FORMULATION AND EVALUATION OF MOUTH DISSOLVING TABLETS OF SIMVASTATIN
Purnima Gedam*, Balkrishna Dubey, Deepak Kumar Basedia and Bhushan Kumar Korde
ABSTRACT
The objective of the present work was to formulate mouth dissolving tablet enriched with taste masking agent to provide rapid onset of action of simvastatin increasing its therapeutic efficacy and also increase the compliance amongst geriatric, pediatric and uncooperative patients. Precompression blends of the MDTs were prepared and evaluated for its micromeritic properties. The angle of repose, bulk and tapped density, Hausner’s ratio and Carr’s Index were determined and all indicated that the prepared blends have excellent flow characteristics. Total seven formulations of MDTs were prepared using direct compression (DCT1 to DCT4) and sublimation method (ST1 to ST3). The concentration of the super-disintegrant or the sublimating agent was varied depending on the method. All the formulations were subjected to post compression evaluation test and the results indicate that the direct compression formulation had hardness of 4 Kg/cm2 while those prepared using sublimation had hardness of 3 Kg/cm2, thickness of 8 mm, weight variation in the range of 3.5-5.1 %, friability of less than 1 %, drug content in the range of 97.9 to 98.5 %, wetting time from 19 to 41 seconds with water absorption ratio of more than 75 %, disintegration time of less than 30 seconds and a drug release of more than 80 % over a period of 5 minutes.
Keywords: Simvastatin, mouth dissolving, sublimation, super-disintegrant, direct compression.
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