The AAPS Journal

, Volume 13, Issue 2, pp 299–308 | Cite as

Evaluation of Physical and Chemical Changes in Pharmaceuticals Flown on Space Missions

  • Brian Du
  • Vernie R. Daniels
  • Zalman Vaksman
  • Jason L. Boyd
  • Camille Crady
  • Lakshmi Putcha
Research Article

Abstract

Efficacy and safety of medications used for the treatment of astronauts in space may be compromised by altered stability in space. We compared physical and chemical changes with time in 35 formulations contained in identical pharmaceutical kits stowed on the International Space Station (ISS) and on Earth. Active pharmaceutical content (API) was determined by ultra- and high-performance liquid chromatography after returning to Earth. After stowage for 28 months in space, six medications aboard the ISS and two of matching ground controls exhibited changes in physical variables; nine medications from the ISS and 17 from the ground met the United States Pharmacopeia (USP) acceptance criteria for API content after 28 months of storage. A higher percentage of medications from each flight kit had lower API content than the respective ground controls. The number of medications failing API requirement increased as a function of time in space, independent of expiration date. The rate of degradation was faster in space than on the ground for many of the medications, and most solid dosage forms met USP standard for dissolution after storage in space. Cumulative radiation dose was higher and increased with time in space, whereas temperature and humidity remained similar to those on the ground. Exposure to the chronic low dose of ionizing radiation aboard the spacecraft as well as repackaging of solid dosage forms in flight-specific dispensers may adversely affect stability of pharmaceuticals. Characterization of degradation profiles of unstable formulations and identification of chemical attributes of stability in space analog environments on Earth will facilitate development of space-hardy medications.

KEY WORDS

chromatography dissolution pharmaceutical stability potency space radiation 

Supplementary material

12248_2011_9270_MOESM1_ESM.doc (51 kb)
Table S I(DOC 51 kb)
12248_2011_9270_MOESM2_ESM.doc (63 kb)
Table S II(DOC 63 kb)
12248_2011_9270_MOESM3_ESM.doc (66 kb)
Table S III A(DOC 66 kb)
12248_2011_9270_MOESM4_ESM.doc (132 kb)
Table S III B(DOC 131 kb)

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Copyright information

© American Association of Pharmaceutical Scientists 2011

Authors and Affiliations

  • Brian Du
    • 1
  • Vernie R. Daniels
    • 1
  • Zalman Vaksman
    • 2
  • Jason L. Boyd
    • 3
  • Camille Crady
    • 1
  • Lakshmi Putcha
    • 4
  1. 1.Wyle Integrated Science and Engineering GroupHoustonUSA
  2. 2.Texas Medical CenterUniversity of TexasHoustonUSA
  3. 3.Universities Space Research AssociationHoustonUSA
  4. 4.Pharmacotherapeutics Laboratory, SK/Human Adaptation and Countermeasures DivisionNASA Johnson Space CenterHoustonUSA

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