US 12,257,277 B2
Adeno-associated virus formulations
Christian Fiedler, Vienna (AT); Eva Fritscher, Vienna (AT); Meinhard Hasslacher, Vienna (AT); Dominik Mittergradnegger, Vienna (AT); and Tanvir Tabish, Kent (GB)
Assigned to TAKEDA PHARMACEUTICAL COMPANY LIMITED, Osaka (JP)
Filed by TAKEDA PHARMACEUTICAL COMPANY LIMITED, Osaka (JP)
Filed on Jan. 13, 2023, as Appl. No. 18/096,853.
Application 18/096,853 is a continuation of application No. 16/347,107, granted, now 11,583,563, previously published as PCT/US2017/059971, filed on Nov. 3, 2017.
Claims priority of provisional application 62/417,750, filed on Nov. 4, 2016.
Prior Publication US 2023/0241139 A1, Aug. 3, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 35/76 (2015.01); A61K 9/00 (2006.01); A61K 9/19 (2006.01); A61K 31/195 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61P 7/00 (2006.01); A61P 7/04 (2006.01)
CPC A61K 35/76 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0053 (2013.01); A61K 9/19 (2013.01); A61K 31/195 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); A61P 7/00 (2018.01); A61P 7/04 (2018.01)] 27 Claims
 
1. A pharmaceutical composition comprising adeno-associated virus (AAV) and a buffering composition consisting of:
i) about 5 mM to about 25 mM of a buffering agent selected from the group consisting of histidine, arginine, lysine, and a combination thereof;
ii) about 50 mM to about 150 mM of a pharmaceutically acceptable salt selected from the group consisting of a sodium salt, an ammonium salt, a potassium salt, a cesium salt, an amine salt, and a combination thereof;
iii) about 0.001% (w/v) to about 0.01% (w/v) of a non-ionic surfactant;
iv) about 1% (w/v) to about 10% (w/v) of a sugar, a sugar alcohol, or a combination thereof; and
v) about 30 mM to about 70 mM of glycine.