Fast dissolving buccal film

ABSTRACTThe present study deals with the formulation of fast dissolving films of vildagliptin that is used for the treatment of Diabetes. The concept of fast dissolving drug delivery emerging from the desire to provide better patient compliance and avoid first pass metabolism. In the present research work, various trials were carried out using film forming agents such as HPMC, Maltodextrine, Polyethylene alcohol, to prepare an ideal film. Solvent casting method was used for the preparation of films. The prepared films were evaluated for weight uniformity, drug content, film thickness, folding endurance. The in vitro dissolution studies were carried out using ph-6.8 phosphate buffer. This approach increase therapeutic efficiency of pharmaceutical actives by avoiding hepatic first pass metabolism, deliver drug molecule in control manner, enhance absorption and improves patient compliance Keywords: Fast dissolving buccal film, Vildagliptin, HPMC, Maltodextrine, poly-ethylene oxide, tween 80,  aspartame Glycerin Solvent casting method, In vitro drug release, Ex-vivo drug diffusion studies,

Fast dissolving buccal films is a novel oral drug delivery system offers new possibilities for drug delivery by providing the advantages of oral delivery coupled with the enhanced safety and efficacy of a drug molecule, enhanced onset of action, improved bioavailability by avoiding first pass metabolism and enzymatic degradation in the GI tract and convenience to special patient categories such as pediatrics, geriatrics and bedridden patients who experience difficulties in swallowing the conventional oral dosage form. This delivery system consists of a thin oral film, which is simply placed on the patient’s tongue or any oral mucosal tissue (buccal/sublingual), instantly wet by saliva, rapidly hydrates and adhere onto site of application, where it disintegrates and dissolves to release the medication for oral mucosal absorption. More recently, fast dissolving films are gaining interest as an alternative to fast dissolving tablets to definitely eliminate patient’s fear of chocking and overcome patient impediments. Fast dissolving films are formulated using polymers, plasticizers, sweeteners, flavours and colours. Fast dissolving films were prepared by solvent casting, rolling, extrusion and solid dispersion method. The films evaluated for disintegration, dissolution, tensile strength, thickness, folding endurance and elastic modulus. This article overview the advancements in oral dosage forms, formulation considerations, method of preparation, evaluation, marketed products and it also suggests that this delivery system can be adopted by various pharmaceutical companies in future at large scale.