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    Cocrystalization and simultaneous agglomeration using hot melt extrusion

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    Publication date
    2010
    Author
    Dhumal, Ravindra S.
    Kelly, Adrian L.
    York, Peter
    Coates, Philip D.
    Paradkar, Anant R.
    Keyword
    Calorimetry; Differential scanning
    ; Chromatography; High pressure liquid
    ; Crystallization; Cocrystals
    ; Hot temperature; Hot melt extrusion; Ibuprofen
    ; Microscopy; Electron; Scanning
    ; Pharmaceutical preparations; Chemistry
    ; Solubility
    ; Spectrophotometry; Ultraviolet; Thermo-mechanical process
    ; X-Ray diffraction
    ; REF 2014
    Peer-Reviewed
    Yes
    
    Metadata
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    Abstract
    PURPOSE: To explore hot melt extrusion (HME) as a scalable, solvent-free, continuous technology to design cocrystals in agglomerated form. METHODS: Cocrystal agglomerates of ibuprofen and nicotinamide in 1:1 ratio were produced using HME at different barrel temperature profiles, screw speeds, and screw configurations. Product was characterized for crystallinity by XRPD and DSC, while the morphology was determined by SEM. Dissolution rate and tabletting properties were compared with ibuprofen. RESULTS: Process parameters significantly affected the extent of cocrystallization which improved with temperature, applied shear and residence time. Processing above eutectic point was required for cocrystallization to occur, and it improved with mixing intensity by changing screw configuration. Product was in the form of spherical agglomerates, which showed directly compressible nature with enhanced dissolution rate compared to ibuprofen. This marks an important advantage over the conventional techniques, as it negates the need for further size modification steps. CONCLUSIONS: A single-step, scalable, solvent-free, continuous cocrystallization and agglomeration technology was developed using HME, offering flexibility for tailoring the cocrystal purity. HME being an established technology readily addresses the regulatory demand of quality by design (QbD) and process analytical technology (PAT), offering high potential for pharmaceuticals.
    URI
    http://hdl.handle.net/10454/5955
    Version
    No full-text in the repository
    Citation
    Dhumal RS, Kelly AL, York P et al (2010) Cocrystalization and simultaneous agglomeration using hot melt extrusion. Pharmaceutical Research. 27(12): 2725-2733.
    Link to publisher’s version
    http://dx.doi.org/10.1007/s11095-010-0273-9
    Type
    Article
    Collections
    Life Sciences Publications
    Engineering and Digital Technology Publications

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