DESIGN AND EVALUATION OF A FIXED DOSE COMBINATION FORMULATION OF VALSARTAN AND METFORMIN HCl FOR BIPHASIC DRUG RELEASE: A NOVEL APPROACH TO INCREASE THERAPEUTIC EFFICACY
Journal Title: International Journal of Pharmaceutical Science and Technology - Year 2011, Vol 6, Issue 1
Abstract
The objective of the present study is to formulate a fixed dose combined drug formulation of valsartan (VAL) as an immediate release layer and metformin HCl (MHCl) as a sustained release form using bilayer tablet technology, which enables biphasic drug release for once daily dosing to get a better therapeutic efficacy. The immediate release layer was prepared using super disintegrant crospovidone and extended release layer using hydroxypropylmethylcellulose (HPMC K100M), sodium carboxy methyl cellulose and povidone K90. The physicochemical compatibility and stability of the tablets were determined by Fourier transform infrared spectroscopy (FTIR), X-ray diffractometry (XRD) and differential scanning calorimetry (DSC). Bilayer tablets were subjected to accelerated stability studies for 6 months. The in-vitro release studies indicate that bi-layer tablets effectively control the drug release. Bilayer tablets were evaluated for hardness, friability, weight variation, thickness, and drug content uniformity and subjected to in vitro drug release studies using different kinetic models. The amount of VAL and MHCl released at different time intervals were estimated by HPLC method. FTIR, XRD and DSC data for the formulations indicate good compatibility and stability. These tablets exhibit no significant change either in physical appearance or dissolution pattern after storage at accelerated condition (40±2°C / 75±5%RH) for 6 months. The results indicated that VAL and MHCl could be a potential fixed dose combination form for the simultaneous treatment of hypertension and diabetes and can be developed into suitable bilayer tablets.
Authors and Affiliations
Subas C. Dinda , Durga P. Pattanayak , Ulna L. Narayan
Keywords
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