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US 9,808,525 B2Granted
Stable aqueous formulations of adalimumab
AssigneeCoherus Biosciences, Inc.
InventorsMark Manning, Robert W. Payne
Life of this patent
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Abstract
The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.
Claims11
An aqueous formulation of adalimumab comprising:
- (a) adalimumab;
- (b) a buffer selected from the group consisting of citrate, phosphate, histidine, succinate, tartrate, maleate and acetate, and combinations thereof, provided the combinations do not include a combination of citrate buffer and phosphate buffer;
- (c) a polyol;
- (d) a salt selected from the group consisting essentially of sodium chloride, sodium sulfate, and potassium chloride;
- and
- (e) a surfactant,
- wherein the formulation has pH of 4 to 8.
4 more elements
An aqueous formulation of adalimumab comprising:
- (a) 20 to 150 mg/ml of adalimumab;
- (b) a citrate buffer;
- (c) mannitol in an amount of 1 to 10% weight by volume of the total formulation (w/v);
- (d) sodium chloride in an amount of 5 to 150 mM;
- and
- (e) PS80 in amount of 1 to 50 μM;
- wherein the formulation has a pH of 4 to 8 and does not contain phosphate.
4 more elements
Dependencies are inferred from the claim text.