{"title":"COUNTERFEIT AND ILLEGAL MEDICINAL PRODUCTS AS AN EXAMPLE OF DRUGS THAT DO NOT MEET THE BASIC QUAITY REQUIREMENTS","authors":"Agnieszka Kalicka, Natalia Tarłowska","doi":"10.56782/pps.164","DOIUrl":"https://doi.org/10.56782/pps.164","url":null,"abstract":"Falsification or counterfeiting of medicinal products is a severe pharmaceutical crime. According to the World Health Organization, about 10% of medicinal products in developing countries are falsified. In the case of medicines sold over the Internet, the figure is as high as 50%, and this phenomenon's scale is increasing yearly. The illegally sourced preparations are not manufactured in accordance with Good Manufacturing Practice (GMP). Among the most frequently falsified medicinal products are preparations used for erectile dysfunction, weight loss aids, or anabolic-androgenic steroids. The presence of undeclared active ingredients and impurities, incorrect dosage due to different than declared contents, and the sourcing of over-the-counter medicines from unknown sources can lead to serious side effects that threaten patients' lives and health. In addition, inaccurate or incomplete descriptions of product formulation can additionally cause the risk of drug interactions, which can consequently lead to serious medical incidents.
 The purpose of this paper is to discuss the requirements for medicinal products and to present the problem of the quality of counterfeit and illegal medicinal products. This issue is discussed using phosphodiesterase type 5 inhibitors (applied to the treatment of erectile dysfunction) as an example.
 KEYWORDS: falsified medicinal products, quality of medicinal products, PDE-5 inhibitors","PeriodicalId":295830,"journal":{"name":"Prospects in Pharmaceutical Sciences","volume":"39 12","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134971590","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}
Falah Saleh Mohammed, Imran Uysal, Hasan Hüseyin Yaz, Mustafa Sevindik
{"title":"Papaver species: usage areas, essential oil, nutrient and elements contents, biological activities","authors":"Falah Saleh Mohammed, Imran Uysal, Hasan Hüseyin Yaz, Mustafa Sevindik","doi":"10.56782/pps.142","DOIUrl":"https://doi.org/10.56782/pps.142","url":null,"abstract":"In this study, the utilisation areas, general characteristics, biological activities, mineral and nutrient contents, and chemical compositions of Papaver species were compiled based on literature data. The research findings indicate that Papaver species are consumed either directly or in conjunction with other food products. Furthermore, it has been determined that the Papaver plant material contains significant amounts of essential nutrients and minerals. Additionally, it has been determined that Papaver species may serve as a natural source of antioxidant, antimicrobial, and anticancer compounds. It has been observed that the compounds reported in Papaver species may be an important source of many biological activities. As a result, it has been determined that Papaver species could be a significant natural resource.","PeriodicalId":295830,"journal":{"name":"Prospects in Pharmaceutical Sciences","volume":"19 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135043588","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}
Małgorzata Krzyżanowska, Katarzyna Kozon, Jakub Olszewski, Andrzej Patyra
{"title":"Efficacy of satralizumab therapy in the treatment of NMOSD","authors":"Małgorzata Krzyżanowska, Katarzyna Kozon, Jakub Olszewski, Andrzej Patyra","doi":"10.56782/pps.166","DOIUrl":"https://doi.org/10.56782/pps.166","url":null,"abstract":"Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune disease of the central nervous system and is associated with the presence of autoantibodies to anti–aquaporin-4 (AQP4-IgG). Interleukin-6 plays a key role in the pathogenesis of this disorder. Satralizumab, a humanized monoclonal antibody, targets the interleukin-6 receptor thus affects the course of the disease. In Poland, satralizumab treatment has been offered free of charge by the public health service since November 2021. The results of SAkura studies demonstrate the long terms efficacy of satralizumab and provide evidence that satralizumab reduces the risk of relapse in patients with aquaporin-4-immunoglobulin G (IgG)–seropositive (AQP4-IgG+) NMOSD.","PeriodicalId":295830,"journal":{"name":"Prospects in Pharmaceutical Sciences","volume":"74 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136098787","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}
Elżbieta Gniazdowska, Edyta Gilant, Katarzyna Buś-Kwaśnik
