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Surface Composition and Formulation Heterogeneity of Protein Solids Produced by Spray Drying.

Nathan E Wilson1, Tarun Tejasvi Mutukuri1, Dmitry Y Zemlyanov2

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Summary

Saccharide excipients like sucrose and trehalose improve spray-dried protein stability by reducing surface protein concentration and matrix heterogeneity. Lower molecular weight saccharides enhance particle surface properties for better physical stability.

Keywords:
protein structuresolid formulationsolid-state hydrogen/deuterium exchange with mass spectrometric analysis (ssHDX-MS)spray-dryingsurface chemistry

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Biochemistry

Background:

  • Spray-dried protein formulations are crucial for drug delivery.
  • Understanding excipient effects on protein surface properties and heterogeneity is vital for stability.

Purpose of the Study:

  • To investigate how saccharide excipients impact the surface composition and matrix heterogeneity of spray-dried protein formulations.
  • To correlate these changes with protein structure and physical stability.

Main Methods:

  • Spray drying of myoglobin or BSA with sucrose, trehalose, or dextrans.
  • Characterization using ssFTIR, DSC, SEC, SEM, XPS, and ssHDX-MS.
  • Quantification of protein surface coverage and conformational changes.

Main Results:

  • Excipients induced structural differences, with dextrans perturbing secondary protein structure.
  • Sucrose and trehalose more effectively reduced protein surface concentration than dextrans.
  • A strong linear correlation (R²=0.853) was observed between protein surface coverage and ssHDX-MS data.

Conclusions:

  • Lower molecular weight saccharides enrich particle surfaces, decreasing protein concentration at the air-liquid interface.
  • This leads to reduced population heterogeneity and enhanced physical stability of protein formulations.
  • ssHDX-MS is a key technique for identifying these stability improvements.