PHARMACEUTICAL QUALITY OF GENERIC SITAGLIPTIN TABLETS COMPARED WITH JANUVIA®
Nebal Betari, Samer Haidar
Faculty of pharmacy, Damascus University, 17 April street, Damascus, Syria.
Keywords: Sitagliptin, Januvia, Pharmaceutical quality, f1, f2 factors, dissolution profile.
Sitagliptin is relatively new hypoglycemic agent. Several generic products are available in the Middle East. However, their pharmaceutical quality which affect safety and efficacy is unknown. Hence, prescribing of some generic products may lead to serious consequences. Januvia tablets were used as reference to determine the quality of five commercial brands of Sitagliptin selected from different Middle East commercial brands. Weight variations, content uniformity, friability, disintegration and dissolution profile were compared. All tested generics of Sitagliptin were complied with the specific requirements for quality control tests of the United State Pharmacopeia 31, whereas the result of two product were not similar to Januvia in dissolution profile, no significant differences in the results of weight variations, content uniformity, friability, disintegration. Differences in dissolution profile are due to the differences in formulations so It can be assumed that most of Sitagliptin generic products are as therapeutically effective as Januvia.
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