Journal articles on the topic 'The production of medicines'
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1
Beregovykh, V. V., and O. R. Spitskii. "TECHNOLOGY TRANSFER TO THE FACILITY FOR PRODUCTION OF MEDICINES." Annals of the Russian academy of medical sciences 68, no. 12 (December 10, 2013): 49–57. http://dx.doi.org/10.15690/vramn.v68i12.860.
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Innovation development of pharmaceutical industry is close connected to knowledge transfer going to each subsequent life cycle phase of medicinal product. Formal regulation of technology and knowledge transfer is essential for achievement high quality during production of medicines designed during development phase. Conceptual tools, approaches and requirements are considered that are necessary for knowledge and technology transfer across all the life cycle phases of medicines. They are based on scientific knowledge of medicinal products and take into account both international and Russian regulations in the area of development, production and distribution of medicines. Importance of taking into consideration all aspects related to quality of medicines in all steps of technology transfer is shown. An approach is described for technology transfer organization for Russian pharmaceutical manufacturers based on international guides in this area.
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Li, Zhiyong, Caifeng Li, Xiaobo Zhang, Shihuan Tang, Hongjun Yang, Xiuming Cui, and Luqi Huang. "Policies and Problems of Modernizing Ethnomedicine in China: A Focus on the Yi and Dai Traditional Medicines of Yunnan Province." Evidence-Based Complementary and Alternative Medicine 2020 (August 14, 2020): 1–14. http://dx.doi.org/10.1155/2020/1023297.
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Yunnan is a multiethnic province in southwest China, rich in Materia medica resources, and is popularly known as the kingdom of plants. Biomedicine and public health industry have been the industrial pillars of Yunnan since 2016, which is the important pharmaceutical industrial base for Dai and Yi medicine in China. This review of the Yunnan ethnic medicine industry describes some of the problems to be solved in the development of sustainable ethnomedicine in China. We investigated Chinese patent medicines (CPMs) declared as ethnomedicine on the drug instructions and identified 28 Dai patent medicines (DPMs) and 73 Yi patent medicines (YPMs) that were approved for clinical use in China. In further research, the clinical indications of these CPMs were determined, and the quality standard of medicinal materials and their usage frequencies in DPMs and YPMs were investigated. We also collected and analyzed the data on use of botanical and animal sources of medicines, the rare and endangered medicinal materials, and toxic medicines in DPMs and YPMs. The application of zootherapy in Yi traditional medicine was introduced from its abundant ancient documents and records; based on the “YaGei” theory in Dai traditional medicine, toxic medicines can be relatively safe in DPMs. However, for promoting the Yunnan traditional medicine industry, it is necessary to strengthen medical research to expand evidence-based clinical practice and balance ethnomedicine production and sustainable utilization of Materia medica resources, especially the animal sources of medicines, toxic medicines, and the protected wild resources reported in this survey. Only in this way can industrialization of ethnomedicine promote the improvement of human health.
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Sheikhmambetova, L. N., E. A. Egorova, E. Yu Bekirova, and K. N. Onishchenko. "MARKETING STUDY OF ORAL FORMS OF OMEPRAZOLE PREPARATIONS USED FOR THE TREATMENT AND PREVENTION OF GASTROESOPHAGEAL REFLUX DISEASE AND GASTRIC ULCER." Modern organization of drug supply 8, no. 2 (June 15, 2021): 28–37. http://dx.doi.org/10.30809/solo.2.2021.3.
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Some of the most widespread illnesses of alimentary canal are the stomach (gastric) ulcer, duodenal ulcer disease, gastroesophageal reflux diseases. The ethanol of antisecretory treatment of the given acid-dependent diseases are the preparations of the proton pump inhibitor group with omeprazole which is considered to be more effective and investigated. The goal of the research is the oral medications omeprazole (20 mg) assortment market investigation. Materials and methods. The research objects are the State register of medicines data of oral medicinal products including omeprazole dosing 20 mg recorded on the pharmaceutical market as well as the State price register data on the vital medicinal products on April, 4, 2021. Results. According to the SRMP 30 trade names of medicinal products including omeprazole dosing 20 mg as active ingredient in capsules and tablets are registered on the pharmaceutical market in Russian Federation. The omeprazole products distribution in the countries holding registration certificates showed the predominance of domestic production medicinal products (18 trade names, 60 %). The cost analysis of standard daily and course dose oral omeprazole form (20 mg) of different trade names allowed to select economically profitable preparations (”Omeprazole”, LLC “Production of Medicines”, Russia; “Omeprazole”, OJSC ‘‘Synthesis”, Russia; “Omeprazole” LLC BFMP, Russia), the insert of which into the list of medicines to provide the gastroesophageal reflux disease and stomach (gastric) ulcer patients at the regional level is economically feasible as well the medicines with the high price (Losec MUPS AstraZeneca AB, Sweden). Сonclusion. The results of the pharmaceutical market research of oral omeprazole form (20mg) indicates a great majority of generic medicine, a sufficient market capacity, medicine predominance of domestic production (60%).
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Camargo, Ely Eduardo Saranz, Mary Anne Medeiros Bandeira, and Anselmo Gomes de Oliveira. "Diagnosis of Public Programs focused on Herbal Medicines in Brazil." Natural Product Communications 6, no. 7 (July 2011): 1934578X1100600. http://dx.doi.org/10.1177/1934578x1100600720.
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The present study is aimed to diagnose the current public programs focused on herbal medicines in Brazil by means of in loco visits to 10 programs selected by means of questionnaires sent to 124 municipalities that count on herbal medicine services. The main purpose of the implementation of program programs is related to the development of medicinal herbs. 70% of them are intended for the production of herbal medicines and 50% are aimed to ensure the access of the population to medicinal plants and or herbal medicines. The initiative of the implementation of these programs was related to the managers (60%). The difficulties in this implementation were due to the lack of funding (100%) of the programs. In 60% of the programs, the physicians did not adhere to herbal medicine services due to the lack of knowledge of the subject. Training courses were proposed (80%) to increase the adhesion of prescribers to the system. Some municipalities use information obtained from patients to assess the therapeutic efficiency of medicinal plants and herbal medicines. Of the programs underway, cultivation of medicinal plants was observed in 90% and 78% of them adopt quality control. In most programs, this control is not performed in accordance with the legal requirements. The programs focused on medicinal plants and herbal medicines implemented in Brazil face some chronic problems of infrastructure, management, operational capacity and self-sustainability, which can be directly related to the absence of a national policy on medicinal plants and herbal medicines.
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Rathod, Rucha, and Raman R. Chandak. "Review on “Standardization an Imp Tool for Herbal Drug Development”." Journal of Drug Delivery and Therapeutics 9, no. 6-s (December 15, 2019): 253–57. http://dx.doi.org/10.22270/jddt.v9i6-s.3784.
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The medicinal plants are important source for pharmaceutical manufacturing. Medicinal plants & herbal medicines account for a significant percentage of the pharmaceutical market. There is increasing awareness and general acceptability of the use of herbal drugs in today’s medical practice although most of these applications are not scientific. Herbal medicines are not a simple task since many factors influence the biological efficacy and Reproducible therapeutic effect. So it is necessary to improve safety of herbal drugs by developing certain quality control parameters & by following the WHO guidelines for herbal medicines. This review seeks to enlighten the need to establish quality parameters for collection, handling, processing and production of herbal medicine as well as employ such parameters in ensuring the safety of the global herbal market. It is necessary to introduce measures on the regulation of herbal medicines to ensure quality, safety, efficacy of herbal medicines by using modern suitable standards & GMP. The processes of good quality assurance and standardization of herbal medicines and products using various spectroscopic, chromatographic and electrophoretic methods were also discussed. In fact, the research field of quality control of herbal medicines is really an interdisciplinary research. It needs crossover of chemistry, pharmacology, medicine and even statistics to provide a platform for the quality control of traditional herbal medicines and further to discover the novel therapeutics composed of multiple chemical compounds.
Keywords: Herbal drugs, Adulteration, Standardization, Chromatography, Electrophoresis, HP-LC and GC-MS.
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He, Chun Xia, Luo Ming Zhang, and Xiao Dong Wang. "Design of a Microwave Vacuum Drying Medicine Extract Model of Process Equipment." Key Engineering Materials 667 (October 2015): 562–67. http://dx.doi.org/10.4028/www.scientific.net/kem.667.562.
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In order to ensure the medicinal efficacy and improve the production efficiency, design and production of a kind of microwave vacuum drying medicine extract new technical equipment. Through analyzing the principle of material characteristics of traditional Chinese medicine extract, drying, microwave vacuum drying, Design of microwave vacuum drying chamber, cylinder body, a door body, a material system. Based on the overall scheme, the main structure parameters were calculated, and the production of a set of test equipment, the dehydration rate test. The new process equipment efficiency, reduces the cost, the volume is greatly reduced, keep the efficacy, and has the functions of sterilization, especially suitable for the production of proprietary Chinese medicines industry.
