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Hot Melt Extrusion for Amorphous Solid Dispersions: Temperature and Moisture Activated Drug–Polymer Interactions for Enhanced Stability

Hot melt extrudates (HMEs) of indomethacin (IND) with Eudragit EPO and Kollidon VA 64 and those of itraconazole (ITZ) with HPMCAS-LF and Kollidon VA 64 were manufactured using a Leistritz twin screw extruder. The milled HMEs were stored at controlled temperature and humidity conditions. The samples were collected after specified time periods for 3 months. The stability of amorphous HMEs was assessed using moisture analysis, thermal evaluation, powder X-ray diffraction, FTIR, HPLC, and dissolution study. In general, the moisture content increased with time, temperature, and humidity levels. Amorphous ITZ was physically unstable at very high temperature and humidity levels, and its recrystallization was detected in the HMEs manufactured using Kollidon VA 64. Although physical stability of IND was better sustained by both Eudragit EPO and Kollidon VA 64, chemical degradation of the drug was identified in the stability samples of HMEs with Eudragit EPO stored at 50 °C. The dissolution rates and the supersatur...

Authors:   Ashish L. Sarode; Harpreet Sandhu; Navnit Shah; Waseem Malick; Hossein Zia
Journal:   Molecular Pharmaceutics
Year:   2013
DOI:   10.1021/mp400165b
Publication date:   03-Sep-2013
Facts, background information, dossiers
  • stability
  • temperature
  • EPO
  • humidity
  • dissolution
  • x-ray diffraction
More about American Chemical Society Publications
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