Sustained release drug delivery devices with coated drug cores

• US 20040219181A1
• Filed: 02/28/2003
• Published: 11/04/2004
• Est. Priority Date: 01/03/2001
• Status: Abandoned Application

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Inventors: Viscasillas, Santos
• Application Number:
  US10/378,374
• Publication Number:
  US 20040219181A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 33/00 Antiparasitic agents
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 39/00 General protective or antinoxious agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/14 Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Abstract

The present invention is directed to an improved sustained release drug delivery device comprising a drug core comprising a polymer coated inner core and an impermeable cup or reservoir.

Claims

1. A sustained release drug delivery device comprising:

a) a drug core comprising an inner 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 and a polymer coating layer, the polymer being permeable to the passage of said agent, wherein the polymer coating layer covers the inner core; and

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.

2. The sustained release drug delivery device according to claim 1, wherein said lip extends around the entirety of said open top end of said unitary cup.

3. The sustained release drug delivery device according to claim 1, wherein said unitary cup comprises a plurality of lips at said open top end of said unitary cup.

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

5. The sustained release drug delivery device according to claim 1, wherein said inner core comprises an effective amount of a low solubility agent.

6. 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, anti-glaucoma agents, anti-biotics, anti-sense compounds, anti-angiogenic compounds, differentiation modulators, anti-viral agents, anti-cancer agents, and nonsteroidal anti-inflammatory agents.

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

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

9. The sustained release drug delivery device according to claim 8, wherein said unitary cup is made of silicone.

10. The sustained release drug delivery device according to claim 9, wherein said polymer coating layer is made of PVA.

11. The sustained release drug delivery device according to claim 8, 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.

35. The device of claim 1, wherein the polymer coating layer completely surrounds the inner core.

36. The device of claim 1, wherein the device has a geometric shape dimensionally suitable for insertion in the eye.

12. A sustained release drug delivery device comprising:

a) a drug core comprising an inner 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 and a polymer coating layer, the polymer being permeable to the passage of said agent, wherein the polymer coating layer covers the inner core; and

b) a reservoir essentially impermeable to the passage of said agent that surrounds and defines an internal compartment to accept said drug core, said reservoir comprising at least one passageway, said passageway allowing passage of said agent out of the inner core, through the polymer coating layer, through the passageway, and out of the device.

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

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

15. 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-angiogenic compounds, differentiation modulators, anti-viral agents, anti-cancer agents, and nonsteroidal anti-inflammatory agents.

16. The sustained release drug delivery device according to claim 12, wherein said reservoir is made of a polymer or a metal.

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

18. The sustained release drug delivery device according to claim 17, wherein said reservoir is made of silicone.

19. The sustained release drug delivery device according to claim 18, wherein said polymer coating layer is made of PVA.

20. The sustained release drug delivery device according to claim 17, 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.

21. The sustained release drug delivery device according to claim 12, wherein said reservoir further comprises:

a) 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

b) a plug which is essentially impermeable to the passage of said agent, said plug is positioned at said open top end of said unitary cup wherein said groove interacts with said plug holding it in position and closing said open top end.

22. The sustained release drug delivery device according to claim 12, wherein said reservoir further comprises:

a) 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

b) a plug which is essentially impermeable to the passage of said agent, said plug is positioned at said open top end of said unitary cup wherein said lip interacts with said plug holding it in position and closing said open top end.

37. The device of claim 12, wherein the polymer coating layer completely surrounds the inner core.

38. The device of claim 12, wherein the device has a geometric shape dimensionally suitable for insertion in the eye.

23. 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 an inner 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 and a polymer coating layer, the polymer being permeable to the passage of said agent, wherein the polymer coating layer covers the inner core; and

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.

24. The method according to claim 23, 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.

25. The method according to claim 23, wherein said inner core comprises a plurality of agents.

26. The method according to claim 23, wherein said inserting step comprises injecting said sustained release drug delivery device at the desired location.

39. The method of claim 23, wherein the device inserted into the body has a polymer layer completely surrounding the inner core.

40. The method of claim 23, wherein the device inserted into the body has a geometric shape dimensionally suitable for insertion in the eye.

27. 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 an inner 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 and a polymer coating layer, the polymer being permeable to the passage of said agent, wherein the polymer coating layer covers the inner core; and

b) a reservoir essentially impermeable to the passage of said agent that surrounds and defines an internal compartment to accept said drug core, said reservoir comprising at least one passageway, said passageway allowing passage of said agent out of the inner core, through the polymer coating layer, through the passageway, and out of the device.

28. The method according to claim 27, 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.

29. The method according to claim 27, wherein said inner core contains a plurality of said agents.

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

41. The method of claim 27, wherein the device inserted into the body has a polymer layer completely surrounding the inner core.

42. The method of claim 27, wherein the device inserted into the body has a geometric shape dimensionally suitable for insertion in the eye.

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

a) manufacturing an inner 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) forming a drug core by coating said inner core with a polymer coating layer permeable to the passage of said agent;

c) providing a unitary cup essentially impermeable to the passage of said agent that surrounds and defines an internal compartment to accept said drag 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; and

d) inserting said drug core into said unitary cup wherein said lip interacts with said permeable plug holding it in position and closing said open top end, allowing passage of said agent out of said inner core, through said polymer coating layer, and out said open top end of said unitary cup.

32. The method of manufacturing a sustained release drug delivery device according to claim 31, comprising the further step of curing said drug core prior to insertion into said unitary cup.

43. The method of claim 31, wherein the device manufactured has a polymer layer completely surrounding the inner core.

44. The method of claim 31, wherein the device manufactured has a geometric shape dimensionally suitable for insertion in the eye.

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

a) manufacturing an inner 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) forming a drug core by coating said inner core with a polymer coating layer permeable to the passage of said agent;

c) encapsulating said drug core in impermeable polymer 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; and

d) making at least one passageway through said impermeable polymer layer allowing passage of said agent out of said inner core, through said polymer coating layer, and out of said passageway.

34. The method of manufacturing a sustained release drug delivery device according to claim 33, comprising the further step of curing said drug core prior to insertion into said unitary cup.

45. The method of claim 33, wherein the device manufactured has a polymer layer completely surrounding the inner core.

46. The method of claim 33, wherein the device manufactured has a geometric shape dimensionally suitable for insertion in the eye.