| CPC A61K 47/6937 (2017.08) [A61K 9/5153 (2013.01); A61K 9/5192 (2013.01); A61K 47/34 (2013.01); A61P 31/14 (2018.01); A61K 2039/55555 (2013.01)] | 7 Claims |

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1. A method for making double-encapsulated nanoparticles for use in vaccines that do not contain PEG or polyethylene glycol for the treatment of COVID-19—and other viral diseases, said nanoparticles having an aqueous core loaded with mRNA, a surrounding phospholipid layer, and an outer surface of biodegradable polymer enveloping the nanoparticle, the method comprising:
a) A first stage, comprising the steps of providing a source of phospholipid material in supercritical, critical or near critical fluid (SFS), providing a source of mRNA, forming a mixture of the phospholipid fluid and mRNA in an inline mixer, decompressing the mixture into a biocompatible solution in a decompression chamber wherein phospholipid lipid fragments nanoencapsulate the mRNA forming phospholipid nanosomes, and recovering the phospholipid nanosomes; and
b) A second stage, comprising the steps of re-pressurizing the phospholipid nanosomes, mixing the phospholipid nanosomes with an SFS stream enriched with a biodegradable polymer, decompressing the mixture to atmospheric pressure to encapsulate the phospholipid nanosomes in the biodegradable polymer to form mRNA nanoparticles, and recovering the mRNA nanoparticles, double-encapsulated in phospholipids and a biodegradable polymer.
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