CA2524271A1 - Controlled release bioactive agent delivery device - Google Patents

Controlled release bioactive agent delivery device Download PDF

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Publication number
CA2524271A1
CA2524271A1 CA002524271A CA2524271A CA2524271A1 CA 2524271 A1 CA2524271 A1 CA 2524271A1 CA 002524271 A CA002524271 A CA 002524271A CA 2524271 A CA2524271 A CA 2524271A CA 2524271 A1 CA2524271 A1 CA 2524271A1
Authority
CA
Canada
Prior art keywords
body member
bioactive agent
meth
acrylate
coated composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002524271A
Other languages
French (fr)
Other versions
CA2524271C (en
Inventor
Aron B. Anderson
Laurie R. Lawin
Byron C. Shen
Eugene De Juan
Signe E. Varner
Ralph A. Chappa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Surmodics Inc
Original Assignee
Surmodics, Inc.
Aron B. Anderson
Laurie R. Lawin
Byron C. Shen
Eugene De Juan
Signe E. Varner
Ralph A. Chappa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Surmodics, Inc., Aron B. Anderson, Laurie R. Lawin, Byron C. Shen, Eugene De Juan, Signe E. Varner, Ralph A. Chappa filed Critical Surmodics, Inc.
Publication of CA2524271A1 publication Critical patent/CA2524271A1/en
Application granted granted Critical
Publication of CA2524271C publication Critical patent/CA2524271C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00353—Bone cement, e.g. polymethylmethacrylate or PMMA

Abstract

The invention provides a controlled release bioactive agent delivery device that includes a body member having a direction of extension, a longitudinal axis along the direction of extension, and a proximal end and a distal end, wherein at least a portion of the body member deviates from the direction of extension, and a polymeric coated composition in contact with the body member, the polymeric coated composition including a first polymer, a second polymer, and a bioactive agent, wherein the first polymer comprises polyalkyl(meth)acrylate, aromatic poly(meth)acrylate, or a combination of polyalkyl(meth)acrylate and aromatic poly(meth)acrylate, and wherein the second polymer comprises poly(ethylene-co-vinyl acetate). The invention also provides the use of said composition for the manufacture of a medicament for delivering a bioactive agent to a patient in a controlled release manner, as well as methods of making a controlled release bioactive agent delivery device.

Claims (44)

