Pub Date : 2022-04-18DOI: 10.33892/aph.2022.92.38-44
M. Bege, A. Borbás
Fomivirsent was approved by the FDA in 1998 and by the EMA in 1999 as the very first antisense drug used to treat CMV retinitis in patients with AIDS. To date, it has been the only first generation antisense oligonucleotide used in therapy. Fomivirsen has been a pioneer in this field and has demonstrated the usefulness of the antisense tehcnology for medicinal science. However, after three years of use, fomivirsen has been withdrawn from the market (in the US in 2001 and in the EU in 2002), and nowadays, gene silencing drugs with a more advanced chemical structure and more complex mechanism of action are used in medicine. On the occasion of the 20th anniversary of its European withdrawal, we briefly overview the history of fomivirsen.
{"title":"Rise and fall of fomivirsen, the first approved gene silencing medicine : A historical review","authors":"M. Bege, A. Borbás","doi":"10.33892/aph.2022.92.38-44","DOIUrl":"https://doi.org/10.33892/aph.2022.92.38-44","url":null,"abstract":"Fomivirsent was approved by the FDA in 1998 and by the EMA in 1999 as the very first antisense drug used to treat CMV retinitis in patients with AIDS. To date, it has been the only first generation antisense oligonucleotide used in therapy. Fomivirsen has been a pioneer in this field and has demonstrated the usefulness of the antisense tehcnology for medicinal science. However, after three years of use, fomivirsen has been withdrawn from the market (in the US in 2001 and in the EU in 2002), and nowadays, gene silencing drugs with a more advanced chemical structure and more complex mechanism of action are used in medicine. On the occasion of the 20th anniversary of its European withdrawal, we briefly overview the history of fomivirsen.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91082880","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 : 2022-04-18DOI: 10.33892/aph.2022.92.20-37
Reihaneh Manteghi, K. Kristó, G. Szakonyi, I. Csóka
With the increasing development of antibiotic resistance among key bacterial pathogens, there is an urgent need to discover novel classes of antibiotics. Although antimicrobial peptides (AMP) with their specific mode of action are considered major candidates for next-generation antibiotics, several challenges limit the use of these peptides for therapeutic applications. In a large body of research, the focus is given to different approaches to the chemical modification of AMPs and how these modifications may improve the stability, antibiotic activity, proteolytic activity and prevent the cytotoxicity and side effects of AMPs. On the other hand, another group of research investigates the delivery of AMPs via nanocarrier systems as strategies used to enhance stability, control the release of peptides and reduce adverse peptide-related side effects, as well as improve their anti-microbial activities. In the present article, we surveyed most recently published researches that provide us with good knowledge on structural features, mechanism of action, therapeutic aim, advantages and limitations, chemical modification approaches and carrying strategies of AMPs. Finally, according to Quality by Design, the most important potential effective factor and potential risk were mentioned in the development of AMP delivery systems.
