Airama Albisa1,2,3, Emma Piacentini4, Victor Sebastian5,6, Manuel Arruebo1,7, Jesus Santamaria1,7, Lidietta Giorno3. 1. Department of Chemical & Environmental Engineering & Nanoscience Institute of Aragon (INA),, University of Zaragoza,, Mariano Esquillor edif. I+D,, 50018, Zaragoza, Spain. 2. Department of Environmental and Chemical Engineering, University of Calabria (DIATIC-UNICAL),, via P. Bucci Cubo 45a, 87036, Rende, CS, Italy. 3. Institute on Membrane Technology,, National Research Council ITM-CNR, Via P. Bucci 17/C, 87036, Rende, CS, Italy. 4. Institute on Membrane Technology,, National Research Council ITM-CNR, Via P. Bucci 17/C, 87036, Rende, CS, Italy. e.piacentini@itm.cnr.it. 5. Department of Chemical & Environmental Engineering & Nanoscience Institute of Aragon (INA),, University of Zaragoza,, Mariano Esquillor edif. I+D,, 50018, Zaragoza, Spain. victorse@unizar.es. 6. CIBER de Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), Centro de Investigación Biomédica en Red, C/Monforte de Lemos 3-5, Pabellón 11, 28029, Madrid, Spain. victorse@unizar.es. 7. CIBER de Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), Centro de Investigación Biomédica en Red, C/Monforte de Lemos 3-5, Pabellón 11, 28029, Madrid, Spain.
Abstract
PURPOSE: The aim of this work is to develop a scalable continuous system suitable for the formulation of polymeric nanoparticles using membrane-assisted nanoprecipitation. One of the hurdles to overcome in the use of nanostructured materials as drug delivery vectors is their availability at industrial scale. Innovation in process technology is required to translate laboratory production into mass production while preserving their desired nanoscale characteristics. METHODS: Membrane-assisted nanoprecipitation has been used for the production of Poly[(D,L lactide-co-glycolide)-co-poly ethylene glycol] diblock) (PLGA-PEG) nanoparticles using a pulsed back-and-forward flow arrangement. Tubular Shirasu porous glass membranes (SPG) with pore diameters of 1 and 0.2 μm were used to control the mixing process during the nanoprecipitation reaction. RESULTS: The size of the resulting PLGA-PEG nanoparticles could be readily tuned in the range from 250 to 400 nm with high homogeneity (PDI lower than 0.2) by controlling the dispersed phase volume/continuous phase volume ratio. Dexamethasone was successfully encapsulated in a continuous process, achieving an encapsulation efficiency and drug loading efficiency of 50% and 5%, respectively. The dexamethasone was released from the nanoparticles following Fickian kinetics. CONCLUSIONS: The method allowed to produce polymeric nanoparticles for drug delivery with a high productivity, reproducibility and easy scalability.
PURPOSE: The aim of this work is to develop a scalable continuous system suitable for the formulation of polymeric nanoparticles using membrane-assisted nanoprecipitation. One of the hurdles to overcome in the use of nanostructured materials as drug delivery vectors is their availability at industrial scale. Innovation in process technology is required to translate laboratory production into mass production while preserving their desired nanoscale characteristics. METHODS: Membrane-assisted nanoprecipitation has been used for the production of Poly[(D,L lactide-co-glycolide)-co-poly ethylene glycol] diblock) (PLGA-PEG) nanoparticles using a pulsed back-and-forward flow arrangement. Tubular Shirasu porous glass membranes (SPG) with pore diameters of 1 and 0.2 μm were used to control the mixing process during the nanoprecipitation reaction. RESULTS: The size of the resulting PLGA-PEG nanoparticles could be readily tuned in the range from 250 to 400 nm with high homogeneity (PDI lower than 0.2) by controlling the dispersed phase volume/continuous phase volume ratio. Dexamethasone was successfully encapsulated in a continuous process, achieving an encapsulation efficiency and drug loading efficiency of 50% and 5%, respectively. The dexamethasone was released from the nanoparticles following Fickian kinetics. CONCLUSIONS: The method allowed to produce polymeric nanoparticles for drug delivery with a high productivity, reproducibility and easy scalability.
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