Development and Evaluation of Fast Dissolving...

Development and Evaluation of Fast Dissolving Oral Film Containing Yohimbine Hydrochloride

Author Name : Rajashree. V. Lode, Nikhil. S. Lohe, Dr. Satish. B. Kosalge

ABSTRACT

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 Yohimbine HCL was formulated in the form of Orodispersible film. The main objective behind this formulation was to formulate taste masked oral fast dissolving film of Yohimbine HCL for maintaining patient compliance regarding adults to geriatrics.  The orodispersible films were prepared by solvent casting method using Pullulan as a film forming agent, PEG-400 as a plasticizer, citric acid as a salivary stimulating agent, mannitol as a sweetener and vanilla flavor as a taste masking agent. Yohimbine hydrochloride film was prepared by inclusion complex formation with Sulfobutyl-ether- β- Cyclodextrin (SBEβCD) cooling method. The 3² factorial designs was used to study the effect of independent variables viz. concentration of Pullulan (X₁) and concentration of PEG-400 (X₂) 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 stability study. The optimized batch (Y5) 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. Taste masked complex of Yohimbine hydrochloride with Sulfobutyl-ether- β- Cyclodextrin could be successfully formulated into orodispersible film.

Keywords: Yohimbine Hydrochloride, Pullulan, Solvent Casting, Oral Film, Erectile dysfunction.