{"title":"Recent insight into strategies for the design of antimicrobial peptides (AMPs)","authors":"Reihaneh Manteghi, K. Kristó, G. Szakonyi, I. Csóka","doi":"10.33892/aph.2022.92.20-37","DOIUrl":"https://doi.org/10.33892/aph.2022.92.20-37","url":null,"abstract":"With the increasing development of antibiotic resistance among key bacterial pathogens, there is an urgent need to discover novel classes of antibiotics. Although antimicrobial peptides (AMP) with their specific mode of action are considered major candidates for next-generation antibiotics, several challenges limit the use of these peptides for therapeutic applications. In a large body of research, the focus is given to different approaches to the chemical modification of AMPs and how these modifications may improve the stability, antibiotic activity, proteolytic activity and prevent the cytotoxicity and side effects of AMPs. On the other hand, another group of research investigates the delivery of AMPs via nanocarrier systems as strategies used to enhance stability, control the release of peptides and reduce adverse peptide-related side effects, as well as improve their anti-microbial activities. In the present article, we surveyed most recently published researches that provide us with good knowledge on structural features, mechanism of action, therapeutic aim, advantages and limitations, chemical modification approaches and carrying strategies of AMPs. Finally, according to Quality by Design, the most important potential effective factor and potential risk were mentioned in the development of AMP delivery systems.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91303817","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 : 2022-04-18DOI: 10.33892/aph.2022.92.45-51
Atilla A. Hincal, Cemre Özseven, M. J. van der Meer, A. Erenmemişoğlu, Mahmut Bilgiç, W. Martin
Aims: The aim of this study was to evaluate the pharmacokinetic profiles and the relative bioavailability of dexketoprofen and thiocolchicoside of the test preparation (dexketoprofen / thiocolchicoside 25 mg / 8 mg effervescent tablet) in comparison with the reference preparations (Keral 25 mg film coated tablet, containing dexketoprofen trometamol equivalent to 25 mg dexketoprofen (Menarini International Operations Luxembourg S.A.) (R1) and Muscoril 8 mg capsule, containing 8 mg thiocolchicoside (Sanofi Aventis İlaçları Ltd. Şti.) (R2) under fasting conditions. Methods: 25 healthy male subjects were enrolled in the study. Volunteers were hospitalised from the evening before drug administration (Day 0) until after the 24-hour blood sampling time on Day 2. Results: 24 subjects completed the study. Relative bioavailability (AUCT/AUCR1) of dexketoprofen from the test preparation was 100.99 %; (AUCT/AUCR2) of 3-O-glucuronide of thiocolchicoside (aglycone) from the test preparation was 100.47 %; (Cmax,T/Cmax,R1) of dexketoprofen from the test preparation was 122.59 %; (Cmax,T/Cmax,R2) of 3-O-glucuronide of thiocolchicoside (aglycone) from the test preparation was 111.43 %. Conclusions: The relative bioavailability AUCT /AUCR of the test preparation compared with both reference preparations is comparable, as shown by the geometric mean ratios of 100.59 % (dexketoprofen) and of 98.20 % (3-O-glucuronide of thiocolchicoside (aglycone).
目的:通过与参比制剂(Keral 25 mg薄膜包衣片，含dexketoprofen trometamol相当于25 mg dexketoprofen (Menarini International Operations Luxembourg S.A.) (R1)和Muscoril 8 mg胶囊)的对比，评价dexketoprofen和硫代红豆糖苷的药动学特征和相对生物利用度。在禁食条件下含有8mg硫代秋糖苷(赛诺菲安万特İlaçları Ltd. Şti.) (R2)。方法:选取25名健康男性受试者。志愿者从给药前晚上(第0天)开始住院，直到第2天24小时采血时间结束。结果:24名受试者完成了研究。dexketoprofen的相对生物利用度(AUCT/AUCR1)为100.99%;(AUCT/AUCR2): 3- o -硫代秋葡萄糖苷(糖苷元)的含量为100.47%;(Cmax,T/Cmax,R1)为122.59%;(Cmax,T/Cmax,R2)为111.43%。结论:两种参比制剂的相对生物利用度AUCT /AUCR具有可比性，其几何平均比值分别为100.59% (dexketoprofen)和98.20% (3-O-glucuronide of thiocolicoside (glycone))。