{"title":"ICH M10 guideline - a harmonized global approach to bioanalysis","authors":"Elżbieta Gniazdowska, Edyta Gilant, Katarzyna Buś-Kwaśnik","doi":"10.56782/pps.152","DOIUrl":"https://doi.org/10.56782/pps.152","url":null,"abstract":"Bioanalytical methods are used in research on small-molecule and large-molecule drug products to determine analytes and their metabolites in biological matrices such as blood, plasma, serum, urine, feces, saliva, other biological fluids, or tissues. Validation of a bioanalytical method is the essential step before the implementation of the method into routine use in toxicokinetic or pharmacokinetic studies. Harmonization of recommendations for the validation of bioanalytical methods has been advocated for many years. In 2022, The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) finished the work on final version of the ICH M10 guideline, as a combination of four regional guidelines (American, European, Brazilian and Japanise). The document uniforms rules for the performance of the bioanalytical method validation and documentation of sample analysis from clinical and non-clinical studies in most countries around the world, which are submitted to registration authorities.","PeriodicalId":295830,"journal":{"name":"Prospects in Pharmaceutical Sciences","volume":"54 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136098786","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}
Falah Saleh Mohammed, Mustafa Sevindik, İmran Uysal, Ali Erdem Sabik
{"title":"Quercetin: derivatives, biosynthesis, biological activity, pharmacological and therapeutic effects","authors":"Falah Saleh Mohammed, Mustafa Sevindik, İmran Uysal, Ali Erdem Sabik","doi":"10.56782/pps.147","DOIUrl":"https://doi.org/10.56782/pps.147","url":null,"abstract":"In this review, the general properties, derivatives and biosynthesis, pharmacological and therapeutic effects, and biological activities of quercetin were examined to shed light on future studies. The literature search has revealed that the effects of quercetin, which is formed from different substrates, also vary. It has been observed that quercetin can be used in the treatment of diseases such as allergy, prostate, arthritis, neurodegenerative diseases, diabetes mellitus, osteoporosis, asthma and hypertension. In addition, it has been observed that quercetin has biological activities such as anticancer, antioxidant, and antimicrobial activities. In the literature, there is no detailed information about daily intakes and doses for human use. In this context, it is thought that quercetin may be an important compound in in vivo and in vitro studies due to its different pharmacological and biological potentials.","PeriodicalId":295830,"journal":{"name":"Prospects in Pharmaceutical Sciences","volume":"73 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136363185","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}
{"title":"Autism: plants with neuro-psychopharmacotherapeutic potential","authors":"M. Sevindik, F. Mohammed, I. Uysal","doi":"10.56782/pps.143","DOIUrl":"https://doi.org/10.56782/pps.143","url":null,"abstract":"In recent years, there has been an increasing prevalence of cases of autism. There is no general cure for autism; however, there are situational treatments available. In this context, plants may be beneficial in suppressing the conditions that may arise in the disease. This study compiles plant species that have been reported in the literature as potential remedies for autism disorders. Furthermore, the general characteristics, usage areas, and biological activities of these plant species have been compiled. As a result of our research, it has been seen that plants can be used to combat many symptoms of autism. It is believed that plants may contribute to the improvement of the well-being of individuals with autism, as a result.","PeriodicalId":295830,"journal":{"name":"Prospects in Pharmaceutical Sciences","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134032017","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}
{"title":"Twenty years of Prospects in Pharmaceutical Sciences: recent changes","authors":"Andrzej Patyra","doi":"10.56782/pps.162","DOIUrl":"https://doi.org/10.56782/pps.162","url":null,"abstract":"Prospects in Pharmaceutical Sciences (fka. Bulletin of the Faculty of Pharmacy of the Medical University of Warsaw) is an open access scientific journal, published since 2003 as a quarterly by the Medical University of Warsaw. Prospects in Pharmaceutical Sciences offers immediate Open Access to its publications, permitting any user to read, download, copy, distribute, print, search, or link to the full texts of articles, crawl them for indexing, pass them as data to software, or use them for any other lawful purpose, free of any charge. The journal does not charge authors fees for submission, editorial process, APC or any other fees. Prospects in Pharmaceutical Sciences is free for both authors and readers. This year we mark its 20th anniversary. Here we present recent changes in the official Journal of the Faculty of Pharmacy of the Medical University of Warsaw.","PeriodicalId":295830,"journal":{"name":"Prospects in Pharmaceutical Sciences","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115304909","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}
Falah Saleh Mohammed, Imran Uysal, Mustafa Sevindik
