Pub Date : 2021-09-30DOI: 10.52540/2074-9457.2021.3.53
E. A. Saliy, A. Y. Honcharuk, O. Getalo, H. Tarasenko
The range of doxycycline drugs on the pharmaceutical market of the Ukraine is very limited and is represented by solid forms (capsules and tablets) while a rapid effect and maximum bioavailability of the drug can be provided by parenteral administration. The object of the study is the drug doxycycline hyclate in the form of lyophilisate to prepare solution for injections. During the development of the drug it was taken into account that aqueous doxycycline solution is pH dependent and tends to shift the solution pH during long-term storage. Therefore, excipients such as stabilizer and antioxidant providing buffering properties and stability of the solution were introduced into the composition. According to the research results an optimal composition of lyophilized powder was selected, the production technology with the stage of solution treatment with activated carbon was developed which allowed to obtain lyophilized powder with a well-formed porous mass without splits, cracks and fissures, resistant to shaking, and the prepared solution for parenteral administration is stable by the «Degree of coloration» quality indicator during accelerated storage regimen. It was found that doxycycline hyclate in the form of a lyophilisate shows a wide range of antibacterial activity. Comparative studies in vitro for two drugs, in the form of lyophilisate with doxycycline hyclate for injections and hard gelatin capsules with 100 mg of doxycycline hyclate, confirm equivalence of their bacteriostatic action against bacteria causing infectious diseases in humans.
{"title":"DEVELOPMENT AND EVALUATION OF LYOPHILIZED POWDER TO PREPARE SOLUTION FOR INJECTIONS BASED ON DOXYCYCLINE","authors":"E. A. Saliy, A. Y. Honcharuk, O. Getalo, H. Tarasenko","doi":"10.52540/2074-9457.2021.3.53","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.3.53","url":null,"abstract":"The range of doxycycline drugs on the pharmaceutical market of the Ukraine is very limited and is represented by solid forms (capsules and tablets) while a rapid effect and maximum bioavailability of the drug can be provided by parenteral administration. The object of the study is the drug doxycycline hyclate in the form of lyophilisate to prepare solution for injections. During the development of the drug it was taken into account that aqueous doxycycline solution is pH dependent and tends to shift the solution pH during long-term storage. Therefore, excipients such as stabilizer and antioxidant providing buffering properties and stability of the solution were introduced into the composition. According to the research results an optimal composition of lyophilized powder was selected, the production technology with the stage of solution treatment with activated carbon was developed which allowed to obtain lyophilized powder with a well-formed porous mass without splits, cracks and fissures, resistant to shaking, and the prepared solution for parenteral administration is stable by the «Degree of coloration» quality indicator during accelerated storage regimen. It was found that doxycycline hyclate in the form of a lyophilisate shows a wide range of antibacterial activity. Comparative studies in vitro for two drugs, in the form of lyophilisate with doxycycline hyclate for injections and hard gelatin capsules with 100 mg of doxycycline hyclate, confirm equivalence of their bacteriostatic action against bacteria causing infectious diseases in humans.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89931956","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 : 2021-09-30DOI: 10.52540/2074-9457.2021.3.88
A. L. Tserkovskiy, O. I. Gapova, E. A. Skorikova, S. A. Petrovich, O. A. Kasyan, M. Deryabina
The aim of the research is to study communicative tolerance of students of the Pharmaceutical Faculty of VSMU and analyze its dynamical characteristics. When comparing the degree of communicative tolerance for the 1st, 2nd and 5th year students respectively, there is a tendency towards a decrease in high and low degree of communicative tolerance and an increase in its average degree. It suggests about positive influence of the educational process on the communicative competence formation of a future pharmacist. Students with a high level of scale indicators (low degree of communicative tolerance) should be within the view of teachers of the Faculty of Pedagogics and Psychology with the course of Retraining and Advanced Training Faculty, employees of the social and pedagogical and psychological services, curators of academic groups and tutors.
