Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.304-305
S. M. H. Habibur Rahman, Telny Thomas Chungath, H. Ranganathan, S. Muthusamy, Manogaran Elumalai, K. Sridhar, K. Siram
{"title":"Development and Pharmacokinetic Assessment of Tetrahydrocurcumin Solid Lipid Nanoparticles","authors":"S. M. H. Habibur Rahman, Telny Thomas Chungath, H. Ranganathan, S. Muthusamy, Manogaran Elumalai, K. Sridhar, K. Siram","doi":"10.33892/aph.2021.91.304-305","DOIUrl":"https://doi.org/10.33892/aph.2021.91.304-305","url":null,"abstract":"","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":"83203497","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.2021.91.236-237
Zsófia Huba, Dávid Virág, T. Kremmer, K. Ludányi, B. Dalmadi Kiss, I. Klebovich, I. Antal
{"title":"Isolation and Analysis of Human Urinary Marker Protein uAGP by Liquid Chromatographic Methods","authors":"Zsófia Huba, Dávid Virág, T. Kremmer, K. Ludányi, B. Dalmadi Kiss, I. Klebovich, I. Antal","doi":"10.33892/aph.2021.91.236-237","DOIUrl":"https://doi.org/10.33892/aph.2021.91.236-237","url":null,"abstract":"","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":"91078528","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.2021.91.114-116
S. Mühlebach
Nanomedicine is a promising innovation path for drug research and development with increasing reality over the last decades; a high number of nanomedicines is in clinical evaluation. Copies of the first generation innovator nano products, called nanosimilars in the EU, aim for market access to substitute or being interchanged with reference nanopharmaceuticals. Biological and nonbiological complex drugs (NBCDs) belong to these nano drug products. They are highly complex regarding the non-homogenous composition, and structure. Critical Quality Attributes (CQA) define the profile in vitro and in vivo, ultimately dependent on specific not fully understood structurefunction correlations originating from a critical drug manufacturing process (fig.1). In contrast to biologicals, the regulatory evaluation and approval of the synthetic NBCDs is highly jeopardized by the not defined equivalence assessment for their copies and a globally not harmonized approach. Selection and use of such nanosimilars in practice has revealed unexpected equivalence problems asking for guidance, knowledge-based standards, and practice to guarantee safe, reliable, and consistent nanopharmaceuticals and similars based on a sufficient regulatory similarity / comparability exercise to allow only switching or interchange for therapeutically equivalent products (2-5).
{"title":"How to Deal with Complexity of Nanomedicine in Practice","authors":"S. Mühlebach","doi":"10.33892/aph.2021.91.114-116","DOIUrl":"https://doi.org/10.33892/aph.2021.91.114-116","url":null,"abstract":"Nanomedicine is a promising innovation path for drug research and development with increasing reality over the last decades; a high number of nanomedicines is in clinical evaluation. Copies of the first generation innovator nano products, called nanosimilars in the EU, aim for market access to substitute or being interchanged with reference nanopharmaceuticals. Biological and nonbiological complex drugs (NBCDs) belong to these nano drug products. They are highly complex regarding the non-homogenous composition, and structure. Critical Quality Attributes (CQA) define the profile in vitro and in vivo, ultimately dependent on specific not fully understood structurefunction correlations originating from a critical drug manufacturing process (fig.1). In contrast to biologicals, the regulatory evaluation and approval of the synthetic NBCDs is highly jeopardized by the not defined equivalence assessment for their copies and a globally not harmonized approach. Selection and use of such nanosimilars in practice has revealed unexpected equivalence problems asking for guidance, knowledge-based standards, and practice to guarantee safe, reliable, and consistent nanopharmaceuticals and similars based on a sufficient regulatory similarity / comparability exercise to allow only switching or interchange for therapeutically equivalent products (2-5).","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":"89840329","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.2021.91.211-213
Noa Fine‐Shamir, A. Dahan
{"title":"Ethanol Based Formulations and the Solubility- Permeability Interplay; does Ethanol Increase the Intestinal Permeability?","authors":"Noa Fine‐Shamir, A. Dahan","doi":"10.33892/aph.2021.91.211-213","DOIUrl":"https://doi.org/10.33892/aph.2021.91.211-213","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"329 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77402641","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.2021.91.322-323
L. É. Uhljar, Péter Gieszinger, P. Szabó-Révész, R. Ambrus
{"title":"Preformulation Studies of Polymeric Nanocapsules","authors":"L. É. Uhljar, Péter Gieszinger, P. Szabó-Révész, R. Ambrus","doi":"10.33892/aph.2021.91.322-323","DOIUrl":"https://doi.org/10.33892/aph.2021.91.322-323","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89078396","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.2021.91.101-102
V. Shah
{"title":"Regulatory Science in Drug Development","authors":"V. Shah","doi":"10.33892/aph.2021.91.101-102","DOIUrl":"https://doi.org/10.33892/aph.2021.91.101-102","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86450626","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.2021.91.117-119
L. Benet, P. Couvreur
