Syringe containing stable aqueous formulations of adalimumab
First Claim
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1. A syringe having a single dose of an aqueous pharmaceutical composition wherein the aqueous pharmaceutical composition comprises:
- (i) adalimumab;
(ii) a buffer; and
(iii) a stabilizer;
wherein the composition is free of polyol, has a pH of about 5 to about 6, and is stable for one week at 40°
C. or two weeks at 25°
C.
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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.
102 Citations
20 Claims
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1. A syringe having a single dose of an aqueous pharmaceutical composition wherein the aqueous pharmaceutical composition comprises:
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(i) adalimumab; (ii) a buffer; and (iii) a stabilizer; wherein the composition is free of polyol, has a pH of about 5 to about 6, and is stable for one week at 40°
C. or two weeks at 25°
C. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A syringe having a single dose of an aqueous pharmaceutical composition wherein the aqueous pharmaceutical composition has a pH of about 5 to about 6 and comprises:
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(i) adalimumab; (ii) a buffer, free of citrate, and consisting essentially of histidine, succinate, or both; and (iii) a stabilizer consisting essentially of; (a) glycine, arginine, or both;
or(a) and (b);
where (b) is sodium chloride, sodium sulfate, or both;wherein the composition is free of polyol, and is stable for one week at 40°
C. or two weeks at 25°
C. - View Dependent Claims (10, 11, 12, 13, 14, 15)
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16. A syringe having a single dose of an aqueous pharmaceutical composition wherein the aqueous pharmaceutical composition has a pH of about 5 to about 6 and comprises adalimumab and a citrate-free buffer, and wherein the composition is free of polyol, has a pH of about 5 to about 6, and is stable for one week at 40°
- C. or two weeks at 25°
C. - View Dependent Claims (17, 18, 19, 20)
- C. or two weeks at 25°
Specification