Pub Date : 2021-04-01DOI: 10.52540/2074-9457.2021.1.20
A. A. Kuhach, V. Kuhach
The purpose of the study is to analyze examination and registration of orphan medicinal preparations in different countries of the world. Methods of description, comparison, grouping and analysis were used in the study. Great importance of the problem of orphan medicinal preparations manufacture and access to the market associated with a large number of rare diseases (7000-8000), their wide distribution in various regions of the world (up to 8% of the population), high cost of development and difficulty in conducting clinical trials is marked. It is shown that criteria for classifying diseases as orphan ones are their prevalence among the population as well as total number of patients in a particular country. Orphan medicinal preparations are those intended to treat rare diseases; in a number of countries (the USA and the European Union) the criterion for orphan medicinal preparations is its unprofitableness for the manufacturer. In the United States, the European Union and Japan special subdivisions for the registration of orphan medicinal preparations have been established in the structure of regulatory authorities. In order to stimulate the orphan medicinal preparations manufacture in the USA, the European Union, Australia and Japan manufacturers are given financial resources for the development and research, tax privileges, discounts and consultations with the specialists are provided during registration. Restructuring technology is widely used in the development of orphan medicinal preparations in the US and Singapore. It has been established that in order to increase accessibility for the population in different countries various accelerated procedures to give access to orphan medicinal preparations to the market are used. The terms of market exclusivity are stated: in Australia - 5 years, in the USA - 7 years, in Japan and the European Union - 10 years. It is determined that there are lists of orphan diseases (from 41 in the Kyrgyz Republic to 262 in the Russian Federation) and (or) orphan medicinal preparations approved in all the EAEU countries; accelerated registration procedures are provided; import of unregistered orphan medicinal preparations is allowed.
{"title":"EXPERTISE AND REGISTRATION OF ORPHAN MEDICINAL PREPARATIONS","authors":"A. A. Kuhach, V. Kuhach","doi":"10.52540/2074-9457.2021.1.20","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.1.20","url":null,"abstract":"The purpose of the study is to analyze examination and registration of orphan medicinal preparations in different countries of the world. Methods of description, comparison, grouping and analysis were used in the study. Great importance of the problem of orphan medicinal preparations manufacture and access to the market associated with a large number of rare diseases (7000-8000), their wide distribution in various regions of the world (up to 8% of the population), high cost of development and difficulty in conducting clinical trials is marked. It is shown that criteria for classifying diseases as orphan ones are their prevalence among the population as well as total number of patients in a particular country. Orphan medicinal preparations are those intended to treat rare diseases; in a number of countries (the USA and the European Union) the criterion for orphan medicinal preparations is its unprofitableness for the manufacturer. In the United States, the European Union and Japan special subdivisions for the registration of orphan medicinal preparations have been established in the structure of regulatory authorities. In order to stimulate the orphan medicinal preparations manufacture in the USA, the European Union, Australia and Japan manufacturers are given financial resources for the development and research, tax privileges, discounts and consultations with the specialists are provided during registration. Restructuring technology is widely used in the development of orphan medicinal preparations in the US and Singapore. It has been established that in order to increase accessibility for the population in different countries various accelerated procedures to give access to orphan medicinal preparations to the market are used. The terms of market exclusivity are stated: in Australia - 5 years, in the USA - 7 years, in Japan and the European Union - 10 years. It is determined that there are lists of orphan diseases (from 41 in the Kyrgyz Republic to 262 in the Russian Federation) and (or) orphan medicinal preparations approved in all the EAEU countries; accelerated registration procedures are provided; import of unregistered orphan medicinal preparations is allowed.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90728193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-04-01DOI: 10.52540/2074-9457.2021.1.53
D. A. Kolyesnik, P. O. Levshukova, Ye. V. Kuvayeva, I. I. Tyerninko, I. Yakovlev
The primary reference sample (RS) use is one of the conditions necessary for conducting pharmaceuticals appropriate quality control. Therefore, their development is an urgent problem for the pharmaceutical industry, especially for new biologically active compounds that can be further used as pharmaceuticals. The aim of the work is to develop a primary standard sample of new sodium 1,2-dipheny l-5-butyl-6-oxo-1,6-dihydropyrimidine-4-olate. This substance can be used in medical practice as an anti-inflammatory agent. Primary RS was obtained by additional purification of the additional pharmaceutical substance by threefold recrystallization of acetone. The work on its certification was the following: the structure was confirmed, such indicators as weight loss on drying, inorganic impurities (chlorides, sulphated ash, heavy metals), related impurities were determined. The main component quantitative content has been established using the material balance.
