International Journal of Pharma and Bio Sciences
 
 
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ORIGINAL RESEARCH ARTICLE
Int J Pharm Bio Sci Volume 12 Issue 2, 2021 (April-June), Pages:80-90

Formulation and Evaluation of Fast Dissolving Oral Films of Chlorpheniramine Maleate by Solvent Casting Method

Miss. AzrahMohdYunus Basar, Dr.Bhushan R. Rane, and Dr.Ashish Jain.
DOI: http://dx.doi.org/10.22376/ijpbs.2020.11.3.p80-90
Abstract:

Chlorpheniramine maleate (CPM), histamine H1 receptor (HRH1) antagonist is a powerful antihistamine drug with bioavailability of 25-45 % (conventional tablets) or 35 to 60 % (oral solutions) due to metabolised in the gastrointestinal and on hepatic first pass metabolism. The main objective of this novel study was to formulate and evaluate fast dissolving oral films of chlorpheniramine maleate using different grades of hydroxypropyl methylcellulose (K15M and E50) and ethyl cellulose to developed alternative dosage forms which allow a rapidly dissolving drug to absorb directly into the systemic circulation through the oral mucosa. The fast dissolving oral films of CPM are prepared by the solvent casting method. HPMC K15M and HPMC E50 and ethyl cellulose are used as a film-forming agents, PEG 400 as plasticizer, citric acid as saliva stimulating agent, vanillin as flavoring agent and Mannitol as sweetener. The films were evaluated for visual inspection, weight variation, thickness measurement, folding endurance, surface pH, drug content uniformity, disintegration time, mouth dissolving time and in vitro dissolution studies. Formulations of fast dissolving films were successfully prepared and evaluated. Amongst all the formulations, formulation F8 containing HPMC E50 (1:3) showed an excellent in vitro disintegration time and percentage cumulative drug release compared to other formulations. Formulation F8 (HPMC E50) in vitro disintegration time in 10 seconds and 97.5%, p<0.01drug release within 5 minutes and was considered as the optimized formulation for future studies

Keywords: Chlorpheniramine maleate; Fast dissolving oral films; Hydroxypropyl methyl cellulose; Fourier-transform infrared spectroscopy and Solvent Casting Method.
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