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ABSTRACT
Purpose: In recent times, Omeprazole a proton pump inhibitor has fast become part of the first line therapy drugs for the treatment of peptic ulcer disease. This has led to the introduction of numerous generic brands into the market and subsequently an increase in production of substandard drugs. Omeprazole is acid labile hence is formulated as enteric coated pellets. This study aims to assess the pharmaceutical quality of various brands of Omeprazole capsule in the Nigerian drug market. Method: Organoleptic and physicochemical properties of ten (10) generic brands of Omeprazole capsules were assessed according to official standards. Quality assurance tests such as weight uniformity test, disintegration time test, drug content assay, and dissolution test were carried out. A double dissolution medium consisting of 0.1 N HCl for 1 hour and Phosphate buffer pH 6.8 for 2 hours was used. Result: Capsules tested were suitably packaged, with capsule shells containing evenly coloured white pellets. All capsules were slightly soluble in water, sparingly soluble in ethanol, and readily dissolved in alkali medium. Of the 10 brands tested, 100% (n=10) met the BP specification for weight uniformity. All capsules had a drug content within 90 – 110%, and an average disintegration time of less than 15 minutes. They failed to release the drug when tested in acidic medium for 1 hour but released more than 75% in 40 minutes when tested in phosphate buffer pH 6.8. Conclusion: Tested brands all passed the pharmacopeia tests for capsule analysis. They are bioequivalent and can be used interchangeably. The study also showed that majority of Omeprazole brands marketed in Nigeria are imported from foreign countries, hence the need arises for regular post marketing analysis of imported drugs in the Nigerian market by regulatory agencies.
