Timolol Maleate is a non-selective beta-adrenergic blocker, widely used in the treatment of hypertension, however it suffers from limitations such as the need for frequent dosing and extensive first-pass metabolism. This study aims to formulate and evaluate a sustained-release mucoadhesive buccal film containing Timolol Maleate intends to address the existing issues associated with oral administration of this drug. The films were prepared by solvent casting method involving multiple mucoadhesive polymers. These films were evaluated for their physicochemical and mechanical properties to ensure the integrity of the films during handling and drug release profile was examined using in vitro drug release and ex vivo drug permeation studies. The findings confirmed that the formulation followed Hixson-Crowell release kinetics and achieved a cumulative drug release of approximately 74% over 8 hours. The drug-excipient compatibility was confirmed by FTIR analysis and the thermal behaviour of the drug-loaded films was characterised using DSC, demonstrating a broad endothermic transition with a reduced peak at 211.64°C (onset at 181.42°C); these tests were performed in conjugation with SEM analysis for visualization of surface morphology of the film. Stability studies conducted in accordance with ICH Q1A(R2) guidelines for a period of three months confirmed that there were no significant changes in the physicochemical properties and drug content of the films. Hence, the data supports the potential development of timolol maleate buccal films as a replacement for oral therapy as the films may offer better patient compliance and bioavailability. Keywords: Timolol Maleate, Buccal Films, Mucoadhesive Polymers, Hypertension
Shubhangi Yashwant Aher (Fri,) studied this question.