Preparation of atropine sulfate syringes (5 mg – 1 ml) as part of terrorist organophosphate (OP) poisoning
Unité Préparation et Contrôle du Médicament - Lyon, France
Terrorist attack is a current concern. It is important to administrate quickly antidotal treatment in case of OP poisoning. The aim of this work was to prepare atropine injectable solution in prefilled syringes, suitable in emergency situation.
Materials and methods
Atropine sulfate (AS) solution 5 mg/mL was prepared in glass vials (250 mg – 50 ml) by preparation unit of hospital pharmacy department in accordance of French Good Manufacturing Practice. This solution has been divided in aseptic conditions into polycarbonate 1 ml syringes with a 0.22 µm filter. After visual control, syringes have been closed by luer lock cap, labeled and packaged (10 unit per bag with needles). Then, environment microbiological controls have been executed during manufacturing process. Moreover, AS syringes have been controlled by UV spectrophotometry assay and tested for sterility. Prefilled syringes were stored at room temperature. According to bibliographic data and start solution stability, limit expiration date have been fixed to 6 month.
Assays result showed that dosage of syringes was correct (5 mg/ml). Test for sterility after 14 days and environment microbiological controls were also in conformity with French Good Manufacturing Practice.
Discussion and conclusion
Stock of AS vials and prefilled syringes are considered as the best pharmaceutical practice for rapid and adequate treatment of intoxicated patients. Further stability study of prefilled syringes will be conducted to approve stability during storage.