Background Methyltioninium chloride is an organic thiazine dye.It is used for management of methaemoglobinaemia, also as a visualising agent in surgical procedures, as an antidote for cyanide poisoning. It should be used with caution in patient with severe renal impairment. It is dark green odourless hygroscopic crystals, soluble 1 in 25 of water. A 1% solution has a pH of 3 to 4,5. Methyltioninium chloride is absorbed in the gastrointestinal tract and usually is excreted in the urine. It is administrated intravenously as a 1% solution in doses 1-4 mg per kg body-weight.
Purpose The fact that is lack of Methyltioninium Chloride 1% injection on the drug market in our country, the aim of presented work was to created the conditions to start small scale productions of this formulation and to determinate the risk assessment of the preparations.
Materials and methods Parenteral Methyltioninium Chloride 1% Solution was prepared in the Department for Compounding Sterile Products in our hospital, following established procedure for parenteral preparations and examined the content of Methyltioninium Chloride according the requirement of Ph.Eur.(Ph.Eur.monograph 1132).The preparation was storage protected from light.
Results According to the Standard Operating Procedure, Parenteral Methyltioninium Chloride 1% Solution was prepared aseptically in the laminar flow cabinet and sterilised by autoclaving. The final solution was then submitted to quality control, where a set of selected assays have been defined that ensures both raw material and final product are of assured quality Risk assessment of preparation.
Conclusions With applied technological procedure, it was possible to prepared Parenteral Methyltioninium Chloride 1% Solution in our hospital. The result for risk assessment is higher than 100, so the preparation was considered a ‘high -risk preparation’, that's why The authors followed GMP Guide to prepare it.
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