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Insulin Formulations: Types and Delivery01:27

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Insulin preparations are categorized by their duration of action into short-acting and long-acting types. Two strategies are used to modify insulin's absorption and pharmacokinetic profile: slowing the absorption post-subcutaneous injection, or altering human insulin's amino acid sequence or protein structure. These changes retain the insulin's ability to bind to the insulin receptor, but alter its behavior in solution or after injection.
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The endoplasmic reticulum (ER) of pancreatic β-cells synthesizes preproinsulin, which consists of a signal peptide, A and B chains, and a C-peptide. Preproinsulin is then cleaved and folded into proinsulin, which translocates to the Golgi apparatus for sorting and packaging into secretory granules. In these granules, enzymatic clipping generates insulin and C-peptide.
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Engineering Insulin Cold Chain Resilience to Improve Global Access.

Caitlin L Maikawa1, Joseph L Mann2, Aadithya Kannan3

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New copolymer excipients stabilize insulin formulations for over six months under severe stress, improving cold chain resilience. This innovation aims to expand global access to essential diabetes treatments.

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Area of Science:

  • Pharmaceutical Sciences
  • Polymer Chemistry
  • Endocrinology

Background:

  • Diabetes affects 150 million people globally, necessitating insulin therapy.
  • Rising diabetes prevalence, particularly in low-income countries, highlights the need for accessible treatments.
  • Current insulin formulations require strict cold chain management, limiting accessibility.

Purpose of the Study:

  • To develop novel amphiphilic copolymer excipients for insulin stabilization.
  • To enhance the integrity, bioactivity, and stability of insulin formulations.
  • To improve the cold chain resilience of commercial insulin products.

Main Methods:

  • Synthesis and characterization of amphiphilic copolymer excipients.
  • Formulation of insulin with copolymer additives under stressed aging conditions (e.g., elevated temperature).
  • Assessment of insulin integrity, aggregation, bioactivity, pharmacokinetics, and pharmacodynamics.

Main Results:

  • Copolymer excipients maintained insulin formulation integrity, bioactivity, pharmacokinetics, and pharmacodynamics for over 6 months under severe stress.
  • Commercial insulin formulations failed in under 2 weeks under identical conditions.
  • Copolymers prevented insulin aggregation for up to 4 days at 50°C in commercial packaging, compared to less than 1 day for insulin alone.

Conclusions:

  • Simple "drop-in" amphiphilic copolymer excipients significantly enhance insulin formulation stability.
  • These excipients improve cold chain resilience, potentially reducing reliance on refrigeration.
  • The developed formulation additives show promise for expanding global access to critical diabetes medications.