredients. (a) Combination of active ingredients for the control of... labeled according to § 358.750. (b) Combination of control of dandruff and external analgesic active...

21 CFR 358.720 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Permitted combinations of active ingredients. 358... Permitted combinations of active ingredients. (a) Combination of active ingredients for the control of... labeled according to § 358.750. (b) Combination of control of dandruff and external analgesic active...

21 CFR 358.720 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Permitted combinations of active ingredients. 358... Permitted combinations of active ingredients. (a) Combination of active ingredients for the control of... labeled according to § 358.750. (b) Combination of control of dandruff and external analgesic active...

21 CFR 358.720 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Permitted combinations of active ingredients. 358... Permitted combinations of active ingredients. (a) Combination of active ingredients for the control of... labeled according to § 358.750. (b) Combination of control of dandruff and external analgesic active...

21 CFR 358.720 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Permitted combinations of active ingredients. 358... Permitted combinations of active ingredients. (a) Combination of active ingredients for the control of... labeled according to § 358.750. (b) Combination of control of dandruff and external analgesic active...

21 CFR 358.510 - Corn and callus remover active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Corn and callus remover active ingredients. 358.510 Section 358.510 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... USE Corn and Callus Remover Drug Products § 358.510 Corn and callus remover active ingredients. The...

21 CFR 332.15 - Combination with non-antiflatulent active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Combination with non-antiflatulent active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.15 Combination with non-antiflatulent active ingredients. An antiflatulent may contain any...

21 CFR 332.15 - Combination with non-antiflatulent active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Combination with non-antiflatulent active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.15 Combination with non-antiflatulent active ingredients. An antiflatulent may contain any...

21 CFR 332.15 - Combination with non-antiflatulent active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Combination with non-antiflatulent active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.15 Combination with non-antiflatulent active ingredients. An antiflatulent may contain any...

21 CFR 332.15 - Combination with non-antiflatulent active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Combination with non-antiflatulent active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.15 Combination with non-antiflatulent active ingredients. An antiflatulent may contain any...

21 CFR 332.15 - Combination with non-antiflatulent active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Combination with non-antiflatulent active... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients § 332.15 Combination with non-antiflatulent active ingredients. An antiflatulent may contain any...

Integration of active pharmaceutical ingredient solid form selection and particle engineering into drug product design.

PubMed

Ticehurst, Martyn David; Marziano, Ivan

2015-06-01

This review seeks to offer a broad perspective that encompasses an understanding of the drug product attributes affected by active pharmaceutical ingredient (API) physical properties, their link to solid form selection and the role of particle engineering. While the crucial role of active pharmaceutical ingredient (API) solid form selection is universally acknowledged in the pharmaceutical industry, the value of increasing effort to understanding the link between solid form, API physical properties and drug product formulation and manufacture is now also being recognised. A truly holistic strategy for drug product development should focus on connecting solid form selection, particle engineering and formulation design to both exploit opportunities to access simpler manufacturing operations and prevent failures. Modelling and predictive tools that assist in establishing these links early in product development are discussed. In addition, the potential for differences between the ingoing API physical properties and those in the final product caused by drug product processing is considered. The focus of this review is on oral solid dosage forms and dry powder inhaler products for lung delivery. © 2015 Royal Pharmaceutical Society.

21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527 Section 310.527 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirement...

21 CFR 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific...

21 CFR 310.542 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia. 310.542 Section 310.542 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific...

21 CFR 201.10 - Drugs; statement of ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...

21 CFR 201.10 - Drugs; statement of ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...

21 CFR 201.10 - Drugs; statement of ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...

21 CFR 201.10 - Drugs; statement of ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...

21 CFR 352.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...

21 CFR 349.79 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...

21 CFR 352.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...

21 CFR 349.79 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...

21 CFR 349.79 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...

21 CFR 352.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...

21 CFR 349.79 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...

21 CFR 349.79 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...

21 CFR 341.14 - Antitussive active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antitussive active ingredients. 341.14 Section 341.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE...

21 CFR 341.12 - Antihistamine active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Antihistamine active ingredients. 341.12 Section 341.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE...

21 CFR 341.18 - Expectorant active ingredient.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Expectorant active ingredient. 341.18 Section 341.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE...

21 CFR 341.16 - Bronchodilator active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Bronchodilator active ingredients. 341.16 Section 341.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE...

21 CFR 201.10 - Drugs; statement of ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear...

21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products containing active ingredients... Section 310.533 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... hay fever, allergy, rhinitis, and the common cold. Atropine sulfate for oral use as an anticholinergic...

21 CFR 346.52 - Labeling of permitted combinations of anorectal active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of anorectal active ingredients. 346.52 Section 346.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... HUMAN USE Labeling § 346.52 Labeling of permitted combinations of anorectal active ingredients...

21 CFR 346.52 - Labeling of permitted combinations of anorectal active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of permitted combinations of anorectal active ingredients. 346.52 Section 346.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... HUMAN USE Labeling § 346.52 Labeling of permitted combinations of anorectal active ingredients...

21 CFR 346.52 - Labeling of permitted combinations of anorectal active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of anorectal active ingredients. 346.52 Section 346.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... HUMAN USE Labeling § 346.52 Labeling of permitted combinations of anorectal active ingredients...

21 CFR 346.52 - Labeling of permitted combinations of anorectal active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of anorectal active ingredients. 346.52 Section 346.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... HUMAN USE Labeling § 346.52 Labeling of permitted combinations of anorectal active ingredients...

21 CFR 346.52 - Labeling of permitted combinations of anorectal active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of permitted combinations of anorectal active ingredients. 346.52 Section 346.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... HUMAN USE Labeling § 346.52 Labeling of permitted combinations of anorectal active ingredients...

21 CFR 341.20 - Nasal decongestant active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Nasal decongestant active ingredients. 341.20 Section 341.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

21 CFR 331.20 - Determination of percent contribution of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Determination of percent contribution of active... Procedures § 331.20 Determination of percent contribution of active ingredients. To determine the percent contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active...

21 CFR 331.20 - Determination of percent contribution of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Determination of percent contribution of active... Procedures § 331.20 Determination of percent contribution of active ingredients. To determine the percent contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active...

21 CFR 331.20 - Determination of percent contribution of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Determination of percent contribution of active... Procedures § 331.20 Determination of percent contribution of active ingredients. To determine the percent contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active...

21 CFR 331.20 - Determination of percent contribution of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Determination of percent contribution of active... Procedures § 331.20 Determination of percent contribution of active ingredients. To determine the percent contribution of an antacid active ingredient, place an accurately weighed amount of the antacid active...

21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...

21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...

21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...

21 CFR 333.160 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active ingredients. 333.160 Section 333.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... HUMAN USE First Aid Antibiotic Drug Products § 333.160 Labeling of permitted combinations of active...

21 CFR 333.160 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active ingredients. 333.160 Section 333.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... HUMAN USE First Aid Antibiotic Drug Products § 333.160 Labeling of permitted combinations of active...

21 CFR 333.160 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 333.160 Section 333.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... HUMAN USE First Aid Antibiotic Drug Products § 333.160 Labeling of permitted combinations of active...

Study on THz spectra of the active ingredients in the TCM

NASA Astrophysics Data System (ADS)

Ma, ShiHua; Wang, WenFeng; Liu, GuiFeng; Ge, Min; Zhu, ZhiYong

2008-03-01

Terahertz spectroscopy has tremendous potential for applications to evaluate the quality of the drugs including the TCM. In this paper, the Terahertz Time-Domain Spectroscopy investigated two active ingredients: Andrographolide and Dehydroandrographoline, isolated from Andrographis paniculata (Burm. f.) Nees. We also measured the mixtures of two active ingredients at the different ratio and the quantitative analysis is also applied to determine the contents of compound. The Terahertz spectroscopy is a potential and promising technique in identifying the components, evaluating the drugs sanitation and inspecting the quality of medicine including TCM.

75 FR 7606 - Safety and Efficacy Review for Additional Ingredients in Over-the-Counter Drug Products for Human...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-22

... in OTC drug monographs based on time and extent applications (TEAs). We are currently evaluating the... effectiveness of 13 active ingredients found eligible for possible addition to an OTC drug monograph via the TEA... ingredients found eligible for inclusion in an OTC drug monograph under the TEA process on the basis of...

21 CFR 341.85 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of permitted combinations of active ingredients. 341.85 Section 341.85 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG...

Towards integrated drug substance and drug product design for an active pharmaceutical ingredient using particle engineering.

PubMed

Kougoulos, Eleftherios; Smales, Ian; Verrier, Hugh M

2011-03-01

A novel experimental approach describing the integration of drug substance and drug production design using particle engineering techniques such as sonocrystallization, high shear wet milling (HSWM) and dry impact (hammer) milling were used to manufacture samples of an active pharmaceutical ingredient (API) with diverse particle size and size distributions. The API instability was addressed using particle engineering and through judicious selection of excipients to reduce degradation reactions. API produced using a conventional batch cooling crystallization process resulted in content uniformity issues. Hammer milling increased fine particle formation resulting in reduced content uniformity and increased degradation compared to sonocrystallized and HSWM API in the formulation. To ensure at least a 2-year shelf life based on predictions using an Accelerated Stability Assessment Program, this API should have a D [v, 0.1] of 55 μm and a D [v, 0.5] of 140 μm. The particle size of the chief excipient in the drug product formulation needed to be close to that of the API to avoid content uniformity and stability issues but large enough to reduce lactam formation. The novel methodology described here has potential for application to other APIs. © 2011 American Association of Pharmaceutical Scientists

21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

Code of Federal Regulations, 2014 CFR

2014-04-01

... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing...

21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

Code of Federal Regulations, 2012 CFR

2012-04-01

... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing...

21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

Code of Federal Regulations, 2013 CFR

2013-04-01

... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing...

21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

Code of Federal Regulations, 2011 CFR

2011-04-01

... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing...

21 CFR 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral...

Code of Federal Regulations, 2010 CFR

2010-04-01

... offered over-the-counter (OTC) for human use as oral wound healing agents. 310.534 Section 310.534 Food... active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. (a... aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing...

Possible Anticancer Mechanisms of Some Costus speciosus Active Ingredients Concerning Drug Discovery.

PubMed

El-Far, Ali H; Badria, Faried A; Shaheen, Hazem M

2016-01-01

Costus speciosus is native to South East Asia, especially found in India, Srilanka, Indonesia and Malaysia. C. speciosus have numerous therapeutic potentials against a wide variety of complains. The therapeutic properties of C. speciosus are attributed to the presence of various ingredients such as alkaloids, flavonoids, glycosides, phenols, saponins, sterols and sesquiterpenes. This review presented the past, present, and the future status of C. speciosus active ingredients to propose a future use as a potential anticancer agent. All possible up-regulation of cellular apoptotic molecules as p53, p21, p27, caspases, reactive oxygen species (ROS) generation and others attribute to the anticancer activity of C. speciosus along the down-regulation of anti-apoptotic agents such as Akt, Bcl2, NFKB, STAT3, JAK, MMPs, actin, surviving and vimentin. Eventually, we recommend further investigation of different C. speciosus extracts, using some active ingredients and evaluate the anticancer effect of these chemicals against different cancers.

[Screening of anti-aging active ingredients and mechanism analysis based on molecular docking technology].

PubMed

Du, Ran-Feng; Zhang, Xiao-Hua; Ye, Xiao-Tong; Yu, Wen-Kang; Wang, Yun

2016-07-01

Dampness evil is the source of all diseases, which is easy to cause disease and promote aging, while aging could also promote the occurence and development of diseases. In this paper, the relationship between the dampness evil and aging would be discussed, to find the anti-aging active ingredients in traditional Chinese medicine (TCM), and analyze the anti-aging mechanism of dampness eliminating drug. Molecular docking technology was used, with aging-related mammalian target of rapamycin as the docking receptors, and chemical components of Fuling, Sangzhi, Mugua, Yiyiren and Houpo as the docking molecules, to preliminarily screen the anti-aging active ingredients in dampness eliminating drug. Through the comparison with active drugs already on the market (temsirolimus and everolimus), 12 kinds of potential anti-aging active ingredients were found, but their drug gability still needs further study. The docking results showed that various components in the dampness eliminating drug can play anti-aging activities by acting on mammalian target of rapamycin. This result provides a new thought and direction for the method of delaying aging by eliminating dampness. Copyright© by the Chinese Pharmaceutical Association.

