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Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF FAST DISSOLVING ORAL FILM OF A LIPID-LOWERING DRUG

Mohd. Adil Khan*1, Girijesh Kumar Pandey1, Amit Joshi1, B.K. Dubey2, Amit Kumar Jain1, Prabhat Jain3

1 Technocrats Institute of Technology-Pharmacy Education and Research, Bhopal (M.P.)

2Technocrats institute of technology- pharmacy, Bhopal (M.P.)

3Scan Research laboratories Bhopal (M.P.)

ABSTRACT

Recently, fast dissolving films are gaining interest as an alternative of fast dissolving tablets. The films are designed to dissolve upon contact with a wet surface, such as the tongue, within a few seconds meaning the consumer can take the product without need for additional liquid. This convenience provides both a marketing advantage and increased patient compliance. As the drug is directly absorbed into systemic circulation, degradation in gastrointestinal tract and first pass effect can be avoided. These points make this formulation most popular and acceptable among pediatric and geriatric patients and patients with fear of choking. Thus the objective of the present study was to formulate and evaluate fast dissolving oral films (FDOFs) of simvastatin to overcome the limitation of bioavailability and increase patient’s compliance. Simvastatin is an anti-hyperlipidemic drug, inhibits HMG CoA reductase enzyme and short half life (t1/2) and usually oral dose regimen (5 to 40 mg) taken to 4 times a day. In the present study oral films were prepared by solvent casting method using HPMC K15 as a film formers and PEG 400, glycerine as plasticizers and evaluated for mechanical properties, disintegration and in vitro dissolution. All formulations showed good mechanical properties and in vitro drug release. The optimized (F5) Formulation (HPMC K15, CCS and PEG 400) exhibited drug release of 98.78 % in 15 minutes which was significantly high when compared to other formulation. Fast dissolving films of Simvastatin can be considered suitable for clinical use to lower cholesterol and triglycerides level, where a quicker onset of action for a dosage form is desirable along with the convenience of administration.

Keywords: Simvastatin, Fast dissolving oral film, Bioavailability, Mechanical properties.


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