Development and Characterization of Fast Dissolving Film of An Antipsychotic Drug

Abstract

In the current scenario oral drug delivery is a widely opted approach for drug administration; however, oral route confines some drawbacks like swallowing or chocking problem, first pass metabolism and stability related issue inspite of its tremendous advantages. Development of fast dissolving film formulations is one of the unique approaches to overcome these problems. The oral film technology is gaining popularity in geriatrics and pediatrics dosage forms as per its edge over other formulations like patient compliance with minimal dose and frequency, as well as ability to form variety of films with varied therapeutic outcome. Fast dissolving film is the category of immediate release formulation which offers several advantages like rapid disintegration, quick dissolution and improved bioavailability. The present investigation focuses on formulation development of fast dissolving film of an anti-psychotic drug by solvent casting method due to its cost effectiveness and ease of industrial adaptability. The model drug (Brexpiprazole, BRX) was selected for the present investigation has lower dose, longer half life and more bio availability compared to the other antipsychotic drugs. Moreover, no fast dissolving formulation of BRX is available in the market as per literature. Varieties of film forming polymers were explored in preliminary batches to identify suitable polymeric materials which provide desired formulation characteristics. Effect of casting surface, solvent media, drug, temperature and duration were studied. Concentration of film formers and plasticizers were varied and optimized using experimental design (32 factorial design was applied). Tensile strength of films was found to be increased at higher concentration of polymer, whereas flexibility was increased at higher concentration of plasticizer. The study shows the possible solution for formulation of fast dissolving films with its desired characteristics. Optimized formed film was evaluated for its organoleptic properties, casting ability, flexibility, tensile strength, muco-adhesion, disintegration and dissolution, taste masking. This dosage form exhibit higher patient compliance, minimal dose frequency compared to marketed conventional dosage form. It is predicted that BPZ, FDFs will be highly beneficial in CNS disorder due to faster onset of action.