Pharmaceutical parenteral composition of dual GLP1/2 agonist
AssigneeZealand Pharma A/S
InventorsLise Giehm, Alistair Vincent Gordon Edwards
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Abstract
The present invention relates to pharmaceutical compositions suitable for parenteral administration in human subjects. In particular, the present invention relates to isotonic pharmaceutical compositions for parenteral administration.
Claims25
An isotonic parenteral pharmaceutical composition, comprising:
- a. at least about 1 mg/mL of one or more GLP-1/GLP-2 dual agonist, wherein the one or more GLP-1/GLP-2 dual agonist is Hy-H[Aib]EGSFTSELATILD[K([17-carboxy-heptadecanoyl]-isoGlu)QAARDFIAWLIQHKITD-OH (CPD10H) (SEQ ID NO:
- 1) or any pharmaceutically acceptable salt thereof
- b. about 5 mM to about 50 mM of phosphate buffer component;
- and
- c. about 190 mM to about 240 mM of one or more tonicity agent,
- wherein said one or more tonicity agent comprises or consists of mannitol, wherein said composition further comprises a solvent, and
- wherein said composition has a pH of about pH 6.0 to about pH 8.2.
A method for improving the chemical stability of an isotonic parenteral pharmaceutical composition comprising at least about 1 mg/mL of one or more GLP-1/GLP-2 dual agonist, wherein the one or more GLP-1/GLP-2 dual agonist is Hy-H[Aib]EGSFTSELATILD[K([17-carboxy-heptadecanoyll-isoGlu)1QAARDFIAWLIQHKITD-OH (CPD10H) (SEQ ID NO:
- 1) or any Pharmaceutically acceptable salt thereof;
- wherein said method comprises adding mannitol to said composition.
Dependencies are inferred from the claim text.