2. Academic Validation
  3. Sex-specific formulations of doxazosin mesylate via direct powder extrusion 3D printing

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

  • Drug Deliv Transl Res. 2025 Apr 22. doi: 10.1007/s13346-025-01862-4.
Patricija Januskaite 1,  Alvaro Goyanes 2 3 4 5,  Mine Orlu 6,  Abdul W Basit 7 8
Affiliations

Affiliations

  • 1 Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London, WC1N 1AX, UK.
  • 2 Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London, WC1N 1AX, UK. a.goyanes@fabrx.co.uk.
  • 3 FABRX Ltd., Henwood House, Henwood, Ashford, Kent, TN24 8DH, UK. a.goyanes@fabrx.co.uk.
  • 4 FABRX Artificial Intelligence, Calle Enrique Vidal Abascal 7, Santiago de Compostela, 15702, Spain. a.goyanes@fabrx.co.uk.
  • 5 Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, Facultad de Farmacia, Instituto de Materiales (iMATUS) and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, Santiago de Compostela, 15782, Spain. a.goyanes@fabrx.co.uk.
  • 6 Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London, WC1N 1AX, UK. m.orlu@ucl.ac.uk.
  • 7 Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London, WC1N 1AX, UK. a.basit@ucl.ac.uk.
  • 8 FABRX Ltd., Henwood House, Henwood, Ashford, Kent, TN24 8DH, UK. a.basit@ucl.ac.uk.
PMID: 40263229 DOI: 10.1007/s13346-025-01862-4
Abstract

Males and females are known to exhibit significant differences in drug pharmacokinetics and pharmacodynamics, which are still overlooked in pharmaceutical research and development. These disparities contribute to adverse effects and increased mortality in females, highlighting the critical need for sex-specific formulations. Extended-release formulations of doxazosin mesylate, an alpha blocker used to treat hypertension, have shown significant sex-based differences in pharmacokinetics, leading to heightened adverse effects in females and rendering current titration recommendations impractical. This study explored the potential of a 3D printing (3DP) technology, direct powder extrusion (DPE), for producing personalised, sex-specific doses of doxazosin mesylate. A simple three component formulation was made composed of hydroxypropyl cellulose (HPC) polymer Klucel JF, D-mannitol, and doxazosin mesylate. Extended-release printlets of varying doses (1, 2, and 3 mg) were manufactured from a single 1% w/w doxazosin pharma-ink batch, enabling easy dose personalisation by adjusting the printlet dimensions. The use of a single pharma-ink supports the technology's ease of use in a pharmacy setting, by eliminating frequent pharma-ink changes during the pharmaceutical compounding process. In vitro dissolution testing revealed an extended drug release profile, influenced by surface-area-to-volume (SA: V) ratios. Introducing channels in larger printlets standardized the SA: V ratios, enhancing release profile uniformity. Release kinetics followed the Hixson-Crowell and Korsmeyer-Peppas models, indicating diffusion and polymer swelling mechanisms. This work highlights the capability of DPE 3DP for creating personalized, extended-release oral dosage forms, supporting precise dose customization for patient-specific therapy. Graphical Abstract.

Keywords

Additive manufacturing of oral drug products; Gender specific drug prescribing; Hypertension; Modified release formulations and pharmaceuticals; Personalized therapeutics; Three-dimensional printing of medications.

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