Aim. To theoretically substantiate the composition of a wound healing ointment with active substances of plant origin for the therapy in the second and third phases of the wound process. Materials and methods. The study object was the generalization and analysis of scientific literature data on the use of medicinal plants in the treatment of the wound process. Results and discussion. Based on the analysis of scientific literature data on the chemical composition and pharmacological properties of medicinal plants used in the treatment of the wound process, the expediency of using the lipophilic extract of marigold flowers, amaranth oil, fennel essential oil as active ingredients in the wound healing ointment has been substantiated. Marigold flowers due to the presence of a large number of carotenoids and flavonoidswill provide a high level of the antimicrobial, reparative action of the ointment. Due to the content of complex biologically active compounds, such as tocopherols, polyunsaturated fatty acids, vitamins, phytosterols and squalene, the amaranth oil has a pronounced antioxidant activity. The components that are part of the essential oil of fennel contributeto the connective tissue growth and the skin restoration, as well as provide a high level of the antifungal action. Conclusions. The analysis of scientific literature data has shown the possibility of using herbal medicines in the treatment of the wound process. The greatest advantage of herbal medicines is the high degree of assimilation of molecules of biologically active substances, which are part of natural compounds as the most physiological form, by skin cells. The expediency of using the lipophilic extract of marigold, amaranth oil and fennel essential oil when developing a wound-healing ointment has been proven. The composition selected will provide the predicted antibacterial, antifungal, antioxidant and reparative effect of the ointment, reduce the likelihood of resistance in pathogenic microorganisms, and accelerate granulation and epithelialization of tissues.
{"title":"The theoretical substantiation of the composition of a wound-healing ointment with active components of plant origin","authors":"O. I. Trembach, N. Khokhlenkova","doi":"10.24959/nphj.22.81","DOIUrl":"https://doi.org/10.24959/nphj.22.81","url":null,"abstract":"Aim. To theoretically substantiate the composition of a wound healing ointment with active substances of plant origin for the therapy in the second and third phases of the wound process.\u0000Materials and methods. The study object was the generalization and analysis of scientific literature data on the use of medicinal plants in the treatment of the wound process.\u0000Results and discussion. Based on the analysis of scientific literature data on the chemical composition and pharmacological properties of medicinal plants used in the treatment of the wound process, the expediency of using the lipophilic extract of marigold flowers, amaranth oil, fennel essential oil as active ingredients in the wound healing ointment has been substantiated. Marigold flowers due to the presence of a large number of carotenoids and flavonoidswill provide a high level of the antimicrobial, reparative action of the ointment. Due to the content of complex biologically active compounds, such as tocopherols, polyunsaturated fatty acids, vitamins, phytosterols and squalene, the amaranth oil has a pronounced antioxidant activity. The components that are part of the essential oil of fennel contributeto the connective tissue growth and the skin restoration, as well as provide a high level of the antifungal action.\u0000Conclusions. The analysis of scientific literature data has shown the possibility of using herbal medicines in the treatment of the wound process. The greatest advantage of herbal medicines is the high degree of assimilation of molecules of biologically active substances, which are part of natural compounds as the most physiological form, by skin cells. The expediency of using the lipophilic extract of marigold, amaranth oil and fennel essential oil when developing a wound-healing ointment has been proven. The composition selected will provide the predicted antibacterial, antifungal, antioxidant and reparative effect of the ointment, reduce the likelihood of resistance in pathogenic microorganisms, and accelerate granulation and epithelialization of tissues.","PeriodicalId":19221,"journal":{"name":"News of Pharmacy","volume":"189 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72828571","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}
O. Demeshko, I. Batiuchenko, S. V. Kovalev, O. V. Krivoruchko, S. Romanova
Aim. To study the anatomical structure of Cercis siliquastrum L. leaves. Materials and methods. The study objects were leaves of Judas tree collected in the Botanical garden of the National University of Pharmacy in June, 2021. Micropreparations were made of fresh, dried material and fixed with a mixture of 96 % ethanol, water and glycerin (1 : 1: 1). Micropreparations were prepared and examined according to the methodsof the SPhU using a Granum microscope (Austria). A Canon PC1251 camera was used for photographing. Results and discussion. The type of the leaf blade is dorsoventral, hypostomatic, there are cells with the orange content. There are numerous stomata of anocytic (sometimes anisocytic) type. Simple multicellular hairs with a weakly warty cuticle were found on the lower and upper epidermis. A 2-3-layered collenchymatous parenchyma is located above the central vein. The bundle sheath is crystalliferous. On the xylem side, 5-6 layers of the sclerenchyma are observed. The petiole has an oval shape, slightly ribbed near the leaf blade. In the middle of the petiole there are three bundles: two radial on the sides and one central with two additional bundles. All bundles are surrounded by a common sclerenchymal ring. There are cells with the orange content in the parenchyma. On the abaxial side there is a layer of cells with calcium oxalate drusens under the sclerenchyma. The petiole is rounded, slightly ribbed. The bundle has a crescent shape in the center. The xylem rays are with the brown content. The sclerenchyma is well developed. There are drusens in the parenchyma of the petiole. Conclusions. The main anatomical features of Judas tree leaves have been determined; it will allow identifying and standardizing the plant raw material. The data obtained are necessary for the development of Drug Quality Control Methods (DQCM) for the medicinal raw material.
