IP Library › Granted Patent US 12,226,456
Granted Patent B2
US 12,226,456 · App. 16/266,640 · Granted Feb 18, 2025

Nasal powder formulation for treatment of hypoglycemia

Inventors: Sankaram Mantripragada (Windsor, CO); Claude A. Piche (Verdun, CA); Jo Jan Filip Van Betsbrugge (Laval, CA)
Assignee: Amphastar Pharmaceuticals, Inc.
A61K38/26A61K9/0043A61K9/145A61K9/146A61K31/724A61K47/12A61K47/24A61M15/0065A61M15/08A61M2202/064
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Quick Facts
Patent No.
US 12,226,456
App. No.
16/266,640
Granted
Feb 18, 2025
Kind
B2
Abstract

The present invention provides a powder formulation containing glucagon or a glucagon analog for nasal administration, useful in the treatment of hypoglycemia, and in particular the treatment of severe hypoglycemia. The present invention also provides a method of making this powder formulation, and to devices and methods for using the powder formulation.

Claims (8)

1. A powder composition comprising glucagon (SEQ ID NO:1), a phospholipid surfactant selected from dilauroylphosphatidylglycerol and dodecylphosphocholine, and α-cyclodextrin, wherein the glucagon, the phospholipid surfactant and α-cyclodextrin are present in formulation selected from the group consisting of:

a. 5 wt % glucagon, 25 wt % phospholipid surfactant, wherein the phospholipid surfactant is dilauroylphosphatidylglycerol, and 70 wt % α-cyclodextrin; and

b. 5 wt % glucagon, 25 wt % phospholipid surfactant, wherein the phospholipid surfactant is dodecylphosphocholine, and 70 wt % α-cyclodextrin.

2. The powder composition according to claim 1 , wherein the composition comprises 5 wt % glucagon, 25 wt % phospholipid surfactant, wherein the phospholipid surfactant is dilauroylphosphatidylglycerol, and 70 wt % α-cyclodextrin.

3. The powder composition according to claim 1 , wherein the composition comprises 5 wt % glucagon, 25 wt % phospholipid surfactant, wherein the phospholipid surfactant is dodecylphosphocholine, and 70 wt % α-cyclodextrin.

4. A nasal applicator for a powder formulation, said applicator including a powder formulation reservoir, and a powder formulation contained within the reservoir, wherein the powder formulation is a composition in accordance with claim 1 .

5. A method for treating hypoglycemia in an individual suffering from hypoglycemia comprising administering to the individual a composition in accordance with claim 1 , wherein the composition is administered in a therapeutically effective amount as a powder to the nasal mucosa of the individual.

6. The method of claim 5 , wherein the powder formulation is administered to only one nostril of the individual.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 10, 2023
From: ELI LILLY AND COMPANY
To: AMPHASTAR PHARMACEUTICALS, INC.
Reel/Frame 064553/0910 →
SECURITY INTEREST Recorded Jun 30, 2023
From: AMPHASTAR PHARMACEUTICALS, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
Reel/Frame 064124/0933 →
Continuity (3)
Continuation 15545332
Provisional Application 62117031 · Feb 17, 2015
Related Publication 20190282666A1 · Sep 19, 2019
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