DoseShield Packaging for Improved Pharmaceutical Protection in Space

The availability of pharmaceuticals necessary to crews during spaceflight is critical to mission success. This need becomes more significant for long-duration missions where the range of physiological and adaptive alterations on the body, in addition to the isolation and distance from Earth, can present additional challenges. Lunar and planetary exploration missions beyond low Earth orbit (LEO) in particular will require an expanded pharmacy that maintains appropriate stability throughout long-term 24- or 36-month durations. Studies have begun to evaluate the stability of pharmaceuticals in space, and a subset of drug products have been demonstrated to fail USP requirements prior to labeled expiration dates when flown in space. The environmental conditions of space introduce additional factors, and space radiation has been shown to significantly differ in the types, dose, and length of exposure compared to that experienced terrestrially. Select medications are currently repackaged outside of manufacturers packaging to conserve mass and volume on the spacecraft, and this will also affect the shelf-life of the drugs if the new package is not protective. To address this critical need, Luna Labs USA, LLC is developing DoseShield packaging. This protective packaging system includes two components. The first component provides protection of susceptible solid doses against environmental exposures known to affect stability (e.g. moisture, oxygen) without the typical costs to mass and volume. Additionally, a radiation-protective casing is under development to address the concerns of radiation exposure during spaceflight. The technology is expected to strengthen readiness for upcoming long-duration space missions. The availability of pharmaceuticals necessary to crews during spaceflight is critical to mission success. Lunar and planetary exploration missions beyond low Earth orbit (LEO) in particular will require an expanded pharmacy that maintains appropriate stability throughout long-term 24- or 36-month durations. The environmental conditions of space introduce additional factors, and space radiation has been shown to significantly differ in the types, dose, and length of exposure compared to Earth. Select medications are currently repackaged outside of manufacturer’s packaging to conserve mass and volume on the spacecraft, and this will also affect the shelf-life of the drugs if the new package is not protective. To address this critical need, Luna Labs is developing DoseShield packaging. This packaging system provides protection of susceptible solid doses against environmental exposures known to affect stability without the typical costs to mass and volume, and a radiation-protective casing addresses the concerns of radiation exposure during spaceflight. The goal of the Phase II program will be to demonstrate efficacy of the technology under long-term and accelerated studies. Objectives of the Phase II program will include: 1) Evaluate medication stability under expanded spaceflight conditions: Luna Labs will expand study of failure mechanisms of representative pharmaceuticals. In addition to typical stressors, the effects of space radiation will be evaluated. 2) Complete development of the packaging system: Protective packages for solid doses with be produced, and repacking processes will be established. A flexible case to reduce the exposure to space radiation will then complete the packaging system. 3) Demonstrate effectiveness under long-term and accelerated conditions: Demonstration of the technology will include a real-time, 2-year stability study for representative medications. Accelerated predictive stability studies will provide information on performance prior to 6-month and 12-month studies. The performance of the full packaging system in a simulated space environment will also be demonstrated. 4) Prepare for production and distribution: Transition to production and distribution will occur along with necessary verifications in preparation for market entry.

The proposed packaging solution will be designed for easy integration into current NASA processes for medical kit packaging for spaceflight. The technology will be engineered to provide stability to pharmaceuticals by protecting them from environmental conditions such as temperature, humidity, and space radiation. Additional non-NASA applications may include commercial spaceflight initiatives. Military and civilian operations that require a reduced pharmaceutical packaging footprint compared to that provided by manufacturer packaging would have applicability.

This is early/mid-stage (TRL 3) — the most realistic path in is NASA SBIR/STTR, which funds small businesses and research institutions to develop technology aligned with NASA's needs (equity-free, phased funding). Check whether a current SBIR/STTR solicitation topic overlaps with this project's technology area, or contact the project directly (above) to ask.

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