{"title":"The study of the anatomical structure of Cercis siliquastrum L. leaves","authors":"O. Demeshko, I. Batiuchenko, S. V. Kovalev, O. V. Krivoruchko, S. Romanova","doi":"10.24959/nphj.22.73","DOIUrl":"https://doi.org/10.24959/nphj.22.73","url":null,"abstract":"Aim. To study the anatomical structure of Cercis siliquastrum L. leaves.\u0000Materials and methods. The study objects were leaves of Judas tree collected in the Botanical garden of the National University of Pharmacy in June, 2021. Micropreparations were made of fresh, dried material and fixed with a mixture of 96 % ethanol, water and glycerin (1 : 1: 1). Micropreparations were prepared and examined according to the methodsof the SPhU using a Granum microscope (Austria). A Canon PC1251 camera was used for photographing.\u0000Results and discussion. The type of the leaf blade is dorsoventral, hypostomatic, there are cells with the orange content. There are numerous stomata of anocytic (sometimes anisocytic) type. Simple multicellular hairs with a weakly warty cuticle were found on the lower and upper epidermis. A 2-3-layered collenchymatous parenchyma is located above the central vein. The bundle sheath is crystalliferous. On the xylem side, 5-6 layers of the sclerenchyma are observed. The petiole has an oval shape, slightly ribbed near the leaf blade. In the middle of the petiole there are three bundles: two radial on the sides and one central with two additional bundles. All bundles are surrounded by a common sclerenchymal ring. There are cells with the orange content in the parenchyma. On the abaxial side there is a layer of cells with calcium oxalate drusens under the sclerenchyma. The petiole is rounded, slightly ribbed. The bundle has a crescent shape in the center. The xylem rays are with the brown content. The sclerenchyma is well developed. There are drusens in the parenchyma of the petiole.\u0000Conclusions. The main anatomical features of Judas tree leaves have been determined; it will allow identifying and standardizing the plant raw material. The data obtained are necessary for the development of Drug Quality Control Methods (DQCM) for the medicinal raw material.","PeriodicalId":19221,"journal":{"name":"News of Pharmacy","volume":"36 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74320903","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}
A rare (orphan) disease is a disease that threatens a person’s life or chronically progresses; it leads to a reduction in life expectancy or disability, which prevalence among the population is not more than 1 : 2000 in Ukraine and not more than 1 : 5000-8000 in other countries. Aim. To analyze the current legal framework on pharmaceutical provision of orphan patients in Ukraine. Materials and methods. The current regulatory framework on pharmaceutical provision of orphan patients in Ukraine was analyzed by constructing and studying the hierarchy of legislative acts regulating the issues of management of orphan (rare) diseases in the world and in Ukraine. Results and discussion. The article describes the main stages of the legislation formation, starting from the USA in 1983 to the EU and Ukraine in 2021. The practical value of the article consists in the current list of normative acts regulating the provision of patients with orphan diseases. The scientific significance is in the use of the results of previous studies of others domestic researchers (2016). The analysis of the legislation and the main issues of providing orphan patients allowed us to formulate the basic problems of the national healthcare system listed in the article. Conclusions. The current state of the legal regulation of orphan patients in Ukraine has been studied. It has been found that the legislative regulation of the issue under study has been actively carried out over the past 7 years by implementing the adopted Law of Ukraine, resolutions of the Cabinet of Ministers and orders of the Ministry ofHealth. The results of the study of international experience in introducing the basic concepts of orphan diseases and orphan patients into the healthcare system in the United States (since 1983), EU countries (since 1999), Japan (since 1993), etc., have been summarized. It has been found that 275 nosologies of orphan diseases have been approved in Ukraine; they are grouped by 11 nosological categories, there are 104 nosologies (+40 %) more than in 2016. A positive trend towards intensification of the process of improving the provision of orphan patients in Ukraine has been revealed.
