Januskaite, Patricija; (2025) Additive manufacturing approaches towards personalised and sex-specific pharmaceutical formulations. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

The demand for personalised medicine is growing rapidly, highlighting the need for age- and sex-specific formulations. Tailored dosing, such as lower doses for females or adjustable titrations for paediatrics as they physiologically develop, can enhance treatment efficacy and minimise side effects. By addressing these needs, personalised formulations can improve therapeutic outcomes and ensure safer, more effective patient care. Additive manufacturing is an innovative technology that enables the precise personalisation of therapeutics. In this PhD project, two additive manufacturing technologies differing in their method of material deposition were investigated: inkjet printing for the direct printing of oestradiol onto skin models, and direct powder extrusion (DPE) for the fabrication of personalised dose tablets of doxazosin mesylate. Both techniques were applied to develop sex- and age-appropriate formulations utilising different drugs: oestradiol for the treatment of Turner syndrome in adolescent females, and doxazosin for the treatment of hypertension in young adult females. Both therapeutic agents require dose titration, as their currently licensed formulations are available in only a limited number of strengths, requiring doxazosin tablets to be split and oestradiol transdermal patches to be cut to tailor the appropriate dose to the individual. To address this limitation, inkjet printing was successfully utilised as a novel drug delivery platform in the form of pharmaceutical temporary ‘tattoos’. Using a small handheld inkjet device, this enabled the personalised dosing and the extended permeation of oestradiol, ideal for the recommended nocturnal administration of oestradiol for adolescent Turner syndrome patients as it avoids inaccurate patch cutting. DPE three-dimensional (3D) printing was used as a single-step method for manufacturing personalised dose doxazosin mesylate tablets from a single batch of powder feed. Oral dosage form design modifications applied during the printing process, such as the inclusion of channels, resulted in improved dissolution similarity (f2) scores, indicating comparable release profiles across different printed tablet sizes. Both DPE and inkjet printed formulations were developed successfully, proving the utilisation of these technologies for the printing of therapeutics requiring tailored dosing.

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