Author/Authors :
El-Sayed, A. University of Alexandria - Faculty of Pharmacy - Department of Pharmaceutics, Egypt , Boraie, N.A. University of Alexandria - Faculty of Pharmacy - Department of Pharmaceutics, Egypt , Ismail, F.A. University of Alexandria - Faculty of Pharmacy - Department of Pharmaceutics, Egypt , El-Khordagui, L.K. University of Alexandria - Faculty of Pharmacy - Department of Pharmaceutics, Egypt , Khalil, S.A. University of Alexandria - Faculty of Pharmacy - Department of Pharmaceutics, Egypt
Abstract :
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.
