Abstract

COMPARATIVE INVIVO EVALUATION OF FIXED DOSE COMBINATION ANTI-DIABETIC FORMULATION AND RESPECTIVE INDIVIDUAL DRUGS

Rajarao Chinta* and Rohini P.

Abstract

Empagliflozin, Linagliptin and Metformin hydrochloride Extended Release tablets are indicated for the treatment of Type 2 diabetes mellitus. Fixed Dose Combination product Empagliflozin, Linagliptin and Metformin hydrochloride Extended Release tablets was successfully developed by using bi-layer tablets technology. The aim of the present study was to evaluate and compare in vivo pharmacokinetic parameters of fixed dose combination anti-diabetic formulation and respective individual drugs using rabbits as animal model. Blood samples were collected at 0, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 h. The pharmacokinetic data was subjected to t-test and very significant differences (p<0.05) were noticed for Tmax, Cmax, AUC and MRT. From the obtained results, it was observed that the IR part (Empagliflozin, Linagliptin) plasma concentrations were comparable to respective individual reference drug solutions and ER part (Metformin hydrochloride) exhibited in better extension of the plasma concentration compared to Metformin hydrochloride reference solution.

Keywords: Empagliflozin, Linagliptin, Metformin hydrochloride, Pharmacokinetics, Animal models.