Acta pharmaceutica Hungarica最新文献

{"title":"The Application of 3D Printing in the Formulation of Personalized Drug Delivery Systems","authors":"Bálint Basa, G. Jakab, E. Balogh, Bence Borbás, I. Antal","doi":"10.33892/aph.2021.91.179-180","DOIUrl":"https://doi.org/10.33892/aph.2021.91.179-180","url":null,"abstract":"the interest toward additive manufacturing is growing considering the formulation of personalized medicines [1]. 3D printing is commonly an additive process, which results in various layer-bylayer built objects. A vast number of methods are available beyond 3D Printing but there are only few of them which can be employed for tailored pharmaceutical manufacturing (e.g. Photopolymerization, Selective Laser Sintering (SLS) and Fused Deposition Modelling (FDM)) [2]. During these methods the number of unit operations is minimalized, and the opportunity to fabricate every single printlet shaped according to the individuals’ profile with only minimal human intervention can be the cause of the increased research activity in this field [3]. The additional benefit of this type of manufacturing is the capability of producing customized ways of medication for pediatrics, geriatrics and patients suffering from organ dsyfunctions, avoiding the slightest chance of reaching toxic doses in their body. Several types of dosage forms were previously microfabricated including floating systems, pulsatile drug release tablets and zero-order release forms [4]. The first 3D printed orodispersible tablet was approved by the FDA in 2015.[5] The objective of our study was to design and print biodegradable drug delivery systems. Commercially available filament materials were screened as well as the print settings were optimized. In addition, the influence of design parameters including wall thickness, morphology, number and size of pores on the drug delivery in case of model drugs was investigated. Moreover, the applicability of matrix polymers and gelling agents in the process of 3D printing was studied. There were some formulations aiming the study of dose proportionality, in order to expand the opportunities of personalized medication. 2. Materials and methods","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"567 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83353972","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":"Lipopeptide Nanoparticulate Vaccine Candidates for the Induction of Protective Immune Responses","authors":"I. Toth, M. Skwarczynski","doi":"10.33892/aph.2021.91.124-125","DOIUrl":"https://doi.org/10.33892/aph.2021.91.124-125","url":null,"abstract":"The development of an effective vaccine for group A streptococci (GAS) has been challenged by the induced autoimmunity of epitopes derived from the C-repeat regions. Additionally, there are B-cell epitopes that have been shown to react with human heart tissue. Shorter safe B-cell epitopes, show little or no immunogenicity unless bound to a delivery platform including the conjugation to an inbuilt adjuvant. Self-adjuvanting lipid core peptide (LCP) systems where the antigen(s), carrier and adjuvant were within the same molecular entity has been developed. The LCP amphiphilic construct was incorporated into liposomes to produce particles with the desired size. The construct alone elicited high-levels of antibody titers comparable to that of the positive control (J8 + Complete Freund’s adjuvant). The developed strategy to produce nanoparticles, consisting of a peripheral antigenic epitope layer conjugated to a dendrimer core, which is both self-adjuvanting and produces a strong immune response to the GAS M-protein, offers an attractive alternative to conventional vaccine approaches. The greatest advantage of this system being the generation of protective immune response after oral administration. Our dendrimer-nanoparticles vaccine approach should be readily acquiescent to other pathogenic organisms in addition to GAS, and may prove particularly useful for the design of vaccines against infection deceases know to stimulate autoimmune response in a host.","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":"90797487","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":"Image Analysis: A Novel Method in the Assessment of Pharmaceutical Foams","authors":"D. Farkas, Nikolett Kállai-Szabó, I. Antal","doi":"10.33892/aph.2021.91.204-205","DOIUrl":"https://doi.org/10.33892/aph.2021.91.204-205","url":null,"abstract":"For almost half a century foams have been present in the pharmaceutical markets worldwide. Generally, they can be defined as thin liquid or solid film separated gas bubble agglomerations, but the pharmacopoeial monograph of medicated foams recognizes only the aforementioned 1,2. Pharmaceutical foams offer an outstanding alternative to conventional dosage forms in topical treatment. Apart from the satisfactory drug delivery ability, the ease and convenience of application contributes to the high acceptance and excellent patient compliance of this dosage form. Despite the growing interest for foams, the current pharmacopoeial examinations are not sufficient for the description of their unique nature and virtue. Although image analysis can not provide an exhaustive overview on