The present investigation was performed by formulating buccal film(s) of the typical anti-psychotic drug Haloperidol. The main objective is to enhance the solubility of the drug and provide quick onset of action, improve patient compatibility, convenience by the patient with mental instability, without the problem of swallowing and using water. Haloperidol belongs to BCS class-II with low solubility and high permeability. The solubility of haloperidol is enhanced by solid dispersion method. The complexes were prepare by hot-melt technique using polyethylene glycol in various ratios (1:1, 1:2, 1:3, 1:4). Solubility study of haloperidol was performed in which highest range was observed for 1:3 ratio. The selected inclusion complexes were then utilized for the preparation of film by solvent casting method using HPMC of different grades as film forming agent and PEG-400 as a plasticizer. Six formulae were prepared and evaluated for the in vitro dissolution characteristics, in vitro disintegration time, and their physico- mechanical properties. The promising film (F2) showed greatest drug dissolution (more than 75% within 15 mins), satisfactory in vitro disintegration time (45 sec) and physico-mechanical properties that are suitable for buccal films. The optimized buccal film was observed for stability studies and they were reported to maintain their Physio-mechanical properties after three months of storage at optimum conditions.
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2022: 6.012
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