Mehta Priti, Bhayani Dhara
Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, 382481, India.
Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, 382481, India.
J Pharm Biomed Anal. 2017 Mar 20;136:111-119. doi: 10.1016/j.jpba.2016.12.040. Epub 2017 Jan 3.
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.
在独特、孤立且极端的太空环境中维护宇航员的健康是成功进行太空任务的首要目标，因此，安全有效的药物对宇航员的健康至关重要。太空药物一直面临着与疗效相关的问题。除了生理变化外，一个可能的原因是太空药物在恶劣的太空飞行环境条件下不稳定。物理和化学稳定性的改变会导致效力降低，进而导致疗效降低。目前，国际空间站的药品在过期前就会被更换。但是，对于前往火星或任何其他小行星的长期任务，将没有更换药品的机会。因此，希望药品在整个太空任务期间都能保持保质期。用于短期或长期太空任务的药品稳定性不能根据基于地球环境因素的药物稳定性指南来判断。与太空飞行相关的独特环境条件包括微重力、过度振动、高真空、湿度变化、温度差异和过度辐射，这些可能会导致药品不稳定。本文对暴露于太空环境的药品问题及应对措施进行了综述。文章的第一部分讨论了国际协调会议药物稳定性指南Q1A（R2）和Q1B的制定背后的思路及其加速稳定性研究的接受限度。文章的第二部分根据不同类型辐射的穿透能力描述了深空辐射环境与航天飞机内部辐射环境的差异。在文章的第三部分，列出了各种有前景的方法，可用于确保太空药物的稳定性。其中一种方法是使用地面太空模拟类似物并对数据进行统计处理，以计算药物的故障率和概率风险评估。另一种方法是创新存储和包装技术，使用抗辐射聚合物或采用低温。
