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US 12,171,800 B2Granted
Lyophilized formulation
AssigneeSterline Therapeutics, Inc.
InventorsJoan Connolly, Frederick Erickson, Madhav Kamat, Jennifer Wasserman, James Zabrecky
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Abstract
Provided herein are improved formulations of tagraxofusp for lyophilization used to manufacture stable formulations of tagraxofusp for intravenous injection.
Claims28
A stable solution in a pharmaceutically acceptable aqueous carrier comprising:
- 0.5 to 1.5 mg/mL of tagraxofusp;
- 2 to 10% w/v of sucrose;
- 0.05 to 1.5% w/v of polysorbate 80;
- 5 to 25 mM Tris HCl;
- and
- having a pH from 6.5-9.0
- wherein the polysorbate 80 has no more than 3% peroxide.
4 more elements
A formulation for intravenous injection comprising 1 part of the stable solution of claim 1 to 50 parts water for injection in an infusion fluid bag.
Dependencies are inferred from the claim text.