Vol 3, No 3 (2021)

From the editor

From the editor

Efimov N.V.
Pharmacy Formulas. 2021;3(3):2-3
pages 2-3 views

Pharmaceutical Sciences

Investigation of the properties and activity of DfCas9 and DsCas9 nucleases in eucaryotic cells

Vlasova Y.V., Madera D.A., Gershovich P.M.

Abstract

This study is focused on the two novel nucleases of the CRISPR/Cas9 family, which were found in bacterial genomes of DfCas9 (Defluviimonas sp) и DsCas9 (Demequina sediminicola). Discovery of these nucleases was part of the results of a joint study conducted by BIOCAD together with Skoltech Institute of Science and Technology and Saint-Petersburg Polytechnical University (SPPU) under a grant agreement with the Department of Science and Education of Russian Federation (Agreement number 14.606.21.0006 from September, 26th 2017). Under the agreement the nucleases DfCas9 and DsCas9 were characterized in vitro by Skoltech and SPPU.

Based on the aforementioned results, in this study we characterized the genome-modifying nuclease activity of these enzymes in a mammalian cell line HEK293. Specifically, we created genetic constructs designed to express the nucleases DsCas9 and DfCas9 together with the necessary guide RNA molecules (sequences of the guide RNAs were described previously) [1]. We demonstrated expression of the nucleases on a protein level, as well as activity of DfCas9 at the VEGF2 locus in HEK293 cells. The theoretical study was conducted by analyzing international and national literature. The experimental part was performed with a restriction-ligation cloning method, transient transfections, Western blot protein detection method, and a T7 nuclease-based method of detection of heteroduplex double-stranded DNA.

Pharmacy Formulas. 2021;3(3):10-23
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Obtaining and research of pharmaceutical properties of antiemetics in a form of powder for inhalation

Ivanov I.M., Pechurina T.B., Vengerovich N.G., Yudin M.A., Nikiforov A.S., Raguzin E.V., Kuzmich V.G., Proshina Y.A.

Abstract

Samples of antiemetic drugs (ondansetronum, palonosetronum, metoclopramidum) in the form of powder for inhalation have been developed by the method of spray drying. The granulometric composition, hygroscopicity and aerodynamic distribution of aerosol particles of the drugs have been investigated. The dosage form of the powder for inhalation of antiemetics (ondansetronum and palonosetronum) in terms of its particle size distribution, hygroscopicity and content of the agent corresponds to those for inhalation using dry powder inhalers. In the study of the phase-dispersed composition of aerosol, ondansetronum and palonosetronum in the dosage form of powder for inhalation as part of the HandiHaler inhaler (at a flow rate of 60 l/min) showed high rates of the released dose up to 72–76%, respirable particle fraction (up to 5 μm) up to 54–56% and a mass median particle size of about 3 microns. Obtaining the inhaled form of metoclopramide requires optimization of the production method for receiving the product with acceptable pharmaceutical properties.

Pharmacy Formulas. 2021;3(3):24-31
pages 24-31 views

Biomedical Sciences

State of the Russian Oncology Service: esophageal cancer. Population-based study at the federal district level. Part I. Morbidity and mortality rates, accuracy index, annual mortality

Merabishvili V.M.

Abstract

Malignant neoplasms (MNO) of esophagus is the localization with a high mortality rate. Years of searching for effective treatment in Russia have resulted in modest success. The median survival rate of patients is expressed in months, 70% of patients die in the first year of dispensary registration, the levels of one-year mortality rates for men and women practically do not differ.

The esophageal cancer (EC) morbidity and mortality rates have slightly decreased in 2000–2018 in Russia and has declined only among the male population of the Northwestern Federal District.

To study the trends in the morbidity and mortality rates in the population of Russia and the Northwestern Federal District of the Russian Federation. Qualitative analytical indicators, such as the accuracy index and the year-to-year mortality patterns in esophageal cancer patients, will be further considered.

The highest standardized EC morbidity rates of the population were found in Zimbabwe (Harare, Africans) – 15.5 0/0000, Japan (Miyage) – 14.3 0/0000 and the Arkhangelsk region of Russia – 12.8 0/0000. In 2000-2019 the level of standardized morbidity rates of the Russian population with EC has decreased from 3.44 to 3.19 0/0000 or 7.3% (both sexes), mortality rates – from 3.32 to 2.66 0/0000, or 19.9%. A decrease in the morbidity and mortality rates from EC occurred in the Northwestern Federal District of the Russian Federation, only among the male population.

Annual EC mortality rate mainly occurs according to the classical model. The highest level is determined in the first year of follow-up (72-74%); by the end of the decade, only 4.1% of patients remain from those initially recorded.

