Pub Date : 2021-11-15DOI: 10.33892/aph.2021.91.272-273
G. Mezőhegyi, B. Buchholcz, I. Puskás, L. Szente, T. Sohajda, F. Darvas
{"title":"Using Space Medicinal Chemistry Against SARS-CoV-2: \u2028SpaceMedChem Consortium–Project 1.","authors":"G. Mezőhegyi, B. Buchholcz, I. Puskás, L. Szente, T. Sohajda, F. Darvas","doi":"10.33892/aph.2021.91.272-273","DOIUrl":"https://doi.org/10.33892/aph.2021.91.272-273","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":"73398574","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.2021.91.232-233
N. Hasler-Nguyen
{"title":"EMA’s proposed Guideline on Quality and Equivalence of Topical Products and Nanotechnology: Future Advances and Challenges","authors":"N. Hasler-Nguyen","doi":"10.33892/aph.2021.91.232-233","DOIUrl":"https://doi.org/10.33892/aph.2021.91.232-233","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":"74443404","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.2021.91.266-267
Szilvia Lohner, Teodora Bodea, S. Gergely, Péter Simon, Eniko Farkas, Zsuzsanna Urbancsok, Júlia Németh-Palotás, Andrea Cseh-Pálos
{"title":"Newest Techniques in the Investigation Procedure of Counterfeit/Illegal Medicinal Products","authors":"Szilvia Lohner, Teodora Bodea, S. Gergely, Péter Simon, Eniko Farkas, Zsuzsanna Urbancsok, Júlia Németh-Palotás, Andrea Cseh-Pálos","doi":"10.33892/aph.2021.91.266-267","DOIUrl":"https://doi.org/10.33892/aph.2021.91.266-267","url":null,"abstract":"","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":"77765800","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.2021.91.193-194
Telny Thomas Chungath, S. M. H. Habibur Rahman, H. Ranganathan, S. Muthusamy, Manogaran Elumalai, K. Sridhar, K. Siram
{"title":"Development of curcumin (nutraceutical) loaded Solid lipid nanoparticle and its Pharmacokinetic assessment","authors":"Telny Thomas Chungath, S. M. H. Habibur Rahman, H. Ranganathan, S. Muthusamy, Manogaran Elumalai, K. Sridhar, K. Siram","doi":"10.33892/aph.2021.91.193-194","DOIUrl":"https://doi.org/10.33892/aph.2021.91.193-194","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82060292","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.2021.91.230-231
Ádám Haimhoffer, Ágnes Rusznyák, K. Réti-Nagy, G. Vasvári, J. Váradi, I. Bácskay, M. Vecsernyés, F. Fenyvesi
{"title":"Cyclodextrin-Based Nanostructures","authors":"Ádám Haimhoffer, Ágnes Rusznyák, K. Réti-Nagy, G. Vasvári, J. Váradi, I. Bácskay, M. Vecsernyés, F. Fenyvesi","doi":"10.33892/aph.2021.91.230-231","DOIUrl":"https://doi.org/10.33892/aph.2021.91.230-231","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":"82167801","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.2021.91.262-263
D. Kósa, Á. Pető, P. Fehér, M. Vecsernyés, I. Bácskay, Z. Ujhelyi
Therapeutic proteins are important in the treatment of several diseases due to their specificity and bioactivity. These proteins and peptides are usually delivered by invasive routes such as subcutaneous route because of their low oral bioavailability [1]. However, oral administration would be better because of its higher patient acceptance and compliance [2]. Therefore, huge efforts have been made over the last decades to develop oral formulation of proteins and peptides [3]. Many advantages can be mentioned, for example patients are able to avoid pain and possible infections associated with injections. Special techniques and modification are required during formulation to improve oral bioavailability as proteins and peptides have several unfavorable properties. The aim of this short discussion is to summarize the possibilities of pharmaceutical formulation procedures.
