Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.316-317
V. Smirnov, E. Fisher, G. Ramenskaya
According to the World Health Organization (WHO), oncological diseases hold second place in the world in terms of mortality after cardiovascular diseases; and in the next few decades the number of cases will continue to increase [1]. Development of medicines based on modified endogenous peptides is one of the most relevant areas of modern medicine. The most interesting among them are antitumor peptide drugs, which are no less effective than chemotherapy with its pronounced side effects, or surgical interventions that often take a toll on patients [2]. When conducting studies of peptide preparations in biological fluids, the structure of the peptide molecule and its physicochemical properties are taken into account.
{"title":"Development and Validation of a Method for Quantitative Determination of Innovative Antitumor Peptide Drugs in Order to Study their Pharmacokinetics","authors":"V. Smirnov, E. Fisher, G. Ramenskaya","doi":"10.33892/aph.2021.91.316-317","DOIUrl":"https://doi.org/10.33892/aph.2021.91.316-317","url":null,"abstract":"According to the World Health Organization (WHO), oncological diseases hold second place in the world in terms of mortality after cardiovascular diseases; and in the next few decades the number of cases will continue to increase [1]. Development of medicines based on modified endogenous peptides is one of the most relevant areas of modern medicine. The most interesting among them are antitumor peptide drugs, which are no less effective than chemotherapy with its pronounced side effects, or surgical interventions that often take a toll on patients [2]. When conducting studies of peptide preparations in biological fluids, the structure of the peptide molecule and its physicochemical properties are taken into account.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90166400","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.2021.91.171-172
P. Arany, Alexa Király, P. Fehér, Z. Ujhelyi, M. Vecsernyés, Marianna Zichar, I. Papp, I. Bácskay
Individualized dose is one of the most emerging problems in the pharmaceutical sciences that can be solved with personalized medication. For the manufacturing of personalized medications we can use 3D printing which promise to manufacture complex, personalized products through a low-cost manufacturing process on-demand. 1 3D printing is an umbrella term referring to different techniques but for our experiments we used FDM (fused deposition modeling) technique because it is an off-patent, widespread and inexpensive technology.2 Polyethylene terephthalate glycol (PETG) removes the hazing effect during heating and prevents the undesirable crystallization effect that causes standard PET to become brittle during the FDM printing this is we we choose this polymer for 3D printing. 3
{"title":"Biocompatibility and Dissolution Profile of FDM 3D Printed PETG Tablets","authors":"P. Arany, Alexa Király, P. Fehér, Z. Ujhelyi, M. Vecsernyés, Marianna Zichar, I. Papp, I. Bácskay","doi":"10.33892/aph.2021.91.171-172","DOIUrl":"https://doi.org/10.33892/aph.2021.91.171-172","url":null,"abstract":"Individualized dose is one of the most emerging problems in the pharmaceutical sciences that can be solved with personalized medication. For the manufacturing of personalized medications we can use 3D printing which promise to manufacture complex, personalized products through a low-cost manufacturing process on-demand. 1 3D printing is an umbrella term referring to different techniques but for our experiments we used FDM (fused deposition modeling) technique because it is an off-patent, widespread and inexpensive technology.2 Polyethylene terephthalate glycol (PETG) removes the hazing effect during heating and prevents the undesirable crystallization effect that causes standard PET to become brittle during the FDM printing this is we we choose this polymer for 3D printing. 3","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"48 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76909221","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.2021.91.103-105
J. Polli
Drug discovery and development is an exciting and complex process that begins with target identification and ends with regulatory approval, launch and product life-cycle management. Along this 10+ year journey, drug metabolism and pharmacokinetics (DMPK) is vital in characterizing the absorption, disposition, metabolism and excretion (ADME) of the drug. Over the past 30 years, DMPK had grown from a relatively qualitative science providing a general description of a drug’s excretion pathways and metabolism, to a robust, integrative and quantitative discipline addressing drug interactions and ADME of complex molecules (1). This transformation has occurred through disruptive advances in bioanalytical and imaging technologies, and software to support extensive modeling and simulations exercises. The integration of these technologies with advances in our understanding of the fundamental biological process underpinning the ADME of new chemical entities has enabled the DMPK field to make significant contributions to drug development and discovery. This plenary presentation will highlight the evolution of the DMPK discipline through several case studies.
