Metformin hydrochloride delayed release tablets – a comparative dissolution profiles study

Autor: Rolando Vargas-Zúñiga, German Leonardo Madrigal-Redondo, Joselyn Bogantes-Molina, Marianela Chavarría-Rojas, Daniel Alejandro Acuña-Amador, Lorena Berrocal-Barrantes
Rok vydání: 2019
Předmět:
Zdroj: GSC Biological and Pharmaceutical Sciences. 8:113-118
ISSN: 2581-3250
DOI: 10.30574/gscbps.2019.8.2.0119
Popis: 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.
Databáze: OpenAIRE