Felodipine Solubility Enhancement via Polymeric-Lipid Extrusion 3D Printing, and Public Acceptance Toward 3D Printed Medicines

Abstract

Poor aqueous solubility of many prospective low molecular weight drug compounds is a barrier to bioavailability and hence therapeutic effectiveness and commercial potential. Multiple formulation-based approaches have been studied to enhance effective solubility, one of which is the formation of the drug in a solid dispersion, whereby the drug is dispersed in a soluble matrix. 3D printing has capabilities to produce personalised medicines and is a manufacturing technique for pharmaceuticals well suited to the creation of solid dispersions. Multiple 3D printing technologies are available, with material extrusion approaches most often used in pharmaceutical research to date. With such advances in 3D printing, there is also the opportunity for studies of patient-perceptions of printed tablets in the context of tablet properties such as size, shape, and colour. As a new manufacturing technology, understanding patient acceptability of 3D printing of medicines is required to understand the public perception toward future market along with policy shaping. As part of this study a public study is carried out on the acceptance of 3D printed tablets. The aligned main aim of this study was to study the potential of polymeric-lipid formulations to enhance drug water solubility in extrusion 3D printed solid dosage forms, designed according to the most acceptable geometries of the public. Such formulations have rarely been studied in 3D printing of tablets. Specifically, I investigated the poorly water soluble drug felodipine and its inclusion in a polymeric-lipid formulation. An immediate-release formulation was developed and tested for printability and compatibility. The developed formulation exhibited enhanced solubility, excellent printability, and compatibility. Subsequently I describe the study of sustained-release formulations with altered ratios of drug and excipients. A significant difference was present between formulations with variable drug content. As most lipids undergo physicochemical changes over time, stability determination is considered. The samples were tested under various storage conditions. Several analytical techniques were used to verify any changes that occur during the stability analysis. Samples stored at room temperature and 0% RH showed rapid crystallisation of felodipine, whereas those stored at 37 ± 1°C and 75% RH maintained their amorphous and dispersed state. Augmentation of the drug release rate was observed in all aged samples compared to the freshly printed samples. Multiple complementary methods were used to study formulation behaviour and structure. Employment of social study results in the design of future medicines can enhance their effectiveness. Additionally, lipids with their versatility as drug carrier are ideal for extrusion 3D printing for the use in pharmaceutical manufacturing, particularly clinical trials.