{"title":"The analysis of the legislative framework regarding pharmaceutical provision of orphan patients in Ukraine","authors":"M. Podgaina, N. Sliptsova","doi":"10.24959/nphj.22.75","DOIUrl":"https://doi.org/10.24959/nphj.22.75","url":null,"abstract":"A rare (orphan) disease is a disease that threatens a person’s life or chronically progresses; it leads to a reduction in life expectancy or disability, which prevalence among the population is not more than 1 : 2000 in Ukraine and not more than 1 : 5000-8000 in other countries.\u0000Aim. To analyze the current legal framework on pharmaceutical provision of orphan patients in Ukraine.\u0000Materials and methods. The current regulatory framework on pharmaceutical provision of orphan patients in Ukraine was analyzed by constructing and studying the hierarchy of legislative acts regulating the issues of management of orphan (rare) diseases in the world and in Ukraine.\u0000Results and discussion. The article describes the main stages of the legislation formation, starting from the USA in 1983 to the EU and Ukraine in 2021. The practical value of the article consists in the current list of normative acts regulating the provision of patients with orphan diseases. The scientific significance is in the use of the results of previous studies of others domestic researchers (2016). The analysis of the legislation and the main issues of providing orphan patients allowed us to formulate the basic problems of the national healthcare system listed in the article.\u0000Conclusions. The current state of the legal regulation of orphan patients in Ukraine has been studied. It has been found that the legislative regulation of the issue under study has been actively carried out over the past 7 years by implementing the adopted Law of Ukraine, resolutions of the Cabinet of Ministers and orders of the Ministry ofHealth. The results of the study of international experience in introducing the basic concepts of orphan diseases and orphan patients into the healthcare system in the United States (since 1983), EU countries (since 1999), Japan (since 1993), etc., have been summarized. It has been found that 275 nosologies of orphan diseases have been approved in Ukraine; they are grouped by 11 nosological categories, there are 104 nosologies (+40 %) more than in 2016. A positive trend towards intensification of the process of improving the provision of orphan patients in Ukraine has been revealed.","PeriodicalId":19221,"journal":{"name":"News of Pharmacy","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78570692","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}
Intestinal infections occupy one of the leading places in diseases of the gastrointestinal tract in humans and animals. Strains of Staphylococcus spp are one of the causative agents of an intestinal infection. When treating an intestinal infection caused by staphylococcus, antibiotics are most often used, but in recent years there has been the formation of resistance in staphylococcus strains to antibiotics that have been used for many years. One of the promising ways to solve the problem of antimicrobial resistance is the use of drugs based on bacteriophages, which have a specific effect on the disease pathogens, however, they are free of toxic and allergenic side effects on the human body and do not cause resistance. Aim. To study the antibacterial effect of the combination of a staphylococcal bacteriophage and a probiotic based on L. acidophilus lactobacilli to different staphylococcal strains. Materials and methods. The following bacterial strains were used in the study: St. aureus ATCC 25923 and St. epidermidis ATCC 12228. The “Polyphag Staf” staphylococcal bacteriophage (manufactured by NVK MVK, Ukraine) and the “Lactofor” probiotic (manufactured by Ananta Medicare Limited, India) based on L. acidophilus lactobacilli were selected as objects. In the study, the antibiotic “Erythromycin” in tablets of 100 mg (the manufacturer – Borschagovsky HFZ, Ukraine) was used as a reference drug. To detect the antibacterial activity to the experimental strains of St. aureus and St. epidermidis, the methods of Appelman and agar diffusion were used. Results and discussion. It was found that when using the combination of a staphylococcal bacteriophage and a probiotic with L. acidophilus lactobacilli the level of the antibacterial activity to the experimental strains of St. aureus and St. epidermidis was higher than when using only the bacteriophage. This is probably due to the synergism of the interaction of the components of the combination of active substances proposed. It was also found that the antibacterial activity of the combination of drugs and the antibiotic erythromycin proposed was at the same level. Thus, the combination of a bacteriophage that destroys staphylococcal bacteria, has no side effects, and does not cause resistance and a probiotics that improves the microflora of the gastrointestinal tract has a number of advantages over antibioticsin the treatment of intestinal infections caused by staphylococcal strains. Conclusions. The studies conducted indicate the prospects of using the combination of a staphylococcal bacteriophage and a probiotic based on L. acidophilus lactobacilli for the treatment of intestinal infections caused by different staphylococcal strains.
