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Quantitative Analysis of Spaceflight Drug Stability Data to Support a Predictive Pharmaceutical Testing StrategyTo systematically quantify the time-dependent effect of spaceflight on active pharmaceutical ingredient (API) degradation, data were extracted from available published and unpublished spaceflight drug stability studies. Seven studies were identified that investigated the stability of individual medications following storage aboard crewed spacecraft. Medications stored for up to 2.4 years in low earth orbit (LEO) show limited change in API potency that, in all cases, falls within 10% of matched terrestrial controls, and within 5% of controls for the most drugs. This investigation shows that spaceflight is associated with a ~1.5-fold increase in the degradation rate relative to lot-matched terrestrial controls. Spaceflight is associated with an increased probability of drug failure over time; however, the incremental increase in degradation risk associated with spaceflight is minor compared to the baseline risk associated with terrestrial controls. Since most drugs across all NASA-supported studies were repackaged solid oral formulations that had been removed from protective manufacturer packaging, it is likely that prolonged exposure to atmospheric factors during both terrestrial and spaceflight treatments is a key contributor to degradation. Unique spaceflight environmental factors, particularly ionizing radiation and elevated CO2, may contribute to the additional cumulative effect of spaceflight. The results of this study show that the effect of spaceflight on drug stability is minor relative to the terrestrial baseline; however, the degradation rate and time-dependent failure of terrestrial controls highlights an extremely critical need to evaluate the effect of current repackaging methods and development of operationally appropriate methods to protected repackaged solid oral medications from environmental factors that mediate degradation.
Document ID
20210022179
Acquisition Source
Johnson Space Center
Document Type
Conference Paper
Authors
J F Reichard
(Johnson Space Center Houston, Texas, United States)
S E Phelps
(Wyle (United States) El Segundo, California, United States)
B D Easter
(Johnson Space Center Houston, Texas, United States)
Date Acquired
September 30, 2021
Subject Category
Aerospace Medicine
Meeting Information
Meeting: HRP IWS 2022
Location: Virtual
Country: US
Start Date: February 7, 2022
End Date: February 10, 2022
Sponsors: National Aeronautics and Space Administration
Funding Number(s)
WBS: 10449.2.02.02.11.0669
Distribution Limits
Public
Copyright
Portions of document may include copyright protected material.
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