Compositions and methods for enhanced mucosal delivery of Y2 receptor-binding peptides and methods for treating and preventing obesity
First Claim
Patent Images
1. A pharmaceutical device comprising:
- a. an aqueous solution formulation of a Y2 receptor binding peptide at a concentration sufficient to produce therapeutically effective plasma concentrations and L-α
-phosphatidylcholine didecanoyl (DDPC); and
b. an actuator able to produce an aerosol of said solution, wherein the spray pattern ellipticity ratio of said aerosol is between 1.00 and 1.40 when measured at a height of between 0.5 cm and 10 cm distance from the actuator tip.
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Abstract
Pharmaceutical compositions and methods are described comprising at least one Y2 receptor-binding peptide, such as peptide YY(PYY), Neuropeptide Y (NPY) or Pancreatic Peptide (PP) and one or more mucosal delivery-enhancing agents for enhanced nasal mucosal delivery of the peptide YY, for treating a variety of diseases and conditions in mammalian subjects, including obesity.
46 Citations
41 Claims
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1. A pharmaceutical device comprising:
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a. an aqueous solution formulation of a Y2 receptor binding peptide at a concentration sufficient to produce therapeutically effective plasma concentrations and L-α
-phosphatidylcholine didecanoyl (DDPC); andb. an actuator able to produce an aerosol of said solution, wherein the spray pattern ellipticity ratio of said aerosol is between 1.00 and 1.40 when measured at a height of between 0.5 cm and 10 cm distance from the actuator tip. - View Dependent Claims (2, 3, 4, 13, 14, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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5. A pharmaceutical device comprising:
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a. an aqueous solution of a Y2 receptor binding peptide, and L-α
-phosphatidylcholine didecanoyl (DDPC); andb. an actuator to produce an aerosol of said solution, wherein the spray pattern major and minor axes of said aerosol are between 10 and 50 mm when measured at a height of between 0.5 cm and 10 cm distance from the actuator tip. - View Dependent Claims (6, 15, 16)
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7. A pharmaceutical device comprising:
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a. an aqueous solution formulation of a Y2 receptor binding peptide at a concentration sufficient to produce therapeutically effective plasma effective plasma concentrations and L-α
-phosphatidylcholine didecanoyl (DDPC); andb. an actuator to produce an aerosol of said solution, wherein less than 10% of the droplets are smaller than 10 microns in size. - View Dependent Claims (8, 9, 10, 17, 18)
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11. A pharmaceutical device comprising:
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a. an aqueous solution formulation of a Y2 receptor binding peptide at a concentration sufficient to produce therapeutically effective plasma concentrations effective plasma concentrations and L-α
-phosphatidylcholine didecanoyl (DDPC); andb. an actuator selected to produce an aerosol of said solution, wherein droplets between 25 and 700 microns are produced. - View Dependent Claims (12)
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28. A pharmaceutical device comprising:
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a. an aqueous solution formulation of a Y2 receptor binding peptide at a concentration sufficient to produce therapeutically effective plasma concentrations, b. methyl-β
-cyclodextrin, EDTA, lactose, sorbitol, and L-α
-phosphatidylcholine didecanoyl, andc. an actuator to produce an aerosol of said solution, wherein less than 10% of the droplets are smaller than 10 microns in size. - View Dependent Claims (29)
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30. A pharmaceutical device comprising:
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a. an aqueous solution formulation of a Y2 receptor binding peptide at a concentration sufficient to produce therapeutically effective plasma concentrations, b. sodium citrate, citric acid, methyl-β
-cyclodextrin, EDTA, lactose, sorbitol, and L-α
-phosphatidylcholine didecanoyl, wherein the formulation has a pH of about 5.0±
0.3, andc. an actuator to produce an aerosol of said solution, wherein less than 10% of the droplets are smaller than 10 microns in size. - View Dependent Claims (31, 32, 33)
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34. A pharmaceutical device comprising:
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a. an aqueous solution formulation of a Y2 receptor binding peptide at a concentration sufficient to produce therapeutically effective plasma concentrations, b. chlorobutanol, sodium citrate, citric acid, methyl-β
-cyclodextrin, EDTA, lactose, sorbitol, and L-α
-phosphatidylcholine didecanoyl, wherein the formulation has a pH of about 5.0±
0.3, andc. an actuator to produce an aerosol of said solution, wherein less than 10% of the droplets are smaller than 10 microns in size. - View Dependent Claims (35)
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36. A pharmaceutical device comprising:
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a. an aqueous solution formulation of a Y2 receptor binding peptide at a concentration sufficient to produce therapeutically effective plasma concentrations, b. benzalkonium chloride, sodium citrate, citric acid, methyl-β
-cyclodextrin, EDTA, lactose, sorbitol, and L-α
-phosphatidylcholine didecanoyl, wherein the formulation has a pH of about 5.0±
0.3, andc. an actuator to produce an aerosol of said solution, wherein less than 10% of the droplets are smaller than 10 microns in size. - View Dependent Claims (37)
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38. A pharmaceutical device comprising:
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a. an aqueous solution formulation of a Y2 receptor binding peptide at a concentration sufficient to produce therapeutically effective plasma concentrations, b. chlorobutanol at a concentration of 5 mg/ml, sodium citrate at a concentration of 1.62 mg/ml, citric acid at a concentration of 0.86 mg/ml, methyl-β
-cyclodextrin at a concentration of 45 mg/ml, EDTA at a concentration of 1 mg/ml, lactose at a concentration of 9 mg/ml, sorbitol at a concentration of 18.2 mg/ml, and L-α
-phosphatidylcholine didecanoyl at a concentration of 1 mg/ml, wherein the formulation has a pH of about 5.0±
0.3, andc. an actuator to produce an aerosol of said solution, wherein less than 10% of the droplets are smaller than 10 microns in size. - View Dependent Claims (39)
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40. A pharmaceutical device comprising:
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a. an aqueous solution formulation of a Y2 receptor binding peptide at a concentration sufficient to produce therapeutically effective plasma concentrations, b. chlorobutanol at a concentration of 5 mg/ml, sodium citrate at a concentration of 1.62 mg/ml, citric acid at a concentration of 0.86 mg/ml, methyl-β
-cyclodextrin at a concentration of 45 mg/ml, EDTA at a concentration of 1 mg/ml, lactose at a concentration of 9 mg/ml, sorbitol at a concentration of 18.2 mg/ml, and L-α
-phosphatidylcholine didecanoyl at a concentration of 1 mg/ml, wherein the formulation has a pH of about 5.0±
0.3, andc. an actuator to produce an aerosol of said solution, wherein less than 10% of the droplets are smaller than 10 microns in size. - View Dependent Claims (41)
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Specification