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SOLUBILITY ENHANCEMENT OF PHENYTOIN BY SOLID DISPERSION AND IT'S COMPARISON WITH INCLUSION COMPLEXATION

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Abstract (2. Language): 
The purpose of this study was to enhance the solubility and dissolution rate of Phenytoin by making solid dispersion with poloxamer-407 and inclusion complexation with 2-hydroxypropyl-P-cyclodextrin (HP-P-CD). It belongs to Class II of Biopharmaceutical Classification System (BCS) which is characterized by high membrane permeability, slow dissolution rate due to low aqueous solubility. For the Solid Dispersion this present report describes the saturation solubility study, drug content analysis, Ratio optimization, preparation of the solid dispersion by melting fusion method. The solid dispersion is compressed into a fast disintegrating tablet. The dissolution rate of the complex was determined In vitro and was compared with that of pure drug. The dissolution data shows 1: 3 weight ratio was optimized ratio. The In-vitro dissolution study of optimized ratio shows 89.85 % corrected cumulative drug release (% CCDR) in 2Hrs and 20mins, whereas with pure drug the value 39.3 % CCDR in water. The Dissolution rate of the dispersion was 2.2 times as much as that of the pure drug. For the inclusion complexation this present report describes the study of the phase solubility diagram, preparation of the inclusion complex by the kneading method, physical evaluation, and determination of the In-vitro dissolution profile in water as well as in 0.1 N HCl. The dissolution rate of the complex was determined In vitro and was compared with that of pure drug. The In-vitro dissolution of optimized ratio shows 91.5 % CCDR in 2Hrs and 20mins, whereas with pure drug the value 39.3 % CCDR in water. The Dissolution rate of the complex was 2.05 times as much as that of the pure drug. After analyzing In-vitro dissolution profile of both the technique it can be concluded that inclusion complex making with HP-P-CD enhance the dissolution rate as well as the solubility more than solid dispersion.
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