1. A controlled release bioactive agent delivery device comprising:
a. a body member having a direction of extension, a longitudinal axis along the direction of extension, and a proximal end and a distal end, wherein at least a portion of the body member deviates from the direction of extension; and b. a polymeric coated composition in contact with the body member, the polymeric coated composition comprising a first polymer, a second polymer, and a bioactive agent, wherein the first polymer comprises polyalkyl(meth)acrylate, aromatic poly(meth)acrylate, or a combination of polyalkyl(meth)acrylate and aromatic poly(meth)acrylate, and wherein the second polymer comprises polyethylene-co-vinyl acetate).
2. The device according to claim 1 wherein the body member is coil-shaped.
3. The device according to claim 1 wherein the body member is spiral.
4. The device according to claim 1 wherein the body member is fabricated from twisted wire.
5. The device according to claim 1 wherein the body member includes surface configurations.
6. The device according to claim 5 wherein the body member has a roughened surface.
7. The device according to claim 1 wherein the body member is a threaded shaft.
8. The device according to claim 1 wherein a cap is positioned at the proximal end of the body member.
9. The device according to claim 1 wherein the body member includes a lumen.
10. The device according to claim 9 wherein the polymeric coated composition is provided entirely within the lumen of the body member.
11. The device according to claim 10 wherein a second polymeric coated composition is provided in contact with an external surface of the body member.
12. The device according to claim 11 wherein the second polymeric coated composition comprises a bioactive agent.
13. The device according to claim 12 wherein the bioactive agent of the second polymeric coated composition is different from the bioactive agent of the polymeric coated composition within the lumen.
14. The device according to claim 12 wherein the bioactive agent of the second polymeric coated composition is the same as the bioactive agent of the polymeric coated composition within the lumen.
15. The device according to claim 9 wherein the lumen includes a substance, and wherein the polymeric coated composition is in contact with an external surface of the body member.
16. The device according to claim 15 wherein the substance is the same as the bioactive agent of the polymeric coated composition.
17. The device according to claim 15 wherein the substance is different from the bioactive agent of the polymeric coated composition.
18. The device according to claim 1 wherein the first polymer comprises polyalkyl(meth)acrylate selected from the group consisting of polyalkyl(meth)acrylates having alkyl chain lengths in the range of 2 to 8 carbons.
19. The device according to claim 18 wherein the first polymer comprises poly(n-butyl)methacrylate.
20. The device according to claim 1 wherein the first polymer comprises aromatic poly(meth)acrylate selected from the group consisting of polyaryl(meth)acrylate, polyaralkyl(meth)acrylate, and polyaryloxyalkyl(meth)acrylate.
21. The device according to claim 20 wherein the aromatic poly(meth)acrylate comprises aryl groups having from 6 to 16 carbon atoms.
22. The device according to claim 1 wherein the polyethylene-co-vinyl acetate) has a vinyl acetate concentration in the range of 10% to 90% by weight.
23. The device according to claim 1 wherein the polymeric coated composition comprises two or more layers on the body member.
24. The device according to claim 1 or claim 23 further comprising a surface pretreatment.
25. The device according to claim 24 wherein the surface pretreatment is selected from the group consisting of silane, polyurethane, parylene, or combinations thereof.
26. The device according to claim 1 wherein the bioactive agent is selected from the group consisting of triamcinolone acetonide, 13-cis retinoic acid, 5-fluorouridine, and combinations thereof.
27. The device according to claim 1 wherein the bioactive agent is present in an amount in the range of 1 µg to 10 mg of bioactive agent per cm2 of the effective surface area of the device.
28. The device according to claim 1 wherein the bioactive agent is present in an amount of 75% by weight or less of the polymeric coated composition.
29. The device according to claim 1 wherein the bioactive agent is released in a therapeutically effective amount when implanted in a patient.
30. The device according to claim 1 wherein the bioactive agent is released in a therapeutically effective amount for a period of 6 months or more when implanted in a patient.
31. The device according to claim 26 wherein the bioactive agent is triamcinolone acetonide, and the triamcinolone acetonide has a release rate in the range of 0.5 µg/day to 2 µg/day when implanted in an eye.
32. The device according to claim 1 wherein the bioactive agent is present in an amount in the range of 1 µg to 5 mg in the polymeric coated composition.
33. The device according to claim 1 wherein the polymeric coated composition has a final coating thickness in the range of 0.1 µm to 100 µm when provided on an external surface of the body member.
34. The device according to claim 1 wherein the distal end of the body member is positioned at the longitudinal axis.
35. The device according to claim 1 wherein the distal end of the body member is spaced from the longitudinal axis.
36. The device according to claim 1 wherein the proximal end of the body member is positioned at the longitudinal axis.
37. The device according to claim 1 wherein the polymeric coated composition is provided with a stepped configuration towards the distal end of the body member.
38. The device according to claim 37 wherein the stepped configuration comprises a tapered configuration towards the distal end of the body member.
39. A method of delivering a bioactive agent to a patient comprising:
a. providing a controlled release bioactive agent delivery device according to any one of claims 1 through 38, b. inserting the device into a patient's body, and c. removing the device from the patient's body once a therapeutically effective amount of bioactive agent has been delivered to the patient.
40. The method according to claim 39 wherein the step of inserting the device into a patient's body comprises inserting the device into an eye of the patient.
41. A method of making a controlled release bioactive agent delivery device comprising:
a. providing a body member having a direction of extension, a longitudinal axis along the direction of extension, and a proximal end and a distal end, wherein at least a portion of the body member deviates from the direction of extension; and b. providing a polymeric coating composition comprising a first polymer, a second polymer, and a bioactive agent in contact with the body member, wherein the first polymer comprises polyalkyl(meth)acrylate, aromatic poly(meth)acrylate, or a combination of polyalkyl(meth)acrylate and aromatic poly(meth)acrylate, and wherein the second polymer comprises polyethylene-co-vinyl acetate).
42. The method according to claim 41 wherein the step of providing a polymeric coating composition in contact with the body member comprises providing the polymeric coating composition on an external surface of the body member.
43. The method according to claim 41 wherein the body member includes a lumen, and wherein the step of providing a polymeric coating composition in contact with the body member comprises providing the polymeric coating composition in the lumen.
44. The method according to any one of claims 41-43 wherein the step of providing a polymeric coating composition in contact with the body member comprises providing the polymeric coating under controlled humidity conditions.
CA2524271A 2003-05-02 2004-04-29 Controlled release bioactive agent delivery device Expired - Fee Related CA2524271C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US46741903P 2003-05-02 2003-05-02
US60/467,419 2003-05-02
PCT/US2004/013327 WO2004098565A2 (en) 2003-05-02 2004-04-29 Implantable controlled release bioactive agent delivery device

Publications (2)

Publication Number Publication Date
CA2524271A1 true CA2524271A1 (en) 2004-11-18
CA2524271C CA2524271C (en) 2012-09-04

Family

ID=33435072

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2524271A Expired - Fee Related CA2524271C (en) 2003-05-02 2004-04-29 Controlled release bioactive agent delivery device

Country Status (8)

Country Link
US (7) US8021680B2 (en)
EP (1) EP1633320A2 (en)
JP (3) JP4824549B2 (en)
AT (1) ATE476960T1 (en)
AU (1) AU2004237774B2 (en)
CA (1) CA2524271C (en)
DE (1) DE602004028638D1 (en)
WO (1) WO2004098565A2 (en)

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