Vol 1, No 1 (2019)

  • Year: 2019
  • Articles: 11
  • URL: https://journals.eco-vector.com/PharmForm/issue/view/1108
  • DOI: https://doi.org/10.17816/phf_11
  • Description:

       

        Дорогие читатели!

     

      Фармация формировалась в течение всей истории развития человечества и науки, практически по всем ее направлениям во многих отраслях хозяйственной деятельности, и стремительно продолжает развиваться дальше. Появляются новые возможности, подходы и технологии исследований, построенные на новых физических принципах и запросах трансляционной медицины со своими успехами в изучении биологии клетки, нормальной и патологической физиологии человека, экологии человека.

     Фармация не может прогрессировать без развития органической и неорганической химии, физики, математических наук, инженерии, промышленных медико-биологических и фармацевтических технологий создания и производства лекарственных средств.

     Лекарства действуют на биохимические процессы организма человека. Благодаря новейшим научным достижениям в общей и клинической биологии, физиологии и патофизиологии, молекулярной генетике и эпигенетике, эндокринологии и токсикологии совершенствуются подходы к разработке новых и оценка эффективности действующих лекарственных средств.

      Объединяющим фактором всех элементов жизненного цикла фармацевтических субстанций и препаратов является их действие на организм человека.

       Новые открытия в фармакологии и клинической фармакологии позволяют решать проблемы фармакодинамики и фармакокинетики. Продолжается изучение взаимодействия при воздействии на организм сочетания лекарственных средств с социальными факторами, продуктами питания и окружающей средой.

      При подготовке каждого выпуска журнала члены редколлегии намерены учитывать, наряду с другими факторами, современные требования к порядку квалифицированного рецензирования, информационной открытости и библиометрическим показателям в оценке публикационной активности авторов.

     При разработке стратегии и макета издания были изучены и проанализированы доступные нам профессиональные материалы информационных ресурсов издателей и владельцев библиографических и реферативных баз данных – лидеров международных систем цитирования по соответствующим отраслям науки и группам научных специальностей.

      В ходе этой работы были определены три группы научных специальностей, которые, по нашему мнению, позволили составить рубрикатор издания и определить его название — «Формулы Фармации». При этом мы максимально учли определение фармации как всего жизненного цикла лекарственных средств, включающего создание, доклинические и клинические исследования, технологию получения, организацию фармацевтического дела, а также вопросы контрольно-аналитических исследований, пищевой и экологической безопасности. В свою очередь, слово «формулы» означает «направления, тренды, тенденции развития» составляющих фармацию научно-практических направлений.

     Особое внимание на страницах издания будет уделяться вопросам, связанным с фармацевтической безопасностью, которые, наряду с глобальными проблемами природопользования и охраны окружающей среды и наравне с пищевой безопасностью, стали актуальной частью экологической безопасности страны. Их решение имеет народно-хозяйственное значение, как и само лекарственное обеспечение населения.

       Нам предстоит преодолеть путь, в ходе которого мы хотим занять достойное место в перечне ВАК и найти своего читателя, публикуя на своих страницах результаты всех этапов исследований и другие материалы авторов в оригинальных рубриках издания.

      Надеемся на продолжительные и плодотворные дискуссии читателей нашего издания, а также на то, что публикации не только будут носить характер передачи информации, но и смогут увлечь читателя. Мы надеемся, что простой и доступный стиль подачи информации, который давно используется за рубежом, будет эффективно способствовать научным коммуникациям с внешним миром.

      Как и в любом новом издании, вся тяжесть ложится на плечи членов редколлегии, экспертов и партнеров, коллектива специалистов редакции и издательства, которые будут работать над реализацией проекта на основе стратегии и политики журнала.

       При разработке всех задач, стоящих перед членами редакционной коллегии журнала «Формулы Фармации», нас объединяет общая цель – способствовать развитию научных коммуникаций по заявленным группам научных специальностей в сфере фармации (от идеи до выхода лекарственных средств на потребительский рынок и управления их отходами и метаболитами) и активно участвовать в этом процессе.