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Burylo, Y. P. "Novelties of the legislation on veterinary medicinal products." Uzhhorod National University Herald. Series: Law 66 (November 29, 2021): 142–46. http://dx.doi.org/10.24144/2307-3322.2021.66.24.
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The article is devoted to the analysis of the latest innovations in the legislation on veterinary medicine, namely the regulation of the production, distribution and use of veterinary medicines. The adoption of the new Law of Ukraine “On Veterinary Medicine” is caused by the need to approximate the relevant national legislation with the legislation of the European Union to fulfill Ukraine’s international obligations under the Association Agreement. This law reflects the latest trends in the development of legislation on veterinary medicinal products in the European Union.
The article pays attention to the strengthening of state regulation of production and distribution of veterinary medicines, in particular the introduction of licensing of imports, wholesale and retail sales of these medicines in Ukraine, due to the need to combat counterfeiting and veterinary medicinal products of dubious quality. It is also noted that the changes in the procedure of state registration of veterinary medicines provided by this law will on the one hand reduce the administrative burden on business due to the transition to indefinite state registration of veterinary drugs, and on the other hand new requirements for the registration dossier will improve the safety, quality and efficacy of veterinary medicinal products.
New requirements for the use of antibiotics are analyzed. Attention is drawn to the fact that along with the regulation of the use of antibiotics in animal husbandry, it is also necessary to regulate in more detail the issues of control of the circulation of active substances (active pharmaceutical ingredients). The article also deals with the mechanism of veterinary pharmacovigilance, which is new for Ukraine. At the same time, it is necessary to study the practical experience of implementing the European model of pharmaco to improve the relevant legislation in Ukraine.
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Koopmans, Marieke, Dirk Martens, and Rene Wijffels. "Towards Commercial Production of Sponge Medicines." Marine Drugs 7, no. 4 (December 2, 2009): 787–802. http://dx.doi.org/10.3390/md7040787.
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Poerwosusanta, Hery, Zairin Noor, Karyono Mintaroem, Edi Widjajanto, and Mulyohadi Ali. "Extraction the Dayak Onion (Eleutherine sp): Scientific Based Herbal Medicine (OHT) Production Protocol." Berkala Kedokteran 15, no. 2 (September 16, 2019): 133. http://dx.doi.org/10.20527/jbk.v15i2.7263.
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Abstract: Indonesia has the second largest tropical forest and the richest in flora biodiversity in the world. Based on the Basic Health Research 2010, 59.29% of Indonesian had consumed herbal medicine, noted that Indonesian had consumed herb since the VIII century. Dayak onion (Eleutherine sp) widely used as traditional medicine, as a bahimang /wound healing agent. Dayak onion is not reassured as a medical treatment and lacked scientific evidence. Until 2018, thousands of herbs consumed by Indonesian, only 85 ingredients clinically tested. Sixty-four herbs have been pre-clinically tested and designated as Scientific based Herbal Medicines/Obat Herbal Terstandar (OHT) and 21 herbs have been tested clinically and determined as Phytopharmaca by the Badan Pengawasan Obat dan Makanan Republik Indonesia (BPOM-RI). Based on the data, the Dayak onion appointed as a Scientific based Herbal medicine (OHT) based on pre-clinical and phase 0 clinical research. Potential and promising for the treatment of metabolic, degenerative, catastrophic, neoplasmic, genetic and infectious diseases, Dayak onions can be developed into phytopharmaca in the future. The study aim is to make guidelines for the standardized herbal medicines development according to the rules and regulations. Keywords: Dayak Onion, Eleutherine sp, Scientific based Herbal Medicines, Phytopharmaca, Pre Clinic and Clinical Trials phases
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Pattanayak, Shibabrata. "Anti-COVID-19 Biomedicines - A Layout Proposal for Production, Storage and Transportation." Open COVID Journal 1, no. 1 (November 24, 2021): 166–88. http://dx.doi.org/10.2174/2666958702101010166.
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Background: Modulation of non-specific immunity and other related activities of succulent parts of effective medicinal plants can prevent viral infections like COVID-19 through their dietary intake. Objective: The succulent parts of the medicinal plants with immunomodulation, anti-oxidation, anti-viral, anti-inflammatory, etc. power can be used orally in the capsular form to prevent as well as to reduce the severity of symptoms of COVID-19. Methods: A proposal is displayed with a detailed description of related steps like the selection of medicinal plant parts consulting related reports, collection of biomedicines, validation of efficacy, dosing, encapsulation, storage, and transportation, etc. Results: The succulent bio-medicines against COVID-19 can be developed and marketed following only some adoptive research. Conclusion: Succulent bio-medicines can be prepared and marketed for the prevention and cure of different infectious and non-infectious diseases.
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Schwabl, Herbert. "The Mercury Puzzle." Asian Medicine 8, no. 1 (September 17, 2013): 181–98. http://dx.doi.org/10.1163/15718069-12341277.
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In the last decades, Tibetan medicine has spread around the globe. From a Western point of view, Tibetan medicine is part of Complementary and Alternative Medicine (cam). In many Asian medicines, mercury sulphide is considered an important ingredient. Tibetan medicine is famous for its precious pills, many of which contain mercury sulphide in the form of an ash called tsotel (btso thal). In the Western, specifically in the European context, such ingredients are not accepted for human consumption. These legalities are discussed from the perspective of today’s pharmaceutical practice in Europe. Neither the law of medicinal products nor the food law allow such ingredients and place strict limits on residues of heavy metals. The cam community is also very cautious about any use of heavy metals. This article advocates that on the global level, the production and distribution of Tibetan medicines has to consider today’s modern pharmaceutical and biomedical environment. The formulas of Tibetan medicine based solely on herbs and certain minerals could be the foundation stone for a modern pharmacopoeia of Tibetan medicine. Tibetan medicines are always a carefully blended mixture of many ingredients. This multi-compound principle could then serve as a basic concept for a modernised Tibetan medicine. Such medicines have to be investigated in their entirety, without reducing the formula to its active ingredients. This article suggests that such a herbal mixture could be understood as a new ‘man-made herb’, where the scientific tools specifically developed to investigate individual herbal constituents would be applied to the entire formula. Tibetan medicine and its products based on pharmaceutical-grade clean herbs and minerals can offer important therapeutic options for humankind on a global level.
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Hadiati, S. W., H. Winarno, and S. Pramono. "Gamma irradiation as suitable preservation method on herbal medicine: a review." Food Research 5, no. 5 (August 31, 2021): 33–42. http://dx.doi.org/10.26656/fr.2017.5(5).494.
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The trend of consuming herbal medicines has been increasing over the past three decades. No less than 80% of the world's population has used herbal medicines as a treatment. One of the problems in herbal medicine is the high level of microbial contamination caused by raw materials and production processes. Various attempts have been made to overcome these problems, one of them is the gamma irradiation method. Although irradiation has been widely used for food sterilization, the use of irradiation for sterilization on herbal medicines is still debated. It is because irradiation may affect the composition of active compounds of herbal medicines. This review aimed to discuss the applications of gamma irradiation for herbal medicines by emphasizing the chemical constituent stabilities of herbal medicines.
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Kiliś-Pstrusińska, Katarzyna, and Anna Wiela-Hojeńska. "Nephrotoxicity of Herbal Products in Europe—A Review of an Underestimated Problem." International Journal of Molecular Sciences 22, no. 8 (April 16, 2021): 4132. http://dx.doi.org/10.3390/ijms22084132.
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Currently in Europe, despite the many advances in production technology of synthetic drugs, the interest in natural herbal medicines continues to increase. One of the reasons for their popular use is the assumption that natural equals safe. However, herbal medicines contain pharmacologically active ingredients, some of which have been associated with adverse effects. Kidneys are particularly susceptible to injury induced by toxins, including poisonous constituents from medicinal plants. The most recognized herb-induced kidney injury is aristolochic acid nephropathy connected with misuse of certain Traditional Chinese herbal medicines. Data concerning nephrotoxicity of plant species of European origin are scarce. Here, we critically review significant data of the nephrotoxicity of several plants used in European phytotherapy, including Artemisia herba-alba, Glycyrrhiza glabra, Euphorbia paralias, and Aloe). Causative mechanisms and factors predisposing to intoxications from the use of herbs are discussed. The basic intention of this review is to improve pharmacovigilance of herbal medicine, especially in patients with chronic kidney diseases.
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Castro, R. D., J. A. Oliveira, L. C. Vasconcelos, P. P. Maciel, and V. L. M. Brasil. "Brazilian scientific production on herbal medicines used in dentistry." Revista Brasileira de Plantas Medicinais 16, no. 3 (September 2014): 618–27. http://dx.doi.org/10.1590/1983-084x/13_101.