{"title":"TO THE QUESTION ABOUT COMMUNICATIVE TOLERANCE OF THE PHARMACEUTICAL STUDENTS OF VSMU","authors":"A. L. Tserkovskiy, O. I. Gapova, E. A. Skorikova, S. A. Petrovich, O. A. Kasyan, M. Deryabina","doi":"10.52540/2074-9457.2021.3.88","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.3.88","url":null,"abstract":"The aim of the research is to study communicative tolerance of students of the Pharmaceutical Faculty of VSMU and analyze its dynamical characteristics. When comparing the degree of communicative tolerance for the 1st, 2nd and 5th year students respectively, there is a tendency towards a decrease in high and low degree of communicative tolerance and an increase in its average degree. It suggests about positive influence of the educational process on the communicative competence formation of a future pharmacist. Students with a high level of scale indicators (low degree of communicative tolerance) should be within the view of teachers of the Faculty of Pedagogics and Psychology with the course of Retraining and Advanced Training Faculty, employees of the social and pedagogical and psychological services, curators of academic groups and tutors.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"189 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73288896","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 : 2021-09-30DOI: 10.52540/2074-9457.2021.3.73
O. A. Sushinskaya, N. S. Golyak
The article presents the results of determining anti-inflammatory activity of the spray based on ibuprofen and liquid wormwood extract. Anti-inflammatory activity was studied on the model of local acute carrageenan inflammation. As a result of the studies it was found that the increase in paw weight averaged 49,66% in the control group of rats, in the group of rats receiving the comparison drug «Ibuleve» - 11,26%. For the group of rats receiving combined composition and the same composition without ibuprofen, the average increase in paw weight was 7,11% and 15,07%, respectively. The index of inflammatory inhibition when using combined composition was 85,68%, the composition with liquid extract of wormwood without ibuprofen was 69,65%, the liquid extract of wormwood 1:1 was 53,00%. The index of edema suppression proves that combined composition of the spray containing ibuprofen and liquid extract of wormwood has the most pronounced anti-inflammatory effect, for which the percentage of edema suppression exceeds the value for the comparison drug on the average by 8,36%.
{"title":"ANTI-INFLAMMATORY ACTIVITY OF THE SPRAY BASED ON IBUPROFEN AND LIQUID WORMWOOD EXTRACT","authors":"O. A. Sushinskaya, N. S. Golyak","doi":"10.52540/2074-9457.2021.3.73","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.3.73","url":null,"abstract":"The article presents the results of determining anti-inflammatory activity of the spray based on ibuprofen and liquid wormwood extract. Anti-inflammatory activity was studied on the model of local acute carrageenan inflammation. As a result of the studies it was found that the increase in paw weight averaged 49,66% in the control group of rats, in the group of rats receiving the comparison drug «Ibuleve» - 11,26%. For the group of rats receiving combined composition and the same composition without ibuprofen, the average increase in paw weight was 7,11% and 15,07%, respectively. The index of inflammatory inhibition when using combined composition was 85,68%, the composition with liquid extract of wormwood without ibuprofen was 69,65%, the liquid extract of wormwood 1:1 was 53,00%. The index of edema suppression proves that combined composition of the spray containing ibuprofen and liquid extract of wormwood has the most pronounced anti-inflammatory effect, for which the percentage of edema suppression exceeds the value for the comparison drug on the average by 8,36%.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"80 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83324273","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 : 2021-09-30DOI: 10.52540/2074-9457.2021.3.5
E. Alexandrova
The article is devoted to the development of quality system documents for the pharmacy organization. The legislation of the Republic of Belarus, as well as the Eurasian Economic Union, requires the development and maintenance of the quality assurance system, the quality management system, the pharmaceutical quality system in a pharmacy organization, a distributor or manufacturer of medicinal products. The article presents the comparative analysis of regulatory requirements as well as approaches of the international standards ISO series to the construction of the quality systems and processes documentation. Such documents as the Quality Manual or its equivalent, Standard Operating Procedures (SOP) and Process Instructions are the most difficult to develop. The distribution of responsibility for processes within the organization is difficult to understand. On the example of RUE «BELPHARMATSIYA» it is shown how the processes in the pharmacy organization can be documented and responsibility for their implementation can be stated. The functioning of the quality system depends on the clarity of the documentation structure and its development and circulation organization. It is the responsibility of the organization authorities to maintain effective functioning of this system.