Encapsulation of new active ingredients.

PubMed

Onwulata, C I

2012-01-01

The organic construct consumed as food comes packaged in units that carry the active components and protect the entrapped active materials until delivered to targeted human organs. The packaging and delivery role is mimicked in the microencapsulation tools used to deliver active ingredients in processed foods. Microencapsulation efficiency is balanced against the need to access the entrapped nutrients in bioavailable forms. Encapsulated ingredients boosted with bioactive nutrients are intended for improved health and well-being and to prevent future health problems. Presently, active ingredients are delivered using new techniques, such as hydrogels, nanoemulsions, and nanoparticles. In the future, nutraceuticals and functional foods may be tailored to individual metabolic needs and tied to each person's genetic makeup. Bioactive ingredients provide health-enhancing nutrients and are protected through encapsulation processes that shield the active ingredients from deleterious environments.

The THz fingerprint spectra of the active ingredients of a TCM medicine: Herba Ephedrae

NASA Astrophysics Data System (ADS)

Ma, Shihua; Liu, Guifeng; Zhang, Peng; Song, Xiyu; Ji, Te; Wang, Wenfeng

2008-12-01

In this paper, THz-TDS has been used to measure the spectral properties of two active ingredients of Herba Ephedrae: ephedrine and pseudoephedrine, which exist in hydrochloride salts. The THz spectra of the sole-ingredient, twoingredient and three-ingredient compounds are studied. We obtained the finger-print spectra of the net active ingredients of the medicine, and also measured the mixtures of by two or three active ingredients at the different ratios. At the same time, theoretical analysis and quantitative analysis is applied to foretell the different THz spectra, identify the ingredients and infer the contents of principal components in samples. The THz spectroscopy is a potential and promising technique in evaluating and inspecting the quality of the drugs in the TCM field.

APT drug R&D: the right active ingredient in the right presentation for the right therapeutic use.

PubMed

Cavalla, David

2009-11-01

Drug repurposing, in which an established active pharmaceutical ingredient is applied in a new way - for example, for a new indication, and often combined with an alternative method of presentation, such as a novel delivery route - is an evolving strategy for pharmaceutical R&D. This article discusses examples of the success of this strategy, and presents an analysis of sales of US pharmaceutical products that suggests that this low-risk approach to new product development retains substantial commercial value.

[Important application of intestinal transporters and metabolism enzymes on gastrointestinal disposal of active ingredients of Chinese materia medica].

PubMed

Bi, Xiaolin; Du, Qiu; Di, Liuqing

2010-02-01

Oral drug bioavailability depends on gastrointestinal absorption, intestinal transporters and metabolism enzymes are the important factors in drug gastrointestinal absorption and they can also be induced or inhibited by the active ingredients of Chinese materia medica. This article presents important application of intestinal transporters and metabolism enzymes on gastrointestinal disposal of the active ingredients of Chinese materia medica, and points out the importance of research on transport and metabolism of the active ingredients of Chinese materia medica in Chinese extract and Chinese medicinal formulae.

21 CFR 310.538 - Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown...

Code of Federal Regulations, 2010 CFR

2010-04-01

... of the safety and effectiveness of these or any other ingredients for OTC use for ingrown toenail... is required for marketing. In the absence of an approved new drug application or abbreviated new drug...

21 CFR 343.13 - Rheumatologic active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...

21 CFR 343.13 - Rheumatologic active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...

21 CFR 343.12 - Cardiovascular active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...

21 CFR 343.13 - Rheumatologic active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...

21 CFR 343.13 - Rheumatologic active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...

21 CFR 343.12 - Cardiovascular active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...

21 CFR 343.12 - Cardiovascular active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...

21 CFR 343.12 - Cardiovascular active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...

21 CFR 343.13 - Rheumatologic active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-COUNTER HUMAN USE Active Ingredients § 343.13 Rheumatologic active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...

21 CFR 343.12 - Cardiovascular active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

...-COUNTER HUMAN USE Active Ingredients § 343.12 Cardiovascular active ingredients. (a) Aspirin. (b) Buffered aspirin. Aspirin identified in paragraph (a) of this section may be buffered with any antacid ingredient(s... milliequivalents of acid-neutralizing capacity per 325 milligrams of aspirin as measured by the procedure provided...

21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

Code of Federal Regulations, 2012 CFR

2012-04-01

... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug...

21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

Code of Federal Regulations, 2014 CFR

2014-04-01

... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug...

21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

Code of Federal Regulations, 2013 CFR

2013-04-01

... offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. 310.533... in cough-cold drug products. (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug...

Minimum Risk Pesticides - Inert Ingredient and Active Ingredient Eligibility under 40 CFR 152.25(f)

EPA Pesticide Factsheets

Ingredients found on both the Minimum Risk Active Ingredient and List 4A Inert Ingredients of Minimal Concern lists may be used either as an active or an inert ingredient. Otherwise, it can only be used based on the list it appears on.

21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

Code of Federal Regulations, 2011 CFR

2011-04-01

... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos... mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect repellent... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs...

21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

Code of Federal Regulations, 2013 CFR

2013-04-01

... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos... mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect repellent... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs...

21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

Code of Federal Regulations, 2010 CFR

2010-04-01

... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos... mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect repellent... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs...

21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

Code of Federal Regulations, 2012 CFR

2012-04-01

... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos... mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect repellent... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs...

21 CFR 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect...

Code of Federal Regulations, 2014 CFR

2014-04-01

... for orally administered OTC insect repellent drug products: “Oral mosquito repellent,” “mosquitos... mosquitos.” Therefore, any drug product containing ingredients offered for oral use as an insect repellent... offered over-the-counter (OTC) for oral use as insect repellents. 310.529 Section 310.529 Food and Drugs...

21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

Code of Federal Regulations, 2012 CFR

2012-04-01

..., testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are powerful...

21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

Code of Federal Regulations, 2014 CFR

2014-04-01

..., testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are powerful...

21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

Code of Federal Regulations, 2013 CFR

2013-04-01

..., testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are powerful...

21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

Code of Federal Regulations, 2011 CFR

2011-04-01

..., testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are powerful...

21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

Code of Federal Regulations, 2010 CFR

2010-04-01

..., testosterone, vitamins, yohimbine, yohimbine hydrochloride, and yohimbinum have been present as ingredients in such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are powerful...

21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

Code of Federal Regulations, 2013 CFR

2013-04-01

... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to...

21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

Code of Federal Regulations, 2014 CFR

2014-04-01

... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to...

21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

Code of Federal Regulations, 2012 CFR

2012-04-01

... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to...

21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

Code of Federal Regulations, 2011 CFR

2011-04-01

... offered over-the-counter (OTC) for use as stomach acidifiers. 310.540 Section 310.540 Food and Drugs FOOD... ingredients offered over-the-counter (OTC) for use as stomach acidifiers. (a) Betaine hydrochloride, glutamic...-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to...

Quality assurance of chemical ingredient classification for the National Drug File - Reference Terminology.

PubMed

Zheng, Ling; Yumak, Hasan; Chen, Ling; Ochs, Christopher; Geller, James; Kapusnik-Uner, Joan; Perl, Yehoshua

2017-09-01

The National Drug File - Reference Terminology (NDF-RT) is a large and complex drug terminology consisting of several classification hierarchies on top of an extensive collection of drug concepts. These hierarchies provide important information about clinical drugs, e.g., their chemical ingredients, mechanisms of action, dosage form and physiological effects. Within NDF-RT such information is represented using tens of thousands of roles connecting drugs to classifications. In previous studies, we have introduced various kinds of Abstraction Networks to summarize the content and structure of terminologies in order to facilitate their visual comprehension, and support quality assurance of terminologies. However, these previous kinds of Abstraction Networks are not appropriate for summarizing the NDF-RT classification hierarchies, due to its unique structure. In this paper, we present the novel Ingredient Abstraction Network (IAbN) to summarize, visualize and support the audit of NDF-RT's Chemical Ingredients hierarchy and its associated drugs. A common theme in our quality assurance framework is to use characterizations of sets of concepts, revealed by the Abstraction Network structure, to capture concepts, the modeling of which is more complex than for other concepts. For the IAbN, we characterize drug ingredient concepts as more complex if they belong to IAbN groups with multiple parent groups. We show that such concepts have a statistically significantly higher rate of errors than a control sample and identify two especially common patterns of errors. Copyright © 2017 Elsevier Inc. All rights reserved.

21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

Code of Federal Regulations, 2010 CFR

2010-04-01

... establish the effectiveness of these or any other ingredients for use in treating achlorhydria and... is required for marketing. In the absence of an approved new drug application, such product is also...

A network pharmacology approach to determine active ingredients and rationality of herb combinations of Modified-Simiaowan for treatment of gout.

PubMed

Zhao, Fangli; Guochun, Li; Yang, Yanhua; Shi, Le; Xu, Li; Yin, Lian

2015-06-20

Modified Simiaowan (MSW) is a traditional Chinese medicine (TCM) formula and is widely used as a clinically medication formula for its efficiency in treating gouty diseases.To predict the active ingredients in MSW and uncover the rationality of herb combinations of MSW. Three drug-target networks including the "candidate ingredient-target network" (cI-cT) that links the candidate ingredients and targets, the "core ingredient-target-pathway network" connecting core potential ingredients and targets through related pathways, and the "rationality of herb combinations of MSW network", which was derived from the cI-cT network, were developed to dissect the active ingredients in MSW and relationship between ingredients in herb combinations and their targets for gouty diseases. On the other hand, herbal ingredients comparisons were also conducted based on six physicochemical properties to investigate whether the herbs in MSW are similar in chemicals. Moreover, HUVEC viability and expression levels of ICAM-1 induced by monosodium urate (MSU) crystals were assessed to determine the activities of potential ingredients in MSW. Predicted by the core ingredient-target-pathway network, we collected 30 core ingredients in MSW and 25 inflammatory cytokines and uric acid synthetase or transporters, which are effective for gouty treatment through some related pathways. Experimental results also confirmed that those core ingredients could significantly increase HUVEC viability and attenuate the expression of ICAM-1, which supported the effectiveness of MSW in treating gouty diseases. Moreover, heat-clearing and dampness-eliminating herbs in MSW have similar physicochemical properties, which stimulate all the inflammatory and uric acid-lowing targets respectively, while the core drug and basic prescription in MSW stimulate the major and almost all the core targets, respectively. Our work successfully predicts the active ingredients in MSW and explains the cooperation between these

Gamma sterilization of pharmaceuticals--a review of the irradiation of excipients, active pharmaceutical ingredients, and final drug product formulations.

PubMed

Hasanain, Fatima; Guenther, Katharina; Mullett, Wayne M; Craven, Emily

2014-01-01

Sterilization by gamma irradiation has shown a strong applicability for a wide range of pharmaceutical products. Due to the requirement for terminal sterilization where possible in the pharmaceutical industry, gamma sterilization has proven itself to be an effective method as indicated by its acceptance in the European Pharmacopeia and the United States Pharmacopeia ( ). Some of the advantages of gamma over competitive procedures include high penetration power, isothermal character (small temperature rise), and no residues. It also provides a better assurance of product sterility than aseptic processing, as well as lower validation demands. Gamma irradiation is capable of killing microorganisms by breaking their chemical bonds, producing free radicals that attack the nucleic acid of the microorganism. Sterility by gamma irradiation is achieved mainly by the alteration of nucleic acid and preventing the cellular division. This review focuses on the extensive application of gamma sterilization to a wide range of pharmaceutical components including active pharmaceutical ingredients, excipients, final drug products, and combination drug-medical devices. A summary of the published literature for each class of pharmaceutical compound or product is presented. The irradiation conditions and various quality control characterization methodologies that were used to determine final product quality are included, in addition to a summary of the investigational outcomes. Based on this extensive literature review and in combination with regulatory guidelines and other published best practices, a decision tree for implementation of gamma irradiation for pharmaceutical products is established. This flow chart further facilitates the implementation of gamma irradiation in the pharmaceutical development process. The summary therefore provides a useful reference to the application and versatility of gamma irradiation for pharmaceutical sterilization. Many pharmaceutical products

21 CFR 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

Code of Federal Regulations, 2014 CFR

2014-04-01

... active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and... products containing active ingredients offered for use in the treatment of hypophosphatemia. (a) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood. This...

