DEVELOPMENT AND CHARACTERIZATION OF ORAL DISSOLVING FILM FOR PROMETHAZINE HCL

Promethazine hydrochloride, one of the most effective agents for treating motion sickness, mainly acts as a strong antagonist of H1 receptor (antihistamine) and it blocks the action of acetylcholine on the receptors (anticholinergic effect). The purpose of present work was a development of fast dissolving oral film of promethazine HCl to overcome the limitation of current routes of administration, to provide faster dissolution rate and increase patient compliance, especially for outpatient setting. The amount of drug was calculated according to the area of petri plate. The amount of drug was then used for the preparation of film by solvent casting method utilizing HPMC E3, HPMC E5, HPMC E15, and HPMC E50 as a film-forming polymers. The effect of plasticizers (PEG 200, PEG 400, PEG 600, glycerine, propylene glycol, triethyl citrate) and their concentration were tested for physicomechanical properties of casted films. Aspartame was used as a sweetener. The IR spectral studies showed no interaction between drug and polymer or with other additives. Using experimental design, the prepared formulations were evaluated for in-vitro dissolution characteristics, in-vitro disintegration time and their physicomechanical properties. The optimized formulation (batch F1) containing HPMC E15 and PEG 400 showed greater drug dissolution (more than 95% within 10 min), satisfactory in vitro disintegration time (18 sec) and physicomechanical properties that were suitable for mouth dissolving film. The stability study of optimized formulation for 1 month showed no appreciable change in drug content, in-vitro drug release and in-vitro disintegration time.