Injection Moulding of Solid Oral Dosage Forms

Oral solid dosage forms are the most patient-accepted and therefore industrially relevant pharmaceutical applications, representing 80% of the market share. In that context, polymer processing techniques, such as hot melt extrusion (HME) or injection molding (IM), are increasingly used to process primary material into the final dosage forms due to several benefits (e.g., enhanced solubility or solvent-free processes). In this study, tablets based on solid dispersion systems were processed via injection molding using either primary powder or pellets prepared by HME. Fenofibrate, a BCS Class 2 substance (low solubility, high permeability), was selected as model API, with loadings of 10%, 20% and 30%, while Soluplus (PVCL-PVAc-PEG co-polymer) served as matrix. It could be shown that both the achieved mechanical properties (e.g., hardness) of the tablet, as well as the release kinetics, are suitable for oral dosage forms.