Intranasal administration of glucose-regulating peptides
First Claim
1. A transmucosal glucose-regulating peptide formulation wherein the glucose-regulating peptide in the transmucosal glucose-regulating peptide formulation has a permeation in an in vitro permeation assay at least 10-fold greater than the glucose-regulating peptide in a saline formulation, wherein the saline formulation consists of a glucose-regulating peptide, water, sodium chloride and a buffering agent, wherein the transmucosal glucose-regulating peptide formulation and the saline formulation have a pH and osmolarity which are identical.
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Abstract
Pharmaceutical compositions and methods are described comprising at least one glucose-regulating peptide, such as amylin, glucagon-like peptide-1 (GLP), pramlintide or exendin-4 and one or more mucosal delivery-enhancing agents for enhanced nasal mucosal delivery of the amylin, for treating a variety of diseases and conditions in mammalian subjects, including obesity and diabetes mellitus.
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Citations
103 Claims
- 1. A transmucosal glucose-regulating peptide formulation wherein the glucose-regulating peptide in the transmucosal glucose-regulating peptide formulation has a permeation in an in vitro permeation assay at least 10-fold greater than the glucose-regulating peptide in a saline formulation, wherein the saline formulation consists of a glucose-regulating peptide, water, sodium chloride and a buffering agent, wherein the transmucosal glucose-regulating peptide formulation and the saline formulation have a pH and osmolarity which are identical.
- 20. An aqueous glucose-regulating peptide formulation comprising a glucose-regulating peptide, water and a solubilizing agent wherein the formulation is substantially free of a stabilizer that is a polypeptide or a protein.
- 29. An aqueous glucose-regulating peptide formulation comprised of water, a glucose-regulating peptide, and a chelating agent wherein the pH of the formulation is about 2 to about 8, and the formulation is substantially free of a stabilizer that is a polypeptide or a protein.
- 37. An aqueous glucose-regulating peptide formulation comprising a glucose-regulating peptide, water, and a solubilizing agent wherein the formulation has a pH of 2.0 to about 8 and the formulation is substantially free of a stabilizer that is a polypeptide or a protein.
- 42. An aqueous formulation of glucose-regulating peptide comprising a glucose-regulating peptide, water, a chelatng agent and a surface-active agent wherein the formulation has a pH of 2.0 to about 8 and the formulation is substantially free of a stabilizer that is a polypeptide or a protein.
- 46. A method of administering glucose-regulating peptide comprising intranasally administering a transmucosal glucose-regulating formulation, wherein the glucose-regulating peptide in the transmucosal glucose-regulating peptide formulation has a permeation in an in vitro permeation assay at least 10-fold greater than the glucose-regulating peptide in a saline formulation, wherein the saline formulation consists of a glucose-regulating peptide, water, sodium chloride and a buffering agent, wherein the transmucosal glucose-regulating peptide formulation and the saline formulation have a pH and osmolarity which are identical.
- 64. A method for administering a glucose-regulating peptide comprising intranasally administering an aqueous glucose-regulating peptide formulation comprised of a glucose-regulating peptide, water and a solubilizing agent wherein the formulation is substantially free of a stabilizer that is a polypeptide or a protein.
- 73. A method for administering a glucose-regulating peptide comprising intranasally administering an aqueous glucose-regulating peptide formulation comprised of water, the glucose-regulating peptide, and a chelating agent wherein the pH of the formulation is about 2 to about 8, and the formulation is substantially free of a stabilizer that is a polypeptide or a protein.
- 81. A method for administering a glucose-regulating peptide comprising intranasally administering an aqueous glucose-regulating peptide formulation comprised of the glucose-regulating peptide, water, and a solubilizing agent wherein the formulation has a pH of 2.0 to about 8 and the formulation is substantially free of a stabilizer that is a polypeptide or a protein.
- 86. A method for administering a glucose-regulating peptide comprising intranasally administering an aqueous glucose-regulating peptide formulation, wherein said formulation is comprised of the glucose-regulating peptide, water, a chelatng agent and a surface-active agent wherein the formulation has a pH of 2.0 to about 8 and the formulation is substantially free of a stabilizer that is a polypeptide or a protein.
- 90. A transmucosal glucose-regulating peptide formulation wherein the glucose-regulating peptide in the transmucosal glucose-regulating peptide formulation has bioavailibility of at least 10% when administered intranasally to a human.
- 98. A method of administering glucose-regulating peptide comprising intranasally administering a transmucosal glucose-regulating formulation, wherein the glucose-regulating peptide in the transmucosal glucose-regulating peptide formulation has bioavailibility of at least 10% when administered intranasally to a human.
Specification