PREPARATION AND EVALUATION OF MOUTH DISSOLIVING FILM OF FLUOXETINE HCL

Abstract

Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor used for treating depression, obsessive-compulsive disorder, and panic disorder. Its bitter taste and first-pass metabolism limit patient compliance, especially in pediatric and geriatric populations. The objective of this study was to formulate and evaluate mouth dissolving films of Fluoxetine HCl with enhanced palatability and rapid onset of action.
The films were prepared by the solvent casting method using HPMC E5 as the primary film-forming polymer due to its good filmogenic and mucoadhesive properties. Doshion P 542, an ion exchange resin, was incorporated as a taste masking agent to complex with Fluoxetine HCl and mask its intense bitterness. Glycerin was used as a plasticizer to provide adequate flexibility and folding endurance. The prepared drug-resin complex was dispersed into the polymeric solution and cast into films.
The formulated films were evaluated for thickness, weight variation, folding endurance, surface pH, disintegration time, drug content, in-vitro dissolution, and taste evaluation. FTIR and DSC studies confirmed drug-excipient compatibility and successful taste masking through complexation. The optimized batch exhibited a disintegration time of <25 seconds and released >95% drug within 4 minutes in phosphate buffer pH 6.8. Taste panel studies showed significant bitterness reduction compared to pure drug. The films also demonstrated adequate mechanical strength and stability.
Thus, mouth dissolving films of Fluoxetine HCl prepared using HPMC E5 and taste-masked with Doshion P 542 by solvent casting method offer a promising approach for rapid drug delivery with improved patient acceptance. For use of Fluoxetine HCl or any prescription medication, consult a healthcare professional to ensure it is appropriate and safe for your condition.

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