IN VITRO EQUIVALENCE STUDY OF GENERIC METFORMIN HYDROCHLORIDE TABLETS UNDER BIOWAIVER CONDITIONS

Authors

Ruaa H. AL Arwadi, Pharm D, Faculty of Pharmacy, Beirut Arab University, Beirut, LebanonFollow
Azza A. K. Gazy, Professor of Pharmaceutical Analytical Chemistry and Drug Quality Control, Faculty of Pharmacy, Beirut Arab University, Beirut, LebanonFollow
Lama Soubra, Associate Professor of Toxicology and Risk Assessment, Faculty of Pharmacy, Beirut Arab University, Beirut, LebanonFollow
Rola D. Ajami, Pharm D, Faculty of Pharmacy, Beirut Arab University, Beirut, LebanonFollow

Keywords

dissolution; metformin; tablet; Quality control of tablets; Pharmaceutical equivalence

Disciplines

Architecture | Business | Life Sciences | Medicine and Health Sciences

Abstract

Background: Generic drugs are smarter alternative to expensive brands, it is bio- equivalent formula of any branded drug. FDA approved that generic drugs are the safest to consume, the medicines meet the similar manufacturing standards followed while producing an innovator drug, however, the color, shape, taste and packaging of generics is different from the innovator product. In short, a generic drug should be bioequivalent to its brand counterpart. Metformin was initially marketed under the name of Glucophage®, and now the market is loaded by generics of different origin, and price variability. Method: Our study was conducted to determine whether metformin generics are bioequivalent to the innovator drug Glucophage®. In-vitro bioequivalence testing under Biowaiver conditions can predict bioequivalence in a safe, fast, and less expensive method. Thus, study was performed on Metformin tablets to assess whether generics are bioequivalent to the innovator and hence be interchangeable. Results: The quality control results of the thickness, hardness, friability, disintegration, weight uniformity, content uniformity, and assay showed that most metformin tablets complied with the USP 34 NF29 2011 specifications. Dissolution testing under biowaiver conditions showed different results. All tablets of the generics and innovator Glucophage® were able to dissolve by more than 85% within 15 min. Two generics were bioequivalent to the innovator Glucophage® having f2≥ 50 in the three dissolution media. The rest of generics showed variable results. Conclusion: Generics of metformin varied in their bioequivalency to the innovator Gluocophage®. This variation could be explained by different excipients, and manufacturing conditions. In-vivo bioequivalence testing should be conducted to confirm that the innovator could be safely interchangeable with the brand and this variation won’t affect the safety and efficacy of the drug.

Recommended Citation

H. AL Arwadi, Ruaa; A. K. Gazy, Azza; Soubra, Lama; and D. Ajami, Rola (2020) "IN VITRO EQUIVALENCE STUDY OF GENERIC METFORMIN HYDROCHLORIDE TABLETS UNDER BIOWAIVER CONDITIONS," BAU Journal - Health and Wellbeing: Vol. 2: Iss. 2, Article 1.
DOI: https://doi.org/10.54729/2789-8288.1033