A new study suggests that medicines do not expire faster in space and that it does not exude significant differences in degradation, compared to what is observed on Earth.
Medications are known to eventually undergo the process of degradation, specifically when it is exposed to oxygen, humidity and light. Although the temperatures and humidity inside the International Space Station (ISS) are recognized to be within conducive ranges for drug storage, the impacts of other factors while in spaceflight such as microgravity and increased radiation have not yet been assessed in terms of deterioration outcomes.
In a new pilot-scale study by Virginia Wotring from Baylor College of Medicine, drugs approved by the U.S. Food and Drug Administration (FDA) were collected from and repackaged by Johnson Space Center (JSC) Pharmacy to follow space mission requirements. A total of nine medication types were processed, including an antihistamine, two sleeping pills, a decongestant, an antidiarrheal, three painkillers and an alertness drug.
The medications were then transported to the ISS via Russia's Progress spacecraft and after 550 days in the space research complex, it was returned back to Earth via Dragon (SpaceX) capsule. The drug samples were sent to California via boat before it was flown to JSC in Houston, Texas for analysis. The total time of travel from capsule splashdown to the final destination is more or less 58 hours.
The samples were analyzed using the procedures included in the 2012 United States Pharmacopeia (USP) to identify levels of active pharmaceutical ingredient (API) and detect and measure degradation products.
The findings of the study showed that most of the drugs did not expire faster in space. "Some ISS-aged medications met API and impurities requirements months after their expiration dates," the study read.
One drug met USP stipulations five months after its official expiration date. Four of the medicines were still usable up to eight months after expiration and three medications conformed to the USP guidelines after being tested three months following the expiration date. Meanwhile, a sleeping pill did not meet USP conditions 11 months after expiration. The study did not find noteworthy degradation products in all of the tests.
The author noted, however, that the results of the study are founded on measurements made in a specific period of time for a handful of drugs only. With this, the results cannot be used to predict the safety and efficacy of other medications or inferred to other storage times.
In the end, Wotring wrote that the study provides valuable initial source of information, but more comprehensive studies are needed to confirm if spaceflight conditions trigger unusual deterioration during storage.
The study was published in the American Association of Pharmaceutical Scientists (AAPS) journal on Friday, Nov. 6.
Photo: Patrik Nygren | Flickr
