Formulation Development and Evaluation of Dapoxetine Hydrochloride Tablets Approved for the Treatment of Premature Ejaculation
Abstract
Dapoxetine Hydrochloride a selective serotonin reuptake inhibitor is a new chemical entity for the treatment of premature ejaculation. Since no systematic studies on design and development of Dapoxetine hydrochloride tablets are available in literature, we propose to develop a suitable formulation to characterize in vitro release profile of Dapoxetine hydrochloride. The aim of the present study was to formulate various formulations of immediate release tablets of Dapoxetine Hydrochloride using different excipients by direct compression and wet granulation method. The granules and tablets of Dapoxetine HCl were evaluated for various pre and post compression parameters like Angle of repose, Compressibility index, Hausner’s ratio, Tablet hardness, Thickness, Friability, and chemical parameters. Punches of different size were used to obtain the desired shape, ease of swallowing of tablets, to improve aesthetic value in terms of appearance and shape of tablets. To match dissolution profile of test formulation with innovator, drug particle size is reduced from D90-158 µ to D90-45 µ, which resulted in an increased surface area exposed to the dissolution medium. Final formulation was evaluated for multimedia dissolution in three different media and dissolution data was found satisfactory. Accelerated stability studies conducted for 2 Months at 40°C and 75% RH and were found within specification.
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