title: Impact of space environment on stability of medicines: Challenges and prospects.
abstract: To upkeep health of astronauts in a unique, isolated, and extreme environment of space is the primary goal for a successful space mission, hence, safe and efficacious medications are essential for the wellness of astronauts. Space medication has been challenged with problems related to efficacy. Along with altered physiology, one of the possible reasons could be instability of space medications in the presence of harsh spaceflight environmental conditions. Altered physical and chemical stability can result in reduced potency which can result in reduced efficacy. Right now, medicines from the International Space Station are replaced before their expiration. But, for longer duration missions to Mars or any other asteroid, there will not be any chance of replacement of medicines. Hence, it is desired that medicines maintain the shelf-life throughout the space mission. Stability of medicines used for short term or long term space missions cannot be judged by drug stability guidelines based on terrestrial environmental factors. Unique environmental conditions related to spaceflight include microgravity, excessive vibration, hard vacuum, humidity variation, temperature differences and excessive radiation, which may cause instability of medicines. This write-up provides a review of the problem and countermeasure approaches for pharmaceuticals exposed to the space environment. The first part of the article discusses thought processes behind outlining of International Conference on Harmonization drug stability guidelines, Q1A (R2) and Q1B, and its acceptance limits for accelerated stability study. The second part of the article describes the difference in the radiation environment of deep space compared to radiation environment inside the space shuttle based on penetration power of different types of radiation. In the third part of the article, various promising approaches are listed which can be used for assurance of space medicine stability. One of the approaches is the use of ground-based space simulation analogues and statistical treatment to data to calculate failure rate of drugs and probabilistic risk assessment. Another approach is to innovate storage and packaging technology using radiation harden polymer or using cryogenic temperatures.
authors.affiliation: Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, 382481, India. Electronic address: drpritimehta@nirmauni.ac.in.
authors.forename: Priti
authors.initials: P
authors.lastname: Mehta
authors.affiliation: Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, 382481, India.
authors.forename: Dhara
authors.initials: D
authors.lastname: Bhayani
mesh_terms: D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D005118:Extraterrestrial Environment; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000528:radiation effects*; D013026:Space Flight; D018561:Space Simulation; D018531:Spacecraft
chemical_list: D004364:Pharmaceutical Preparations
keywords: Cryogenic storage; Innovative packaging technology; Shelf life; Space medicine stability; Space-hardy formulation; Spaceflight environment