Sex-specific formulations of doxazosin mesylate via direct powder extrusion 3D printing

Sex differences in how drugs are absorbed and processed in the body are often overlooked in pharmaceutical development, leading to higher rates of adverse effects and mortality in females. This study focuses on doxazosin mesylate, a medication used to treat hypertension, which shows significant pharmacokinetic differences between males and females. Current extended-release formulations only exist in high doses of 4 and 8 mg, and can result in greater side effects in women, highlighting the need for sex-specific titrated dosing.

Using direct powder extrusion (DPE) 3D printing, researchers developed a personalised drug delivery system that allows flexible dosing from a single batch of "pharma-ink" containing doxazosin mesylate, hydroxypropyl cellulose (Klucel JF), and D-mannitol. Printlets (3D printed tablets) in 1, 2, and 3 mg doses were easily manufactured by adjusting dimensions, with no need to switch powder formulations.

In vitro dissolution testing confirmed extended drug release profiles influenced by the surface-area-to-volume (SA:V) ratio. The addition of internal channels helped standardise SA:V across printlets, improving drug release consistency. This research demonstrates the feasibility of personalised, sex-specific oral medication using 3D printing, paving the way for safer, more precise hypertension treatment.

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