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The objective of this study was to critically analyze the scientific production published in specialized Brazilian journals concerning the use of medicinal plants in dentistry. A literature review was carried out using an indirect documentation technique by means of a bibliographical study. Four examiners performed independent searches in Brazilian journals of medicinal plants indexed in the database SciELO (Brazilian Journal of Pharmacognosy; Brazilian Journal of Medicinal Plants; Brazilian Journal of Pharmaceutical Sciences; and Acta Botanica Brasilica) using the descriptors "herbal medicine/phytotherapy" or "medicinal plants" and "dentistry ". The articles published from 2002 to 2012 addressing the use of medicinal plants in dentistry were included and analyzed. The searches based on the descriptors and reading of abstracts, resulted in 155 articles. Of these, 44 were read in full and a total of 16 publications met the eligibility criteria and were selected. Laboratory studies predominated (10) and were limited to the evaluation of antimicrobial properties by means of tests for determining inhibitory, fungicidal and bactericidal concentrations. Three literature reviews and only one clinical trial with no blinding and randomization were found. It is highlighted the need for better methodological designs in the researches and greater production of clinical or in vivo studies.
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Naudé, C. Te W., and J. M. Luiz. "An industry analysis of pharmaceutical production in South Africa." South African Journal of Business Management 44, no. 1 (March 30, 2013): 33–46. http://dx.doi.org/10.4102/sajbm.v44i1.146.
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The purpose of this research is to investigate the shifting structure of pharmaceutical production in South Africa and examine the global and local factors that have contributed to this change. Generally, these factors have resulted in a decline in the number of pharmaceutical manufacturers in South Africa and in particular manufacturing operations owned by multinational companies. Simultaneously the global demand for generic medicines has increased due to their ability to improve access to affordable medicines. As a result, the supply of medicines in South Africa is being increasingly met by imported generic medicines and to a lesser extent locally manufactured generic medicines. These changes, together with a turbulent and sometimes uncertain regulatory environment, have led to interesting dynamics and changes within the structure of the pharmaceutical manufacturing industry in South Africa.
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Ara, Toshiaki, Sachie Nakatani, Kenji Kobata, Norio Sogawa, and Chiharu Sogawa. "The Biological Efficacy of Natural Products against Acute and Chronic Inflammatory Diseases in the Oral Region." Medicines 5, no. 4 (November 13, 2018): 122. http://dx.doi.org/10.3390/medicines5040122.
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The oral inflammatory diseases are divided into two types: acute and chronic inflammatory diseases. In this review, we summarize the biological efficacy of herbal medicine, natural products, and their active ingredients against acute and chronic inflammatory diseases in the oral region, especially stomatitis and periodontitis. We review the effects of herbal medicines and a biscoclaurin alkaloid preparation, cepharamthin, as a therapy against stomatitis, an acute inflammatory disease. We also summarize the effects of herbal medicines and natural products against periodontitis, a chronic inflammatory disease, and one of its clinical conditions, alveolar bone resorption. Recent studies show that several herbal medicines such as kakkonto and ninjinto reduce LPS-induced PGE 2 production by human gingival fibroblasts. Among herbs constituting these herbal medicines, shokyo (Zingiberis Rhizoma) and kankyo (Zingiberis Processum Rhizoma) strongly reduce PGE 2 production. Moreover, anti-osteoclast activity has been observed in some natural products with anti-inflammatory effects used against rheumatoid arthritis such as carotenoids, flavonoids, limonoids, and polyphenols. These herbal medicines and natural products could be useful for treating oral inflammatory diseases.
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Tanaka, Ken, Masanori Arita, Hiroaki Sakurai, Naoaki Ono, and Yasuhiro Tezuka. "Analysis of Chemical Properties of Edible and Medicinal Ginger by Metabolomics Approach." BioMed Research International 2015 (2015): 1–7. http://dx.doi.org/10.1155/2015/671058.
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In traditional herbal medicine, comprehensive understanding of bioactive constituent is important in order to analyze its true medicinal function. We investigated the chemical properties of medicinal and edible ginger cultivars using a liquid-chromatography mass spectrometry (LC-MS) approach. Our PCA results indicate the importance of acetylated derivatives of gingerol, not gingerol or shogaol, as the medicinal indicator. A newly developed ginger cultivar,Z. officinalecv. Ogawa Umare or “Ogawa Umare” (OG), contains more active ingredients, showing properties as a new resource for the production of herbal medicines derived from ginger in terms of its chemical constituents and rhizome yield.
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Figueiredo, Tatiana Aragão, Renato Gonçalves Fialho Neto, and Jorge Lima de Magalhães. "The public production of medicines in Brazil." Ciência & Saúde Coletiva 26, suppl 2 (2021): 3423–34. http://dx.doi.org/10.1590/1413-81232021269.2.31962019.
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Abstract The paper aims to contribute as a reflection on the public production of medicines in Brazil. Public producers present themselves as strategic in Brazil, either as price regulators, in meeting the demands of the Ministry of Health (MoH) on neglected products and those at risk of shortage to SUS. The study used the official bases of the MoH, National Health Surveillance Agency (ANVISA) and Website of Official Pharmaceutical Laboratories (OPL). Thirty-three OPL were identified, 16 with active production of drug registration at ANVISA. For the remaining 17 LFOs, no one identified active portfolio in the bases surveyed. There are 80% of the OPL portfolio concentrated in the first level of the Anatomical Therapeutic Chemical Classification, such as alimentary tract and metabolism, blood and blood forming organs, cardiovascular system, anti-infective for systemic use and nervous system. The OPL participation in the health complex is 48.6% of its portfolio dedicated to the strategic component, 30.6% for primary care and 20.7% for the specialized. It concludes the relevance of the OPL for the Brazilian health policy, with the better realignment of their potential in the face of technological advancement, health legislation, drug dependence and new treatment protocols.
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Mirzaeian, Razieh, Farahnaz Sadoughi, Shahram Tahmasebian, and Morteza Mojahedi. "The role of herbal medicines in health care quality and the related challenges." Journal of Herbmed Pharmacology 10, no. 2 (January 5, 2021): 156–65. http://dx.doi.org/10.34172/jhp.2021.17.
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In recent years, there has been a renewed interest in the use of herbal medicines. Quality control and safety are two critical principles to be considered in the production process of herbal medicines. This review study aimed to investigate the condition of the countries other than Iran in terms of observing the safety principles, quality control, and meeting the standard of herbal drug use. In this systematic review, references were selected using the search terms "health-care quality" and "challenges of herbal medicine usage" from the databases "Web of Science" and "PubMed" published between 2000 and 2019. To select the resources among the selected literature, confirmation was accomplished by two researchers and Cohen’s kappa coefficient (κ). The selected papers were classified based on publication year, journal, country, reference standards, regulation, toxicity evaluation, quality control, efficacy, safety, and adverse effects in herbal medicine. From 1532 retrieved papers, 27 papers with an estimated Cohen’s kappa coefficient of 0.81 were confirmed and included in the study. Based on the analysis, the main findings of the papers were thematically classified into seven subcategories as follows: reference standards in herbal medicine, regulation of herbal medicinal products, toxicity evaluation for herbal products, quality control of herbal medicine, efficacy, adverse effects of herbal medicine, and safety. Given the significance of the effects of herbal medicines on health care quality, it is essential to codify guidelines on the proper use of these drugs.
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Заліська, О. М., Ю. В. Качерай, З. О. Заболотня, and О. М. Семенов. "Analysis of extemporal production trends in pharmacies for children." Farmatsevtychnyi zhurnal, no. 6 (December 20, 2021): 18–27. http://dx.doi.org/10.32352/0367-3057.6.21.02.
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Medicines for children are insufficiently represented in pediatric dosages and appropriate dosage forms in the pharmaceutical market of Ukraine. Pediatricians are forced to prescribe children's medicines in dosages that are not available in the State Register of Medicines of Ukraine. Extemporaneously compounded medicines (ECM) are useful when a required dose or dose form is unavailable commercially, or is needed for individualised dosing.
The aim of the study was to analysis a real data of the list of medicines which are produced in hospital and public pharmacies of Lviv region during 2020–2021.
Methods. Content analysis of extemporal prescriptions for children, depending on the composition of the active pharmaceutical ingredient, dose and dosage form, comparative cost analysis of ECM and industrial medicines.
In the hospital doctors prescribe ECМ in liquid forms (75%) – solutions for injection and in solid forms (25%) – dosed simple powders – 19%, dosed complex powders – 6%. It was determined the structure of ECM, which are produced in 6 studied pharmacies in 2020–2021. There are soft ECM 61.6% in dosage forms: ointments, creams, paste; liquid ECM are 28.3% in mixtures, solutions, mumbles; solid ECM are 8.3% in mono, combine powders, suppositories and 1.8% – other ECM: powders and nail polishs. There were highlighted unique recipes of ECM which analogues were not present in industrial dosage forms.
We conducted analysis of the cost of children’s ECM in these pharmacies. It was determined that ECM cost were 40.5–305.6 UAH depending on the dosage form. The comparative analysis showed that ECM are in 2.2–4.9 times more cheaper for children compare with similar active ingredients in industrial medicines.
