title: Injection molding as a one-step process for the direct production of pharmaceutical dosage forms from primary powders.
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.
authors.affiliation: Research Center Pharmaceutical Engineering (RCPE) GmbH, Graz, Austria.
authors.forename: K
authors.initials: K
authors.lastname: Eggenreich
authors.affiliation: Research Center Pharmaceutical Engineering (RCPE) GmbH, Graz, Austria.
authors.forename: S
authors.initials: S
authors.lastname: Windhab
authors.affiliation: Institute of Pharmaceutical Sciences, Department of Pharmaceutical Technology, Karl-Franzens University Graz, Graz, Austria.
authors.forename: S
authors.initials: S
authors.lastname: Schrank
authors.affiliation: Institute of Process and Particle Engineering, Graz University of Technology, Graz, Austria.
authors.forename: D
authors.initials: D
authors.lastname: Treffer
authors.affiliation: Institute of Polymer Injection Molding and Process Automation, Johannes Kepler University, Linz, Austria.
authors.forename: H
authors.initials: H
authors.lastname: Juster
authors.affiliation: Institute of Polymer Injection Molding and Process Automation, Johannes Kepler University, Linz, Austria.
authors.forename: G
authors.initials: G
authors.lastname: Steinbichler
authors.affiliation: Research Center Pharmaceutical Engineering (RCPE) GmbH, Graz, Austria.
authors.forename: S
authors.initials: S
authors.lastname: Laske
authors.affiliation: Research Center Pharmaceutical Engineering (RCPE) GmbH, Graz, Austria. Electronic address: gerold.koscher@rcpe.at.
authors.forename: G
authors.initials: G
authors.lastname: Koscher
authors.affiliation: Research Center Pharmaceutical Engineering (RCPE) GmbH, Graz, Austria; Institute of Pharmaceutical Sciences, Department of Pharmaceutical Technology, Karl-Franzens University Graz, Graz, Austria.
authors.forename: E
authors.initials: E
authors.lastname: Roblegg
authors.affiliation: Research Center Pharmaceutical Engineering (RCPE) GmbH, Graz, Austria; Institute of Process and Particle Engineering, Graz University of Technology, Graz, Austria.
authors.forename: J G
authors.initials: JG
authors.lastname: Khinast
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004337:Drug Carriers / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods; D065546:Drug Liberation; D011345:Fenofibrate / Q000008:administration & dosage* / Q000737:chemistry; D011092:Polyethylene Glycols / Q000737:chemistry*; D011145:Polyvinyls / Q000737:chemistry*; D011208:Powders; D013607:Tablets; D013997:Time Factors
chemical_list: D004337:Drug Carriers; D011145:Polyvinyls; D011208:Powders; D013607:Tablets; C572167:polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer; D011092:Polyethylene Glycols; D011345:Fenofibrate
keywords: Direct powder processing; Fenofibrate; Graft co-polymer; Hot melt extrusion; Injection molding; Solid dispersion