Design, Formulation and Evaluation of Pravastatin Fast Dissolving Tablets.
Objective: The main objective of present research investigation is to formulate the Pravastatin Fast Dissolving tablets. Pravastatin, a newer antihyperlipidemic agent, belongs BCS class-III agent and used to treat hypercholesterolemia and to reduce the risk of Cardiovascular disease. Methods: The Fast Dissolving tablets of Pravastatin were prepared employing various concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Superdisintegrants by Direct Compression technique using 32 factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1 and X2 respectively whereas, wetting time, Disintegration time, t50% ,t90% were selected as dependent variables. Results and Discussion: Totally nine formulations were designed and are evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, In-vitro drug release. From the Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines the formulation (F1) containing combination of 8% Crospovidone and 8% Croscarmellose, is the most similar formulation (similarity factor f2= 89.724, dissimilarity factor f1= 1.307 & No significant difference, t= 0.0465) to marketed product (PRAVACHOL-40). Conclusion: The selected formulation (F5) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non- Fickian Diffusion Super Case-II Transport (n= 1.875).