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Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
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Updated: Jun 6, 2025

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Molecular mechanisms for stabilizing biologics in the solid state.

Jing Ling1, Yong Du2, W Peter Wuelfing1

  • 1Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, NJ 07065, USA.

Journal of Pharmaceutical Sciences
|December 1, 2024
PubMed
Summary

Solid-state biologics enhance protein drug stability using sugar substitution and matrix vitrification. Understanding these mechanisms aids in designing more stable protein drug formulations.

Keywords:
BiologicsInteractionLyophilizationMiscibilityMolecular dynamicsStability

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Area of Science:

  • Biophysics
  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Protein drugs face stability challenges due to their complex structures and dynamics.
  • Solid-state formulations offer enhanced stability compared to liquid formulations for biologics.
  • Understanding stabilization mechanisms is crucial for effective drug product design.

Purpose of the Study:

  • To review molecular mechanisms of protein drug stabilization in solid-state formulations.
  • To elucidate the roles of water-to-sugar substitution and matrix vitrification.
  • To provide a scientific rationale for designing stable solid biological drug products.

Main Methods:

  • Review of experimental investigations using advanced biophysical techniques.
  • Analysis of protein structure and protein-excipient interactions.
  • Assessment of molecular dynamics and microenvironmental properties in various states.

Main Results:

  • Detailed examination of thermodynamic and kinetic stabilization models.
  • Elucidation of protein-sugar and protein-salt miscibility and microenvironmental acidity.
  • Insights into molecular-level interactions influencing protein stability.

Conclusions:

  • Mechanistic understanding facilitates prediction of protein drug stability.
  • This knowledge enables rational design of solid biological drug products.
  • Advanced biophysical techniques are key to analyzing solid-state protein behavior.