Back to results
US 12,741,024 B2Granted
Pharmaceutical products and stable liquid compositions of IL-17 antibodies
AssigneeNovartis AG
InventorsSusanne Joerg, Kathrin Serno-Schersch
Life of this patent
Estimating the term…
Abstract
The disclosure is directed to pharmaceutical products and stable liquid compositions of IL-17 antibodies and antigen-binding fragments thereof, e.g., AIN457 (secukinumab), and processes of making these pharmaceutical products and compositions. The disclosure is also directed to the use of these pharmaceutical products and liquid compositions (e.g., as part of a kit having instructions for use) for the treatment of various IL-17-mediated disorders (e.g., autoimmune disorders, such as psoriasis, ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis).
Claims30
A liquid pharmaceutical composition comprising:
- (i) about 150 mg/mL secukinumab;
- (ii) a stabilizer selected from methionine, arginine, and combinations thereof;
- (iii) a surfactant;
- and
- (iv) optionally a sugar, wherein if present, the sugar is selected from trehalose, raffinose, maltose, sorbitol, and mannitol;
- wherein the composition has a pH of about 5.2 to about 6.4;
- and
- wherein upon storage of the liquid pharmaceutical composition at 2-8° C. for at least 6 months, at least one of the following criteria is met:
- no more than 5% of secukinumab main variant is degraded as measured by reverse phase-high performance liquid chromatography (RP-HPLC);
- and
- no more than 5% of secukinumab pre-main peak variant is formed as measured by RP-HPLC.
8 more elements
Dependencies are inferred from the claim text.