21 CFR 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

Code of Federal Regulations, 2012 CFR

2012-04-01

... active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and... products containing active ingredients offered for use in the treatment of hypophosphatemia. (a) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood. This...

21 CFR 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

Code of Federal Regulations, 2011 CFR

2011-04-01

... active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and... products containing active ingredients offered for use in the treatment of hypophosphatemia. (a) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood. This...

21 CFR 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

Code of Federal Regulations, 2013 CFR

2013-04-01

... active ingredients offered for use in the treatment of hypophosphatemia. 310.541 Section 310.541 Food and... products containing active ingredients offered for use in the treatment of hypophosphatemia. (a) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood. This...

Active ingredients of substance use-focused self-help groups.

PubMed

Moos, Rudolf H

2008-03-01

This paper provides an overview of some of the probable active ingredients of self-help groups in light of four related theories that identify common social processes that appear to underlie effective psychosocial treatments for and continuing remission from these disorders. Social control theory specifies active ingredients such as bonding, goal direction and structure; social learning theory specifies the importance of norms and role models, behavioral economics and behavioral choice theory emphasizes involvement in rewarding activities other than substance use, and stress and coping theory highlights building self-efficacy and effective coping skills. A review of existing studies suggests that the emphasis on these active ingredients probably underlies some aspects of the effectiveness of self-help groups. Several issues that need to be addressed to enhance understanding of the active ingredients of action of self-help groups are discussed, including consideration of indices of Alcoholics Anonymous (AA) affiliation as active ingredients, identification of personal characteristics that may moderate the influence of active ingredients on substance use outcomes, examination of whether active ingredients of self-help groups, can amplify or compensate for treatment, identification of potential detrimental effects of involvement in self-help groups and focusing on the link between active ingredients of self-help groups and other aspects of the overall recovery milieu, such as the family and social networks.

Scope of claim coverage in patents of fufang Chinese herbal drugs: Substitution of ingredients

PubMed Central

2011-01-01

Herbal ingredients in a Chinese fufang prescription are often replaced by one or several other herbal combinations. As there have been very few Chinese herbal patent infringement cases, it is still unclear how the Doctrine of Equivalents should be applied to determine the scope of 'equivalents' in Chinese fufang prescriptions. Case law principles from cases in other technical areas such as chemical patents and biological drug patents can be borrowed to ascertain a precise scope of a fufang patent. This article summarizes and discusses several chemical and biopharmaceutical patent cases. In cases where a certain herbal ingredient is substituted by another herb or a combination of herbs, accused infringers are likely to relate herbal drug patents to chemical drug patents with strict interpretation whereas patent owners may take advantage of the liberal application of Doctrine of Equivalence in biopharmaceutical patents by analogizing the complex nature of herbal drugs with biological drugs. Therefore, consideration should be given to the purpose of an ingredient in a patent, the qualities when combined with the other ingredients and the intended function. The scope of equivalents also depends on the stage of the prior art. Moreover, it is desirable to disclose any potential substitutes when drafting the application. Claims should be drafted in such a way that all foreseeable modifications are encompassed for the protection of the patent owner's intellectual property. PMID:21854570

Scope of claim coverage in patents of fufang Chinese herbal drugs: Substitution of ingredients.

PubMed

Wang, Xinsheng; Tian, Jiaher; Chan, Albert Wai-Kit

2011-08-19

Herbal ingredients in a Chinese fufang prescription are often replaced by one or several other herbal combinations. As there have been very few Chinese herbal patent infringement cases, it is still unclear how the Doctrine of Equivalents should be applied to determine the scope of 'equivalents' in Chinese fufang prescriptions. Case law principles from cases in other technical areas such as chemical patents and biological drug patents can be borrowed to ascertain a precise scope of a fufang patent. This article summarizes and discusses several chemical and biopharmaceutical patent cases. In cases where a certain herbal ingredient is substituted by another herb or a combination of herbs, accused infringers are likely to relate herbal drug patents to chemical drug patents with strict interpretation whereas patent owners may take advantage of the liberal application of Doctrine of Equivalence in biopharmaceutical patents by analogizing the complex nature of herbal drugs with biological drugs. Therefore, consideration should be given to the purpose of an ingredient in a patent, the qualities when combined with the other ingredients and the intended function. The scope of equivalents also depends on the stage of the prior art. Moreover, it is desirable to disclose any potential substitutes when drafting the application. Claims should be drafted in such a way that all foreseeable modifications are encompassed for the protection of the patent owner's intellectual property.

Supercritical carbon dioxide processing of active pharmaceutical ingredients for polymorphic control and for complex formation.

PubMed

Moribe, Kunikazu; Tozuka, Yuichi; Yamamoto, Keiji

2008-02-14

Supercritical fluid technique have been exploited in extraction, separation and crystallization processes. In the field of pharmaceutics, supercritical carbon dioxide (scCO(2)) has been used for the purpose of micronization, polymorphic control, and preparation of solid dispersion and complexes. Particle design of active pharmaceutical ingredients is important to make the solid dosage forms with suitable physicochemical properties. Control of the characteristic properties of particles, such as size, shape, crystal structure and morphology is required to optimize the formulation. For solubility enhancement of poorly water-soluble drugs, preparation of the solid dispersion or the complexation with proper drugs or excipients should be a promising approach. This review focuses on aspects of polymorphic control and complexation behavior of active pharmaceutical ingredients by scCO(2) processing.

Data-mining of potential antitubercular activities from molecular ingredients of traditional Chinese medicines.

PubMed

Jamal, Salma; Scaria, Vinod

2014-01-01

Background. Traditional Chinese medicine encompasses a well established alternate system of medicine based on a broad range of herbal formulations and is practiced extensively in the region for the treatment of a wide variety of diseases. In recent years, several reports describe in depth studies of the molecular ingredients of traditional Chinese medicines on the biological activities including anti-bacterial activities. The availability of a well-curated dataset of molecular ingredients of traditional Chinese medicines and accurate in-silico cheminformatics models for data mining for antitubercular agents and computational filters to prioritize molecules has prompted us to search for potential hits from these datasets. Results. We used a consensus approach to predict molecules with potential antitubercular activities from a large dataset of molecular ingredients of traditional Chinese medicines available in the public domain. We further prioritized 160 molecules based on five computational filters (SMARTSfilter) so as to avoid potentially undesirable molecules. We further examined the molecules for permeability across Mycobacterial cell wall and for potential activities against non-replicating and drug tolerant Mycobacteria. Additional in-depth literature surveys for the reported antitubercular activities of the molecular ingredients and their sources were considered for drawing support to prioritization. Conclusions. Our analysis suggests that datasets of molecular ingredients of traditional Chinese medicines offer a new opportunity to mine for potential biological activities. In this report, we suggest a proof-of-concept methodology to prioritize molecules for further experimental assays using a variety of computational tools. We also additionally suggest that a subset of prioritized molecules could be used for evaluation for tuberculosis due to their additional effect against non-replicating tuberculosis as well as the additional hepato-protection offered by

Data-mining of potential antitubercular activities from molecular ingredients of traditional Chinese medicines

PubMed Central

Jamal, Salma

2014-01-01

Background. Traditional Chinese medicine encompasses a well established alternate system of medicine based on a broad range of herbal formulations and is practiced extensively in the region for the treatment of a wide variety of diseases. In recent years, several reports describe in depth studies of the molecular ingredients of traditional Chinese medicines on the biological activities including anti-bacterial activities. The availability of a well-curated dataset of molecular ingredients of traditional Chinese medicines and accurate in-silico cheminformatics models for data mining for antitubercular agents and computational filters to prioritize molecules has prompted us to search for potential hits from these datasets. Results. We used a consensus approach to predict molecules with potential antitubercular activities from a large dataset of molecular ingredients of traditional Chinese medicines available in the public domain. We further prioritized 160 molecules based on five computational filters (SMARTSfilter) so as to avoid potentially undesirable molecules. We further examined the molecules for permeability across Mycobacterial cell wall and for potential activities against non-replicating and drug tolerant Mycobacteria. Additional in-depth literature surveys for the reported antitubercular activities of the molecular ingredients and their sources were considered for drawing support to prioritization. Conclusions. Our analysis suggests that datasets of molecular ingredients of traditional Chinese medicines offer a new opportunity to mine for potential biological activities. In this report, we suggest a proof-of-concept methodology to prioritize molecules for further experimental assays using a variety of computational tools. We also additionally suggest that a subset of prioritized molecules could be used for evaluation for tuberculosis due to their additional effect against non-replicating tuberculosis as well as the additional hepato-protection offered by

77 FR 41415 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... INFORMATION CONTACT: Astrid Lopez-Goldberg, Center for Drug Evaluation and Research, Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0563] Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and...

Grapefruit-felodipine interaction: effect of unprocessed fruit and probable active ingredients.

PubMed

Bailey, D G; Dresser, G K; Kreeft, J H; Munoz, C; Freeman, D J; Bend, J R

2000-11-01

To determine whether unprocessed grapefruit can cause a drug interaction, whether the active ingredients are naturally occurring, and whether specific furanocoumarins or flavonoids are involved. The oral pharmacokinetics of felodipine and its dehydrofelodipine metabolite were determined after administration of felodipine 10 mg extended-release tablet with 250 mL commercial grapefruit juice, homogenized grapefruit segments, or extract of segment-free parts equivalent to one unprocessed fruit or water in a randomized four-way crossover study. Inhibition of recombinant CYP3A4 by furanocoumarins (bergamottin, 6',7'-epoxybergamottin, 6',7'-dihydroxybergamottin) and flavonoids (naringenin optical isomers) was determined. Furanocoumarin and naringenin precursor (naringin) concentrations were measured in each grapefruit treatment. Felodipine AUC with commercial grapefruit juice, grapefruit segments, or grapefruit extract was on average 3-fold higher than that with water. Felodipine peak concentration was higher, but the half-life was unchanged. The dehydrofelodipine/felodipine AUC ratio was reduced. The furanocoumarins produced mechanism-based and competitive inhibition of CYP3A4. Bergamottin was the most potent mechanism-based inhibitor. Naringenin isomers produced only competitive inhibition. Bergamottin, 6',7'-dihydroxybergamottin, and naringin concentrations varied among grapefruit treatments but were sufficient to inhibit markedly in vitro CYP3A4 activity. Unprocessed grapefruit can cause a drug interaction with felodipine. The active ingredients are naturally occurring in the grapefruit. Bergamottin is likely important in drug interactions with commercial grapefruit juice. 6',7'-Dihydroxybergamottin and naringin may be more important in grapefruit segments because they are present in higher concentrations. Any therapeutic concern for a drug interaction with commercial grapefruit juice should now be extended to include whole fruit and possibly confectioneries made

Active Ingredient - AZ

EPA Pesticide Factsheets

EPA Pesticide Chemical Search allows a user to easily find the pesticide chemical or active ingredient that they are interested in by using an array of simple to advanced search options. Chemical Search provides a single point of reference for easy access to information previously published in a variety of locations, including various EPA web pages and Regulations.gov.

21 CFR 341.40 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the...

21 CFR 341.40 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the...

21 CFR 341.40 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the...

21 CFR 341.40 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the...

21 CFR 341.40 - Permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ingredients, or any aspirin and antacid combination provided that the product is labeled according to § 341.85... combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid... other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the...

Suspended particle and drug ingredient concentrations in hospital dispensaries and implications for pharmacists' working environments.