{"title":"Challenges of Oral Protein Administration","authors":"D. Kósa, Á. Pető, P. Fehér, M. Vecsernyés, I. Bácskay, Z. Ujhelyi","doi":"10.33892/aph.2021.91.262-263","DOIUrl":"https://doi.org/10.33892/aph.2021.91.262-263","url":null,"abstract":"Therapeutic proteins are important in the treatment of several diseases due to their specificity and bioactivity. These proteins and peptides are usually delivered by invasive routes such as subcutaneous route because of their low oral bioavailability [1]. However, oral administration would be better because of its higher patient acceptance and compliance [2]. Therefore, huge efforts have been made over the last decades to develop oral formulation of proteins and peptides [3]. Many advantages can be mentioned, for example patients are able to avoid pain and possible infections associated with injections. Special techniques and modification are required during formulation to improve oral bioavailability as proteins and peptides have several unfavorable properties. The aim of this short discussion is to summarize the possibilities of pharmaceutical formulation procedures.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"108 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77056322","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.2021.91.133-134
D. Jordan
{"title":"The Place of Science in the “One FIP Strategy”","authors":"D. Jordan","doi":"10.33892/aph.2021.91.133-134","DOIUrl":"https://doi.org/10.33892/aph.2021.91.133-134","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"58 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84205553","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.2021.91.110-111
J. S. D. de Vlieger
The rise of bioand nano-technologies has accelerated the development of complex medicines, and at the same time it has revealed new hurdles in regulatory science and accelerating patient access to new therapies. Complex medicines include biologics (e.g. vaccines, gene therapies, recombinant proteins) and non-biological complex drug products (NBCDs) Their diverse nature poses challenges for the development of regulatory guidelines. While complexity is not new in medicines, our technical capacity to measure and analyze data has increased. This requires a determination of which measurements are relevant to demonstrate therapeutic efficacy and safety. Further, many obstacles remain in regulatory harmonization across global authorities, given their different approaches and legal frameworks. To advance research and build consensus, it is necessary to engage together key stakeholders from academia, regulatory bodies, industry, and drug manufacturing. The Non Biological Complex Drugs Working Group hosted at the not-for-profit Foundation Lygature was established to do exactly that. Three action lines were defined: – Create awareness of the intricacies of complex drug products – Build understanding of the challenges with characterization of complex drug products, including the determination of Critical Quality Attributes – Aim for alignment across the globe on rules and regulations for complex drug products. Over the years, many scientific publications have been published with the involvement from scientists of the NBCD WG. The papers have identified the best scientific approaches for complex medicines development and regulation, have outlined outstanding challenges in the assessment of equivalence, and touched upon how to improve timely patient access for new medicines. The discussions continue to facilitate the translation of scientific findings into advancements in medicine for the benefit of patients.
{"title":"Complex Drugs: What Are They and Why Do They Need Special Attention?","authors":"J. S. D. de Vlieger","doi":"10.33892/aph.2021.91.110-111","DOIUrl":"https://doi.org/10.33892/aph.2021.91.110-111","url":null,"abstract":"The rise of bioand nano-technologies has accelerated the development of complex medicines, and at the same time it has revealed new hurdles in regulatory science and accelerating patient access to new therapies. Complex medicines include biologics (e.g. vaccines, gene therapies, recombinant proteins) and non-biological complex drug products (NBCDs) Their diverse nature poses challenges for the development of regulatory guidelines. While complexity is not new in medicines, our technical capacity to measure and analyze data has increased. This requires a determination of which measurements are relevant to demonstrate therapeutic efficacy and safety. Further, many obstacles remain in regulatory harmonization across global authorities, given their different approaches and legal frameworks. To advance research and build consensus, it is necessary to engage together key stakeholders from academia, regulatory bodies, industry, and drug manufacturing. The Non Biological Complex Drugs Working Group hosted at the not-for-profit Foundation Lygature was established to do exactly that. Three action lines were defined: – Create awareness of the intricacies of complex drug products – Build understanding of the challenges with characterization of complex drug products, including the determination of Critical Quality Attributes – Aim for alignment across the globe on rules and regulations for complex drug products. Over the years, many scientific publications have been published with the involvement from scientists of the NBCD WG. The papers have identified the best scientific approaches for complex medicines development and regulation, have outlined outstanding challenges in the assessment of equivalence, and touched upon how to improve timely patient access for new medicines. The discussions continue to facilitate the translation of scientific findings into advancements in medicine for the benefit of patients.","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":"90245043","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.2021.91.243-244
