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.
Abstract

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.

Article Information

Identifiers and Pagination:
Year:2014
Volume:6
First Page:172
Last Page:178
Publisher Id:JAppPharm (2014 ). 6:3. 172-178
Article History:
Received:February 05, 2014
Accepted:February 12, 2014
Collection year:2014
First Published:April 1, 2014


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Editor in Chief
Prof. Dr. Cornelia M. Keck (Philipps-Universität Marburg)
Marburg, Germany

Bibliography

Welcome to the research group of Prof. Dr. Cornelia M. Keck in Marburg. Cornelia M. Keck is a pharmacist and obtained her PhD in 2006 from the Freie Universität (FU) in Berlin. In 2009 she was appointed as Adjunct Professor for Pharmaceutical and Nutritional Nanotechnology at the University Putra Malaysia (UPM) and in 2011 she obtained her Venia legendi (Habilitation) at the Freie Universität Berlin and was appointed as a Professor for Pharmacology and Pharmaceutics at the University of Applied Sciences Kaiserslautern. Since 2016 she is Professor of Pharmaceutics and Biopharmaceutics at the Philipps-Universität Marburg. Her field of research is the development and characterization of innovative nanocarriers for improved delivery of poorly soluble actives for healthcare and cosmetics. Prof. Keck is executive board member of the German Association of Nanotechnology (Deutscher Verband Nanotechnologie), Vize-chairman of the unit „Dermocosmetics“ at the German Society of Dermopharmacy, active member in many pharmaceutical societies and member of the BfR Committee for Cosmetics at the Federal Institute for Risk Assessment (BfR).

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