Abstract

FORMULATION AND EVALUATION OF MOUTH DISSOLVING FILMS OF PALIPERIDONE

Lakshmi Usha A.*, Arthi Saranya, Meghana, Karthik Sriram, Chandralekha, Parimala Rani

ABSTRACT

The present work aimed at preparing Mouth dissolving films of paliperidone and incorporating an amorphous solid dispersion (ASD) of Paliperidone. Paliperidone is a poorly water-soluble drug that can be converted to an amorphous form by preparing solid dispersions with chitosan (a natural polymer) and Eudragit L100 (a pH-dependent polymer) in different ratios to improve its solubility, dissolution characteristics, and bioavailability. The optimized ASDs were further incorporated into fast-dissolving oral films via the solvent-casting method, using suitable film-forming polymers, plasticizers, and other excipients. The formulated mouth dissolving films were evaluated for physicochemical properties, including thickness, weight uniformity, folding endurance, tensile strength, surface pH, drug content uniformity, and in vitro disintegration and dissolution parameters. The FTIR and DSC confirmed the conversion of the drug to an amorphous state and the absence of significant drug–polymer interactions. The formulation were subjected to disintegration, in vitro drug release studies and enhanced dissolution compared with the pure drug, indicating that the ASD approach combined with mouth-dissolving film technology is a promising strategy for improving the oral delivery of poorly soluble drugs.

Keywords: Paliperidone; Amorphous solid dispersion, Mouth dissolving films; Solvent casting method; Chitosan; Eudragit L100.