Vol 3, No 4 (2021)

From the editor

FROM THE EDITOR

Narkevich I.A.

Abstract

This issue closes the creative publication year for the Editorial Board. In this regard, we, like all our readers, summarize and analyze the results of our work

Pharmacy Formulas. 2021;3(4):2-3
pages 2-3 views

Pharmaceutical Sciences

Applications of chitosan as a polymer carrier for increasing the drugs’ bioavailability

Ustinova T.M., Vengerovich N.G., Glinko D.K.

Abstract

Oral drug delivery is a dynamic research area, yet associated with multiple issues in its using: enzymatic degradation, hydrolysis, low permeability of intestinal epithelium. The review presents a research papers’ analysis on the development of targeted drug delivery using a biodegradable polymer chitosan. Chitosan application, singly or in composites, is suitable for various drug delivery systems. Upon oral delivery, chitosan serves as a mucoadhesive polymer with controlled and targeted release. During the last five years, various approaches to the delivery of insulin and other drugs had been reported in literature. The main technological strategy for insulin delivery was its protection against intestinal pH, as well as increasing of permeability via transcellular and/or paracellular pathways. It is observed that application of the biopolymer and its derivatives has a controlled absorption profile. In publications on the drugs delivery, most of the research is focused on development and modification of methods for their producing. According to the presented experimental data, there were obtained particles with well-defined spherical shapes and microparticles’ capacity of 85–97%. A number of research articles provide data on the chitosan application as a mucoadhesive coating for various nano- or microparticles. It was also noted that application of chitosan microparticles contributed to diminishing adverse side effects.

Pharmacy Formulas. 2021;3(4):10-19
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Information technologies in the analysis of pharmaceutical personnel security

Klishchenko M.Y., Kuznetsov D.A.

Abstract

The implementation of the “Development of the pharmaceutical and medical industry” State Program is largely determined by the human resources of pharmaceutical organizations. In this regard, personnel are the most important element for organizations; the effectiveness of the organization, its development and success depend on their experience, abilities, competencies. Ensuring personnel security requires special attention at all stages of the organization’s activities, which determines the need to study the factors and threats that have a special impact on it and, therefore, determines the relevance of this issue. The computer program “Pharmaceutical Personnel Security” developed by us was implemented in accordance with the national project “Healthcare”, which identified the need for digitalization of the national system in order to improve the quality and effectiveness of pharmaceutical care. Against this background, we consider the introduction of the Pharmaceutical Personnel Security program into the activities of pharmaceutical industry organizations to automate the process of analyzing the state of personnel security relevant and promising.

Pharmacy Formulas. 2021;3(4):20-27
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Biomedical Sciences

Development of the emulsion composition and technology based on iron oleate micelles

Trofimov M.A., Goncharenko A.A., Plisko G.A., Semivelichenko E.D., Muslimov A.R., Ivkina A.S.

Abstract

This paper addresses the problem of drugs for the treatment of iron deficiency anemia (IDA). Iron deficiency anemia is a clinical and hematological syndrome based on a violation of hemoglobin synthesis resulting from iron deficiency. Clinically, IDA is manifested by symptoms of anemia and sideropenia. The aim of the study is to develop new drugs for the treatment of IDA based on lipophilic iron compounds with oleic acid in the form of a microemulsion. Analogues of the developed compounds are presented on the pharmaceutical market, being registered exclusively as biologically active food additives (Lipofer, Sideral Forte). During the study, the following materials and methods were used: iron (III) oleate with an iron ion concentration of 25 mg/g was obtained by mixing 1.1 g (0.03 mol) of iron nitrate with 6.0 g (0.21 mol) of oleic acids. After that, the mixture was heated to 90℃ for 24 hours under constant stirring. To 3 g of the previously obtained iron (III) oleate solution, 0.56 g of ascorbyl palmitate was added in an equimolar ratio to the iron ion. The mixture was stirred for 24 hours at 90℃. The resulting iron (II) oleate emulsion showed the presence of divalent ions at a concentration of 4.77 mg/g. The total concentration of iron ions in the analyzed oleates of both types was the same. Recalculation for the initial solution in oleic acid showed that the concentration was close to the expected values. Solutions for quantifying the concentrations of the active substances of the drugs under development have been presented. The fundamental possibility of carrying out the in situ reduction of the iron ion in oleic acid using a lipophilic reducing agent, ascorbyl palmitate, has been demonstrated.

Pharmacy Formulas. 2021;3(4):28-34
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State of the Russian Oncology Service: lip cancer. Population-based study at the federal district level. Part I. Incidence rate, annual mortality rate, localization and histological structure

Merabishvili V.M., Vasilyev A.B., Merabishvili E.N., Barsukov A.F.

