Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILMS CONTAINING BACLOFEN

Anusha*, Rakesh K, Sumana G

Department of Pharmaceutics, Shree devi College of Pharmacy, Kenjar, Mangalore, Karnataka, India.

ABSTRACT

Fast dissolving oral films (FDOFs) are the most advanced form of oral solid dosage form due to more flexibility and comfort. Baclofen is a muscle relaxant used for the symptomatic relief of severe chronic spasticity associated with a variety of conditions. The present study was undertaken with the objective of formulating fast dissolving oral films of Baclofen to enhance the convenience and compliance by the patients specifically elderly and paediatric. The films were formulated by solvent casting method with different concentrations of Hydroxy propyl cellulose and hydroxyl ethyl cellulose as film forming polymers. Propylene glycol is used as plasticizer and croscarmellose sodium is used as superdisintegrant. The compatibility of the drug in the formulation was confirmed by FTIR studies. Fifteen formulations were prepared and evaluated for physico-chemical parameters such as weight uniformity, thickness uniformity, folding endurance, drug content, surface pH, tensile strength, percentage elongation, swelling index, water absorption ratio, In-vitro disintegration time, In-vitro dissolution studies and In-vitro permeation studies. The formulations having polymers at low concentrations showed better results. All formulated films showed the good physico-mechanical properties. The formulation containing 2.5%w/v of HEC and 8%w/w of croscarmellose sodium has a disintegration time of 34 seconds, folding endurance of 272 and %CDR of 95.32% at the end of 14 minutes.

Keywords: Fast dissolving oral films, Baclofen, Croscarmellose, Solvent casting method, Hydroxy propyl cellulose, Hydroxyl ethyl cellulose.