Drug-Smectite Clay Amorphous Solid Dispersions Processed by Hot Melt Extrusion.

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 2h in the acidic media and a rapid release of IND at pH7.4. The work demonstrates that preparation of amorphous solid dispersion using inorganic smectite clay particles can effectively increase the dissolution rate of IND.