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). The content of the model drug in the formulations was 10% (w/w), 20% (w/w) and 30% (w/w), respectively. After 120min, both powder-based and pellet-based injection-molded tablets exhibited a drug release of 60% independent of the processing route. Content uniformity analysis demonstrated that the model drug was homogeneously distributed. Moreover, analysis of single dose uniformity also revealed geometric drug homogeneity between tablets of one shot.
['Eggenreich|K|K|', 'Windhab|S|S|', 'Schrank|S|S|', 'Treffer|D|D|', 'Juster|H|H|', 'Steinbichler|G|G|', 'Laske|S|S|', 'Koscher|G|G|', 'Roblegg|E|E|', 'Khinast|J G|JG|']
D002626:Chemistry, Pharmaceutical D004337:Drug Carriers D004339:Drug Compounding D065546:Drug Liberation D011345:Fenofibrate D011092:Polyethylene Glycols D011145:Polyvinyls D011208:Powders D013607:Tablets D013997:Time Factors
Injection molding Fenofibrate Graft co-polymer Hot melt extrusion Direct powder processing Solid dispersion