Electrospun Solid Formulation of Anaerobic Gut Microbiome Bacteria

AAPS PharmSciTech. 2020 Jul 31;21(6):214. doi: 10.1208/s12249-020-01769-y.

Abstract

A model anaerobic bacterium strain from the gut microbiome (Clostridium butyricum) producing anti-inflammatory molecules was incorporated into polymer-free fibers of a water-soluble cyclodextrin matrix (HP-β-CD) using a promising scaled-up nanotechnology, high-speed electrospinning. A long-term stability study was also carried out on the bacteria in the fibers. Effect of storage conditions (temperature, presence of oxygen) and growth conditions on the bacterial viability in the fibers was investigated. The viability of the sporulated anaerobic bacteria in the fibers was maintained during 12 months of room temperature storage in the presence of oxygen. Direct compression was used to prepare tablets from the produced bacteria-containing fibers after milling (using an oscillating mill) and mixing with tableting excipients, making easy oral administration of the bacteria possible. No significant decrease was observed in bacterial viability following the processing of the fibers (milling and tableting).

Keywords: aqueous electrospinning; bacteria-loaded fibers; cyclodextrin; oral dosage form; scaled-up production.

MeSH terms

  • Anaerobiosis
  • Bacteria, Anaerobic / genetics
  • Bacteria, Anaerobic / isolation & purification*
  • Clostridium butyricum / genetics
  • Clostridium butyricum / isolation & purification*
  • Drug Compounding*
  • Excipients
  • Gastrointestinal Microbiome*
  • Humans
  • Phylogeny
  • RNA, Ribosomal, 16S / genetics
  • Sequence Analysis, DNA
  • Tablets
  • Temperature

Substances

  • Excipients
  • RNA, Ribosomal, 16S
  • Tablets