Development of Taste Masked Orodispersible Film Containing Paroxetine Hydrocloride

Aim and Objectives: The present study was to formulate and evaluate orodispersible films to overcome drawbacks of conventional dosage forms such as degradation by first-pass hepatic metabolism, decreased bioavailability and patient non-compliance. In the present work the taste masked Paroxetine HCl was formulated in the form of Orodispersible film. Rationale for formulating the taste masked PXT in ODF form was to increase convenience of paediatric, geriatric, bedridden, psychiatric patients and those who have dysphasia. Materials and Methods: The orodispersible films were prepared by solvent casting method using HPMC E-5, Propylene glycol (plasticizer), citric acid (saliva stimulating agent), stevioside (sweetener) and PVP K-30 as superdisintegrant. Paroxetine hydrochloride was taste masked by inclusion complex formation with HP β–CD by freeze drying. The 3 factorial designs was used to study the effect of independent variables viz. concentration of HPMC E-5 (X ) and concentration of PG (X ) on three dependent variables such as in vitro drug release, folding endurance and disintegration time. Optimized formulation was evaluated for physical appearance, thickness, moisture content, weight uniformity, surface pH measurement and taste masking ability by human gustatory sensation test. Results: The optimized batch (F3) showed 99.94% drug release with 72 as folding endurance and disintegration time of 24 sec. Ex vivo permeation, oral mucosa sensitivity test, release kinetics and accelerated stability studies confirmed that developed formulation exhibited flash drug release and was stable, non–irritant and therapeutically effective. Conclusion: Taste masked complex of paroxetine hydrochloride with HP β-CD could be successfully formulated into orodispersible film. Key words: Paroxetine hydrochloride, Hydroxy Propyl Beta Cyclodextrin, Taste-masking, Freeze-drying, Oral films.