Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat 382481, India.
Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat 382481, India.
J Pharm Biomed Anal. 2022 Oct 25;220:115019. doi: 10.1016/j.jpba.2022.115019. Epub 2022 Aug 24.
Primary goal of any space mission is to keep astronauts healthy and fit during entire mission. One of the important challenges for that is providing a safe and effective pharmacy with the capabilities to address both scheduled and unanticipated medical conditions that may arise during spaceflight. Extended exposure to space environmental conditions may trigger drug deterioration, impacting quality, effectiveness, and safety. To assess the influence of space ionizing radiations on the stability of medicines launched aboard spacecraft, a preliminary ground-based ionizing radiation drug interaction study was carried out at different doses in the present work. Four different types of radiations - proton, neutron (thermal, fast), gamma and heavy ions (Fe) were used to irradiate selected drugs namely diclofenac, ciprofloxacin and metoprolol along with their formulations. Chemical stability of each irradiated sample was checked using high performance liquid chromatographic method. Significant degradation was observed in even solid-state during proton irradiation in both Active Pharmaceutical Ingredient (API) and tablet dosage form. Solution of active pharmaceutical ingredient and liquid dosage forms were prone to degradation in presence of gamma radiation. No physical and chemical changes observed after neutron and Fe irradiation. Irradiation of the same drug with different radiations demonstrated varying HPLC chromatographic profiles in terms of %degradation as well as proportion of same degradation products. This indicates possibility of different degradation pathways to generate degradation products.
任何太空任务的首要目标都是在整个任务期间保持宇航员的健康和适应能力。为此，一个重要的挑战是提供一个安全有效的药房，具备应对太空飞行中可能出现的计划内和意外医疗状况的能力。长时间暴露在空间环境条件下可能会引发药物劣化，影响质量、效果和安全性。为了评估空间离子辐射对随航天器发射的药物稳定性的影响，本研究在不同剂量下进行了初步的基于地面的离子辐射药物相互作用研究。本研究使用了四种不同类型的辐射——质子、中子（热、快）、γ 和重离子（Fe），来辐照选定的药物，如双氯芬酸、环丙沙星和酒石酸美托洛尔及其制剂。使用高效液相色谱法检查了每个辐照样品的化学稳定性。在质子辐照下，即使在固态下，活性药物成分（API）和片剂剂型都观察到了显著的降解。在γ 辐射存在下，活性药物成分的溶液和液体剂型容易降解。在中子和 Fe 辐照后没有观察到物理和化学变化。用不同的射线辐照同一种药物，在降解百分比和相同降解产物的比例方面表现出不同的高效液相色谱图谱。这表明可能存在不同的降解途径来生成降解产物。
