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Polymers as Stabilizing Excipients for Spray-Dried Protein Formulations.

Chanakya D Patil1, Yijing Huang1, Kinnari Santosh Arte1

  • 1Department of Industrial and Molecular Pharmaceutics, College of Pharmacy, Purdue University, West Lafayette, IN, 47907, USA.

Pharmaceutical Research
|December 22, 2025
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Summary
This summary is machine-generated.

New polymeric excipients, (2-hydroxypropyl)-β-cyclodextrin (HPβCD) and hydrolyzed gelatin, enhance spray-dried bovine serum albumin (BSA) stability. These alternatives show promise over traditional sugar stabilizers for biologic drug products.

Keywords:
aggregationpolymerprotein formulationsreconstitutionspray drying

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Area of Science:

  • Pharmaceutical Sciences
  • Biotechnology
  • Materials Science

Background:

  • Biologic drug products require stabilization during storage, often achieved through drying techniques.
  • Spray drying is a high-throughput alternative to freeze-drying for enhancing drug product stability.
  • Stabilizing excipients are crucial for protecting sensitive proteins from degradation during processing and storage.

Purpose of the Study:

  • To evaluate polysaccharide- and protein-lysate-based polymeric excipients as alternatives to conventional stabilizers like trehalose and mannitol.
  • To assess the stabilizing potential of (2-hydroxypropyl)-β-cyclodextrin (HPβCD) and hydrolyzed gelatin for spray-dried bovine serum albumin (BSA).
  • To compare the efficacy of novel excipients against traditional sugar stabilizers for protein protection during spray drying and storage.

Main Methods:

  • Preparation of spray-dried BSA formulations using HPβCD, hydrolyzed gelatin, dextran 20 kDa, or sodium carboxymethyl cellulose (NaCMC), with or without trehalose or mannitol.
  • Assessment of protein stability by monitoring monomer loss under stressed storage conditions (40°C for 3 months).
  • Analysis of crystallinity (PXRD), secondary structure changes (ssFTIR), particle characteristics, and reconstitution times.

Main Results:

  • Formulations with HPβCD or hydrolyzed gelatin demonstrated significantly lower BSA monomer loss compared to trehalose or mannitol alone.
  • Dextran 20 kDa and NaCMC formulations exhibited poor protein stability.
  • Powder X-ray diffraction revealed salt crystallization, and solid-state Fourier transform infrared spectroscopy indicated secondary structure changes in BSA over time.

Conclusions:

  • HPβCD and hydrolyzed gelatin effectively improved the physical stability of spray-dried BSA.
  • These polymeric excipients show potential as superior stabilizing additives compared to traditional sugar-based stabilizers.
  • The findings support the use of HPβCD and hydrolyzed gelatin for enhancing the stability of protein-based pharmaceuticals.