RATIONALE FOR PHARMACEUTICAL DEVELOPMENT OF MEDICINAL PRODUCTS FOR THE PERFORMANCE OF IODIC PREVENTION OF RADIATION IN CHILDREN
DOI:
https://doi.org/10.11603/2312-0967.2020.1.10904Keywords:
radiation accident, iodine prophylaxis, newborns and infants, potassium iodideAbstract
The aim of the work. Substantiation of the need to expand the range of medicines for iodine prophylaxis in case of radiation accidents.
Materials and Methods. The methods of information search, systematization, content analysis, comparison and generalization were applied.
Results and Discussion. According to the analysis of the assortment of potassium iodide remedies as of December 1, 2019, it is established that 30 positions with potassium iodide in the form of 7 dosage forms have been registered in the Ukrainian pharmaceutical market. The registered drugs are intended for the treatment of thyroid diseases and the prevention of iodine deficiency and contain a dose of stable iodine of 100–200 mcg, which is not enough for the prevention of radiation damage. The necessity of development of liquid potassium iodide medicines in the form of oral solution of extemporaneous or industrial manufacture for carrying out iodine prophylaxis for the infant population and children in maternity hospitals, children's hospitals and other children's institutions is substantiated. The introduction of industrial production of oral solution with a potassium iodide concentration of 65 mg/ml (6.5 %) is proposed. Pharmacies with the right to extramural drug production in the event of receiving a radiation accident are suggested to produce 0.65 % and 0.32 % solution of potassium iodide for the prevention of radiation damage in children of all ages.
Conclusions. The absence of potassium iodide preparations on the Ukrainian pharmaceutical market for the protection of newborns and children under 3 years of age from radiation damage to the thyroid gland. Taking into account international and national requirements the necessity of development of liquid oral medicines with potassium iodide of industrial production or extemporal manufacture for carrying out iodine prophylaxis for children from birth to 3 years is substantiated.
References
On approval of the Procedure for implementation of urgent measures of iodine prevention among the population of Ukraine in the event of a radiation accident. Order of the State Nuclear Regulatory Inspectorate of Ukraine No. 154 of 08.11.2011. [Про затвердження Порядку здійснення невідкладних заходів йодної профілактики серед населення України у разі виникнення радіаційної аварії. Наказ Державної інспекції ядерного регулювання України № 154 від 08.11.2011] https://zakon.rada.gov.ua/laws/show/z1353-11. Ukrainian.
PAG Manual: Protective Action Guidesand Planning Guidance for Radiological Incidents. Available at: https://www.nrc.gov/docs/ML1635/ML16351A497.pdf
Guidance. Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies. FDA. 2001. https://www.fda.gov/media/72510/download
Guidelines for Iodine Prophylaxis following Nuclear Accidents. WHO. 1999. https://www.who.int/ionizing_radiation/pub_ meet/Iodine_Prophylaxis_guide.pdf
Afanasiev DYe. [Medical assistance to the infant population during radiation events in the first stages]. Problemy radiatsiinoi medytsyny ta radiobiolohii. 2016;21: 21-44. Ukrainian.
U.S. Food and Drug Administration. Available at: https://www.fda.gov/drugs
State Register of Medicines of Ukraine [Державний реєстр лікарських засобів України]. Available at: http://www.drlz.kiev.ua/ Ukrainian.
Guidance. Requirements for the manufacture of non-sterile medicines in pharmacies. [Настанова СТ-Н МОЗУ 42-4.5:2015 Вимоги до виготовлення нестерильних лікарських засобів в умовах аптек]. Kyiv; 2015. Ukrainian.
Guidance. Requirements for the manufacture of sterile and aseptic drugs in pharmacies. [Настанова СТ-Н МОЗУ 42-4.6:2015. Вимоги до виготовлення стерильних та асептичних лікарських засобів в умовах аптек]. Kyiv; 2015. Ukrainian.
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