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Acta pharmaceutica Hungarica最新文献

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Development and Pharmacokinetic Assessment of Tetrahydrocurcumin Solid Lipid Nanoparticles 四氢姜黄素固体脂质纳米颗粒的研制及药动学评价
Acta pharmaceutica Hungarica Pub Date : 2021-11-15 DOI: 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}
引用次数: 0
Isolation and Analysis of Human Urinary Marker Protein uAGP by Liquid Chromatographic Methods 人尿标记蛋白uAGP的液相色谱分离与分析
Acta pharmaceutica Hungarica Pub Date : 2021-11-15 DOI: 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}
引用次数: 0
How to Deal with Complexity of Nanomedicine in Practice 实践中如何应对纳米医学的复杂性
Acta pharmaceutica Hungarica Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.114-116
S. Mühlebach
{"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}
引用次数: 0
Ethanol Based Formulations and the Solubility- Permeability Interplay; does Ethanol Increase the Intestinal Permeability? 乙醇基配方及其溶解度-渗透性相互作用乙醇会增加肠道通透性吗?
Acta pharmaceutica Hungarica Pub Date : 2021-11-15 DOI: 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}
引用次数: 0
Formulation and Investigation of Gels Containing Spirulina Powder 螺旋藻粉凝胶的配方及研究
Acta pharmaceutica Hungarica Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.245-246
Liza Józsa, I. Bácskay, Z. Ujhelyi, Á. Pető, D. Kósa, P. Arany, D. Nemes, Dávid Sinka, M. Vecsernyés, P. Fehér
{"title":"Formulation and Investigation of Gels Containing Spirulina Powder","authors":"Liza Józsa, I. Bácskay, Z. Ujhelyi, Á. Pető, D. Kósa, P. Arany, D. Nemes, Dávid Sinka, M. Vecsernyés, P. Fehér","doi":"10.33892/aph.2021.91.245-246","DOIUrl":"https://doi.org/10.33892/aph.2021.91.245-246","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"254 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76535933","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}
引用次数: 0
How Should Synthetic Follow-Ons of Biological Products Be Regulated? What Are the Implications for Automatic Substitution? 生物制品的后续合成应如何监管?自动替代意味着什么?
Acta pharmaceutica Hungarica Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.108-109
J. Heisterberg
{"title":"How Should Synthetic Follow-Ons of Biological Products Be Regulated? What Are the Implications for Automatic Substitution?","authors":"J. Heisterberg","doi":"10.33892/aph.2021.91.108-109","DOIUrl":"https://doi.org/10.33892/aph.2021.91.108-109","url":null,"abstract":"Follow-on products referencing biological medicines have from 2005 until recently been licensed as biosimilars in the European Union (EU), because they have themselves been biological medicines. However, synthetically produced follow-on products referencing biological medicines are now emerging. This presentation will address the EU regulatory and scientific challenges associated with these products – primarily with respect to licensing, but also in relation to allowing automatic substitution at the pharmacy level.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"39 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79868549","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}
引用次数: 0
Prodrug Nano-Squalene Bioconjugate Drug Products 前药纳米角鲨烯生物偶联药物产品
Acta pharmaceutica Hungarica Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.117-119
L. Benet, P. Couvreur
{"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}
引用次数: 0
Investigation of the Drug Dose, Alongside the Solubility, the Permeability, and their Interplay, as Key Factors in Formulation Development for Oral Lipophilic Drugs 药物剂量、溶解度、渗透性及其相互作用在口服亲脂性药物处方开发中的关键因素研究
Acta pharmaceutica Hungarica Pub Date : 2021-11-15 DOI: 10.33892/aph.2021.91.209-210
Noa Fine‐Shamir, A. Dahan
{"title":"Investigation of the Drug Dose, Alongside the Solubility, the Permeability, and their Interplay, as Key Factors in Formulation Development for Oral Lipophilic Drugs","authors":"Noa Fine‐Shamir, A. Dahan","doi":"10.33892/aph.2021.91.209-210","DOIUrl":"https://doi.org/10.33892/aph.2021.91.209-210","url":null,"abstract":"","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":"83009002","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}
引用次数: 0
Preformulation Studies of Polymeric Nanocapsules 高分子纳米胶囊的预配方研究
Acta pharmaceutica Hungarica Pub Date : 2021-11-15 DOI: 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}
引用次数: 0
Regulatory Science in Drug Development 药物开发中的监管科学
Acta pharmaceutica Hungarica Pub Date : 2021-11-15 DOI: 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}
引用次数: 0
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