foams, it offers a great complementary method for their assessment 3,4. This research aims to demonstrate the extensive applicability of image analysis in the evaluation process of pharmaceutical foams. It also aims to make assumptions on important foam characteristics based on the composition and the microand macroscopic properties of foams.","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":"91070820","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":"Study on Drug Release from Oleogel Carriers","authors":"Zsófia Vilimi, M. Hajdú, Nikolett Kállai-Szabó, I. Antal","doi":"10.33892/aph.2021.91.328-329","DOIUrl":"https://doi.org/10.33892/aph.2021.91.328-329","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":"91070909","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":"Berberine-loaded Nano-Liposomes Generated with Ethanol-Injection and Thin-film Hydration Methods","authors":"Duong Thi Thuan, A. Isomäki, Urve Paaver, Ivo Laidmäe, A. Tõnisoo, Tran Thi Hai Yen, Karin Kogermann, A. Raal, J. Heinämäki, Pham Thi Minh Hue","doi":"10.33892/aph.2021.91.293-295","DOIUrl":"https://doi.org/10.33892/aph.2021.91.293-295","url":null,"abstract":"The poor solubility in water is very often a problem for active pharmaceutical substances of plant origin. The formulation of such drugs as liposomal preparations enables to improve the bioavailability of these drugs. Berberine (BBR) is a quaternary isoquinoline alkaloid derived from many native plant species (Coptis spp., Berberis spp., Hydrastis canadensis etc.). BBR has been traditionally used for the treatment of different disorders including hyper-cholesterolemia and cardiovascular diseases [1,2]. BBR has a strong antimicrobial activity enabling the use of it as an anti-diarrheal, anti-protozoal, fungal, candida, yeast, and parasitic intestinal active ingredient [3]. In addition, BBR has shown an anti-inflammatory, anti-diabetic, lipid peroxidation, and neuroprotective activity [3,4]. Unfortunaterly, BBR is poorly soluble in water and has a low bioavailability (<10%) due to the induced activity of multidrug efflux transporter Pglycoprotein (P-gp) in the intestine itself [2]. Such limitations associated with a poor oral bioavailability of BBR could be overcome by nanoformulating BBR to liposomes. Pharmaceutical liposomes can be fabricated by ethanol-injection and thin-film hydration methods. The lamellarity, size, shape and ultra-structure of liposomes can be determined by using different advanced techniques, such as cryogenic electron microscopy (Cryo-EM), dynamic light scattering (DLS), size-exclusion chromatography (SEC), and atomic force microscopy (AFM) [5]. Confocal laser scanning microscopy (CLSM) has been also used for such imaging [6]. The aim of our study is to investigate ethanolinjection and film hydration methods for generating BBR-loaded liposomes and to study the structure, size, size distribution and entrapment efficiency of the liposomes. The liposomes are ultimately intended for the oral treatment of hypercholesterolemia.","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77176836","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":"Regulatory Science Challenges : Encouraging Innovation Through an Adaptive Regulatory System","authors":"K. Fodor","doi":"10.33892/aph.2021.91.106-107","DOIUrl":"https://doi.org/10.33892/aph.2021.91.106-107","url":null,"abstract":"ATMPs - a new era A boy from Hungary, Zente, was one and a half years old when the crowd-funding campaign to finance his life-saving medicine Zolgensma concluded with a happy end. He was the third European patient that received the new gene therapy, which replaces the function of the missing or nonworking survival motor neuron 1 (SMN1) gene with a new, working copy of a human SMN gene that helps motor neuron cells work properly and survive. From a European perspective, it has been almost 15 years by now since regulatory framework for advanced therapy medicinal products (ATMPs) had been established to ensure the free movement of these medicines within the European Union, to facilitate their access to the EU market, and to foster the competitiveness of European pharmaceutical companies in the field. Zolgensma has been approved in the EU in May 2020. The FDA expects it will be reviewing and approving up to 20 cell and gene therapies each year until 2025. Rapid development of technology and better understanding of the manufacturing challenges are not the only prerequisites of the growth. Assessment of products like Zolgensma requires very specific knowledge and often an adaptive approach from regulators. They have to gain enough experience and need to be able to summarize knowledge in guidelines that would help developers of products that are substantially different from traditional medicines. FDA issued seven new guidelines in January 2020, in which, for example, they highlight the importance of long-term follow-up for gene therapies that offer one-time fix for inherited diseases and where pre-market studies may have limited value. 