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Research ArticleResearch

Degradation of Obidoxime Chloride Solution for Injection upon Long-Term Storage under Field Conditions of Mediterranean Climate vs the Controlled Environment

Constantin Itin, Meital Zur and Pavel Gorenbein
PDA Journal of Pharmaceutical Science and Technology September 2024, 78 (5) 537-547; DOI: https://doi.org/10.5731/pdajpst.2022.012792
Constantin Itin
1Israel Defense Forces (IDF), Medical Corps, Pharmacy, Biomedical Engineering & Medical Supplies Branch, Israel; and
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  • For correspondence: kostia84@gmail.com
Meital Zur
1Israel Defense Forces (IDF), Medical Corps, Pharmacy, Biomedical Engineering & Medical Supplies Branch, Israel; and
2Pharmacoepidemiology Research Unit, Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem 91120, Israel
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Pavel Gorenbein
1Israel Defense Forces (IDF), Medical Corps, Pharmacy, Biomedical Engineering & Medical Supplies Branch, Israel; and
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Abstract

Obidoxime chloride is an antidote for nerve gas intoxication. As an emergency medicine, it is being stored by the Israel Defense Forces (IDF) scattered throughout Israel in depots without a controlled environment (field conditions), thus being exposed to high and fluctuating temperatures. These conditions do not meet the manufacturer’s requirements. In addition, due to possible supply shortages, the utilization of expired batches was suggested. The current work investigated these matters. Long-term (15 years) storage under different conditions was initiated. Chemical stability and toxicity in rats were assessed. No difference was found between field conditions vs the controlled environment. The obidoxime assay remained >95% for 5 years and >90% for 7 years. The pH remained above the lower specification limit for 7–8 years. The major degradation product, 4-pyridinealdoxime, surpassed the allowed limit at 5 years. The content of total unknown impurities reached its maximum allowed by the IDF limit at 4–5 years. Threefold higher than clinically utilized doses of valid-to-date Toxogonin batches administered to rats did not cause any abnormality. However, expired batches produced significant toxic effects. Although no difference was found between storage of obidoxime ampoules when adhering to manufacturer’s recommendations vs field conditions, accumulation of degradants over the limit allowed by the IDF at 4–5 years of storage and the toxicity of the expired batches observed in rats led the IDF to a decision to shorten the shelf-life of this product from 5 to 4 years when stored in an uncontrolled environment of the Mediterranean climate.

  • Obidoxime
  • 4-Pyridinealdoxime
  • Stability
  • Storage
  • Toxogonin
  • © PDA, Inc. 2024
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PDA Journal of Pharmaceutical Science and Technology: 78 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 5
September/October 2024
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Degradation of Obidoxime Chloride Solution for Injection upon Long-Term Storage under Field Conditions of Mediterranean Climate vs the Controlled Environment
Constantin Itin, Meital Zur, Pavel Gorenbein
PDA Journal of Pharmaceutical Science and Technology Sep 2024, 78 (5) 537-547; DOI: 10.5731/pdajpst.2022.012792

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Degradation of Obidoxime Chloride Solution for Injection upon Long-Term Storage under Field Conditions of Mediterranean Climate vs the Controlled Environment
Constantin Itin, Meital Zur, Pavel Gorenbein
PDA Journal of Pharmaceutical Science and Technology Sep 2024, 78 (5) 537-547; DOI: 10.5731/pdajpst.2022.012792
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Keywords

  • Obidoxime
  • 4-pyridinealdoxime
  • stability
  • storage
  • Toxogonin

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