In recent decades, there has been a growing awareness in our society of the impor- tance of medicines that are personalized to the needs of patients. This dissertation contributes to the research on personalized dosage forms with controlled drug release. The basis of our investigations is the simulation of the expected diffusion properties of these personalized dosage forms using computer-aided statistical methods and the subsequent adaptation of suitable models to experimentally obtained data. This novel approach makes it possible to verify the parameters determined from exper- imental data, such as the diffusion coefficient. A key finding is that, for instance, the homogeneity of the sample, the precision of the measurement data collection and the consideration of the measurement environment have a greater influence on the validity of the diffusion coefficient than the choice of the diffusion model. The experimental part of this thesis comprises the development and characterization of drug-loaded polymer resins, the implant fabrication, and the pharmaceutical and physical investigation of the polymer-drug implants. The formulation of polymer resins and their suitability for 3D printing (3DP), as well as their use in pharmaceu- tical applications, are extensively addressed. The release properties and, in partic- ular, the polymer network’s mesh size influence on the active ingredient’s diffusion rate in aqueous solution are studied. In addition, the production of polymer sam- ples by means of UV photopolymerization in a molding process developed for this purpose, as well as by using stereolithographic 3DP, are examined comparatively. The polymerization process and the polymer properties resulting from the different production methods are presented. The major findings from these studies include the successful development of a polymer resin formulation whose release and swelling properties are comprehensively demonstrated using a model drug. Furthermore, the optimization of this resin for the use of the active pharmaceutical ingredient (API) testosterone was achieved. A comparison of the two developed resin formulations clearly shows the limitations and the possibilities of transferability of both systems. In addition, the results concerning the release of API from the polymer, as well as the diffusion of the solvent into the polymer and the resulting increase in the volume, provide insight into the changed interfacial diffusion resistance in 3D printed poly- mers compared to molded polymers. This work thus contributes to the development of personalized drug forms and paves the way for the production of release-controlled polymer resin implants for future follow-up work.
Mi Steinbach (Wed,) studied this question.