     

    С уважением и надеждой на сотрудничество,

    Председатель редакционного совета Игорь Наркевич

    Главный редактор Владимир Перелыгин

    Президент ООО «Эко-Вектор» Игорь Родин

Full Issue

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Pharmaceutical Sciences
Rabbit models of ischemic stroke in biomedical research
Sysoev Y.I., Prikhodko V.A., Ivkin D.Y., Okovity S.
Abstract

The development of experimental models of ischemic stroke allowing for effective translation of results from animal studies to humans is an important task of modern neuropharmacology. Due to the fact that new drugs with neuroprotective properties that have shown activity in rodents most often turn out to be not effective enough in humans, the use of larger laboratory animals may become a viable solution. Among the latter, rabbits are the most accessible species for laboratories. Since they have gyrencephalic brains and a significant amount of white matter, they can be considered to be highly similar to humans. In the present review, we discussed the main methods of ischemic stroke modelling in rabbits. The breed, age and sex of the animals, anesthesia methods as well as criteria for functional state assessment after cerebral ischemia are the issues that should be addressed before the start of the study.

Pharmacy Formulas. 2019;1(1):10-21
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Creating new drugs design patterns.Step one. Pharmaceutical development
Basevich A.V., Dzjuba A.S., Kaukhova I.E., Andreeva P.I.
Abstract

 To optimize the process of pharmaceutical development, it is necessary to take into account the timeframes of the processes and to track all its key stages. To do this, it is necessary to create an algorithm for conducting research, taking into account the modern approach to pharmaceutical development — the concept of Quality by Design.

The aim of this work was to create an algorithm of actions in conducting research when developing a new drug that can be used in the production process.

Flowcharts were used for depicting algorithms. To account the timeframes of the processes, a Gantt diagram was used.

The process of pharmaceutical development when launching a new generic drug has been studied at an operating pharmaceutical company. An algorithm for the actions of staff involved in research is proposed The algorithm minds the concept of Quality by Design. A temporary Gannta scheme and a project manager's control card for the process of pharmaceutical development of a generic drug have been developed.

Based on the results of the work, an algorithm of actions in conducting research when developing a new drug that can be used in the production process was proposed.

Pharmacy Formulas. 2019;1(1):22-31
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A unified and simplified flow diagram of the production of active pharmaceutical ingredients and the finished dosage form
Gabidova A., Galynkin V.
Abstract

The article shows that all biotechnological processes consist of four stages which include the step of obtaining the biomass (micro-organisms), fitosyrya biomass (plants, lichens) and biomass from animal raw materials; obtaining the active pharmaceutical substance; obtaining the final dosage form; storage and sale of APS and SFS. The authors have proposed a unified and simplified process sequence that represents the life cycle of the production of APS and SFR, showing the potential risks. Introduction of the HACCP system at the same time to the GMP system allows the identification of CCPs and therefore to analyze the product and manage the risk only in the CCP. The authors have proposed a multi-level model of a complex of pharmaceutical quality system. It is necessary to emphasize that in all environmental conditions to obtain drugs should be carried out in strict compliance with GMP and HACCP system and under the strict control of all types of risk, and, in particular, be sure to microbiological risk.

Pharmacy Formulas. 2019;1(1):32-37
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Pharmacists in the system of pediatric palliative care: international practice and prospects in Russia
Narkevich I.A., Nemyatykh O.D., Medvedeva D.M.
Abstract

Improvement of the palliative care system is one of the development priorities of health care system in Russia, as well as all around the world. This work represents the review of scientific literature dedicated to evaluation of the pharmaceutical staff as a member of interdisciplinary team providing palliative care for children.

The major improvement priorities of drug provision of children in need of palliative care, including the area of drugs’ range, inventory management, compounding pharmacies activity, pharmaceutical information and counseling, were set up on the basis of the comparative analysis of Russian and international pharmaceutical practices.

