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Abstract

The aim of the current work was to formulate and determine a fixed dose combination of immediate release oral solid dosage form containing two anti-diabetic drugs for the management of type 2 diabetes mellitus. Metformin HCL500mg and Vildagliptin 50mg immediate release tablets were prepared by wet granulation method. A total number of six different batches (F1, F2, F3, F4, F5 and F6) were developed to optimize the quantity of super disintegrants Crosscarmellose sodium, Micro Crystalline Cellulose and PVP K 30. Drugs – excipients compatibility were examined by FTIR studies. The results revealed that there were no interaction between the drugs and excipients used. The above batches were evaluated for various pre-compression  characteristics  like  bulk  density,  tapped  density,  compressibility  index,  hausner’s  ratio and angle  of repose and the results of all six batches complies with the standard values. Various physico chemical evaluations such as dimensions, thickness, hardness, friability, disintegration time, in-vitro drug release and assay were performed. Amongst six batches, the formulation F6 showed 86% for Vildagliptin and 102% for Metformin Hcl at the end of 45 mins and selected as optimized formulation. The Stability studies were performed at 400C and 75% RH, 250C and 60%RH. Samples were analyzed at regular intervals as mentioned in stability protocol. The stability study of the formulated product complies with ICH guidelines in the initial two month, it showed no significant change in the physicochemical parameters and in vitro release pattern. The encouraging results confirm the effectiveness of fixed dose combination and may improve patient compliance.

Keywords

vildadagliptin Hydrochloride

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