Orally disintegrating films focusing on formulation, manufacturing process, and characterization
The aim of the present work was to develop and characterize mucoadhesive film of cellulose (methyl cellulose and hydroxy propyl methyl cellulose) and polymethacrylate (Eudragit RSPO) polymers for buccal delivery of carvedilol. Drug and polymers were found to be compatible as revealed by FTIR and DSC analysis. Mucoadhesive films were prepared by solvent casting technique. Swelling studies up to 4h did not show erosion of film, which was further confirmed by SEM analysis. New, simple and precise instrumental methods were established for the evaluation of mucoadhesive strength (33.8 ± 0.37-38.4 ± 0.24 g) and film strength (331.2 ± 0.73-369.0 ± 1.00 g) of developed films. Mucoadhesive film F5 showed 88 ± 1.15% in vitro drug release and 80 ± 2.30% ex vivo drug permeation through goat buccal mucosa in 12h. Drug release and permeation followed Higuchi's model and mechanism was found to be Fickian type diffusion controlled.