PHARMACEUTICAL COMPOSITIONS AND METHODS
Disclosed herein are stable solution, suspension and dry powder compositions, and methods for delivering stabilized biodegradable substances, including peptides and proteins, small molecules, and methods for delivering the dry powders in the treatment of lung disease. In particular, the compositions comprise vasoactive intestinal peptide for pulmonary inhalation to treat respiratory disorders and/or diseases in the lung, including, inflammation, acute and chronic lung injury and pulmonary edema.
1 . A dry powder for treating lung disease comprising, an inhalable dry powder pharmaceutical formulation comprising vasoactive intestinal peptide, a derivative thereof, an analog thereof, or a salt thereof, one or more amino acids, one or more antioxidants, and/or a pharmaceutically acceptable carrier or excipient.
2 . The dry powder of claim 1 , wherein the vasoactive intestinal peptide is up to 300 μg for treatment session.
3 . The dry powder of claim 1 , wherein the pharmaceutically acceptable carrier is a sugar selected from the group consisting of mannose, mannitol, trehalose, and sorbitol.
4 . The dry powder of claim 1 , wherein the pharmaceutically acceptable carrier is a mannitol.
5 . The dry powder of claim 1 , wherein the pharmaceutically acceptable carrier is a diketopiperazine.
6 . The dry powder of claim 4 , wherein the diketopiperazine is fumaryl diketopiperazine, or succinyl diketopiperazine.
7 . The dry powder of claim 1 , wherein the one or more amino acids is selected from the group consisting of lysine, glycine, leucine, isoleucine, trileucine, histidine, and methionine.
8 . The dry powder of claim 7 , wherein the one or more amino acids are leucine and methionine.
9 . The dry powder of claim 1 , wherein the one or more amino acids or antioxidants is methionine.
10 . The dry powder of claim 1 , wherein the one or more antioxidants is selected from the group consisting of ascorbic acid, vitamin E, selenium, methionine and carotenoids.
11 . The dry powder of claim 1 , wherein a dose of the inhalable dry powder pharmaceutical formulation comprises up to 200 μg of vasoactive intestinal peptide, derivative thereof, analog thereof, or a salt thereof and up to 90 wt % mannitol.
12 . An inhalable pharmaceutical formulation comprising mannitol, leucine, methionine and vasoactive intestinal peptide, an analog thereof, or a derivative thereof, in a dose of up to 200 μg for the treatment of edema in a subject.
13 . The inhalable pharmaceutical formulation of claim 12 , wherein the inhalable pharmaceutical formulation is manufacture in the dose is to be administered at least once a day.