Formulation and evaluation of oral mouth dissolving film of pitavastatin calcium

Abstract

The aim of this study was to develop an oral mouth dissolving film (OMDF) formulation containing pitavastatin calcium, a lipid-lowering agent, for enhanced patient compliance and convenience. The films were prepared using a solvent casting method with a blend of suitable polymers and excipients. Various formulations were prepared and evaluated for their physical characteristics, disintegration time, drug content uniformity, and in vitro drug release profile. Optimization was conducted to achieve the desired properties of the films. Characterization studies including FTIR and DSC were performed to assess the compatibility between the drug and excipients. In vivo studies were carried out in human volunteers to evaluate the taste, palatability, and pharmacokinetics of the optimized OMDF. The results demonstrated that the formulated OMDF of pitavastatin calcium exhibited rapid disintegration in the oral cavity, uniform drug content, and sustained drug release profile. The optimized formulation showed good taste and palatability, indicating its potential for improving patient adherence to therapy. Overall, the developed OMDF of pitavastatin calcium presents a promising dosage form for enhanced drug delivery and patient convenience.