Radiation Physics and Chemistry ( IF 2.9 ) Pub Date : 2021-09-24 , DOI: 10.1016/j.radphyschem.2021.109795 Geoffrey P. Jacobs 1
Regulatory authorities require pharmaceuticals to be sterilized wherever practicable by a terminal sterilization method that is sterilized in the final container rather than by aseptic techniques. Hence, many pharmaceuticals that are heat labile are being sterilized by gamma irradiation. In view of the increasing interest in this sterilization technology in the pharmaceutical industry, an updated review of the effects of ionizing radiation (gamma, electron beam and X-ray) on pharmaceuticals is in place. This review on the effects of irradiating pharmaceuticals and pharmaceutical materials, attempts to cover the pertinent literature from 1995 to 2020. The reviewed data give useful insights into overall radiation stability of these products, and indicate whether more extensive testing of the product is worth undertaking.
中文翻译:
药物辐照:文献综述
监管机构要求药品在可行的情况下通过最终灭菌方法进行灭菌,该方法在最终容器中进行灭菌,而不是通过无菌技术。因此,许多不耐热的药物正在通过伽马辐射进行灭菌。鉴于制药行业对这种灭菌技术的兴趣日益增加,对电离辐射(伽马、电子束和 X 射线)对药物的影响的最新审查已经到位。这篇关于辐照药物和药物材料影响的综述试图涵盖 1995 年至 2020 年的相关文献。所审查的数据为这些产品的整体辐射稳定性提供了有用的见解,并表明是否值得对产品进行更广泛的测试。