Colloidal Stability Analysis in the Formulation Process of the Type II Diabetes Drug

Researcher(s)

  • Lila Hintz, Chemical Engineering, University of Delaware

Faculty Mentor(s)

  • Norman Wagner, Chemical & Biomolecular Engineering, University of Delaware

Abstract

GLP-1 receptor agonist drugs are meant to revolutionize the course of treatment for patients with type II diabetes. This new type of medication activates the GLP-1 receptors in the pancreas, which then increases insulin production in the patient. With this drug being a weekly injectable, it is meant to be an improved substitution for patients who require daily insulin injections. Because type II diabetes is becoming an increasing problem in today’s world, it is crucial to study GLP-1 receptor agonist drugs. The focus of my summer research is on obtaining a better understanding of the parameters that affect the stability and particle size distribution of semaglutide, which is one example of a GLP-1 receptor agonist drug. To achieve this goal, a series of formulations with varying excipient conditions (NaCl, propylene glycol) and varying preservative concentrations (phenol, 2-30 mg/mL) are studied on a range of temperatures (5-25 °C) by utilizing light scattering techniques. Using the obtained data, a phase diagram and particle size distribution diagram are generated for the molecule. From this preliminary analysis, three main conclusions are reached:

(1) Structural similarities seem to exist between these acylated peptides and surfactants (micelles)

(2) The acylated peptides do not show the same temperature dependency pattern of micelles

(3) NaCl seems to be the main factor affecting micelle formation and turbidity

These observed trends will be further studied in the hope of eventually creating a better understanding of the parameters affecting the stability of GLP-1 receptor agonist drugs.