Abstract

PREPARATION & CHARACTERIZATION OF ORAL FAST DISSOLVING FILM OF LEVOCETRIZINE DIHYDROCHLORIDE

Sandeep V. Gapat*, Ram S. Pentewar, Baswaraj K. Sugave, Keshav B. Kulkarni, Aparark V. Mohalkar and Vishwanath K. Morkhande.

Abstract

Aim of the present study was to develop the Fast Dissolving Oral Films of Levocetrizine Hydrochloride, a non sedative antihistamine drug. Chemically, Levocetrizine is the active enantiomer of Cetirizine. Fast dissolving oral films deliver drug directly in the vascular system and bypasses the hepatic first pass metabolism so dose of the drug may also reduce significantly. Fast dissolving films were prepared using solvent casting method, hydrophilic polymers (HPMC15cps, HPMC E- 15 15cps, CMC, Lacroate, Sodium alginate, Eudragit L-100 & Chitosan) were selected as film forming agents and propylene glycol was used as plasticizer to give flexibility to the films. In FT-IR study no interaction was observed between drug and the excipients. Blank films were prepared and evaluated. Concentration of polymer was optimized during preliminary studies. Three blank films were selected for the incorporation of drug. After characterization the drug loaded films and studying their disintegration time & in-vitro drug release studies, among the formulations F1- F8, F1 was selected the best formulation as its disintegration and dissolution time was less and it release drug to a greater extent compared to other formulations with minimum time. As dose of the drug gets reduced from 5 mg to just 2 mg, therefore adverse effects of the drug may also get reduced. Therefore fast dissolving oral films can play an important role in oral drug delivery.

Keywords: Mouth dissolving film, Levocetrizine, solvent casting method, Disintegration time, Drug release, Fast onset of action.