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Drug Dev Ind Pharm. 2009 Aug;35(8):917-21. doi: 10.1080/03639040802698802.

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

Author information

  • 1Office 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.

PMID:
19555236
[PubMed - indexed for MEDLINE]
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