Sustained release drug delivery devices with prefabricated permeable plugs

• US 6,964,781 B2
• Filed: 12/27/2001
• Issued: 11/15/2005
• Est. Priority Date: 01/03/2001
• Status: Expired due to Fees

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Inventors: Brubaker, Michael J.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): GHALI, ISIS A D
• Application Number:
  US10/034,795
• Publication Number:
  US 20020106395A1
• Time in Patent Office: 1,419 Days
• Field of Search: 424/473, 424/422, 424/423, 424/427, 424/400
• US Class Current: 424/473
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants

Abstract

The present invention is directed to an improved sustained release drug delivery device comprising a drug core, a unitary cup, and a prefabricated permeable plug.

Claims

1. A sustained release drug delivery device comprising:

a) a drug core comprising a therapeutically effective amount of at least one agent effective in obtaining a diagnostic effect or effective in obtaining a desired local or systemic physiological or pharmacological effect;

b) a unitary cup essentially impermeable to the passage of said agent that surrounds and defines an internal compartment to accept said drug core, said unitary cup comprising an open top end with at least one recessed groove around at least some portion of said open top end of said unitary cup; and

c) a prefabricated plug which is permeable to the passage of said agent, said prefabricated plug is positioned at said open top end of said unitary cup wherein said groove interacts with said prefabricated plug holding it in position and closing said open top end, said prefabricated plug allowing passage of said agent out of said drug core, through said prefabricated plug, and out said open top end of said unitary cup.

2. The sustained release drug delivery device according to claim 1, wherein said unitary cup is made of a polymer, a metal, a ceramic, or glass.

3. The sustained release drug delivery device according to claim 1, wherein said unitary cup further comprises an integral suture tab.

4. The sustained release drug delivery device according to claim 3, wherein said integral suture tab has a hole through the proximal end through which a suture can be placed to anchor the device to a structure.

5. The sustained release drug delivery device according to claim 3, wherein said unitary cup is made of silicone.

6. The sustained release drug delivery device according to claim 5, wherein said prefabricated plug is a zeolite plug.

7. The sustained release drug delivery device according to claim 1, wherein said unitary cup further comprises a plurality of recessed grooves around at least some portion of said open top end of said unitary cup.

8. The sustained release drug delivery device according to claim 1, wherein said agent is a low solubility agent.

9. The sustained release drug delivery device according to claim 1, wherein said agent is selected from a group consisting of immune response modifiers, neuroprotectants, corticosteroids, angiostatic steriods, anti-parasitic agents, antiglaucoma agents, antibiotics, anti-sense compounds, anti-angiogentic compounds, differentiation modulators, anti-viral agents, anti-cancer agents, and nonsteroidal anti-inflammatory agents.

10. The sustained release drug delivery device according to claim 1, wherein said drug core comprises a plurality of agents.

11. The sustained release drug delivery device according to claim 1, wherein said prefabricated plug comprises a holder and a permeable member.

12. A sustained release drug delivery device comprising:

a) a drug core comprising at least one agent effective in obtaining a diagnostic effect or effective in obtaining a desired local or systemic physiological or pharmacological effect;

b) a unitary cup essentially impermeable to the passage of said agent that surrounds and defines an internal compartment to accept said drug core, said unitary cup comprising an open top end and at least one lip around at least a portion of said open top end of said unitary cup; and

c) a prefabricated plug permeable to the passage of said agent positioned at said open top end of said unitary cup wherein said lip interacts with said prefabricated plug holding it in position and closing said open top end, said permeable plug allowing passage of said agent out of said drug core, through said permeable plug, and out said open top end of said unitary cup.

13. The sustained release drug delivery device according to claim 12, wherein said lip extends around the entirety of said open top end of said unitary cup.

14. The sustained release drug delivery device according to claim 12, wherein said unitary cup comprises a plurality of lips at said open top end of said unitary cup.

15. The sustained release drug delivery device according to claim 12, wherein said drug core comprises an effective amount of a low solubility agent.

16. The sustained release drug delivery device according to claim 12, wherein said agent is selected from a group consisting of immune response modifiers, neuroprotectants, corticosteroids, angiostatic steriods, anti-parasitic agents, anti-glaucoma agents, anti-biotics, anti-sense compounds, anti-angiogentic compounds, differentiation modulators, anti-viral agents, anti-cancer agents, and nonsteroidal anti-inflammatory agents.

17. The sustained release drug delivery device according to claim 12, wherein said unitary cup is made of a polymer, a metal, a ceramic, or glass.

18. The sustained release drug delivery device according to claim 12, wherein said unitary cup further comprises an integral suture tab.

19. The sustained release drug delivery device according to claim 18, wherein said unitary cup is made of silicone.

20. The sustained release drug delivery device according to claim 19, wherein said prefabricated plug is a zeolite plug.

21. The sustained release drug delivery device according to claim 18, wherein said suture tab has a hole through the proximal end through which a suture can be placed to anchor the device to a structure.