{"title":"The study of the effectiveness of the antibacterial action of the combination of a bacteriophage with a probiotic","authors":"M. Rybalkin, N. Khokhlenkova, К. Y. Nikiforova","doi":"10.24959/nphj.22.83","DOIUrl":"https://doi.org/10.24959/nphj.22.83","url":null,"abstract":"Intestinal infections occupy one of the leading places in diseases of the gastrointestinal tract in humans and animals. Strains of Staphylococcus spp are one of the causative agents of an intestinal infection. When treating an intestinal infection caused by staphylococcus, antibiotics are most often used, but in recent years there has been the formation of resistance in staphylococcus strains to antibiotics that have been used for many years. One of the promising ways to solve the problem of antimicrobial resistance is the use of drugs based on bacteriophages, which have a specific effect on the disease pathogens, however, they are free of toxic and allergenic side effects on the human body and do not cause resistance.\u0000Aim. To study the antibacterial effect of the combination of a staphylococcal bacteriophage and a probiotic based on L. acidophilus lactobacilli to different staphylococcal strains.\u0000Materials and methods. The following bacterial strains were used in the study: St. aureus ATCC 25923 and St. epidermidis ATCC 12228. The “Polyphag Staf” staphylococcal bacteriophage (manufactured by NVK MVK, Ukraine) and the “Lactofor” probiotic (manufactured by Ananta Medicare Limited, India) based on L. acidophilus lactobacilli were selected as objects. In the study, the antibiotic “Erythromycin” in tablets of 100 mg (the manufacturer – Borschagovsky HFZ, Ukraine) was used as a reference drug. To detect the antibacterial activity to the experimental strains of St. aureus and St. epidermidis, the methods of Appelman and agar diffusion were used.\u0000Results and discussion. It was found that when using the combination of a staphylococcal bacteriophage and a probiotic with L. acidophilus lactobacilli the level of the antibacterial activity to the experimental strains of St. aureus and St. epidermidis was higher than when using only the bacteriophage. This is probably due to the synergism of the interaction of the components of the combination of active substances proposed. It was also found that the antibacterial activity of the combination of drugs and the antibiotic erythromycin proposed was at the same level. Thus, the combination of a bacteriophage that destroys staphylococcal bacteria, has no side effects, and does not cause resistance and a probiotics that improves the microflora of the gastrointestinal tract has a number of advantages over antibioticsin the treatment of intestinal infections caused by staphylococcal strains.\u0000Conclusions. The studies conducted indicate the prospects of using the combination of a staphylococcal bacteriophage and a probiotic based on L. acidophilus lactobacilli for the treatment of intestinal infections caused by different staphylococcal strains.","PeriodicalId":19221,"journal":{"name":"News of Pharmacy","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85270760","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}
Today, leading foreign and domestic pharmaceutical companies are aware of the importance of using socially oriented tools of marketing communication to achieve economic stability, strengthen competitive positions and form a positive image at the pharmaceutical market. Aim. To study PR-technologies used by domestic pharmaceutical companies as part of the implementation of the concept of socially oriented marketing in the global COVID-19 pandemic. Materials and methods. The methods of logical and meaningful problem formation, desk marketing research, the content analysis of publications in scientific and practice-oriented medical and pharmaceutical literature were used in the work. Results and discussion. The issues of social responsibility of pharmaceutical industry enterprises as a key factor in the successful development of companies under the conditions of coronavirus infection have been highlighted. The specificityhas been considered, and the features of modern PR-tools of pharmaceutical companies have been determined. The Internet resources play an important role among them. The content analysis of the web-sites of the TOP-5 major manufacturers of drugs at the pharmaceutical market of Ukraine has been conducted; the social responsibility areas and the main PR-technologies have been analyzed. Conclusions. It has been found that the leading domestic pharmaceutical companies take an active public position and constantly implement various social programs aimed at supporting the society welfare, especially in the conditions of the COVID-19 pandemic. The information content of the sites of the enterprises under study fully reflects the activities of companies in the field of public relations on the principles of openness, relevance, reliability and social responsibility. Considerable attention is paid to the quality, safety and availability of pharmaceutical products and the provision ofappropriate assistance to healthcare institutions in the fight against COVID-19.