Abstract

Malignant neoplasms of the lip (C00) are rare types of malignancies. It is ranked 30 in terms of the structure of oncopathology in Russia and the Northwestern Federal District of the Russian Federation. There is a positive trend in the incidence rate as its share takes modestly 0,4% (both sexes) in the database of the Population-based Cancer Registry (PCR) of the Northwestern Federal Region of the Russian Federation.

It should be noted that according to the official reporting (Form No. 7) it is impossible to obtain any other criteria for assessing the effectiveness of combating this tumor in addition to the trends of morbidity. We have presented the estimation on the state of the effectiveness of anticancer measures regarding malignant tumors of the lip (C00) on the basis of the PCR database of Saint Petersburg.

In February 2019 we created a unified database of malignant neoplasms of the Federal Region. In fact, there has been organized the first in Russia Population-based Cancer Registry at the Federal Region level. As of January 1, 2020 the Northwestern Federal Region of the Russian Federation (NWFD RF) includes 11 subjects with the population of 1 397 727. Total number of registered lip cancer cases – more than 1 million 350 thousand cases. To develop analytical criteria, only reliable materials –952791 cases including 2663 cases of malignant tumors of the lip were selected.

Aim and objectives of the study were to determine the prevalence of malignant neoplasms of the lip, annual mortality, features of localization and histological structure.

Materials for the study were cancer incidence books. Standard research methods recommended by the International Association of Cancer Registries were used.

The study has revealed a high level of lip cancer morbidity of the population in Russia and the North-Western Federal District against the background of indicators for economically developed countries, but the incidence rate is gradually decreasing.

The highest standardized incidence rate of malignant tumors of the lip in the Northwestern Federal District of the Russian Federation remains among the male population of the Vologda, Pskov regions and the Komi Republic.

We have established a special procedure for the death of patients with malignant neoplasms of the lip in the Northwestern Federal District of the Russian Federation. A surge in mortality from lip cancer has been revealed in women in the second, fourth, seventh, ninth and tenth years of follow-up, in men – in the fourth, seventh and tenth. It requires fundamental research to identify the causes of the surge in mortality. Unfavorable annual mortality trends have been revealed. The features of localization and histological structure of malignant tumors of the lip have been established.

Pharmacy Formulas. 2021;3(4):36-43
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State of the Russian Oncology Service: lip cancer. Population-based study at the federal district level. Part II. Survival of patients, median of survival, survival of patients taking into account the localization, histological structure and disease stage

Merabishvili V.M., Vasilyev A.B., Merabishvili E.N., Barsukov A.F.

Abstract

Malignant neoplasms of the lip are a rare type of tumor. State reporting provides only a set of data for calculating incidence rates. The Population-Based Cancer Registry (PCR) database developed by us at the level of the Northwestern Federal District of the Russian Federation allowed, for the first time in Russia, to calculate a set of analytical indicators, such as the median survival, one-year and five-year cumulative survival rates of lip cancer patients, taking into account the detailed localization and histological structure.

The aim of the study was to investigate the level and trends in survival of lip cancer patients in the Northwestern Federal District of the Russian Federation considering the localization and histological structures and the stage of the disease.

The material of the study was the Population-based Cancer Registry of the Northwestern Federal District of the Russian Federation. Data processing was carried out using the methodology recommended by the International Association of Cancer Registries under the EUROCARE program.

Unfavorable trends in the lip cancer incidence rate have been established in Russia and the Northwestern Federal District of the Russian Federation. The median survival remained within 6–8 years. Survival rates of patients have indicated a high level of treatment of patients with malignant lip neoplasms at the level of the Northwestern Federal District. Survival of patients in the first year of observation was: observed – 89.3%, relative – 93.8%. The five-year observed survival did not reach 50%, the relative exceeded 60%.

Detailed localization development of the PCR data has revealed that patients with malignant neoplasms of the outer surface of the lower lip (C00.1) account for 60%. Histological characteristics of the registered patients have been significantly improved.

Pharmacy Formulas. 2021;3(4):44-51
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Biological sciences

Supergroups of eukaryotes through a biotechnologist’s look. The system of eukaryotes and the need for a taxonomic/biotechnological interface

Zmitrovich I.V., Perelygin V.V., Zharikov M.V.

Abstract

Eukaryotes represent a group of rich biotechnological potential, and its classification having high heuristic power and great predictive capabilities is needed by the biotechnological community. The requirements for biological classification by applied sciences can be reduced to 1) the stability of the classification system and 2) its adequacy to the nature relationships. The present paper provides a retrospective review of eukaryotic megataxonomy, assesses the stability of current system, and outlines approaches to building an interface that ensures a crosstalk of taxonomic and biotechnological communities.