{"title":"Drug Development Strategy in the United States: An Industrial View of DMPK","authors":"J. Polli","doi":"10.33892/aph.2021.91.103-105","DOIUrl":"https://doi.org/10.33892/aph.2021.91.103-105","url":null,"abstract":"Drug discovery and development is an exciting and complex process that begins with target identification and ends with regulatory approval, launch and product life-cycle management. Along this 10+ year journey, drug metabolism and pharmacokinetics (DMPK) is vital in characterizing the absorption, disposition, metabolism and excretion (ADME) of the drug. Over the past 30 years, DMPK had grown from a relatively qualitative science providing a general description of a drug’s excretion pathways and metabolism, to a robust, integrative and quantitative discipline addressing drug interactions and ADME of complex molecules (1). This transformation has occurred through disruptive advances in bioanalytical and imaging technologies, and software to support extensive modeling and simulations exercises. The integration of these technologies with advances in our understanding of the fundamental biological process underpinning the ADME of new chemical entities has enabled the DMPK field to make significant contributions to drug development and discovery. This plenary presentation will highlight the evolution of the DMPK discipline through several case studies.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79293120","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.2021.91.296-297
Krisztina A. Paulik, Dina Wafa, P. Szilágyi, Z. Benyó, Z. Miklós
{"title":"Potential Mechanisms Involved in Sphingosine-1-phosphate Induced Coronary Flow Reduction","authors":"Krisztina A. Paulik, Dina Wafa, P. Szilágyi, Z. Benyó, Z. Miklós","doi":"10.33892/aph.2021.91.296-297","DOIUrl":"https://doi.org/10.33892/aph.2021.91.296-297","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":"79658504","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.2021.91.240-242
Milena Jadrijević-Mladar Takač, Tin Takač
Ecstasy (MDMA) and its structural analogs are capable of inducing an ”entactogenic syndrome”, a reversible controlled alteration of consciousness in humans characterized by emotional relaxation, feelings of happiness, and empathy. This makes MDMA the most popular recreational drug with a high potential for abuse. Recently there has been increasing evidence that MDMA may be used in MDMA-assisted psychotherapy to treat post-traumatic stress disorder (PTSD), autism anxiety, alcoholism, and mood disorders. There is a widespread belief among adolescents and younger adults that ecstasy is a safe drug. However, the “street drugs” that are very commonly sold under this name can vary widely in purity and often contain adulterants or undeclared entactogens with unknown properties. (1‒4) Entactogens (Figure 1) and reference molecules, the antidepressants paroxetine (SSRI) and venflaxine (SNRI), were studied for their toxic potential and affinity for drug-drug interactions (DDI) via membrane transporters.
{"title":"Estimating the Toxic Potential of Entactogens – In silico Study","authors":"Milena Jadrijević-Mladar Takač, Tin Takač","doi":"10.33892/aph.2021.91.240-242","DOIUrl":"https://doi.org/10.33892/aph.2021.91.240-242","url":null,"abstract":"Ecstasy (MDMA) and its structural analogs are capable of inducing an ”entactogenic syndrome”, a reversible controlled alteration of consciousness in humans characterized by emotional relaxation, feelings of happiness, and empathy. This makes MDMA the most popular recreational drug with a high potential for abuse. Recently there has been increasing evidence that MDMA may be used in MDMA-assisted psychotherapy to treat post-traumatic stress disorder (PTSD), autism anxiety, alcoholism, and mood disorders. There is a widespread belief among adolescents and younger adults that ecstasy is a safe drug. However, the “street drugs” that are very commonly sold under this name can vary widely in purity and often contain adulterants or undeclared entactogens with unknown properties. (1‒4) Entactogens (Figure 1) and reference molecules, the antidepressants paroxetine (SSRI) and venflaxine (SNRI), were studied for their toxic potential and affinity for drug-drug interactions (DDI) via membrane transporters.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78740693","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.2021.91.298-299
Á. Pető, D. Kósa, P. Fehér, Zoltán Jhelyi, Dávid Sinka, M. Vecsernyés, Z. Szilvássy, B. Juhász, Z. Csanádi, I. Bácskay
BGP-15 is a drug candidate that was originally developed against insulin resistance by Hungarian researchers. This compound was discovered while investigating heat shock proteins, which are essentials in the functioning of the immune system [1]. BGP-15 is a versatile compound, many research groups pay outstanding attention to the molecule and investigate its effects all around the world. It has been reported to be safe and well tolerated, it entered into clinical phase II [2]. In the followings we summarize BGP-15’s effects to increase the knowledge about the molecule.
{"title":"Pharmacological Overview of the Drug Candidate BGP-15","authors":"Á. Pető, D. Kósa, P. Fehér, Zoltán Jhelyi, Dávid Sinka, M. Vecsernyés, Z. Szilvássy, B. Juhász, Z. Csanádi, I. Bácskay","doi":"10.33892/aph.2021.91.298-299","DOIUrl":"https://doi.org/10.33892/aph.2021.91.298-299","url":null,"abstract":"BGP-15 is a drug candidate that was originally developed against insulin resistance by Hungarian researchers. This compound was discovered while investigating heat shock proteins, which are essentials in the functioning of the immune system [1]. BGP-15 is a versatile compound, many research groups pay outstanding attention to the molecule and investigate its effects all around the world. It has been reported to be safe and well tolerated, it entered into clinical phase II [2]. In the followings we summarize BGP-15’s effects to increase the knowledge about the molecule.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83052132","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.2021.91.91-92
C. Peck
While frequent employment of the phrase “regulatory science” by regulators and academics arose within the last three decades, “science” applied to “regulation” of medicinals dates back many centuries. Descriptive science characterized the earliest classifications of medicinal substances, employed for self-regulation by apothecaries and physicians. Later, development of chemical and biological techniques permitted more precise descriptions of biological and drug products, which were adaptable to development of quantitative product specifications for governmental regulation of manufacturers. Motivated by need to protect and support public health, advanced regulatory science has been applied to research regulatory standards and requirements. Advanced regulatory science is currently being researched and intensively applied in both medical product regulation and development. Ever more novel regulatory science is likely to contribute in a crucial way to undreamed of advances in pharmaceutical development and improved public health.
