Repetitive stability study of remdesivir/cyclodextrin complex on the international space station

Stability assessment of drugs in space is particularly important for future missions. In space there are multiple factors, such as the variability of the conditions (radiation, microgravity, vacuum etc.) that could affect the reliability and reproducibility of the data. Therefore, we investigated the stability of an anti-Covid drug formulation, Remdesivir (RDV) sulfobutylether-beta-cyclodextrin (SBECD) complex, in two separate flight experiments on the International Space Station (ISS). While HPLC/MS studies revealed no degradation of the cyclodextrin excipient in any of the samples investigated in both missions, RDV purity analysis of the RDV/SBECD complex after the first mission revealed different stabilities and altered degradation in space and on Earth. This latter interesting finding was not supported by the second mission, where no differences in the drug stabilities were identified. This anomaly highlighted the importance of standardization together with increased control of the variable parameters during the entire space missions and the terrestrial control experiments.

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Publication Details

Journal
Scientific Reports
Published
2025-02-04
DOI
https://doi.org/10.1038/s41598-024-81428-5
Primary Topic
Spaceflight effects on biology
Type
article
Field-Weighted Citation Impact
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article

Repetitive stability study of remdesivir/cyclodextrin complex on the international space station

Balázs Buchholcz, György M. Keserű, Ferenç Darvas, István Puskás et al.
Scientific Reports
Spaceflight effects on biology
article

Repetitive stability study of remdesivir/cyclodextrin complex on the international space station

Balázs Buchholcz, György M. Keserű, Ferenç Darvas, István Puskás, Pál Tamás Szabó, György Dormán, Lajos Szente, Erzsébet Varga
article en

Abstract

Stability assessment of drugs in space is particularly important for future missions. In space there are multiple factors, such as the variability of the conditions (radiation, microgravity, vacuum etc.) that could affect the reliability and reproducibility of the data. Therefore, we investigated the stability of an anti-Covid drug formulation, Remdesivir (RDV) sulfobutylether-beta-cyclodextrin (SBECD) complex, in two separate flight experiments on the International Space Station (ISS). While HPLC/MS studies revealed no degradation of the cyclodextrin excipient in any of the samples investigated in both missions, RDV purity analysis of the RDV/SBECD complex after the first mission revealed different stabilities and altered degradation in space and on Earth. This latter interesting finding was not supported by the second mission, where no differences in the drug stabilities were identified. This anomaly highlighted the importance of standardization together with increased control of the variable parameters during the entire space missions and the terrestrial control experiments.

Scientific ReportsVol. 15(1)
Budapest University of Technology and Economics (HU), CycloLab (Hungary) (HU), Innostart (Hungary) (HU), HUN-REN Research Centre for Natural Sciences (HU)
Yukawa Institute for Theoretical Physics, Kyoto University, Nemzeti Kutatási Fejlesztési és Innovációs Hivatal, National Research, Development and Innovation Office
Openalex Percentile: Top 97%
Spaceflight effects on biology
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