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Manufacturing Considerations for the Development of Lipid Nanoparticles Using Microfluidics.
Roces, Carla B; Lou, Gustavo; Jain, Nikita; Abraham, Suraj; Thomas, Anitha; Halbert, Gavin W; Perrie, Yvonne.
  • Roces CB; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK.
  • Lou G; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK.
  • Jain N; Precision NanoSystems Inc., #50 655 W Kent Ave N, Vancouver, BC V6P 6T7, Canada.
  • Abraham S; Precision NanoSystems Inc., #50 655 W Kent Ave N, Vancouver, BC V6P 6T7, Canada.
  • Thomas A; Precision NanoSystems Inc., #50 655 W Kent Ave N, Vancouver, BC V6P 6T7, Canada.
  • Halbert GW; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK.
  • Perrie Y; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK.
Pharmaceutics ; 12(11)2020 Nov 15.
Article in English | MEDLINE | ID: covidwho-937530
ABSTRACT
In the recent of years, the use of lipid nanoparticles (LNPs) for RNA delivery has gained considerable attention, with a large number in the clinical pipeline as vaccine candidates or to treat a wide range of diseases. Microfluidics offers considerable advantages for their manufacture due to its scalability, reproducibility and fast preparation. Thus, in this study, we have evaluated operating and formulation parameters to be considered when developing LNPs. Among them, the flow rate ratio (FRR) and the total flow rate (TFR) have been shown to significantly influence the physicochemical characteristics of the produced particles. In particular, increasing the TFR or increasing the FRR decreased the particle size. The amino lipid choice (cationic-DOTAP and DDAB; ionisable-MC3), buffer choice (citrate buffer pH 6 or TRIS pH 7.4) and type of nucleic acid payload (PolyA, ssDNA or mRNA) have also been shown to have an impact on the characteristics of these LNPs. LNPs were shown to have a high (>90%) loading in all cases and were below 100 nm with a low polydispersity index (≤0.25). The results within this paper could be used as a guide for the development and scalable manufacture of LNP systems using microfluidics.
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Full text: Available Collection: International databases Database: MEDLINE Topics: Vaccines Language: English Year: 2020 Document Type: Article Affiliation country: Pharmaceutics12111095

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Full text: Available Collection: International databases Database: MEDLINE Topics: Vaccines Language: English Year: 2020 Document Type: Article Affiliation country: Pharmaceutics12111095