Sustained drug release sheet for treating nerve injury

Patent metadata

Field	Value
Publication number	US-12016959-B2
Application number	US-202117163871-A
Country	US
Kind code	B2
Filing date	Feb 1, 2021
Priority date	Mar 7, 2016
Publication date	Jun 25, 2024
Grant date	Jun 25, 2024

Abstract

A sustained release sheet that includes a drug for treating nerve injury, wherein the sheet is applied to a nerve injury site, can maintain a high concentration of the drug over a long period, and promotes nerve regeneration without stimulating the nerves, even when the sheet is implanted in the periphery of the nerve injury site. Also provided is a production method for the sheet. This sustained drug release sheet for treating nerve injury is a sheet including a non-woven fabric that is formed from nanofibers each containing a drug such as vitamin B12 and a biocompatible polymer such as a biodegradable aliphatic polyester, and is implanted in the periphery of the nerve injury site to promote nerve regeneration.

First claim

The invention claimed is:

1. A method of treating nerve injury including administering an effective amount of a drug to a subject in need thereof,
wherein the drug is sustainably administered in a sustained drug release sheet comprising a non-woven fabric that is formed from nanofibers containing the drug and a biocompatible polymer,
the drug consists of vitamin B12,
the vitamin B12 is a sole effective ingredient for treating the nerve injury,
the drug is sustainably released in the sustained drug release sheet for more than 25 days, and
the effective amount of the drug is administered in order to treat the nerve injury.

2. The method of treating nerve injury according to claim 1 , wherein the vitamin B12 is methylcobalamin.

3. The method of treating nerve injury according to claim 1 , wherein the biocompatible polymer is a biodegradable aliphatic polyester or a polyacrylamide derivative.

4. The method of treating nerve injury according to claim 3 , wherein the biodegradable aliphatic polyester is at least one selected from the group consisting of polycaprolactone or a copolymer thereof, polylactic acid or a copolymer thereof, polyglycolic acid or a copolymer thereof, and mixtures of these components.

5. The method of treating nerve injury according to claim 3 , wherein the polyacrylamide derivative is at least one selected from the group consisting of poly(N-isopropylacrylamide) or a copolymer thereof, poly(2-hydroxyethylmethacrylamide) or a copolymer thereof, a copolymer of N-isopropylacrylamide and 2-hydroxyethylmethacrylamide, and mixtures of these components.

6. The method of treating nerve injury according to claim 1 , wherein the nerve injury is a discontinuity nerve injury or a continuity nerve injury of peripheral nerve.

7. The method of treating nerve injury according to claim 6 , wherein the continuity nerve injury is an entrapment neuropathy.

8. The method of treating nerve injury according to claim 1 , wherein the weight of the sheet is in a range of 1 mg/cm 2 to 100 mg/cm 2 .

9. The method of treating nerve injury according to claim 1 , wherein the weight of the sheet is in a range of 1 mg/cm 2 to 10 mg/cm 2 .

10. The method of treating nerve injury according to claim 1 , wherein the sheet is implanted into the periphery of a nerve injury site.

11. A method treating nerve injury including administering an effective amount of a drug to a subject in need thereof,
wherein the drug is sustainably administered in a sustained drug release sheet comprising a non-woven fabric that is formed from nanofibers containing the drug and a biocompatible polymer,
the drug is vitamin B12 in the absence of GDF-5 or GDF-5-related proteins,
the drug is sustainably released in the sustained drug release sheet for more than 25 days, and
the effective amount of the drug is administered in order to treat the nerve injury.

12. The method of treating nerve injury according to claim 11 , wherein the vitamin B12 is methylcobalamin.

13. The method of treating nerve injury according to claim 11 , wherein the biocompatible polymer is a biodegradable aliphatic polyester or a polyacrylamide derivative.

14. The method of treating nerve injury according to claim 13 , wherein the biodegradable aliphatic polyester is at least one selected from the group consisting of polycaprolactone or a copolymer thereof, polylactic acid or a copolymer thereof, polyglycolic acid or a copolymer thereof, and mixtures of these components.

15. The method of treating nerve injury according to claim 13 , wherein the polyacrylamide derivative is at least one selected from the group consisting of poly(N-isopropylacrylamide) or a copolymer thereof, poly(2-hydroxyethylmethacrylamide) or a copolymer thereof, a copolymer of N-isopropylacrylamide and 2-hydroxyethylmethacrylamide, and mixtures of these components.

16. The method of treating nerve injury according to claim 11 , wherein the nerve injury is a discontinuity nerve injury or a continuity nerve injury of peripheral nerve.

17. The method of treating nerve injury according to claim 16 , wherein the continuity nerve injury is an entrapment neuropathy.

18. The method of treating nerve injury according to claim 11 , wherein the weight of the sheet is in a range of 1 mg/cm 2 to 100 mg/cm 2 .

19. The method of treating nerve injury according to claim 11 , wherein the weight of the sheet is in a range of 1 mg/cm 2 to 10 mg/cm 2 .

20. The method of treating nerve injury according to claim 11 , wherein the sheet is implanted into the periphery of a nerve injury site.

Assignees

• Univ Osaka
• Nat Inst Materials Science
• Nippon Zoki Pharmaceutical Co

Inventors

• Tanaka Hiroyuki
• Okada Kiyoshi
• Yoshikawa Hideki
• Suzuki Koji
• Ebara Mitsuhiro

Classifications

• A61K47/32

  Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} · CPC title

• A61K38/185 Primary

  Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3 · CPC title

• A61P25/02

  for peripheral neuropathies · CPC title

• A61K38/18

  Growth factors; Growth regulators · CPC title

• A61K9/70 Primary

  Web, sheet or filament bases {; Films; Fibres of the matrix type containing drug (hollow drug-filled fibres A61K9/0092)} · CPC title