2. Regulatory tools These examples may already show that rapid change in technology leads to new kinds of medicines that require a properly adapted regulatory system. Patients would expect state-of-the-art medicines within the shortest possible time frame, however, authorities are traditionally more cautious. Still, there are several various initiatives from the EMA and the FDA to foster early access to medicines. Some of these have been available for a longer time. EMA's accelerated assessment reduces the timeframe for review of innovative applications of medicines with major public health interest. Conditional marketing authorisation grants authorization before a complete dataset is available, and compassionate use allows the use of an unauthorized medicine for patients with an unmet medical need. A more recent regulatory tool of EMA is the priority medicines scheme (PRIME) that aims to enhance support for the development of medicines that are expected to make a real difference to patients. Early dialogue between EMA and the developers is a crucial part of the tool, together with accelerated assessment and continuous scientific advice and protocol assistance. Up to now, 282 applications for PRIME eligibility have been assessed by the CHMP of which 95 have received a green light. Most of the applicants are small and medi","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73460152","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":"Structural Analysis of Human Glycoproteins by Tandem Mass Spectrometry","authors":"A. Ács, Dániel Szabó, K. Vékey, G. Sármay, L. Drahos, Lilla Turiák","doi":"10.33892/aph.2021.91.163-164","DOIUrl":"https://doi.org/10.33892/aph.2021.91.163-164","url":null,"abstract":"The process of glycosylation is a highly conserved mechanism among species. The enzymatic addition of oligosaccharide chain to the protein significantly changes the physicochemical properties and protein-protein interactions. Therefore glycosylation considered as a CQA (Critical Quality Attribute) for biopharmaceutical products. At this point there is no routinely used, widespread analytical method to determine glycosylation. This may derive from the fact that the term glycosylation summarizes various features. The most often examined feature is the relative abundance of glycoforms. The position of different sugar residues within the oligosaccharide chain has been less frequently analyzed. In this study we have developed a method which, in addition to the commonly investigated features, determines the structural position of the fucose residue. We have examined glycosylation of three proteins: AGP (alpha-1-acid glycoprotein), PSA (Prostate Specific Antigen) and IgG (Immunoglobulin G).","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":"75879761","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":"Is the Multi-Attribute Method (MAM) the Next Big Thing? A High-Resolution Accurate Mass Multi-Attribute Method for Critical Quality Attribute Monitoring","authors":"Orsolya Kóréh, L. Milivojevic","doi":"10.33892/aph.2021.91.154-155","DOIUrl":"https://doi.org/10.33892/aph.2021.91.154-155","url":null,"abstract":"the focus has turned to automation and software development to allow for automated identification and quantitative analysis of each molecular attribute. With automation and software developments, a true benefit of MAM can be realized by building a comprehensive molecular attribute database linked to process conditions which can then be used to increase product and process knowledge throughout the development pipeline. With this increased product and process knowledge, MAM can reduce the amount of time taken to develop a product, reduce the time needed to manufacture and release a product by add-ing efficient process controls, and reduce the time needed to investigate a process issue. MAM can help to solve major manufacturing challenges plaguing the biopharmaceutical industry today as they strive to develop more biotherapeutics on a faster timeline. The multi-attribute for the of monoclonal critical quality describe the optimization and applica-tion of the Multi- Attribute Method as a complete workflow to monitor CQAs of the NISTmAb including glycosylation, deamidation, isomerization, succinimide formation, oxidation,","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"138 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73017269","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":"Revolutionary Application of 3D-Two-Photon Microscopes for Human Therapy and Drug Research","authors":"Z. Mucsi, Gergely Szalay, G. Katona, B. Rózsa","doi":"10.33892/aph.2021.91.278-279","DOIUrl":"https://doi.org/10.33892/aph.2021.91.278-279","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"48 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78489905","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":"Comparative Dissolution Study of Coated Pellets Containing Microcrystalline Cellulose and Lactose As Core Materials","authors":"Á. Barna, K. Sántha, Nikolett Kállai-Szabó, E. Balogh, Bálint Basa, G. Jakab, I. Antal","doi":"10.33892/aph.2021.91.177-178","DOIUrl":"https://doi.org/10.33892/aph.2021.91.177-178","url":null,"abstract":"","PeriodicalId":6941,"journal":{"name":"Acta pharmaceutica Hungarica","volume":"123 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79478837","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}