Irradiation of pharmaceuticals: A literature review

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. Radiation-induced volatile compounds originating either from the molecular degradation of the drug itself, or, because of the nature of some radiolytic products from the residual solvents present in the non-irradiated compound, may be responsible for the odour associated with irradiated compounds. • There is an increasing interest in the radiation sterilization of pharmaceuticals • An update of the effects of ionizing radiation on pharmaceuticals • The data give useful insights into overall radiation stability of drugs • They indicate whether more extensive testing is worth undertaking • Authorities require pharmaceuticals to be sterilized by terminal sterilization