plasticizer

Fast dissolving oral film was prepared by using pullulan as a film forming agent, glycerine as a plasticizer, Aspartame as sweetening agent. Solvent  casting method was used for formulation of film. The 2 x 2 cm film is placed on tongue it get instantly hydrated by saliva ,adhere to tongue and rapidly disintegrate and dissolves to release the drug.  The prepared films were also evaluated for their weight uniformity, thickness, surface pH, drug content, in vitro disintegration time, in vitro drug release, film stability and mechanical properties as folding endurance.  The film thickness (mm) ranges from 0.021±0.0015 to 0.032±0.015 and the folding endurance ranges from 9.33±0.577 to 14.23±1.15 respectively. The drug content (mg %) was studied and it ranges from 97.04±1.08 to 99.07±1.02. Increase in the levels of Glycerin causes an increase in the Folding Endurance while Pullulan had a negative effect. A plasticizer has a negative effect on the Drug Release. % Drug Release of the film increased with decrease in levels of both polymer and plasticizer. All film having acceptable mechanical properties and the time required to disintegrate were within 25 second and total % drug release is in 5 min. Stability study of optimized Fast Dissolving Film of Buspirone hydrochloride was revealed for 3 month which shows no significant difference. This study revealed, successful formulation of Fast Dissolving Oral Film. The Fast Dissolving Oral Film  showed highest drug release and average folding endurance. The high % drug release of the film in phosphate buffer pH 6.8 at 5 min indicated that these films can be real alternative to traditional OTC product like tablets and capsule.

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.