Pharmacy Formulas. 2021;3(4):52-65
pages 52-65 views

Problems of solid radioactive waste management on the example of the radioactive isotope 14C

Perelygin V.V., Kotenko P.K., Podboronova A.G., Zharikov M.V., Sklyarova L.V.

Abstract

The management of irradiated graphite waste continues to attract the attention of specialists from a number of related industries, in connection with the technical and economic component, along with the fact that solid radioactive waste entering the environment in the process of disposal acquires biogenic character. The environmental safety of solid radioactive waste management is associated with the possibility of biologically significant 14C to enter the human body.

Resulting from the development of the nuclear industry, 14C has become one of the causes of global and local pollution.  The consequences of thermonuclear explosions, operation of nuclear power plants, as well as nuclear fuel cycle enterprises, isotope production for the production of drugs labeled with 14C, research institutions are considered as sources of 14C.

The world output of accumulated reactor graphite is estimated at 250,000 tons. In the Russian Federation, the total volume is approximately 60,000 tons of graphite. The share of accumulated irradiated graphite in Russia comprises 24% of the total volume of accumulated graphite.

Having studied and analyzed the statistical data of scientific research, using the methods of generalized data processing, systematization and comparative analysis, we have taken the liberty to make a general conclusion about modern approaches and the relevance of solving the problem of SRW management on the example of the 14C radioactive isotope.

Pharmacy Formulas. 2021;3(4):66-76
pages 66-76 views

Information and Prevention

Current aspects of the preclinical studies development for the pharmaceutical industry of the Eurasian Economic Union

Ivkin D.Y.

Abstract

The article discusses current aspects of the preclinical studies development for the pharmaceutical industry of the Eurasian Economic Union.

Pharmacy Formulas. 2021;3(4):78-80
pages 78-80 views

Arctic as a radiation zone: problems and solutions

Troshin V.A.

Abstract

The article discusses the Arctic as a radiation zone, describing problems and solutions.

Pharmacy Formulas. 2021;3(4):82-83
pages 82-83 views

Pharmaceutical learning activit

A roadmap for the development of “Training system of specialists for nuclear medicine facilities at the Saint Petersburg State Chemical and Pharmaceutical University”

Perelygin V.V., Sklyarova N.A.

Abstract

In this paper, we present part of the discussion materials, as well as general conclusions about the training system of specialists for nuclear medicine facilities during speeches and reports at the Scientific and Practical Forum, which was held in person at Saint Petersburg Chemical and Pharmaceutical University (SPCPU) in June and December 2021 on the following topics: “Environmental protection. Environmental Risk Assessment at Nuclear Medicine Facilities and Experimental Pharmacology Centers” and “Environmental Protection. Environmental Risks Assessment in the Radiopharmaceuticals Waste Management”.

The main goal of the Scientific and Practical Forum was to determine approaches to improving and harmonizing master’s programs and to develop new programs of additional education at SPCPU in the field of training masters and qualified specialists for nuclear medicine infrastructure facilities, the Ministry of Industry and Trade of the Russian Federation, the Ministry of Health of the Russian Federation of the Federal Medical and Biological Agency and the Rosatom State Atomiс Energy Corporation.

At the core of our work is the solution of the problem of training personnel for nuclear medicine facilities - the development of an integrated system for monitoring the science progress, technology and innovation in Russia and abroad, forming an information base on promising trends in scientific and technological development, as well as the identification global technological trends that may have the greatest impact on the development of nuclear medicine.

For a clear solution of the tasks to achieve the goal of training specialists for nuclear medicine facilities, we propose approaches to develop a roadmap for the development of the “Training system of specialists for nuclear medicine facilities at the Saint Petersburg State Chemical and Pharmaceutical University” and tools for collecting and processing statistical data and other elements, in accordance with the regulatory legal acts, federal and local regulatory documents.

Pharmacy Formulas. 2021;3(4):84-91
pages 84-91 views

Actual problems: discussion tribune

Current issues in clinical trials of radiopharmaceutical drugs at the present stage of nuclear medicine development

Efimov N.V., Lebedinets A. .