PubMed

Inaba, Ryoichi; Hioki, Atsushi; Kondo, Yoshihiro; Nakamura, Hiroki; Nakamura, Mitsuhiro

2016-03-01

The aim of this study was to assess the present status of working environments for pharmacists, including the concentrations of suspended particles and suspended drug ingredients in dispensaries. We conducted a survey on the work processes and working environment in 15 hospital dispensaries, and measured the concentrations of suspended particles and suspended drug ingredients using digital dust counter and high-performance liquid chromatography tandem mass spectrometry (LC-MS/MS), respectively. Of 25 types of powdered drugs that were frequently handled in the 15 dispensaries surveyed, 11 could be quantitatively determined. The amounts of suspended particles were relatively high, but below the reference value, in three dispensaries without dust collectors. The sedative-hypnotic drug zopiclone was detected in the suspended particles at one dispensary that was not equipped with dust collectors, and the antipyretic and analgesic drug acetaminophen was detected in two dispensaries equipped with dust collectors. There was no correlation between the daily number of prescriptions containing powdered drugs and the concentration of suspended particles in dispensaries. On the basis of the suspended particle concentrations measured, we concluded that dust collectors were effective in these dispensaries. However, suspended drug ingredients were detected also in dispensaries with dust collectors. These results suggest that the drug dust control systems of individual dispensaries should be properly installed and managed.

Completeness assessment of type II active pharmaceutical ingredient drug master files under generic drug user fee amendment: review metrics and common incomplete items.

PubMed

Zhang, Huyi; Li, Haitao; Song, Wei; Shen, Diandian; Skanchy, David; Shen, Kun; Lionberger, Robert A; Rosencrance, Susan M; Yu, Lawrence X

2014-09-01

Under the Generic Drug User Fee Amendments (GDUFA) of 2012, Type II active pharmaceutical ingredient (API) drug master files (DMFs) must pay a user fee and pass a Completeness Assessment (CA) before they can be referenced in an Abbreviated New Drug Application (ANDA), ANDA amendment, or ANDA prior approval supplement (PAS). During the first year of GDUFA implementation, from October 1, 2012 to September 30, 2013, approximately 1,500 Type II API DMFs received at least one cycle of CA review and more than 1,100 Type II DMFs were deemed complete and published on FDA's "Available for Reference List". The data from CA reviews were analyzed for factors that influenced the CA review process and metrics, as well as the areas of DMF submissions which most frequently led to an incomplete CA status. The metrics analysis revealed that electronic DMFs appear to improve the completeness of submission and shorten both the review and response times. Utilizing the CA checklist to compile and proactively update the DMFs improves the chance for the DMFs to pass the CA in the first cycle. However, given that the majority of DMFs require at least two cycles of CA before being deemed complete, it is recommended that DMF fees are paid 6 months in advance of the ANDA submissions in order to avoid negatively impacting the filling status of the ANDAs.

21 CFR 358.760 - Labeling of permitted combinations of active ingredients for the control of dandruff.

Code of Federal Regulations, 2011 CFR

2011-04-01

... established in the statement of identity sections of the applicable OTC drug monographs. (1) Combinations of... ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this... established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use...

21 CFR 358.760 - Labeling of permitted combinations of active ingredients for the control of dandruff.

Code of Federal Regulations, 2010 CFR

2010-04-01

... established in the statement of identity sections of the applicable OTC drug monographs. (1) Combinations of... ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this... established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use...

Research Advances in the Intervention of Inflammation and Cancer by Active Ingredients of Traditional Chinese Medicine.

PubMed

Huang, Yinghong; Cai, Tiange; Xia, Xi; Cai, Y; Wu, Xiao Yu

2016-01-01

A large body of evidence has shown that inflammation and cancer are strongly related. Thus anti-inflammatory agents have been investigated for cancer prevention and treatment in preclinical and clinical studies, including the nonsteroidal anti-inflammatory drugs (NSAIDs) and traditional Chinese medicine (TCM). In TCM, there exist a wide range of biologically active substances, such as saponins, flavonoids, alkaloids, polysaccharides, polyphenols, phenylpropanoids, and quinones. Many of these active ingredients have been reported to inhibit inflammation, activate inflammatory immune response, and/or inhibit cancer cell proliferation and tumor growth. Given the potential role of inflammation in cancer initiation and progression, the inflammatory tumor microenvironment, the cross-talks between inflammatory and cancer cells, and multitargeting activities of some TCM compounds, we summarize the current knowledge on the anti-inflammatory and anti-cancer properties of ingredients of TCM together with their underlying mechanisms in an integrated way. We hope to provide a reliable basis and useful information for the development of new treatment strategies of inflammation and cancer comprehensively using TCM and their active ingredients.

[Several changes of Indocalamus leaf active ingredients contents].

PubMed

Su, Chun-hua; Liu, Guo-hua; Wang, Fu-sheng; Ding, Yu-long; Xue, Jian-hui

2011-09-01

In this paper, the leaves of Indocalamus herklotsii, Indocalamus decorus, and Indocalamus latifolius were collected from Nanjing in different seasons to study the seasonal changes of the total flavonoids, tea polyphenols, and soluble sugar contents in the leaves. There existed significant differences in the test active ingredients contents among the leaves of the three Indocalamus species. The leaf total flavonoids content of the three Indocalamus species in different seasons ranged in 1.7%-2.7%, being the highest for I. herklotsii and I. decorus in spring and for I. latifolius in winter. The leaf tea polyphenols content varied from 5.5% to 7.6%; and the leaf soluble sugar content was 1.0%-8.5%, with the maximum in spring. Within the three months after leaf unfolding, the active ingredients contents in I. herklotsii and I. decorus leaves increased with leaf age. The optimal period for harvesting Indocalamus leaves was from December to next March. Among the three Indocalamus species, I. latifolius had the highest contents of the three active ingredients in leaves, suggesting that I. latifolius had greater potential value in the utilization of its leaf active ingredients than the other two species.

21 CFR 201.117 - Inactive ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Inactive ingredients. 201.117 Section 201.117 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... drug that is ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient...

Choleretic Activity of Turmeric and its Active Ingredients.

PubMed

Wang, Yonglu; Wang, Liyao; Zhu, Xinyi; Wang, Dong; Li, Xueming

2016-07-01

Turmeric, a rhizome of Curcumin longa L. is widely used as both a spice and an herbal medicine. The traditional use of turmeric in gastroenterology is mainly based on its choleretic activity. The aim of this study is to determine the effects of turmeric on bile flow (BF) and total bile acids (TBAs) excretion in a bile fistula rat model after acute duodenal administration. A significant dose-dependent enhancement in both BF and TBAs was detected after treatment with the turmeric decoctions which suggested the choleretic activity was bile acid-dependent secretion. In order to direct the active group of compounds, aqueous (AE), ethyl acetate (EtOAc), and petroleum ether (PE) extracts were investigated. The EtOAc and PE extracts showing high effects were purified to locate the active ingredients. Three curcuminoids (curcumin, demethoxycurcumin, and bisdemethoxycurcumin) and 2 sesquiterpenes (bisacurone B and ar-turmerone) were isolated. It was found Bisacurone B was the most potent choleretic ingredient followed by ar-turmerone, bisdemethoxycurcumin demethoxycurcumin, and then curcumin. The amounts of the active ingredients were quantitatively analyzed by high-performance liquid chromatography. The EtOAc and PE extracts had high sesquiterpenes and curcuminoids content, while the AE extract had poor content of sesquiterpenes and curcuminoids which affected neither BF nor TBAs. Based on the results of multiple linear regression analysis, the content of BIS and TUR were dominant factors (P < 0.01) of controlling BL and TBAs in EtOAC and PE extracts. © 2016 Institute of Food Technologists®

Chemically-related Groups of Active Ingredients

EPA Pesticide Factsheets

Many pesticide active ingredients affect pests in similar ways, and we re-evaluate them together as a group. Groups include carbamate insecticides, neonicotinoids, organochlorines, organophosphates, pyrethrins, and pyrethroids.

Cholinesterase inhibitory activities of Apai-sa-le recipe and its ingredients.

PubMed

Senavong, Pimolvan; Sattaponpan, Chitsanucha; Silavat Suk-um; Itharat, Arunporn

2014-08-01

Acetylcholinesterase and butyrylcholoinesterase inhibitors are well-known drugs commonly used in the treatment ofAlzheimer's disease (AD) to improve cognitive function. These enzyme inhibitors were reported to be found in manyplants. Apai-sa-le recipe was a Thai tradition used as nootropic recipe and formerly claimed to improve memory. Therefore, it is interesting to investigate cholinesterase inhibitory activity ofthe recipe and its ingredients. To determine the whole recipe ofApai-sa-le and its ingredients for inhibitory effect on acetylcholinesterase (AChE) and human butyrylcholinesterase (BuChE) activities. Thirty grams of each plant and 181 grams of the whole recipe were separately extracted by 95% ethanol, after filtered the filtrate were evaporated and vacuum-dried at 45°C. By Elman method, the inhibitory activities of both enzymes were assessed. The volatile constituents ofeach extract were determined by GCMS. The constituents in the non- volatile extract were examined by TLC and the antioxidant activity was determined. Four plants exhibited specific BuChE inhibitor were Lepidium sativum Linn. (Ls), Piper nigrum L. (Pn), Angelica dahurica Benth (Ad) andAtractylodes lancea DC. (Al), which shown the lC50 of 5.59, 24.52, 73.23, 96.25 μg/ml, respectively whereas galantamine and the whole recipe showed IC50 of 0.59 and 236 μg/ml. Only Pn extract inhibited AChE at lCso of 25.46 μg/ml. By GCMS and TLC fingerprints revealed the main constituents in LS, Ad, Al andPn as apiol, cumialdehyde, furanodiene and piperine. Moreover nine plant extracts and the whole recipe showed antioxidant activity. Lepidium sativum Linn. (Ls) extract showed the most potency on BuChE inhibitory effect. Three ingredients and the whole recipe exhibited mild activity. Only Piper nigrum L demonstrated inhibition effect on both AChE and BuChE.

77 FR 48519 - Registration Applications for Pesticide Products Containing New Active Ingredients

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-14

... Pesticide Products Containing New Active Ingredients AGENCY: Environmental Protection Agency (EPA). ACTION... new active ingredients not included in any currently registered products pursuant to the provisions of... as follows to register pesticide products containing active ingredients not included in any...

Analysis of low active-pharmaceutical-ingredient signal drugs based on thin layer chromatography and surface-enhanced Raman spectroscopy.

PubMed

Li, Xiao; Chen, Hui; Zhu, Qingxia; Liu, Yan; Lu, Feng

2016-11-30

Active pharmaceutical ingredients (API) embedded in the excipients of the formula can usually be unravelled by normal Raman spectroscopy (NRS). However, more and more drugs with low API content and/or low Raman scattering coefficient were insensitive to NRS analysis, which was for the first time defined as Low API-Signal Drugs (LASIDs) in this paper. The NRS spectra of these LASIDs were similar to their dominant excipients' profiles, such as lactose, starch, microcrystalline cellulose (MCC), etc., and were classified into three types as such. 21 out of 100 kinds of drugs were screened as LASIDs and characterized further by Raman microscopic mapping. Accordingly, we proposed a tailored solution to the qualitation and quantitation problem of these LASIDs, using surface-enhanced Raman spectroscopic (SERS) detection on the thin layer chromatographic (TLC) plate both in situ and after-separation. Experimental conditions and parameters including TLC support matrix, SERS substrate, detection mode, similarity threshold, internal standard, etc., were optimized. All LASIDs were satisfactorily identified and the quantitation results agreed well with those of high performance liquid chromatography (HPLC). For some structural analogues of LASIDs, although they presented highly similar SERS spectra and were tough to distinguish even with Raman microscopic mapping, they could be successfully discriminated from each other by coupling SERS (with portable Raman spectrometer) with TLC. These results demonstrated that the proposed solution could be employed to detect the LASIDs with high accuracy and cost-effectiveness. Copyright © 2016 Elsevier B.V. All rights reserved.

Processed aconite root and its active ingredient neoline may alleviate oxaliplatin-induced peripheral neuropathic pain.