The accuracy index has decreased in Russia and in the Northwestern Federal District of the Russian Federation, respectively, to 0.84 and 0.86 (both sexes) but has remained above the critical mark of 0.7 for localizations with a high mortality rate.

Pharmacy Formulas. 2021;3(3):32-39
pages 32-39 views

State of the Russian Oncology Service: esophageal cancer. Population-based study at the federal district level. Part II. Median survival, observed and relative survival of patients considering disease stage and histological structure of tumors

Merabishvili V.M.

Abstract

Esophageal cancer (EC) is the most severe pathology of malignant tumors, with the mortality rate of patients exceeding 70% in the first year of observation. Over the past 19 years, there was a slight improvement in the effectiveness of anticancer measures for this localization of tumors. In February 2019 the Population-based Cancer Registry database (PCRD) of the Northwestern Federal District of the Russian Federation (NWFD RF) was developed with more than 1 million 350 thousand observations which provides insight into the real state of the effectiveness of anti-cancer measures and directs the following development of the database. After a thorough data quality assurance, about 1 million observations were selected for analysis.

From 2000 to 2018, 15760 primary EC cases were accumulated in the NWFD RF PCRD. Considering that the levels of standardized morbidity and mortality rates of the population of Russia and the Northwestern Federal District of the Russian Federation are close in terms of the level of indicators, we believe that the data obtained for the first time in Russia on the survival of EC patients in the Northwestern Federal District of the Russian Federation fully reflect the state of the effectiveness of combating EC in Russia.

The purpose of the study is to carry out a set of analytical calculations of the survival rates of EC patients in the dynamics over the past 19 years according to the NWFD RF PCRD. All calculations were performed in accordance with the international requirements for such development and, first of all, according to Eurocare standards.

The results of our study indicate that the EC median survival rate for both sexes has increased from five to six months.

The mortality rate of patients in the first year of follow-up has decreased from 72.4 to 71.4% (both sexes), from 73.9 to 71.6% among men, from 69.3 to 65.1% among women.

The five-year survival rate of EC patients in the NWFD RF had slight fluctuations, especially among the female population. Data grouped for three five-year observation cycles has shown an increase in the five-year survival rate of EC patients from 7.3 to 8.1%, and the one-year survival rate has increased over four five-year cycles from 25.3 to 30.8%.

For the first time in Russia, at the population level, the effect of treating EC patients has been shown according to the fourth sign of ICD-10.

The greatest treatment success has been achieved for Cervical esophagus cancer patients (C15.0) from 23.3 to 35.0% (one-year survival), Thoracic esophagus cancer patients (C15.1) from 29.6 to 35.8%. The most significant improvement has been made for Upper third of esophagus cancer patients (C15.3) – from 18.2 to 34.0%.

It is important to note that over the four observation periods, the proportion of Esophagus, unspecified cancer patients (C15.9) has decreased (from 29.3 to 19.8%), which indicates a major diagnosis quality improvement.

Pharmacy Formulas. 2021;3(3):40-47
pages 40-47 views

Biological sciences

Preliminary evaluation of patient radiation doses during radionuclide diagnostic with monoclonal antibodies labeled with 89Zr

Chipiga L.A., Petrova A.E., Mosunov A.A., Naurzbaeva L.T., Kushnarenko S.M., Lavreshov D.D., Vodovatov A.V., Stanzhevsky A.A., Maistrenko D.N.

Abstract

In connection with the constantly increasing use of monoclonal antibodies labeled with 89Zr, in clinical practice, it is urgent to study their pharmacokinetics with the determination, based on the data obtained, of absorbed doses in tumor foci, as well as intact organs and tissues, and effective doses of patients. To date, there are a limited number of studies that provide patient doses for diagnostic examinations using 89Zr-labeled monoclonal antibodies. In this regard, the purpose of this work was to assess the biodistribution of various monoclonal antibodies (ramucirumab, trastuzumab, atezolizumab) labeled with 89Zr, based on published data, with subsequent calculation of absorbed doses in radiosensitive organs and tissues and effective doses of patients.

Based on the analysis of experimental data on the biodistribution of monoclonal antibodies labeled with 89Zr for the diagnosis of oncological diseases from the available literature sources and our own assessments, it has been concluded that the results of the determination of absorbed in organs and tissues and effective doses are inconsistent. The absorbed doses in organs, according to different literature sources, vary up to an order of magnitude within one organ and reach 440 mGy per examination, the effective dose varies from 3 to 112 mSv per examination. This may be due to differences in study design, radiometry and dose assessment methods. Comparison with doses obtained on the basis of a general model of biodistribution of monoclonal antibodies demonstrates the possibility of using this model for a rough estimate of internal doses of patients. However, for a more accurate assessment, it is necessary to standardize approaches to the determination of internal radiation doses using the most effective methodological solutions and software products.

