TWO-PIECE INJECTABLE DRUG DELIVERY DEVICE WITH HEAT-CURED SEAL

• US 20120238994A1
• Filed: 12/21/2011
• Published: 09/20/2012
• Est. Priority Date: 12/22/2010
• Status: Abandoned Application

• Current Assignee: Josh York, Martin Nazzaro, Paul Ashton
• Original Assignee: Josh York, Martin Nazzaro, Paul Ashton
• Inventors: Nazzaro, Martin, York, Josh, Ashton, Paul
• Application Number:
  US13/333,743
• Publication Number:
  US 20120238994A1
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/61 containing two or more active agents in different layers
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The invention provides a drug delivery device for latanoprost or latanoprost acid. The device has a core of latanoprost or latanoprost acid which is surrounded by an internal and external sheath. The external sheath has a first cap that is permeable to latanoprost or latanoprost acid. The first cap may comprise polyvinyl alcohol (PVA), and the PVA may be heat cured. In certain aspects, there are one or more additional caps on the ends of the sheaths formed from one or more polymers. In certain aspects, one or more portions of the drug delivery device is substantially impermeable to latanoprost or latanoprost acid. In certain aspects, the latanoprost or latanoprost acid elutes through the first cap into a biological environment. The invention further provides methods for manufacturing the drug delivery device.

Claims

1. A drug delivery device comprising:

a core comprising latanoprost or latanoprost acid;

a first sheath at least partially surrounding the core, the first sheath having a first and second end;

a second sheath disposed about an exterior surface of the first sheath, the second sheath having a first and second end; and

a first cap covering the second end of the second sheath,

wherein the first cap is permeable to latanoprost or latanoprost acid, and wherein the first cap is adjacent to the second end of the first sheath.

2. The drug delivery device of claim 1, further comprising a second cap covering the first end of the first sheath.

3. The drug delivery device of claim 2, wherein the second cap is substantially impermeable to latanoprost or latanoprost acid in the core.

4. The drug delivery device of claim 2, wherein the second cap is formed from one or more polymers.

5. The drug delivery device of claim 4, wherein the second cap comprises one or more biodegradable polymers.

6. The drug delivery device of claim 5, wherein the second cap comprises poly(lactic-co-glycolic acid) (PLGA).

7. The drug delivery device of claim 2, wherein the first sheath and the second cap are integrally formed as a single unitary structure.

8. The drug delivery device of claim 1, wherein at least one of the first or second sheaths is substantially impermeable to latanoprost or latanoprost acid in the core.

9. The drug delivery device of claim 1, wherein the first end of the second sheath is covered by an impermeable seal.

10. The drug delivery device of claim 9, wherein the impermeable seal comprises silicone.

11. The drug delivery device of claim 1, wherein the second sheath substantially surrounds the first sheath.

12. The drug delivery device of claim 1, wherein the first sheath has a longitudinal dimension slightly smaller than a longitudinal dimension of the second sheath.

13. The drug delivery device of claim 1, wherein the first sheath is frictionally engaged with the second sheath.

14. The drug delivery device of claim 1, wherein the first cap is formed from one or more polymers.

15. The drug delivery device of claim 14, wherein the first cap comprises one or more biodegradable polymers.

16. The drug delivery device of claim 14, wherein said first cap comprises poly(vinyl alcohol) (PVA).

17. The drug delivery device of claim 16, wherein the PVA is heat cured.

18. The drug delivery device of claim 1, wherein, when the device is placed in a biological environment, latanoprost or latanoprost acid elutes through the first cap into the biological environment.

19. The drug delivery device of claim 18, wherein, when the device is placed in the biological environment, latanoprost or latanoprost acid elutes substantially exclusively through the first cap into the biological environment.

20. The drug delivery device of claim 1, wherein at least one of the first and second sheaths is formed from one or more polymers.

21. The drug delivery device of claim 20, wherein at least one of the first and second sheaths comprises one or more biodegradable polymers.

22. The drug delivery device of claim 21, wherein the first and second sheaths comprise poly(lactic-co-glycolic acid) (PLGA).

23. The drug delivery device of claim 6 or 22, wherein said PLGA comprises lactic acid (L) and glycolic acid (G) monomers in a ratio of about 95% L and 5% G.

24. The drug delivery device of claim 1, wherein the first and second sheaths and the first cap do not substantially biodegrade in a biological environment prior to release of at least 90% of latanoprost or latanoprost acid in the core.

