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One-step continuous extrusion process for the manufacturing of solid dispersions
journal contribution
posted on 2023-06-09, 00:10 authored by M Maniruzzaman, A Nair, N Scoutaris, Michael S A Bradley, M J Snowden, D DouroumisThe 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.
History
Publication status
- Published
Journal
International Journal of PharmaceuticsISSN
0378-5173Publisher
ElsevierExternal DOI
Issue
1Volume
496Page range
42-51Department affiliated with
- Chemistry Publications
Full text available
- No
Peer reviewed?
- Yes
Legacy Posted Date
2016-01-29Usage metrics
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