{"title":"PROBLEMS OF MAKING QUALITY ASSURANCE DOCUMENTATION","authors":"E. Alexandrova","doi":"10.52540/2074-9457.2021.3.5","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.3.5","url":null,"abstract":"The article is devoted to the development of quality system documents for the pharmacy organization. The legislation of the Republic of Belarus, as well as the Eurasian Economic Union, requires the development and maintenance of the quality assurance system, the quality management system, the pharmaceutical quality system in a pharmacy organization, a distributor or manufacturer of medicinal products. The article presents the comparative analysis of regulatory requirements as well as approaches of the international standards ISO series to the construction of the quality systems and processes documentation. Such documents as the Quality Manual or its equivalent, Standard Operating Procedures (SOP) and Process Instructions are the most difficult to develop. The distribution of responsibility for processes within the organization is difficult to understand. On the example of RUE «BELPHARMATSIYA» it is shown how the processes in the pharmacy organization can be documented and responsibility for their implementation can be stated. The functioning of the quality system depends on the clarity of the documentation structure and its development and circulation organization. It is the responsibility of the organization authorities to maintain effective functioning of this system.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"80 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79356800","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 : 2021-09-30DOI: 10.52540/2074-9457.2021.3.32
G. Buzuk
The purpose of this work was to develop a device and technique for determining the soil trophiсity using the electrophysical method based on the measurement of the soil specific resistivity (SR). In the proposed device the F. Wenner installation is used as a sensor. The device has a modular design and includes a voltage boosting module, a PWM generator of rectangular pulses, a rectangular signal inverter and an H-bridge that switches the polarity of the power supply in order to prevent polarization of the electrodes. The metrological characteristics of the specific resistivity measurement as well as the influence of the electrodes immersion depth in the substrate studied are determined. Its significant influence and nonlinear character which was well approximated by the power function were established. The simplest equations for bringing the measured values of the RS to a certain depth of the electrodes in the object studied are proposed.
{"title":"DETERMINATION OF SOIL TROPHICITY BY ELECTROPHYSICAL METHOD. MESSAGE 1. DEVICE AND LABORATORY TECHNIQUE","authors":"G. Buzuk","doi":"10.52540/2074-9457.2021.3.32","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.3.32","url":null,"abstract":"The purpose of this work was to develop a device and technique for determining the soil trophiсity using the electrophysical method based on the measurement of the soil specific resistivity (SR). In the proposed device the F. Wenner installation is used as a sensor. The device has a modular design and includes a voltage boosting module, a PWM generator of rectangular pulses, a rectangular signal inverter and an H-bridge that switches the polarity of the power supply in order to prevent polarization of the electrodes. The metrological characteristics of the specific resistivity measurement as well as the influence of the electrodes immersion depth in the substrate studied are determined. Its significant influence and nonlinear character which was well approximated by the power function were established. The simplest equations for bringing the measured values of the RS to a certain depth of the electrodes in the object studied are proposed.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78743359","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 : 2021-09-30DOI: 10.52540/2074-9457.2021.3.41
A. Kirilyuk
The article is devoted to the nomenclature analysis of medicines prepared at 21 pharmacies of the 1st category of RUE «BELPHARMATSIYA», the largest state pharmacy network in Minsk. Medicines preparation at pharmacies is carried out according to the doctors’ prescriptions and the requirements (applications) of healthcare organizations as well as in the form of intra-pharmacy stocking and packing. The main tasks of pharmacy preparation are: providing the population and healthcare organizations with dosage forms not manufactured by industry, preparation of dosage forms mainly used in pediatric and geriatric practice, individual pharmacotherapy provision. Pharmacists make from 38 to 174 dosage forms in one day. The nomenclature of the medicines prepared numbers 392most common prescriptions of which 47,2% prescriptions are unique: they were prepared by one pharmacy only. The most prevalent (42,8%) is preparation of complex in composition dosage forms which contain at least 4 ingredients. Therefore, there is an urgent question about the stability of dosage forms and shelf life detection (currently, the legislation hasn’t established shelf life of medicines prepared at pharmacy). The assortment of active ingredients and excipients has been analyzed. There are cases of medicines preparation from industrial medicines. The need for almost 100 names of active ingredients has been established. Nomenclature analysis of the prescriptions has confirmed the importance of medicines preparation development at a pharmacy to provide the population with medicines.
