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Radiation Impact on Pharmaceutical Stability: Retrospective Data ReviewHistorical studies performed by the JSC Pharmacotherapeutics Discipline suggest that exposure to spaceflight conditions may compromise the safety and efficacy of some medications. Follow-on studies have revealed that affected medications demonstrate reductions in active pharmaceutical ingredient (API) concentrations and altered release characteristics. It was hypothesized that the changes in API potency and release were from the medication's exposure to the harsh environmental conditions of spaceflight. Subsequent review of the spaceflight environmental control records from the time of these studies indicated that temperature and humidity levels aboard all spacecraft remained within United States Pharmacopeia (USP) recommended ranges to maintain optimal pharmaceutical stability. Therefore, space radiation was presumed to be the source of observed drug degradation. The Pharmacotherapeutics Discipline conducted a ground analog radiation experiment in 2006 at the NASA Space Radiation Laboratory (NSRL) at Brookhaven to validate this theory and to characterize the effects of high-energy radioactive particles on pharmaceutical stability. These data were never published. Recently, the Exploration Medical Capability (ExMC) Element finalized a research plan (RP) aimed at providing a safe and effective medication formulary for exploration spaceflight. As ExMC begins to design new flight and ground analog radiation studies, further analysis of the 2006 NSRL study data is essential for the characterization of the impact of radiation on medication potency and efficacy in the exploration spaceflight environment.
Document ID
20170009940
Acquisition Source
Johnson Space Center
Document Type
Conference Paper
Authors
Daniels, V. R. (KBRwyle Science, Technology and Engineering Houston, TX, United States)
Bayuse, T. M. (KBRwyle Science, Technology and Engineering Houston, TX, United States)
McGuire, K. M. (NASA Johnson Space Center Houston, TX, United States)
Antonsen, E. L. (NASA Johnson Space Center Houston, TX, United States)
Putcha, L. (NASA Johnson Space Center Houston, TX, United States)
Date Acquired
October 12, 2017
Publication Date
January 22, 2017
Subject Category
Space Radiation
Aerospace Medicine
Report/Patent Number
JSC-CN-40553
Meeting Information
Meeting: NASA Human Research Program Investigators'' Workshop (HRP IWS 2018)
Location: Galveston, TX
Country: United States
Start Date: January 22, 2018
End Date: January 25, 2018
Sponsors: NASA Headquarters
Distribution Limits
Public
Copyright
Public Use Permitted.

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