Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.184
M. Malinao, Morgen Kramer, Chad Elchman, B. Rivera, S. Orlowicz, Helko Behr
{"title":"Analytical Comparison of Infliximab and Related Biosimilars","authors":"M. Malinao, Morgen Kramer, Chad Elchman, B. Rivera, S. Orlowicz, Helko Behr","doi":"10.33892/aph.2021.91.184","DOIUrl":"https://doi.org/10.33892/aph.2021.91.184","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78054107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.330-331
Dávid Virág, T. Kremmer, Zsófia Huba, Adina Borbély, Gitta Schlosser, B. Dalmadi Kiss, I. Antal, I. Klebovich, K. Ludányi
{"title":"A HILIC-MS/MS Method for the Structural Analysis of Human Alpha-1-Acid Glycoprotein","authors":"Dávid Virág, T. Kremmer, Zsófia Huba, Adina Borbély, Gitta Schlosser, B. Dalmadi Kiss, I. Antal, I. Klebovich, K. Ludányi","doi":"10.33892/aph.2021.91.330-331","DOIUrl":"https://doi.org/10.33892/aph.2021.91.330-331","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88245746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.260-261
Arle Kõrkjas, Ivo Laidmäe, Karin Kogermann, A. Salmi, H. Nieminen, E. Hæggström, J. Heinämäki
to generate nanofibrous
生成纳米纤维
{"title":"Application of Automated Ultrasound Signal Generator in the Development of Electrospun Multi-Layered Polymeric Nanofibrous Structures","authors":"Arle Kõrkjas, Ivo Laidmäe, Karin Kogermann, A. Salmi, H. Nieminen, E. Hæggström, J. Heinämäki","doi":"10.33892/aph.2021.91.260-261","DOIUrl":"https://doi.org/10.33892/aph.2021.91.260-261","url":null,"abstract":"to generate nanofibrous","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"70 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86251008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.226-227
R. Góra, M. Hutta, Erik Beňo
{"title":"Determination of Amino Sugars in Blood Serum Samples by RP-HPLC Method","authors":"R. Góra, M. Hutta, Erik Beňo","doi":"10.33892/aph.2021.91.226-227","DOIUrl":"https://doi.org/10.33892/aph.2021.91.226-227","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"19 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91474652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.308-309
U. Musazzi, Domenico Di Giorgio, P. Minghetti
{"title":"Insights for a Risk-Assessment Tool to Manage Medicines’ Shortages","authors":"U. Musazzi, Domenico Di Giorgio, P. Minghetti","doi":"10.33892/aph.2021.91.308-309","DOIUrl":"https://doi.org/10.33892/aph.2021.91.308-309","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"269 1-4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91509029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.306-307
F. Selmin, L. Camuffo, Francesca Vasile, Greta Mangoni, Mariantonietta Piccoli, M. Rivano, L. Cancanelli, P. Minghetti
{"title":"Evaluation of a Pneumatic Tube System for Delivering Nivolumab Diluted Solutions","authors":"F. Selmin, L. Camuffo, Francesca Vasile, Greta Mangoni, Mariantonietta Piccoli, M. Rivano, L. Cancanelli, P. Minghetti","doi":"10.33892/aph.2021.91.306-307","DOIUrl":"https://doi.org/10.33892/aph.2021.91.306-307","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83225945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.287-289
Alaa Alghananim, Y. Özalp, B. Mesut, Y. Özsoy, S. Güngör
Deferasirox (DFR) is an oral tridentate iron chelator effective for reduction of body iron in ironoverloaded patients with transfusion-dependent anemias [1]. It is a highly lipophilic molecule (log P: 3.52) which is classified as BCS Class II drug substance [2]. Self-nanoemulsifying drug delivery systems (SNEDDs) are isotropic mixtures of drug, oil and hydrophilic surfactants and co-surfactant/co-solvents. In recent years, SNEDDs gained more attention in the solubility enhancement of lipophilic molecule hence enhancing their oral bioavailability. The selection of appropriate components in the SNEDDs formulation is crucial for development of a successful formulation. The goal of this work is to select and to screen appropriate components for the optimization of DFR loaded SNEDDs formulations. In this respect, different SNEDDs formulations were prepared and pseudo-ternary phase diagrams were constructed. 2. Materials and Methods
{"title":"Assigning the components of a Self-Nanoemulsifying Drug Delivery System (SNEDDs) of Deferasirox","authors":"Alaa Alghananim, Y. Özalp, B. Mesut, Y. Özsoy, S. Güngör","doi":"10.33892/aph.2021.91.287-289","DOIUrl":"https://doi.org/10.33892/aph.2021.91.287-289","url":null,"abstract":"Deferasirox (DFR) is an oral tridentate iron chelator effective for reduction of body iron in ironoverloaded patients with transfusion-dependent anemias [1]. It is a highly lipophilic molecule (log P: 3.52) which is classified as BCS Class II drug substance [2]. Self-nanoemulsifying drug delivery systems (SNEDDs) are isotropic mixtures of drug, oil and hydrophilic surfactants and co-surfactant/co-solvents. In recent years, SNEDDs gained more attention in the solubility enhancement of lipophilic molecule hence enhancing their oral bioavailability. The selection of appropriate components in the SNEDDs formulation is crucial for development of a successful formulation. The goal of this work is to select and to screen appropriate components for the optimization of DFR loaded SNEDDs formulations. In this respect, different SNEDDs formulations were prepared and pseudo-ternary phase diagrams were constructed. 2. Materials and Methods","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"90 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85227245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.144-145
O. Pelkonen
