Development and Evaluation of Fast Dissolving Tablets of Pravastatin by Enhancing Dissolution Rate and Bioavailability

Abstract

Pravastatin orally disintegrating films were successfully formulated using HPMC E15CPS and combinations of HPMC E15 and HPMC E5 polymers. Visual inspection and tactile evaluation revealed that the films possessed a smooth surface and were visually appealing. The film thickness ranged between 0.234 mm and 0.271 mm, with weight variation within ±10%. Folding endurance values ranged from 38 ± 1 to 57 ± 2, indicating good flexibility. Surface pH measurements showed neutrality with no color change on litmus paper, ensuring suitability for oral administration. Drug content uniformity tests demonstrated consistent drug loading, ranging from 98% to 102%. The films exhibited rapid disintegration times between 21 and 32 seconds. Among all batches, formulation F-9 displayed optimal mechanical properties and an in vitro disintegration time under 27 seconds, making it the most suitable formulation. Overall, formulation F-9 met the desired criteria and was selected as the optimized batch for further evaluation. This study confirms the potential of these orally disintegrating films as effective delivery systems for Pravastatin, combining acceptable mechanical strength, uniform drug distribution, and rapid disintegration for enhanced patient compliance.