Clonidine compounds in a biodegradable polymer

Patent metadata

Field	Value
Publication number	US-RE48948-E
Application number	US-201916374300-A
Country	US
Kind code	E1
Filing date	Apr 3, 2019
Priority date	Apr 18, 2008
Publication date	Mar 1, 2022
Grant date	Mar 1, 2022

Abstract

Effective treatments of pain for extended periods of time are provided. Through the administration of an effective amount of clonidine in a drug depot at or near a target site, one can relieve pain caused by diverse sources, including but not limited to spinal disc herniation (i.e. sciatica), spondilothesis, stenosis, discogenic back pain and joint pain. When appropriate drug depot formulations are provided within biodegradable polymers, this pain relief can be continued for at least fourteen days.

First claim

What is claimed is:

1. A method for treating chronic pain in a patient in need of such treatment, the method comprising administering an implantable drug depot to a target tissue site beneath the skin of the patient, the implantable drug depot comprising clonidine hydrochloride in an amount from about 5.0 wt % to about 20 wt % of the implantable drug depot, and at least one biodegradable polymer in an amount from about 80 wt % to about 95 wt %, wherein the implantable drug depot has a surface that releases a burst dose of the clonidine hydrochloride in an amount from about 5 wt % to about 20 wt % based on the total weight of the clonidine hydrochloride in the drug depot within 24 hours, and the biodegradable polymer is poly(D,L-lactide) and has an inherent viscosity of from about 0.45 dig dL/g to about 0.55 dig dL/g and the implantable medical device drug depot releases the clonidine hydrochloride over a period of at least 14 days.

2. A method of treating chronic pain according to claim 1 , wherein the chronic pain is caused by sciatica.

3. A method of treating chronic pain according to claim 2 , wherein the drug depot triangulates the target tissue site.

4. A method of treating chronic pain according to claim 1 , wherein the drug depot is administered at or near the spine.

5. A method of treating chronic pain according to claim 1 , wherein the implantable drug depot comprises a length from about 0.5 mm to 50 mm and a diameter from about 0.01 to about 4 mm.

6. A method of treating chronic pain according to claim 1 , wherein the implantable drug depot is a solid.

7. A method of treating chronic pain according to claim 1 , wherein the implantable drug depot comprises about 15 wt % of clonidine hydrochloride, about 85 wt % of the poly(D,L-lactide) having an inherent viscosity of about 0.5 dL/g, and the surface releases a burst dose from about 5 wt % to about 10 wt % of the clonidine hydrochloride based on the total weight of the clonidine hydrochloride in the drug depot within 24 hours.

8. A method of treating chronic pain according to claim 1 , wherein the implantable drug depot further comprises mPEG.

9. A method for treating pain in a patient in need of such treatment, the method comprising administering an implantable drug depot to a target tissue site beneath the skin of the patient, the implantable drug depot comprising clonidine hydrochloride in an amount from about 5.0 wt % to about 20 wt % of the implantable drug depot, and at least one biodegradable polymer is poly(D,L-lactide) in an amount from about 80 wt % to about 95 wt %, and has an inherent viscosity of from about 0.45 dL/g to about 0.55 dL/g, wherein the implantable drug depot has a surface that releases a burst dose of the clonidine hydrochloride in an amount from about 5 wt % to about 20 wt % based on the total weight of the clonidine hydrochloride in the drug depot within 24 hours, and the implantable medical device drug depot releases the clonidine hydrochloride over a period of at least 14 days.

10. A method of treating pain according to claim 9, wherein the pain is caused by sciatica.

11. A method of treating pain according to claim 10, wherein the drug depot triangulates the target tissue site.

12. A method of treating pain according to claim 9, wherein the drug depot is administered at or near the spine.

13. A method of treating pain according to claim 9, wherein the implantable drug depot comprises a length from about 0.5 mm to 50 mm and a diameter from about 0.01 to about 4 mm.

14. A method of treating pain according to claim 9, wherein the implantable drug depot is a solid.

15. A method of treating pain according to claim 9, wherein the implantable drug depot comprises about 15 wt % of clonidine hydrochloride, about 85 wt % of the poly(D,L-lactide), and the surface releases a burst dose from about 5 wt % to about 10 wt % of the clonidine hydrochloride based on the total weight of the clonidine hydrochloride in the drug depot within 24 hours, and wherein the pain is caused by sciatica.

16. A method of treating pain according to claim 9, wherein the implantable drug depot comprises about 15 wt % of clonidine hydrochloride, and the surface releases a burst dose from about 5 wt % to about 10 wt % of the clonidine hydrochloride based on the total weight of the clonidine hydrochloride in the drug depot within 24 hours, and wherein the pain is caused by sciatica.

17. A method of treating pain according to claim 9, wherein the implantable drug depot comprises about 85 wt % of the poly(D,L-lactide), and the surface releases a burst dose from about 5 wt % to about 10 wt % of the clonidine hydrochloride based on the total weight of the clonidine hydrochloride in the drug depot within 24 hours, and wherein the pain is caused by sciatica.

18. A method of treating pain according to claim 9, wherein the implantable drug depot comprises about 15 wt % of clonidine hydrochloride, about 85 wt % of poly(D,L-lactide) having an inherent viscosity of about 0.5 dL/g, and wherein the pain is caused by sciatica.

19. A method of treating pain according to claim 9, wherein administering the implantable drug depot comprises administering three implantable drug depots, and wherein the total weight of the clonidine hydrochloride in the drug depot is between 900 micrograms and 1050 micrograms.

20. A method of treating chronic pain according to claim 1, wherein the implantable drug depot comprises about 15 wt % of clonidine hydrochloride, about 85 wt % of the poly(D,L-lactide), and the surface releases a burst dose from about 5 wt % to about 10 wt % of the clonidine hydrochloride based on the total weight of the clonidine hydrochloride in the drug depot within 24 hours, and wherein the chronic pain is caused by sciatica.

21. A method of treating chronic pain according to claim 1, wherein the implantable drug depot comprises about 15 wt % of clonidine hydrochloride, and the surface releases a burst dose from about 5 wt % to about 10 wt % of the clonidine hydrochloride based on the total weight of the clonidine hydrochloride in the drug depot within 24 hours, and wherein the chronic pain is caused by sciatica.

22. A method of treating chronic pain according to claim 1, wherein the implantable drug depot comprises about 85 wt % of the poly(D,L-lactide), and the surface releases a burst dose from about 5 wt % to about 10 wt % of the clonidine hydrochloride based on the total weight of the clonidine hydrochloride in the drug depot within 24 hours, and wherein the chronic pain is caused by sciatica.

23. A method of treating chronic pain according to claim 1, wherein the implantable drug depot comprises about 15 wt % of clonidine hydrochloride, about 85 wt % of the poly(D,L-lactide), and wherein the chronic pain is caused by sciatica.

24. A method of treating chronic pain according to claim 1, wherein administering the implantable drug depot comprises administering three implantable drug depots, and wherein the total weight of the clonidine hydrochloride in the drug depot is between 900 micrograms and 1050 micrograms.

Assignees

• Warsaw Orthopedic Inc

Inventors

• Clay Danielle L
• Roy Josee
• Mckay William F

Classifications

• A61K31/4168

  having a nitrogen attached in position 2, e.g. clonidine · CPC title

• A61K9/0024 Primary

  Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L) · CPC title

• A61K9/204

  Polyesters, e.g. poly(lactide-co-glycolide) · CPC title

• A61K9/0085

  Brain, e.g. brain implants; Spinal cord · CPC title

• A61P1/00

  Drugs for disorders of the alimentary tract or the digestive system · CPC title