Thursday , 23 May 2024

Preparation and Stability Studies of Sitagliptin Phosphate and Simvastatin Bilayered Tablets

Harshal S. Bhandari*1, Jayshri A. Patil2, Hemant V. Deore1, Dipak K. Borole 1, Vilas L. Badgujar1
1DCS’S A.R.A College of Pharmacy, Nagaon, Dhule
2NES’S Gangamai College of Pharmacy, Nagaon, Dhule

The aim of the present work was to develop a novel and elegant pharmaceutica; combinational dosage form for simultaneous treatment of many patients with Type 2 diabetes with at high risk for coronary artery disease and associated co- morbidities. In general the work deals with the combine formulation and evaluation of bilayered tablets of DDP-4 inhibitor i.e., sitagliptin phosphate and HMG-CoA  reductase i.e. simvastatin. Ten formulations of sitagliptin phosphate and simvastatin bilayered tablets were prepared by varying the ratios of polymers in the sitagliptin phosphate layer and simvastatin layer F1 to F10 by direct compression method. FTIR studies revealed there is no interaction between the drugs i.e. sitagliptin phosphate and simvastatin and the polymers such as pregelatinised starch, potato starch and sodium starch glycolate. All the powdered blends of formulations were evaluated for pre- compression parameters for flow properties such as angle of repose, tapped density, compressibility index and post compression parameters such as thickness, weight variation, friability, hardness, drug content, In-vitro disintegration time and dissolution studies. The physical appearance was good and elegant. The weight variation, friability and hardness of tablets were found to be within USP limits.  In-vitro drug release for sitagliptin phosphate and simvastatin of all formulations of F1 to F10 was carried out in phosphate buffer pH 6.8 dissolution media. Among all the formulations F7 was optimised as best formulation.  F7 formulation showed (97.23%) for sitaglipti phosphate and simvastatin (98.32%) maximum drug release drug release at the end of 45 minutes.

Keywords: Stability Studies, Sitagliptin Phosphate, Simvastatin, Bilayered

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