FORMULATION AND EVALUATION OF FAST DISSOLVING FILM OF CYPROHEPTADINE HYDROCHLORIDE
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Author:
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RAVI GARALA, RUSHIK GHODASARA, KINESH PATEL
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Abstract:
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In the present research work, aimed to prepare and evaluate the fast dissolving oral films containing Cyproheptadine hydrochloride, an antihistaminic drug using different ratios of polymer Hydroxypropyl methylcellulose E5 and plasticizer PEG 400. The film was prepared by solvent casting technique using citric acid, sucralose and menthol as saliva stimulating agent, sweetening and cooling agent respectively. The study examines the influence of polymers to plasticizer ratio on physicochemical properties and drug release potential of films. Cyproheptadine hydrochloride is first generation antihistaminic and bind with specifically H1-receptor at nerves ending.which has low oral bioavailability due to hepatic first pass metabolism. The present study investigated the possibility of developing Cyproheptadine hydrochloride fast dissolving oral films allowing fast, reproducible drug dissolution in the oral cavity, thus bypassing first pass metabolism to provide rapid onset of action of the drug. The films were thin, smooth, flexible, and uniform in drug content, weight and thickness as observed from low SD values. The film formulation, (F5) consisting of 300mg of HPMC E5 and 20% PEG 400 was found to be suitable in the form of fast dissolving oral film based on in vitro evaluation studies. The optimized formulation, F5 showed less disintegration time and faster drug release. All the systems were found to be stable with respect to drug content as well as physical changes at 30?C and 65% RH and 40?C and 75% RH. The results suggest that polymer based fast dissolving films are potential means to achieve rapid drug release for effective therapy.
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Keyword:
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Antihistaminic, Cyproheptadine HCL, First pass metabolism, Fast dissolving film, Hydroxypropyl methyl cellulose
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EOI:
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DOI:
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