Design and in vitro evaluation of a novel polymeric excipient for buccal applications

Future Med Chem. 2013 Apr;5(5):511-22. doi: 10.4155/fmc.13.33.

Abstract

Background: The objective of this study was to develop and evaluate a more effective mucoadhesive thiomer for buccal drug-delivery systems.

Methods: 2-iminothiolane was covalently attached to a chitosan backbone. A preactivation step followed, mediated by 6,6´dithionicotinamide, thiol groups were modified by disulfide bonds formation. Mucoadhesion studies were performed on buccal mucosa. In addition, water-uptake capacity, disintegration, release and cytotoxicity studies were completed.

Results: The obtained chitosan-thiobutylamidine conjugate displayed 647.4 ± 85.23 µmol/g immobilized thiol groups. Due to the preactivation, approximately 60% of thiol groups were modified by formation of disulfide bonds. Chitosan-thiobutylamidine-mercaptonicotinamide displayed 1.8-fold higher stability and 1.6-fold higher mucoadhesive properties, respectively. The release study demonstrated a 1.4-fold more prolonged drug release compared with corresponding thiomers.

Conclusion: According to these results, preactivated thiomers demonstrate an improved stability and increased mucoadhesive properties. Therefore, they seem to be advantageous for buccal administration over corresponding thiomers and chitosan.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Buccal
  • Animals
  • Caco-2 Cells
  • Cell Survival / drug effects
  • Chitin / analogs & derivatives*
  • Chitin / chemistry
  • Chitin / toxicity
  • Chitosan / analogs & derivatives
  • Chitosan / chemistry
  • Drug Carriers / chemistry*
  • Drug Carriers / toxicity
  • Excipients / chemistry
  • Excipients / toxicity
  • Hardness
  • Humans
  • Niacinamide / chemistry
  • Niacinamide / toxicity
  • Rhodamine 123 / administration & dosage
  • Sulfhydryl Compounds / chemistry*
  • Sulfhydryl Compounds / toxicity
  • Swine
  • Tablets
  • Water / chemistry

Substances

  • Drug Carriers
  • Excipients
  • Sulfhydryl Compounds
  • Tablets
  • chitosan 2-iminothiolane
  • chitosan-4-thiobutylamidine
  • Water
  • Chitin
  • Rhodamine 123
  • Niacinamide
  • Chitosan