PEPTIDE PHARMACEUTICAL FORMULATIONS
A pharmaceutical composition for administration to a mammal is disclosed. The composition includes a therapeutically effective amount of a peptide, such as a GLP-1 molecule, a PTH molecule, or a GRF molecule. The composition further includes a buffer including a weak acid having an acid dissociation constant value of greater than about 1×10 −5 , such as acetic acid. The composition also includes an excipient for making the composition generally isotonic, such as D -mannitol.
1 . A pharmaceutical composition comprising:
a GRF molecule;
an acid having a dissociation constant value of greater than 1×10 −5 ; and
an excipient;
wherein the pH of said composition is between about 3.0 and 5.0 and wherein the excipient includes at least D -mannitol.
2 . The composition according to claim 1 , wherein said acid comprises acetic acid.
3 . The composition according to claim 1 , wherein said excipient is D -mannitol.
4 . The composition according to claim 1 wherein said acid is acetic acid and said excipient is D -mannitol.
5 . The composition according to claim 1 , wherein said composition comprises GRF(1-44)amide.
6 . The composition of claim 1 , wherein said composition is in unit dosage form.
7 . The composition of claim 1 , wherein said composition is sterile.
8 . A system for administering a pharmaceutical composition comprising:
an infusion pump for administering a unit dose of the composition according to claim 1 .
9 . A system of claim 8 , wherein said composition is diluted up to about 40-fold with isotonic saline prior to administration.
10 . A method for the treatment of a disease or condition in a mammal, which may be treated or prevented by growth hormone, comprising administering to the mammal a pharmaceutically effective amount of a composition according to claim 1 .
11 . The method of claim 10 , wherein the disease or condition osteoporosis.
12 . The method of claim 10 , wherein said composition is administered to said mammal by a method selected from the group consisting of intravenous, subcutaneous, continuous, intermittent, parenteral, and combinations thereof.