ECMs are much more compliant for treatment in children and babies, they provide higher effect, safety, reduce dosing errors, especially at the inpatient stage, and continuation of therapy on an outpatient basis and more cost-effective for individual needs. The use of ECMs allows parents to properly dose them for children, to avoid errors in dosing, improper administration, which is extremely important to ensure the rational use of medicines in pediatric practice.
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Sitepu, Sukma Aditya. "ANALYSIS OF RELATIONSHIP BETWEEN PRODUCTION FACTORS AND PRODUCTION TILAPIA FARMING BUSINESS IN TOBA SAMOSIR REGENCY." AGRITROPICA : Journal of Agricultural Sciences 2, no. 1 (July 8, 2019): 40–45. http://dx.doi.org/10.31186/j.agritropica.2.1.40-45.
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ABSTRACTThis study aims to analyze the relationship between floating net cage size, labor, feed, seeds and medicine with tilapia production in Toba Samosir Regency. The selection of the study area was carried out purposively because Toba Samosir district was a tilapia aquaculture area that had the largest harvest area in North Sumatra. The data used are secondary data and primary data obtained in the study area. The analytical method used is Chi-Square analysis using SPSS 18.0 software. The results of this research are floating net cage areas, labor, feed, seeds, and medicines used in relation to the production of tilapia fish in floating net cages in Toba Samosir District significantly. With the closeness of the relationship between the extent of Floating Net Cages, feed, medicine with a production of 78.7%, and the closeness of the relationship of seeds with production 89.2 and the closeness of labor relations with a production 70.4%.Keywords: Floating Net Cages, Production, Production Factors, Tilapia.
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Аbdulaeva, D., A. Cholponbaeva, U. Gulieva, and K. Alekseev. "TECHNOLOGICAL METHODS USED IN THE PRODUCTION OF THE DOSAGE FORM "NAIL LACQUER"." National Association of Scientists 1, no. 67 (June 15, 2021): 67–69. http://dx.doi.org/10.31618/nas.2413-5291.2021.1.67.421.
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Therapy of nail disease is determined by the type of disease. We do not even think about how vulnerable and susceptible to various diseases our nails are. A number of diseases involve the use of local medicines. One of the dosage forms intended for topical use are medicinal lacquers.
This article is devoted to the consideration and evaluation of the functional characteristics of excipients in the technology of medicinal lacquers.
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Utami, N., I. S. Bidara, J. I. Royani, R. Reninta, I. Dwimahyani, and D. Mulyono. "Increasing secondary metabolites production of Phyllanthus sp to support development of herbal medicine industry." IOP Conference Series: Earth and Environmental Science 1114, no. 1 (December 1, 2022): 012082. http://dx.doi.org/10.1088/1755-1315/1114/1/012082.
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Abstract This study aim to improve the quality of Phyllanthus sp production by increasing the content of secondary metabolites as a bioactive compound. Phyllanthus sp contains various secondary metabolites that enhance immunity and treat diabetes, hypertension, antioxidants, anti-cancer, kidney disorders, and other illnesses. Since the Covid-19 pandemic, Phyllanthus sp widely used as a raw material for making herbal medicines. The trade value of Indonesian herbal medicines is estimated to increase in 2022, and the price will reach around the US $ 910 million, so it has very bright business prospects. These relatively limited phytopharmaceutical products constrain the supply of high-quality raw materials under the requirements of the herb medicine industry. Therefore, conducting a depth assessment related to efforts to improve the quality of Phyllanthus sp production by increasing the content of secondary metabolites is necessary. The efforts to enhance the quality of Phyllanthus sp as a source of herbal medicine raw materials can be made through plant breeding such as genetic mutations and in combination with the environmental arrangements of soil water content and solar radiation intensity. The efforts to increase the quality of herbal medicine raw materials are critical to support the development of the herbal medicine industry.
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Tereshina, N. S., M. N. Lyakina, and O. A. Naumova. "Sea Water-Based Medicines: Manufacturing Technology and Standardisation." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 10, no. 4 (December 11, 2020): 228–34. http://dx.doi.org/10.30895/1991-2919-2020-10-4-228-235.
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Sea water and sea salt obtained from it are widely used as substances in the production of medicinal products. Complex chemical composition of sea water which contains various salts, calls for the development of a common quality standard for sea water-based medicines. The aim of the study was to analyse and summarise available data on the sources of sea water-based medicines, and on the current test methods, as well as to develop a unified approach to quality control. The paper summarises information on the use of sea water for medical purposes. It presents comparative data on the chemical composition of sea water obtained from different sources, manufacturing technologies of sea water-based medicines, and composition of medicines produced from sea water or sea salt. The paper summarises data on the use of sea water for the production of various dosage forms: drops, sprays, aerosols. The study revealed qualitative and quantitative differences in the content of major cations and anions in drug products. The authors analysed the use of various chemical and physico-chemical test methods for qualitative and quantitative characterisation of medicines. It was concluded that there is a need to harmonise quality control methods for sea water-based medicines.
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Nistor, Adina-Loredana, Elizabeth Pisani, and Maarten Olivier Kok. "Why falsified medicines reach patients: an analysis of political and economic factors in Romania." BMJ Global Health 6, Suppl 3 (February 2023): e009918. http://dx.doi.org/10.1136/bmjgh-2022-009918.
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IntroductionTo protect patients against falsified medicines, countries around the world implement stringent regulations. Despite efforts to protect supply chains in the European Union (EU), authorities continue to find falsified medicine. We studied how in Romania, one of the poorest EU countries, political and economic factors influence the risk of patients being exposed to falsified medicines.MethodsFor this case study, we reviewed 131 documents and interviewed 22 purposively selected key informants.ResultsIn Romania, several politically and economically motivated policies have led to persistent medicine shortages. Following the 2007 accession to the EU, fierce competition led to a decline in domestic medicine production. Soon after, the government introduced a tax on reimbursed medicines to support the national health budget. Prior to the 2015 elections, medicine prices were abruptly lowered to provide voters with the cheapest medicine in Europe. The low prices incentivised traders to buy medicines in Romania and sell them elsewhere in the EU. The high taxes and low prices led manufacturers to withdraw medicines from the market and impose product quotas to limit parallel trading. The accumulated effect of these market responses translated into persistent shortages of essential medicine, which have pushed patients and health professionals to unregulated markets with a high risk of exposure to falsified medicine.ConclusionStrategies against falsified medicine with a narrow focus on safeguarding quality in the regulated supply are insufficient. To protect patients, governments must also ensure that patients have access to affordable medicines, as shortages provide an opportunity for those selling fake products.
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Sieler, Roman. "Mercurial Medicines." Asian Medicine 17, no. 1 (March 14, 2022): 148–85. http://dx.doi.org/10.1163/15734218-12341510.
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Abstract Using ethnographic data, this article suggests that the therapeutic use of various mercury compounds in siddha medicine has so far not decreased despite international regulation of the substance and discussions surrounding the safety of mercury. Siddha practitioners portray mercury as central to their therapeutics. The article demonstrates this for different contexts, including the preparation of mercuric medicines; the production of mercury amulets; and recent research studies on mercury-based siddha drugs, targeting, for instance, dementia-related syndromes. Contextualizing siddha mercurial procedures and preparations through interlinking therapeutic, historical, and global frames underscores the fact that mercury use in siddha medicine today derives from alchemical traditions, but also transcends them. It is embedded in political contexts of science and healthcare in India, as it answers to concerns about safety and toxicity and at the same time takes center stage in negotiating siddha medical specialty and alterity vis-à-vis other medical practices, most notably ayurveda.
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Manocha, Sachin, Umesh D. Suranagi, Ravinder K. Sah, Rakhamaji D. Chandane, Sumit Kulhare, Nitesh Goyal, and Krishna Tanwar. "Current Disposal Practices of Unused and Expired Medicines Among General Public in Delhi and National Capital Region, India." Current Drug Safety 15, no. 1 (February 3, 2020): 13–19. http://dx.doi.org/10.2174/1574886314666191008095344.
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Background: Stocking unused or expired medicines or donating these to others can lead to accidental or inappropriate ingestion, increasing the risk of adverse drug reaction(s) and even lead to antibiotic resistance. Further improper disposal of expired or unused medicines is associated with environmental pollution, health hazards and damage to ecosystem. Ecopharmacovigilance is an important area in this context. Objective: To explore the awareness and disposal practices of unused/expired in the general public. Material and Methods: The current study is an observational, cross-sectional, questionnaire-based study conducted in 956 medicine consumers in New Delhi and National Capital Region, India. The knowledge, attitude, and practice of consumers regarding the disposal of unused medicines were evaluated. Results: The majority (89.9%) of consumers opined that expiry of medicine(s) meant for completion of shelf life, production of toxic chemical and loss of or decreasing of beneficial effects of medicines. Majority (87%) of the consumers stored medicines at home. Almost all (92.6%) of the consumers threw away the expired medicines after storing for few days. Consumers discarded the expired medicines mainly in household trash (73%). The majority (93%) of consumers were in favour of a government program to collect unused or expired medicines from their home. Conclusion: The knowledge and practices of consumers towards disposal of unused and expired medicines needs to be improved. Health care professionals, government and policy makers should offer training to educate and guide the general public on safe and proper disposal practices of expired or unused medicines.
