Responsible Center: NASA JSC
Grant Monitor: Norsk, Peter
Center Contact:
Peter.norsk@nasa.gov
Unique ID: 9393
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Solicitation / Funding Source: Directed Research
Grant/Contract No.: Directed Research
Project Type: FLIGHT,GROUND
Flight Program: ISS
TechPort: No |
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| Human Research Program Elements: |
(1) HHC:Human Health Countermeasures
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| Human Research Program Risks: |
(1) Pharm:Risk of Ineffective or Toxic Medications During Long-Duration Exploration Spaceflight
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| Human Research Program Gaps: |
(1) Pharm-101:We need to determine the optimal packaging/storage strategy for medications in space that balances the needs of mitigating toxicity, preserving effectiveness, and minimizing resource “costs” (mass, volume, power, etc.).
(2) Pharm-201:We need to establish an exploration formulary that identifies medications with maximal clinical benefit and minimal resource “costs” (mass, volume, etc.).
(3) Pharm-301:We need to categorize all medications that are included in the iterative Exploration Candidate Formulary based upon the current state of knowledge of their effectiveness and safety in the spaceflight environment.
(4) Pharm-401:We need to perform further research to understand and characterize the active pharmaceutical ingredient and degradation profiles of medications for which we have low to moderate confidence in their safety and effectiveness for exploration missions.
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| Flight Assignment/Project Notes: |
ISS |
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| Task Description: |
This study will analyze 9 expired medications that were returned from the ISS in numbers sufficient for analysis (at least 40 units each). These medications include several of the most heavily used by our crewmembers: 2 sleep aids, 2 antihistamines/decongestants, 3 pain relievers, an antidiarrheal, and an alertness medication. All of these medications expired between February and June 2012. The Clinical Pharmacy has records of their lot numbers, purchase dates, launch dates, and for those medications that were repackaged, repackaging dates. There are no control samples available, which is a significant drawback. Notwithstanding, we suggest that analysis should be conducted using the HPLC/MS methods described in the United States Pharmacopeia for each of these medications to measure the amount of intact active ingredient in each medication, identify degradation products, and measure their amounts as well. Without ground controls, we cannot answer the question of differences in flight-aging compared to ground-aging. However, determination of the safety and efficacy of these 9 heavily-used medications soon after storage on the ISS will provide useful information on the stability of these medications and may help determine the priority of future studies. |
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| Rationale for HRP Directed Research: |
Pharmacology has obtained some medications that expired on the ISS and were returned on the fall 2012 SpaceX flight. These medications have now been inventoried by the Clinical Pharmacy and transferred to a stability chamber in the research laboratory, pending approval to proceed. A rapid determination of the safety and efficacy of these 9 heavily-used medications soon after storage on the ISS will be very informative. |
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| Research Impact/Earth Benefits: |
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