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FORMULATION AND IN VITRO EVALUATION OF MUCOADHESIVE BUCCAL FILMS OF DILTIAZEM HYDROCHLORIDE

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ABSTRACT

The aim of this work was the design and evaluation of Buccal mucoadhesive patches consisting basically of bioadhesive polymeric layer and impermeable backing layer to provide unidirectional flow of Diltiazem Hydrochloride across buccal mucosa. Mucoadhesive patches of about five formulations containing 20 mg Diltiazem hydrochloride are designed and evaluated for their Drug content, physical characteristics such as Appearance, Surface Texture, Folding Endurance, Thickness, Area, Swelling Studies and in-vitro release. The invitro release studies are carried out using fabricated diffusion cell and dialysis sac was used as a membrane. The patches were prepared with good bio-adhesive polymer like HPMC and copolymers like PVP K-30 and Eudragit L-100-55 .Convenient bioadhesion, acceptable elasticity, swelling and surface pH were obtained. Patches exhibited sustained release over more than 6 h and the addition of polyvinyl pyrrolidone (PVP) generally enhanced the release rate. Optimum release behaviour was shown with patches containing300mg HPMC (5cps) and 25mg Eudragit L-100-55.Storage of these patches for 6 months did not affect the elastic properties, however, enhanced release rates were observed.

Key words: Mucoadhesive polymers, Patches, Diltiazem hydrochloride, In vitro release, Buccal delivery.

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