CPC A61K 38/1825 (2013.01) [A61K 47/549 (2017.08); A61K 47/60 (2017.08); A61P 3/10 (2018.01); C07K 14/50 (2013.01)] | 20 Claims |
1. A prefilled syringe or autoinjector comprising a liquid pharmaceutical composition, the liquid pharmaceutical composition comprising:
(a) from 28.8 to 43.2 mg/ml of a mutant Fibroblast Growth Factor-21 (FGF-21) peptide conjugate comprising:
i) a mutant FGF-21 peptide comprising the amino acid sequence of SEQ ID NO: 2,
ii) a glycosyl moiety, and
iii) a 20 kDa polyethylene glycol (PEG),
wherein the mutant FGF-21 peptide is attached to the glycosyl moiety by a covalent bond between a threonine at amino acid position 173 of SEQ ID NO: 2 and a first site of the glycosyl moiety and wherein the glycosyl moiety is attached to the 20 kDa PEG by a covalent bond between a second site of the glycosyl moiety and the 20 kDa PEG;
(b) from 160 to 240 mM arginine HCl;
(c) from 0.016 to 0.024% (w/v) Polysorbate 80 (PS-80);
(d) from 16 to 24 mM Tris buffer, wherein pH is from 7 to 7.5; and
(e) a pharmaceutically acceptable carrier,
wherein the liquid pharmaceutical composition is stable at a temperature of 2° C. to 8° C. for 12 months or more.
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