DESIGN, DEVELOPMENT AND EVALUATION OF ALOGLIPTIN AND METFORMIN HYDROCHLORIDE BILAYER TABLET

Abstract

The objective of the present work was to formulate and evaluate bilayer tablets of alogliptin and metformin HCl. Combining alogliptin with metformin HCL gives additional benefits in comparison with either drug alone and could be considered for patients whose quality of life is impaired by diabetes mellitus. The study was performed to design bilayer tablets of alogliptin immediate release layer and metformin HCl sustained release layer by wet granulation method. The immediate release layer comprised Crospovidone superdisintegrant and sustained release layer comprised HPMC K4M as rate release controlling polymers and PVPK30 was used as binder for both layers. The in vitro release of drug from the formulations was studied in 0.1N HCl acidic buffer and pH 6.8 phosphate buffer, and it was found that the prepared sustained release layer tablets were able to sustain the release of the drug up to 12 h and in vitro studies of alogliptin shown more than 80% of drug was released within 30 min. As per ICH guidelines, accelerated stability studies were carried out and results were found within the range. The release of alogliptin follows a zero order release model and the release of metformin HCl follows Higuchi model release.