PubMed

Suzuki, Toshiaki; Miyamoto, Keisuke; Yokoyama, Naomi; Sugi, Mayuko; Kagioka, Akina; Kitao, Yuka; Adachi, Takumi; Ohsawa, Masahiro; Mizukami, Hajime; Makino, Toshiaki

2016-06-20

Processed aconite root (PA, the root of Aconitum carmichaeli, Ranunculaceae) is a crude drug used in traditional Chinese or Japanese kampo medicine to generate heat in the body and to treat pain associated with coldness. Oxaliplatin (L-OHP) is a platinum-based anticancer drug that frequently causes acute and chronic peripheral neuropathies, including cold and mechanical hyperalgesia. We investigated the effects of PA on L-OHP-induced peripheral neuropathies and identified the active ingredient within PA extract. L-OHP was intraperitoneally injected into mice, and PA boiled water extract was orally administered. Cold and mechanical hyperalgesia were evaluated using the acetone test and the von Frey filament method, respectively. Dorsal root ganglion (DRG) neurons were isolated from normal mice and cultured with L-OHP with or without PA extract. Cell viability and neurite elongation were evaluated. PA extract significantly attenuated cold and mechanical hyperalgesia induced by L-OHP in mice. In cultured DRG neurons, L-OHP reduced cell viability and neurite elongation in a dose-dependent manner. Treatment with PA extract significantly alleviated the L-OHP-induced reduction of neurite elongation, while the cytotoxicity of L-OHP was not affected. Using activity-guided fractionation, we isolated neoline from PA extract as the active ingredient. Neoline significantly alleviated L-OHP-induced reduction of neurite elongation in cultured DRG neurons in a concentration-dependent manner. Moreover, subcutaneous injection of neoline attenuated cold and mechanical hyperalgesia in L-OHP-treated mice. PA extract and neoline did not show sedation and motor impairment. The present study indicates that PA and its active ingredient neoline are promising agents to alleviate L-OHP-induced neuropathic pain. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

78 FR 75343 - Pesticide Products; Registration Applications for New Active Ingredients

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-11

...; Registration Applications for New Active Ingredients AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA has received several applications to register pesticide products containing active... products containing active ingredients not included in any currently registered pesticide products...

Active Pharmaceutical Ingredients and Aquatic Organisms

EPA Science Inventory

The presence of active pharmaceuticals ingredients (APIs) in aquatic systems in recent years has led to a burgeoning literature examining environmental occurrence, fate, effects, risk assessment, and treatability of these compounds. Although APIs have received much attention as ...

Pesticide Active Ingredients

Science.gov Websites

; Environment Human Health Animal Health Safe Use Practices Food Safety Environment Air Water Soil Wildlife Ingredients Low-Risk Pesticides Organic Pesticide Ingredients Pesticide Incidents Human Exposure Pet Exposure :00PM Pacific Time, Mon-Fri A B C D E F G H I J K L M N O P Q R S T U V W X Y Z A-Z Index Health &

Encapsulation of cosmetic active ingredients for topical application--a review.

PubMed

Casanova, Francisca; Santos, Lúcia

2016-02-01

Microencapsulation is finding increasing applications in cosmetics and personal care markets. This article provides an overall discussion on encapsulation of cosmetically active ingredients and encapsulation techniques for cosmetic and personal care products for topical applications. Some of the challenges are identified and critical aspects and future perspectives are addressed. Many cosmetics and personal care products contain biologically active substances that require encapsulation for increased stability of the active materials. The topical and transdermal delivery of active cosmetic ingredients requires effective, controlled and safe means of reaching the target site within the skin. Preservation of the active ingredients is also essential during formulation, storage and application of the final cosmetic product. Microencapsulation offers an ideal and unique carrier system for cosmetic active ingredients, as it has the potential to respond to all these requirements. The encapsulated agent can be released by several mechanisms, such as mechanical action, heat, diffusion, pH, biodegradation and dissolution. The selection of the encapsulation technique and shell material depends on the final application of the product, considering physical and chemical stability, concentration, required particle size, release mechanism and manufacturing costs.

Drugs@FDA: FDA Approved Drug Products

MedlinePlus

... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

Drugs and Diseases Interacting with Cigarette Smoking in US Prescription Drug Labelling.

PubMed

Li, Haibo; Shi, Qiang

2015-05-01

The US Food and Drug Administration (FDA) draft guidance for industry on drug interaction studies recommends, but does not mandate, that both cigarette smokers and non-smokers can be used to study drug metabolism in clinical trials, and that important results related to smoking should be included in drug labelling to guide medication usage. This study aimed to provide a comprehensive review of drugs or diseases interacting with smoking, as presented in all US drug labelling. The 62,857 drug labels deposited in the FDA Online Label Repository were searched using the keywords 'smoke', 'smoker(s)', 'smoking', 'tobacco' and 'cigarette(s)' on 19 June 2014. The resultant records were refined to include only human prescription drug labelling, for manual examination. For 188 single-active-ingredient drugs and 36 multiple-active-ingredient drugs, the labelling was found to contain smoking-related information. The pharmacokinetics of 29 and 21 single-active-ingredient drugs were affected and unaffected, respectively, by smoking. For the remaining drugs, the provided information related to smoking affecting efficacy, safety or diseases but not pharmacokinetics. Depending on the nature of specific drugs, the perturbation in pharmacokinetic parameters in smokers ranged from 13 to 500%, in comparison with non-smokers. Dosage modifications in smokers are necessary for four drugs and may be necessary for six drugs, but are unnecessary for seven drugs although the pharmacokinetic parameters of four of them are affected by smoking. Cigarette smoking is a risk factor for 16 types of diseases or adverse drug reactions. For one single-active-ingredient contraceptive drug and 10 multiple-active-ingredient contraceptive drugs, a black box warning (the FDA's strongest safety warning) is included in the labelling for increased risks of heart attacks and strokes in female smokers, and "women are strongly advised not to smoke" when using these drugs. This study presents the first

High throughput screening of active pharmaceutical ingredients by UPLC.

PubMed

Al-Sayah, Mohammad A; Rizos, Panagiota; Antonucci, Vincent; Wu, Naijun

2008-07-01

Ultra performance LC (UPLC) was evaluated as an efficient screening approach to facilitate method development for drug candidates. Three stationary phases were screened: C-18, phenyl, and Shield RP 18 with column dimensions of 150 mm x 2.1 mm, 1.7 microm, which should theoretically generate 35,000 plates or 175% of the typical column plate count of a conventional 250 mm x 4.6 mm, 5 microm particle column. Thirteen different active pharmaceutical ingredients (APIs) were screened using this column set with a standardized mobile-phase gradient. The UPLC method selectivity results were compared to those obtained for these compounds via methods developed through laborious trial and error screening experiments using numerous conventional HPLC mobile and stationary phases. Peak capacity was compared for columns packed with 5 microm particles and columns packed with 1.7 microm particles. The impurities screened by UPLC were confirmed by LC/MS. The results demonstrate that simple, high efficiency UPLC gradients are a feasible and productive alternative to more conventional multiparametric chromatographic screening approaches for many compounds in the early stages of drug development.

21 CFR 701.3 - Designation of ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Designation of ingredients. 701.3 Section 701.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... such term as commonly understood by consumers. Where one or more ingredients is accepted by the Food...

21 CFR 701.3 - Designation of ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Designation of ingredients. 701.3 Section 701.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... such term as commonly understood by consumers. Where one or more ingredients is accepted by the Food...

21 CFR 701.3 - Designation of ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Designation of ingredients. 701.3 Section 701.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... such term as commonly understood by consumers. Where one or more ingredients is accepted by the Food...

Chinese single herbs and active ingredients for postmenopausal osteoporosis: From preclinical evidence to action mechanism.

PubMed

Lin, Jing; Zhu, Jun; Wang, Yan; Zhang, Na; Gober, Hans-Jürgen; Qiu, Xuemin; Li, Dajin; Wang, Ling

2017-01-01

Postmenopausal osteoporosis is a systemic metabolic skeletal disease generally ascribable to a dearth of estrogen. Whether traditional Chinese medicine is effective in management of postmenopausal osteoporosis remains unclear. This article reviews the experimental evidence of both in vitro and in vivo preclinical studies with the theme of the application of Chinese single herbs and active ingredients in postmenopausal osteoporosis. It includes three single herbs (Herba Epimedium, Rhizoma Drynariae, and Salvia miltiorrhiza) and eight active ingredients (saikosaponins, linarin, echinacoside, sweroside, psoralen, poncirin, vanillic acid, and osthole). The experimental studies indicated their potential use as treatment for postmenopausal osteoporosis and investigated the underlying mechanisms including osteoprotegerin/receptor activator of nuclear factor κB ligand (OPG/RANKL), extracellular-signal-regulated kinase/c-Jun N terminal kinase/mitogen-activated protein kinase (ERK/JNK/MAPK), estrogen receptor (ER), bone morphogenetic protein (BMP), transforming growth factor (TGF)-β, Wnt/β-catenin, and Notch signaling pathways. This review contributes to a better understanding of traditional Chinese medicine and provides useful information for the development of more effective anti-osteoporosis drugs.

HIM-herbal ingredients in-vivo metabolism database.

PubMed

Kang, Hong; Tang, Kailin; Liu, Qi; Sun, Yi; Huang, Qi; Zhu, Ruixin; Gao, Jun; Zhang, Duanfeng; Huang, Chenggang; Cao, Zhiwei

2013-05-31

Herbal medicine has long been viewed as a valuable asset for potential new drug discovery and herbal ingredients' metabolites, especially the in vivo metabolites were often found to gain better pharmacological, pharmacokinetic and even better safety profiles compared to their parent compounds. However, these herbal metabolite information is still scattered and waiting to be collected. HIM database manually collected so far the most comprehensive available in-vivo metabolism information for herbal active ingredients, as well as their corresponding bioactivity, organs and/or tissues distribution, toxicity, ADME and the clinical research profile. Currently HIM contains 361 ingredients and 1104 corresponding in-vivo metabolites from 673 reputable herbs. Tools of structural similarity, substructure search and Lipinski's Rule of Five are also provided. Various links were made to PubChem, PubMed, TCM-ID (Traditional Chinese Medicine Information database) and HIT (Herbal ingredients' targets databases). A curated database HIM is set up for the in vivo metabolites information of the active ingredients for Chinese herbs, together with their corresponding bioactivity, toxicity and ADME profile. HIM is freely accessible to academic researchers at http://www.bioinformatics.org.cn/.

78 FR 10167 - Pesticide Products; Registration Applications for a New Active Ingredient

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-13

...; Registration Applications for a New Active Ingredient AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA has received applications to register pesticide products containing an active... applications to register pesticide products containing an active ingredient not included in any currently...

The Cosmetic Ingredient Review Program-Expert Safety Assessments of Cosmetic Ingredients in an Open Forum.

PubMed

Boyer, Ivan J; Bergfeld, Wilma F; Heldreth, Bart; Fiume, Monice M; Gill, Lillian J

The Cosmetic Ingredient Review (CIR) is a nonprofit program to assess the safety of ingredients in personal care products in an open, unbiased, and expert manner. Cosmetic Ingredient Review was established in 1976 by the Personal Care Products Council (PCPC), with the support of the US Food and Drug Administration (USFDA) and the Consumer Federation of America (CFA). Cosmetic Ingredient Review remains the only scientific program in the world committed to the systematic, independent review of cosmetic ingredient safety in a public forum. Cosmetic Ingredient Review operates in accordance with procedures modeled after the USFDA process for reviewing over-the-counter drugs. Nine voting panel members are distinguished, such as medical professionals, scientists, and professors. Three nonvoting liaisons are designated by the USFDA, CFA, and PCPC to represent government, consumer, and industry, respectively. The annual rate of completing safety assessments accelerated from about 100 to more than 400 ingredients by implementing grouping and read-across strategies and other approaches. As of March 2017, CIR had reviewed 4,740 individual cosmetic ingredients, including 4,611 determined to be safe as used or safe with qualifications, 12 determined to be unsafe, and 117 ingredients for which the information is insufficient to determine safety. Examples of especially challenging safety assessments and issues are presented here, including botanicals. Cosmetic Ingredient Review continues to strengthen its program with the ongoing cooperation of the USFDA, CFA, the cosmetics industry, and everyone else interested in contributing to the process.

