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Abstract

Based on the preliminary studies, different formulation trials (F1-F7) were carried out with different concentrations of disintegrants, diluents. From the various formulations it was decided that the formulation batch of F7 was finalized as the optimized formula. Compression method; evaluation of their compliance to various critical process quality parameters, i.e., weight variation, friability, hardness, thickness, moisture content, disintegration, assay, and dissolution; and their comparison with marketed brands for determination of pharmaceutical equivalency Formulation F7 showed satisfactory results with various physicochemical evaluation parameters like Disintegration time, Dissolution profile, Assay when matched with that of the marketed product. The stability studies at all condition, indicates that the formulated tablet were found to be stable. Hence, it is finally concluded that, tablet are pharmaceutically comparable, low cost, quality improved and stable formulation.

Keywords

Formulation Evaluation Ketorolac Tromethamine QBD Novel Technology Physicochemical evaluation parameter

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