The effect of unloading and ejection conditions on the properties of pharmaceutical tablets

Int J Pharm. 2024 Jun 10:658:124150. doi: 10.1016/j.ijpharm.2024.124150. Epub 2024 Apr 23.

Abstract

This study investigates decompression and ejection conditions on tablet characteristics by comparing compact densities and tensile strengths made using regular rigid dies and custom-built die systems that enable triaxial decompression. Die-wall pressure evolution during decompression and ejection stresses did not meaningfully impact the density and tensile strength of the materials tested: microcrystalline cellulose, crystalline lactose monohydrate, and mannitol. Furthermore, the apparent differences in tensile strength between rectangular cuboids and cylindrical compacts are unrelated to decompression and ejection conditions, but rather a consequence of their shapes and of the test configurations. This suggests that elastic and plastic deformations that may occur during decompression and ejection are not significantly influenced by die-wall pressure evolution. We thus conclude that while triaxial decompression and constraint-free ejection may allow the production of defect-free compacts for materials that otherwise are defect prone using a rigid die, they seem to pose no benefits when the materials already produce defect-free compacts using a rigid die.

Keywords: Mechanical properties; Pharmaceutical powder; Powder compaction; Tableting; Tensile strength; Triaxial decompression.

MeSH terms

  • Cellulose* / chemistry
  • Chemistry, Pharmaceutical / methods
  • Drug Compounding / methods
  • Excipients* / chemistry
  • Lactose* / chemistry
  • Mannitol* / chemistry
  • Pressure
  • Tablets*
  • Technology, Pharmaceutical / methods
  • Tensile Strength*

Substances

  • Tablets
  • Cellulose
  • microcrystalline cellulose
  • Lactose
  • Mannitol
  • Excipients