Pharmaceutical Formation For Increased Epithelial Permeability of Glucose-Regulating Peptide
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Abstract
What is described is a pharmaceutical formulation comprising a mixture of a pharmaceutically effective amount of glucose-regulating peptide (GRP) and enhancers, wherein the pharmaceutical formulation is used in the treatment of a metabolic syndrome.
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Citations
59 Claims
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1-42. -42. (canceled)
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43. An aqueous pharmaceutical formulation for intranasal delivery comprising a therapeutically effective amount of exendin-4 or an exendin-4 agonist analog, a permeation-enhancing solubilizing agent, a permeation-enhancing cation chelator, a buffer and optionally a permeation-enhancing viscosity enhancing agent, wherein
a. the solubilizing agent is selected from at least one of the group consisting of hydroxypropyl-β - -cyclodextrin, sulfobutylether-β
-cyclodextrin, dimethyl-β
-cyclodextrin, methyl-β
-cyclodextrin and Cremophor EL, andb. the viscosity enhancer is selected from at least one of the group consisting of gelatin, methylcellulose and hydroxypropylmethylcellulose, and wherein c. the formulation provides at least 5% permeation of exendin-4 in an in vitro tissue permeation assay, has a viscosity up to 150 cps, has a pH from 2 to 8 and is stable at least two weeks at 5°
C. - View Dependent Claims (44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59)
- -cyclodextrin, sulfobutylether-β
Specification