Space Environment Effects on Stability of Medications Flown on Space Shuttles and the International Space Station (ISS)

The purpose is to assess physical and chemical degradation of select pharmaceutical formulations from the Shuttle and ISS medical kits. Eleven pharmaceuticals dispensed as different dosage forms were selected based on their physical / chemical characteristics and susceptibility to environmental factors such as, temperature, humidity and light sensitivity. When available, ground-controls of the study medications with matching brand and lot numbers were used for comparison. Samples retrieved from flight were stored along with their matching controls in a temperature and humidity controlled environmental chamber. Temperature, humidity, and radiation data from the Shuttle and ISS were retrieved from onboard HOBO U12 Temp/RH Data Loggers, and from passive dosimeters. Physical and chemical analyses of the pharmaceuticals were conducted using validated United States Pharmacopeia (USP) methods. Results indicated degradation of 6 of the 11 formulations returned from space flights. Four formulations, Amoxicillin / Clavulanate, promethazine, sulfamethoxazole / trimethoprim, and ciprofloxacin tablets depicted discoloration after flight. Chemical content analyses using High or Ultra Performance Liquid Chromatography (HPLC / UPLC) methods revealed that dosage forms of Amoxicillin / Clavulanate, promethazine, sulfamethoxazole / trimethoprim, lidocaine, ciprofloxacin and mupirocin contained less than 95% of manufacturer s labeled claim of active drug compound. Shuttle and ISS environments affect stability and shelf life of certain mediations flown on these missions. Data analysis is in progress to examine the effect of specific space flight environmental factors on pharmaceutical stability. The degradation profiles generated from ground studies in analog environments will be useful in establishing predictive shelf-life profiles for medications intended for use during long-term space exploration missions

Stability of Formulations Contained in the Pharmaceutical Payload Aboard Space Missions

Efficacious pharmaceuticals with adequate shelf life are essential for successful space medical operations in support of space exploration missions. Physical and environmental factors unique to space missions such as vibration, G forces and ionizing radiation may adversely affect stability of pharmaceuticals intended for standard care of astronauts aboard space missions. Stable pharmaceuticals, therefore, are of paramount importance for assuring health and wellness of astronauts in space. Preliminary examination of stability of formulations from Shuttle and International Space Station (ISS) medical kits revealed that some of these medications showed physical and chemical degradation after flight raising concern of reduced therapeutic effectiveness with these medications in space. A research payload experiment was conducted with a select set of formulations stowed aboard a shuttle flight and on ISS. The payload consisted of four identical pharmaceutical kits containing 31 medications in different dosage forms that were transported to the International Space Station (ISS) aboard the Space Shuttle, STS 121. One of the four kits was stored on the shuttle and the other three were stored on the ISS for return to Earth at six months intervals on a pre-designated Shuttle flight for each kit; the shuttle kit was returned to Earth on the same flight. Standard stability indicating physical and chemical parameters were measured for all pharmaceuticals returned from the shuttle and from the first ISS increment payload along with ground-based matching controls. Results were compared between shuttle, ISS and ground controls. Evaluation of data from the three paradigms indicates that some of the formulations exhibited significant degradation in space compared to respective ground controls; a few formulations were unstable both on the ground and in space. An increase in the number of pharmaceuticals from ISS failing USP standards was noticed compared to those from the shuttle flight. A comprehensive evaluation of results is in progress

Stability of Dosage Forms in the Pharmaceutical Payload Aboard Space Missions

Efficacious pharmaceuticals with adequate shelf lives are essential for successful space medical operations. Stability of pharmaceuticals, therefore, is of paramount importance for assuring the health and wellness of astronauts on future space exploration missions. Unique physical and environmental factors of space missions may contribute to the instability of pharmaceuticals, e.g., radiation, humidity and temperature variations. Degradation of pharmaceutical formulations can result in inadequate efficacy and/or untoward toxic effects, which could compromise astronaut safety and health. Methods: Four identical pharmaceutical payload kits containing 31 medications in different dosage forms (liquid, tablet, capsule, ointment and suppository) were transported to the International Space Station aboard the Space Shuttle (STS-121). One of the 4 kits was stored on the Shuttle and the other 3 were stored on the International Space Station (ISS) for return to Earth at 6-month interval aboard a pre-designated Shuttle flight for each kit. The kit stored on the Shuttle was returned to Earth aboard STS-121 and 2 kits from ISS were returned on STS 117 and STS-122. Results: Analysis of standard physical and chemical parameters of degradation was completed for pharmaceuticals returned by STS-121 after14 days, STS - 117 after11 months and STS 122 after 19 months storage aboard ISS. Analysis of all flight samples along with ground-based matching controls was completed and results were compiled. Conclusion: Evaluation of results from the shuttle (1) and ISS increments (2) indicate that the number of formulations degraded in space increased with duration of storage in space and was higher in space compared to their ground-based counterparts. Rate of degradation for some of the formulations tested was faster in space than on Earth. Additionally, some of the formulations included in the medical kits were unstable, more so in space than on the ground. These results indicate that the space flight environment may adversely affect the shelf life of pharmaceuticals aboard space missions