Liquid formulation
AssigneeHanmi Pharm. Co., Ltd.
InventorsJi Hye Moon, Ji Eun Lee
Life of this patent
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Abstract
A liquid formulation of a long-acting conjugate of a peptide having activities for a glucagon receptor and a GLP-1 receptor, and a method for preparing the liquid formulation are disclosed. The liquid formulation contains 18 nmol/mL to 940 nmol/mL of the long-acting conjugate, a buffering agent in an amount for maintaining the pH of the liquid formulation in the range of 4.5 to 7.5, and 1% (w/v) to 20% (w/v) of saccharide, and 0.001% (w/v) to 0.2% (w/v) of a nonionic surfactant.
Claims17
A liquid formulation for stabilizing a long-acting glucagon-like peptide-1 (GLP-1)/glucagon receptor dual agonist peptide conjugate of Chemical Formula 1, the liquid formulation comprising:
- 18 nmol/mL to 940 nmol/mL of the long-acting GLP-1/glucagon receptor dual agonist peptide conjugate of Chemical Formula 1,
- 5 mM to 25 mM of acetic acid or a salt thereof in an amount for maintaining a pH of the liquid formulation in a range of 4.8 to 5.5,
- 4% w/v to 10% w/v of sucrose, and
- 0.01% w/v to 0.1% w/v of a nonionic surfactant selected from poloxamer, polysorbate, or a combination thereof;
- wherein Q is a peptide comprising the amino acid sequence set forth in SEQ ID NOS:
- 2, 3, or 4;
- Z is an immunoglobulin Fc fragment;
- and
- n is a natural number, wherein the value of n is determined such that the average molecular weight of the [OCH2CH2]n region in the peptide conjugate is 10 kDa.
Dependencies are inferred from the claim text.