Liquid pharmaceutical composition
AssigneeArecor Limited
InventorsLuca Badiali, David Gerring, Jan Jezek
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Abstract
The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, arginine and/or methionine, and a small polyol stabiliser such as glycerol. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.
Claims23
A liquid pharmaceutical composition comprising:
- (a) 75 mg/ml to 200 mg/ml adalimumab;
- (b) 28.7 mM to 86.1 mM arginine;
- (c) 16.7 mM to 50.2 mM methionine;
- and
- (d) 50 mM to 200 mM propylene glycol or glycerol;
- (e) 5 mM to 10 mM acetate;
- and
- (f) 0.1 mg/ml to 10 mg/ml of a surfactant;
- wherein the arginine:methionine molar ratio is 1:5 to 5:1;
- and wherein the composition has a pH of 4.5 to 5.5 and is visually clear after 30° for 4 weeks as assessed using the 2.9.20. European Pharmacopoeia Monograph.
Dependencies are inferred from the claim text.