FORMULATION AND EVALUATION OF RAPID DISSOLVING ORAL FILM CONTAING BREXPIPRAZOLE

Zeel Shah*, Bhakti Shah and Vishal Kumar Modi

ABSTRACT

The objective of this research work was to formulate and evaluate rapid dissolving film containing brexpiprazole by enhancement of solubility by preparing solid dispersion of brexpiprazole and to increase patient compliance which is useful in the treatment. In this research, the method used to prepare rapid dissolving oral films was solvent casting to decrease time and cost. First prepare solid dispersion by solvent evaporation method then preliminary study was done for the selection of excipients such as, film-forming agent and plasticizers. Preliminary batches were evaluated for Physico-chemical parameters. 32 Full Factorial design was used for optimization by selecting two independent factors concentration of film forming agent (HPMC E5)-X I and concentration of plasticizer (PEG 400)-X II and their effect on Disintegration time-(R1), and % drug release-(R II). Optimization of factorial batches was done using Design Expert 13 software. Result: Best results were obtained in Batch F8 in which HPMC E5 (SD 1:2) was 40 mg and PEG 400 was 20mg with 34 seconds of disintegration time and 91.6 % cumulative drug release at 9 minutes. Check point batch shows 37 seconds of disintegration time 89.87 % cumulative drug release. A 1 month accelerated stability study was done on prepared films and it is stable for 1 month.

Keywords: Rapid dissolving oral films, Brexpiprazole, Solid dispersion, PEG 6000, solvent evaporation, design expert.