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Scientia et Securitas
Author: György Miklós Keserű

Összefoglaló. A COVID–19-járvány egyre növekvő számú fertőzött betegének ellátása érdekében rövid időn belül szükség mutatkozott vírusellenes terápiás lehetőségekre. A gyors reagálás szempontját figyelembe véve erre a célra elsősorban más vírusok ellen már kifejlesztett vírusellenes szerek jöhetnek szóba. A magyar betegek ellátásbiztonsága szempontjából különösen fontos a hatóanyagok és gyógyszerkészítmények hazai gyártása. Ezt a cél tűzte ki a favipiravir, egy széles spektrumú antivirális hatóanyag hazai fejlesztése, amely sikeresen befejeződött, a gyógyszerkészítmény klinikai vizsgálata folyamatban van.

Summary. Increasing impact of COVID-19 on the healthcare system prompted the identification of potential antiviral therapies. Due to the immediate demand, known drugs were subjected to repositioning attempts. These drugs include agents inhibiting the viral entry into the host cells, drugs potentially blocking the release of the viral RNA from the endosomes, antivirals inhibiting the replication of the viral RNA and finally compounds that might prevent the assembly of the new virion. Since there is less experience with camostat and nafamostat, the entry inhibitors tested in Japan, and due to the ambiguous data collected with the endosome blocking chloroquine and hydroxyl-chloroquine, we focused on the actual antiviral treatment options for COVID-19 infections. In addition to favipiravir and remdesivir that were used early, at the onset of the pandemic, we discuss novel candidates including molnupiravir, a promising antiviral actually investigated in clinical trials. Considering the needs of Hungarian COVID patients and the security of supply as first priority, we selected favipiravir and developed a convenient process for the industry-scale production of the active pharmaceutical ingredient (API). At the end of this review we summarize the development and clinical investigation of favipiravir, a wide spectrum antiviral drug used for the treatment of mild and moderate COVID patients in Hungary in both ambulant and clinical settings. The Hungarian COVID Task Force set up two consortia, one for the development and the other for the clinical investigations of favipiravir. The objective of the favipiravir development consortium was to develop processes for the production of Favipiravir API and dosage forms. The consortium completed the pilot plant scale industrial production of the API and produced clinical samples for the upcoming trials. The selection and laboratory scale optimization of the synthesis route was performed at the Medicinal Chemistry Research Group of the Research Center for Natural Sciences. The laboratory scale synthesis was scaled up for pilot plant production at EVI plc and Gedeon Richter plc. GMP production was realized at the facilities of Gedeon Richter plc. Finished dosage forms were developed at Meditop Ltd who produced the clinical samples under GMP conditions. The clinical consortium is headed by the Hungarian section of the European Clinical Research Infrastructure Network (ECRIN) and organized two trials. One of these trials investigates favipiravir produced in Hungary while the other trial is performed with favipiravir produced in Japan. Both studies were approved by the Hungarian regulatory agency (OGYÉI) and are ongoing.

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Acta Chromatographica
Authors: M. Malesevic, L. Zivanovic, A. Protic, M. Radisic, M. Lausevic, Z. Jovic, and M. Zecevic

Handbook of Stability Testing in Pharmaceutical Development Springer Science New York . [31]. K.M. Alsante

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risks in pharmaceutical products originating from the manufacturing conditions. PAT-enabled tools are defined as tools that allow process understanding for scientific, risk-managed pharmaceutical development, manufacture, and quality assurance. The

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and safety. The method developed was merely focused on studying the analytes examined during pre- formulation phase of the pharmaceutical development. Then, the method was utilised to investigate the solubility's of the analytes in a organic solvent

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by design (AQbD) in pharmaceutical development . Am. Pharm. Rev. 2013 , 144191 . 19. ICH of Techical Requirements for Registration of Pharmaceuticals for Human Use ; Q8 R2 Pharmaceutical Development , http://www.ich.org/fileadmin/Public Web Site

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around the world have been highlighted. The power of flow has been seen in all phases of pharmaceutical development from hit to lead discovery to manufacturing. The uptake of flow in the earlier phases of drug discovery will only lead to more applications

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, 1043 – 1049 . 10.1016/j.talanta.2011.05.015 9. Ebrahimzadeh , H. ; Shekari , N. ; Saharkhiz , Z. ; Asgharinezhad , A.A. Talanta 2012 , 94 , 77 – 83 . 10.1016/j.talanta.2012.02.054 10. ICH Q8 (R2) . Pharmaceutical development 2009

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Interventional Medicine and Applied Science
Authors: Anand Maurya, Anurag Kumar Singh, Gaurav Mishra, Komal Kumari, Arati Rai, Bhupesh Sharma, Giriraj T. Kulkarni, and Rajendra Awasthi

, Liang XJ : Innovative pharmaceutical development based on unique properties of nanoscale delivery formulation . Nanoscale 5 , 8307 – 8325 ( 2013 ) 10.1039/c3nr01525d 21

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