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.
Subject(s)
Pharmaceutical Preparations/chemistry , Space Flight , Spacecraft , Chromatography, High Pressure Liquid , Drug Stability , Drug Storage , Humidity , Pharmaceutical Preparations/radiation effects , Radiation Dosage , Radiation, Ionizing , Solubility , Temperature , Time FactorsABSTRACT
The effect of storage in space on the stability of vitamin B complex in two commercial vitamin tablets was examined. Multiple vitamin samples returned after storage on the space shuttle and International Space Station (ISS) along with two ground control and three positive control groups were included in the study. Content of vitamin B(3) in the tablets and in vitro dissolution rate were determined using a modified high performance liquid chromatographic assay from USP/NF 2010. Results indicate that vitamin B(3) in one of the brands tested (#2) may be subject to marginal degradation after storage on ISS for 4 months as indicated by the chromatograms for all six tablets showing a split peak appearing as a notch at the peak tip. Chromatograms were not different for ground and flight samples for Brand #1 suggesting that this may be more suitable for use in space.
Subject(s)
Chromatography, High Pressure Liquid/methods , Dietary Supplements , Pharmaceutical Preparations/chemistry , Space Flight , Vitamin B Complex/analysis , Biological Availability , Chromatography/methods , Drug Stability , Drug Storage , Pharmaceutical Preparations/radiation effects , Radiation Dosage , Radiation, Ionizing , Solubility , Spacecraft , Temperature , Time FactorsABSTRACT
The NASA Reduced Gravity Office (RGO) uses scopolamine (SCOP) alone and in combination with dextoamphetamine (DEX) to treat motion sickness symptoms during DC-9 parabolic flights. The medications are sometimes dispensed as custom dosage forms in gelatin capsules for convenience. Reports of treatment failure during flights by the flight surgeons suggest that these formulations may be less efficacious for the treatment of motion sickness due to unreliable and inadequate bioavailability. We estimated bioavailability of four different oral formulations used by the NASA RGO physicians for the treatment of motion sickness.
