Dr. H. Padmalatha*, B. Anvesh, B. Divya, G. Sharmitra, M. Manisha and M. Saikiran


The aim of this is study is to formulate and evaluate fixed dose combination of Fenofibrate and Pravastatin sodium in tablet dosage for the treatment of Dyslipidemia. Monolithic and Bilayer tablets prototype formulation were investigated because there is a compatibility in between Fenofibrate and Pravastatin sodium based on Infrared spectroscopy studies, So a monolithic tablet is possible. For the formulation and optimization of fenofibrate layer, two factor three level factorial design was used as experimental design for optimization with a minimum of nine run. All the nine trial (F1 – F9) has been formulated according to the experimental design by wet granulation method. The independent variable studied were amount of HPMC (X1) and amount of crospovidone (X2). Drug release at 45 minutes (Y1) and disintegration time (Y2) was chosen as dependent variable. The software generated the optimized formulation and predict the response based on the constraint and the response of the dependent variable of the nine trial. Then batch was formulated based on the suggested formulation and response were obsereved. The observed pre and post compression parameter of the suggested trial was within the acceptable limit. Hence it has chosen as optimized formulation and used for formulating fixed dose combination of bilayer and monolithic tablets. For the formulation and optimization of Pravastatin sodium layer, Trial and error method was employed. Total three trial (P1-P3) has been formulated. Trial P1 was formulated by direct compression, the results of this trial indicates that it has extremely poor flow property and lower hardness and high %friability. So it is concluded that direct compression is not feasible. So trial P2 is formulated using wet granulation all the post compression parameter was within the acceptable range but trial P2 show poor flow property. Hence trial P3 was formulated as like trial P2 but with increased quantity of cellulose microcrystalline in extragranular material. The observed precompression parameter of trial P3 shows it has good flow property and weight variation, hardness, friability and assay where within the limit. The disintegration time of Trial P3 was found to be optimum. The In-vitro drug dissolution of the Trial P3 was 91.74%. Hence trial P3 was chosen as optimized formulation. Thus for the further formulation of Fixed dose combination of bilayer and monolithic tablet, the blend of trial P3 was used.

Keywords: Formulation, Evaluation, Fixed Dose Combination, Fenofibrate And Pravastatin Sodium, Tablet Dosage Form.

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