Authorization and Toxicity of Veterinary Drugs and Plant Protection Products: Residues of the Active Ingredients in Food and Feed and Toxicity Problems Related to Adjuvants

PubMed Central

Klátyik, Szandra; Bohus, Péter; Darvas, Béla; Székács, András

2017-01-01

Chemical substances applied in animal husbandry or veterinary medicine and in crop protection represent substantial environmental loads, and their residues occur in food and feed products. Product approval is governed differently in these two sectors in the European Union (EU), and the occurrence of veterinary drug (VD) and pesticide residues indicated by contamination notification cases in the Rapid Alert System for Food and Feed of the EU also show characteristic differences. While the initial high numbers of VD residues reported in 2002 were successfully suppressed to less than 100 cases annually by 2006 and on, the number of notification cases for pesticide residues showed a gradual increase from a low (approximately 50 cases annually) initial level until 2005 to more than 250 cases annually after 2009, with a halt occurring only in 2016. Main notifiers of VD residues include Germany, Belgium, the UK, and Italy (63, 59, 42, and 31 notifications announced, respectively), and main consigning countries of non-compliances are Vietnam, India, China, and Brazil (88, 50, 34, and 23 notifications, respectively). Thus, countries of South and Southeast Asia are considered a vulnerable point with regard to VD residues entering the EU market. Unintended side effects of VDs and plant protection products may be caused not only by the active ingredients but also by various additives in these preparations. Adjuvants (e.g., surfactants) and other co-formulants used in therapeutic agents and feed additives, as well as in pesticide formulations have long been considered as inactive ingredients in the aspects of the required main biological effect of the pharmaceutical or pesticide, and in turn, legal regulations of the approval and marketing of these additives specified significantly less stringent risk assessment requirements, than those specified for the active ingredients. However, numerous studies have shown additive, synergistic, or antagonistic side effects between the

Authorization and Toxicity of Veterinary Drugs and Plant Protection Products: Residues of the Active Ingredients in Food and Feed and Toxicity Problems Related to Adjuvants.

PubMed

Klátyik, Szandra; Bohus, Péter; Darvas, Béla; Székács, András

2017-01-01

Chemical substances applied in animal husbandry or veterinary medicine and in crop protection represent substantial environmental loads, and their residues occur in food and feed products. Product approval is governed differently in these two sectors in the European Union (EU), and the occurrence of veterinary drug (VD) and pesticide residues indicated by contamination notification cases in the Rapid Alert System for Food and Feed of the EU also show characteristic differences. While the initial high numbers of VD residues reported in 2002 were successfully suppressed to less than 100 cases annually by 2006 and on, the number of notification cases for pesticide residues showed a gradual increase from a low (approximately 50 cases annually) initial level until 2005 to more than 250 cases annually after 2009, with a halt occurring only in 2016. Main notifiers of VD residues include Germany, Belgium, the UK, and Italy (63, 59, 42, and 31 notifications announced, respectively), and main consigning countries of non-compliances are Vietnam, India, China, and Brazil (88, 50, 34, and 23 notifications, respectively). Thus, countries of South and Southeast Asia are considered a vulnerable point with regard to VD residues entering the EU market. Unintended side effects of VDs and plant protection products may be caused not only by the active ingredients but also by various additives in these preparations. Adjuvants (e.g., surfactants) and other co-formulants used in therapeutic agents and feed additives, as well as in pesticide formulations have long been considered as inactive ingredients in the aspects of the required main biological effect of the pharmaceutical or pesticide, and in turn, legal regulations of the approval and marketing of these additives specified significantly less stringent risk assessment requirements, than those specified for the active ingredients. However, numerous studies have shown additive, synergistic, or antagonistic side effects between the

Active ingredients from natural botanicals in the treatment of obesity.

PubMed

Zhang, W-L; Zhu, L; Jiang, J-G

2014-12-01

Obesity is considered as a chronic disease that can induce a series of comorbidities and complications. Chinese medicine has long clinical experiences in the treatment of obesity. This review summarizes the natural products from traditional Chinese medicine (TCM) that are reported to have anti-obesity effects in the past two decades. Botanic TCM comprises 90% of total Chinese crude drugs, and generally contains various active ingredients, in which the effective anti-obesity ingredients identified can be divided into saponins, polysaccharides, alkaloids, polyphenols and others. Astragaloside IV, glycyrrhizin, macrostemonoside A, berberine, betaine, capsaicin, matrine, methyl piperate, piperine, rutaecarpine, asimilobine, epigallocatechingallate, magnolol, resveratrol, soybean-isoflavone, α-linolenic acid, emodin, geniposide, phillyrin, salidroside and ursolic acid are specified in this review, and their sources, models, efficacy are described. It is concluded that the mechanisms of these components for the treatment of obesity include: (i) suppression of appetite, increase of satiety, reduction of energy intake; (ii) reduction in the digestion and absorption of exogenous lipid; (iii) attenuation of the synthesis of endogenous lipid; (iv) promotion of the oxidation and expenditure of lipid and (v) improvement of lipid metabolism disorder. Authors believe that the effective compounds from TCM will provide an alternative and hopeful way for the treatment of obesity. © 2014 World Obesity.

21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

Code of Federal Regulations, 2012 CFR

2012-04-01

... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and...

21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

Code of Federal Regulations, 2014 CFR

2014-04-01

... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and...

21 CFR 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as...

Code of Federal Regulations, 2013 CFR

2013-04-01

... offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. 310.527... products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and...

78 FR 70043 - Pesticide Product Registration; Receipt of an Application for a New Active Ingredient

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-22

...; Receipt of an Application for a New Active Ingredient AGENCY: Environmental Protection Agency (EPA... active ingredient not included in any previously registered pesticide product. Pursuant to the Federal... Application EPA has received an application to register a pesticide product containing an active ingredient...

Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

PubMed Central

Chollet, John L.; Jozwiakowski, Michael J.

2012-01-01

The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena®). Samples of API were obtained from every source confirmed to be an original manufacturer of the drug for human use, which were all companies in China that were not registered with FDA. Eight of the ten API samples (80%) did not meet the impurity specifications required by FDA for the API used in the approved product. One API sample was found to not be HPC at all; additional laboratory testing showed that it was glucose. Thirty samples of HPC injection obtained from com pounding pharmacies throughout the US were also tested, and eight of these samples (27%) failed to meet the potency requirement listed in the USP monograph for HPC injection and/or the HPLC assay. Sixteen of the thirty injection samples (53%) exceeded the impurity limit setforthe FDA-approved drug product. These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable. PMID:22329865

Role of herbal bioactives as a potential bioavailability enhancer for Active Pharmaceutical Ingredients.

PubMed

Ajazuddin; Alexander, Amit; Qureshi, Azra; Kumari, Leena; Vaishnav, Pramudita; Sharma, Mukesh; Saraf, Swarnlata; Saraf, Shailendra

2014-09-01

The current review emphasizes on the herbal bioenhancers which themselves do not possess inherent pharmacological activity of their own but when co-administered with Active Pharmaceutical Ingredients (API), enhances their bioavailability and efficacy. Herbal bioenhancers play a crucial role in enhancing the bioavailability and bioefficacy of different classes of drugs, such as antihypertensives, anticancer, antiviral, antitubercular and antifungal drugs at low doses. This paper highlights various natural compounds that can be utilized as an efficient bioenhancer. Several herbal compounds including piperine, quercetin, genistein, naringin, sinomenine, curcumin, and glycyrrhizin have demonstrated capability to improve the pharmacokinetic parameters of several potent API. This article also focuses on various United States patents on herbal bioenhancers, which has proved to be beneficial in improving oral absorption of nutraceuticals like vitamins, minerals, amino acids and certain herbal compounds. The present paper also describes proposed mechanism of action, which mainly includes absorption process, drug metabolism, and action on drug target. The herbal bioenhancers are easily available, safe, free from side effects, minimizes drug toxicity, shortens the duration of treatment, lowers the drug resistance problems and minimizes the cost of treatment. Inspite of the fact that herbal bioenhancers provide an innovative concept for enhancing the bioavailability of several potent drugs, there are numerous bioenhancers of herbal origin that are yet to be explored in several vital areas. These bioenhancers must also be implied to enhance the bioavailability and bioefficacy through routes other than the oral route of drug delivery. There is a vast array of unexploited plants which can be investigated for their drug bioenhancing potency. The toxicity profiles of these herbal bioenhancers must not be overlooked. Researches must be carried out to solve these issues and to

Improved properties of fine active pharmaceutical ingredient powder blends and tablets at high drug loading via dry particle coating.

PubMed

Kunnath, Kuriakose; Huang, Zhonghui; Chen, Liang; Zheng, Kai; Davé, Rajesh

2018-05-30

It has been shown that dry coating cohesive active pharmaceutical ingredients (APIs) with nano-silica can improve packing and flow of their blends, facilitating high speed direct compression tableting. This paper examines the broader scope and generality of previous work by examining three fine APIs; micronized Acetaminophen (mAPAP), coarse Acetaminophen (cAPAP) and micronized Ibuprofen (mIBU), and considers dry coating with both hydrophobic or hydrophilic nano-silica to examine the effect not only on packing density and flow of their blends, but also dissolution and tensile strength of their tablets. The impact of the excipient size on blend and tablet properties are also investigated, indicating blend flow is most improved when matching API particle size with excipient particle size. In all cases where the API is dry coated, the blend packing and flow improve, so as to suggest such high drug loaded blends could enable direct compression. Using dry coated API along with finer excipients in blends lead to improved hardness of the corresponding tablets. Interestingly, dissolution profiles show dry coated API tablets generally have faster dissolution rates, regardless of silica hydrophilicity, suggesting API powder deagglomeration via nano-silica coating plays a crucial role. The most significant conclusion is that, although there are differences in properties of blends that depend on the API, hydrophobic or hydrophilic nano-silica coating, as well as large or fine excipients, in all cases, dry coating of APIs significantly improves the possibility of using the specific blend at high drug loading in direct compression tableting. Copyright © 2018 Elsevier B.V. All rights reserved.

21 CFR 358.760 - Labeling of permitted combinations of active ingredients for the control of dandruff.

Code of Federal Regulations, 2013 CFR

2013-04-01

... control of dandruff and external analgesic active ingredients in § 358.720(b). The label states “dandruff...) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b). The labeling.... (1) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b...

21 CFR 358.760 - Labeling of permitted combinations of active ingredients for the control of dandruff.

Code of Federal Regulations, 2014 CFR

2014-04-01

... control of dandruff and external analgesic active ingredients in § 358.720(b). The label states “dandruff...) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b). The labeling.... (1) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b...

21 CFR 358.760 - Labeling of permitted combinations of active ingredients for the control of dandruff.

Code of Federal Regulations, 2012 CFR

2012-04-01

... control of dandruff and external analgesic active ingredients in § 358.720(b). The label states “dandruff...) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b). The labeling.... (1) Combinations of control of dandruff and external analgesic active ingredients in § 358.720(b...

Using Indices of Fidelity to Intervention Core Components to Identify Program Active Ingredients

ERIC Educational Resources Information Center

Abry, Tashia; Hulleman, Chris S.; Rimm-Kaufman, Sara E.

2015-01-01

Identifying the active ingredients of an intervention--intervention-specific components serving as key levers of change--is crucial for unpacking the intervention black box. Measures of intervention fidelity can be used to identify specific active ingredients, yet such applications are rare. We illustrate how fidelity measures can be used to…

Neotropics and natural ingredients for pharmaceuticals: why isn't South American biodiversity on the crest of the wave?

PubMed

Desmarchelier, Cristian

2010-06-01

Despite the advent of biotechnology and modern methods of combinatorial chemistry and rational drug design, nature still plays a surprisingly important role as a source of new pharmaceutical compounds. These are marketed either as herbal drugs or as single active ingredients. South American tropical ecosystems (or the Neotropics) encompass one-third of the botanical biodiversity of the planet. For centuries, indigenous peoples have been using plants for healing purposes, and scientists are making considerable efforts in order to validate these uses from a pharmacological/phytochemical point of view. However, and despite the unique plant diversity in the region, very few natural pharmaceutical ingredients from this part of the world have reached the markets in industrialized countries. The present review addresses the importance of single active ingredients and herbal drugs from South American flora as natural ingredients for pharmaceuticals; it highlights the most relevant cases in terms of species of interest; and discusses the key entry barriers for these products in industrialized countries. It explores the reasons why, in spite of the region's competitive advantages, South American biodiversity has been a poor source of natural ingredients for the pharmaceutical industry. (c) 2010 John Wiley & Sons, Ltd.

21 CFR 331.20 - Determination of percent contribution of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE Testing... ingredient equal to the amount present in a unit dose of the product into a 250-milliliter (mL) beaker. If wetting is desired, add not more than 5 mL of alcohol (neutralized to an apparent pH of 3.5), and mix to...

