The goal of this project is suggesting and testing (in laboratory conditions) the most optimal synthesis of oxime K027 together with the suitable analytical methods needed for characterization of oxime purity. This project aims to gain all data about acetylcholinesterase (AChE) reactivator – oxime K027 so that all the materials needed for Drug Master File and all preclinical and clinical studies are prepared.
One of the main project solution tools are conclusions of the meeting of project scientific board which will clearly evaluate the up-to-date progress of the solution and will set new directions so that the factual and financial part of the solution is fulfilled.
The most important part of the project solution is meeting all legislation conditions for using the project results for the use of Integrated rescue system or Army of the Czech Republic. The conditions for meeting these legislations conditions are specified in individual project stages.
Oxime K027 is currently one the best AChE reactivators used as antidote in case of organophosphate poisoning at laboratory level. This antidote has better use than currently used oximes (pralidoxime, obidoxime, trimedoxime or HI-6). Due to this it is an important task to bring this compound to the market. The project solution is aimed at developing the optimalized synthesis of this compound, selection of suitable salt, development of analytical method for monitoring its purity during its production, suggestion of application equipment etc. Data will be summarized and will then be used as base for Drug Master File and for futher approval process for SÚKL (eg. Czech alternative of FDA).
CHemProtect, a. s. is a reciever of this project. Co-recievers are VAKOS XT a.s. and Decomkov Praha s.r.o..
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