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One-step continuous extrusion process for the manufacturing of solid dispersions

One-step continuous extrusion process for the manufacturing of solid dispersions

Maniruzzaman, M., Nair, A., Scoutaris, N., Bradley, Michael S.A., Snowden, M.J. and Douroumis, D. (2015) One-step continuous extrusion process for the manufacturing of solid dispersions. International Journal of Pharmaceutics Special Issue on "Continuous Manufacturing and Process Analytical Tools”, 496 (1). pp. 42-51. ISSN 0378-5173 (Print), 1873-3476 (Online) (doi:10.1016/j.ijpharm.2015.09.048)

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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 1 h. 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.

Item Type: Article
Uncontrolled Keywords: Inorganic excipients; Solid dispersions; Continuous extrusion
Faculty / Department / Research Group: Faculty of Engineering & Science
Faculty of Engineering & Science > Department of Applied Engineering & Management
Faculty of Engineering & Science > Department of Engineering Science
Last Modified: 04 Dec 2017 11:16
URI: http://gala.gre.ac.uk/id/eprint/14553

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