Development and Characterization of Rapid Dissolving films of Fluoxetine HCl by 32 Factorial Design Approach

Abstract

Introduction: The present study was aimed at formulating and optimizing rapid dissolving films (RDFs) of fluoxetine hydrochloride to enhance patient compliance, particularly for pediatric, geriatric, and dysphagic populations, while providing rapid therapeutic onset in depressive conditions. Fluoxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI), is widely used in the management of major depressive disorder and related conditions, but its conventional dosage forms often pose administration challenges. Rapid dissolving films, capable of disintegrating within seconds in the oral cavity without water, offer a convenient and effective alternative.

Method: The films were prepared using a solvent casting method with hydroxypropyl methylcellulose 5 centipoise (HPMC 5cps) as the film-forming polymer, propylene glycol as a plasticizer, and suitable sweeteners and flavoring agents. A 3² factorial design was employed to investigate the effects of polymer and plasticizer concentrations on tensile strength and in vitro disintegration time.

Results: The optimized formulation exhibited desirable mechanical properties, excellent flexibility, uniform drug content, and rapid disintegration in simulated salivary conditions. Drug release studies confirmed an immediate and complete release profile, ensuring prompt therapeutic action.

Conclusions: The study successfully demonstrates the potential of fluoxetine hydrochloride RDFs as a fast, effective, and patient-friendly alternative to conventional dosage forms.

Introduction: The present study was aimed at formulating and optimizing rapid dissolving films (RDFs) of fluoxe- tine hydrochloride to enhance patient compliance, particularly for pediatric, geriatric, and dysphagic populations, while providing rapid therapeutic onset in depressive conditions. Fluoxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI), is widely used in the management of major depressive disorder and related conditions, but its conventional dosage forms often pose administration challenges. Rapid dissolving films, capable of disinte- grating within seconds in the oral cavity without water, offer a convenient and effective alternative. Method: The films were prepared using a solvent casting method with hydroxypropyl methylcellulose 5 centipoise (HPMC 5cps) as the film-forming polymer, propylene glycol as a plasticizer, and suitable sweeteners and flavoring agents. A 3² factorial design was employed to investigate the effects of polymer and plasticizer concentrations on tensile strength and in vitro disintegration time. Results: The optimized formulation exhibited desirable mechanical properties, excellent flexibility, uniform drug content, and rapid disintegration in simulated salivary conditions. Drug release studies confirmed an immediate and complete release profile, ensuring prompt therapeutic action. Conclusions: The study successfully demonstrates the potential of fluoxetine hydrochloride RDFs as a fast, effec- tive, and patient-friendly alternative to conventional dosage forms.