21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... active ingredients for cardiovascular-rheumatologic use. Combinations containing aspirin must meet the... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified...

21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... active ingredients for cardiovascular-rheumatologic use. Combinations containing aspirin must meet the... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified...

21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... active ingredients for cardiovascular-rheumatologic use. Combinations containing aspirin must meet the... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified...

21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... active ingredients for cardiovascular-rheumatologic use. Combinations containing aspirin must meet the... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified...

21 CFR 343.22 - Permitted combinations of active ingredients for cardiovascular-rheumatologic use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... active ingredients for cardiovascular-rheumatologic use. Combinations containing aspirin must meet the... permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified...

[New drugs for small animals in 2017].

PubMed

Emmerich, Ilka Ute

2018-04-01

In 2017 the active pharmaceutical ingredient Lokivetmab (Cytopoint®), a caninized anti-canine Interleukin 31 monoclonal antibody, was released on the German market for small animals. One substance was authorized for an additional species. Sarolaner, an ectoparasiticide of the isoxazoline group, is now authorized for use in combination with Selamectin (Stronghold® Plus) additionally for cats. The testosterone derivate Nandrolone (Nandrosol®) and the combination of the benzodiazepine Zolazepam with the "dissociative anesthetic" Tiletamine (Zoletil®) were once again authorized. Furthermore, two veterinary drugs with a new combination of active ingredients, one drug with a new active ingredient and two veterinary drugs with a new pharmaceutical form have been launched on the market for small animals. Schattauer GmbH.

Specific Chemical (Active Ingredient) Information

Science.gov Websites

; Environment Human Health Animal Health Safe Use Practices Food Safety Environment Air Water Soil Wildlife Ingredients Low-Risk Pesticides Organic Pesticide Ingredients Pesticide Incidents Human Exposure Pet Exposure :00PM Pacific Time, Mon-Fri A B C D E F G H I J K L M N O P Q R S T U V W X Y Z A-Z Index Health &

[New drugs for horses and production animals in 2017].

PubMed

Emmerich, Ilka Ute

2018-04-01

In 2017, no new active pharmaceutical ingredients were released on the German market for horses or food-producing animals. Four established veterinary active pharmaceutical ingredients became available for additional species: the ectoparasitic Fluralaner (Exzolt®) of the isoxazoline group was additionally authorized for chickens, the macrolide antibiotics Gamithromycin (Zactran®) and Tulathromycin (Draxxin®) for sheep and the nonsteroidal anti-inflammatory drug Tolfenamic Acid (Tolfedol®) from the fenamate group for cattle and pigs. Additionally, one drug with a new combination of active ingredients, one drug with a new pharmaceutical form and one drug with a new mode of administration have been launched on the market for horses and food-producing animals. Schattauer GmbH.

21 CFR 106.20 - Ingredient control.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis...

21 CFR 106.20 - Ingredient control.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis...

21 CFR 106.20 - Ingredient control.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis...

A systematic reactor design approach for the synthesis of active pharmaceutical ingredients.

PubMed

Emenike, Victor N; Schenkendorf, René; Krewer, Ulrike

2018-05-01

Today's highly competitive pharmaceutical industry is in dire need of an accelerated transition from the drug development phase to the drug production phase. At the heart of this transition are chemical reactors that facilitate the synthesis of active pharmaceutical ingredients (APIs) and whose design can affect subsequent processing steps. Inspired by this challenge, we present a model-based approach for systematic reactor design. The proposed concept is based on the elementary process functions (EPF) methodology to select an optimal reactor configuration from existing state-of-the-art reactor types or can possibly lead to the design of novel reactors. As a conceptual study, this work summarizes the essential steps in adapting the EPF approach to optimal reactor design problems in the field of API syntheses. Practically, the nucleophilic aromatic substitution of 2,4-difluoronitrobenzene was analyzed as a case study of pharmaceutical relevance. Here, a small-scale tubular coil reactor with controlled heating was identified as the optimal set-up reducing the residence time by 33% in comparison to literature values. Copyright © 2017 Elsevier B.V. All rights reserved.

21 CFR 106.20 - Ingredient control.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Ingredient control. 106.20 Section 106.20 Food and... CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES (Eff. until 7-10-14) Quality Control Procedures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106...

Theory-Based Active Ingredients of Effective Treatments for Substance Use Disorders

PubMed Central

Moos, Rudolf H.

2007-01-01

This paper describes four related theories that specify common social processes that protect individuals from developing substance use disorders and may underlie effective psychosocial treatments for these disorders: social control theory, behavioral economics and behavioral choice theory, social learning theory, and stress and coping theory. It then provides an overview of the rationale and evidence for four effective psychosocial treatments for substance use disorders: motivational interviewing and motivational enhancement therapy, 12-step facilitation treatment, cognitive-behavioral treatment and behavioral family counseling, and contingency management and community reinforcement approaches. The presumed active ingredients of these treatments are described in terms of how they exemplify the social processes highlighted by the four theories. The identified common components of effective treatment include support, goal direction, and structure; an emphasis on rewards that compete with substance use, a focus on abstinence-oriented norms and models, and attempts to develop self-efficacy and coping skills. Several issues that need to be addressed to enhance our understanding of the active ingredients involved in effective treatment are discussed, including how to develop measures of these ingredients, how well the ingredients predict outcomes and influence conceptually comparable aspects of clients’ life contexts, and how much their influence varies depending upon clients’ demographic and personal characteristics. PMID:17129682

Theory-based active ingredients of effective treatments for substance use disorders.

PubMed

Moos, Rudolf H

2007-05-11

This paper describes four related theories that specify common social processes that protect individuals from developing substance use disorders and may underlie effective psychosocial treatments for these disorders: social control theory, behavioral economics and behavioral choice theory, social learning theory, and stress and coping theory. It then provides an overview of the rationale and evidence for four effective psychosocial treatments for substance use disorders: motivational interviewing and motivational enhancement therapy, 12-step facilitation treatment, cognitive-behavioral treatment and behavioral family counseling, and contingency management and community reinforcement approaches. The presumed active ingredients of these treatments are described in terms of how they exemplify the social processes highlighted by the four theories. The identified common components of effective treatment include support, goal direction, and structure; an emphasis on rewards that compete with substance use, a focus on abstinence-oriented norms and models, and attempts to develop self-efficacy and coping skills. Several issues that need to be addressed to enhance our understanding of the active ingredients involved in effective treatment are discussed, including how to develop measures of these ingredients, how well the ingredients predict outcomes and influence conceptually comparable aspects of clients' life contexts, and how much their influence varies depending upon clients' demographic and personal characteristics.

A survey of the syntheses of active pharmaceutical ingredients for antiretroviral drug combinations critical to access in emerging nations.

PubMed

Pinheiro, Eloan Dos Santos; Antunes, Octavio Augusto Ceva; Fortunak, Joseph M D

2008-09-01

irrelevant, except for "advanced salvage" drugs such as enfuvirtide. In resource-poor settings cost is a huge factor that limits drug access, resulting in high rates of new infection and subsequent mortality. IP coverage, where granted, can keep access prices for essential ARVs higher than would otherwise be the case. Large, innovator companies have made drugs available at prices very close to the cost of manufacturing for "lowest income" countries. Generic providers in India and elsewhere provide the largest supply of drugs for the developing world. The recent issuance of Voluntary and Compulsory Licenses (VLs, CLs) through the World Trade Organization's TRIP (Treaty Respecting Intellectual Property) provisions arguably contribute to bringing down access prices. The utilization of improved science, pooled purchasing and intelligent procurement practices all definitely contribute to access. This work surveys the production processes for several critical ARVs. These are discussed in terms of scale up, raw material/intermediates and active pharmaceutical ingredient (API) costs. In some cases new routes to APIs or critical intermediates are needed. Based on potential new chemistries, there are significant opportunities to reduce cost for a number of critical ARVs.

Application of metabonomic strategy to discover an unreported active ingredient in LiuWeiDiHuang pills suppressing beta-glucuronidase.

PubMed

Xie, Baogang; Zhang, Zhirong; Gong, Tao; Zhang, Ningning; Wang, Huiyun; Zou, Huiqing

2015-01-01

Identification of the bioactive ingredient from traditional Chinese medicine (TCM) remains a challenging task by traditional approach that focuses on chemical isolation coupled with biological activity screening. Here, we present a metabonomics-based approach for bioactive ingredient discovery in LiuWeiDiHuang pills (LWPs). First, a non-targeted high-performance liquid chromatography ultraviolet (HPLC-UV) profiling of rat urine was used to discriminate urinary profiling intervened by LWPs. Orthogonal partial least-squares discriminant analysis (OPLS-DA) revealed that eight chromatographic peaks made a significant contribution to the classification of the LWPs group and the control group. Five of these chromatographic peaks were successfully isolated and identified as hippurate, genistein (GT), daidzein (DZ), and glucuronide conjugate of GT and that of DZ by mass spectroscopy (MS). Subsequently, we found that LWPs significantly decreased the activity of intestinal β-glucuronidase by 18 % and exerted a dose-dependent inhibitory effect on rat liver lysosomal fraction, suggesting that LWPs were a β-glucuronidase inhibitor. In the end, by inhibiting β-glucuronidase-guided isolation, D-glucaro-1,4-lactone, a previously unreported ingredient of LWPs, was identified by MS, MS/MS, and nuclear magnetic resonance spectroscopy. Our findings indicated that metabonomics might increase research productivity toward the drug targets and/or bioactive compounds from TCM.

PRN 96-8: Toxicologically Significant Levels of Pesticide Active Ingredients

EPA Pesticide Factsheets

This notice sets out EPA's interpretation of the term toxicologically significant as it applies to contaminants in pesticide products that are also pesticide active ingredients. It provides risk-based concentration levels of such contaminants.

21 CFR 331.11 - Listing of specific active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... contributing at least 25 percent of the total acid neutralizing capacity; maximum daily dosage limit is 8 grams...., 8 grams calcium carbonate). (e) Citrate-containing active ingredients: Citrate ion, as citric acid or salt; maximum daily dosage limit 8 grams. (f) Glycine (aminoacetic acid). (g) Magnesium-containing...

Antiviral Effects of Saffron and its Major Ingredients.

PubMed

Soleymani, Sepehr; Zabihollahi, Rezvan; Shahbazi, Sepideh; Bolhassani, Azam

2018-01-01

The lack of an effective vaccine against viral infections, toxicity of the synthetic anti-viral drugs and the generation of resistant viral strains led to discover novel inhibitors. Recently, saffron and its compounds were used to treat different pathological conditions. In this study, we tested the anti-HSV-1 and anti-HIV-1 activities of Iranian saffron extract and its major ingredients including crocin and picrocrocin as well as cytotoxicity in vitro. The data showed that the aqueous saffron extract was not active against HIV-1 and HSV-1 virions at certain doses (i.e., a mild activity), but crocin and picrocrocin indicated significant anti-HSV-1 and also anti-HIV-1 activities. Crocin inhibited the HSV replication at before and after entry of virions into Vero cells. Indeed, crocin carotenoid suppressed HSV penetration in the target cells as well as disturbed virus replication after entry into the cells. Picrocrocin was also effective for inhibiting virus entry and also its replication. This monoterpen aldehyde showed higher anti-HSV effects after virus penetrating in the cells. Generally, these sugar-containing compounds extracted from saffron showed to be effective antiherpetic drug candidates. The recent study is the first report suggesting antiviral activities for saffron extract and its major ingredients. Crocin and picrocrocin could be a promising anti-HSV and anti-HIV agent for herbal therapy against viral infections. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Acetylcholinesterase inhibitory activity of Thai traditional nootropic remedy and its herbal ingredients.

PubMed

Tappayuthpijarn, Pimolvan; Itharat, Arunporn; Makchuchit, Sunita

2011-12-01

The incidence of Alzheimer disease (AD) is increasing every year in accordance with the increasing of elderly population and could pose significant health problems in the future. The use of medicinal plants as an alternative prevention or even for a possible treatment of the AD is, therefore, becoming an interesting research issue. Acetylcholinesterase (AChE) inhibitors are well-known drugs commonly used in the treatment of AD. The aim of the present study was to screen for AChE inhibitory activity of the Thai traditional nootropic recipe and its herbal ingredients. The results showed that ethanolic extracts of four out of twenty-five herbs i.e. Stephania pierrei Diels. Kaempfera parviflora Wall. ex Baker, Stephania venosa (Blume) Spreng, Piper nigrum L at 0.1 mg/mL showed % AChE inhibition of 89, 64, 59, 50; the IC50 were 6, 21, 29, 30 microg/mL respectively. The other herbs as well as combination of the whole recipe had no synergistic inhibitory effect on AChE activity. However some plants revealed antioxidant activity. More research should have be performed on this local wisdom remedy to verify the uses in scientific term.