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Vasyliev, Stanislav. "The legal status of participants who create medicines in the national innovation system." Law and innovations, no. 1 (33) (April 5, 2021): 22–28. http://dx.doi.org/10.37772/2518-1718-2021-1(33)-3.
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Formulation of the problem. Carrying out scientific research in the field of creating innovative medicines is the key to the competitiveness of pharmaceutical enterprises in the internal Ukrainian and world markets. Proper legal regulation of the legal status of business entities and scientific institutions that create medicines should become a guarantee of state support for scientific research in this area. Recent research on the topic. The scientific works of V.M. Pashkova, I.S. Voronina, M.V. Bunyak and other researchers are devoted to certain problems of innovative activity in the sphere of medicine circulation. At the same time, the problems of the legal status of participants in the national innovation system who create new medicines have not found their coverage in the scientific literature. The purpose of this research is to determine the legal status of participants in the national innovation system, who create medicines. Article’s main body. The scientific research is devoted to the determination of the legal status of the participants of the national innovation system who create medicines. Legislative and by-laws, statistical information posted on the official websites of authorities, publications of researchers who studied innovative activities in the field of medicine circulation were studied. It is stated that the development of innovative medicines can be carried out by research institutes, institutions of higher education and pharmaceutical manufacturing enterprises. Medicines productions are created in the organizational and legal form of private and state enterprises, business entities. Research institutes and institutions of higher education have legal form of organization. These institutions are subordinate to either the Ministry of Education and Science, or the Ministry of Health Protection, or the National Academy of Medical Sciences, or the State Service for Medicines and Drug Control of Ukraine. Among the conditions for obtaining a license for the medication production there is no requirement for a laboratory to create new medicines at the enterprise. Requirements for such a laboratory are not provided for in legislative and bylaws. Conclusions and prospects for the development. The author proposes definitions of “medicine developer” and “innovative pharmaceutical organization”. The features of the pharmaceutical enterprise innovativeness, in our opinion, are the presence of a scientific department in the structure of the enterprise and the registration of an innovative project by this enterprise in the prescribed manner. The consolidation of these definitions in the legislation of Ukraine may be important for obtaining state support for scientific research on the new medicines creation.
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Santoso, Vincent Audi. "BEST RAW MATERIAL STORAGE METHOD FOR KEEPING QUALITY OF FOOD PRODUCTION." IJTI (International Journal of Transportation and Infrastructure) 1, no. 2 (March 9, 2018): 57–62. http://dx.doi.org/10.29138/ijti.v1i2.632.
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Food is a basic human need that is needed at all times and requires good and proper management in order to benefit the body. According to WHO, the intended food is: “Food include all substances, whether in a natural state or in a manufactured or preparedform, wich are part of human diet.”These food restrictions do not include water, medicines and substances needed for medicinal purposes.
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Vandana, Rajesh Lather, Sridevi Tallapragada, and Gurnam Singh. "Medicinal and Aromatic plants: “Natural bio-chemicals and medicine factories”." INTERNATIONAL JOURNAL OF AGRICULTURAL SCIENCES 17, no. 2 (June 15, 2021): 691–98. http://dx.doi.org/10.15740/has/ijas/17.2/691-698.
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Since thousands years back approximately around 900 BC, medicinal plants are considered as a source of many biomolecules with therapeutic potential. Herbal medicines are considered as safer, better, physiologically compatible and costeffective. The oldest evidence of medicinal and aromatic plants depicts that with the emergence of human civilization, plants have been considered as the main source to heal and cure various serious ailments. It has been proven that the secondary metabolites e.g. alkaloid, glycosides, flavonoides, steroids etc present in the medicinal plants possesses ability to prevent occurrence of some of the diseases, means medicinal plants acts as a “preventive medicine”. Medicinal plants have a paramount importance and a great interest due to its pharmaceutical, cosmetic and nutritional values. Some plants are also considered as an important source of nutrition and are known to have a variety of compounds with potential therapeutic properties. India is the principal repository of large number of medicinal and aromatic plants or we can say India is one of the rich mega-biodiversity countries of the world. Medicinal plants are “backbone” of traditional medicinal system (TMS). Crude drugs are usually dried parts of medicinal and aromatic plants (MAPs) such as roots, stems, wood, bark, seeds, fruits, flowers, leaves, rhizomes, whole plant etc. that form the essential raw material for the production of medicines in various systems of Ayurveda, Siddha, Unani, Tibatian, Tribal and Homeopathy. According to the survey of the World Health Organization (WHO), about 80% of the world population are using herbs and other traditional medicines for their primary healthcare and have established three kinds of herbal medicines: raw plant material, processed plant material, and herbal products. Now days, variety of available herbs are used throughout the world and they continue to promote good health. As the benefits from medicinal and aromatic plants are recognized, these plants will have a special role for humans in the future. The present review on medicinal and aromatic plants revealed similar combination of studies.
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Zlahoda, V. S., and L. O. Bobrytska. "Segmentation of modern dosage forms at the pharmaceutical market of Ukraine." News of Pharmacy 104, no. 2 (October 3, 2022): 45–48. http://dx.doi.org/10.24959/nphj.22.94.
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In the current conditions of the pharmaceutical industry development the segmentation of available dosage forms among 13898 medicines registered on the territory of Ukraine allows to optimize the pharmaceutical provision of the population. Aim. To comprehensively analyze medicines registered in Ukraine. Materials and methods. The study material was data of the State Register of Medicines of Ukraine in 2022. The research methods used were frequency and content analysis. Results and discussion. As a result of the content analysis, it has been found that the pharmaceutical market of Ukraine is represented by 13898 items of medicines; among them 10965 are ready-made medicinal products (78.89 %) and 2146 are substances (15.44 %), where the largest share is made up of finished dosage forms, namelysolid dosage forms: tablets (49.96 %), solutions (17.17 %), capsules (10.37 %) and powders (10.01 %) with a preference for foreign production of 66.35 %. Medicines in the form of capsules and their varieties with the advantage of foreign production of 76.01 % of trade names are also determined. Conclusions. As a result of the content analysis, the range of dosage forms registered on the territory of Ukraine amounting to 13898 trade names has been determined. Solid dosage forms (tablets, capsules) account for 6617 trade names and occupy 60.35 % of the pharmaceutical market of Ukraine. When analyzing manufacturers of modern dosage forms it has been found that the ratio of capsules of foreign and domestic production is 2:1, where Indian dosageforms make up 18.54 %.
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Mustafa, Ayesha, and Anam Yasmeen. "ACCESS TO MEDICINE." International Journal of Pharmacy & Integrated Health Sciences 3, no. 2 (October 24, 2022): 118–21. http://dx.doi.org/10.56536/ijpihs.v3i2.34.
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Availability and access to the health care facility is a fundamental right of human, it is the timely used of services according to the needs. It is included in International treaties and is recognized by authorities and various Governments throughout the world. What does it means the access to medicine? According to WHO (World Health Organization) access to medicines is “having medicines continuously available and affordable at public or private health facilities or medicine outlets that are within one hour’s walk from the homes of the population”. The affordability and availability of medicines is directly related to the strength of health care system, but the high prices of the medicines, prevalence of Non-communicable diseases (diabetes, hypertension) and increasing demand of patients are the major obstacles in this regard. According to Forbes “at least 2 billion people don’t have access to medicines and 1 billion people live in extreme poverty (less than $1.25 per day) and 2.2 billion live on less than $2 per day which is quite disturbing situation”. The World Health Organization (WHO) analyzed the global production of pharmaceutical products and it was concluded that 15% of the world’s population consumes over 90% of them. And by World Health Organization it is also estimated that one-third of the developing world population is unable to receive or purchase essential medicine on a regular basis, especially those which are on high demand. The situation is even worst in the under-privileged countries like Africa and Asia, where approximately 50% of the total population does not have sufficient medicines access and healthcare resources and the remaining 50% are using medication incorrectly. However about 10 million lives a year could be saved out of which 4 million in Africa and South-East Asia alone, if we improve the availability, balanced distribution and rational use of medicines. The overall situation of global access to essential medicines is still considered critical. In the privileged countries the budget for healthcare facilities corresponds to 24-66% of National health expenses, which indicates that there is need to monitor the availability and affordability of medicines in these countries. National policies, economical cost of medicine and strategies of procurement are required to ensure the availability of medicines cost-effectively. The people with low income and in-equal health can’t afford costly services of healthcare system. The policies for the improvement of infrastructure, financing of medical system and the rational use of medicines are formulated and followed on primarily basis. And Governments need reliable information in order to evaluate the impact of policy implementation. In addition to the cost and availability of medicines, it is mandatory to assess the quality of use and various aspects, such as rational medicine use, adherence of patients and appropriate prescription practices. Thus the access to healthcare system can be made effective, by the assessment of practices in facilities like record reviews and National expert reports. That’s why we are providing healthcare facilities to each person with the help of balanced geographical distribution. The 2016 Index showed that there is moderate progress by the pharmaceutical industries to improve medicines access. Besides these Pharmaceutical industries should play their role to perk up the medicines access. There is not any particular strategy that suits all systems, but all systems need to promote the provision of new medicinal products, by ensuring medical advancement, improving communication barriers and affordable treatment. And a Reliable Health and Supply system must provide all aspects of health system like procurement, supply and regulation of the medicines.
