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Developing Subcutaneous Formulations for Irisin as a Potential Therapeutic.

Gang Hu1,2, Xi Luan1, Michael J Hageman1,2

  • 1Department of Pharmaceutical Chemistry, The University of Kansas, Lawrence, KS, 66047, USA.

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Summary
This summary is machine-generated.

Researchers developed stable subcutaneous irisin formulations for potential obesity therapies. These formulations preserve irisin

Keywords:
irisinlyophilizationobesitystabilitysubcutaneous formulation

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Area of Science:

  • Biochemistry
  • Pharmacology
  • Endocrinology

Background:

  • Irisin, a myokine released during exercise, demonstrates potential therapeutic benefits.
  • Pharmaceutical development of irisin is hindered by limited characterization and formulation research.

Purpose of the Study:

  • To develop subcutaneous formulations of irisin suitable for pharmaceutical applications.
  • To characterize irisin and assess its biological activity.

Main Methods:

  • Irisin expression in E. coli, purification, and characterization using biophysical techniques.
  • Assessment of irisin's biological activity, specifically adipocyte browning induction.
  • Screening of pH, excipients, and formats (lyophilized vs. aqueous) for subcutaneous formulations.
  • Investigation of formulation stability under various storage conditions.

Main Results:

  • Successfully expressed and purified soluble and refolded irisin with comparable biophysical properties and bioactivity.
  • Developed stable lyophilized irisin formulations using phosphate buffer (pH 7), sucrose/trehalose, and polysorbate 80.
  • Formulations demonstrated rapid reconstitution, preserved irisin properties and bioactivity post-lyophilization, and showed stability at 40°C/75% RH for one month.

Conclusions:

  • Established stable subcutaneous irisin formulations suitable for pharmaceutical development.
  • These formulations provide a foundation for irisin-based therapies targeting obesity and related metabolic disorders.