Experimental and density functional theory studies on benzalkonium ibuprofenate, a double active pharmaceutical ingredient.

PubMed

Safna Hussan, K P; Thayyil, M Shahin; Rajan, Vijisha K; Muraleedharan, K

2018-02-01

Molecular aspects of a double active pharmaceutical ingredient in ionic liquid form, benzalkonium ibuprofenate (BaIb), were studied using density functional theory (DFT/B3LYP/6-31+G (d, p)). A detailed discussion on optimized geometry, energy, heat and the enthalpy of BaIb was carried out. The computed vibrational results agree well with the experimental results. The stability and biological activity were compared to the parent drugs on the basis of global descriptive parameters. The electrophilic and nucleophilic sites were pointed out in the MESP structures well evidently. NBO analysis was also done to predict the relative aromaticity, delocalization effects and the contribution towards stabilization energy of the title compound. The information about non-covalent, non-ionic weak interaction between the cation and anion was obtained from the list of Mulliken charges and NBO analysis. Copyright © 2017 Elsevier Ltd. All rights reserved.

UPLC-MS/MS determination and gender-related pharmacokinetic study of five active ingredients in rat plasma after oral administration of Eucommia cortex extract.

PubMed

Hu, Fangdi; An, Jing; Li, Wen; Zhang, Zijia; Chen, Wenxia; Wang, Changhong; Wang, Zhengtao

2015-07-01

Eucommiae cortex (EC), the bark of Eucommia ulmoides Oliv., has been traditionally used to treat many diseases in China for more than 2000 years. The pharmacological effects are primarily attributed to the presence of lignans, iridoids and phenolics, which are main active ingredients in EC. First, to investigate the active ingredients that can be absorbed into the rat plasma according to which ingredients exhibit significant correlation of drug concentration-time curve. Second, to establish an efficient ultra-performance liquid chromatography/tandem mass spectrometry (UPLC-MS/MS) method for simultaneous determination of ingredients absorbed in rat plasma. Finally, to investigate gender effect on the pharmacokinetics of the ingredients absorbed in male and female rats plasma after oral administration with EC extract. 18 ingredients from EC were detected by UPLC-MS/MS, 9 out of 18 ingredients were absorbed into rat plasma. And 5 ingredients exhibit significant correlation of drug concentration-time curve. They were pinoresinol di-O-β-d-glucopyranoside (PDG), geniposide (GE), geniposidic acid (GA), aucubin (AN) and chlorogenic acid (CA). The analytes were extracted from rat plasma via a simple protein precipitation procedure and osalmid was used as the internal standard. Chromatographic separation was achieved on a Waters ACQUITY HSS T3 column (2.1mm×100mm, 1.8μm) using a gradient elution program with acetonitrile and 0.1% formic acid water as the mobile phase, with a flow rate of 0.3mLmin(-1). The detection was performed on a triple-quadrupole tandem mass spectrometer by multiple reactions monitoring (MRM) mode in a positive ion mode via electrospray ionization (ESI). The transition monitored were /z 683.00[M+H](+)→235.10 for PDG, / z 389.00[M+H](+)→208.80 for GE, m/z 375.00[M+H](+)→194.79 for GA, m/z 364.00[M+NH4](+)→148.81 for AN, m/z 355.10[M+H](+)→162.84 for CA and m/z 230.03[M+H](+)→120.77 for internal standard. The developed method showed good

Source characterization of nervous system active pharmaceutical ingredients in healthcare wastewaters

EPA Science Inventory

Nervous system active pharmaceutical ingredients (APIs), including anti-depressants and opioids, are important clinically administered pharmaceuticals within healthcare facilities. Concentrations and mass loadings of ten nervous system APIs and three nervous system API metaboli...

21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

Code of Federal Regulations, 2010 CFR

2010-04-01

... recognition of the safety and effectiveness of these or any other orally administered ingredients for OTC use... is required for marketing. In the absence of an approved application, such product is also misbranded...

40 CFR 152.114 - Approval of registration under FIFRA sec. 3(c)(7)-Products that contain a new active ingredient.

Code of Federal Regulations, 2013 CFR

2013-07-01

... sec. 3(c)(7)-Products that contain a new active ingredient. 152.114 Section 152.114 Protection of...)(7)—Products that contain a new active ingredient. An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for a...

40 CFR 152.114 - Approval of registration under FIFRA sec. 3(c)(7)-Products that contain a new active ingredient.

Code of Federal Regulations, 2010 CFR

2010-07-01

... sec. 3(c)(7)-Products that contain a new active ingredient. 152.114 Section 152.114 Protection of...)(7)—Products that contain a new active ingredient. An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for a...

Regulatory requirements for genotoxicity assessment of plant protection product active ingredients, impurities, and metabolites.

PubMed

Booth, Ewan D; Rawlinson, Paul J; Maria Fagundes, Priscila; Leiner, Kevin A

2017-06-01

Active ingredients in plant protection products are subject to rigorous safety assessment during their development, including assessment of genotoxicity. Plant protection products are used for agriculture in multiple regions and for the registration of active ingredients it is necessary to satisfy the data requirements of these different regions. There are no overarching global agreements on which genotoxicity studies need to be conducted to satisfy the majority of regulatory authorities. The implementation of new OECD guidelines for the in vitro micronucleus, transgenic rodent somatic and germ cell gene mutation and in vivo comet assays, as well as the revision of a number of other OECD test guidelines has resulted in some changes to data requirements. This review describes the genotoxicity data requirements for chemical active ingredients as well as biologicals, microbials, ground water metabolites, metabolites, and impurities in a number of regions. Similarities and differences are highlighted. Environ. Mol. Mutagen. 58:325-344, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Equivalence studies for complex active ingredients and dosage forms.

PubMed

Bhattycharyya, Lokesh; Dabbah, Roger; Hauck, Walter; Sheinin, Eric; Yeoman, Lynn; Williams, Roger

2005-11-17

This article examines the United States Pharmacopeia (USP) and its role in assessing the equivalence and inequivalence of biological and biotechnological drug substances and products-a role USP has played since its founding in 1820. A public monograph in the United States Pharmacopeia-National Formulary helps practitioners and other interested parties understand how an article's strength, quality, and purity should be controlled. Such a monograph is a standard to which all manufactured ingredients and products should conform, and it is a starting point for subsequent-entry manufacturers, recognizing that substantial additional one-time characterization studies may be needed to document equivalence. Review of these studies is the province of the regulatory agency, but compendial tests can provide clarity and guidance in the process.

Anti-bacteria Effect of Active Ingredients of Cacumen Platycladi on the Spoilage Bacteria of Sauced Pork Head Meat

NASA Astrophysics Data System (ADS)

Li, Xiao; Xu, Lingyi; Cui, Yuqian; Pang, Meixia; Wang, Fang; Qi, Jinghua

2017-12-01

Extraction and anti-bacteria effect of active ingredients of Cacumen Platycladi were studied in this paper. Extraction combined with ultrasonic was adopted. The optimum extraction condition was determined by single factor test; the anti-bacteria effect of active ingredients and minimum inhibitory concentration(MIC) were valued by Oxford-cup method. The results indicated that kaempferol was the active ingredients of Cacumen Platycladi whose optimum extraction condition for ethanol concentrations were sixty-five percent and twenty minutes with ultrasonic assisted extraction.; the active ingredients of Cacumen Platycladi had anti-bacteria effect on Staphylococcus, Proteus, Bacillus, Serratia and MIC was 0.5 g/mL,0.5 g/mL,0.0313 g/mL and 0.0625 g/mL. The active constituent of Cacumen Platycladi is kaempferol which has obvious anti-bacteria effect and can be used to prolong the shelf-life of Low-temperature meat products.

Estimation of dietary supplements intake in a selected group of women over 50 and the risk assessment of interactions between the ingredients of dietary supplements and drugs

PubMed

Sadowska, Joanna; Bruszkowska, Magda

Concurrent use of dietary supplements and drugs may result in complications of pharmacotherapy due to possible interactions between their ingredients. The aim of the survey was to estimate the intake of dietary supplements in a group of women over 50 and to analyse the risk of interactions between the ingredients of dietary supplements and drugs taken by the women. The study was carried out among 146 women over 50 years of age. Questionnaire included detailed questions on the type of prescription drugs, OTC (over-the-counter) drugs, and dietary supplements taken. The risk of interactions was determined on the basis of chemical composition of the drugs and supplements specified by the manufacturer, by comparing the obtained data with literature reports on known interactions. The analysis has shown that 88.4% of respondents constantly took prescription drugs, 44.5% of them took OTC drugs, and 66.4% of respondents took dietary supplements throughout the survey period. It has been found that 71.3% of surveyed women taking prescription drugs, took dietary supplements as well. Among women taking supplements and drugs, 36.9% of respondents were taking them concurrently, 60.9% kept such an interval, but only 21.8% of them waited for at least two hours. It has been found that the drug-supplement interactions might occur in 35.8% women under the survey. The analysis of the obtained results has revealed that taking dietary supplements by the group under survey was frequent, and the risk of interactions between dietary supplements and drugs was significant. It is recommended that doctors ask their patients about taken supplements during regular check-ups, and inform them about possible interactions between dietary supplements and drugs. Moreover, appropriate would be to change the labelling of dietary supplements, so that the packaging provides information on possible interactions between their ingredients and drugs.

Development of new polysilsesquioxane spherical particles as stabilized active ingredients for sunscreens

NASA Astrophysics Data System (ADS)

Tolbert, Stephanie Helene

Healthy skin is a sign of positive self-worth, attractiveness and vitality. Compromises to this are frequently caused by extended periods of recreation in the sun and in turn exposure to the harmful effects of UV radiation. To maintain strength and integrity, protection of the skin is paramount. This can be achieved by implementing skin-care products which contain sunscreen active ingredients that provide UV protection. Unfortunately, photo-degradation, toxicity, and photo-allergies limit the effectiveness of present day sunscreen ingredients. Currently, this is moderated by physically embedding within inert silica particles, but leaching of the active ingredient can occur, thereby negating protective efforts. Alternatively, this research details the preparation and investigation of bridged silsesquioxane analogues of commercial ingredients which can be chemically grafted to the silica matrix. Studies with bridged salicylate particles detail facile preparation, minimized leaching, and enhanced UV stability over physically encapsulated and pendant salicylate counterparts. In terms of UVB protective ability, the highest maintenance of sun protection factor (SPF) after extended UV exposure was achieved with bridged incorporation, and has been attributed to corollary UV stability. Additionally, bridged salicylate particles can be classified as broad-spectrum, and rate from moderate to good in terms of UVA protective ability. Particles incorporated with a bridged curcuminoid silsesquioxane were also prepared and displayed comparable results. As such, an attractive method for sunscreen isolation and stabilization has been developed to eliminate the problems associated with current sunscreens, all while maintaining the established UV absorbance profiles of the parent compound. To appreciate the technology utilized in this research, a thorough understanding of sol-gel science as it pertains to hybrid organic/silica particles, including methods of organic fragment

78 FR 72838 - Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503B...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-04

... represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include...

21 CFR 700.15 - Use of certain halogenated salicylanilides as ingredients in cosmetic products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ingredients in cosmetic products. 700.15 Section 700.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS GENERAL Requirements for Specific Cosmetic Products § 700.15 Use of certain halogenated salicylanilides as ingredients in cosmetic products. (a...

21 CFR 700.15 - Use of certain halogenated salicylanilides as ingredients in cosmetic products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ingredients in cosmetic products. 700.15 Section 700.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS GENERAL Requirements for Specific Cosmetic Products § 700.15 Use of certain halogenated salicylanilides as ingredients in cosmetic products. (a...

21 CFR 700.15 - Use of certain halogenated salicylanilides as ingredients in cosmetic products.