Injection Molding as a One-Step Process for the Direct Production of Pharmaceutical Dosage Forms from Primary Powders
The objective of the present study was to develop a one-step process for the production of tablets directly from primary powder by means of injection molding (IM), to create solid-dispersion based tablets. Fenofibrate was used as the model API, a polyvinyl caprolactame-polyvinyl acetate-polyethylene glycol graft co-polymer served as a matrix system. Formulations were injection-molded into tablets using state-of-the-art IM equipment. The resulting tablets were physico-chemically characterized and the drug release kinetics and mechanism were determined. Comparison tablets were produced, either directly from powder or from pre-processed pellets prepared via hot melt extrusion (HME).
Keywords: Solid dispersion; Fenofibrate; Graft co-polymer; Hot melt extrusion; Injection molding; Direct powder processing; excipient