Formulation and evaluation of amlodipine besylate elementary osmotic tablets

Author : D. Sherly, S. Palanichamy, M. Rajesh and P. Solairaj

The present work was aimed to formulate and evaluate osmotic pump delivery system of Amlodipine Besylate using two osmogens (NaCl and KCl) by wet granulation method. The osmogens used in this study did not alter the physicochemical properties of drug, as tested by FTIR. Prior to compression, the prepared granules were evaluated for flow and compression characteristics. After compression, the tablets were evaluated for thickness, hardness, weight variation, friability, percentage of weight gain, drug content, and in vitro release studies. The tablets were further coated and evaluation of coated tablets were performed and compared with uncoated tablets. The coated tablets after drying were drilled on the surface using Microdrill to get delivery orifices of different diameters (0.5mm, 1.0mm & 1.5mm). The percentage of weight gain after coating was found to be between 5.57-7.11%.A slow drug release was observed in coated tablets compared to uncoated formulations. The optimized formulation, F3 (1.5mm diameter pore size) showed maximum drug release 88.2% at the end of 24th hours. The optimized formulation F3 (1.5mm diameter) was found to be stable even after subjected to stability study maintained at 2520C/605%RH and 4020C/ 755% RH for two months. In conclusion, Amlodipine Besylate may be successfully formulated as elementary osmotic pump tablets to provide a control release of drug upto 24 hours.

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