SOLUBILITY ENHANCEMENT AND QUALITY BY DESIGN (QBD) ASSISTED FABRICATION OF FAST DISSOLVING BUCCAL FILM FOR RISPERIDONE

Rapidly Dissolving Drug Delivery Systems have become interested in the pharmaceutical industry as frameworks that provide quick onset of action with enhanced dissolution characteristics. Risperidone, a poorly water-soluble drug, is a second-generation antipsychotic of the benzisoxazole derivatives used in treating schizophrenia and other mood disorders. The present research work aimed to fabricate fast dissolving buccal film of Risperidone solid dispersion, using a quality by design (QbD) approach. Formulation with the drug: polymer ratio of 1:1 prepared by a solvent evaporation method using polyethylene glycol 400 showed the highest drug release. QbD was applied to the films prepared by the solvent casting method. Preliminary screening studies, along with initial risk assessment and the use of Box- Behnken design, allowed the selection of HPMC E5, PEG 400, and Croscarmellose sodium as critical material attributes for film formulation and as independent variables. In contrast, folding endurance, disintegration time, and tensile strength were taken as response variables. The films were evaluated based on in-vitro percent drug dissolution, disintegration time, percent elongation, tensile strength, folding endurance, thickness, and uniformity of mass. The optimized transparent formulation showed faster in-vitro drug dissolution within 12 min and an average disintegration time of 31.66±0.5773. The ex-vivo studies showed a dissolution of 95.43%. DSC, XRD, and SEM studies revealed excellent film characteristics. The results concluded that fast dissolving buccal film (FDBF) containing solid dispersion of the drug may provide the advantage of faster onset of action, enhanced dissolution, avoidance of extensive first-pass metabolism, and improved patient compliance for the delivery of Risperidone.