Abstract

DESIGN AND EVALUATION OF FAST DISSOLVING BUCCAL FILMS CONTAINING DIPHENHYDRAMINE HCl AND PHENYLEPHRINE HCl

Akshith K.*, S. T. Bhagawati and Manjunath K.

ABSTRACT

The main objective of this research work is to formulate fast dissolving films to improve the patient compliance and bioavailability of Diphenhydramine HCl and Phenylephrine HCl. Diphenhydramine HCl and phenylephrine HCl undergo first-pass metabolism, the development of fast dissolving buccal films of Diphenhydramine HCl and Phenylephrine HCl release the drug in the buccal cavity and absorb through the buccal region. Hence first-pass metabolism of the drug could be avoided by developing into a fast-dissolving film of diphenhydramine HCl and phenylephrine HCl. Fast dissolving Buccal films were prepared by solvent casting method using various polymers like hydroxyl propyl methyl cellulose E15, HPC, PVA and Glycerol as plasticizer and saccharin as a sweetening agent and vanillin as a flavoring agent and % Drug release is calculated using the simultaneous estimation equation method. Dissolution profile as studied in a USP dissolution apparatus type 1 using a pH 6.8 simulated saliva. The influence of variables like polymer type, concentration, and release profile was studied. The formulation was optimized on the basis of various evaluation parameters like the Folding endurance test, Weight uniformation test, Drug content, Stability test and invitro drug release. Formulation F3 successfully fast the release of drug within 3 minutes. The IR spectra showed stable properties of Diphenhydramine HCl and Phenylephrine HCl in mixture of polymers used and revealed the absence of interaction between drug and selected polymer, stability studies were as per ICH guidelines and result indicated that the selected formulation was stable.

Keywords: Diphenhydramine HCl and Phenylephrine HCl, HPMC E 15, HPC, PVA, Vanillin, Sodium saccharin.