FORMULATION AND EVALUATION OF PIAVASTATIN CALCIUM LOADED WAFER

Urvesh Rangi*, Dr. Shailesh T. Prajapati

ABSTRACT

Objective[1]: The primary goal of this study was to develop and assess a Wafer containing Pitavastatin Calcium by enhancing the drug's solubility through Solid Dispersion Method. The intent was to bypass hepatic first-pass metabolism, thereby improving bioavailability, ensuring faster onset of action, and increasing patient compliance. Materials and Methods: Wafer was produced using the solvent casting technique, chosen for its simplicity, cost-effectiveness, and time efficiency. Initially, a Solubility Enhancement of Pitavastatin Calcium was done using the Solid Dispersion method. A preliminary investigation was conducted to identify suitable excipients, including film forming agents and plasticizers. The trial formulations were evaluated for their physicochemical characteristics. To optimize the formulation, a 3² full factorial design was employed, focusing on two independent variables: the concentration of the film forming polymer (HPMCE5 denoted as X1) and the amount of plasticizer (PEG400 denoted as X2). The impact of these variables was assessed on two dependent responses- disintegration time Drug release(Y1) and percentage drug release (Y2).The optimization process was carried out using Design Expert V.13 software. Result and Discussion: The most promising outcome was observed in Batch F2, which contained Solid Dispersion in a 1:2 ratio, 5 mg of HPMC E5, and 1 ml of PEG 400. This batch showed a disintegration time of 33 seconds and a cumulative drug release of 99.21% within 10 minutes. An accelerated stability study conducted over one month confirmed the formulation's stability during that period. Conclusion: Based on the findings, it can be concluded that the Wafer of Pitavastatin calcium offers rapid disintegration and enhanced drug release. This formulation strategy effectively improves the drug's solubility and bioavailability while bypassing hepatic first- pass metabolism due to its sublingual mode of administration.

Keywords: Pitavastatin Calcium, Wafer, Full Factorial Design, Solvent Casting, Solubility, Hyperlipidemia.