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Fatokun, Omotayo. "Fostering local production of essential medicines in Nigeria." Bulletin of the World Health Organization 98, no. 7 (June 2, 2020): 507–8. http://dx.doi.org/10.2471/blt.19.249508.
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Rodríguez-Pombo, Lucía, Xiaoyan Xu, Alejandro Seijo-Rabina, Jun Jie Ong, Carmen Alvarez-Lorenzo, Carlos Rial, Daniel Nieto, Simon Gaisford, Abdul W. Basit, and Alvaro Goyanes. "Volumetric 3D printing for rapid production of medicines." Additive Manufacturing 52 (April 2022): 102673. http://dx.doi.org/10.1016/j.addma.2022.102673.
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Kalkman, Shona, Marlous Arentshorst, Jarno Hoekman, Wouter Boon, Esther Uijtendaal, Ghislaine van Thiel, and Ellen Moors. "In-Hospital Production of Medicines: Preparing for Disruption." Trends in Biotechnology 38, no. 10 (October 2020): 1045–47. http://dx.doi.org/10.1016/j.tibtech.2019.09.011.
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Mousavi Hosseini, Kamran, and Mehran Ghasemzadeh. "Implementation of Plasma Fractionation in Biological Medicines Production." Iranian Journal of Biotechnology 14, no. 4 (December 28, 2016): 213–20. http://dx.doi.org/10.15171/ijb.1401.
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Ryshchenko, Oksana, Dmytro Lytkin, Illya Podolsky, Alina Volkova, and Inna Vladymyrova. "Monitoring of indicators of physical availibility and socio-economic affordability of metformin hydrochloride medicines." ScienceRise: Pharmaceutical Science, no. 4 (38) (August 29, 2022): 36–43. http://dx.doi.org/10.15587/2519-4852.2022.263675.
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The aim of the study was to monitor the physical availability and socio-economic affordability of metformin hydrochloride medicines, which are used for the treatment of type II diabetes mellitus.
Materials and methods. Medical and technological documentation on the standardization of medical care for patients with type II diabetes, data from the State Register of Medicinal Products of Ukraine, software complex “Apteka” of the company “Morion” and data from the pharmaceutical market research analytical company “Pharmstandard” of the company “Morion” were used as research materials to determine indicators of physical availability and socio-economic affordability of metformin HCL medicines for the treatment of type II diabetes. Documentary, analytical methods, the method of marketing research and the method of logical summarization of data were used during the research.
Results. According to the results of the analysis of the medical and technological documentation on the standardization of medical care for diabetes mellitus (DM) type II and the State Register of Medicines of Ukraine, a number of characteristics were formed for Metformin HCL pharmaceuticals, namely: tablets or film-coated tablets in a dose of 500 mg, which are manufactured: Ukrainian manufacturers (full cycle of production); Ukrainian manufacturers of tablets in bulk (primary and secondary packaging) and foreign manufacturers. The specified characteristics became the basis for the further selection of several metformin HCL medicines in terms of determining their indicators of physical availability and socio-economic affordability. When determining the physical availability of metformin HCL medications, it was established that Ukrainian-made pharmaceuticals (full production cycle) are presented in the wholesale chain of the pharmaceutical market in full. According to the socio-economic indicator of the solvency adequacy of payment capacity, among the metformin HCL pharmaceuticals, the most economically justified are the Ukrainian-made pharmaceuticals, which are made from tablets in bulk according to the full production cycle. Only 1 medicine was singled out among foreign-made ones, which has the lowest indicator of solvency adequacy for various categories of the population.
Conclusions. Monitoring of indicators of physical availability and socio-economic affordability of metformin HCL medicines showed that the most economically justified for able-bodied people and people of retirement age is the use of the Ukrainian-made pharmaceuticals (full cycle and production from tablets in bulk) for the treatment of type II DM)
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Gachenko, R. A., and A. B. Goryachev. "MODERN REQUIREMENTS TO INDUSTRIAL PRODUCTION AND PHARMACEUTICAL MANUFACTURE OF INFUSION MEDICINAL PREPARATIONS IN THE RUSSIAN FEDERATION: SIMILARITIES AND DIFFERENCES." Pharmacy & Pharmacology 6, no. 3 (July 16, 2018): 214–28. http://dx.doi.org/10.19163/2307-9266-2018-6-3-214-228.
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The quantitative reduction of the manufacturing pharmaceutical organizations significantly lowers public accessibility to medicinal preparations manufactured by pharmacies. The aim of this research has is the analysis of the normative legal standards regulating the industrial production and the pharmaceutical manufacture of infusion medicinal preparations in the territory of the Russian Federation. Materials and methods: The research has been carried out by the analysis of the current legislative and normative acts by means of documentary observation and content analysis. Results and discussion. Hereby the review has been done of the main acts along with normativelegal documentation regulating the industrial production and the pharmaceutical manufacture of infusion medicines such as federal laws, regulations of the Government of the Russian Federation, the State Pharmacopeia (Editions XI and XIII), orders of the Ministry of Health of the Russian Federation, etc. It has been established that in the Russian Federation there has been developed and currently functioning the system of mandatory requirements to industrial production and quality control of infusion medicinal preparations produced by manufacturing enterprises. At the same time, despite the restrictions on the pharmaceutical manufacture of the aseptic medicines registered in the Russian Federation, the pharmaceutical organizations implement manufacture of the medicines which are not produced industrially. That makes it possible to provide an individual dosage of ingredients and take into account patients’ individual characteristics. The normative legal regulation system for the pharmaceutical manufacture significantly differs from the similar system for the industrial production. The scientific discussion on the implementation of the international Rules of Good Manufacturing Practices (GMP) into pharmaceutical activities has not arrived at a unanimous organizational and technological opinion because of essentially different purposes, a diverse range of the undertaken tasks and dissimilar economic opportunities of pharmaceutical organizations and manufacturing enterprises. Conclusion: The currently existing normative legal regulation system for the industrial production and the pharmaceutical manufacture of infusion medicines in the Russian Federation is aimed at providing the national health services’ needs of necessary remedies for infusion therapy. At the same time, the pharmaceutical manufacture does not oppose the industrial production, but quite the contrary, expands public accessibility to such preparations for treatment in emergency or urgent cases and also during routine treatment of patients.
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Hill, Andrew M., Melissa J. Barber, and Dzintars Gotham. "Estimated costs of production and potential prices for the WHO Essential Medicines List." BMJ Global Health 3, no. 1 (January 2018): e000571. http://dx.doi.org/10.1136/bmjgh-2017-000571.
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IntroductionThere are persistent gaps in access to affordable medicines. The WHO Model List of Essential Medicines (EML) includes medicines considered necessary for functional health systems.MethodsA generic price estimation formula was developed by reviewing published analyses of cost of production for medicines and assuming manufacture in India, which included costs of formulation, packaging, taxation and a 10% profit margin. Data on per-kilogram prices of active pharmaceutical ingredient exported from India were retrieved from an online database. Estimated prices were compared with the lowest globally available prices for HIV/AIDS, tuberculosis (TB) and malaria medicines, and current prices in the UK, South Africa and India.ResultsThe estimation formula had good predictive accuracy for HIV/AIDS, TB and malaria medicines. Estimated generic prices ranged from US$0.01 to US$1.45 per unit, with most in the lower end of this range. Lowest available prices were greater than estimated generic prices for 214/277 (77%) comparable items in the UK, 142/212 (67%) in South Africa and 118/298 (40%) in India. Lowest available prices were more than three times above estimated generic price for 47% of cases compared in the UK and 22% in South Africa.ConclusionA wide range of medicines in the EML can be profitably manufactured at very low cost. Most EML medicines are sold in the UK and South Africa at prices significantly higher than those estimated from production costs. Generic price estimation and international price comparisons could empower government price negotiations and support cost-effectiveness calculations.
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Hasnida, Amalia, Maarten Olivier Kok, and Elizabeth Pisani. "Challenges in maintaining medicine quality while aiming for universal health coverage: a qualitative analysis from Indonesia." BMJ Global Health 6, Suppl 3 (May 2021): e003663. http://dx.doi.org/10.1136/bmjgh-2020-003663.
