Impact of spin-freezing parameters and excipient composition on product stability of a PEGylated peptide formulation.
Quick Facts
What This Study Found
For a PEGylated peptide drug, the choice of sugar excipient (trehalose, mannitol, or sucrose-mannitol) had a far greater impact on stability than spin-freezing parameters. Trehalose gave the best stability. Sucrose-mannitol degraded badly at high temperature.
Key Numbers
Three formulations tested: trehalose, mannitol, sucrose-mannitol (75:25). Four spin-freezing conditions. Storage at 2-8°C or 50°C for up to 13 weeks. Sucrose-mannitol showed cake collapse, browning, and degradation at 50°C.
How They Did This
Compared trehalose, mannitol, and sucrose-mannitol formulations across four spin-freezing conditions. Evaluated peptide concentration, monomer content, and cake morphology after batch drying and accelerated/refrigerated storage.
Why This Research Matters
Continuous freeze-drying is a promising manufacturing method for peptide drugs. This study shows that formulation choice matters more than processing conditions for product stability.
What This Study Doesn't Tell Us
Single PEGylated peptide studied. Results may not generalize to all peptide drugs. 50°C is an accelerated stress condition, not normal storage.
Trust & Context
- Original Title:
- Impact of spin-freezing parameters and excipient composition on product stability of a PEGylated peptide formulation.
- Published In:
- International journal of pharmaceutics, 683, 126007 (2025)
- Authors:
- Schaal, Zarah, Bockstal, Pieter-Jan Van, Lammens, Joris, Lenger, Julian H, Funke, Adrian P, Schneid, Stefan C, Beer, Thomas De
- Database ID:
- RPEP-13449
Evidence Hierarchy
Read More on RethinkPeptides
Cite This Study
https://rethinkpeptides.com/research/RPEP-13449APA
Schaal, Zarah; Bockstal, Pieter-Jan Van; Lammens, Joris; Lenger, Julian H; Funke, Adrian P; Schneid, Stefan C; Beer, Thomas De. (2025). Impact of spin-freezing parameters and excipient composition on product stability of a PEGylated peptide formulation.. International journal of pharmaceutics, 683, 126007. https://doi.org/10.1016/j.ijpharm.2025.126007
MLA
Schaal, Zarah, et al. "Impact of spin-freezing parameters and excipient composition on product stability of a PEGylated peptide formulation.." International journal of pharmaceutics, 2025. https://doi.org/10.1016/j.ijpharm.2025.126007
RethinkPeptides
RethinkPeptides Research Database. "Impact of spin-freezing parameters and excipient composition..." RPEP-13449. Retrieved from https://rethinkpeptides.com/research/schaal-2025-impact-of-spinfreezing-parameters
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.