NSBs display extended blood circulation times, improved bioactivity, and reduced toxicity in multiple preclinical models. This technology platform has several applications with high drug loading that is supported by robust in-vitro and in-vivo data in animal models for a variety of indications. A. Pain – Squal Lenk The endogenous neuropeptide Leucine enkephalin (LENK) is conjugated to squalene. SQUAL – LENK formed with Squal NanoPro technology is an efficient approach to use the currently unusable LENK to act as an analgesic drug via peripheral opioid receptors (no addiction potential). Self-assembly into NSB’s; Slow release of peptide; Cmax at 45 min; Degraded over 10 hrs; Analgesic effect only in inflamed tissues; Exclusively acts on peripheral opioid receptors; Longer duration than morphine
{"title":"Prodrug Nano-Squalene Bioconjugate Drug Products","authors":"L. Benet, P. Couvreur","doi":"10.33892/aph.2021.91.117-119","DOIUrl":"https://doi.org/10.33892/aph.2021.91.117-119","url":null,"abstract":"NSBs display extended blood circulation times, improved bioactivity, and reduced toxicity in multiple preclinical models. This technology platform has several applications with high drug loading that is supported by robust in-vitro and in-vivo data in animal models for a variety of indications. A. Pain – Squal Lenk The endogenous neuropeptide Leucine enkephalin (LENK) is conjugated to squalene. SQUAL – LENK formed with Squal NanoPro technology is an efficient approach to use the currently unusable LENK to act as an analgesic drug via peripheral opioid receptors (no addiction potential). Self-assembly into NSB’s; Slow release of peptide; Cmax at 45 min; Degraded over 10 hrs; Analgesic effect only in inflamed tissues; Exclusively acts on peripheral opioid receptors; Longer duration than morphine","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"59 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80248947","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.2021.91.220-221
V. I. Gegechkori, A. M. Sukhanova, G. M. Rodionova
Overweight is currently a common problem in modern society. People from all over the world are in search of the easiest and fastest, as well as the most effective ways to lose weight [1].To solve this problem, people turn to various fitness routines, but most people resort to taking anorexigenic biologically active dietary supplements, as well as medications. The most effective drug on the pharmaceutical market is sibutramine. It is included in the list of potent and toxic substances and is prescription-only, which makes it difficult to buy sibutramine in a pharmacy; therefore, people often prefer herbal supplements. Sibutramine has been banned in the United States, as well as the European Union, since 2010 following the decision of the Food and Drug Administration (FDA). However, some unscrupulous manufacturers add sibutramine to anorexigenic dietary supplements to increase their effectiveness [2]. Thusthere is a need to develop analytical methods for quality control of food additives, to detect cases of fraud on the pharmaceutical market in a timely manner.
{"title":"Determination of the Anorexigenic Drug Sibutramine in Biologically Active Dietary Supplements","authors":"V. I. Gegechkori, A. M. Sukhanova, G. M. Rodionova","doi":"10.33892/aph.2021.91.220-221","DOIUrl":"https://doi.org/10.33892/aph.2021.91.220-221","url":null,"abstract":"Overweight is currently a common problem in modern society. People from all over the world are in search of the easiest and fastest, as well as the most effective ways to lose weight [1].To solve this problem, people turn to various fitness routines, but most people resort to taking anorexigenic biologically active dietary supplements, as well as medications. The most effective drug on the pharmaceutical market is sibutramine. It is included in the list of potent and toxic substances and is prescription-only, which makes it difficult to buy sibutramine in a pharmacy; therefore, people often prefer herbal supplements. Sibutramine has been banned in the United States, as well as the European Union, since 2010 following the decision of the Food and Drug Administration (FDA). However, some unscrupulous manufacturers add sibutramine to anorexigenic dietary supplements to increase their effectiveness [2]. Thusthere is a need to develop analytical methods for quality control of food additives, to detect cases of fraud on the pharmaceutical market in a timely manner.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91553389","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.2021.91.332-333
Dávid Virág, T. Kremmer, K. Lőrincz, Norbeert Kiss, S. Bozsányi, A. Jobbágy, N. Wikonkál, B. Dalmadi Kiss, I. Klebovich, K. Ludányi
{"title":"Alpha-1-Acid Glycoprotein as a Diagnostic Biomarker for Malignant Melanoma","authors":"Dávid Virág, T. Kremmer, K. Lőrincz, Norbeert Kiss, S. Bozsányi, A. Jobbágy, N. Wikonkál, B. Dalmadi Kiss, I. Klebovich, K. Ludányi","doi":"10.33892/aph.2021.91.332-333","DOIUrl":"https://doi.org/10.33892/aph.2021.91.332-333","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"37 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91378480","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.2021.91.175-176
Tamás Bakos, Erik Őrfi, T. Mészáros, Gergely Milosevits, Domonkos Csukás, L. Rosivall, P. Hamar, L. Dézsi, J. Szebeni, G. Szénási
{"title":"Complement Activation-Related Pseudoallergy (CARPA) in Rats: The Example of Liposomal Amphotericin-B (AmBisome)","authors":"Tamás Bakos, Erik Őrfi, T. Mészáros, Gergely Milosevits, Domonkos Csukás, L. Rosivall, P. Hamar, L. Dézsi, J. Szebeni, G. Szénási","doi":"10.33892/aph.2021.91.175-176","DOIUrl":"https://doi.org/10.33892/aph.2021.91.175-176","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76031546","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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