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IntroductionIndonesia, the world’s fourth most populous nation, is close to achieving universal health coverage (UHC). A widely-publicised falsified vaccine case in 2016, coupled with a significant financial deficit in the national insurance system, has contributed to concern that the rapid scale-up of UHC might undermine medicine quality. We investigated the political and economic factors that drive production and trade of poor-quality medicines in Indonesia.MethodsWe reviewed academic publications, government regulations, technical agency documents and news reports to develop a semi-structured questionnaire. We interviewed healthcare providers, policy-makers, medicine regulators, pharmaceutical manufacturers, patients and academics (n=31). We included those with in-depth knowledge about the falsified vaccine case or the pharmaceutical business, medicine regulation, prescribing practice and the implementation of UHC. We coded data using NVivo software and analysed by constant comparative method.ResultsThe scale-up of UHC has cut revenues for physicians and pharmaceutical manufacturers. In the vaccine case, free, quality-assured vaccines were available but some physicians, seeking extra revenue, promoted expensive alternatives. Taking advantage of poor governance in private hospitals, they purchased cut-price ‘vaccines’ from freelance salespeople.A single-winner public procurement system which does not explicitly consider quality has slashed the price paid for covered medicines. Trade, industrial and religious policies simultaneously increased production costs, pressuring profit margins for manufacturers and distributors. They reacted by cutting costs (potentially threatening quality) or by market withdrawal (leading to shortages which provide a market for falsifiers). Shortages and physician-promoted irrational demand push patients to buy medicines in unregulated channels, increasing exposure to falsified medicines.ConclusionMarket factors, including political pressure to reduce medicine prices and healthcare provider incentives, can drive markets for substandard and falsified medicines. To protect progress towards UHC, policy-makers must consider the potential impact on medicine quality when formulating rules governing health financing, procurement, taxation and industry.
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Sakaguchi, Tatsuma, Tetsuya Okuyama, Masaya Kotsuka, Terufumi Yoshida, Tadayoshi Okumura, Mikio Nishizawa, Masaki Kaibori, and Mitsugu Sekimoto. "Hepatoprotective and anti-inflammatory profile of sokeikakketsuto and makyoyokukanto in primary cultured rat hepatocytes." Functional Foods in Health and Disease 12, no. 2 (February 15, 2022): 81. http://dx.doi.org/10.31989/ffhd.v12i2.887.
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Background: Sokeikakketsuto (SOK) is a Kampo medicine that can mitigate several types of pain, including arthralgia, neuralgia, low back pain, and myalgia, which may be introduced for the treatment of neuropathic pain in anti-cancer therapy. Considering that several Kampo medicines are known to have hepatoprotective and anti-inflammatory effects, we investigated the pharmacological mechanism of SOK in hepatocytes. Additionally, we examined another Kampo medicine, makyoyokukanto (MAK), as a reference as it has been reported to have similar efficacy for neuropathic pain.Methods: SOK or MAK was incubated with rat primary cultured hepatocytes treated with interleukin (IL)-1β. The induction of inducible nitric oxide synthase (iNOS), nitric oxide (NO) production, iNOS signaling pathways, and the expression of other inflammatory mediators was investigated.Results: IL-1β activated iNOS induction, followed by NO production. SOK and MAK reduced the expression of iNOS mRNA and its protein and decreased NO production. SOK and MAK also decreased the levels of tumor necrosis factor (TNF)-α and increased the levels of IL-6 and IL-1β. Transfection experiments with iNOS promoter-luciferase constructs revealed that MAK reduced iNOS mRNA synthesis and stability; however, SOK only reduced mRNA synthesis. Both medicines suppressed the activation of nuclear factor (NF)-κB but did not block the upregulation of type I IL-1 receptor in two essential signaling pathways.Conclusions: SOK and MAK could prevent NO production by inhibiting iNOS gene expression, partly through NF-κB activation, in inflamed hepatocytes. However, both medicines may have different mechanisms of action in the treatment of injured organs.
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Nemchenko, A. S., К. О. Тsareva, and V. M. Khomenko. "Analysis of the current state and problems of pharmacy production of medicines in UKRAINE." Farmatsevtychnyi zhurnal, no. 3 (July 9, 2020): 29–38. http://dx.doi.org/10.32352/0367-3057.3.20.03.
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The current state of providing of the population of Ukraine with extemporaneous drugs produced in pharmacies is one of the most acute social problems of the healthcare system and pharmacy. In this regard, the analysis and determination of the directions for solving of the existing problems of pharmacies’ production activities, as well as the development of approaches to increase the availability of extemporaneous medicines for the population are of particular relevance. The aim of the work is an analysis of the current state and problems of the extemporaneous drugs’ production using a questionnaire of pharmaceutical workers in production pharmacies in Ukraine.
The object of the study have been scientific publications, as well as the study of the opinions of pharmaceutical workers in production pharmacies for the compounding (production) of extemporaneous drugs. The studies were carried out by using questionnaire survey method, systematization and generalization methods.
Conducted nationwide questionnaire of the heads of pharmacy establishments and pharmacy specialists has been showed that over the past decade there has been a tendency to enlarge pharmacy production of medicines: if in 2010 biggest part of production pharmacies (85.50%) had small volumes of production - up to 20 thousand units, now about a third part – 29.63%, are pharmacies with significant production volumes, namely from 100 to 500 thousand production units (24.07%). An analysis of the profitability of production pharmacies has made it possible to determine that the main part of them is profitable (57.14%), but has certain problems. It has been established that the reason for this condition is an untimely revision of tariffs for the production of medicines – only a third part of pharmacies do this once a year. At the same time, the situation has not changed over the past ten years, while 95% of production pharmacies looked at tariffs no more than once every 3 years. According to the results of the study, the main problems of pharmaceutical manufacturing of medicines were identified, namely: high VAT rate (60.71%), complicated licensing conditions (55.36%) and lack of registration for substances (46.43%). It was also suggested a set of measures and outlined the priority areas for reforming the system of providing the population with extemporaneous medicines.
According to the results of the nationwide questionnaire of the heads of pharmacy establishments and pharmacy specialists of production pharmacies, the main trends of establishments have been established, namely the enlargement of pharmacy production of medicines, the low profitability of such pharmacies due to untimely revision of tariffs for the production of medicines, as well as the sales leaders - a group of dermatological and anti-allergic extemporaneous medicines. The study has also identified the current problems of pharmacy production, priorities in reforming the providing of extemporaneous medicines to the population, and a set of approaches to increase their availability.
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Adams, Vincanne, and Sienna Craig. "Global Pharma in the Land of Snows: Tibetan Medicines, SARS, and Identity Politics Across Nations." Asian Medicine 4, no. 1 (2008): 1–28. http://dx.doi.org/10.1163/157342108x381205.
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AbstractThis article takes as its starting point the outbreak of the SARS epidemic in 2002–2003 in the People's Republic of China (PRC) to ask pertinent questions about the politics of identity in the Tibet Autonomous Region (TAR), and to connect these issues to the circulation of, as well as the social and economic value placed on, Tibetan medicines within China and abroad. We aim to connect the global pharmaceutical industry—including the ways it shapes science, disseminates knowledge, increases market demand, and influences clinical and social practice—to the production of Tibetan identities. We discuss dramatic increases in the production and sale of Tibetan medicinal products, specifically protective amulets, 'precious pills', and incense, during a particularly traumatic and widely publicised public health crisis in the PRC. These products clearly demand that we rethink the category 'medicine'. The popularity of these products during the SARS epidemic also points to the complicated positions of Tibetans and Tibetan cultural forms within contemporary China. What was it about these products that gave rise to the perception among Chinese and Tibetans alike they could 'save' or 'protect' people from contracting SARS. In more general terms, we ask if this exponential growth of the Tibetan medical industry in China—heightened during the SARS epidemic, but continuing apace since then—is allowing for cultural expression that highlights Tibetan uniqueness difference within otherwise contested social and political arenas. Or, is the global pharmaceutical industry in China in the process of encompassing and reformulating Tibetan medicine? Finally, we explore connections and distinctions between the rise in highly marketed Tibetan medicinals in China and their availability and appeal in the West.
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Liu, Fengyi, and Shenghui Chen. "Political economy analysis of the properties of doctors' labour and medicines." China Political Economy 3, no. 1 (June 1, 2020): 75–91. http://dx.doi.org/10.1108/cpe-05-2020-0003.
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PurposeDoctors' labour and medicines are special necessities for human survival and evolution. Since China launched the healthcare reform, the theoretical circles' discussions have not yet clarified the respective special properties of doctors' labour and medicines as goods and the internal relations between doctors' labour and medicines at the level of the theoretical basis.Design/methodology/approachHealth is a prerequisite for people's all-round development, a precondition for economic and social development and the people's common aspiration. The all-round moderately prosperous society could not be achieved without people's all-round health.FindingsThe authors believe the socialist relation between doctors' labour and medicines with Chinese characteristics should be one that is people-oriented, and the corporatization of hospitals or the capitalization of doctors' labour should be avoided.Originality/valueIn this paper, the authors explore the particularity of doctors' labour, particularity of medicine production, circulation, consumption and the internal relations between doctors' labour and medicines by using the analytical approach of Marxist political economy while considering the special roles of doctor's labour and medicines in the reproduction of labour power and put forward the theoretical basis for the segregation of doctor's labour and medicines.
