«AN INNOVATIVE BREAKTHROUGH IN TRANSFUSIOLOGY AND TRANSPLANTOLOGY - R&D SOLOPHARM STARTS FURTHER DEVELOPMENT OF HIGHLY EFFECTIVE SUBSTITUTE FOR DIFFERENT BLOOD TYPES THE DRUG PLASMOSOL «BLUE BLOOD»».
Kamenchuk Y.A., Muratov D.V., Gareeva F.R., Zagladkina E.V. 2022
Keywords: blood, blue blood, further development, highly effective, substitute for different blood types, highly effective blood substitute, blood substitute for different blood types, universal blood substitute, advanced technologies for synthesis of artificial blood, transfusiology, transfusion, blood replacement, blood transfusion, blood substitute, organofluorocarbon compound, fluorocarbon, perfluorocarbon, nanoemulsion, emulsion for parenteral administration, infusion, gas transport function, oxygen transport, transplantology, protection of donor organs.
The main technological know-how: the development of a sterile nanoemulsion based on inert organofluorine compounds with a gas transport function, the particle diameter of which is 70 times smaller than the diameter of a mature human erythrocyte, will solve the problem of acute and chronic hypovolemia (traumatic, hemorrhagic, burn and infectious-toxic shock, traumatic brain injury, surgical and postoperative hypovolemia), as well as for the anti-ischemic protection of donor organs. This is possible due to the prevention of tissue death due to the easy penetration of drug particles even into vessels narrowed due to spasm and the supply of oxygen to tissues during complex operations and serious injuries associated with significant blood loss, as well as during transplantation of donor organs. PLAZMOSOL, unlike donor blood, is suitable for transfusion to all patients, regardless of blood type, has a much longer shelf life and does not transmit infections (from donor to recipient) and therefore is highly effective and safe.
The development of a stable, biocompatible and safe nanoemulsion based on organofluorine compounds is a complex scientific task both from the point of view of technology, and from the point of view of analytical and microbiological development of methods, since in addition to strict normalization of the size of emulsion particles, it is necessary to obtain a stable emulsion throughout the shelf life, and from the point of view of analytics, this is associated with the search and development of reliable methods of quality control of the resulting product, namely, control of the content of impurities, quantitative determination of active substances, the volume of transferred oxygen, bacterial endotoxins, sterility and abnormal toxicity.
Since the blood substitute drug with a gas transport function developed by R&D Solopharm is an innovative product in the leading pharmacopoeias of the world there is no data on the structure and methods of control of its related impurities and the content of active substances, there are also no standards of impurities and active substances necessary for the development and production of a high-quality finished drug on the market.
Using certified primary R&D standards, Solopharm will develop and validate modern methods for controlling the content of active substances and their impurities, which will allow using input control of the initial components and stability of the finished drug to produce a safe, stable, biocompatible blood substitute with a gas transport function - containing a minimum amount of impurities throughout the shelf life.
