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US 12,653,871 B2Granted
Factor IX polypeptide formulations
AssigneeBioverativ Therapeutics Inc.
InventorMark Brader
Life of this patent
Estimating the term…
Abstract
The present invention provides formulations comprising a Factor IX—FcRn Binding Partner (FIXFBP) polypeptide, and methods of administering FIXFBP.
Claims21
A pharmaceutical kit comprising:
- (a) a first container comprising a lyophilizate, where the lyophilizate comprises
- i) a chimeric polypeptide comprising a Factor IX (FIX) polypeptide and an Fc region,
- ii) sucrose;
- iii) mannitol;
- iv) L-histidine;
- and
- v) polysorbate 20 or polysorbate 80;
- and
- (b) a second container comprising a 0.325% (w/v) NaCl diluent solution at a volume sufficient to produce, when combined with the lyophilized powder of the first container, a solution comprising:
- i) between about 10 mg/ml and about 20 mg/ml of sucrose;
- ii) between about 20 mg/ml and about 40 mg/ml of mannitol;
- iii) between about 3 mg/ml and about 4 mg/ml of sodium chloride (NaCl);
- iv) between about 3 mg/ml and about 6 mg/ml of L-histidine;
- and
- v) between about 0.08 mg/ml and about 0.2 mg/ml of polysorbate 20 or polysorbate 80.
12 more elements
A vial comprising a pharmaceutical composition, the composition comprising:
- (i) about 250 IU, about 500 IU, about 1000 IU, about 2000 IU, about 3000 IU, or about 4000 IU of a chimeric polypeptide comprising a Factor IX (FIX) polypeptide and an Fc region;
- (ii) about 59.5 mg of sucrose
- (iii) about 119 mg of mannitol;
- (iv) about 0.325% (w/v) sodium chloride (NaCl);
- (v) about 19.4 mg of L-histidine;
- and
- (vi) about 0.50 mg of polysorbate 20 or polysorbate 80.
4 more elements
A syringe comprising a pharmaceutical composition comprising:
- i) about 50 IU/ml, about 100 IU/ml, about 200 IU/ml, about 400 IU/ml, about 600 IU/ml, or about 800 IU/ml of a chimeric polypeptide comprising a Factor IX (FIX) polypeptide and an Fc region,
- ii) about 11.9 mg/mL of sucrose;
- iii) about 23.8 mg/ml of mannitol;
- iv) about 3.88 mg/ml of L-histidine;
- and
- v) about 0.10 mg/ml of polysorbate 20 or polysorbate 80;
- and
- vi) about 0.325% (w/v) NaCl.
5 more elements
Dependencies are inferred from the claim text.