FORMULATION DESIGN OF EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS: OPTIMIZATION OF FORMULATION USING STATISTICAL EXPERIMENTAL DESIGN

The objective of the present study was to develop Empagliflozin and Metformin hydrochloride extended release tablets, comprising immediate release empagliflozin and extended release metformin hydrochloride in a single tablet. Wet granulation process was employed to develop extended release part metformin hydrochloride. Impact of various formulation variables in extended release part was assessed using statistical interpretation such as analysis of variance. A 3² (two factor, three level) factorial design was employed to study the effect of independent variables (binder concentration [sodium CMC] and ER polymer [HPMC K100M CR/polyethylene oxide/carbopol] concentration)on dependent variables (drug release at 1, 4 and 10h). Optimization was done by fitting experimental data to the software program (design expert). The design space for formulation variables and its influence on drug release was developed. In-vitro release data observed from the optimized formulation was fitted into various kinetic equations. Extended release part drug release was extended for 12 h following zero order kinetics and non-fickian diffusion process. Extended drug delivery system of empagliflozin and metformin hydrochloride extended release tablets was successfully developed by employing granulation technology and formulation optimization facilitated by experimental design.