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Drug–Smectite Clay Amorphous Solid Dispersions Processed by Hot Melt Extrusion

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  • Theme: Pharmaceutical Thermal Processing - An Update
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Abstract

The aim of this study was to introduce smectite clay matrices as a drug delivery carrier for the development of amorphous solid dispersions (ASD). Indomethacin (IND) was processed with two different smectite clays, magnesium aluminium and lithium magnesium sodium silicates, using hot melt extrusion (HME) to prepare solid dispersions. Scanning electron microscopy (SEM), powdered X-ray diffraction (PXRD), and differential scanning calorimetry (DSC) were used to examine the physical form of the drug. Energy-dispersive X-ray (EDX) spectroscopy was used to investigate the drug distribution, and attenuated total reflectance-Fourier transform infrared (ATR-FTIR) spectroscopic analysis was done to detect any chemical interaction between these two kinds. Both PXRD and DSC analyses showed that drug–clay solid dispersion contained IND in amorphous form. EDX analysis showed a uniform IND dispersion in the extruded powders. ATR-FTIR data presented possible drug and clay interactions via hydrogen bonding. In vitro drug dissolution studies revealed a lag time of about 2 h in the acidic media and a rapid release of IND at pH 7.4. The work demonstrates that preparation of amorphous solid dispersion using inorganic smectite clay particles can effectively increase the dissolution rate of IND.

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Funding

This project has received funding from the Interreg 2 Seas programme 2014–2020 co-funded by the European Regional Development Fund under subsidy contract 2S01-059_IMODE.

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Authors and Affiliations

  1. Faculty of Engineering and Science, School of Science, University of Greenwich, Chatham Maritime, Chatham, Kent, ME4 4TB, UK

    Uttom Nandi, Md. S.H. Mithu & Andrew P. Hurt

  2. CIPER Centre for Innovation and Process Engineering Research, Chatham, Kent, ME4 4TB, UK

    Uttom Nandi, Md. S.H. Mithu & Dennis Douroumis

  3. Medway School of Pharmacy, University of Kent, Central Avenue, Chatham Maritime, Canterbury, Kent, ME4 4TB, UK

    Vivek Trivedi

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  1. Uttom Nandi
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Correspondence to Dennis Douroumis.

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Nandi, U., Mithu, M.S., Hurt, A.P. et al. Drug–Smectite Clay Amorphous Solid Dispersions Processed by Hot Melt Extrusion. AAPS PharmSciTech 21, 276 (2020). https://doi.org/10.1208/s12249-020-01813-x

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  • DOI: https://doi.org/10.1208/s12249-020-01813-x

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