Abstract

FORMULATION AND EVALUATION OF ORODISPERSIBLE FILM OF HYDROXYZINE HYDROCHLORIDE

Rupal Jani,* Reeni Patel, Pratik Shah.

Abstract

In the present study, an attempt was made to develop orodispersible film of Hydroxyzine Hydrochloride by solvent casting method. Drugexcipients and excipients-excipients incompatibility study was carried out using fourier transform Infrared Spectroscopy (FTIR) which shows that drug-excipient and excipient-excipient were compatible to each other. Orodispersible film of Hydroxyzine Hydrochloride containing hydroxy propyl methyl cellulose E5LV and hydroxy propyl methyl cellulose E15LV were developed by solvent casting method using propylene glycol as a plasticizer and citric acid as a saliva stimulating agent. Batch H1( hydroxy propyl methyl cellulose E15LV 100 mg, citric acid 20 mg and propylene glycol 20% w/w) showed excellent appearance, transparency,% elongation 1.7±0.30,tensile strength 35±0.49,folding endurance 770±3 and maximum drug entrapment 98.12%. This result revealed that presence of propylene glycol (20% w/w of polymer) was used which gave good physicochemical properties and citric acid (0.2%w/w of polymer) was rapid disintegration of orodispersible film. Stability studies of the optimised batch H1 showed that there were no significant changes in appearance, elasticity, folding endurance, thickness, drug entrapment, tensile strength and in vitro disintegration time after storage at 40±2ºC and 75±5%RH for a one month. This approach suggested that the orodispersible film of Hydroxyzine Hydrochloride using hydroxy propyl methyl cellulose E15LV, citric acid and propylene glycol gave rapid disintegration of orodispersible film and provide faster onset of action.

Keywords: Orodispersible film, solvent casting method, Hydroxyzine HCl, HPMC E5LV, HPMC E15LV.