Pharmacy Formulas. 2021;3(3):48-61
pages 48-61 views

Pharmaceutical learning activit

Development of professional standards in the area of medical and biological waste management for workers of 3-4 skill levels

Perelygin V.V., Sklyarova N.A., Vasiliev V.P., Zharikov M.V., Sklyarova L.V.

Abstract

Issues related to the updating of professional standards for workers of 3-4 skill levels are relevant for all sectors of the national economy. In this study, we have analyzed the qualifications and training of the main participants in the labor market in the field of biomedical waste management in health care organizations, agriculture and veterinary medicine, food and biotechnology industries, food trade, hospitality sectors, tourism, as well as other organizations in which medico-biological waste is generated. The purpose of this work is to analyze the algorithm for updating professional standards for management of medical and biological waste specialists.

In the course of updating the Professional standard “Worker in the area of medical and biological waste management”, employees of the Department of Industrial Ecology of the Saint Petersburg Chemical and Pharmaceutical University of the Ministry of Health of the Russian Federation made a proposal to supplement the labor functions of this standard with new competencies and a new qualification “Specialist in medical waste management, formed in the organizations of pharmaceutical activity”.

Pharmacy Formulas. 2021;3(3):62-67
pages 62-67 views

Actual problems: discussion tribune

Interactomics and personalized pharmacotherapy – present and looking to the future

Tyukavin A.I., Studneva M. ., Suchkov S.V.

Abstract

The review highlights the advances in natural science that form the basis of the concept of personalized and precision medicine (PPM). The provisions of PPM (prediction, prevention, personalization) have been disclosed and modern molecular genetic tools have been shown, which are used in leading scientific and practical biomedical centers to improve the quality of treatment of patients with multifactorial diseases (MFD). The main principles of molecular genetic biomarking of MFDs, as well as gene technologies (CRISPR, non-coding RNA, etc.) used in medical practice and at the stage of clinical trials were highlighted. Particular attention has been paid to molecular genetic methods of targeted therapy for cancer, including antitumor vaccines. Scientific developments in the field of prediction and preventive treatment of MFD have been considered - precision healing technologies of tomorrow. The main provisions of interactomics as an interdisciplinary field of natural science have been highlighted, as well as the applied aspects of this section of fundamental science for the development of diagnostic and treatment-and-prophylactic technologies of a new generation.

Pharmacy Formulas. 2021;3(3):68-77
pages 68-77 views

The role of society in public administration in the field of environmental protection. Global problems of our time. Part I

Sapunov V.B., Zharikov M.V.

Abstract

The need for environmental protection is based on the assumption that environmental degradation harms humans and hinders economic development. However, the real resolution of the contradiction between the economy and nature in the field of environmental protection causes certain difficulties, as evidenced by the growing threat to environmental safety in the world.

We invite readers to discuss the materials of our analysis and a general assessment of the global problems of our time and possible ways for the further development of mankind. The author grouped them in a number of areas: the essence and classification of the main problems of our time; the origins of the global problems of our time; possible consequences of a nuclear war; theories of «Global crises» and «Cornucopia»; the concepts of «Sustainable Development», «Golden Billion», «10 Golden Billions»; the problem of the relationship between the social and the biological in man. Based on the results of the discussion, we hope to determine the role of the state, man and society as a whole, their level of interaction in developing solutions for the preservation of the environment and humanity as a species at the present stage of its development.

Pharmacy Formulas. 2021;3(3):78-83
pages 78-83 views

Heritage

Viktor Nikolaevich Ivanov: the Director of the Leningrad Institute of Chemistry and Pharmacy in the 1950s

Narkevich I.A., Stepanov S.V., Zvyagin Y.Y., Vorobeva S.A., Perelygin V.V.

Abstract

The article is dedicated to the director of the Leningrad Chemical and Pharmaceutical Institute (now the Saint Petersburg Chemical and Pharmaceutical University), a specialist in the field of chemical absorbers, Viktor Nikolaevich Ivanov, who headed the university in 1951–1958. The contribution to the development of chemical science has been revealed, also the activities during the years of the defense of Leningrad in 1941–1944 have been traced. In addition to the Chemical and Pharmaceutical Institute, his teaching activities were associated with the Leningrad and Moscow State Universities. During the era of his directorship at the Chemical and Pharmaceutical Institute, he managed to significantly strengthen the teaching staff, including specialists in the humanities, the famous sociologist I. S. Kon, as well as construct a new building and create a medicinal plant nursery in Lembolovo.

Pharmacy Formulas. 2021;3(3):86-91
pages 86-91 views

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