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


OBJECTIVE
To investigate the quality of five different marketed generic omeprazole delayed-release capsules.


METHODS
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.
Moore
Terry
T
Office of Testing and Research, Division of Pharmaceutical Analysis, Food and Drug Administration, St. Louis, MO 63101, USA. terry.moore@fda.hhs.gov
Smith
Anjanette
A
Ye
Wei
W
Toler
Duckhee Y
DY
Westenberger
Benjamin J
BJ
Lionberger
Robert
R
Raw
Andre
A
Yu
Lawrence
L
Buhse
Lucinda F
LF
D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000592:standards; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D017277:Drug Approval; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000592:standards; D009853:Omeprazole / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000592:standards; D010602:Pharmacopoeias as Topic; D012995:Solubility; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
D000897:Anti-Ulcer Agents; D002214:Capsules; D003692:Delayed-Action Preparations; D016568:Drugs, Generic; D009853:Omeprazole