{"title":"Relative bioavailability study of a generic effervescent tablet formulation of dexketoprofen and thiocolchicoside versus the originator 25 mg film coated tablet (dexketoprofen) and 8 mg capsule (thiocolchicoside)","authors":"Atilla A. Hincal, Cemre Özseven, M. J. van der Meer, A. Erenmemişoğlu, Mahmut Bilgiç, W. Martin","doi":"10.33892/aph.2022.92.45-51","DOIUrl":"https://doi.org/10.33892/aph.2022.92.45-51","url":null,"abstract":"Aims: The aim of this study was to evaluate the pharmacokinetic profiles and the relative bioavailability of dexketoprofen and thiocolchicoside of the test preparation (dexketoprofen / thiocolchicoside 25 mg / 8 mg effervescent tablet) in comparison with the reference preparations (Keral 25 mg film coated tablet, containing dexketoprofen trometamol equivalent to 25 mg dexketoprofen (Menarini International Operations Luxembourg S.A.) (R1) and Muscoril 8 mg capsule, containing 8 mg thiocolchicoside (Sanofi Aventis İlaçları Ltd. Şti.) (R2) under fasting conditions. Methods: 25 healthy male subjects were enrolled in the study. Volunteers were hospitalised from the evening before drug administration (Day 0) until after the 24-hour blood sampling time on Day 2. Results: 24 subjects completed the study. Relative bioavailability (AUCT/AUCR1) of dexketoprofen from the test preparation was 100.99 %; (AUCT/AUCR2) of 3-O-glucuronide of thiocolchicoside (aglycone) from the test preparation was 100.47 %; (Cmax,T/Cmax,R1) of dexketoprofen from the test preparation was 122.59 %; (Cmax,T/Cmax,R2) of 3-O-glucuronide of thiocolchicoside (aglycone) from the test preparation was 111.43 %. Conclusions: The relative bioavailability AUCT /AUCR of the test preparation compared with both reference preparations is comparable, as shown by the geometric mean ratios of 100.59 % (dexketoprofen) and of 98.20 % (3-O-glucuronide of thiocolchicoside (aglycone).","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"38 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91453647","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 : 2022-04-18DOI: 10.33892/aph.2022.92.3-19
Beáta-Mária Benkő, I. Sebe, Z. Szabó
Aims: The role of insulin in the regulation of energy metabolism, protein synthesis, proliferation, migration, secretion by keratinocytes, endothelial cells, and fibroblasts suggests that its presence is essential for wound healing (WH). The present study aims to explore the opportunities and limitations of topical insulin (TI) formulations. Methods: To obtain a complete picture of the challenges of the local insulin formulation a chronological review of previous publications in electronic databases was performed, applying data collection and selection criteria. Results: The opportunity of topically applied insulin has shown active interest over time. According to studies, regular insulin and isophane are suitable for local use, but currently there is no consensus on the appropriate concentration. Insulin can be incorporated into cutaneous liquid, semisolid, and solid dosage forms, either by itself, or by prior nano-or microencapsulation methods. The most important limiting factors to be evaluated are the stability of the peptide and the sterility of the obtained products. Conclusion: Examination of the balance of opportunities and limitations of TI formulations, it can be concluded that the range of applicable technological methods is wide. A high-quality, safe, and efficacious form of TI would have great value from a socio-economic point of view.
{"title":"Insulin for topical use in wound healing: opportunities and limitations","authors":"Beáta-Mária Benkő, I. Sebe, Z. Szabó","doi":"10.33892/aph.2022.92.3-19","DOIUrl":"https://doi.org/10.33892/aph.2022.92.3-19","url":null,"abstract":"Aims: The role of insulin in the regulation of energy metabolism, protein synthesis, proliferation, migration, secretion by keratinocytes, endothelial cells, and fibroblasts suggests that its presence is essential for wound healing (WH). The present study aims to explore the opportunities and limitations of topical insulin (TI) formulations. Methods: To obtain a complete picture of the challenges of the local insulin formulation a chronological review of previous publications in electronic databases was performed, applying data collection and selection criteria. Results: The opportunity of topically applied insulin has shown active interest over time. According to studies, regular insulin and isophane are suitable for local use, but currently there is no consensus on the appropriate concentration. Insulin can be incorporated into cutaneous liquid, semisolid, and solid dosage forms, either by itself, or by prior nano-or microencapsulation methods. The most important limiting factors to be evaluated are the stability of the peptide and the sterility of the obtained products. Conclusion: Examination of the balance of opportunities and limitations of TI formulations, it can be concluded that the range of applicable technological methods is wide. A high-quality, safe, and efficacious form of TI would have great value from a socio-economic point of view.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"729 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74335383","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.2021.91.234-235
