title: Influence of Molecular Weight of Carriers and Processing Parameters on the Extrudability, Drug Release, and Stability of Fenofibrate Formulations Processed by Hot-Melt Extrusion.
abstract: The objective of this study was to investigate the extrudability, drug release, and stability of fenofibrate (FF) formulations utilizing various hot-melt extrusion processing parameters and polyvinylpyrrolidone (PVP) polymers of various molecular weights. The different PVP grades selected for this study were Kollidon®12 PF (K12), Kollidon®30 (K30), and Kollidon®90 F (K90). FF was extruded with these polymers at three drug loadings (15%, 25%, and 35% w/w). Additionally, for FF combined with each of the successfully extruded PVP grades (K12 and K30), the effects of two levels of processing parameters for screw design, screw speed, and barrel temperature were assessed. It was found that the FF with (K90) was not extrudable up to 35% drug loading. With low drug loading, the polymer viscosity significantly influenced the release of FF. The crystallinity remaining was vital in the highest drug-loaded formulation dissolution profile, and the glass transition temperature of the polymer significantly affected its stability. Modifying the screw configuration resulted in more than 95% post-extrusion drug content of the FF-K30 formulations. In contrast to FF-K30 formulations, FF release and stability with K12 were significantly influenced by the extrusion temperature and screw speed.
authors.affiliation: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
authors.forename: Bader B
authors.initials: BB
authors.lastname: Alsulays
authors.affiliation: College of Pharmacy, Sahm Yook University, Seoul 139-742, Republic of Korea.
authors.forename: Jun-Bom
authors.initials: JB
authors.lastname: Park
authors.affiliation: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
authors.forename: Sultan M
authors.initials: SM
authors.lastname: Alshehri
authors.affiliation: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
authors.forename: Joseph T
authors.initials: JT
authors.lastname: Morott
authors.affiliation: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
authors.forename: Saad M
authors.initials: SM
authors.lastname: Alshahrani
authors.affiliation: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
authors.forename: Roshan V
authors.initials: RV
authors.lastname: Tiwari
authors.affiliation: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
authors.forename: Abdullah S
authors.initials: AS
authors.lastname: Alshetaili
authors.affiliation: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
authors.forename: Soumyajit
authors.initials: S
authors.lastname: Majumdar
authors.affiliation: BASF Corporation, 500 White Plains Road, Tarrytown, NY 10591, USA.
authors.forename: Nigel
authors.initials: N
authors.lastname: Langley
authors.affiliation: BASF SE, R&D Project, Management Excipients, Ludwigshafen 67056, Germany.
authors.forename: Karl
authors.initials: K
authors.lastname: Kolter
authors.affiliation: BASF SE, Global Development and Technical Marketing, Ludwigshafen 67056, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Gryczke
authors.affiliation: Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA ; Pii Center for Pharmaceutical Technology, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Repka
keywords: Fenofibrate; PVP grades; hot-melt extrusion; processing parameters; stability