Drug delivery device having zero or near zero-order release kinetics

• US 20060292222A1
• Filed: 06/21/2006
• Published: 12/28/2006
• Est. Priority Date: 06/21/2005
• Status: Abandoned Application

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Inventors: Jonasse, Matthew
• Application Number:
  US11/472,237
• Publication Number:
  US 20060292222A1
• Time in Patent Office: Days
• US Class Current: 424/468
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

The present invention is directed to an improved sustained release drug delivery device comprising a drug core, a cup, and a prefabricated crystalline or semi-crystalline polymeric 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 cup essentially impermeable to the passage of the agent that surrounds and defines an internal compartment to accept the drug core, the cup comprising an open top end with at least one recessed groove around at least some portion of the open top end of the cup; and

c) a prefabricated plug which is permeable to the passage of the agent, the prefabricated plug comprising at least one crystalline or semi-crystalline polymer, the prefabricated plug is positioned at the open top end of the cup wherein the groove interacts with the prefabricated plug holding it in position and closing the open top end, the prefabricated plug allowing passage of the agent out of the drug core, through the prefabricated plug, and out the open top end of the cup;

wherein the thickness and degree of crystallinity of the plug results in zero order or near zero order release kinetics for at least 120 days.

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

3. The sustained release drug delivery device according to claim 1, wherein the cup further comprises a suture tab.

4. The sustained release drug delivery device according to claim 3, wherein the 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 the cup is made of silicone.

6. The sustained release drug delivery device according to claim 1, wherein the prefabricated plug is between about 75 μ

m to about 250 μ

m in thickness.

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

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

9. The sustained release drug delivery device according to claim 1, wherein the agent is selected from a group consisting of immune response modifiers, neuroprotectants, corticosteroids, angiostatic steroids, 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 the drug core comprises a plurality of agents.

11. The sustained release drug delivery device according to claim 1, wherein the 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 cup essentially impermeable to the passage of the agent that surrounds and defines an internal compartment to accept the drug core, the cup comprising an open top end and at least one lip around at least a portion of the open top end of the cup; and

c) a prefabricated plug permeable to the passage of the agent positioned at the open top end of the cup, the prefabricated plug comprising at least one crystalline or semi-crystalline polymer, wherein the lip interacts with the prefabricated plug holding it in position and closing the open top end, the permeable plug allowing passage of the agent out of the drug core, through the permeable plug, and out the open top end of the cup at zero order or near zero order release kinetics for at least 120 days.

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

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

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

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

18. The sustained release drug delivery device according to claim 12, wherein the cup further comprises a suture tab.

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

20. The sustained release drug delivery device according to claim 12, wherein the prefabricated plug is between about 75 μ

m to about 250 μ

m in thickness.

21. The sustained release drug delivery device according to claim 18, wherein the 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 the prefabricated plug comprises a holder and a permeable member.

23. The sustained release drug delivery device according to claim 12, wherein the 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 cup essentially impermeable to the passage of the agent that surrounds and defines an internal compartment to accept the drug core, the cup comprising an open top end with at least one recessed groove around at least some portion of the open top end of the cup; and

c) a prefabricated plug which is permeable to the passage of the agent, the prefabricated plug comprising at least one crystalline or semi-crystalline polymer, the prefabricated plug is positioned at the open top end of the cup wherein the groove interacts with the prefabricated plug holding it in position and closing the open top end, the prefabricated plug allowing passage of the agent out of the drug core, through the prefabricated plug, and out the open top end of the cup;

wherein the thickness and degree of crystallinity of the plug results in zero order or near zero order release kinetics for at least 120 days.

25. The method according to claim 24, wherein the inserting step comprises inserting the 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 the drug core comprises a plurality of agents.

27. The method according to claim 24, wherein the inserting step comprises injecting the 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 cup essentially impermeable to the passage of the agent that surrounds and defines an internal compartment to accept the drug core, the cup comprising an open top end and at least one lip around at least a portion of the open top end of the cup; and

c) a prefabricated plug permeable to the passage of the agent positioned at the open top end of the cup, the prefabricated plug comprising at least one semi-crystalline polymer, wherein the lip interacts with the prefabricated plug holding it in position and closing the open top end, the permeable plug allowing passage of the agent out of the drug core, through the permeable plug, and out the open top end of the cup at zero order or near zero order release kinetics for at least 120 days.

29. The method according to claim 28, wherein the inserting step comprises inserting the 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 the drug core contains a plurality of the agents.

31. The method according to claim 28, wherein the inserting step comprises injecting the 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 cup essentially impermeable to the passage of the agent that surrounds and defines an internal compartment to accept the drug core, the cup comprising an open top end with at least one recessed groove around at least some portion of the open top end of the cup;

c) inserting the drug core into the cup; and

d) placing a prefabricated plug which is permeable to the passage of the agent into the open top end of the cup, the prefabricated plug comprising at least one crystalline or semi-crystalline polymer, wherein the groove interacts with the permeable member holding it in position and closing the open top end, the permeable plug allowing passage of the agent out of the drug core, through the permeable plug, and out the open top end of the cup at zero order or near zero order release kinetics for at least 120 days.

33. The method of manufacturing a sustained release drug delivery device according to claim 32, wherein the 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 the 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 cup essentially impermeable to the passage of the agent that surrounds and defines an internal compartment to accept the drug core, the cup comprising an open top end with at least one lip extending around at least a portion of the open top end of the cup;

c) inserting the drug core into the cup; and

d) placing a prefabricated plug comprising at least one crystalline or semi-crystalline polymer which is permeable to the passage of the agent into the open top end of the cup wherein the lip interacts with the permeable member holding it in position and closing the open top end, the permeable plug allowing passage of the agent out of the drug core, through the permeable plug, and out the open top end of the cup at zero order or near zero order release kinetics for at least 120 days.

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