Medicines are generally manufactured in standardized strengths, even though patients can have very different dosing requirements. Research at Åbo Akademi University in Finland shows how a manufacturing technology inspired by 3D printing could enable pharmacies to produce medicines in doses tailored to individual patients.
In her doctoral thesis in drug development, Mahsa Bahman investigated a semi-solid extrusion (SSE) compounding platform for producing personalized medicines. The research focused not only on dose accuracy, but also on whether the technology could provide a reproducible and scalable alternative to traditional manual compounding. Bahman conducted her doctoral research at Finnish health technology company CurifyLabs, a spin-off from Åbo Akademi University.
Alternative to manual compounding
Personalized doses can be particularly important for children, older people, patients with rare diseases and hospital patients whose medication needs change frequently. Commercially available strengths do not always meet these requirements. Healthcare professionals or caregivers may therefore need to split tablets or adapt existing medicines.
Pharmacies can also compound medicines manually, but these processes are time-consuming and can introduce variability in dosing, consistency and contamination control. The technology studied by Bahman uses semi-solid extrusion. Rather than building medicines layer by layer, as in conventional 3D printing, the system dispenses precisely measured quantities of gel-like, semi-solid or liquid pharmaceutical formulations directly into molds or blister packaging.
The thesis evaluated different dosage forms and strengths, including formulations relevant to pediatric care. Researchers assessed properties including dose accuracy, repeatability, mass and content uniformity, dissolution and chemical stability.
Focus on medicines for children
One part of the research investigated medicines for children and newborns who have difficulty swallowing. Gel tablets containing propranolol, spironolactone or prednisolone were tested for administration through nasogastric tubes. The results supported the suitability of the formulations for this route of administration.
The platform was also tested with different formulations of ondansetron, demonstrating that multiple pharmaceutical base materials could be processed. These formulations and their manufacturing parameters were subsequently transferred to a hospital pharmacy. Medicines produced there were compared with previously validated batches to assess whether accuracy and repeatability could be maintained in a clinical pharmacy environment.
Another study explored personalized tuberculosis medication. Isoniazid and rifampicin were manufactured both as individual tablets and combined in polypills at different doses. Further work is still needed to improve stability, uniformity and palatability before such formulations could be considered for pediatric treatment.
The thesis also investigated Raman spectroscopy as a non-destructive method for checking the drug content of manufactured tablets. While the approach showed potential for real-time quality control, Bahman concluded that additional samples, method development and validation are required before routine use.
Towards automated production
The research points towards a model in which personalized pharmaceutical production could eventually become more integrated with hospital and pharmacy IT systems. One possibility described in the thesis is linking electronic prescriptions and electronic health records directly to manufacturing systems. This could automate documentation and potentially reduce errors during production.
Real-time analytical technologies such as Raman or near-infrared spectroscopy could meanwhile provide additional quality checks without destroying the manufactured medicine. Such developments could make automated compounding more practical for hospital and community pharmacies, particularly where patient-specific formulations need to be produced quickly.
The work does not mean that 3D-printed personalized medicines are ready to replace conventional pharmaceuticals. Individual formulations and manufacturing processes still require appropriate validation and quality controls, while some applications investigated in the thesis need further development. The hospital pharmacy experiments nevertheless demonstrate that semi-solid extrusion can move beyond laboratory testing into a real-world pharmaceutical setting, providing a potential route towards more individualized drug dosing.
References
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