title: One-step continuous extrusion process for the manufacturing of solid dispersions.
abstract: The purpose of this study was to evaluate the performance of synthetic magnesium aluminometasilicate (MAS) as a novel inorganic carrier in hot melt extrusion (HME) processing of indomethacin (IND) for the development of solid dispersions. A continuous extrusion process at various IND/excipient blend ratios (20%, 30% and 40%) was performed using a twin-screw extruder. Physicochemical characterization carried out by SEM, DSC, and XRPD demonstrated the presence of IND in amorphous nature within the porous network of the inorganic material for all extruded formulations. Further, AFM and FTIR studies revealed a single-phase amorphous system and intermolecular H-bonding formation. The IND/MAS extrudates showed enhanced INM dissolution rates within 100% been released within 1h. Stability studies under accelerated conditions (40°C, RH 75%) showed that MAS retained the physical stability of the amorphous solid dispersions even at high drug loadings for 12 months.
authors.affiliation: Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent ME4 4TB, UK.
authors.forename: M
authors.initials: M
authors.lastname: Maniruzzaman
authors.affiliation: Fuji Chemical Industry Co., Ltd., 12F The Front Tower Shiba Koen, 2-6-3 Shibakoen, Minato-Ward, Tokyo 105-0011, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Nair
authors.affiliation: Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent ME4 4TB, UK.
authors.forename: N
authors.initials: N
authors.lastname: Scoutaris
authors.affiliation: The Wolfson Centre for Bulk Solids Handling Technology, Medway School of Engineering, University of Greenwich, Medway Campus, Chatham Maritime, Kent, UK.
authors.forename: Michael S A
authors.initials: MS
authors.lastname: Bradley
authors.affiliation: Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent ME4 4TB, UK.
authors.forename: M J
authors.initials: MJ
authors.lastname: Snowden
authors.affiliation: Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent ME4 4TB, UK. Electronic address: d.douroumis@gre.ac.uk.
authors.forename: D
authors.initials: D
authors.lastname: Douroumis
mesh_terms: D017607:Aluminum Compounds / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004337:Drug Carriers / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods; D065546:Drug Liberation; D004355:Drug Stability; D004356:Drug Storage; D005079:Excipients / Q000737:chemistry; D007213:Indomethacin / Q000008:administration & dosage* / Q000737:chemistry; D017616:Magnesium Compounds / Q000737:chemistry*; D016062:Porosity; D017640:Silicates / Q000737:chemistry*; D012995:Solubility; D017550:Spectroscopy, Fourier Transform Infrared
chemical_list: D017607:Aluminum Compounds; D004337:Drug Carriers; D005079:Excipients; D017616:Magnesium Compounds; D017640:Silicates; C033065:aluminum magnesium silicate; D007213:Indomethacin
keywords: Continuous extrusion; Inorganic excipients; Solid dispersions