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A Study on the Effect of Disintegrants and Processing Methods on the Physicochemical and In Vitro Release Characteristics of Immediate Release Tablets of Bosentan Monohydrate
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The present investigation attempted to study the effect of disintegrants and processing methods on the physicochemical and in vitro release characteristics of immediate release tablets of Bosentan Monohydrate. To achieve this goal various formulations of Bosentan Monohydrate were prepared by direct compression, wet granulation and fluidized bed granulation methods to achieve maximum drug content with reference to innovator. Varying proportion of disintegrants such as sodium starch glycolate, pregelatinised starch used to compare drug release profile with innovator. Different formulations were prepared and evaluated with respect to various precompression and post compression parameters. The results indicated that the superdisintegrants used have influenced on the disintegration time. The final selection of the formulation F8 (f2 = 71) containing sodium starch glycolate was based on highest f2 value among all formulations with reference to marketed product.
Keywords
Bosentan Monohydrate, Direct Compression, Wet Granulation, Fluid Bed Granulation, Disintegrants, Drug Release.
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