The effect of long-term spaceflight on drug potency and the risk of medication failure

Abstract

Pharmaceuticals selected for exploration space missions must remain stable and effective throughout mission timeframes. Although there have been six spaceflight drug stability studies, there has not been a comprehensive analytical analysis of these data. We sought to use these studies to quantify the rate of spaceflight drug degradation and the time-dependent probability of drug failure resulting from the loss of active pharmaceutical ingredient (API). Additionally, existing spaceflight drug stability studies were reviewed to identify research gaps to be addressed prior to exploration missions. Data were extracted from the six spaceflight studies to quantify API loss for 36 drug products with long-duration exposure to spaceflight. Medications stored for up to 2.4 years in low Earth orbit (LEO) exhibit a small increase in the rate of API loss with a corresponding increase in risk of product failure. Overall, the potency for all spaceflight-exposed medications remains within 10% of terrestrial lot-matched control with a ~1.5 increase in degradation rate. All existing studies of spaceflight drug stability have focused primarily on repackaged solid oral medications, which is important because non-protective repackaging is a well-established factor contributing to loss of drug potency. The factor most detrimental to drug stability appears to be nonprotective drug repackaging, based on premature failure of drug products in the terrestrial control group. The result of this study supports a critical need to evaluate the effects of current repackaging processes on drug shelf life, and to develop and validate suitable protective repackaging strategies that help assure the stability of medications throughout the full duration of exploration space missions.

Pharmacogenomics Guided Spaceflight: the intersection between space-flown drugs and space genes

“…29 Notably, all of the changes in drug stability aboard the ISS were within 10% of the changes seen at the Johnson Space Center. 29 These differences may be the result of confounding variables, including drug formulation and pre-flight storage conditions. In a study of different Vitamin B formulations within multivitamin brands, it was shown that the API of Vitamin B 1 was changed significantly in one brand after storage on the ISS for 12 or 19 months, while the second brand demonstrated no statistically significant changes.…”

Optimising plant form and function for controlled environment agriculture in space and on earth

“…68,69 This effect is, however, controversial, with other investigators arguing that it is the unusual packaging used during spaceflight that accelerates degradation and that this could be mitigated against by using the manufacturer's original packaging. 70 Even given perfect storage conditions and shelf stability, taking a fully adequate pharmacy for all likely eventualities would be impossible owing to the vast range of possible needs in such a long-term mission. A predetermined pharmacy would also not account for emerging health risks, for example, an outbreak of a novel infectious disease.…”

The human biology of spaceflight

“…The combination of communication delays and hamstrung resupply creates a unique clinical decision system that must account for the constraints in medical treatment options and equipment capabilities without the option of rapid evacuation or immediate rescue for any mission beyond low‐earth orbit (Russell et al, 2023). With limited‐to‐no resupply, pharmaceutical shelf life and safety of consumption also become a primary issue (Blue et al, 2019; Reichard et al, 2023). Further, the psychological distress of being distant from Earth and all that it represents (e.g., access to help, friends and family, and flora/fauna) can be substantial and may have an impact on crew dynamics, both increasing dependencies and feelings of closeness among the crew and exacerbating interpersonal issues (Stuster, 2021; Stuster et al, 2019).…”