Assessment of the pharmaceutical quality of omeprazole capsule brands marketed in Egypt.
The pharmaceutical quality of 7 local omeprazole capsule brands in Egypt was assessed relative to the proprietary product (Losec). Drug content, content uniformity, drug release (using USP test for enteric coated articles and a modified release test) were determined. Products were subjected to a 3-month stability study. Of the 7 brands, 6 had satisfactory drug content and content uniformity. All brands passed the USP drug release test. The modified release test proved to be more discriminative. After 3 months storage, drug content of 3 brands remained > 90% and 2 of these brands maintained drug release above 75%. Changes in pellet appearance during storage were indicative of omeprazole chemical degradation.
El-Sayed
A
A
Department of Pharmaceutics, Faculty of Pharmacy, University of Alexandria, Alexandria, Egypt.
Boraie
N A
NA
Ismail
F A
FA
El-Khordagui
L K
LK
Khalil
S A
SA
D000704:Analysis of Variance; D000897:Anti-Ulcer Agents / Q000737:chemistry / Q000191:economics / Q000592:standards* / Q000600:supply & distribution; D001682:Biological Availability; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D016527:Drug Costs / Q000706:statistics & numerical data; D004349:Drug Packaging / Q000592:standards; D004355:Drug Stability; D004356:Drug Storage; D004335:Drug and Narcotic Control; D004534:Egypt; D006801:Humans; D006813:Humidity; D006863:Hydrogen-Ion Concentration; D009853:Omeprazole / Q000737:chemistry / Q000191:economics / Q000592:standards* / Q000600:supply & distribution; D011358:Product Surveillance, Postmarketing; D012995:Solubility; D013608:Tablets, Enteric-Coated / Q000737:chemistry / Q000592:standards / Q000600:supply & distribution; D013997:Time Factors
D000897:Anti-Ulcer Agents; D002214:Capsules; D013608:Tablets, Enteric-Coated; D009853:Omeprazole