FORMULATION AND EVALUATION OF METFORMIN HYDROCHLORIDE AND GLICLAZIDE SUSTAINED RELEASE BILAYER TABLETS: A COMBINATION THERAPY IN MANAGEMENT OF DIABETES

RAJESWARI ALETI; SRINIVASA RAO BARATAM; BANGARUTHALLI JAGIRAPU; SRAVYA KUDAMALA

doi:10.22159/ijap.2021v13i5.41339

Authors

RAJESWARI ALETI Department of Pharmaceutical Technology, Andhra University, Andhra Pradesh 530003, India
SRINIVASA RAO BARATAM St. Ann's College of Pharmacy, Andhra University, Andhra Pradesh 530003, India
BANGARUTHALLI JAGIRAPU Department of Pharmaceutical Technology, Andhra University, Andhra Pradesh 530003, India
SRAVYA KUDAMALA Department of Pharmaceutical Technology, Andhra University, Andhra Pradesh 530003, India

DOI:

https://doi.org/10.22159/ijap.2021v13i5.41339

Keywords:

Bilayer tablet, Sustained-release, Metformin hydrochloride, Gliclazide and type 2 diabetes mellitus

Abstract

Objective: The main objective of the present investigation is to develop a sustained-release (SR) formulation to optimize the postprandial elevation of glucose level in type 2 Diabetic subjects using combination therapy. In the present research work, bilayer sustained release formulation of metformin hydrochloride (MFH) and gliclazide (GLZ), based on monolithic-matrix technology was developed and evaluated.

Methods: The formulations of metformin hydrochloride layer and gliclazide layer that contain polyox WSR coagulant and different viscosity grades of hydroxyl propyl methylcellulose (HPMC) as sustained-release matrix were prepared by direct compression and wet granulation method respectively. The bilayer tablets were prepared after carrying out the optimization of metformin layer and evaluated for various pre-compression and post-compression parameters. For the best formulation selected on basis of in vitro evaluation of tablets, Fourier-transform infrared spectroscopy (FT-IR) studies and comparison of in vitro dissolution profile of developed formulation with the innovator were performed.

Results: Metformin hydrochloride and gliclazide showed sustained release of drug by diffusion mechanism and followed first-order kinetics. The best formulation of metformin hydrochloride (M7) and gliclazide (G8) show 99.93% and 99.65% of drug release in 24 h respectively. The similarity factor (f2) was 79.95 for metformin hydrochloride and 73.62 for gliclazide when compared with the innovator.

Conclusion: The monolith diffusion-controlled bilayer tablets of metformin hydrochloride and gliclazide offer improved patient compliance and convenience with better postprandial hyperglycemic control with once-a-day dosing. The sustained release of the drug up to 24 h regulate antidiabetic activity round the clock with minimal side effects.

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