I. Mándity, J. Maléth, Beáta Mándityné Huszka, P. Pallagi, G. Heltovics
{"title":"EpiPharma – From Cutting Edge Synthesis Technologies to Complete Preclinical Characterization","authors":"I. Mándity, J. Maléth, Beáta Mándityné Huszka, P. Pallagi, G. Heltovics","doi":"10.33892/aph.2021.91.234-235","DOIUrl":"https://doi.org/10.33892/aph.2021.91.234-235","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"31 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73474914","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.2021.91.249-250
A. Kedves, Andrea Rónavári, Z. Kónya
contrast, at 25 mg/L GO NPs, NH 4 -N concentration in the effluent increased marginally after 5.5 day and was 2.39 mg/L after 7 days. In the case of 75 and 95 mg/L GO NPs, the effluent ammonia concentration continuously increased to 13.41 and 21.75 mg/L. The addition of GO NPs showed similar effects on COD removal efficiency than in case of NH 4 -N removal. In contrast, GO NPs influenced negatively the phosphorus removal, even at low concentration. When the SWW contained 15 and 95 mg/L GO NPs, the PO 4 - P concentration was 3.42 and 6.38 mg/L. Similar observations were also reported, wherein ZnO and CuO NPs negatively influenced the phosphorus removal in case of AGS [6,7]. At 15, 25, and 35 mg/L GO NPs, the secretion of polysaccharide (PS) slightly decreased, whereas the concentration of protein (PN) increased considerably ( Figure 1 )
{"title":"Effect Of Graphene Oxide Nanoparticles on the Performance of Aerobic Granular Sludge Treatment System","authors":"A. Kedves, Andrea Rónavári, Z. Kónya","doi":"10.33892/aph.2021.91.249-250","DOIUrl":"https://doi.org/10.33892/aph.2021.91.249-250","url":null,"abstract":"contrast, at 25 mg/L GO NPs, NH 4 -N concentration in the effluent increased marginally after 5.5 day and was 2.39 mg/L after 7 days. In the case of 75 and 95 mg/L GO NPs, the effluent ammonia concentration continuously increased to 13.41 and 21.75 mg/L. The addition of GO NPs showed similar effects on COD removal efficiency than in case of NH 4 -N removal. In contrast, GO NPs influenced negatively the phosphorus removal, even at low concentration. When the SWW contained 15 and 95 mg/L GO NPs, the PO 4 - P concentration was 3.42 and 6.38 mg/L. Similar observations were also reported, wherein ZnO and CuO NPs negatively influenced the phosphorus removal in case of AGS [6,7]. At 15, 25, and 35 mg/L GO NPs, the secretion of polysaccharide (PS) slightly decreased, whereas the concentration of protein (PN) increased considerably ( Figure 1 )","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"64 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74063154","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.2021.91.320-321
Petra Szalkai, Z. Pápay, L. Budai, Ágnes Sárádi-Kesztyűs, I. Antal
{"title":"Rheological Studies of Hydrogels and Liposomal Dispersions: Factors Influencing the Viscoelastic Properties","authors":"Petra Szalkai, Z. Pápay, L. Budai, Ágnes Sárádi-Kesztyűs, I. Antal","doi":"10.33892/aph.2021.91.320-321","DOIUrl":"https://doi.org/10.33892/aph.2021.91.320-321","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"761 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77522245","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.2021.91.142-143
F. Rădulescu, D. Miron, V. Shah
The Topical drug Classification System (TCS) is a framework specifically design for the comparative assessment of semisolid dosage forms. Compared to the Biopharmaceutics Classification System, TCS relies on the assessment of the qualitative and quantitative compositions as well as on the sensitivity of the in vitro release tests (IVRT) to signal potential differences in the microstructure. The arrangement of the components of the semisolid matrix is the complex results of the nature and intensity of interactions between the excipients, the impact of the manufacturing process and the changes which occurring during the shelf life of the product. When applied in vivo, a topical dosage form is subjected to shearing forces for spreading at the site of administration. The complexity of structural changes is difficult to simulate in vitro and a wide variety of methods have been proposed to evaluate the internal interactions for a cream, gel or ointment. For the comparative