Project No. 1
Injection preparation in 5 ml ampoules. The content of the main active substance (DHA) is 50 mg in 5 ml ampoule. It is a transparent sterile solution of yellow color in glass ampoules. The drug is designed to reduce the time of acute coronary artery spasm and the treatment of coronary heart disease, the prevention of cardiovascular pathology.
In contrast to the injection form of quercetin (created as a lyophilized form), we have developed a water-soluble form of dihydroquercetin in ampoules with the content of the active 50 and 100 mg. At present, we have developed the technology for production of OTC and prepared a draft pharmaceutical article for Dihydroquercetin. Production of Dihydroquercetin Substance has been arranged.
The technology of preparation of injection solution of water-soluble Dihydroquercetin is based on creation of composition of auxiliary substances permitted for these purposes, which convert Dihydroquercetin into water-soluble form. The uniqueness of the technology lies in the stabilization of Dihydroquercetin in relation to oxygen. This technology can be modified in relation to other water-soluble substances by changing the ratio of auxiliary substances in the composition.
Competitors widely use similar solutions for similar tasks, but they could not find a solution for Dihydroquercetin, as well as for Quercetin, for which the lyophilizate form was developed.
The production of Dihydroquercetin requires: the presence of an ampoule substance licensed in the GMP standard, the presence of a substance licensed in the GMP standard, approved reports of all stages of research: quality module, dossier for the substance, pharmacy for the substance and Dihydroquercetin, production regulations for Dihydroquercetin, preclinical and clinical trials 1 and 2 phases.
The water-soluble form of Dihydroquercetin is widely used in veterinary medicine, food industry, specialized nutrition and production, feed industry and in vegetative fertilizers.
There are no technological risks.
Preclinical studies are coming to an end, clinical trials have been started. Preparation for construction of industrial building is in progress.
LLC “DIAFARM SM” is ready to consider various options of partnership with interested companies.