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Low molecular weight chitosan-insulin polyelectrolyte complex: characterization and stability studies.

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Low molecular weight chitosans (LMWCs) enhance insulin stability, with 13 kDa LMWC being most effective. This forms an oral insulin delivery system with good bioactivity in diabetic rats.

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Area of Science:

  • Biochemistry
  • Materials Science
  • Pharmaceutical Sciences

Background:

  • Insulin stability is crucial for effective diabetes management.
  • Developing oral insulin delivery systems remains a significant challenge.
  • Low molecular weight chitosans (LMWCs) offer potential for biopolymer applications.

Purpose of the Study:

  • To investigate the impact of various LMWCs on insulin stability.
  • To explore the formation of insulin-LMWC polyelectrolyte complexes (PECs).
  • To evaluate the potential of an oral insulin delivery system using these PECs.

Main Methods:

  • Utilized United States Pharmacopeia (USP) High-Performance Liquid Chromatography (HPLC) methods.
  • Formed polyelectrolyte complexes (PECs) between insulin and LMWCs.
  • Investigated insulin-LMWC PECs in a Tris-buffer at pH 6.5.
  • Incorporated insulin-LMWC PECs into a reverse micelle (RM) system for oral administration.

Main Results:

  • Insulin demonstrated stability within the insulin-LMWC PEC in Tris-buffer (pH 6.5).
  • Insulin stability increased as the molecular weight of LMWC decreased.
  • 13 kDa LMWC proved most effective in enhancing both physical and chemical stability of insulin.
  • The developed oral delivery system showed acceptable bioactivity in diabetic rats.

Conclusions:

  • LMWCs significantly enhance the stability of insulin.
  • 13 kDa LMWC is optimal for stabilizing insulin through PEC formation.
  • Insulin-LMWC PECs solubilized in reverse micelles provide a viable oral delivery system for insulin with demonstrated bioactivity.