US 12,343,387 B2
Formulations of polyalkylene oxide-asparaginase and methods of making and using the same
GianFranco Fornasini, Bethesda, MD (US); Nadejda Soukhareva, Derwood, MD (US); and Christopher Phillips, Doylestown, PA (US)
Assigned to Servier IP UK Limited, Slough (GB)
Appl. No. 16/306,302
Filed by Servier IP UK Limited, Slough (GB)
PCT Filed Jun. 1, 2017, PCT No. PCT/US2017/035461
§ 371(c)(1), (2) Date Nov. 30, 2018,
PCT Pub. No. WO2018/017190, PCT Pub. Date Jan. 25, 2018.
Claims priority of provisional application 62/344,249, filed on Jun. 1, 2016.
Claims priority of provisional application 62/344,256, filed on Jun. 1, 2016.
Claims priority of provisional application 62/344,252, filed on Jun. 1, 2016.
Prior Publication US 2019/0240300 A1, Aug. 8, 2019
Int. Cl. A61K 38/50 (2006.01); A61K 9/19 (2006.01); A61K 47/54 (2017.01); A61K 47/60 (2017.01); A61K 47/69 (2017.01); A61P 35/04 (2006.01)
CPC A61K 38/50 (2013.01) [A61K 9/19 (2013.01); A61K 47/542 (2017.08); A61K 47/60 (2017.08); A61K 47/6921 (2017.08); A61P 35/04 (2018.01); C12Y 305/01001 (2013.01); Y02A 50/30 (2018.01)] 10 Claims
 
1. A lyophilized composition prepared by lyophilizing an aqueous composition comprising, per gram of the aqueous composition:
750 IU of a polyalkylene oxide-asparaginase;
about 2.79 mg of dibasic sodium phosphate;
about 0.6 mg of monobasic sodium phosphate;
about 4.25 mg of sodium chloride; and
about 45 mg of sucrose, wherein the polyalkylene oxide-asparaginase comprises an asparaginase covalently linked to a polyalkylene oxide group that is a polyethylene glycol, and wherein the lyophilized composition is substantially dehydrated, comprising less than 25% water.