25. The drug delivery device of claim 1, wherein, when the device is placed in a biological medium, latanoprost or latanoprost acid are released from the device according to a substantially zero-order release profile.

26. The drug delivery device of claim 1, wherein the first and second sheaths are cylindrical in shape.

27. The drug delivery device of claim 1, wherein the first sheath is dimensionally stable and retains its shape in the absence of the core and the second sheath.

28. The drug delivery device of claim 1, wherein the second sheath is dimensionally stable and retains its shape in the absence of the core and the first sheath.

29. The drug delivery device of claim 1, wherein the device is for implantation, injection, or insertion into a patient.

30. The drug delivery device of claim 1, wherein the device is shaped and sized for injection.

33. A method for delivering a drug to an animal, comprising implanting a drug delivery device according to claim 1 or 32 into the animal, whereby latanoprost or latanoprost acid diffuses out of the drug delivery device into the animal after implantation.

31. A method for manufacturing an injectable drug delivery device comprising:

providing a first sheath having a first and second end;

placing latanoprost or latanoprost acid into an interior region of the first sheath to form a drug core at least partially surrounded by the first sheath;

providing a second sheath having a first and second end; and

inserting the first sheath into an interior region of the second sheath such that the second sheath at least partially surrounds the first sheath.

32. A drug delivery device manufactured by the method of claim 31.

34. A drug delivery device comprising:

an inner casing comprising a) an inner wall defining a central cavity having a first and second end;

an outer casing comprising b) an outer wall disposed about an exterior surface of the inner wall and c) a first outer cap sealing the outer casing adjacent to the second end; and

a drug core comprising latanoprost or latanoprost acid disposed in the central cavity,

wherein the first outer cap is permeable to latanoprost or latanoprost acid disposed in the central cavity.

37. A method for delivering latanoprost or latanoprost acid to an animal, comprising implanting a drug delivery device according to claim 34 or 36 into the animal, whereby latanoprost or latanoprost acid diffuses out of the drug delivery device into the animal after implantation.

35. A method for manufacturing a drug delivery device comprising:

providing an inner casing comprising a) an inner wall defining a central cavity having a first and second end;

placing latanoprost or latanoprost acid into the central cavity of the inner casing to form a drug core at least partially surrounded by the inner casing; and

inserting the inner casing into an outer casing comprising b) an outer wall disposed about an exterior surface of the inner wall and c) a first outer cap sealing the outer casing adjacent to the second end,

wherein the first outer cap is permeable to latanoprost or latanoprost acid in the drug core.

36. A drug delivery device manufactured by the method of claim 35.

38. A drug delivery device comprising:

an inner casing comprising an inner tube having a first and second end;

an outer casing slidably engaged with the inner casing, the outer casing comprising an outer tube disposed about the inner tube and a first outer cap sealing an end of the outer casing adjacent to the second end; and

a drug core comprising latanoprost or latanoprost acid disposed in the inner tube,

wherein the first outer cap is permeable to latanoprost or latanoprost acid disposed in the central cavity.

41. A method for delivering a drug to an animal, comprising implanting a drug delivery device according to claim 38 or 40 into the animal, whereby latanoprost or latanoprost acid diffuses out of the drug delivery device into the animal after implantation.

39. A method for manufacturing a drug delivery device comprising:

providing an inner casing comprising an inner tube having a first and second end;

placing at least on drug selected from latanoprost and latanoprost acid into the inner tube to form a drug core at least partially surrounded by the inner casing; and

slidably engaging an outer casing with the inner casing, the outer casing comprising an outer tube disposed about the inner tube and a first outer cap sealing an end of the outer casing adjacent to the second end,

wherein the first outer cap is permeable to latanoprost or latanoprost acid in the drug core.

40. A drug delivery device manufactured by the method of claim 39.

42. A drug delivery device comprising:

an inner casing comprising an inner tube having a first and second end;

an outer casing slidably engaged with the inner casing, the outer casing comprising an outer tube disposed about the inner tube and a first outer cap sealing an end of the outer casing adjacent to the second end; and

a drug core comprising latanoprost or latanoprost acid disposed in the inner tube,

wherein the inner casing and outer casing comprise poly(lactic-co-glycolic acid) (PLGA) and the first outer cap comprises poly(vinyl alcohol) (PVA).