Abstract

To date, doctors are becoming increasingly interested in radiopharmaceutical drugs associated with an improvement in their effectiveness and safety due to the use of alpha-emitting isotopes and highly selective ligands in the formulation. According to MarketsandMarkets, the nuclear medicine market will grow from $4.8 billion in 2021 to $7.5 billion by 2026 at a compound annual growth rate of 9%. The Russian Federation will have to work on import substitution with the analogue development of foreign-made drugs not registered in Russia, as well as original development that must meet world standards. Promotion of new drugs to patients is impossible without conducting clinical trials that meet GCP criteria. Even in countries with a high development of biomedical technologies, there are not enough resources to conduct clinical trials of new RPCDs. The most important limiting factors are the high cost of studies using open sources of radiation and the discrepancy between the traditional method of clinical trials, the unique properties of new RPCD and the effective method of theranostics using diagnostic and therapeutic pairs of radionuclides. To overcome these difficulties in evaluating RPCD, in particular, a phase zero clinical trial on several volunteers with the disease and the establishment of specialized testing clinical centers are proposed.

Pharmacy Formulas. 2021;3(4):92-95
pages 92-95 views

The use of Mexidol-Vet® against the background of ultraviolet and gamma irradiation in rats

Troshin E.I., Yugatova N.Y., Vasil'ev R.O.

Abstract

The article presents data on the results of using Mexidol-Vet® in rats exposed to a bactericidal lamp, which is a generator of shortwave radiation with a wavelength of 253.7 nm, as well as gamma radiation at a dose that causes acute radiation damage in rats. The results of the dynamics of the clinical and hematological status have been described both against the background of the influence of physical factors and during the use of the drug. The paper presents data that the use of Mexidol-Vet® according to the described treatment regimen has an erythropoietic effect under ultraviolet irradiation, and can be recommended for inclusion in a combined treatment regimen for acute radiation injury.

Pharmacy Formulas. 2021;3(4):96-101
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Ecotoxicological assessment of waste and soil cover of anthropogenic polluted territories using biotest systems

Bardina T.V., Podboronova A.G., Sklyarova L.V.

Abstract

The possibility of using various methods of biotesting together with chemical-analytical methods for the ecotoxicological assessment of waste from the oil industry (drilling sludge) and contaminated soil cover of objects of accumulated environmental damage located in the north-west of Russia is considered. Ecotoxicological studies by biotesting methods have been carried out using test organisms from different systematic groups. Conventional and proprietary biotesting methods were used. The proposed set of biotest systems for the purposes of environmental control of such objects along with chemical and analytical methods may increase the reliability of the research results.

Pharmacy Formulas. 2021;3(4):102-107
pages 102-107 views

Biodizine as a civilizational challenge of modern pharmaceuticals

Tyukavin A.I., Arseniev N.А., Studneva M.A., Medvedeva V.S., Suchkov S.V.

Abstract

The review discusses the role of pharmaceutical and drug design methodology in the development of the high-tech segment of the development and production of original drugs for personalized and precision medicine (PPM). Topical issues of using predictively personalized tools for precision medicine in pharmaceuticals are highlighted. New opportunities and prospects for increasing the effectiveness of drugs in various fields of medicine created on the basis of pharmaceutical design are shown. Discussed are original approaches to standardization and reproducibility of the effects of new drugs at the preclinical stage using microfluidic bioconstructs – organ-on-a-chip systems. The relevance of improving university curricula for training specialists in the field of molecular drug design (drug design), harmonized with dynamically developing biotechnologies in pharmaceuticals, as well as the needs of domestic healthcare in original medicines for PPM, is shown.

Pharmacy Formulas. 2021;3(4):108-117
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Heritage

The formation of the SPSUVM Department of Pharmacology and Toxicology

Lunegov A.M.

Abstract

The Department of Pharmacology and Toxicology of the Saint Petersburg State University of Veterinary Medicine is rightly considered to be the center of veterinary pharmacology in Russia. Over the hundred years of its existence, it has made a huge contribution to the training of highly qualified specialists in the field of veterinary pharmacology and toxicology. During the existence of the department, the scientific school of its former leaders V. D. Sokolov and N. L. Andreeva has been formed and is actively developing. Years of work of the department staff in the scientific and pedagogical field have resulted in the introduction of textbooks on pharmacology, clinical pharmacology and veterinary pharmacy into the educational process of the country. Since 2005, the department has been using alternative forms of teaching students using adapted computer programs to study neurotropic drugs in more depth and detail, many of which, due to special reasons, are sharply regulated. The university was included in the list of the first universities in Russia that introduced such a progressive teaching method and was awarded at the international level.

The message briefly describes the 100-year activity of the department. It tells about its leaders and about the progress made to date in the training of modern highly qualified specialists in the veterinary pharmacology and toxicology.

Pharmacy Formulas. 2021;3(4):118-123
pages 118-123 views

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