1. Injection molding as a one-step process for the direct production of pharmaceutical dosage forms from primary powders
- Author
-
Gerold Koscher, Johannes Khinast, G Steinbichler, Daniel Franz Treffer, H. R. Juster, Karin Eggenreich, Eva Roblegg, Simone Schrank, Stephan Laske, and Sarah Windhab
- Subjects
Drug Liberation ,Materials science ,Time Factors ,Chemistry, Pharmaceutical ,Drug Compounding ,Pellets ,Pharmaceutical Science ,02 engineering and technology ,Molding (process) ,030226 pharmacology & pharmacy ,Dosage form ,Polyethylene Glycols ,Matrix (chemical analysis) ,03 medical and health sciences ,0302 clinical medicine ,Fenofibrate ,Pellet ,Drug Carriers ,Chromatography ,021001 nanoscience & nanotechnology ,Extrusion ,Polyvinyls ,Powders ,0210 nano-technology ,Drug carrier ,Tablets - Abstract
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.
- Published
- 2015