{"title":"Regulatory Perspectives : Where We Came from, Where Are We Today, Where Are We Headed?","authors":"C. Peck","doi":"10.33892/aph.2021.91.91-92","DOIUrl":"https://doi.org/10.33892/aph.2021.91.91-92","url":null,"abstract":"While frequent employment of the phrase “regulatory science” by regulators and academics arose within the last three decades, “science” applied to “regulation” of medicinals dates back many centuries. Descriptive science characterized the earliest classifications of medicinal substances, employed for self-regulation by apothecaries and physicians. Later, development of chemical and biological techniques permitted more precise descriptions of biological and drug products, which were adaptable to development of quantitative product specifications for governmental regulation of manufacturers. Motivated by need to protect and support public health, advanced regulatory science has been applied to research regulatory standards and requirements. Advanced regulatory science is currently being researched and intensively applied in both medical product regulation and development. Ever more novel regulatory science is likely to contribute in a crucial way to undreamed of advances in pharmaceutical development and improved public health.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"67 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89057502","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.2021.91.280-281
D. Nemes, H. Fekete, Renáta Gyulai, F. Nagy, R. Kovács, P. Fehér, Z. Ujhelyi, M. Vecsernyés, I. Bácskay
{"title":"Cytotoxicity and Antimicrobial Action of Methyl and Butyl Paraben in Different Complex Co-Solvent Systems","authors":"D. Nemes, H. Fekete, Renáta Gyulai, F. Nagy, R. Kovács, P. Fehér, Z. Ujhelyi, M. Vecsernyés, I. Bácskay","doi":"10.33892/aph.2021.91.280-281","DOIUrl":"https://doi.org/10.33892/aph.2021.91.280-281","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"36 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73743478","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.2021.91.126-127
R. Zelkó
A significant proportion of new drug candidates possesses poor solubility and/or membrane permeability. Several promising techniques have been developed to overcome these disadvantageous properties, including different fiber formation methods. The electrospinning and high-speed rotary spinning are the most commonly used spinning techniques for fiber formation. The fiber properties (high specific surface area, porosity, the possibility of controlling the crystalline-amorphous phase transitions of the loaded drugs) enhance the dissolution rate and apparent solubility of actives and thus their rate and extent of absorption. The hydrophilic polymer-based drug-loaded nanofibrous orally dissolving webs are promising candidates for rapid drug release, which is due to the advantageous morphological and physicalchemical features of the system. They are also capable of controlled drug delivery over time for local or systemic drug administration. The solubility of the polymer, the fiber diameter and the fiber structure are the primary parameters affecting drug release. In the case of small molecules, developments focus mostly on overcoming the unfavourable physicochemical feature of the active agents (1). However, the physical and chemical stability of these systems has not yet been thoroughly investigated and thus poses a challenge in their development. Since the stability of these systems is a crucial issue, its sensitive and non-destructive tracking could be of great practical relevance in the prediction of their applicability.
{"title":"Supramolecular Structure and Stability of Nanofibrous Drug Delivery Systems","authors":"R. Zelkó","doi":"10.33892/aph.2021.91.126-127","DOIUrl":"https://doi.org/10.33892/aph.2021.91.126-127","url":null,"abstract":"A significant proportion of new drug candidates possesses poor solubility and/or membrane permeability. Several promising techniques have been developed to overcome these disadvantageous properties, including different fiber formation methods. The electrospinning and high-speed rotary spinning are the most commonly used spinning techniques for fiber formation. The fiber properties (high specific surface area, porosity, the possibility of controlling the crystalline-amorphous phase transitions of the loaded drugs) enhance the dissolution rate and apparent solubility of actives and thus their rate and extent of absorption. The hydrophilic polymer-based drug-loaded nanofibrous orally dissolving webs are promising candidates for rapid drug release, which is due to the advantageous morphological and physicalchemical features of the system. They are also capable of controlled drug delivery over time for local or systemic drug administration. The solubility of the polymer, the fiber diameter and the fiber structure are the primary parameters affecting drug release. In the case of small molecules, developments focus mostly on overcoming the unfavourable physicochemical feature of the active agents (1). However, the physical and chemical stability of these systems has not yet been thoroughly investigated and thus poses a challenge in their development. Since the stability of these systems is a crucial issue, its sensitive and non-destructive tracking could be of great practical relevance in the prediction of their applicability.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"258 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75224258","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.2021.91.300-301
Zsolt Preisz, Balázs Bognár, T. Kállai, L. Kollár, S. Kunsági-Máté
{"title":"Some Interactions of the Novel Photoswitchable Compound Phototrexate","authors":"Zsolt Preisz, Balázs Bognár, T. Kállai, L. Kollár, S. Kunsági-Máté","doi":"10.33892/aph.2021.91.300-301","DOIUrl":"https://doi.org/10.33892/aph.2021.91.300-301","url":null,"abstract":"","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":"72942670","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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