The influence of stevia on the flow, shear and compression behavior of sorbitol, a pharmaceutical excipient for direct compression

Pharm Dev Technol. 2018 Feb;23(2):125-131. doi: 10.1080/10837450.2017.1315132. Epub 2017 Apr 13.

Abstract

Good flow and compaction properties are necessary for the manipulation of particulate material in the pharmaceutical industry. The influence of the addition of an alternative sweetener, rebaudioside A, in a concentration 0.2% w/w and 0.5% w/w on the flow, shear and compaction properties of sorbitol for direct compaction, Merisorb® 200, was investigated in this work. Rebaudioside A worsened the flow properties of sorbitol: the Hausner ratio, the compressibility index and the mass flow rate through the aperture of a model hopper. Using a Jenike shear cell revealed a significant increase in cohesion leading to the decrease of the flow function; moreover, the addition of rebaudioside A increased the total energy for compression of tablets and plasticity estimated by the force-displacement method. Finally, the tablets showed a higher tensile strength and needed longer time to disintegrate compared to the tablets made of sorbitol itself. In view of the results for the free-flowable excipient, sorbitol, the effects of stevia even for a 0.2% w/w concentration have to be carefully considered, particularly whenever used in pharmaceutical formulations of poor flow properties.

Keywords: Jenike shear tester; Sorbitol; flowability; force–displacement method; rebaudioside A; tablets.

MeSH terms

  • Diterpenes, Kaurane / chemistry
  • Drug Compounding / methods
  • Excipients / chemistry*
  • Pressure
  • Sorbitol / chemistry*
  • Stevia / chemistry*
  • Sweetening Agents / chemistry
  • Tablets / chemistry
  • Technology, Pharmaceutical / methods
  • Tensile Strength

Substances

  • Diterpenes, Kaurane
  • Excipients
  • Sweetening Agents
  • Tablets
  • Sorbitol
  • rebaudioside A