(95af) Manufacture of Personalised Medicines By API Printing on Porous Tablets

Personalised medicine offers an opportunity to produce tailor-made medicaments for patients. In order to realize this vision, it is necessary to find an alternative approach to the conventional tablet design and production. One that will replace the existing mass production of drugs offering only a few dose options of the active pharmaceutical ingredient (API), while at the same time it must meet the strict reproducibility and a defined relationship between composition and release rate of active substances requirements.

One of such approaches is to print the API on demand on a solid substrate directly when it becomes needed. Appropriate dosing of API and the possibility to even combine several APIs into a single medicament improves the variability of the dosages available for prescription and reduces the overall number of pills the patient has to take. The goal of this work is to find a simple, automated and cost-effective method of preparing personalised medicaments, which could take place directly in the pharmacy shops or at home.

The method in this work consists of a precise dosing of a dissolved API into an already prepared substrate – porous placebo tablets with high sorption capacity. The tablets are prepared using direct compression in a tablet press from a simple physical mixture of a binder, filler, disintegrant and lubricant. As a filler, mesoporous silica particles were used. The high pore volume provides the free space for API sorption into the tablets and the small size of the mesopores ensure the API is deposited in an amorphous form.

The prepared particles used in the formulation were characterized using Transmission electron microscopy (TEM), Dynamic light scattering (DLS) and nitrogen sorption analysis (BET). The prepared tablets hardness and uniformity was characterized both prior and after loading. The tablets after loading were characterized using the X-ray powder diffraction and the Fourier transform infrared spectroscopy to determine the API form and deposition uniformity, followed by dissolution tests to confirm the applied dosage strength and to measure the release profile. So far, several BCS Class II APIs were successfully infused into the substrates using precise on-demand dosing. Impregnation of various doses of API were accurate. Later characterization revealed no crystalline API were present and the dissolution profiles were very satisfactory.