Method of Encapsulating a Nucleic Acid in a Lipid Nanoparticle Host

Abstract

Encapsulated nucleic acid nanoparticles of uniformly small particle size are produced by intersecting one or more nucleic acid streams with one or more lipid streams. The encapsulated nucleic acid nanoparticles include a nucleic acid encapsulated within a lipid nanoparticle host. Uniformly small particle sizes are obtained by intersecting an aqueous nucleic acid stream and a stream of lipids in organic solvent at high linear velocities and with total organic solvent concentrations less than 33%.

1 . An encapsulated nucleic acid nanoparticle composition comprising:
 a pharmaceutically acceptable carrier; and
 an encapsulated nucleic acid nanoparticle, the encapsulated nucleic acid nanoparticle comprising a lipid nanoparticle host and a nucleic acid, the nucleic acid being encapsulated in the lipid nanoparticle host; 
 wherein the encapsulated nucleic acid nanoparticle has an average particle size of from about 40 nm to about 70 nm and a polydispersity index of less than about 0.1 as determined by dynamic light scattering. 
   
     
     
         2 . The composition of  claim 1 , wherein the lipid nanoparticle host comprises a degradable cationic lipid, a lipidated polyethylene glycol, cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine.