A technique patented by the Galenic Development of Medicines group at the University of La Laguna (ULL) allows improving three-dimensional printing to dose pediatric drugs, so that the required dose is adjusted in individualized treatments for child patients.
The University of La Laguna has explained this Monday that the British company FabRx has developed the world’s first GMP 3D printer for the production of individualized medicines, called M3DIMAKER™, recently acquired by the aforementioned Galenic Medicines Development group.
Thanks to the license signed between the University of La Laguna and the company that owns the 3D printing platform (FabRx), the latter will be able to benefit from the invention developed in the patent and from the use of the computer program created by the research group that Directed by Professor José Bruno Fariña.
“In the preparation of pharmaceutical forms at an industrial level or on a pilot scale, it is essential to guarantee that the amount (dose) of active ingredient present in each one of the dosage units produced is that declared, and that, furthermore, the production process does not affect the stability of the active ingredient”, explains the professor of Pharmacy and Pharmaceutical Technology.
One of the technologies that this printing platform presents is the semi-solid extrusion technique in which a semi-solid is dispensed through a nozzle, which layer by layer will form the final solid pharmaceutical form.
The process has the advantage that it is carried out at low temperatures, compared to other techniques, without altering the stability of the active ingredient.
The preparation of these starting semi-solid mixtures represents one of the greatest challenges when it comes to the development of individualized medicines, since the study of their flow and deformation (rheological properties) constitute a critical limiting point in the process, he adds.
“The patent allows the rheological characterization of the masses used, which facilitates their optimization for extrusion on the 3D printing platform, improving the quality of the printing process and therefore of the dosage form obtained”, explains the expert.
On the other hand, it ensures that the flow of the semi-solid mass to be extruded through the nozzle of the printing platform is constant, which guarantees that the dose obtained is the one required, one of the fundamental requirements for a medicine to be authorized. .
In turn, the ULL patent, managed by the academic center’s Research Results Transfer Office and whose creation also includes Ana Santoveña and Eduardo Díaz, facilitates the detection of possible printing errors, such as the existence of air inside the mass to be extruded that produces errors in the flow or solidification inside the nozzles.
This patent allows the printing pressure to be added, controlling the progress of the extrusion process and, therefore, detecting any failure during manufacturing, which allows continuous control of the process and the pertinent corrections to be made in real time.
Thus, once the printing process is finished, it is possible to discard those dosage units in which some of the predefined errors have been recorded for each batch produced.
For all these reasons, the license of this invention from the group of researchers from the University of La Laguna represents “a clear advance for the development of this novel technology”, since it makes it easier to adjust the printing parameters before the start of the process, while at the same time ensures that the flow of the semi-solid mass through the nozzle is constant and, therefore, the volume and the extruded dose is correct.
“This process consolidates the roadmap for the certification and regulation of this 3D printing technology for the manufacture of safe and quality individualized medicines,” concludes Fariña.
