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Minoxidil is a hydrophobic drug with a short half-life (2–8 hours) and poor oral bioavailability due to low solubility. The present study aimed to enhance its solubility, dissolution rate, and onset of action by developing solid dispersion (SD)-based orally disintegrating tablets (ODTs) for improved administration in patients with swallowing difficulties.
Minoxidil SDs were prepared by solvent evaporation using polymers such as hydroxypropyl methylcellulose (HPMC), polyethylene glycol (PEG), and polyvinylpyrrolidone (PVP) in different ratios. Preformulation studies, including solubility testing, UV spectroscopy, differential scanning calorimetry (DSC), and Fourier-transform infrared spectroscopy (FTIR), were conducted to evaluate compatibility and physicochemical properties. Drug content, saturation solubility, and in vitro release were analyzed. The optimized SDs were compressed into ODTs using disintegrants (sodium alginate, sodium starch glycolate, and crospovidone). Physical parameters and dissolution performance were assessed.
SDs significantly improved the solubility and dissolution profile of minoxidil compared to the pure drug. Among polymers, PVP-based SDs demonstrated the highest drug release. The ODTs exhibited suitable hardness, friability, rapid disintegration, and faster drug release, ensuring desirable performance.
The findings confirm that solid dispersion technology effectively overcomes the solubility limitation of minoxidil. PVP emerged as the most effective carrier for drug release enhancement. While the in vitro outcomes are promising, further pharmacokinetic and in vivo studies are warranted to confirm bioavailability improvements and clinical efficacy.
Solid dispersion-based ODTs significantly enhanced the solubility and dissolution of minoxidil, providing a rapid onset of action and improved patient compliance, especially in pediatric, geriatric, and dysphagic populations.