Formulation and Characterization of Dapoxetine Hcl Sublingual Tablets
Abstract
The present study aimed to develop and optimize sublingual tablets of Dapoxetine HCl using solid dispersion technology and factorial design to enhance solubility, dissolution, and onset of action for the management of premature ejaculation. Premature ejaculation is a prevalent male sexual disorder significantly affecting quality of life, requiring rapid-acting therapeutic interventions. Dapoxetine HCl, a short-acting selective serotonin reuptake inhibitor, exhibits poor aqueous solubility and variable oral bioavailability due to extensive first-pass metabolism, making it a suitable candidate for sublingual delivery. Preformulation studies confirmed the identity and purity of the drug, with melting point observed in the range of 173–177°C and λmax at 291 nm. The calibration curve showed excellent linearity (R² = 0.9992). FTIR analysis confirmed compatibility between drug and excipients. Sublingual tablets were formulated using a 3² factorial design. Among all batches, DM9 exhibited optimal performance with rapid disintegration (14.63 sec) and 99.64% drug release within 14 minutes. Stability studies confirmed no significant changes under accelerated conditions. Thus, the optimized formulation demonstrated enhanced solubility, rapid disintegration, and improved drug release, making it a promising approach for fast-acting treatment of premature ejaculation.
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