Development and in vitro/in vivo evaluation of taste-masked orodispersible films of dapoxetine hydrochloride using ion exchange resins
Abstract
Abstract Dapoxetine hydrochloride tablets are the most commonly used drug for the treatment of premature ejaculation (PE). However, there exists a limitation about medication with water, thereby decreasing patient compliance. This study aimed to develop taste-masked orodispersible films (ODFs) of dapoxetine hydrochloride using ion exchange resins. It was found that the based-Kyron T-134 resin complex achieved a high drug loading rate of 75.9 ± 1.4%, establishing the mass ratio of dapoxetine hydrochloride to Kyron T-134 at 2:1, and adjusting the solution pH to 5.4 ± 0.05. The effect of pH on the drug loading of the resin was initially characterized by SEM, while the binding mechanism between dapoxetine hydrochloride and the resin was investigated by XRD, DSC, and FTIR. The ODF exhibited favorable mechanical properties and palatability. Meanwhile, the drug release could reach 100.8% of the drug over 15 minutes in a simulated gastric environment medium. Furthermore, pharmacokinetic studies conducted in healthy volunteers demonstrated that the ODF was bioequivalent to commercially available tablets Priligy®. Therefore, this ODF, characterized by its pleasant taste and water-free administration, offers a novel and convenient oral formulation for patients with PE, thereby enhancing patient compliance.
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