{"title":"SODIUM 1,2-DIPHENYL-5-BUTYL- 6-OXO-1,6-DIHYDROPYRIMIDINE-4-OLATE PRIMARY REFERENCE SAMPLE DEVELOPMENT","authors":"D. A. Kolyesnik, P. O. Levshukova, Ye. V. Kuvayeva, I. I. Tyerninko, I. Yakovlev","doi":"10.52540/2074-9457.2021.1.53","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.1.53","url":null,"abstract":"The primary reference sample (RS) use is one of the conditions necessary for conducting pharmaceuticals appropriate quality control. Therefore, their development is an urgent problem for the pharmaceutical industry, especially for new biologically active compounds that can be further used as pharmaceuticals. The aim of the work is to develop a primary standard sample of new sodium 1,2-dipheny l-5-butyl-6-oxo-1,6-dihydropyrimidine-4-olate. This substance can be used in medical practice as an anti-inflammatory agent. Primary RS was obtained by additional purification of the additional pharmaceutical substance by threefold recrystallization of acetone. The work on its certification was the following: the structure was confirmed, such indicators as weight loss on drying, inorganic impurities (chlorides, sulphated ash, heavy metals), related impurities were determined. The main component quantitative content has been established using the material balance.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87865526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-04-01DOI: 10.52540/2074-9457.2021.1.99
A. V. Shalukhina, V. F. Sosonkina, N. Bizunok
This article presents the history of the Pharmacology department establishment and development during 1922-1940 with the teaching staff description, the department location and the disciplines taught. The problem of training pharmacy specialists in Belarus connected with the growth of pharmacies and the development of pharmaceutical industry in the period given is stated. The problem is solved by building the system of secondary and higher pharmaceutical education in the country. The Pharmacology department made particular contribution to the educational process in 1930 s-1940s when professor Anischenko V. A. having a great experience in organizational, teaching and pharmaceutical activities headed it. The Pharmacology department provided facilities to run courses in training pharmacists and pharmaceutical laboratory workers, and advanced training courses for pharmacists. The teaching staff conducted classes with the students and trainees of the courses. The Pharmacology department worked in close contact with Minsk Chemical-pharmaceutical factory dealing with some drug manufacture issues, held conferences with specialists.
本文介绍了药学系在1922-1940年间的建立和发展历史，包括教学人员的描述、院系的位置和所教授的学科。报告指出，在上述期间，白俄罗斯培训药房专家的问题与药店的增长和制药业的发展有关。要解决这一问题，必须在我国建立中高等药学教育体系。药学系在20世纪30年代至40年代对教育进程作出了特别贡献，当时Anischenko V. a .教授在组织、教学和药物活动方面具有丰富的经验。药理学部提供设施开办培训药剂师和药学实验室工作人员的课程，并为药剂师提供高级培训课程。教学人员对课程的学生和学员进行授课。药理学部门与明斯克化学制药厂密切联系，处理一些药品生产问题，与专家举行会议。
{"title":"BELARUSIAN PHARMACEUTICAL EDUCATION DEVELOPMENT DURING THE PRE-WAR PERIOD AND CONTRIBUTION OF PHARMACOLOGY DEPARTMENT OF BELARUSIAN STATE MEDICAL UNIVERSITY TO PHARMACISTS EDUCATION","authors":"A. V. Shalukhina, V. F. Sosonkina, N. Bizunok","doi":"10.52540/2074-9457.2021.1.99","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.1.99","url":null,"abstract":"This article presents the history of the Pharmacology department establishment and development during 1922-1940 with the teaching staff description, the department location and the disciplines taught. The problem of training pharmacy specialists in Belarus connected with the growth of pharmacies and the development of pharmaceutical industry in the period given is stated. The problem is solved by building the system of secondary and higher pharmaceutical education in the country. The Pharmacology department made particular contribution to the educational process in 1930 s-1940s when professor Anischenko V. A. having a great experience in organizational, teaching and pharmaceutical activities headed it. The Pharmacology department provided facilities to run courses in training pharmacists and pharmaceutical laboratory workers, and advanced training courses for pharmacists. The teaching staff conducted classes with the students and trainees of the courses. The Pharmacology department worked in close contact with Minsk Chemical-pharmaceutical factory dealing with some drug manufacture issues, held conferences with specialists.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85663357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-04-01DOI: 10.52540/2074-9457.2021.1.65
D. V. Kazak, E. Dikusar, S. Stepin
The urgent task of modern pharmaceutical chemistry is the development of new methods of synthesis, the study of chemical properties, as well as the search for biologically active compounds among derivatives of nicotinic and isonicotinic acids. The review examines synthetic approaches to the production of carboxylic acid esters including nicotinic and isonicotinic acids, gives examples of the biological activity of nicotinic and isonicotinic acids and their derivatives. The methods for the synthesis of azomethines, substituted acridines and pyrazolones are discussed, examples of their biological activity are given. A promising concept for the synthesis of new potential drugs based on heterocyclic derivatives of nicotinic and isonicotinic acids is presented. The methods of functionalization of organic compounds considered in this review with regard to the synthesis of heterocyclic derivatives of nicotinic and isonicotinic acids make it possible to obtain new promising compounds potentially having antibacterial, antiviral, fungicidal and antitumor activity.