{"title":"NOMENCLATURE ANALYSIS OF MEDICINES PREPARED BY PHARMACIES OF RUE «BELPHARMATSIYA»","authors":"A. Kirilyuk","doi":"10.52540/2074-9457.2021.3.41","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.3.41","url":null,"abstract":"The article is devoted to the nomenclature analysis of medicines prepared at 21 pharmacies of the 1st category of RUE «BELPHARMATSIYA», the largest state pharmacy network in Minsk. Medicines preparation at pharmacies is carried out according to the doctors’ prescriptions and the requirements (applications) of healthcare organizations as well as in the form of intra-pharmacy stocking and packing. The main tasks of pharmacy preparation are: providing the population and healthcare organizations with dosage forms not manufactured by industry, preparation of dosage forms mainly used in pediatric and geriatric practice, individual pharmacotherapy provision. Pharmacists make from 38 to 174 dosage forms in one day. The nomenclature of the medicines prepared numbers 392most common prescriptions of which 47,2% prescriptions are unique: they were prepared by one pharmacy only. The most prevalent (42,8%) is preparation of complex in composition dosage forms which contain at least 4 ingredients. Therefore, there is an urgent question about the stability of dosage forms and shelf life detection (currently, the legislation hasn’t established shelf life of medicines prepared at pharmacy). The assortment of active ingredients and excipients has been analyzed. There are cases of medicines preparation from industrial medicines. The need for almost 100 names of active ingredients has been established. Nomenclature analysis of the prescriptions has confirmed the importance of medicines preparation development at a pharmacy to provide the population with medicines.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77187978","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 : 2021-09-30DOI: 10.52540/2074-9457.2021.3.21
E. N. Tarasova, M. R. Konorev, K. V. Lapkouskaya
The article is devoted to the assortment analysis of 5-aminosalicylic acid drugs used for the treatment of mild and moderate ulcerative colitis. A brief description of dosage forms for oral and rectal administration used for the treatment of this disease is given. It is shown that therapeutic efficacy of the drug is associated with the concentration of the active substance in the large intestine. Therefore, in order to increase its effectiveness it is important to use such dosage forms that would help to prevent and reduce mesalazine absorption in the proximal small intestine and contribute to maximum release in the large intestine. It is shown that the rectal suspension of mesalazine, which is a first-line drug and is included in the list of essential medicines, is not produced in the Republic of Belarus. Special attention is paid to the possibility of expanding the range of mesalazine drugs if there is a possibility of extemporal suspension production from tablets presented in the assortment including a domestic manufacturer.
