Task Book


Key Personnel Changes / Previous PI:	NOTE: previously combined in project entitled Stability of Pharmacotherapeutics and Nutrition Compounds, with Scott Smith as PI and Lakshmi Putcha as Co-PI; split into two Task Book projects in January 2010 for the entire project period, per JSC direction, with each CoPI listed as PI (ed.)

Project Information:

Responsible Center: NASA JSC Grant Monitor: Goodwin, Thomas Center Contact: thomas.j.goodwin@nasa.gov	Solicitation / Funding Source: 2004 Space Life Sciences 04-OBPR-01: ILSRA 2004 Project Type: FLIGHT Flight Program: Shuttle/ISS TechPort: No	No. of Post Docs: 0 No. of PhD Candidates: 1 No. of Master's Candidates: 0 No. of Bachelor's Candidates: 0	No. of PhD Degrees: 1 No. of Master's Degrees: 0 No. of Bachelor's Degrees: 0

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) PH09:What is the stability of drugs during long duration spaceflight? (this gap has become Pharm02) (IRP Rev D)

Flight Assignment/Project Notes:	ISS STS-121, STS-117, STS-122, STS-126

Task Description:	Data gathered from past Space Shuttle missions suggest that some of the medications packed in the Shuttle's medical pack degrade even after relatively brief periods (less than 20 days) of space flight. The observed degradation included both physical and chemical characteristics of medicine formulations. The degradation was sufficient to influence FDA stipulated shelf-life for these formulations and may result in a loss of potency. Physical and chemical instability of medications could render treatments with degraded drugs ineffective for assurance of optimal crew health during long duration space exploration missions. An evaluation of subjective data on medications used by crewmembers during space flight indicated that eight percent of all treatments administered in the Space Shuttle program were reported ineffective. Pharmaceutical instability may modify effectiveness and safety, and is one possible cause of the ineffectiveness of treatments. Degradation of food products will also render them ineffective in providing health and energy sustenance. The stability of medications and foods used by the crew, therefore, must be adequate to facilitate safe exploration of space in the future. The Stability of Pharmaceuticals, constituent Stability payload investigation, evaluated mission critical medications understand issues relating to loss of potency and resultant impact on shelf-life of medications in space. See also http://www.nasa.gov/mission_pages/station/science/experiments/Stability.html

Research Impact/Earth Benefits:	The results of this investigation will help understand the effects of adverse environments on stability and shelf-life of medications, this information will be useful for long-range military operations and Earth based explorers make choices for efficacious treatments in remote and adverse habitats like the Antarctic, arctic and multiple world terrains. With the advent of emerging global pharmaceutical supply industry and adverse environment war-zone activities, understanding shelf-life characteristics of medications will assure safe and effective therapeutics in the future.

Task Progress & Bibliography Information FY2010

Task Progress:	Sixteen medication kits were designed containing identical sets of 35 medications from various dosage forms and therapeutic classes exposed to flight and ground-control environment paradigms. The flight paradigm involved 4 medication kits flown aboard a Shuttle to the International Space Station (ISS). Three flight kits were stored on the ISS and returned to Earth incrementally; while one kit remained on the Shuttle for immediate return 13 days later. Content-indicating assays produced by Ultra and High Performance Liquid Chromatography and physical stability assessments for each medication were performed using methods and testing procedures obtained from the most current version available of the United States Pharmacopoeia or scientific literature. Simultaneous analysis was performed on flight and ground-control kit medications. After 28 month of space exposure, 17 percent of flight kit and 5 percent of ground-control kit medications had changes in appearance; which included discoloration, and phase separation for semi-solid formulations. Nine medications in the flight kits met content acceptance criteria following 28 months of space exposure; which included one aqueous formulation, ciprofloxacin ophthalmic solution, a semi-solid, triamcinolone ointment, and seven solids, acyclovir tablet, atorvastatin tablet, azithromycin tablet, cefadroxil capsule, ibuprofen tablet, imipenem / cilastatin injection powder, and metronidazole tablet. After 28 months of spaceflight, there were medications that failed content requirement in flight, but met it in the control kits; which suggests altered physiochemical stability due to the spaceflight environment.

