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, 496 (1). pp. 42-51. ISSN 0378-5173

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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
Schools and Departments: School of Life Sciences > Chemistry
Depositing User: Mohammed Maniruzzaman
Date Deposited: 29 Jan 2016 10:58
Last Modified: 29 Jan 2016 10:58
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