Stable formulation of modified GLP-1
AssigneeNovo Nordisk A/S
InventorsJames M. Flink, Silke Moller Larsen, Simon Bjerregaard Jensen, Dorthe Kot Engelund
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Abstract
Pharmaceutical formulations of GLP-1 compounds and methods for preparation thereof.
Claims25
A pharmaceutical formulation comprising a GLP-1 compound and a buffer, wherein:
- (i) said GLP-1 compound is (a) GLP-1 (7-37) or (b) an analogue thereof wherein an amino acid residue of the parent peptide has a lipophilic substituent attached optionally via a spacer;
- (ii) said GLP-1 compound is present in a concentration from 0.1 mg/ml to 100 mg/ml;
- and
- (iii) aid formulation has a pH from 7.0 to 10;
- provided that if an isotonic agent is present and the pH of the formulation is 7.4, then mannitol or NaCl is not the isotonic agent.
A method of preparing a physically stable pharmaceutical formulation of a GLP-1 compound wherein said GLP-1 compound is GLP-1 (7-37) or an analogue thereof wherein an amino acid residue of the parent peptide has a lipophilic substituent attached optionally via a spacer, said method comprising preparing a formulation containing the GLP-1 compound, and a buffer, wherein said GLP-1 compound is present in a concentration from 0.1 mg/ml to 100 mg/ml, and wherein said formulation has a pH from 7.0 to 10.
A method of preparing a physically stable pharmaceutical formulation of a GLP-1 compound wherein said GLP-1 compound is GLP-1 (7-37) or an analogue thereof, wherein an amino acid residue of the parent peptide has a lipophilic substituent attached optionally via a spacer, said method comprising preparing a formulation containing the GLP-1 compound, water, and a buffer, wherein said GLP-1 compound is present in a concentration from 0.1 mg/ml to 100 mg/ml, and wherein said formulation has a pH from 7.0 to 10.
Dependencies are inferred from the claim text.