de Dios Azorín Abraham Juan, Durán Guillermo Torrado, Pabón Norma Sofía Torres, Peña-Fernández Antonio, Fernández María Ángeles Peña
Military Defence Pharmacy Centre, Road M-609, Km 34, 28770 Colmenar Viejo, Madrid, Spain.
Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Alcala, E-28871 Alcalá de Henares, Madrid, Spain.
Saudi Pharm J. 2023 Nov;31(11):101814. doi: 10.1016/j.jsps.2023.101814. Epub 2023 Oct 5.
Potassium iodide (KI) is a treatment to neutralize radioactive agents that could be inhaled or ingested in nuclear incidents. The inorganic salt KI constitutes a source of iodine, which in the body acts by accumulating in the thyroid gland, producing its saturation, and thus preventing the fixation of radioactive iodine species. In Spain, the Military Defence Pharmacy Centre (CEMILFARDEF) was challenged to develop this antidote to be distributed among the population surrounding nuclear power plants, in only one new solid pharmaceutical form for oral administration, in order to replace the two pharmaceutical forms available, which are capsules for adults and oral solution for children, considered less versatile.
A selection of excipients was carried out to achieve pharmacotechnical behaviour suitable for the industrial manufacture of potassium iodide in tablets, complying with the pre-established process and finished product quality parameters. The development allowed the preparation of three industrial-sized batches on which the stability of the developed formulation was studied.
An uncoated 65 mg double-scored potassium iodide tablet was developed using easily accessible excipients in the formulation and direct compression as the manufacturing method. The formula complied with the stability tests, with which the development carried out can respond to the eventual demand that its elaboration would entail in the event of nuclear incidents.
The developed formulation of a 65 mg double-scored potassium iodide tablet allows the great variability of user needs, from infants to adults with a single pharmaceutical form, which additionally implies logistical benefits in distribution, stock control and appropriate renewal according expiration dates, among the population surrounding nuclear power plants and available to deployed military personnel, in the event of potential nuclear incidents.
碘化钾（KI）是一种用于中和在核事故中可能吸入或摄入的放射性物质的治疗方法。无机盐KI是碘的一种来源，碘在体内通过在甲状腺中积累起作用，使其饱和，从而防止放射性碘物种的固定。在西班牙，军事国防药房中心（CEMILFARDEF）面临挑战，要开发这种解毒剂，以单一的新型口服固体剂型在核电站周边人群中分发，以取代现有的两种剂型，即成人胶囊和儿童口服溶液，这两种剂型被认为通用性较差。
进行辅料筛选，以实现适合碘化钾片剂工业生产的药学技术行为，符合预先确定的工艺和成品质量参数。该研发成果允许制备三批工业规模的批次，并对所开发制剂的稳定性进行了研究。
采用制剂中易于获取的辅料并以直接压片作为制造方法，开发出了一种65毫克双面刻痕的未包衣碘化钾片剂。该配方符合稳定性测试要求，所开展的研发能够应对核事故发生时其生产可能带来的最终需求。
所开发的65毫克双面刻痕碘化钾片剂剂型能够满足从婴儿到成人的广泛用户需求，采用单一剂型，这在核电站周边人群以及部署的军事人员中，在潜在核事故发生时，还意味着在分发、库存控制和根据有效期进行适当更新方面具有后勤优势。
