Tableting of fluidized bed granules containing living microorganisms

Eur J Pharm Biopharm. 2023 Jun:187:57-67. doi: 10.1016/j.ejpb.2023.03.011. Epub 2023 Apr 18.

Abstract

Tablets are the favored dosage form for numerous active pharmaceutical ingredients, among others because they are easy to take, ensure safe dosing and allow cost-effective production on a large scale. This dosage form is also frequently chosen for the administration of viable probiotic microorganisms. Saccharomyces cerevisiae cells granulated in a fluidized bed process, with dicalcium phosphate (DCP), lactose (LAC) and microcrystalline cellulose (MCC) as carrier materials, were tableted using a compaction simulator, varying the compression stress. The tablets were analyzed regarding physical properties, e.g., porosity and tensile strength, as well as microbial survival. Carrier material and compression stress showed a significant influence on survival rate and physical tablet properties. The dependencies were related to material specific deformation characteristics and linked to mechanistic approaches to explain the different sensitivities.

Keywords: Compactibility; Compressibility; Deformation behavior; Porosity; Probiotics; Saccharomyces cerevisiae; Tableting; Tensile strength.

MeSH terms

  • Excipients* / chemistry
  • Tablets / chemistry
  • Tensile Strength

Substances

  • Tablets
  • Excipients