{"title":"NEW APPROACHES TO SYNTHESIS OF HETEROCYCLIC DERIVATIVES OF PYRIDINE CARBOXYLIC ACIDS, ACRIDINE AND PYRAZOLONE","authors":"D. V. Kazak, E. Dikusar, S. Stepin","doi":"10.52540/2074-9457.2021.1.65","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.1.65","url":null,"abstract":"The urgent task of modern pharmaceutical chemistry is the development of new methods of synthesis, the study of chemical properties, as well as the search for biologically active compounds among derivatives of nicotinic and isonicotinic acids. The review examines synthetic approaches to the production of carboxylic acid esters including nicotinic and isonicotinic acids, gives examples of the biological activity of nicotinic and isonicotinic acids and their derivatives. The methods for the synthesis of azomethines, substituted acridines and pyrazolones are discussed, examples of their biological activity are given. A promising concept for the synthesis of new potential drugs based on heterocyclic derivatives of nicotinic and isonicotinic acids is presented. The methods of functionalization of organic compounds considered in this review with regard to the synthesis of heterocyclic derivatives of nicotinic and isonicotinic acids make it possible to obtain new promising compounds potentially having antibacterial, antiviral, fungicidal and antitumor activity.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"51 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83641581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-04-01DOI: 10.52540/2074-9457.2021.1.42
V. Leontiev, O. I. Lazovskaya
Industrial manufacture of palleted medicinal preparations requires the use of excipients of various purposes among which magnesium stearate is of great importance giving lubrication properties to the tabletted substance. However, magnesium stearate has an unequal lubricating effect despite the fact that quality indicators of magnesium stearate from different manufacturers comply with the requirements of the Pharmacopoeia Monograph. In this work, a comparative analysis of magnesium stearate quality indicators from Merck KGaA (Germany) and Accent Microcell Pvt. Ltd. (India) was carried out. It was found that magnesium stearate from Merck KGaA (Germany) has the best lubrication properties having the smallest particle size and predominantly dihydrated form and characterized by the highest content of stearic acid. To identify hydrated forms of magnesium stearate thermal analysis was used making it possible to determine dehydration temperatures and melting of pseudopolymorphic structures by endothermic heat effects.
{"title":"MAGNESIUM STEARATE QUALITY INDICATORS TO ESTIMATE ITS LUBRICATION PROPERTIES","authors":"V. Leontiev, O. I. Lazovskaya","doi":"10.52540/2074-9457.2021.1.42","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.1.42","url":null,"abstract":"Industrial manufacture of palleted medicinal preparations requires the use of excipients of various purposes among which magnesium stearate is of great importance giving lubrication properties to the tabletted substance. However, magnesium stearate has an unequal lubricating effect despite the fact that quality indicators of magnesium stearate from different manufacturers comply with the requirements of the Pharmacopoeia Monograph. In this work, a comparative analysis of magnesium stearate quality indicators from Merck KGaA (Germany) and Accent Microcell Pvt. Ltd. (India) was carried out. It was found that magnesium stearate from Merck KGaA (Germany) has the best lubrication properties having the smallest particle size and predominantly dihydrated form and characterized by the highest content of stearic acid. To identify hydrated forms of magnesium stearate thermal analysis was used making it possible to determine dehydration temperatures and melting of pseudopolymorphic structures by endothermic heat effects.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"118 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79755009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.52540/2074-9457.2021.1.15
Я. П. Матвеенко
{"title":"Использование информационных технологий в работе аптек учреждений здравоохранения (больничных аптек)","authors":"Я. П. Матвеенко","doi":"10.52540/2074-9457.2021.1.15","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.1.15","url":null,"abstract":"","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"104 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79221690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.52540/2074-9457.2021.1.12
Я. А. Бородич
{"title":"Внутриаптечная заготовка и фасовка лекарственных средств в рецептуре аптек Могилевского ТП РУП \"Фармация\"","authors":"Я. А. Бородич","doi":"10.52540/2074-9457.2021.1.12","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.1.12","url":null,"abstract":"","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81815573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 1900-01-01DOI: 10.52540/2074-9457.2021.1.48
I. Y. Smekhova, Yu. M. Ladutko, O. Kalinina