{"title":"Analysis of the use of PR-technologies by domestic pharmaceutical enterprises in the implementation of socially oriented marketing in the conditions of the global COVID-19 pandemic","authors":"I. Pestun, G. S. Babicheva, S. Zhadko","doi":"10.24959/nphj.22.71","DOIUrl":"https://doi.org/10.24959/nphj.22.71","url":null,"abstract":"Today, leading foreign and domestic pharmaceutical companies are aware of the importance of using socially oriented tools of marketing communication to achieve economic stability, strengthen competitive positions and form a positive image at the pharmaceutical market.\u0000Aim. To study PR-technologies used by domestic pharmaceutical companies as part of the implementation of the concept of socially oriented marketing in the global COVID-19 pandemic.\u0000Materials and methods. The methods of logical and meaningful problem formation, desk marketing research, the content analysis of publications in scientific and practice-oriented medical and pharmaceutical literature were used in the work.\u0000Results and discussion. The issues of social responsibility of pharmaceutical industry enterprises as a key factor in the successful development of companies under the conditions of coronavirus infection have been highlighted. The specificityhas been considered, and the features of modern PR-tools of pharmaceutical companies have been determined. The Internet resources play an important role among them. The content analysis of the web-sites of the TOP-5 major manufacturers of drugs at the pharmaceutical market of Ukraine has been conducted; the social responsibility areas and the main PR-technologies have been analyzed.\u0000Conclusions. It has been found that the leading domestic pharmaceutical companies take an active public position and constantly implement various social programs aimed at supporting the society welfare, especially in the conditions of the COVID-19 pandemic. The information content of the sites of the enterprises under study fully reflects the activities of companies in the field of public relations on the principles of openness, relevance, reliability and social responsibility. Considerable attention is paid to the quality, safety and availability of pharmaceutical products and the provision ofappropriate assistance to healthcare institutions in the fight against COVID-19.","PeriodicalId":19221,"journal":{"name":"News of Pharmacy","volume":"94 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83541517","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}
Aim. To substantiate the target quality profile for planning the development of a combined drug for injection based on sodium hyaluronate (SH) and dihydroquercetin (DHQ) with an expanded spectrum of the specific activity, as well as to determine the risk factors affecting the quality of the combined drug for injections at the stage of pharmaceuticaldevelopment (PD). Materials and methods. The study objects were the active pharmaceutical ingredients (АРІ) of SH, DHQ and a drug in the form of a solution for injection based on them, as well as potential risk factors affecting the quality of the product. The target product quality profile (QTPP) was developed based on the review and analysis of scientific literature, materials of the State Register of Medicines of Ukraine, pharmacopoeias of the leading countries of the world, articles of scientific publications. The Ishikawa diagram was used to analyze potential risk factors for a drug for injection at the stage of PD. Results and discussion. The application of scientific approaches to the analysis of scientific materials from various information sources on combination therapy with drugs with multidirectional medicinal substances and the availability of information on parenteral medicines (PM) allowed us to plan a QTPP for the development of a combined drug for injection for intradermal administration. In order to identify the most dangerous factors affecting the quality of the drug, the causal analysis of these factors at the PD stage of the combined drug for injection was carried out, and an Ishikawa diagram was constructed. Conclusions. The QTPP has been developed. The expected set of quality indicators that would ideally be achieved to ensure the required quality of the drug has been determined taking into account its safety and efficacy. Based on the risk assessment methodology, the Ishikawa diagram for a combined drug for injection has been constructed; potential risks associated with the quality of active ingredients (AI) and excipients, quality of primary packaging, production conditions, quality control of the drug, the technological process affecting the quality of the combined drug for injection and the causes leading to deviations from these indicators have been identified. This diagram is used as a baseline for the overall assessment of quality risks at the stage of drug development.
{"title":"Substantiation of the target quality profile and risk assessment in the development of a combined drug for injection","authors":"K. M. Semenova, L. Almakaieva","doi":"10.24959/nphj.22.89","DOIUrl":"https://doi.org/10.24959/nphj.22.89","url":null,"abstract":"Aim. To substantiate the target quality profile for planning the development of a combined drug for injection based on sodium hyaluronate (SH) and dihydroquercetin (DHQ) with an expanded spectrum of the specific activity, as well as to determine the risk factors affecting the quality of the combined drug for injections at the stage of pharmaceuticaldevelopment (PD).\u0000Materials and methods. The study objects were the active pharmaceutical ingredients (АРІ) of SH, DHQ and a drug in the form of a solution for injection based on them, as well as potential risk factors affecting the quality of the product. The target product quality profile (QTPP) was developed based on the review and analysis of scientific literature, materials of the State Register of Medicines of Ukraine, pharmacopoeias of the leading countries of the world, articles of scientific publications. The Ishikawa diagram was used to analyze potential risk factors for a drug for injection at the stage of PD.\u0000Results and discussion. The application of scientific approaches to the analysis of scientific materials from various information sources on combination therapy with drugs with multidirectional medicinal substances and the availability of information on parenteral medicines (PM) allowed us to plan a QTPP for the development of a combined drug for injection for intradermal administration. In order to identify the most dangerous factors affecting the quality of the drug, the causal analysis of these factors at the PD stage of the combined drug for injection was carried out, and an Ishikawa diagram was constructed.\u0000Conclusions. The QTPP has been developed. The expected set of quality indicators that would ideally be achieved to ensure the required quality of the drug has been determined taking into account its safety and efficacy. Based on the risk assessment methodology, the Ishikawa diagram for a combined drug for injection has been constructed; potential risks associated with the quality of active ingredients (AI) and excipients, quality of primary packaging, production conditions, quality control of the drug, the technological process affecting the quality of the combined drug for injection and the causes leading to deviations from these indicators have been identified. This diagram is used as a baseline for the overall assessment of quality risks at the stage of drug development.","PeriodicalId":19221,"journal":{"name":"News of Pharmacy","volume":"94 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83906079","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}
