Stability studies of hot-melt extruded ternary solid dispersions of poorly-water soluble indomethacin with poly(vinyl pyrrolidone-co-vinyl acetate)and polyethylene oxide

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Abstract

This investigation aims to evaluate the effect of moisture and temperature on the physical stability and dissolution behaviour of hot-melt extruded binary and plasticised ternary solid dispersions. Poorly water-soluble indomethacin (IND), poly(vinyl pyrrolidone-co-vinyl acetate)(PVPVA)and plasticiser polyethylene oxide (PEO)were selected as model compounds. Extruded samples were stored with 40 °C, at 0% and 75% relative humidity (RH)for 12 weeks. Results confirmed that binary solid dispersions of PVPVA-IND were successfully prepared by twin-screw hot-melt extrusion producing amorphous single-phase systems. The inclusion of semi-crystalline PEO reduced the melt viscosity of the system acting as a processing aid during extrusion without modifying the glass transition temperature (Tg)of the final doses. Samples stored at low humidity levels exhibited a dissolution profile similar to the unannealed dispersions. Samples annealed at 75% RH showed a decrease in the dissolution rate, likely related to phase separation due to the increase in molecular mobility after the water sorption. However, all the annealed samples showed a total release of IND, indicating that the dispersions were relatively stable up to 12 weeks.

Original languageEnglish
Pages (from-to)248-254
Number of pages7
JournalJournal of Drug Delivery Science and Technology
Volume52
DOIs
Publication statusPublished - Aug 2019

Keywords

  • Amorphous solid dispersions
  • Hot-melt extrusion
  • Indomethacin
  • Poly(vinyl pyrrolidone-co-vinyl acetate)
  • Polyethylene oxide
  • Stability

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