Počet záznamů: 1
Industrial scale manufacturing and downstream processing of PLGA-based nanomedicines suitable for fully continuous operation
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SYSNO ASEP 0552535 Druh ASEP J - Článek v odborném periodiku Zařazení RIV J - Článek v odborném periodiku Poddruh J Článek ve WOS Název Industrial scale manufacturing and downstream processing of PLGA-based nanomedicines suitable for fully continuous operation Tvůrce(i) Operti, M. C. (NL)
Bernhardt, A. (DE)
Sincari, Vladimir (UMCH-V) ORCID, RID
Jäger, Eliezer (UMCH-V) ORCID, RID
Grimm, S. (DE)
Engel, A. (US)
Hrubý, Martin (UMCH-V) RID, ORCID
Figdor, C. G. (NL)
Tagit, O. (NL)Číslo článku 276 Zdroj.dok. Pharmaceutics. - : MDPI
Roč. 14, č. 2 (2022)Poč.str. 18 s. Jazyk dok. eng - angličtina Země vyd. CH - Švýcarsko Klíč. slova PLGA ; poly(lactic-co-glycolic acid) ; nanomedicine Vědní obor RIV CD - Makromolekulární chemie Obor OECD Polymer science Způsob publikování Open access Institucionální podpora UMCH-V - RVO:61389013 UT WOS 000765108700001 EID SCOPUS 85124366355 DOI 10.3390/pharmaceutics14020276 Anotace Despite the efficacy and potential therapeutic benefits that poly(lactic-co-glycolic acid) (PLGA) nanomedicine formulations can offer, challenges related to large-scale processing hamper their clinical and commercial development. Major hurdles for the launch of a polymeric nanocarrier product on the market are batch-to-batch variations and lack of product consistency in scale-up manufacturing. Therefore, a scalable and robust manufacturing technique that allows for the transfer of nanomedicine production from the benchtop to an industrial scale is highly desirable. Downstream processes for purification, concentration, and storage of the nanomedicine formulations are equally indispensable. Here, we develop an inline sonication process for the production of polymeric PLGA nanomedicines at the industrial scale. The process and formulation parameters are optimized to obtain PLGA nanoparticles with a mean diameter of 150 ± 50 nm and a small polydispersity index (PDI < 0.2). Downstream processes based on tangential flow filtration (TFF) technology and lyophilization for the washing, concentration, and storage of formulations are also established and discussed. Using the developed manufacturing and downstream processing technologies, production of two PLGA nanoformulations encasing ritonavir and celecoxib was achieved at 84 g/h rate. As a measure of actual drug content, encapsulation efficiencies of 49.5 ± 3.2% and 80.3 ± 0.9% were achieved for ritonavir and celecoxib, respectively. When operated in-series, inline sonication and TFF can be adapted for fully continuous, industrial-scale processing of PLGA-based nanomedicines. Pracoviště Ústav makromolekulární chemie Kontakt Eva Čechová, cechova@imc.cas.cz ; Tel.: 296 809 358 Rok sběru 2023 Elektronická adresa https://www.mdpi.com/1999-4923/14/2/276
Počet záznamů: 1