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Repetitive stability study of remdesivir/cyclodextrin complex on the international space station
György Dormán1,2, Balázs Buchholcz1, István Puskás3
1Innostudio, Inc., Záhony u. 7., Budapest, 1031, Hungary.
Scientific Reports
|February 5, 2025
Summary
Drug stability in space is crucial. Remdesivir (RDV) sulfobutylether-beta-cyclodextrin (SBECD) complex showed varied results across two space missions, highlighting the need for standardized conditions and controls for reliable space-based drug research.
Area of Science:
- Pharmaceutical Sciences
- Space Medicine
- Astrobiology
Background:
- Assessing drug stability in space is critical for long-duration space missions.
- Environmental factors in space, including radiation and microgravity, can impact drug integrity.
- The Remdesivir (RDV) and sulfobutylether-beta-cyclodextrin (SBECD) complex is a key anti-COVID-19 formulation.
Purpose of the Study:
- To evaluate the stability of the RDV/SBECD complex under spaceflight conditions.
- To compare drug degradation in space versus terrestrial environments.
- To identify critical parameters affecting drug stability during space missions.
Main Methods:
- Two separate International Space Station (ISS) flight experiments were conducted.
- High-Performance Liquid Chromatography/Mass Spectrometry (HPLC/MS) was used for analysis.
- Purity analysis of RDV and degradation studies were performed on returned samples.
Main Results:
- No degradation of the SBECD excipient was observed in either mission.
- The first mission indicated differing stabilities and altered degradation of RDV in space compared to Earth.
- The second mission did not replicate these findings, showing no significant differences in RDV stability.
Conclusions:
- Anomalous results from the first mission underscore the need for stringent standardization and control of variables in space experiments.
- Consistent and reproducible drug stability data requires meticulous attention to experimental conditions during spaceflight and ground controls.
- Further research is needed to fully understand and mitigate the effects of space environments on pharmaceutical formulations.
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