Menu

 

Task Book: Biological & Physical Sciences Division and Human Research Program
Advanced Search     

Project Title:  Development of Methods/Technologies for Medication Stability and Shelf-life Reduce
Fiscal Year: FY 2014 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 01/31/2013  
End Date: 12/31/2013  
Task Last Updated: 09/04/2014 
Download report in PDF pdf
Principal Investigator/Affiliation:   Wotring, Virginia  Ph.D. / Baylor College of Medicine 
Address:  Center for Space Medicine 
6500 Main St, Suite 910 
Houston , TX 77030 
Email: Virginia.Wotring@bcm.edu 
Phone:   
Congressional District:
Web:  
Organization Type: UNIVERSITY 
Organization Name: Baylor College of Medicine 
Joint Agency:  
Comments: PI formerly with Universities Space Research Association until fall 2015.  
Project Information: Grant/Contract No. Directed Research 
Responsible Center: NASA JSC 
Grant Monitor: Norsk, Peter  
Center Contact:  
Peter.norsk@nasa.gov 
Solicitation / Funding Source: Directed Research 
Grant/Contract No.: Directed Research 
Project Type: FLIGHT,GROUND 
Flight Program: ISS 
TechPort: No 
No. of Post Docs:  
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Pharm:Risk of Clinically Relevant Unpredicted Effects of Medication (IRP Rev D)
Human Research Program Gaps: (1) Pharm02:We do not know how long medications may be safe and effective beyond their expiration dates (IRP Rev E)
Flight Assignment/Project Notes: ISS

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.

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.

Research Impact/Earth Benefits: 0

Task Progress & Bibliography Information FY2014 
Task Progress: Nine medications were chosen on the basis of their availability for study. Each medication was available at a single time point; analysis of the same medication at multiple time points was not possible. Because the samples examined in this study were obtained opportunistically from medical supplies, there were no control samples available (i.e. samples aged for a similar period of time on Earth); a significant limitation of this study. Medications were analyzed using the HPLC/MS methods described in the United States Pharmacopeia (USP) to measure the amount of intact active ingredient, identify degradation products and measure their amounts. Only more comprehensive analysis of flight-aged samples compared to appropriately matched ground controls will permit determination of spaceflight effects on medication stability.

Bibliography Type: Description: (Last Updated: 12/24/2019)  Show Cumulative Bibliography Listing
 
Articles in Peer-reviewed Journals Wotring VE. "Chemical potency and degradation products of medications stored over 550 Earth days at the International Space Station." AAPS J. 2016 Jan;18(1):210-6. Epub 2015 Nov 6. http://dx.doi.org/10.1208/s12248-015-9834-5 ; PubMed PMID: 26546565; PubMed Central PMCID: PMC4706284 , Jan-2016
Project Title:  Development of Methods/Technologies for Medication Stability and Shelf-life Reduce
Fiscal Year: FY 2013 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 01/31/2013  
End Date: 12/31/2013  
Task Last Updated: 08/23/2013 
Download report in PDF pdf
Principal Investigator/Affiliation:   Wotring, Virginia  Ph.D. / Baylor College of Medicine 
Address:  Center for Space Medicine 
6500 Main St, Suite 910 
Houston , TX 77030 
Email: Virginia.Wotring@bcm.edu 
Phone:   
Congressional District:
Web:  
Organization Type: UNIVERSITY 
Organization Name: Baylor College of Medicine 
Joint Agency:  
Comments: PI formerly with Universities Space Research Association until fall 2015.  
Project Information: Grant/Contract No. Directed Research 
Responsible Center: NASA JSC 
Grant Monitor: Norsk, Peter  
Center Contact:  
Peter.norsk@nasa.gov 
Solicitation / Funding Source: Directed Research 
Grant/Contract No.: Directed Research 
Project Type: FLIGHT,GROUND 
Flight Program: ISS 
TechPort: No 
No. of Post Docs:  
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Pharm:Risk of Clinically Relevant Unpredicted Effects of Medication (IRP Rev D)
Human Research Program Gaps: (1) Pharm02:We do not know how long medications may be safe and effective beyond their expiration dates (IRP Rev E)
Flight Assignment/Project Notes: ISS

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.

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.

Research Impact/Earth Benefits: 0

Task Progress & Bibliography Information FY2013 
Task Progress: New project for FY2013.

Bibliography Type: Description: (Last Updated: 12/24/2019)  Show Cumulative Bibliography Listing
 
 None in FY 2013