{"title":"ASSORTMENT ANALYSIS OF DRUGS FOR THE TREATMENT OF MILD AND MODERATE ULCERATIVE COLITIS","authors":"E. N. Tarasova, M. R. Konorev, K. V. Lapkouskaya","doi":"10.52540/2074-9457.2021.3.21","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.3.21","url":null,"abstract":"The article is devoted to the assortment analysis of 5-aminosalicylic acid drugs used for the treatment of mild and moderate ulcerative colitis. A brief description of dosage forms for oral and rectal administration used for the treatment of this disease is given. It is shown that therapeutic efficacy of the drug is associated with the concentration of the active substance in the large intestine. Therefore, in order to increase its effectiveness it is important to use such dosage forms that would help to prevent and reduce mesalazine absorption in the proximal small intestine and contribute to maximum release in the large intestine. It is shown that the rectal suspension of mesalazine, which is a first-line drug and is included in the list of essential medicines, is not produced in the Republic of Belarus. Special attention is paid to the possibility of expanding the range of mesalazine drugs if there is a possibility of extemporal suspension production from tablets presented in the assortment including a domestic manufacturer.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75242747","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 : 2021-09-30DOI: 10.52540/2074-9457.2021.3.64
E. Dikusar, A. Pushkarchuk, T. V. Bezyazychnaya, E. A. Akishina, A. Soldatov, S. Kuten, S. Stepin, A. Nizovtsev, S. Kilin, L. F. Babichev, V. Potkin
One of the methods for treating oncological diseases is application of short-lived radionuclides. Existing risks of intoxication and radioactive contamination can be eliminated by introduction of a short-lived radon isotope into a hard strong fullerene coat. To increase the effectiveness of these drugs it is promising to introduce structural fragments of amino acids, peptides, steroid hormones, nucleic bases or heterocyclic compounds being able to accumulate exactly in tumoral but not in healthy tissues of the body. The article presents data on quantum-chemical simulation of electronic structure and thermodynamic stability of fullerenol radon-containing agents of radionuclide therapy on the example of a model cortisonefullerenol bioconjugate.
{"title":"PROSPECTS FOR CREATING RADON CONTAINING AGENTS IN RADIONUCLIDE THERAPY","authors":"E. Dikusar, A. Pushkarchuk, T. V. Bezyazychnaya, E. A. Akishina, A. Soldatov, S. Kuten, S. Stepin, A. Nizovtsev, S. Kilin, L. F. Babichev, V. Potkin","doi":"10.52540/2074-9457.2021.3.64","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.3.64","url":null,"abstract":"One of the methods for treating oncological diseases is application of short-lived radionuclides. Existing risks of intoxication and radioactive contamination can be eliminated by introduction of a short-lived radon isotope into a hard strong fullerene coat. To increase the effectiveness of these drugs it is promising to introduce structural fragments of amino acids, peptides, steroid hormones, nucleic bases or heterocyclic compounds being able to accumulate exactly in tumoral but not in healthy tissues of the body. The article presents data on quantum-chemical simulation of electronic structure and thermodynamic stability of fullerenol radon-containing agents of radionuclide therapy on the example of a model cortisonefullerenol bioconjugate.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"55 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89179520","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 : 2021-06-30DOI: 10.52540/2074-9457.2021.2.64
V. Kuhach
The purpose of this work was to study foreign experience in pharmacy manufacture and quality control of medicinal preparations (MP). Scientific literature and internet sources analysis, the author's own observations from 2005 to 2020 were made. It has been established that pharmacy manufacture of MPs abroad is carried out for the special needs of patients when pharmaceutical industry cannot produce them for various reasons. There are various approaches to standardization of the number of manufacturing pharmacies abroad: from complete prohibition of pharmacy manufacture of medicinal preparations in Portugal to mandatory license requirement in Austria and Germany. To manufacture medicinal preparations at a pharmacy the laboratory is established where necessary equipment, inventory, pharmaceutical substances and excipients are placed and the technological process is carried out. Pharmacy manufacture of sterile medicinal preparations is conducted under aseptic conditions in a specially equipped room or in a laminar-airflow cabinet. MPs must not be registered in most countries of the world. In the US and the European Union (EU) medicinal preparations are classified into medicines for immediate use and for prolonged storage. Expiration date must be stated for prolonged storage medicinal preparations, a dossier is made for them in the EU pharmacies. Pharmacies in most countries of the world manufacture medicinal preparations from tablets and capsules. Much attention abroad is given to ensure the quality of pharmacy manufacture of medicinal preparations: in the US, pharmacy manufacture of medicinal preparations is carried out in accordance with the requirements of Pharmacopoeia, in the EU according to the EU Council Resolution. A number of countries have developed guidelines or standard operational procedures for pharmacy manufacture of medicinal preparations. Constant training and assessment of employees’ competencies engaged in pharmacy manufacture of medicinal preparations is performed.
