NDLI: Generic omeprazole delayed-release capsules: in vitro performance evaluations.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Moore, Terry Smith, Anjanette Ye, Wei Toler, Duckhee Y. Westenberger, Benjamin J. Lionberger, Robert Raw, Andre Yu, Lawrence Buhse, Lucinda F.
Spatial Coverage	United States
Description	Country affiliation: United States Author Affiliation: Moore T ( Office of Testing and Research, Division of Pharmaceutical Analysis, Food and Drug Administration, St. Louis, MO 63101, USA. terry.moore@fda.hhs.gov)
Abstract	BACKGROUND: After the patent on omeprazole delayed-release capsules expired, Food and Drug Administration (FDA) approved several generic omeprazole delayed-release capsule applications. FDA has received some complaints concerning a lack of therapeutic effect of the generic omeprazole delayed-release capsules. AIM: To investigate the quality of five different marketed generic omeprazole delayed-release capsules. METHOD: The dissolution characteristics of these generic omeprazole delayed-release capsules were determined according to the United States Pharmacopeia (USP). Additional dissolution studies under simulated in vivo physiological conditions were also conducted to determine whether generic omeprazole capsules would perform similarly under these conditions. RESULTS: The experimental data show that all the generic omeprazole delayed-release capsules met the USP standards. The in vitro dissolution of generic drugs is similar to that of the brand omeprazole product. CONCLUSIONS: There is no scientific evidence to support the claims that the generic omeprazole delayed-release capsules perform differently from the brand omeprazole product in vitro.
File Format	HTM / HTML
ISSN	03639045
Issue Number	8
Volume Number	35
e-ISSN	15205762
Journal	Drug Development and Industrial Pharmacy
Language	English
Publisher	Taylor & Francis
Publisher Date	2009-08-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Anti-ulcer Agents Administration & Dosage Drugs, Generic Omeprazole Pharmacokinetics Standards Capsules Chemistry, Pharmaceutical Delayed-action Preparations Drug Approval Pharmacopoeias As Topic Solubility Therapeutic Equivalency United States United States Food And Drug Administration Comparative Study Journal Article
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Drug Discovery Pharmacology Pharmaceutical Science

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