Despite the decrease in the number of pharmacies having prescription and manufacturing departments the need for extemporally manufactured dosage forms remains high. Pharmaceutical organization dealing with medicines manufacture is currently facing a number of problems: lack of modern pharmaceutical substances at pharmacies, manufacture of medicines containing narcotic substances, psychotropic substances and their precursors, high costs, low profitability of in-pharmacy manufacture and etc. The urgency to preserve and revive ex tempore formulations at pharmacies is highlighted. The groups of patients for whom individual manufacture of medicines is most relevant are identified: children, especially newborn and children under 1 year old, elderly patients, as well as patients with orphan diseases and patients requiring palliative care. The advantages of the extemporal formulation are noted, in particular, the selection of an individual composition and dosage taking into account body characteristics, age, concomitant diseases of the patient, tolerance of medicinal substances and their excipients, etc. Some ways to solve problems arising are suggested. Promising directions for the development of extemporal manufacture are noted: the use of modern excipients, technologies, packaging facilities, the development of internal regulatory documentation for the pharmaceutical quality system and etc.
{"title":"EXTEMPORAL MANUFACTURE OF MEDICINES. PROBLEMS AND SOLUTIONS","authors":"I. Y. Smekhova, Yu. M. Ladutko, O. Kalinina","doi":"10.52540/2074-9457.2021.1.48","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.1.48","url":null,"abstract":"Despite the decrease in the number of pharmacies having prescription and manufacturing departments the need for extemporally manufactured dosage forms remains high. Pharmaceutical organization dealing with medicines manufacture is currently facing a number of problems: lack of modern pharmaceutical substances at pharmacies, manufacture of medicines containing narcotic substances, psychotropic substances and their precursors, high costs, low profitability of in-pharmacy manufacture and etc. The urgency to preserve and revive ex tempore formulations at pharmacies is highlighted. The groups of patients for whom individual manufacture of medicines is most relevant are identified: children, especially newborn and children under 1 year old, elderly patients, as well as patients with orphan diseases and patients requiring palliative care. The advantages of the extemporal formulation are noted, in particular, the selection of an individual composition and dosage taking into account body characteristics, age, concomitant diseases of the patient, tolerance of medicinal substances and their excipients, etc. Some ways to solve problems arising are suggested. Promising directions for the development of extemporal manufacture are noted: the use of modern excipients, technologies, packaging facilities, the development of internal regulatory documentation for the pharmaceutical quality system and etc.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"86 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81132033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 1900-01-01DOI: 10.52540/2074-9457.2021.1.59
S. V. Shevchuk
The results of the toxicological experiment on extracts from Epilobium angustifolium L. herb are presented. Absence of reliable negative changes, structural and functional disorders was established in accordance with the criteria for assessing the harmfulness and danger of toxic effect of the raw materials studied in Good Laboratory Practice (GLP). Significant differences in some hematological parameters in the experimental group of animals where the dose of Epilobium angustifolium extract making 800 mg/kg of animal weight was chosen for study compared to the control one are not diagnostically significant and are within the fluctuations of physiological norms for the animals species given. It was found that the extracts in doses of 200, 500 and 800 mg/kg (by dry residue) in repeated oral administration for 28 days do not cause detectable toxic effects.
{"title":"STUDYING GENERAL TOXIC EFFECT OF EPILOBIUM ANGUSTIFOLIUM L","authors":"S. V. Shevchuk","doi":"10.52540/2074-9457.2021.1.59","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.1.59","url":null,"abstract":"The results of the toxicological experiment on extracts from Epilobium angustifolium L. herb are presented. Absence of reliable negative changes, structural and functional disorders was established in accordance with the criteria for assessing the harmfulness and danger of toxic effect of the raw materials studied in Good Laboratory Practice (GLP). Significant differences in some hematological parameters in the experimental group of animals where the dose of Epilobium angustifolium extract making 800 mg/kg of animal weight was chosen for study compared to the control one are not diagnostically significant and are within the fluctuations of physiological norms for the animals species given. It was found that the extracts in doses of 200, 500 and 800 mg/kg (by dry residue) in repeated oral administration for 28 days do not cause detectable toxic effects.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"47 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77595272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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