Formulation and evaluation of tramadol HCl oral fast dissolving films

Abstract

Tramadol hydrochloride an opioid analgesic drug has been used for moderate to severe pain management in patients. The present work aimed at preparing oral fast dissolving films of Tramadol Hydrochloride with the purpose of developing a dosage form for a very quick onset of action, which is very convenient for administration, without the problem of swallowing and using water. Oral fast dissolving films of tramadol hydrochloride were prepared using Pullulan and HPMC (E3, E5 and E15) polymers as film forming agents and propylene glycol as plasticizer by solvent casting method. FTIR showed that there is no interaction between drug and excipients. Dissolution of prepared fast dissolving oral films of tramadol hydrochloride was performed using USP type II apparatus in pH 6.8 phosphate buffer medium at 50 rpm with temperature being maintained at 37±0.5ºC. The films prepared were evaluated for various parameters like thickness, percent elongation, drug content uniformity, weight variation, disintegration time, folding endurance and in vitro drug release and were showed satisfactory results. Formulation with 5% Pullulan has shown better in vitro dissolution profile compared with other formulations. In conclusion, development of fast dissolving oral films using Pullulan polymer gives rapid drug delivery and rapid onset of action.