Aim. The choice of the qualitative and quantitative composition of excipients to provide the required mechanical strength and disintegration time when developing a pharmaceutical composition in the form of orally disintegrating tablets (ODT) based on paracetamol and N-acetyl-D-glucosamine. Materials and methods. The study object was pharmaceutically accepted excipients used in the pharmaceutical development of solid dosage forms. To conduct the statistical analysis of experimental data, a Minitab® 19.1.1 software was used. Results and discussion. The excipients (povidone of different brands, copovidone, crospovidone of different brands, croscarmellose) used when developing ODT were considered, and it was determined that copovidone and crospovidone type A showed the most optimal quality indicators of the composition. It was found that the particle sizeof crospovidone and the route of its introduction affected the rate of disintegration in the aqueous medium. Using the method of mathematical prediction the optimal content of excipients in the composition and the experimental confirmation ofthe quality indicators of the mixture selected to create ODT were determined. Conclusions. Excipients used in the development of ODT have been considered, and the excipients exhibiting the best quality indicators of the compositions have been found. Both the influence of the particle size of crospovidone, and the route of its administration have been determined. The optimal content of excipients in the composition and their experimental confirmation have been determined due to mathematical prediction.
的目标。在以对乙酰氨基酚和n -乙酰- d -氨基葡萄糖为基础开发口腔崩解片(ODT)形式的药物组合物时，辅料的定性和定量组成的选择以提供所需的机械强度和崩解时间。材料和方法。研究对象是用于固体剂型药物开发的药学上公认的赋形剂。采用Minitab®19.1.1软件对实验数据进行统计分析。结果和讨论。考察了开发ODT时使用的辅料(不同品牌聚维酮、不同品牌聚维酮、不同品牌交叉聚维酮、交联棉糖)，确定了该制剂的质量指标以不同品牌的聚维酮和A型交叉聚维酮最优。研究发现，交叉聚维酮的粒径大小和引入途径影响其在水介质中的分解速率。采用数学预测的方法确定了制剂中辅料的最佳含量，并对优选的制剂质量指标进行了实验确认。考虑了ODT开发中使用的赋形剂，并找到了具有最佳质量指标的赋形剂。确定了交叉聚维酮的粒径和给药途径。通过数学预测，确定了该制剂中辅料的最佳含量并进行了实验验证。
{"title":"The choice of excipients and optimization of the composition of orally disintegrating tablets based on paracetamol and N-acetyl-D-glucosamine","authors":"I. Zupanets, O. Ruban","doi":"10.24959/nphj.22.76","DOIUrl":"https://doi.org/10.24959/nphj.22.76","url":null,"abstract":"Aim. The choice of the qualitative and quantitative composition of excipients to provide the required mechanical strength and disintegration time when developing a pharmaceutical composition in the form of orally disintegrating tablets (ODT) based on paracetamol and N-acetyl-D-glucosamine.\u0000Materials and methods. The study object was pharmaceutically accepted excipients used in the pharmaceutical development of solid dosage forms. To conduct the statistical analysis of experimental data, a Minitab® 19.1.1 software was used.\u0000Results and discussion. The excipients (povidone of different brands, copovidone, crospovidone of different brands, croscarmellose) used when developing ODT were considered, and it was determined that copovidone and crospovidone type A showed the most optimal quality indicators of the composition. It was found that the particle sizeof crospovidone and the route of its introduction affected the rate of disintegration in the aqueous medium. Using the method of mathematical prediction the optimal content of excipients in the composition and the experimental confirmation ofthe quality indicators of the mixture selected to create ODT were determined.\u0000Conclusions. Excipients used in the development of ODT have been considered, and the excipients exhibiting the best quality indicators of the compositions have been found. Both the influence of the particle size of crospovidone, and the route of its administration have been determined. The optimal content of excipients in the composition and their experimental confirmation have been determined due to mathematical prediction.","PeriodicalId":19221,"journal":{"name":"News of Pharmacy","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84503473","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}
V. Zlahoda, T. Ivko, Т. A. Germanyuk, L. Bobrytska
Acute respiratory viral infections (ARVI) are highly prevalent, and it is especially dangerous during the COVID-19 pandemic. The most effective way to prevent the ARVI is vaccination. Aim. To analyze the pharmaceutical market of vaccines registered in Ukraine. Material and methods. The material of the study was data of the State Register of Medicines of Ukraine 2020, information on the results of the epidemic season of influenza and ARVI of the Center for Public Health of the Ministry of Health of Ukraine, declared wholesale prices for vaccines in Ukraine in December 2020. The methods of frequencyand descriptive analysis were used. Results and discussion. As a result of the structural analysis of ATC classification it was found that viral vaccines against influenza of J07B В group were presented at the pharmaceutical market. The frequency analysis revealed that there were 665.000 doses of vaccines of 4 trade names at the pharmaceutical market of Ukraine in 2020, all of them were of foreign production from France, the Netherlands, Great Britain, Korea. Among the vaccines purchased, 75 % were French-made vaccines. The cost of one vaccine dose ranged from 185.00 to 249.69 UAH. It was found that the number of vaccine doses purchased for the population during the study period (2016-2020) increased in 190 times. The population vaccination increased from 106683 to 238079 people, i.e. by 123 %. Conclusions. As a result of the research conducted it was found that in 2020-2021 there were 4 trade names of foreign vaccines at the pharmaceutical market of Ukraine. The cost of one dose of vaccines ranged from 185.00 tо 249.69 UAH.
