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US 2025/0057915 A1Published application
Improved Lyophilized Formulation
AssigneeStemline 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.
Claims30
A stable solution for lyophilization in a pharmaceutically acceptable aqueous carrier comprising:
- 0.5 to 1.5 mg/mL of tagraxofusp;
- 2 to 10% w/v of at least one disaccharide sugar;
- 0.05 to 1.5% w/v of at least one surfactant;
- at least one 5 to 25 mM buffering agent;
- and a pH 6.5-9.0
- wherein the surfactant has no more than 3% peroxide.
3 more elements
A stable pharmaceutically acceptable lyophilization solution in a pharmaceutically acceptable aqueous medium 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;
- 2 to 10% w/v of mannitol;
- and
- having a pH from 6.5 to 9;
- wherein the polysorbate 80 has no more than 3% peroxide.
5 more elements
A stable lyophile comprising:
- 1 mg of tagraxofusp;
- 25 mg of at least one disaccharide sugar;
- 25 mg of at least one surfactant;
- and
- 2.4 mg of at least one buffering agent,
- wherein, the lyophile has no more than 2% oxidation impurity as determined by reversed-phase ultrahigh performance chromatography (RP-UPLC) for at least 24 months.
3 more elements
A pharmaceutically acceptable formulation reconstituted in an aqueous medium for intravenous injection comprising:
- 0.5 to 1.5 mg/mL of tagraxofusp;
- 2 to 10% w/v of at least one disaccharide sugar;
- 0.05 to 1.5% w/v of at least one surfactant;
- and
- at least one 5 to 25 mM buffering agent.
2 more elements
Dependencies are inferred from the claim text.