assessment of topical semisolids, the available guidance documents have strict requirements in terms of similarity of the qualitative and quantitative composition (Q1 and Q2). Differences in the amounts of the same excipients are usually limited to +/-5%, considering their potential role in the permeation and penetration across the skin barrier. Larger limits, i.e. +/10% are mentioned ingredients with specific functionality by the current version of the European Medicine Agency draft guidance on quality and equivalence of topical products. For mitigation of the risks associated with the manufacturing process, several rheological parameters are to be evaluated, i.e. yield stress, storage and loss modulus, zero-shear viscosities or areas and model parameters associated with the thixotropy loops. Considering the product-specific draft guidance issued by US-Food and Drug Administration (US-FDA), the assessment of Q3 (microstructural) similarity depends upon the complexity of the dosage forms and may include, in addition to rheology, specific parameters, such as particle or droplet size determination, crystal behavior, polymorphism, fraction of drug dissolved etc. IVRT was initially mentioned in the SUPAC-SS guidance of US-FDA (1997) for the evaluation of well defined, level 2 changes of composition or manufacturing process, based on the ability to reflect in aggregate the influence of several critical variables. Gradually, its role and applicability have been extended to comparison of topical semisolid across manufacturers. In the 1998 draft guidance Topical dermatological drug product NDA’s and ANDA’s In vivo bioavailability, bioequivalence, in vitro release, and associated studies, IVRT was proposed for the evaluation of the lower strength, once the bioequivalence for the higher strength of a generic product has been demonstrated in relation with the reference. Moreover, as part of “sponsor-specific comparability protocol”, IVRT was to be used for approval of more extensive variations,
{"title":"The Relations Between Q3 Measurements, In vitro Release and TCS","authors":"F. Rădulescu, D. Miron, V. Shah","doi":"10.33892/aph.2021.91.142-143","DOIUrl":"https://doi.org/10.33892/aph.2021.91.142-143","url":null,"abstract":"The Topical drug Classification System (TCS) is a framework specifically design for the comparative assessment of semisolid dosage forms. Compared to the Biopharmaceutics Classification System, TCS relies on the assessment of the qualitative and quantitative compositions as well as on the sensitivity of the in vitro release tests (IVRT) to signal potential differences in the microstructure. The arrangement of the components of the semisolid matrix is the complex results of the nature and intensity of interactions between the excipients, the impact of the manufacturing process and the changes which occurring during the shelf life of the product. When applied in vivo, a topical dosage form is subjected to shearing forces for spreading at the site of administration. The complexity of structural changes is difficult to simulate in vitro and a wide variety of methods have been proposed to evaluate the internal interactions for a cream, gel or ointment. For the comparative assessment of topical semisolids, the available guidance documents have strict requirements in terms of similarity of the qualitative and quantitative composition (Q1 and Q2). Differences in the amounts of the same excipients are usually limited to +/-5%, considering their potential role in the permeation and penetration across the skin barrier. Larger limits, i.e. +/10% are mentioned ingredients with specific functionality by the current version of the European Medicine Agency draft guidance on quality and equivalence of topical products. For mitigation of the risks associated with the manufacturing process, several rheological parameters are to be evaluated, i.e. yield stress, storage and loss modulus, zero-shear viscosities or areas and model parameters associated with the thixotropy loops. Considering the product-specific draft guidance issued by US-Food and Drug Administration (US-FDA), the assessment of Q3 (microstructural) similarity depends upon the complexity of the dosage forms and may include, in addition to rheology, specific parameters, such as particle or droplet size determination, crystal behavior, polymorphism, fraction of drug dissolved etc. IVRT was initially mentioned in the SUPAC-SS guidance of US-FDA (1997) for the evaluation of