A preliminary assessment of the impact of hot-melt extrusion on the physico-mechanical properties of a tablet

Drug Dev Ind Pharm. 2014 Oct;40(10):1386-94. doi: 10.3109/03639045.2013.828216. Epub 2013 Aug 19.

Abstract

Objectives: This research aimed at investigating the difference between the powders prior to and after hot melt extrusion. A preliminary assessment was also conducted to gain a better mechanistic understanding of the impact of hot melt extrusion on tabletability.

Materials and methods: Kollidon® VA 64 and mannitol were sieved into different particles sizes and used as is or after drying for 24 h. Hot melt extrusion was used to manufacture an amorphous solid dispersion of Kollidon® VA 64 and mannitol. The extrudates were milled and sieved into different particles sizes. Tablets were manufactured from the different powders and their tabletability, compressibility and compactibility determined.

Results and discussions: It was shown that the as received tablets gave higher tabletability compared with the tablets manufactured from the dried or hot melt extruded (HME) powder. Differences in the tabletability between the as received. dried and HME material could be related back to changes in the bonding area and bonding strength as a result of the hot melt extrusion process and/or a loss of moisture because of the high processing temperature.

Conclusions: The reduced tabletability of the HME tablets appeared to be a function of multiple factors. Both the hot melt extrusion process and the moisture content may play significant roles in determining this phenomenon.

Keywords: Bonding area; bonding strength; compressibility; moisture content; physico-mechanical properties.

MeSH terms

  • Chemistry, Pharmaceutical / methods*
  • Drug Compounding / methods*
  • Mannitol / chemistry*
  • Particle Size
  • Powders
  • Pyrrolidines / chemistry*
  • Solubility
  • Tablets
  • Temperature
  • Time Factors
  • Vinyl Compounds / chemistry*

Substances

  • Powders
  • Pyrrolidines
  • Tablets
  • Vinyl Compounds
  • poly(vinylpyrrolidone-co-vinyl-acetate)
  • Mannitol