In-vitro and In-vivo Evaluation of Cevimeline HCl Fast Dissolving Films

Abstract

The primary aim and objective of the present work was to formulate the cevimeline HCl fast-dissolving films and assess the films, a pharmaceutical compound utilized for the management of xerostomia symptoms linked to Sjogren’s disease. Fast-dissolving films of cevimeline HCl were formulated by utilizing the solvent casting technique and the sodium carboxy methyl cellulose, HPMC E5, polyvinyl alcohol, and polyvinyl pyrrolidone were used as film-forming agents. Additionally, polyethylene glycol 600 and sodium starch glycolate were used as a super disintegrant and plasticizers. The formulation contains citric acid and stevia powder, which serve the purpose of stimulating saliva and providing sweetness, respectively. This study focused mainly on the development and assessment of cevimeline HCl fast-dissolving films, specifically examining parameters such as film thickness, folding resistance, drug content, air bubble entrapment, and film curling. The obtained results were found to be consistent with the preset ranges established for these parameters. The drug release from the fast-dissolving films formulated with PVP K30 was 99.91% released within 5 minutes timeframe. The results indicates that the films prepared with PVP K30 show enhanced solubility, rate of dissolution, flexibility, and tensile strength in comparison to the films formulated with sodium carboxy methyl cellulose, HPMC E5 and Polyvinyl alcohol. Fourier transform infrared (FTIR) and differential scanning calorimetry (DSC) studies were done to characterize the pure drug, polymers and to C11 the optimized formulation. These findings indicated, no observed incompatibilities among the drug and polymers utilized in this study. Moreover, in-vivo investigations were conducted on optimized formulation C11, which demonstrated its notable stability.