Pharmacy Formulas. 2019;1(1):38-43
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Alopecia: from clinic to preclinic and back
Ivkin D.Y., Nogaeva U.V., Flisyuk E.V., Pisetskaya M.V., Shtyrlin Y.G.
Abstract

On average, 60–70% of men and 25–40% of women suffer from various forms of hair loss on our planet. If we turn to WHO statistics, we can see that about 75% of Russians are more or less susceptible to baldness. The hair follicle is an appendage of the skin, a kind of mini-organ that cyclically changes throughout a person’s life. Periods of regeneration and rapid growth (anagen) alternate with periods of involution (catagen) and dormancy (telogen). As a rule, hair begins to fall out when the correlation between the number of hair follicles in different phases of development is violated. The occurrence of alopecia is associated with the influence of heterogeneous etiological factors, which further determine the pathogenesis of the disease and the clinical picture. The treatment of alopecia requires the use of a personalized approach to each patient. Both medicinal and cosmetic compositions are available for therapy in different dosage forms. At the same time, there remains a need for the search for new active pharmaceutical substances and the development of drugs based on them. However, in order to develop effective therapies, we need to reconstruct in detail the pathogenesis of alopecia on animal models. Then the extrapolation of the result human-animal-human will be accurate and problem-free, and the search for new means — successful.

Pharmacy Formulas. 2019;1(1):44-51
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Biomedical Sciences
Continuous glucose monitoring - proved hypoglycemia in sodium-glucose co-transporter-2 inhibitors - treated type 2 diabetes patients: a link to ketosis development
Levit S., Giveon S., Musin I.N., Barnea R., Korek-Abadi I., Levit V., Ryder D., Ryder C.
Abstract

Background: Latest studies have shown the remarkable ability of sodium-glucose co-transporter-2 inhibitors (SGLT2i) to reduce cardiovascular morbidity and mortality. However, real-life data and the results of several other studies seem to contradict these outcomes, pointing out possibilities of serious side effects. Ketoacidosis (KA) remains one of the most dangerous complications, yet, not fully understood. All of the above urgently requires real-practice data, which may shed some light on side effects of this novel anti-diabetic drug family.

Aims: To investigate the real-life rates of hypoglycemia and ketosis (K) in SGLT2i treated patients, using Continuous Glucose Monitoring (CGM) and capillary blood β-hydroxybutyrate measurements.

Methods: We report the results of a two-year retrospective analysis of 136 Type 2 Diabetes (T2DM) patients, all (100%) treated with a SGLT2i, combined with Metformin or Metformin with Incretin-Based therapy (MT-IBT). CGM recordings were done in 52 persons. In 9 patients (Group A), CGM-proved hypoglycemic episodes were discovered. The rest of 43 patients (Group B) didn’t show any hypoglycemia. Three patients in Group A and 11 from Group B were also treated with small doses of basal insulin on admission; the insulin was later discontinued in all patients of Group A and seven patients of Group B . Main characteristics of two groups were subsequently compared.

Results: CGM data analysis showed significantly lower average Sensor Glucose (SG) , 7.2±1.3 vs. 8.2±1.7 mmol/l, p=0.04, and estimated HbA1c , 6.1±0.7 vs. 6.8±1.1%, p=0.02, in Group A patients.

We also report three cases of ketosis, proved by elevated capillary β-hydroxybutyrate concentrations. Pathophysiological link between frequent hypoglycemia rates (Six patients without insulin treatment (11.5 % in total CGM group of 52 patients)) and ketosis development (Three patients (2.2% in total cohort of 136 participants)) was suggested.

Conclusions: More frequent than previously reported rates of hypoglycemia and ketoacidosis were discovered in patients taking SGLT2 inhibitors. Pathophysiological link between the two conditions is assumed. More studies are needed to confirm our hypothesis.