{"title":"PHARMACY MANUFACTURE AND QUALITY CONTROL OF MEDICINAL PREPARATIONS ABROAD","authors":"V. Kuhach","doi":"10.52540/2074-9457.2021.2.64","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.2.64","url":null,"abstract":"The purpose of this work was to study foreign experience in pharmacy manufacture and quality control of medicinal preparations (MP). Scientific literature and internet sources analysis, the author's own observations from 2005 to 2020 were made. It has been established that pharmacy manufacture of MPs abroad is carried out for the special needs of patients when pharmaceutical industry cannot produce them for various reasons. There are various approaches to standardization of the number of manufacturing pharmacies abroad: from complete prohibition of pharmacy manufacture of medicinal preparations in Portugal to mandatory license requirement in Austria and Germany. To manufacture medicinal preparations at a pharmacy the laboratory is established where necessary equipment, inventory, pharmaceutical substances and excipients are placed and the technological process is carried out. Pharmacy manufacture of sterile medicinal preparations is conducted under aseptic conditions in a specially equipped room or in a laminar-airflow cabinet. MPs must not be registered in most countries of the world. In the US and the European Union (EU) medicinal preparations are classified into medicines for immediate use and for prolonged storage. Expiration date must be stated for prolonged storage medicinal preparations, a dossier is made for them in the EU pharmacies. Pharmacies in most countries of the world manufacture medicinal preparations from tablets and capsules. Much attention abroad is given to ensure the quality of pharmacy manufacture of medicinal preparations: in the US, pharmacy manufacture of medicinal preparations is carried out in accordance with the requirements of Pharmacopoeia, in the EU according to the EU Council Resolution. A number of countries have developed guidelines or standard operational procedures for pharmacy manufacture of medicinal preparations. Constant training and assessment of employees’ competencies engaged in pharmacy manufacture of medicinal preparations is performed.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"83 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85602974","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 : 2021-06-30DOI: 10.52540/2074-9457.2021.2.39
T. V. Shakolo, A. V. Kurliuk, A. Kalinova
The article presents the nomenclature of medicines, medical devices and dietary supplements based on chitosan derivatives registered in the Republic of Belarus and the neighboring countries. Comparative marketing research of the product groups studied has been carried out. Marketing parameters of this market sector have been established: the list and the structure of this segment by the drug form, manufacturing countries, pharmaceutical distributors and sources of origin. The assortment was analyzed in the specified regions according to the indicators: the number of names, pharmacological action, dosage form and the group of products in accordance with their registration. The coefficients of breadth, completeness and depth of assortment have been calculated. The expediency of studying pharmacological properties of chitosan derivatives further and the development of new original medicinal products based on them is shown.
{"title":"COMPARATIVE CHARACTERISTICS OF MEDICINAL PRODUCTS ASSORTMENT, MEDICAL DEVICES AND DIETARY SUPPLEMENTS BASED ON CHITOSAN DERIVATIVES REGISTERED IN THE REPUBLIC OF BELARUS, THE RUSSIAN FEDERATION, UKRAINE AND THE REPUBLIC OF KAZAHSTAN","authors":"T. V. Shakolo, A. V. Kurliuk, A. Kalinova","doi":"10.52540/2074-9457.2021.2.39","DOIUrl":"https://doi.org/10.52540/2074-9457.2021.2.39","url":null,"abstract":"The article presents the nomenclature of medicines, medical devices and dietary supplements based on chitosan derivatives registered in the Republic of Belarus and the neighboring countries. Comparative marketing research of the product groups studied has been carried out. Marketing parameters of this market sector have been established: the list and the structure of this segment by the drug form, manufacturing countries, pharmaceutical distributors and sources of origin. The assortment was analyzed in the specified regions according to the indicators: the number of names, pharmacological action, dosage form and the group of products in accordance with their registration. The coefficients of breadth, completeness and depth of assortment have been calculated. The expediency of studying pharmacological properties of chitosan derivatives further and the development of new original medicinal products based on them is shown.","PeriodicalId":23657,"journal":{"name":"Vestnik Farmacii","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76296915","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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