Abstract

FORMULATION AND EVALUATION OF ORAL FAST DISSOLVING FILM OF LEVOSALBUTAMOL SULPHATE

Thonte S.S., Pentewar R.S., Bhusnure O.G.*, Gholve S.B., Giram P.S. and Khadkutkar V.K.

Abstract

Aim of the present study was to develop the Fast Dissolving Oral Films of levosalbutamolsulphate, a short-acting β2 adrenergic receptor agonist used in the treatment of Asthma and chronic obstructive pulmonary disease. Chemically, levosalbutamol is the active enantiomer of salbutamol. Fast dissolving oral films deliver drug directly in the vascular system and by passes 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 (HPMC K-15cps, HPMC E-15, HPMC K-100) 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 to F10] F3,F9toF10 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: Orally disintegrating film, Levosalbutamol sulphate, HPMC, Solvent casting method, Drug release.