22. The sustained release drug delivery device according to claim 12, wherein said prefabricated plug comprises a holder and a permeable member.

23. The sustained release drug delivery device according to claim 12, wherein said drug core comprises a plurality of agents.

24. A method for providing controlled and sustained administration of an agent effective in obtaining a desired local or systemic physiological or pharmacological effect comprising inserting in a desired location in the body of a mammalian organism a sustained release drug delivery device comprising;

a) a drug core comprising a therapeutically effective amount of at least one agent effective in obtaining a diagnostic effect or effective in obtaining a desired local or systemic physiological or pharmacological effect;

b) a unitary cup essentially impermeable to the passage of said agent that surrounds and defines an internal compartment to accept said drug core, said unitary cup comprising an open top end with at least one recessed groove around at least some portion of said open top end of said unitary cup; and

c) a prefabricated plug which is permeable to the passage of said agent positioned at said open top end of said unitary cup wherein said groove interacts with said prefabricated permeable plug holding it in position and closing said open top end, said permeable plug allowing passage of said agent out of said drug core, through said permeable plug, and out said open top end of said unitary cup.

25. The method according to claim 24, wherein said inserting step comprises inserting said sustained release drug delivery device in a location selected from a group consisting of the vitreous of the eye, under the retina, and onto the sclera.

26. The method according to claim 24, wherein said drug core comprises a plurality of agents.

27. The method according to claim 24, wherein said inserting step comprises injecting said sustained release drug delivery device at the desired location.

28. A method for providing controlled and sustained administration of an agent effective in obtaining a desired local or systemic physiological or pharmacological effect comprising inserting at a desired location in the body of a mammalian organism a sustained release drug delivery device comprising;

a) a drug core comprising at least one agent effective in obtaining a diagnostic effect or effective in obtaining a desired local or systemic physiological or pharmacological effect;

b) a unitary cup essentially impermeable to the passage of said agent that surrounds and defines an internal compartment to accept said drug core, said unitary cup comprising an open top end and at least one lip around at least a portion of said open top end of said unitary cup; and

c) a prefabricated plug permeable to the passage of said agent positioned at said open top end of said unitary cup wherein said lip interacts with said prefabricated plug holding it in position and closing said open top end, said permeable plug allowing passage of said agent out of said drug core, through said permeable plug, and out said open top end of said unitary cup.

29. The method according to claim 28, wherein said inserting step comprises inserting said sustained release drug delivery device in a location selected from a group consisting of the vitreous of the eye, under the retina, and onto the sclera.

30. The method according to claim 28, wherein said drug core contains a plurality of said agents.

31. The method according to claim 28, wherein said inserting step comprises injecting said sustained release drug delivery device at the desired location.

32. A method of manufacturing a sustained release drug delivery device comprising:

a) manufacturing a drug core comprising at least one agent effective in obtaining a diagnostic effect or effective in obtaining a desired local or systemic physiological or pharmacological effect;

b) providing a unitary cup essentially impermeable to the passage of said agent that surrounds and defines an internal compartment to accept said drug core, said unitary cup comprising an open top end with at least one recessed groove around at least some portion of said open top end of said unitary cup;

c) inserting said drug core into said unitary cup; and

d) snapping a prefabricated plug which is permeable to the passage of said agent into said open top end of said unitary cup wherein said groove interacts with said permeable member holding it in position and closing said open top end, said permeable plug allowing passage of said agent out of said drug core, through said permeable plug, and out said open top end of said unitary cup.

33. The method of manufacturing a sustained release drug delivery device according to claim 32, wherein said drug core is manufactured as a solid dose form.

34. The method of manufacturing a sustained release drug delivery device according to claim 32, wherein said drug core is manufactured as a solid dispersion.

35. A method of manufacturing a sustained release drug delivery device comprising:

a) manufacturing a drug core comprising at least one agent effective in obtaining a diagnostic effect or effective in obtaining a desired local or systemic physiological or pharmacological effect;

b) providing a unitary cup essentially impermeable to the passage of said agent that surrounds and defines an internal compartment to accept said drug core, said unitary cup comprising an open top end with at least one lip extending around at least a portion of the said open top end of said unitary cup;

c) inserting said drug core into said unitary cup; and

d) snapping a prefabricated plug which is permeable to the passage of said agent into said open top end of said unitary cup wherein said lip interacts with said permeable member holding it in position closing said open top end, said permeable plug allowing passage of said agent out of said drug core, through said permeable plug, and out said open top end of said unitary cup.

36. The method of manufacturing a sustained release drug delivery device according to claim 35, wherein said drug core is manufactured as a solid dose form.

37. The method of manufacturing a sustained release drug delivery device according to claim 35, wherein said drug core is manufactured as a solid dispersion.