Method for delivering insulin

Patent metadata

Field	Value
Publication number	US-12280125-B2
Application number	US-202217941384-A
Country	US
Kind code	B2
Filing date	Sep 9, 2022
Priority date	Sep 9, 2022
Publication date	Apr 22, 2025
Grant date	Apr 22, 2025

Abstract

A method of delivering insulin, including: orally administering to a subject a composition containing a ferrisilicate material, polyethylene glycol, and insulin. The insulin at least partially penetrates pores of the ferrisilicate material to form a ferrisilicate insulin composite and the polyethylene glycol, at least partially enfolds the ferrisilicate insulin composite to form the composition. The composition has an insulin release rate of 10-50% after 100-500 hours following oral administration.

First claim

The invention claimed is:

1. A method of delivering insulin, comprising:
orally administering to a subject a composition comprising,
a ferrisilicate material having one or more pores, the one or more pores having an average pore size of from 2 nm to 5 nm;
polyethylene glycol; and
insulin;
wherein the insulin at least partially penetrates the pores of the ferrisilicate material to form a ferrisilicate insulin composite,
wherein the polyethylene glycol, at least partially enfolds the ferrisilicate insulin composite, and
wherein the composition has a cumulative insulin release of about 40% after 500 hours following oral administration.

2. The method of claim 1 , wherein the ferrisilicate material has an atomic ratio of silicon to iron of 10-300 to 1.

3. The method of claim 1 , wherein the ferrisilicate material has cubic shaped pores.

4. The method of claim 1 , wherein the insulin is amorphous.

5. The method of claim 1 , wherein the ferrisilicate insulin composite has a surface area of 300-350 square meter per gram (m2/g).

6. The method of claim 1 , wherein the composition has a pore volume of 0.1-0.5 cubic centimeter per gram (cm3/g).

7. The method of claim 1 , wherein at least a portion of the polyethylene glycol is hydrogen-bonded to the insulin.

8. The method of claim 1 , wherein the ferrisilicate insulin composite has 5-90 weight percent (wt %) insulin based on the total weight of the ferrisilicate insulin composite.

9. The method of claim 1 , wherein the ferrisilicate insulin composite has 60-80 wt % insulin based on the total weight of the ferrisilicate insulin composite.

10. The method of claim 1 , wherein 1-100 milligrams (mg) of the composition per kg body weight of the subject is orally administered.

11. The method of claim 1 , wherein the blood glucose level of the subject is decreased following oral administration of the composition.

12. The method of claim 11 , wherein the blood glucose level is decreased by 5-40% after 1-3 hours following oral administration of the composition.

13. The method of claim 1 , wherein the composition is administered daily.

14. The method of claim 13 , wherein the blood glucose level of the subject is decreased by 20-50% after 28 days.

15. The method of claim 11 , wherein the blood glucose level is decreased by a greater amount than a same method administering only the insulin.

16. The method of claim 1 , wherein the ferrosilicate material is substantially free of iron oxide as measured by X-ray diffraction (XRD).

17. The method of claim 1 , wherein the ferrosilicate has an average pore size of 3.2 nm.

Assignees

• Univ Imam Abdulrahman Bin Faisal

Inventors

• Jermy B Rabindran
• Ravinayagam Vijaya
• Salahuddin Mohammed

Classifications

• A61K38/28 Primary

  Insulins · CPC title

• A61K47/60

  the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol · CPC title

• A61K9/0053

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title

• A61K31/695

  Silicon compounds · CPC title

• A61K33/26

  Iron; Compounds thereof · CPC title