| Evaluation of physical and chemical changes in pharmaceuticals flown on space missions. | |
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MedLine Citation:
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PMID: 21479701 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Brian Du; Vernie R Daniels; Zalman Vaksman; Jason L Boyd; Camille Crady; Lakshmi Putcha |
Publication Detail:
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Type: Journal Article; Research Support, U.S. Gov't, Non-P.H.S. Date: 2011-04-09 |
Journal Detail:
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Title: The AAPS journal Volume: 13 ISSN: 1550-7416 ISO Abbreviation: AAPS J Publication Date: 2011 Jun |
Date Detail:
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Created Date: 2011-05-03 Completed Date: 2011-08-26 Revised Date: 2012-04-09 |
Medline Journal Info:
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Nlm Unique ID: 101223209 Medline TA: AAPS J Country: United States |
Other Details:
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Languages: eng Pagination: 299-308 Citation Subset: IM |
Affiliation:
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Wyle Integrated Science and Engineering Group, Houston, Texas 77058-2769, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Chromatography, High Pressure Liquid Drug Stability Drug Storage Humidity Pharmaceutical Preparations / chemistry*, radiation effects Radiation Dosage Radiation, Ionizing Solubility Space Flight* Spacecraft* Temperature Time Factors |
| Chemical | |
Reg. No./Substance:
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0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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