Scientific And Production Association “Pharmatron”
NPA "Pharmatron" serves as an important and unique bridge between new biologically active organic substances synthesized by scientists of the Faculty of Pharmacy of the University and new drugs made from these substances by Ukrainian enterprises.
Honored Worker of Science and Technology of Ukraine, Doctor of Pharmaceutical Sciences, Professor Mazur Ivan Antonovich is the Head of SPA "Pharmatron". He is the author of the first original drug "Tiotriazolin" and a number of other drugs.
The pharmacy provides the following steps on the way from a new synthesized organic biologically active compound to a new drug on the shelves. Among them are:
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Carrying out of physicochemical researches of new compounds, analytical analysis of their purity and experimental detection of the compound-leader of a certain biological action.
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Conducting preclinical studies (biological activity of the new compound, as well as toxicological, pharmacological, pharmacokinetic studies of this compound) in laboratories accredited by the Pharmacological Center of the Ministry of Health of Ukraine.
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Development of technological regulations for the manufacture of a new drug from a new compound in a certain pharmaceutical form (tablets, injectable solution, ampoule forms, ointment, drops, etc.) as well as methods of drug analysis.
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Concluding an agreement with a pharmaceutical company for the industrial production of a new drug with positive results of preclinical trials.
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Submission a package of documents for obtaining a permit for clinical trials of a new drug to the Pharmacological Center of the Ministry of Health of Ukraine. Conducting such trials in the clinical departments of medical universities or hospitals of Ukraine accredited by the Pharmacological Center.
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The author submits to the Pharmacological Center of the Ministry of Health of Ukraine a package of documents for registration of a new drug in case of positive results of clinical trials of a new drug.
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Industrial release of the drug at a particular enterprise.
For the first time in Ukraine, industrial production of Tiotriazoline in tablets, ampoule solutions, injectable solutions, eye drops, ointments and suppositories has been established within the framework of the Pharmatron SPA. They are registered in Uzbekistan, Kazakhstan, Georgia, Moldova. Development and industrial release of new drugs through the SPA "Pharmatron" created under the leadership of Professor Mazur IA. It has had the following dynamics:
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the Pharmacological Center of the Ministry of Health of Ukraine approved the use of "Thiocetam" (tablets, injectable solutions) with antioxidant, nootropic and cerebro-protective effects in 2003.
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a new antiarrhythmic drug "Thiodarone" was developed, Levotil ointment for the treatment of infected wounds and periodontitis was developed and passed preclinical studies. Clinical trials of the new drug "Amyotril" with antianginal and antiarrhythmic action have been completed in 2004;
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the development of scientific and technical documentation for the new original drug "Trianol" was completed in 2005;
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Сlinical trials of tablets "Thiodarone" with antiarrhythmic action was passed in 2006. The Pharmacological Center of the Ministry of Health of Ukraine presented regulatory and technical documentation for the new drug "Indotril" (tablets) for the treatment of osteoarthritis, arthritis and osteoarthritis in 2006;
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the industrial production of Tiocetam-forte tablets and Tiodarone tablets was established in 2007. Preclinical trials of Cardiotril solution and tablets have been completed. Thiocetam injectable solutions and tablets are registered in the Kazakhstan, Moldova, Uzbekistan, Turkmenistan, Tajikistan;
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the industrial production of Tiocetam tablets and Tiodarone tablets was established in 2008. The Pharmacological Center of the Ministry of Health of Ukraine allowed the medical use of Indotril tablets, completed preclinical trials of a new combined drug - Carbatril tablets;
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a package of documents for clinical trials of cardiotonic and antianginal drug "Cardiotril" was transferred to the Pharmacological Center of the Ministry of Health of Ukraine in 2009. Thiocetam-Forte tablets were registered in Uzbekistan.