Acta pharmaceutica Hungarica最新文献

{"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}

{"title":"Glycopeptide Antibiotic Derivatives Against Resistant Bacteria","authors":"Ilona Bereczki, Z. Szűcs, Erzsébet Rőth, E. Lőrincz, M. Milánkovits, E. Ostorházi, Zsuzsanna Dombrádi, A. Borbás, P. Herczegh","doi":"10.33892/aph.2021.91.173-174","DOIUrl":"https://doi.org/10.33892/aph.2021.91.173-174","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"43 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79075734","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}

{"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}

{"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}

{"title":"Formulation of Apigenin-Loaded Liposomes for Pulmonary Delivery","authors":"Sabrina Magramane, Z. Pápay, Anna Kovács, R. Zelkó, I. Antal","doi":"10.33892/aph.2021.91.268-269","DOIUrl":"https://doi.org/10.33892/aph.2021.91.268-269","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":"78388433","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}

{"title":"Formulation and Physicochemical Characterization of NLC–miRNA Complexes","authors":"Amina Tucak-Smajić, E. Vranić, M. Sirbubalo, Lamija Hindija, O. Rahić, J. Hadžiabdić, I. Klebovich, A. Zimmer","doi":"10.33892/aph.2021.91.334-336","DOIUrl":"https://doi.org/10.33892/aph.2021.91.334-336","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"137 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78574244","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}

{"title":"Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic Method for the Determination of Domperidone in Bulk and Pharmaceutical Dosage Forms","authors":"Fateme Chavoshy, Niloofar Nejati, A. Mohammadi, N. Adib, Azam Sadat Montazeri","doi":"10.33892/aph.2021.91.191-192","DOIUrl":"https://doi.org/10.33892/aph.2021.91.191-192","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88474833","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}

{"title":"Characteristics and Mechanisms of the Hypersensitivity Reactions Caused by Nanodrugs in Mice","authors":"Erik Őrfi, T. Mészáros, László Hricisák, L. Dézsi, P. Hamar, L. Rosivall, Z. Benyó, J. Szebeni, G. Szénási","doi":"10.33892/aph.2021.91.284-286","DOIUrl":"https://doi.org/10.33892/aph.2021.91.284-286","url":null,"abstract":"","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":"88725606","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}

{"title":"Vaccine Development in Global Pandemic Time","authors":"Tibor Fabó","doi":"10.33892/aph.2021.91.95-96","DOIUrl":"https://doi.org/10.33892/aph.2021.91.95-96","url":null,"abstract":"Introduction Pfizer-BioNTech collaboration started in 2018 in order to develop mRNA flu vaccine. Because of the covid19 pandemic the two companies started to focus on mRNA vaccine development for the prevention of covid19 infection. In March they signed the Letters of Intent. Initially there were four vaccine candidates including unmodified mRNA, nucleoside-modified mRNA and self-amplifying mRNA. For further development the nucleoside- modified mRNA was chosen. In April Phase 1/2 study was completed in Germany and in May in the USA. Two 30 μg doses 3 weeks apart induced neutralizing antibody titers comparable to natural infection and strong CD4+ and CD8+ Tcell responses were observed. Phase 2b/3 clinical trial started in July involving more than 43.000 participants in 153 sites. The result showed 95% efficacy with mild and moderate local and systemic events. For safety reason all participants will be followed for 2 years after the second dose. Based on rolling review regulatory agencies were able to approve within a short period of time in December 2020, first MHRA in UK, then FDA authorized for Emergency Use and EMA granted Conditional Marketing Authorization on 21 December 2021 for 16 years old and older. The first shipments were sent all European countries on 27 December. Direct shipments to vaccination centers on ultra-low temperature (minus 9060 degree of centigrade) using dry ice. Each thermal shipping container has a temperature monitoring device. All shipments are tracked via GPS monitoring device to ensure end-to-end distribution within required temperatures. In May EMA granted an extension of indication for covid-19 vaccine to include in children aged 12-15. The effect of vaccine was investigated in 2260 children aged 12-15, about half of them received dummy injection. Of the 1,005 children receiving the vaccine, none developed COVID-19 compared to 16 children out of the 978 who received the dummy injection. This means that, in this study, the vaccine was 100% effective at preventing COVID-19. The most common side effects in children aged 12 to 15 are similar like those in people aged 16 and above. They include pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever. These effects are usually mild or moderate and improve within a few days from the vaccination. EMA granted approval for booster dose (third dose) for immune weakened people 28 days after the second dose, and 6 months after the second dose for 18 years of age and older. Approval is based on the clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of covid-19 vaccine. A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to mo","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":"91330768","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}

{"title":"Flowability of Pharmaceutical Powders: Impact of Humidity","authors":"Daniela Ehgartner, H. Weingrill, Timothy Aschl, D. Schuetz","doi":"10.33892/aph.2021.91.340-341","DOIUrl":"https://doi.org/10.33892/aph.2021.91.340-341","url":null,"abstract":"Surrounding conditions impact the behavior of many powders. Depending on the geographical location, bulk solids exhibit differing flowability due to different environmental conditions, e.g. Caracas (30°C, 80 %rH) vs. Boulder/Colorado (25°C, 35 %rH). The powder adjusts dynamically to its environmental condition until reaching saturation at a certain point (1). Besides that, many powders show a “sticky point”. At this point, a significant change in flow and adhesion behavior has been reported (2). Granular media generally tend to increase their cohesive character when surrounded by moisture. This is attributed to several mechanisms whereas formation of adhesive films on the grain surface, liquid bridging between the grains, or if the cohesive behavior decreases, a “lubrication” of the interstitials between grains are considered as the main underlying mechanisms (3). The investigated powder is a pharmaceutical cold and flu hot drink which comprises high amounts of vitamin C, citric acid, sugar and pharmaceutically active materials. The powder exhibits a tendency to cake and time consolidate. This is most likely due to a partial dissolution in condensed water as Groen et al. suggests for a pure citric acid (2). This partial dissolution is desired as the powder is supposed to dissolve in water. As the investigated powder contains a large amount of citric acid as well, a similar “sticky point” is expected. However, this property results in the forming of knots and clumps which is problematic for storage and processing. Thus, the aim of the presented work is to investigate changes in the powder’s flowability behavior after exposure to different relative humidity levels as well as to investigate the difference between consolidated and non-consolidated samples with the help of powder shear cell measurements. 2. Methods","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":"82012202","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}