Traditionally, experimental animal studies have constituted a backbone of drug development, in particular in toxicity evaluation. Almost from the beginning of modern drug development the reliance on animal experiments has been critisised on various grounds, from obvious differences between animals and humans to the emergence of 3R principles (refine, reduce, replace). Increasingly, in vitro methodologies have paved the way for more mechanistic and molecular approaches and, even more recently, the application of computational methods have provided platforms for simulating and integrating various approaches. Indeed, some circles even anticipate a more or less rapid disappearance of animal experiments (unless the question is about the animals’ own health and disease) or at least their replacement for a majority of current purposes by combined in vitro and in silico approaches. It is useful to remember some arguments related to this topic: 1. Variability is a fact of life at all levels of biological organization, be it a population or a gene. 2. Animals are different from humans and thus unreliable predictors without extensive focussed investigations (interspecies differences). 3. ’In vivo at an individual level’ constitutes such a complex whole that ’in vivo at a general (group, population etc) level’ could provide only approximate predictions (interindividual differences). 4. In vitro-methods can provide answers only to rather specific and well-understood and researched problems (in vitro-in vivo correlations). 5. in silico-tools, especially at a higher level of simulations and machine learning, have to be interpreted and explained in the end at the level of bioscience language and concepts (in this case pharmacology and toxicology). On the basis of the above arguments one might think that animal studies in drug development (as an example) are not very useful and the reason they are still a prominent part of DD has more to do with historical inertia than with a real necessity. Quite contrary, the use of experimental animals under proper ethical and scientific conditions offers still useful, sometimes absolutely necessary information for the advancement of drug development. In the following, some examples to illustrate this point are briefly described. Regulatory animal studies on toxicology and toxicokinetics constitute a general framework for understanding in vivo effects and behaviour of new chemical entities (NCE) including adverse effects in various bodily functions and organs and in the fate of a specific NCE in a whole organism. Currently the first kinetic study informs on mass balance, extent of absorption and elimination, metabolism, principal metabolites etc, all of which provide an initial view and comprehension of (toxico)kinetic characteristics of an NCE. This view is certainly of importance in the planning of future kinetic studies and in the interpretation of toxicity profile of an NCE. Currently in vitro studies in human-derived syst
{"title":"ADMET in Drug Development: What is the Role of Animals between In Silico : In vitro and In Vivo Humans?","authors":"O. Pelkonen","doi":"10.33892/aph.2021.91.144-145","DOIUrl":"https://doi.org/10.33892/aph.2021.91.144-145","url":null,"abstract":"Traditionally, experimental animal studies have constituted a backbone of drug development, in particular in toxicity evaluation. Almost from the beginning of modern drug development the reliance on animal experiments has been critisised on various grounds, from obvious differences between animals and humans to the emergence of 3R principles (refine, reduce, replace). Increasingly, in vitro methodologies have paved the way for more mechanistic and molecular approaches and, even more recently, the application of computational methods have provided platforms for simulating and integrating various approaches. Indeed, some circles even anticipate a more or less rapid disappearance of animal experiments (unless the question is about the animals’ own health and disease) or at least their replacement for a majority of current purposes by combined in vitro and in silico approaches. It is useful to remember some arguments related to this topic: 1. Variability is a fact of life at all levels of biological organization, be it a population or a gene. 2. Animals are different from humans and thus unreliable predictors without extensive focussed investigations (interspecies differences). 3. ’In vivo at an individual level’ constitutes such a complex whole that ’in vivo at a general (group, population etc) level’ could provide only approximate predictions (interindividual differences). 4. In vitro-methods can provide answers only to rather specific and well-understood and researched problems (in vitro-in vivo correlations). 5. in silico-tools, especially at a higher level of simulations and machine learning, have to be interpreted and explained in the end at the level of bioscience language and concepts (in this case pharmacology and toxicology). On the basis of the above arguments one might think that animal studies in drug development (as an example) are not very useful and the reason they are still a prominent part of DD has more to do with historical inertia than with a real necessity. Quite contrary, the use of experimental animals under proper ethical and scientific conditions offers still useful, sometimes absolutely necessary information for the advancement of drug development. In the following, some examples to illustrate this point are briefly described. Regulatory animal studies on toxicology and toxicokinetics constitute a general framework for understanding in vivo effects and behaviour of new chemical entities (NCE) including adverse effects in various bodily functions and organs and in the fate of a specific NCE in a whole organism. Currently the first kinetic study informs on mass balance, extent of absorption and elimination, metabolism, principal metabolites etc, all of which provide an initial view and comprehension of (toxico)kinetic characteristics of an NCE. This view is certainly of importance in the planning of future kinetic studies and in the interpretation of toxicity profile of an NCE. Currently in vitro studies in human-derived syst","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75125197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.185-186
T. Körmöczi, P. Kovács, Éva Sija, L. Institóris, É. Kereszty, I. Ilisz, R. Berkecz
{"title":"Metabolomic Characterization of Newest Designer Drugs","authors":"T. Körmöczi, P. Kovács, Éva Sija, L. Institóris, É. Kereszty, I. Ilisz, R. Berkecz","doi":"10.33892/aph.2021.91.185-186","DOIUrl":"https://doi.org/10.33892/aph.2021.91.185-186","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81848051","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：