Formulation and characterization of pediatric paracetamol oral mouth dissolving film

Abstract

Oral mouth dissolving drug delivery system is considered to be an important alternative to the peroral route for the systemic administration of drugs, as it considered the most convenient, easy, safest route of administration. Mouth dissolving film may be preferred over the mouth dissolving tablets in terms of flexibility and comfort. The aim of this study is to formulate and characterize oral mouth dissolving film of paracetamol .Oral films were pre- pared by Solvent casting method using HPMC-E 15, PEG 400, glycerin, and other recipients. Films were evaluated for mechanical properties, disintegration time, and invitro drug release. The dissolution kinetics of optimized batch was applied to various dissolution models. The similarity factor (f2) between the optimized batch and marketed Tablet (Dispirit) was determined using the data obtained from the drug release studies. Optimized batch showed maximum invitro drug release 97.48% following zero order kinetics. The release exponent ‘n’ was found to follow Non- Fiction diffusion and may indicate that the drug release was controlled by zero order release.