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Rustam, Kuswadi. "ANALISIS PENGEMBANGAN DAN KELAYAKAN USAHA OBAT TRADISIONAL JAMU MASYARAKAT KABUPATEN KULONPROGO." Kajian Ekonomi dan Bisnis 17, no. 1 (June 15, 2022): 75–90. http://dx.doi.org/10.51277/keb.v17i1.119.
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On the economic side, the herbal medicine industry has contributed greatly to national income, increasing people’s welfare and providing employment opportunities. Approximately 99% of herbal ingredients are domestic products and are considered capable of bringing a significant multiplier effect in economic growth in Indonesia, starting from the upstream sector (agriculture) to the downstream sector which includes industry and trade. However, along with the incessant variety of medicines (pharmaceuticals and imported herbal medicines) that are circulating and appear to be attractive to the public, it is not impossible that the demand for herbal medicines as traditional medicines in the last five years has tended to decline. Considering that herbal medicine is a product of the nation’s cultural heritage and has contributed greatly to the creation of domestic workers, the herbal medicine industry, which incidentally is a small and medium industry, must continue to exist amid increasingly fierce competition. Kulonprogo Regency has quite a number of diverse herbal and traditional medicinal plants businesses, most of which are classified as UMKM.. In general, the business diversity is divided into four types of businesses, namely, (1). Liquid herbal medicine business; (2). Herbal medicine business; (3). Herbal dipping business; and (4). Business of herbal tablets/capsules. In order to survive, they need to find some business strategy development to remain viable and profitable. Based on these problems, it is necessary to research the Feasibility and Development Analysis of the Traditional Herbal Medicine Business of the Kulonprogo Regency, with the aim of finding several development strategies and business feasibility. The sample was randomly selected as many as 30 traditional herbal medicine business actors in Kulonprogo Regency. Through the results of the SWOT analysis, there are several business strategies, including (1). Increasing the scale of production and business scale, (2). Following the development of market trends, (3). Marketing innovation and market expansion. (4). Development of licensing legality (certification), such as the legality of an official distribution permit, and being under the guidance of the health office/BPOM. Meanwhile, based on the business feasibility analysis using the Payback Periode (PP) and Benefit Cost Ratio (B/C) method, the liquid herbal medicine business, the brewed herbal medicine business, the dipping herbal medicine business, and the herbal tablet business, capsules are feasible
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Dwinta, Eliza, Ajie Kusuma, Baniady Gennody Pronosokodewa, and Raden Jaka Sarwadhamana. "Fuzzy Logic of Work Conformity in Small Enterprises of Traditional Medicines." EKSAKTA: Journal of Sciences and Data Analysis 2, no. 1 (December 14, 2020): 1–10. http://dx.doi.org/10.20885/eksakta.vol2.iss1.art1.
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Good Manufacturing Practices for Traditional Medicine (CPOTB) certification given by National Food and Drug Agency (BPOM) to Small Enterprises of Traditional Medicines (UKOT) is a claim from the production process of traditional medicines that is in accordance with CPOTB. However, not all human resources at UKOT understand and apply existing guidelines in the work practices of traditional medicine production. This study aims to assess the conformity of work by calculating the gap between knowledge of work practices in human resources in one UKOT Yogyakarta with fuzzy method. This assessment is a quantitative, cross-sectional study using a questionnaire that was adapted and modified from six categories of cause and effect. Respondents included in this study were all human resources in UKOT as many as 24 people (total sampling). The results obtained from the gap calculation of work conformity based on the six categories are machinery that have positive values (0,1146). Human resources who work at UKOT have a good understanding of the CPOTB and are already good at implementing work practices in accordance with the CPOTB in the machinery category. The findings that personnel pass through the production area, storage area and quality control area, as well as analysis methods that have not been validated periodically, can be used as an ingredient for improvement by implementing corrective-action-preventive-action on order to improve the quality of work in accordance with CPOTB and guarantee the quality of traditional medicine products from the UKOT Yogyakarta.
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Shen, Liang, and Yu Yan Wang. "The Limit Price Strategy Analysis of Integrated Medicine Supply Chain Based on Government Regulation." Applied Mechanics and Materials 397-400 (September 2013): 2553–56. http://dx.doi.org/10.4028/www.scientific.net/amm.397-400.2553.
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Considering the integrated medicine supply chain, and introducing the government limit pricing and subsidy mechanism, the pricing strategy of integrated medicine supply chain was studied in this paper. And the optimal strategy in the face of market fluctuations caused by unconventional emergencies based on government regulation was given. The study shows that, under different subsidy levels, the optimal production volume, retail price and profit of the supply chain are related to production cost, market size, government regulation and government subsidy; governments limit price regulation on medicines is welfare for both consumers and retailers, and it is favorable for medicine supply chains normal development.
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Blynskaya, E. V., S. V. Tishkov, K. V. Alekseev, V. V. Bueva, and A. A. Ivanov. "SPECIAL ASPECTS OF THE TECHNOLOGY OF MEDICATED CHEWING GUM PRODUCTION." Russian Journal of Biotherapy 19, no. 3 (October 13, 2020): 21–28. http://dx.doi.org/10.17650/1726-9784-2020-19-3-21-28.
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Chewing gum medicines are solid dosage forms intended for chewing for a certain period of time without subsequent ingestion to provide local and systemic effects. This article describes the basic technologies for producing chewing gum medicinal products, analyzes and compares the technological aspects of production. In addition, the advantages and disadvantages of the various technologies used, the features of the use in pharmaceutical technology, as well as additional technological methods for creating modifications of the release of drugs from chewing gum medicinal gums are given. It is concluded that the application of various technologies for the production of chewing gums and the methods for improving individual stages of the process are promising.
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Protsenko, Valentyna M. "The Current Priorities of the Formation of the Pharmaceutical Market of Ukraine in the Context of Ensuring the Quality of Medicinal Products." Business Inform 12, no. 539 (2022): 79–86. http://dx.doi.org/10.32983/2222-4459-2022-12-79-86.
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The article studies the current state of the pharmaceutical market of Ukraine in the context of ensuring the quality of medicinal products and preventing the spread of falsified medicinal products. It is found that according to the State Register of Medicinal Products of Ukraine, 13.664 drugs were registered in October 2020. It is further found that today in the structure of the assortment of medicines in the pharmaceutical market of Ukraine, foreign drugs make up more than 70%, and in certain classification groups they reach 90%. It is determined that the main importers of medicines to Ukraine are Germany, India, France, Italy, Slovenia and Hungary. It is specified that Ukraine practically does not have its own production of active pharmaceutical ingredients (APIs), about 80% of APIs is imported from China and India, therefore distributors are mainly responsible for the quality of APIs. It is found that in the period from 2000 to 2020, the State Drug Inspectorate annually detected and removed from circulation circa 4–117 series and 3–63 names of falsified medicinal products. It is determined that the counterfeiting and underground production of falsified medicinal products in 2017–2020 on the territory of Ukraine were detected both by the State Medical Service and law enforcement agencies. It is further determined that in 2017 the State Medical Service issued 18 orders prohibiting the circulation of falsified medicinal products, in 2018 – 11 respective prohibiting orders, in 2019 – 21, and in 2020 – 4 respective prohibiting orders. It is specified that over the past 10 years there has been a steady trend towards an increase in the number of falsified medicinal products in the pharmaceutical market of Ukraine. The main factors stimulating the circulation of falsified medicinal products have been established: the unstable economic situation in Ukraine; a developed system of online sales of medicines; the shortage of medicines creates the possibility of distribution of falsified medicines; high drug prices when compared with the average paying capacity of the population, as well as a large difference in market prices, which stimulates the sale of a cheaper counterfeit drug.
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Prokopov, I. A., E. L. Kovaleva, E. D. Minaeva, and A. D. Avtushenko. "Impurities in Animal-Derived Medicines (Relevant Issues)." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation 12, no. 3 (September 7, 2022): 277–87. http://dx.doi.org/10.30895/1991-2919-2022-12-3-277-287.
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The global anthropogenic load on the biosphere results in a potentially unmanageable problem of ecosystem pollution with organic and inorganic impurities, which may carry significant risks for human health. Therefore, the development and production of medicinal products from raw materials of animal origin require a careful risk-based assessment of impurities that may be found in the finished product. The aim of the study was to categorise the impurities in animal-derived medicines, identify and characterise specific impurity groups, and suggest a control methodology. The article reviews the factors that allow grouping impurities in animal-derived medicines, namely, the origin (anthropogenic or natural), type (process- or raw material-related), nature (product-related or foreign), and presence (inherent or potential impurities). The authors note the necessity of considering the specific production conditions, the origin of raw materials, and the intended use of medicinal products to determine an optimal control strategy for each impurity group and to justify the level at which a specific impurity should be controlled (the raw material, active substance, or finished product). A product’s marketing authorisation application must contain comprehensive data on the choice of the control strategy for potential impurities, including a justification of the selected control level and the established limits, details of the chosen control procedures, and risk-assessment reports.