Microimplants for ocular administration

• US 20060204548A1
• Filed: 03/01/2005
• Published: 09/14/2006
• Est. Priority Date: 03/01/2005
• Status: Abandoned Application

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Nivaggioli, Thierry, Weber, David A.
• Application Number:
  US11/070,158
• Publication Number:
  US 20060204548A1
• Time in Patent Office: Days
• US Class Current: 424/427
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• 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 9/204 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Implants and microimplants are provided comprising homogeneous mixtures of active ingredient and bioerodible polymer, including microimplants having diameters of 0.019 inches or less and which can be delivered to the eye using self-sealing methods. Methods of manufacturing the implants and microimplants are provided that yield batches of highly uniform implants and microimplants within very narrow tolerance ranges.

Claims

12. The microimplant of 9 further comprising hydroxypropylmethylcellulose (HPMC).

13. A batch of ocular microimplants comprising:

a plurality of microimplants having a desired target mass per microimplant, wherein each microimplant comprises a homogeneous mixture of one or more active ingredients and one or more bioerodible polymers, has a diameter of 0.019 inches or less, and has a mass within 10% by weight of the desired target mass.

14. The batch of microimplants according to claim 13 wherein each microimplant has a mass within 5% by weight of the desired target mass.

15. The batch of microimplants according to claim 13 wherein each microimplant has a diameter of0.015 inches or 381 microns or less.

16. The batch of microimplants of claim 13 wherein each microimplant has a length of 10 millimeters or less.

17. The batch of microimplants of claim 13 wherein each microimplant has a length of 7 millimeters or less.

18. The batch of microimplants of claim 13 wherein each microimplant has a length of 1 millimeter or less.

19. The batch of microimplants of claim 13 wherein said one or more bioerodible polymers is polylactic acid polyglycolic acid (PLGA) copolymer.

20. The batch of microimplants of claim 13 wherein said one or more active ingredients is an anti-inflammatory agent.

21. The batch of microimplants of claim 20 wherein said anti-inflammatory agent is a steroidal anti-inflammatory agent selected from the group consisting of cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, and triamcinolone.

22. The batch of microimplants of claim 20 wherein said anti-inflammatory agent is dexamethasone.

23. The batch of microimplants of claim 22 wherein said one or more bioerodible polymers is polylactic acid polyglycolic acid (PLGA) copolymer.

24. The batch of microimplants of claim 22 wherein said one or more bioerodible polymers comprises a mixture of a polylactic acid polyglycolic acid (PLGA) copolymer and a polylactic acid polyglycolic acid (PLGA) copolymer having a free acid end.

25. The batch of microimplants of claim 20 further comprising hydroxypropylmethylcellulose (HPMC).

26. A batch of ocular microimplants comprising:

a plurality of microimplants having a desired target mass per microimplant, wherein each microimplant comprises a homogeneous mixture of one or more active ingredients and one or more bioerodible polymers and has a diameter of 0.019 inches or less, and wherein the mass standard deviation of the plurality of microimplants is 5 or less.

1. An ocular microimplant for implantation in the eye comprising:

a homogeneous mixture of one or more active ingredients and one or more bioerodible polymers, wherein said microimplant has a diameter of 0.019 inches or less.

2. The microimplant of claim 1 wherein said microimplant has a diameter of 0.015 inches or less.

3. The microimplant of claim 1 wherein said microimplant has a length of 10 millimeters or less.

4. The microimplant of claim 1 wherein said microimplant has a length of 7 millimeters or less.

5. The microimplant of claim 1 wherein said microimplant has a length of 1 millimeter or less.

6. The microimplant of claim 1 wherein said one or more bioerodible polymers is polylactic acid polyglycolic acid (PLGA) copolymer.

7. The microimplant of claim 1 wherein said active ingredient is an anti-inflammatory agent.

8. The microimplant of claim 7 wherein said anti-inflammatory agent is a steroidal anti-inflammatory agent selected from the group consisting of cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, and triamcinolone.

9. The microimplant of claim 7 wherein said anti-inflammatory agent is dexamethasone.

10. The microimplant of claim 9 wherein said one or more bioerodible polymers is a polylactic acid polyglycolic acid (PLGA) copolymer.

11. The microimplant of claim 9 wherein said one or more bioerodible polymers comprises a mixture of a polylactic acid polyglycolic acid (PLGA) copolymer and a polylactic acid polyglycolic acid (PLGA) copolymer having a free acid end.

27. The batch of microimplants according to claim 26 wherein the mass standard deviation of the plurality of microimplants is 2 or less.

28. The batch of microimplants according to claim 26 wherein each microimplant has a diameter of 0.015 inches or less.

29. The batch of microimplants of claim 26 wherein each microimplant has a length of 10 millimeters or less.

30. The batch of microimplants of claim 26 wherein each microimplant has a length of 7 millimeters or less.

31. The batch of microimplants of claim 26 wherein each microimplant has a length of 1 millimeter or less.

32. The batch of microimplants of claim 26 wherein said active ingredient is an anti-inflammatory agent.

33. The batch of microimplants of claim 32 wherein said anti-inflammatory agent is a steroidal anti-inflammatory agent selected from the group consisting of cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, and triamcinolone.

34. The batch of microimplants of claim 32 wherein said anti-inflammatory agent is dexamethasone.

35. The batch of microimplants of claim 34 wherein said one or more bioerodible polymers is polylactic acid polyglycolic acid (PLGA) copolymer.

36. The batch of microimplants of claim 34 wherein said one or more bioerodible polymers comprises a mixture of polylactic acid polyglycolic acid (PLGA) copolymer and polylactic acid polyglycolic acid (PLGA) copolymer having a free acid end.

37. The batch of microimplants of claim 32 further comprising hydroxypropylmethylcellulose (HPMC).

31-1. The batch of microimplants of claim 26 wherein said one or more bioerodible polymers is polylactic acid polyglycolic acid (PLGA) copolymer.

38. An ocular microimplant for implantation in the eye comprising:

a homogeneous mixture of dexamethasone and a polylactic polyglycolic acid (PLGA) copolymer, wherein said microimplant has a diameter of 0.019 inches or less.

39. The microimplant of claim 38 wherein said microimplant has a length of 7 millimeters or less.

40. The microimplant of claim 38 further comprising a polylactic polyglycolic acid (PLGA) copolymer having a free acid end.

41. The microimplant of claim 40 wherein said dexamethasone, said polylactic polyglycolic acid .(PLGA) copolymer having a free acid end, and said polylactic polyglycolic acid (PLGA) copolymer, are present at a respective ratio of 60:

30;

10.