well defined, level 2 changes of composition or manufacturing process, based on the ability to reflect in aggregate the influence of several critical variables. Gradually, its role and applicability have been extended to comparison of topical semisolid across manufacturers. In the 1998 draft guidance Topical dermatological drug product NDA’s and ANDA’s In vivo bioavailability, bioequivalence, in vitro release, and associated studies, IVRT was proposed for the evaluation of the lower strength, once the bioequivalence for the higher strength of a generic product has been demonstrated in relation with the reference. Moreover, as part of “sponsor-specific comparability protocol”, IVRT was to be used for approval of more extensive variations,","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":"80398540","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.2021.91.138-139
Z. Holló
Biological drugs are highly innovative pharmaceuticals derived from living cells or organisms for the treatment of high-burden diseases such as cancer, autoimmune/chronic inflammatory, cardiovascular, metabolic and central nervous system diseases. Biosimilar medicines have been developed after the patent expiry of originator biological drugs in order to facilitate access to these effective drugs, at a reduced cost.
{"title":"Global Biosimilar Drug Development: Any Chance for Consolidation after 15 Years of Positive Regulatory Experience?","authors":"Z. Holló","doi":"10.33892/aph.2021.91.138-139","DOIUrl":"https://doi.org/10.33892/aph.2021.91.138-139","url":null,"abstract":"Biological drugs are highly innovative pharmaceuticals derived from living cells or organisms for the treatment of high-burden diseases such as cancer, autoimmune/chronic inflammatory, cardiovascular, metabolic and central nervous system diseases. Biosimilar medicines have been developed after the patent expiry of originator biological drugs in order to facilitate access to these effective drugs, at a reduced cost.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"588 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77221238","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.2021.91.167-168
L. Aloum, T. Al‐Tel, Hamadah M. Tarzi, D. Lorke, G. Petroianu
The unintended consequence of the ingestion of certain foods to alter the scent or color of urine is well known [1]. Less awareness exists regarding the practice of ingestion of natural products or drugs with the intended purpose of conferring urine the scent of violets [2]. The resin of the terebinth tree and the derived turpentine were widely used in Antiquity in wine-making, both as taste enhancer and conserving agent, so the effect on urine was possibly noticed due to the presence in wines [3]. The scent altering effect requires metabolic conversion of pinene, the main turpentine component to ionone, the molecule mainly responsible for the scent of violets [2,4]. The metabolic pathway (in humans or otherwise) was (to our knowledge) not yet described [4]. Thus, we here propose a possible metabolic pathway for the conversion of pinene to ionone, explaining the scent altering effect of turpentine.
{"title":"Possible Metabolic Transformation of Pinenes to Ionones","authors":"L. Aloum, T. Al‐Tel, Hamadah M. Tarzi, D. Lorke, G. Petroianu","doi":"10.33892/aph.2021.91.167-168","DOIUrl":"https://doi.org/10.33892/aph.2021.91.167-168","url":null,"abstract":"The unintended consequence of the ingestion of certain foods to alter the scent or color of urine is well known [1]. Less awareness exists regarding the practice of ingestion of natural products or drugs with the intended purpose of conferring urine the scent of violets [2]. The resin of the terebinth tree and the derived turpentine were widely used in Antiquity in wine-making, both as taste enhancer and conserving agent, so the effect on urine was possibly noticed due to the presence in wines [3]. The scent altering effect requires metabolic conversion of pinene, the main turpentine component to ionone, the molecule mainly responsible for the scent of violets [2,4]. The metabolic pathway (in humans or otherwise) was (to our knowledge) not yet described [4]. Thus, we here propose a possible metabolic pathway for the conversion of pinene to ionone, explaining the scent altering effect of turpentine.","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":"78253756","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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