HPLC method development for fampridine using Analytical Quality by Design approach

Offering a systematic and multivariate analysis of the analytical procedure, development and validation of HPLC methods using Quality by Design approach are in the limelight of current research trends. A new, experimental design-aided HPLC method for fampridine was developed and preliminarily validated according to current in-force international guidelines for linearity, accuracy, robustness and precision. The method offers a high throughput sample analysis, with an elution time of 2.9 minutes, and signal detection without excipient interference performed at 262 nm. The method proved to be linear between 1–15 µg mL–1 (R2 = 0.9996). The mean recovery was found to be 98.7 ± 1.9 % in the tested range of 2.5–7.5 µg mL–1. Low RSD values (< 1 %) were obtained for both model, intra- and inter-day precision. The limit of detection and limit of quantification were 0.24 and 0.78 µg mL–1, resp. The method proved to be applicable for active substance assay in a pharmaceutical dosage form

Quality-by-design in pharmaceutical development: From current perspectives to practical applications

Current pharmaceutical research directions tend to follow a systematic approach in the field of applied research and development. The concept of quality-by-design (QbD) has been the focus of the current progress of pharmaceutical sciences. It is based on, but not limited, to risk assessment, design of experiments and other computational methods and process analytical technology. These tools offer a well-organized methodology, both to identify and analyse the hazards that should be handled as critical, and are therefore applicable in the control strategy. Once implemented, the QbD approach will augment the comprehension of experts concerning the developed analytical technique or manufacturing process. The main activities are oriented towards the identification of the quality target product profiles, along with the critical quality attributes, the risk management of these and their analysis through in silico aided methods. This review aims to offer an overview of the current standpoints and general applications of QbD methods in pharmaceutical development

A társadalmi tanulási folyamatok szerepe a megújuló energiahordozókkal kapcsolatos ismeretekben két magyarországi megye példáján

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Differentiation of Mycoplasma gallisepticum strains using molecular methods

Increasing use of Mycoplasma gallisepticum (MG) live vaccines has led to a need for the differentiation of MG strains. The MG strains MK-7, MS-16, S6, FS-9 and R strains and the MG live vaccine strain F were compared by random amplification of polymorphic DNA (RAPD) in this study. Using RAPD, different patterns were found among the MG strains. In addition to this, we examined the differentiating potential of polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) primers targeted at the crmA, crmB, crmC, gapA, mgc2 and pvpA genes encoding cytadherence-related surface proteins. These proteins may take part in the pathogenesis of MG-induced disease. Differentiation of strain F is based on the identification of restriction enzyme sites in the PCR amplicons. Using HphI enzyme, crmC PCR amplicons produced different RFLP patterns. Digestion of amplicons of gapA-specific PCR with MboI enzyme also produced distinct patterns. Differences were observed among strains R and F by digestion of mgc2 PCR amplicons with HaeIII and VspI enzymes and digestion of pvpA PCR amplicons with AccI, PvuII and ScrFI endonucleases. This method can be used for the rapid differentiation of vaccine strain from wild strains. Differentiation of MG strains is a great advantage for diagnosticians or practitioners and it is useful for epidemiological studies

HPLC method development for fampridine using Analytical Quality by Design approach

Offering a systematic and multivariate analysis of the analytical procedure, development and validation of HPLC methods using Quality by Design approach are in the limelight of current research trends. A new, experimental design-aided HPLC method for fampridine was developed and preliminarily validated according to current in-force international guidelines for linearity, accuracy, robustness and precision

Binding of mycoplasmas to solid phase adsorbents

The capture of mycoplasmas (M. hominis, M. buccale, M. fermentans, M. bovis, M. synoviae, M. gallisepticum and M. arthritidis) based on lipid structures and adhesion molecules present in the mycoplasmal membrane was tested using different chromatographic resins (ActiClean Etox, ClarEtox, Heparin-Actigel, Sulfated Hiflow and SulfEtox). All of the resins efficiently reduced mycoplasma concentrations in Phosphate Buffered Saline (PBS) and in Fetal Bovine Serum (FBS) by 3-8 logs in a few minutes. This technology could be used for removing mycoplasmas from tissue culture components such as serum, and for concentrating mycoplasmas in vaccine production

From genomes to diaries: a 3-year prospective, real-life study of ragweed-specific sublingual immunotherapy

During the last decades, the prevalence of allergy has dramatically increased. Allergen-specific immunotherapy is the only currently available medical intervention that has the potential to affect the natural course of the disease, but there are still many questions and unmet needs hindering its widespread use to fulfill its treatment potential and maximize its benefits for the society. To provide a comprehensive phenome-wide overview in sublingual immunotherapy, using ragweed allergy as a target, we planned and carried out a longitudinal, prospective, observational, open-label study (DesensIT). In this paper we present challenges of using deep and comprehensive phenotypes embracing biological, clinical and patient-reported outcomes in allergen-specific immunotherapy and show how we designed the DesensIT project to optimize data collection, processing and evaluation

Structural changes in Polish and Hungarian agriculture since EU accession: lessons learned and implications for the design of future agricultural policies

Hungary’s accession to the European Union (EU) has had a significant impact on the agro-food sector. On accession the country became part of a large, organised but highly competitive market which offered great opportunities for the stakeholders but also brought along serious challenges. Newly accessing Member States not only had to cope with competition within the EU but also in their domestic markets, resulting in significant economic, social and environmental changes. In general, EU accession has had a positive impact on the ‘new’ Member States (i.e. those that joined from 2004 onwards) although each country has used the opportunities in different ways. Each country has enjoyed benefits from EU accession but Poland has managed to adapt the most to the conditions that were set by the EU and has exploited the potential well. One of the most critical factors in this process has been the agricultural and support policy followed in the years before EU accession. If the available subsidies had been used primarily to promote improvements in producer competitiveness they would have been very beneficial. However, in Hungary subsidies mainly took the form of price support and consequently the opportunities provided by the accession to the EU were not fully exploited. Those countries where the level of subsidies was lower and price support was minimal have responded to EU membership in a more positive way. For Hungary an understanding of the workings of the food economy in Poland is particularly important because this country not only represents the largest market among the countries of the Visegrad Group but its food economy has developed remarkably in the decade since EU accession. Poland has evolved from being a net importer of agricultural and food products to a net exporter and in recent years Hungary has incurred its largest deficit in agricultural and food exports in trade with Poland. This is the first publication that the Research Institute of Agricultural Economics, during its 60 years of existence, has produced in close cooperation with a foreign partner institution and it aims to give a detailed comparison of the food economies of the two countries. This book provides instructive and useful knowledge for researchers, stakeholders in the agro-food sector and agricultural policy decision makers and we hope that it will be followed by similar volumes in the coming years