Subcutaneous implant

• US 5,633,000 A
• Filed: 06/23/1994
• Issued: 05/27/1997
• Est. Priority Date: 06/23/1994
• Status: Expired due to Term

• Current Assignee: Axxia Technologies
• Original Assignee: Axxia Technologies
• Inventors: Leong, Kam W., Grossman, Stuart A., Lo, Hungnan, Lesser, Glenn J.
• Primary Examiner(s): Mullis, Jeffrey C.
• Application Number:
  US08/264,689
• Time in Patent Office: 1,069 Days
• Field of Search: 424/423, 424/424, 424/425, 424/468, 424/473, 424/486, 424/422
• US Class Current: 424/422
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 9/0024 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 Class Codes: A61P 23/00 Anaesthetics
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/30 for treating abuse or dependence
• CPC Class Codes: A61P 25/36 Opioid-abuse
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

A non-abusable, non-inflammatory, biocompatible, non-biodegradable, subcutaneous, polymeric implant for the prolonged, controlled release of hydromorphone with near zero-order kinetics is described. Methods of alleviating cancer pain and treating opioid drug addiction with the implant are also described.

Claims

1. A method of providing prolonged relief of pain in a mammal suffering from pain comprising subcutaneously administering a delivery system comprising:

i) a matrix comprising poly(ethylene-vinyl acetate),

ii) hydromorphone embedded homogeneously in said matrix,

iii) poly(methyl methacrylate) coating said matrix,

wherein said delivery system is adapted to deliver said hydromorphone at a rate of plus or minus 500% of the target delivery rate, to said mammal, and wherein said delivery system has a geometry such that there is an external coated wall and an internal uncoated wall and the distance between the uncoated wall and the coated wall opposite the uncoated wall is substantially constant throughout the delivery system.

2. A method as in claim 1 wherein said delivery system is cylindrical in shape and has a cylindrical shaped opening along the axis of said delivery system forming an internal wall in said delivery system.

3. A method as in claim 1 wherein the thickness of said coating is 0.1-1 min.

4. A method as in claim 1 wherein said matrix contains 50% by weight hydromorphone and 50% by weight poly(ethylene-vinyl acetate).

5. A method as in claim 2 wherein the length of the delivery system along its axis is 1-20 mm and the diameter of the delivery system is 5-100 mm.

6. A method as in claim 2 wherein said cylindrical shaped opening has a diameter of 0.05-3 mm.

7. A method as in claim 1 wherein said pain is cancer pain.

8. A method as in claim 1 wherein said delivery system is adapted to deliver said hydromorphone at a rate of plus or minus 200% of the target delivery rate.

9. A method as in claim 1 wherein said delivery system is adapted to deliver said hydromorphone at a rate of plus or minus 100% of the target delivery rate.

10. A method as in claim 1 wherein the distance between the uncoated wall and the coated wall opposite the uncoated wall varies by no more than plus or minus 20%.

11. A method of providing prolonged relief of pain in a mammal suffering from pain comprising subcutaneously administering a delivery system comprising:

i) a matrix comprising polyethylene vinyl (acetate),

ii) hydromorphone embedded homogeneously in said matrix, and

iii) a poly(methyl methacrylate) coating surrounding said matrix

wherein said delivery system is cylindrical in shape and has a cylindrical shaped opening along the axis of said delivery system forming an internal uncoated wall in said delivery system, to said mammal.

12. A method as in claim 11 wherein the thickness of said coating is 0.1-1 min.

13. A method as in claim 11 wherein said matrix contains 50% by weight hydromorphone and 50% by weight poly(ethylene-vinyl acetate).

14. A method as in claim 13 wherein said hydromorphone is homogeneously distributed in said matrix.

15. A method as in claim 11 wherein the length of the delivery system along its axis is 1-20 mm and the diameter of the delivery system is 5-100 mm.