Metformin hydrochloride delayed release tablets – a comparative dissolution profiles study
1 Pharmacy School, Universidad Latina of Costa Rica, San José, Costa Rica.
2 Faculty of Pharmacy, University of Costa Rica, San José, Costa Rica.
Research Article
GSC Biological and Pharmaceutical Sciences, 2019, 08(02), 113-118.
Article DOI: 10.30574/gscbps.2019.8.2.0119
Publication history:
Received on 05 July 2019; revised on 26 August 2019; accepted on 30 August 2019
Abstract:
Multisource or generic drugs represent an important decrease in treatment cost for multiple diseases, which improves patient’s medicine access. However, the therapeutic equivalence between original drugs (innovator) and generic or multisource drugs need to be demonstrated. Bioequivalence represents drug efficacy and higher security for patients, and it is considered as a fundamental factor for product commercialization. This work main objective was to make a comparison between the dissolution profiles of the original and multisource metformin hydrochloride tablets commercialized in Costa Rica. We used a validated analytical method to quantify metformin in dissolution medium, a phosphates buffered solution of pH (6.8 ± 0.05). The obtained results demonstrated products interchangeability using the model-independent similarity factor (f2) and difference factor (f1) criteria.
Keywords:
Metformin hydrochloride; Dissolution profiles; Multisource drugs; Tablets
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Copyright information:
Copyright © 2019 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
