Individualized patient treatment – lipid based nanosuspensions as inks for pharmaceutical 2D-printing

The formulation of poorly water-soluble drugs in personalized medicine is a widely discussed topic in pharmaceutical science. Taking into account the medical needs of vulnerable patient groups such as children or the elderly, a tailored approach of suitable dosage forms is the opposed of the “one-fits-all“-approach which is mainly used and results in higher patient acceptance. An often used formulation strategy for active pharmaceutical ingredients (APIs) categorized in class II of the biopharmaceutical classification system (BCS) is a lipid-based formulation, which could improve bioavailability of the substances and reduce food effects [1]. The API inks in pharmaceutical 2D-printing have a low viscosity to enable a reproduceable printing process and are mainly based on alcohol-water mixtures. In this study, oily API nanosuspensions are applied for 2D-printing on structured orodispersible film templates (SOFTs, [2]). Therefore, the API griseofulvin is dispersed directly in the oil MCT (medium chain triglycerides) and nanosized by wet milling using LipoidS20 as a stabilizing agent. The grinding process was performed in a dual centrifuge using 2 ml vials equipped with zirconium dioxide milling beads (0.3-0.4 mm). Placed on the SOFT, the API-containing oily ink integrates into the porous film structure which results in less smearing effects compared to printing on conventional films. To meet the regulatory requirements of the European Pharmacopoeia regarding orodispersible films, the API-loaded SOFTs were characterized according to their disintegration time, mechanical strength and dissolution behavior.