{"title":"Functıonal food Momordıca charantıa: bıologıcal actıvıtıes","authors":"Falah Saleh Mohammed, Imran Uysal, Mustafa Sevindik","doi":"10.56782/pps.138","DOIUrl":"https://doi.org/10.56782/pps.138","url":null,"abstract":"Complementary medicine history includes a lot of knowledge based on human history. In this context, different plant species are used in the treatment and prevention of diseases. Plants are important natural productsthat attract attention with their nutritive and non-nutritive compounds. They contain many bioactive compounds that are not particularly nutritious but very important from a medical point of view. In our study, the biological activities of Momordica charantia reported in the literature were compiled. In addition, mineral, nutrient and chemical contents reported in the literature were compiled. The fruits of M. charantia are known as bitter gourd. In different parts of the world, it is used for many purposes as salad, direct food product, dried and spiced. It is used locally for different purposes in different countries. It is used as a supplement or sweetener in many foods, especially in East Asian countries. In our study, in addition to the nutritional properties of the plant, its medicinal properties were emphasized. As a result of the research, it was determined that the plant has many biological activities such as antioxidant, antimicrobial, antiinflammatory, antihyperglycemic, antiulcer, DNA protective, cytotoxic, anthelmintic, antiepimastigote, antiviral, immunomodulative, radioprotective, hepatoprotective, antidiabetes, antitumor, antiproliferative, antistress, hypoglycaemic, antimutagenic, or antiaging. In addition, it stands out with its nutritional properties. It is thought that it may be a natural source for the compounds reported in the literature data. Based on these studies, it is thought that Momordica charantia may be an important natural agent.","PeriodicalId":295830,"journal":{"name":"Prospects in Pharmaceutical Sciences","volume":"113 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124338018","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}
{"title":"Overview of cyclodextrins and medicinal products containing cyclodextrins currently registered in Poland","authors":"Ewa Napiórkowska","doi":"10.56782/pps.161","DOIUrl":"https://doi.org/10.56782/pps.161","url":null,"abstract":"Cyklodekstryny należą do cyklicznych oligosacharydów o unikalnych zdolnościach do tworzenia niekowalencyjnych kompleksów inkluzyjnych typu gospodarz-gość z wieloma cząsteczkami o właściwościach hydrofobowych, w tym także lekami. W efekcie mogą poprawiać rozpuszczalność wiązanych cząsteczek, a także zwiększać ich stabilność. Liczne zastosowania cyklodekstryn, m.in. w produkcji żywności, przemyśle kosmetycznym oraz naukach farmaceutycznych, świadczą o ich uniwersalności. Przeanalizowanie potencjału cyklodekstryn w naukach farmaceutycznych stwarza nowe możliwości poprawy właściwości fizykochemicznych leków, tworzenia nowych formulacji, projektowania systemów dostarczania leków, a także rozwoju innowacyjnych metod leczenia. Celem pracy było zebranie najważniejszych aspektów dotyczących cyklodekstryn, w tym ich budowy, sposobu tworzenia kompleksów inkluzyjnych, zastosowania w przemyśle farmaceutycznym, a także bezpieczeństwa stosowania cyklodekstryn. Artykuł obejmuje także przegląd dostępnych produktów leczniczych zarejestrowanych w Polsce zawierających w swoim składzie cyklodekstryny, wraz ze wskazaniami do ich stosowania oraz podaniem postaci farmaceutycznych. Różnorodność dostępnych produktów leczniczych podkreśla potencjał wykorzystania cyklodekstryn w projektowaniu nowych leków.","PeriodicalId":295830,"journal":{"name":"Prospects in Pharmaceutical Sciences","volume":"65 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127249863","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}
{"title":"Thiamine: overview of history of discovery, mechanism of action, role and deficiency","authors":"E. Napiórkowska","doi":"10.56782/pps.159","DOIUrl":"https://doi.org/10.56782/pps.159","url":null,"abstract":"Thiamine is the first water-soluble vitamin to be discovered that acts as a cofactor of several important enzymes. Vitamin B1 plays an essential role in obtaining energy in carbohydrates metabolism and substrates production which are further used as neurotransmitters, nucleic acids, and coenzymes. The aim of this work was to give a summary of various aspects related to thiamine including a rich history of the discovery, synthesis, role in human organism, mechanism of action and also the consequences of its insufficient intake leading to beriberi disease. The study takes into consideration pharmaceutical aspects like main sources of vitamin B1, its absorption, nutrient recommendations, interaction with drugs and the variety of formulations available in treating its deficiency. Understanding the role of vitamin B1 in cellular metabolism shows its significance in maintaining health and emphasizes the importance of ensuring adequate dietary intake to maintain the proper functioning of the nervous and cardiovascular systems. Although thiamine deficiency is less common in developed countries, it can be still observed due to poor diet intake, alcoholism, and certain medical conditions which reduce absorption, e.g. celiac disease. Overall, all mentioned aspects make the problem of its deficiency still present and important. Performing an overview of various aspects related to thiamine deficiency can help to properly diagnose or even to prevent an insufficient intake of vitamin B1 among patients with specific medical conditions.","PeriodicalId":295830,"journal":{"name":"Prospects in Pharmaceutical Sciences","volume":"226 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116603459","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}