G. Jakab, Bálint Basa, Á. Barna, Nikolett Kállai-Szabó, E. Balogh, I. Antal
Baicalin is a flavone glycoside, extracted from the root of Scutellaria baicalensis Georgi, a traditional Chinese herbal medicine (Fig.1.). The root is officially listed in the Chinese Pharmacopoeia and was assumed in European Pharmacopoeia (Ph. Eur.) 9th Edition in 2018. It was shown, that the poorly water soluble and poorly permeable polyphenolic flavonoid has remarkable pharmacological effects including antioxidant, antimicrobial and anti-tumor actions1. In our previous publication the fundamental physicochemical properties influencing the pharmacokinetic behavior of baicalin like the acid-base properties, lipophilicity, permeability and solubility were thoroughly characterized. Considering the data, baicalin can be classified as class IV. according to the Biopharmaceutical Classification System (BCS)2. Self-emulsifying drug delivery systems (SEDDS) are isotropic mixtures of oil, surfactant, co-surfactant and the lipophilic compound, which are spontaneously form oil-in-water (o/w) emulsions upon mild agitation followed by dilution in gastro-intestinal fluids3. In another publication of our research group liquid SEDDS were developed and formulated to counterbalance the challenging physicochemical and pharmaceutical properties of baicalin4. Dissolution kinetics of baicalin was improved in the optimized self-nanoemulsifying system taking different types of oils, surfactants, cosurfactants, and ideal ratio of components into consideration, based on response surface methodology, using a central composite experimental design. The best composition contains Peceol® (14.29%, w/w), Kolliphor® EL (57.14%, w/w), and Transcutol® P (28.57%, w/w). Droplet size after dispergation of BSNEDDS pre-concentrate was highly desirable, with 86.75 ± 0.3553 nm. The main objective of this work was to formulate and develop baicalin-loaded solid SEDDS by transforming liquid self-emulsifying preconcentrates to solid carriers and prepare matrix pellets by extrusion-spheronization. Furthermore, the focus was put on the evaluation and analysis of fundamental relationships between drug and dosage form.
{"title":"Development and Formulation of Baicalin-loaded Self-nanoemulsifying Matrix Pellets","authors":"G. Jakab, Bálint Basa, Á. Barna, Nikolett Kállai-Szabó, E. Balogh, I. Antal","doi":"10.33892/aph.2021.91.243-244","DOIUrl":"https://doi.org/10.33892/aph.2021.91.243-244","url":null,"abstract":"Baicalin is a flavone glycoside, extracted from the root of Scutellaria baicalensis Georgi, a traditional Chinese herbal medicine (Fig.1.). The root is officially listed in the Chinese Pharmacopoeia and was assumed in European Pharmacopoeia (Ph. Eur.) 9th Edition in 2018. It was shown, that the poorly water soluble and poorly permeable polyphenolic flavonoid has remarkable pharmacological effects including antioxidant, antimicrobial and anti-tumor actions1. In our previous publication the fundamental physicochemical properties influencing the pharmacokinetic behavior of baicalin like the acid-base properties, lipophilicity, permeability and solubility were thoroughly characterized. Considering the data, baicalin can be classified as class IV. according to the Biopharmaceutical Classification System (BCS)2. Self-emulsifying drug delivery systems (SEDDS) are isotropic mixtures of oil, surfactant, co-surfactant and the lipophilic compound, which are spontaneously form oil-in-water (o/w) emulsions upon mild agitation followed by dilution in gastro-intestinal fluids3. In another publication of our research group liquid SEDDS were developed and formulated to counterbalance the challenging physicochemical and pharmaceutical properties of baicalin4. Dissolution kinetics of baicalin was improved in the optimized self-nanoemulsifying system taking different types of oils, surfactants, cosurfactants, and ideal ratio of components into consideration, based on response surface methodology, using a central composite experimental design. The best composition contains Peceol® (14.29%, w/w), Kolliphor® EL (57.14%, w/w), and Transcutol® P (28.57%, w/w). Droplet size after dispergation of BSNEDDS pre-concentrate was highly desirable, with 86.75 ± 0.3553 nm. The main objective of this work was to formulate and develop baicalin-loaded solid SEDDS by transforming liquid self-emulsifying preconcentrates to solid carriers and prepare matrix pellets by extrusion-spheronization. Furthermore, the focus was put on the evaluation and analysis of fundamental relationships between drug and dosage form.","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":"87551916","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：