BIOERODIBLE SILICON-BASED DELIVERY VEHICLES FOR DELIVERY OF THERAPEUTIC AGENTS

• US 20160346211A1
• Filed: 05/27/2016
• Published: 12/01/2016
• Est. Priority Date: 03/12/2013
• Status: Abandoned Application

• Current Assignee: EyePoint Pharmaceuticals, Inc.
• Original Assignee: pSivida US, Inc
• Inventors: Ashton, Paul, Riedel, Gerard, Guo, Hong
• Application Number:
  US15/167,066
• Publication Number:
  US 20160346211A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 38/35 Corticotropin [ACTH]
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/1611 Inorganic compounds

Abstract

This invention discloses bioerodible delivery compositions for delivering peptide therapeutic agents. The delivery compositions comprise a porous silicon-based carrier material loaded with the therapeutic agent. The delivery compositions may be used in vitro or in vivo to deliver the therapeutic agent, preferably in a controlled fashion over an intended period of time such as over multiple days, weeks or months. The delivery compositions may be used for treating or preventing conditions of a patient such as chronic diseases.

Claims

1. A sustained release drug delivery composition comprising:

a porous carrier material comprising a silicon-based compound; and

at least one therapeutic agent associated with the carrier material, wherein the at least one therapeutic agent includes adrenocorticotropic hormone (ACTH) or an analog thereof.

2. The delivery composition according to claim 1, wherein the silicon-based compound comprises one or more of:

porous silicon, polycrystalline silicon, resorbable silicon or bio-erodible silicon.

3. The delivery composition according to claim 2, wherein the silicon-based compound comprises porous silicon, and the porous silicon is mesoporous silicon.

4. The delivery composition according to claim 1, wherein the silicon-based compound has a silica or silicon oxide surface.

5. The delivery composition according to claim 1, wherein the silicon-based compound is amorphous silica.

6. The delivery composition according to claim 1, wherein the at least one therapeutic agent includes an ACTH analog selected from corticotropin, tetracosactide, or cosyntropin.

7. The delivery composition according to claim 1, wherein the carrier material is sized for injection through a needle.

8. A method of making the delivery composition according to claim 2, comprising introducing the at least one therapeutic agent into the pores of the carrier material.

9. A method of administering at least one therapeutic agent to a mammal in need thereof, comprising administering a composition according to claim 1 to a mammal.

10. The method according to claim 9, wherein the at least one therapeutic agent is adsorbed to a surface of the carrier material.

11. The method according to claim 9, wherein the composition delivers the at least one therapeutic agent locally to a specific site of the mammal.

13. The delivery composition according to claim 1, wherein the average pore size of the porous carrier material is about 1 nm to about 10 nm.

14. The delivery composition according to claim 13, wherein the average pore size of the porous carrier material is about 5 nm to about 10 nm.

15. The delivery composition according to claim 1, wherein the adrenocorticotropic hormone or analog thereof has a molecular weight of about 1,000 amu to about 10,000 amu.

16. The delivery composition according to claim 15, wherein the adrenocorticotropic hormone or analog thereof has a molecular weight of about 2,000 amu to about 5,000 amu.

17. The delivery composition according to claim 1, wherein the adrenocorticotropic hormone or analog thereof is stable at 25°

C. for at least 6 months.

18. The delivery composition according to claim 1, wherein the adrenocorticotropic hormone or analog thereof has a half-life that is at least twice as long as the adrenocorticotropic hormone or analog thereof outside of the carrier material under the same conditions.

19. The delivery composition according to claim 1, wherein the composition is configured to release the adrenocorticotropic hormone or analog thereof over the course of about one month to about one year.

12. (canceled)

20. A sustained release drug delivery composition, comprising a porous silicon-based carrier material and a therapeutic agent disposed in pores of the carrier material, wherein:

the average pore size of the carrier material is about 1 nm to about 10 nm;

the therapeutic agent is adrenocorticotropic hormone or an analog thereof;

the therapeutic agent has a molecular weight of about 2,000 amu to about 5,000 amu; and

the composition is configured to release the therapeutic agent over the course of about one month to about one year.

21. The delivery composition according to claim 20, wherein the carrier material is sized for injection through a needle.