{"title":"Marketing analysis of influenza vaccines in Ukraine","authors":"V. Zlahoda, T. Ivko, Т. A. Germanyuk, L. Bobrytska","doi":"10.24959/nphj.21.51","DOIUrl":"https://doi.org/10.24959/nphj.21.51","url":null,"abstract":"Acute respiratory viral infections (ARVI) are highly prevalent, and it is especially dangerous during the COVID-19 pandemic. The most effective way to prevent the ARVI is vaccination.\u0000Aim. To analyze the pharmaceutical market of vaccines registered in Ukraine.\u0000Material and methods. The material of the study was data of the State Register of Medicines of Ukraine 2020, information on the results of the epidemic season of influenza and ARVI of the Center for Public Health of the Ministry of Health of Ukraine, declared wholesale prices for vaccines in Ukraine in December 2020. The methods of frequencyand descriptive analysis were used.\u0000Results and discussion. As a result of the structural analysis of ATC classification it was found that viral vaccines against influenza of J07B В group were presented at the pharmaceutical market. The frequency analysis revealed that there were 665.000 doses of vaccines of 4 trade names at the pharmaceutical market of Ukraine in 2020, all of them were of foreign production from France, the Netherlands, Great Britain, Korea. Among the vaccines purchased, 75 % were French-made vaccines. The cost of one vaccine dose ranged from 185.00 to 249.69 UAH. It was found that the number of vaccine doses purchased for the population during the study period (2016-2020) increased in 190 times. The population vaccination increased from 106683 to 238079 people, i.e. by 123 %.\u0000Conclusions. As a result of the research conducted it was found that in 2020-2021 there were 4 trade names of foreign vaccines at the pharmaceutical market of Ukraine. The cost of one dose of vaccines ranged from 185.00 tо 249.69 UAH.","PeriodicalId":19221,"journal":{"name":"News of Pharmacy","volume":"30 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81757841","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}
An important task in the course of pharmaceutical development of solid dosage forms is to determine a set of technological methods and study the technological parameters of the powders under research for the purpose of further encapsulation or tabletting of substances with different physicochemical characteristics. Aim. To study the main technological parameters of the standardized substance of the propolis phenolic hydrophobic drug (PPHD), grape seeds, bitter chestnut seeds and their mixtures for the purpose of their further introduction into the capsules with the anti-inflammatory and venotonic action developed. Materials and methods. The pharmaco-technological studies of AFI powder masses (fluidity, angle of repose, bulk density, etc.) were performed in accordance with the requirements of the State Pharmacopoeia of Ukraine and scientific and practical sources of literature. Results and discussion. The tests performed indicate that the substances studied and their mixtures do not have satisfactory pharmaco-technological properties, are characterized by a low value of fluidity and the ability to absorb moisture during storage. Conclusions. The results of the research conducted confirm the need to add certain groups of excipients in the powder mass for their further encapsulation and the use of appropriate technological methods when developing oral dosage forms.
