The present investigation was undertaken in formulating mouth dissolving film(s) of the non-steroidal anti-inflammatory drug indomethacin. The main objective is to enhance the quick on set of action, convenience and compliance by the elderly and pediatric patients without the problem of swallowing and using water. Indomethacin belongs to BCS Class-II with low solubility and high permeability. The solubility of indomethacin is enhanced by complexing with cyclodextrins. The inclusion complexes of indomethacin were prepared by various techniques using HP β cyclodextrin in various ratios (1:1, 1:1.5, 1:2 and 1:2.5). Solubility study of indomethacin was performed in which highest was observed for 1:2 ratio. The selected inclusion complexes were then utilized for the preparation of film by solvent casting method using HPMC 15 Cps as a film forming agent and PEG-400 as plasticizer. Six formulae were prepared and evaluated for in vitro dissolution characteristics, in vitro disintegration time, and their physico-mechanical properties. The promising film (F4) showed greatest drug dissolution (more than 75% within 15 min), satisfactory in vitro disintegration time (45 sec) and physico-mechanical properties that are suitable for mouth dissolving films. By complexation taste masking also improved. Optimized mouth dissolving film was compared with marketed product by similarity and dissimilarity factors.
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2022: 6.012
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