US 12,377,050 B2
Methods of forming particles by continuous droplet formation and dehydration
Jason G. Auer, Weymouth, MA (US); Paul Brown, Boston, MA (US); Tyler L. Carter, Newburyport, MA (US); Chase Spenser Coffman, Newton, MA (US); Paul F. Herbert, Framingham, MA (US); James W. Ivey, Reading, MA (US); Moin Khwaja, Boston, MA (US); Lisa Liu, Somerville, MA (US); Sadiqua Shadbar, Allston, MA (US); and Shankul Vartak, Cambridge, MA (US)
Assigned to Elektrofi, Inc., Boston, MA (US)
Appl. No. 17/916,618
Filed by Elektrofi, Inc., Boston, MA (US)
PCT Filed Apr. 16, 2021, PCT No. PCT/US2021/027755
§ 371(c)(1), (2) Date Oct. 3, 2022,
PCT Pub. No. WO2021/212019, PCT Pub. Date Oct. 21, 2021.
Claims priority of provisional application 63/011,820, filed on Apr. 17, 2020.
Prior Publication US 2023/0181473 A1, Jun. 15, 2023
Int. Cl. A61K 9/16 (2006.01); A61K 38/38 (2006.01); A61K 39/395 (2006.01); A61K 41/17 (2020.01); B01J 13/04 (2006.01)
CPC A61K 9/1694 (2013.01) [A61K 9/1617 (2013.01); A61K 9/1623 (2013.01); A61K 9/1652 (2013.01); A61K 38/385 (2013.01); A61K 39/3955 (2013.01); A61K 41/17 (2020.01); B01J 13/04 (2013.01)] 18 Claims
 
1. A method of forming particles, the method comprising:
a) providing an aqueous first liquid comprising a therapeutic biologic;
b) contacting the aqueous first liquid comprising the therapeutic biologic with an organic second liquid by a continuous process, thereby forming a mixture comprising aqueous liquid droplets, wherein the aqueous liquid droplets comprise the therapeutic biologic;
c) dehydrating the aqueous liquid droplets in the mixture; and
d) removing the aqueous first liquid and organic second liquid from the mixture, thereby forming particles comprising the therapeutic biologic,
wherein the particles comprise less than about 10% internal void spaces and the circularity of the particles is from about 0.80 to about 1.00 after removing the aqueous first liquid and organic second liquid from the mixture,
wherein the concentration of the therapeutic biologic in the aqueous first liquid is from about 10 mg/mL to about 500 mg/mL,
wherein the aqueous first liquid has a viscosity of less than about 10 mPa-s, and
wherein the continuous process of step b), comprises continuous membrane emulsification, continuous homogenization, continuous impinging jet mixing, continuous static mixing, or a combination thereof.