US 12,409,210 B2
CNS delivery of therapeutic agents
Pericles Calias, Melrose, MA (US); Jing Pan, Boxborough, MA (US); Jan Powell, Concord, MA (US); Lawrence Charnas, Natick, MA (US); Thomas McCauley, Cambridge, MA (US); Teresa Leah Wright, Lexington, MA (US); Richard Pfeifer, North Granby, CT (US); and Zahra Shahrokh, Weston, MA (US)
Assigned to Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed by TAKEDA PHARMACEUTICAL COMPANY LIMITED, Osaka (JP)
Filed on Aug. 16, 2022, as Appl. No. 17/820,155.
Application 15/016,141 is a division of application No. 13/168,961, filed on Jun. 25, 2011, granted, now 9,283,181, issued on Mar. 15, 2016.
Application 17/820,155 is a continuation of application No. 16/573,557, filed on Sep. 17, 2019, granted, now 11,471,516.
Application 16/573,557 is a continuation of application No. 15/016,141, filed on Feb. 4, 2016, granted, now 10,456,454, issued on Oct. 29, 2019.
Claims priority of provisional application 61/358,857, filed on Jun. 25, 2010.
Claims priority of provisional application 61/360,786, filed on Jul. 1, 2010.
Claims priority of provisional application 61/387,862, filed on Sep. 29, 2010.
Claims priority of provisional application 61/435,710, filed on Jan. 24, 2011.
Claims priority of provisional application 61/442,115, filed on Feb. 11, 2011.
Claims priority of provisional application 61/476,210, filed on Apr. 15, 2011.
Claims priority of provisional application 61/495,268, filed on Jun. 9, 2011.
Prior Publication US 2023/0165942 A1, Jun. 1, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/43 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 9/19 (2006.01); A61K 35/76 (2015.01); A61K 35/761 (2015.01); A61K 38/46 (2006.01); A61K 38/47 (2006.01); A61K 47/02 (2006.01); A61K 47/26 (2006.01); C07K 14/65 (2006.01); C12N 9/24 (2006.01); C12N 9/42 (2006.01)
CPC A61K 38/47 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0085 (2013.01); A61K 9/08 (2013.01); A61K 9/19 (2013.01); A61K 35/76 (2013.01); A61K 35/761 (2013.01); A61K 38/46 (2013.01); A61K 38/465 (2013.01); A61K 47/02 (2013.01); A61K 47/26 (2013.01); C07K 14/65 (2013.01); C12N 9/2402 (2013.01); C12N 9/2437 (2013.01); C12Y 301/06008 (2013.01); C12Y 301/06013 (2013.01); C12Y 302/01045 (2013.01); C12Y 302/01046 (2013.01); C12Y 302/0105 (2013.01); C12Y 310/01001 (2013.01)] 5 Claims
 
1. A formulation comprising a lysosomal enzyme at a concentration of at least 5 mg/ml and a surfactant, wherein the formulation comprises no greater than 5 mM phosphate and has a pH of 5.5-7.0, wherein the surfactant is polysorbate 20 or polysorbate 80, and wherein the formulation is suitable for CNS delivery.