{"title":"Determination of technological parameters of powder masses of the propolis phenolic hydrophobic drug, grape seeds, bitter chestnut seeds and their mixtures in solid dosage forms","authors":"A. S. Gurtovsky, O. Shpychak, S. Spyrydonov","doi":"10.24959/nphj.21.66","DOIUrl":"https://doi.org/10.24959/nphj.21.66","url":null,"abstract":"An important task in the course of pharmaceutical development of solid dosage forms is to determine a set of technological methods and study the technological parameters of the powders under research for the purpose of further encapsulation or tabletting of substances with different physicochemical characteristics.\u0000Aim. To study the main technological parameters of the standardized substance of the propolis phenolic hydrophobic drug (PPHD), grape seeds, bitter chestnut seeds and their mixtures for the purpose of their further introduction into the capsules with the anti-inflammatory and venotonic action developed.\u0000Materials and methods. The pharmaco-technological studies of AFI powder masses (fluidity, angle of repose, bulk density, etc.) were performed in accordance with the requirements of the State Pharmacopoeia of Ukraine and scientific and practical sources of literature.\u0000Results and discussion. The tests performed indicate that the substances studied and their mixtures do not have satisfactory pharmaco-technological properties, are characterized by a low value of fluidity and the ability to absorb moisture during storage.\u0000Conclusions. The results of the research conducted confirm the need to add certain groups of excipients in the powder mass for their further encapsulation and the use of appropriate technological methods when developing oral dosage forms.","PeriodicalId":19221,"journal":{"name":"News of Pharmacy","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72565179","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}
N. Herbina, O. Ruban, T. Gontova, M. Yaremenko, C. Yurchenko
In recent years, herbal medicines have become increasingly popular in the pharmacotherapy of many diseases. One of the medicinal plants widely distributed in the wild on the territory of Ukraine is common tansy (Tanacetum vulgare L.) of the Asteraceae family; it is a promising raw material for the development of new medicines. In this regard,it is relevant to study and standardize a dense extract of common tansy flowers (DECTF) to predict the possible pharmacological action and the feasibility of further use in the production of solid dosage forms. Aim. To study the qualitative and quantitative content of the amount of flavonoids and the amount of hydroxycinnamic acids in a dense extract of common tansy flowers. Materials and methods. The study object was DECTF. The qualitative composition of phenolic compounds in the extract was determined by TLC. The quantitative determination of the amount of flavonoids calculated with reference to luteolin was performed by the spectrophotometric method. Results and discussion. The identification of DECTF was performed by TLC. It allowed us to identify 3 dominant compounds of phenolic nature – luteolin, luteolin-7-glycoside and chlorogenic acid. The quantitative content of phenolic substances in DECTF was studied by spectrophotometry; it was found that the amount of flavonoids (calculated with reference to luteolin) was 3.69 ± 0.01 %; the amount of hydroxycinnamic acids (calculated with reference to chlorogenic acid) was 16.88 ± 0.02 %. Conclusions. A significant content of flavonoids and hydroxycinnamic acids in DECTF indicates the prospects for further research and development of new drugs with the anti-inflammatory, antimicrobial and choleretic action based on it.
{"title":"The study of the qualitative and quantitative content of the amount of flavonoids and hydroxycinnamic acids in a dense extract of common tansy flowers","authors":"N. Herbina, O. Ruban, T. Gontova, M. Yaremenko, C. Yurchenko","doi":"10.24959/nphj.21.55","DOIUrl":"https://doi.org/10.24959/nphj.21.55","url":null,"abstract":"In recent years, herbal medicines have become increasingly popular in the pharmacotherapy of many diseases. One of the medicinal plants widely distributed in the wild on the territory of Ukraine is common tansy (Tanacetum vulgare L.) of the Asteraceae family; it is a promising raw material for the development of new medicines. In this regard,it is relevant to study and standardize a dense extract of common tansy flowers (DECTF) to predict the possible pharmacological action and the feasibility of further use in the production of solid dosage forms.\u0000Aim. To study the qualitative and quantitative content of the amount of flavonoids and the amount of hydroxycinnamic acids in a dense extract of common tansy flowers.\u0000Materials and methods. The study object was DECTF. The qualitative composition of phenolic compounds in the extract was determined by TLC. The quantitative determination of the amount of flavonoids calculated with reference to luteolin was performed by the spectrophotometric method.\u0000Results and discussion. The identification of DECTF was performed by TLC. It allowed us to identify 3 dominant compounds of phenolic nature – luteolin, luteolin-7-glycoside and chlorogenic acid. The quantitative content of phenolic substances in DECTF was studied by spectrophotometry; it was found that the amount of flavonoids (calculated with reference to luteolin) was 3.69 ± 0.01 %; the amount of hydroxycinnamic acids (calculated with reference to chlorogenic acid) was 16.88 ± 0.02 %.\u0000Conclusions. A significant content of flavonoids and hydroxycinnamic acids in DECTF indicates the prospects for further research and development of new drugs with the anti-inflammatory, antimicrobial and choleretic action based on it.","PeriodicalId":19221,"journal":{"name":"News of Pharmacy","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82375286","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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