Pharmacy Formulas. 2019;1(1):52-69
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Biological sciences
Tendencies and perspectives of central alpha2-adrenomimetic application in medicobiological research
Vengerovich N.G., Ivanov I.M., Proshina Y.A.
Abstract

The pharmacodynamic effects of the administration of α2-adrenergic agonists both in a monovariant and in combination with drugs of other pharmacological groups are considered. Based on analysis of safety nonclinical studies the characteristics of main physiological effects of α2-adrenergic receptors as well as physiological effects of α2-agonists on various organs and systems are presented. For the determination of tendencies and directions in research of central α2-AM (dexmedetomidine) the analysis of bibliographical data, accumulated and extracted from Medline database with 5 year time-filter (VOSviewer, 1.6.11 version) has been carried out. For the further research of central α2-adrenomimetics and their application in clinical practice the following perspective directions have been determined: the study of effects and mechanisms of cytoprotectant and antioxidant action, the study of the use of drugs in a monovariant and in combinations for the development of analgesic drugs, anesthesia and development of combined formulations with a delayed release of antagonists designed to mitigate side effects.

Pharmacy Formulas. 2019;1(1):70-77
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Approaches to a comprehensive solution to the problem of medical waste management
Perelygin V., Sklyarova N., Paramonov S., Pyatizbyantsev T.
Abstract

Topical issues of medical waste compliance with Federal Law 89-ФЗ “On Production and Consumption Wastes” and aspects of conducting medical waste management activities in order to comply with this regulatory legal act are considered. It has been established that when medical waste falls under the federal law FZ-89, additional requirements for conducting waste management activities are not taken into account, the entry of “medical waste” into the Federal Classification Catalog of Waste (FCCW) as a separate unit and optimization of the certification of medical waste. In our opinion, there are currently gaps in the medical waste management activities in the environmental legislation of the Russian Federation and, as a consequence, in law enforcement practice. An algorithm of scientifically based approaches to solving the main problems of the existing problems that can be applied during the preparation and development of the Information and Technical Guide on the best available technologies (BAT) for medical waste management is proposed.

Pharmacy Formulas. 2019;1(1):78-83
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Information and Prevention
Features of regulation and control of emissions at the facility of category III
Lamikhova M.V.
Abstract

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Pharmacy Formulas. 2019;1(1):84-87
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Discharge Inventory: A New Duty
Subbotinskaya V.A.
Abstract

31 июля 2019 года вступили в силу Правила проведения инвентаризации сбросов загрязняющих веществ
в окружающую среду1. Когда следует приступать к инвентаризации?
Закон №7-ФЗ2 содержит ряд специальных норм, которые применяются к лицам, эксплуатирующим
объекты централизованных систем водоотведения поселений или городских округов (далее – ЦСВ). В
частности, к таким нормам относятся положения, определяющие особенности:
1) исчисления платы за негативное воздействие на окружающую среду (НВОС) за сбросы загрязняющих веществ организациями, эксплуатирующими ЦСВ;
2) установления нормативов допустимых сбросов (НДС) для объектов ЦСВ в отношении загрязняющих веществ, не относящихся к технологически нормируемым веществам;
3) установления технологических нормативов;
4) установления временно разрешенных сбросов;
5) разработки программ повышения экологической эффективности и планов мероприятий по охра-
не окружающей среды.

Pharmacy Formulas. 2019;1(1):88-94
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Heritage
He created a modern pharmacologist
Narkevich I.A., Zvyagin Y.Y., Vorobieva S.A., Perelygin V.V., Dobrova D.O.
Abstract

From the editors: Editorial Board "Formula Pharmacy" plans to make a contribution to the preparation and publication on its pages of essays about all the rectors of Saint-Petersburg chemical-pharmaceutical University from the beginning of its existence up to the present time about other scientists, especially the veterans who gave years of his life and work for the benefit of pharmaceutical science.

Pharmacy Formulas. 2019;1(1):95-103
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