Formulation and Evaluation of Mouth Dissolving Films of Captopril by using Natural Polymers.

Abstract

Mouth dissolving films (MDFs) of captopril were developed using natural polymers, including pectin, sodium alginate, and guar gum, in combination with the plasticizer polyethylene glycol 400 (PEG 400) and other ingredients like saliva stimulating agent, sweetener and super disintegrator etc. A total of nine formulations were prepared using different concentrations of the polymers by the solvent casting method. The objective of the study was to evaluate the suitability of these polymers and the effect of polymer concentration on the performance of the MDFs. The MDFs were evaluated based on various parameters, including folding endurance, dissolution, and disintegration studies. Among the different formulations, batch F4, which contained 50% (w/w) pectin as the polymer and 17% (w/w) PEG 400 as the plasticizer, exhibited satisfactory results. The folding endurance test indicated that batch F4 had good flexibility and strength, suggesting that it could withstand repeated folding without breaking or cracking. The in vitro dissolution study revealed that the MDFs of batch F4 exhibited rapid and complete drug release in 6 min, indicating their potential for enhanced drug delivery. The disintegration study further confirmed that the MDFs disintegrated within a short time, ensuring rapid disintegration and dissolution of the drug in the oral cavity.