Bibliography Type:	Description: (Last Updated: 11/12/2020) Show Cumulative Bibliography Listing

Abstracts for Journals and Proceedings	Du B, Daniels V, Crady C, Boyd J, Putcha L. "Pharmaceutical stability in Space - content analysis." Presented at the Annual meeting and Exposition of the AAPS, Sept. 8-12, 2009. AAPS Journal 2009(S2). , Nov-2009

Abstracts for Journals and Proceedings	Chuong MC, Prasad D, LeDuc B, Du B, Putcha L. "Pharmaceutical Stability of Vitamin B Complex in the Outer Space Bioenvironments Retrieved Multivitamin and Multimineral Supplements." Presented at the Annual Meeting and Exposition of the AAPS, November 8-12, 2009. AAPS Journal 2009;11(S2): abstract #1021. http://www.aapsj.org/abstracts/AM_2009/AAPS2009-001021.PDF , Nov-2009

Articles in Peer-reviewed Journals	Du B, Daniels VR, Vaksman Z, Boyd JL, Crady C, Putcha L. "Evaluation of physical and chemical changes in pharmaceuticals flown on space missions." AAPS J. 2011 Jun;13(2):299-308. Epub 2011 Apr 9. PMID: 21479701 , Jun-2011

Articles in Peer-reviewed Journals	Chuong MC, Prasad D, Leduc B, Du B, Putcha L. "Stability of vitamin B complex in multivitamin and multimineral supplement tablets after space flight." J Pharm Biomed Anal. 2011 Jul 15;55(5):1197-200. Epub 2011 Mar 29. PubMed PMID: 21515013 , Jul-2011

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Project Title: Stability of Pharmacotherapeutics and Nutrition Compounds-Pharma

Reduce

Fiscal Year: FY 2006
Division: Human Research
Research Discipline/Element:
HRP HHC:Human Health Countermeasures

Start Date: 10/01/2005
End Date: 12/31/2009
Task Last Updated: 01/12/2010

Download report in PDF pdf

Principal Investigator/Affiliation: Putcha, Lakshmi Ph.D. / NASA Johnson Space Center

Address:

2101 NASA Parkway
Mail Code: SK
Houston , TX 77058

Email: lakshmi.putcha-1@nasa.gov, jason.boyd-1@nasa.gov
Phone: 281-483-7760
Congressional District: 22
Web:

Organization Type: NASA CENTER
Organization Name: NASA Johnson Space Center
Joint Agency:
Comments: Deceased as of September 2015.

Co-Investigator(s)
Affiliation:

Du, Brian	Wyle Life Sciences
Boyd, Jason	Universities Space Research Association


Key Personnel Changes / Previous PI:	NOTE: previously combined in project entitled Stability of Pharmacotherapeutics and Nutrition Compounds, with Scott Smith as PI and Lakshmi Putcha as Co-PI; split into two Task Book projects in January 2010 for the entire project period, per JSC direction, with each CoPI listed as PI (ed.)

Project Information:

Responsible Center: NASA JSC Grant Monitor: Meck, J@n Center Contact: 281-244-5405 janice.v.meck@nasa.gov	Solicitation / Funding Source: 2004 Space Life Sciences 04-OBPR-01: ILSRA 2004 Project Type: FLIGHT Flight Program: Shuttle/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) PH09:What is the stability of drugs during long duration spaceflight? (this gap has become Pharm02) (IRP Rev D)

Flight Assignment/Project Notes:	ISS STS-121, STS-117, STS-122, STS-126

Task Description:	Data gathered from past Space Shuttle missions suggest that some of the medications packed in the Shuttle's medical pack degrade even after relatively brief periods (less than 20 days) of space flight. The observed degradation included both physical and chemical characteristics of medicine formulations. The degradation was sufficient to influence FDA stipulated shelf-life for these formulations and may result in a loss of potency. Physical and chemical instability of medications could render treatments with degraded drugs ineffective for assurance of optimal crew health during long duration space exploration missions. An evaluation of subjective data on medications used by crewmembers during space flight indicated that eight percent of all treatments administered in the Space Shuttle program were reported ineffective. Pharmaceutical instability may modify effectiveness and safety, and is one possible cause of the ineffectiveness of treatments. Degradation of food products will also render them ineffective in providing health and energy sustenance. The stability of medications and foods used by the crew, therefore, must be adequate to facilitate safe exploration of space in the future. The Stability of Pharmacotherapeutic and Nutritional Compounds (Stability) investigation will evaluate mission critical medications and foods to understand issues relating loss of potency for medicines and to nutritional adequacy of foods in space. See also http://www.nasa.gov/mission_pages/station/science/experiments/Stability.html

Research Impact/Earth Benefits:	The results of this investigation will help understand the effects of adverse environments on food and medicines, this information will assist Earth based explorers make healthy choices for long term exploration of remote and adverse habitats like the Antarctic, arctic and the world oceans.

Task Progress & Bibliography Information FY2006

Task Progress:	New project for FY2006. [Ed. note: added to Task Book in January 2010; previously combined in project entitled Stability of Pharmacotherapeutics and Nutrition Compounds, with Scott Smith as PI and Lakshmi Putcha as Co-PI]

Bibliography Type:	Description: (Last Updated: 11/12/2020) Show Cumulative Bibliography Listing
	None in FY 2006

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