FabRx, a leader in 3D printing of pharmaceuticals, has successfully accomplished the world’s first in-human clinical study using their proprietary Printlets™ technology. This pioneering study will help in bringing true personalised patient treatment by 3D printing of pharmaceutical products.
This study can now be applied in real-world clinical settings for individual patients to revolutionise the way drug delivery happens worldwide.
The in-human study was conducted in collaboration with scientists from University of Santiago de Compostela (USC), University College London (UCL) and the Clinical University Hospital in Santiago de Compostela.
Clinical Study incorporating 3D Printing of Pharmaceuticals
The clinical study was the first instance where an automated 3D printing system was used for the preparation of a personalised dose of therapy in a hospital setting.
It reports the first time integration of an automated 3D printing system for the preparation of personalised dose of the therapy into a hospital setting. The results of the clinical study were published in the International Journal of Pharmaceutics earlier in August this year.
The study was specifically carried out for children diagnosed with the rare Maple Syrup Urine Disease (MSUD). MSUD is a metabolic disorder which is treated by following a strict diet combined with tailored doses of isoleucine and valine supplements that depend on the patients’ blood concentration of isoleucine.
Since such a tailored manufacturing is not possible in any automatic system, these doses are prepared manually in hospitals catering to such patients. But since MSUD is a life-long condition, this medication has to be prepared regularly for the patients. This process takes a lot of time and adds a huge economic burden on the hospital. Hence, an alternative manufacturing technique that could enable the flexible production of such personalised dosage forms is desirable and expected to enhance patients’ compliance to their treatment.
The study therefore, carried out at the Clinical University Hospital in Santiago de Compostela, involved formulation of personalised doses of isoleucine for the children through a 3D printing system.
The 3D printing system is faster than the manual preparation and the hospital can now make blister packs equivalent to one month’s therapy (28 printlets or 3D printed tablets) in less than 8 minutes.
The MSUD patients were closely monitored and after 6 months of examination, the study showed that the printlets were as effective as the conventional medication prepared manually in controlling the patients’ blood levels of isoleucine.
Furthermore, isoleucine blood concentrations following the administration of printlets were closer to the isoleucine target value with less variation when compared with blood levels achieved by conventional compounded treatment.
The ability of the 3D printing system to create printlets with different colours and flavours had a further positive impact in enhancing patients’ acceptability of the treatment.
The 3D printing of pharmaceuticals seems to be the way forward for the treatment of MSUD patients.
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