DRUG DELIVERY COATING AND DEVICES

• US 20130273137A1
• Filed: 05/03/2011
• Published: 10/17/2013
• Est. Priority Date: 05/03/2010
• Status: Abandoned Application

• Current Assignee: Massachusetts Institute of Technology
• Original Assignee: Massachusetts Eye And Ear Infirmary (Foundation of The Massachusetts Eye and EAR Infirmary Incorporated), Massachusetts Institute of Technology
• Inventors: Hammond, Paula T., Shukla, Anita, Mandell, Kenneth J., Fuller, Renee C., Rizzo, Joseph F. III
• Application Number:
  US13/695,836
• Publication Number:
  US 20130273137A1
• Time in Patent Office: Days
• US Class Current: 424/428
• CPC Class Codes: A61F 2002/169053 Segments fold
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/196 the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
• CPC Class Codes: A61K 31/7052 having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 27/28 Materials for coating prostheses
• 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: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

In various embodiments, the present invention provides certain systems comprising a multi-layer decomposable film coating composition on a substrate, where the coating composition includes one or more releasable agents in at least one of its layers, and decomposes layer-by-layer to release such agent(s) over time. In some embodiments, an intra-ocular lens (IOL) system comprising an IOL coated with a multi-layer decomposable film coating composition is disclosed.

Claims

1. A decomposable film comprising:

a plurality of multi-layers of alternating first and second charges,

wherein the multi-layers comprise polyelectrolyte layers and one or more releasable agents; and

wherein decomposition of the film is characterized by sequential removal of at least a portion of the polyelectrolyte layers by alternating delamination of polyelectrolyte layers having the first charge and degradation of polyelectrolyte layers having the second charge, such that a controlled release of the at least one or more releasable agents is achieved.

13. The decomposable film of claim 1, wherein the one or more releasable agents are associated with a polyelectrolyte in the polyelectrolyte layers of the film.

18. The decomposable film of claim 1, wherein the one or more releasable agents comprise an anti-infective agent, an anti-flammatory agent or any combination thereof.

19. The decomposable film of claim 18, wherein the anti-infective agent is an antibiotic selected from the group consisting of a fluoroquinilone, macrolide, aminoglycoside, beta lactam, vancomycin and any combination thereof.

20. The decomposable film of claim 18, wherein the anti-inflammatory agent is selected from the group consisting of a corticosteroid, non-steroidal anti-inflammatory agent, mTOR inhibitor, calcineurin inhibitor, PI3K inhibitor, p38 inhibitor, JAK inhibitor, SYK inhibitor, HDAC inhibitor and any combination thereof.

21. The decomposable film of claim 1, wherein the film is deposited on a substrate.

22. The decomposable film of claim 21, wherein the substrate comprises at least a portion of a medical device.

23. The decomposable film of claim 21, wherein the substrate comprises at least a portion of an intraocular lens (IOL).

24. The decomposable film of claim 23, wherein the substrate comprises at least a portion of haptics of the IOL, at least a portion of an optic of the IOL or any combinations thereof.

25. The decomposable film of claim 23, wherein the substrate comprises a portion of an optic of the IOL.

2-12. -12. (canceled)

14-17. -17. (canceled)

26-28. -28. (canceled)

29. An intraocular lens (IOL) system comprising:

an IOL and

one or more decomposable films deposited on the IOL,

wherein each decomposable film comprises a plurality of multi-layers of alternating first and second charges, and wherein the multi-layers comprise polyelectrolyte layers and one or more releasable agents;

wherein decomposition of the film is characterized by sequential removal of at least a portion of the polyelectrolyte layers by alternating delamination of polyelectrolyte layers having the first charge and degradation of polyelectrolyte layers having the second charge, such that a controlled release of the at least one or more releasable agents is achieved.

30. The IOL system of claim 29, wherein the one or more decomposable films are respectively deposited on at least a portion of haptics of the IOL, at least a portion of an optic of the IOL or any combinations thereof.

31. The IOL system of claim 29, wherein the IOL is foldable.

32. In a method of utilizing an IOL, which method comprising implanting the IOL, the improvement that comprises depositing one or more decomposable films on at least a portion of the IOL,

wherein each decomposable film comprises a plurality of multi-layers of alternating first and second charges, and wherein the multi-layers comprise polyelectrolyte layers and one or more releasable agents;

wherein decomposition of the film is characterized by sequential removal of at least a portion of the polyelectrolyte layers by alternating delamination of polyelectrolyte layers having the first charge and degradation of polyelectrolyte layers having the second charge, such that a controlled release of the at least one or more releasable agents is achieved.

33. The methods of claim 32, wherein the at least one or more releasable agents comprise an anti-inflammatory agent, such that inflammation after the IOL implantation is reduced as compared with that observed for an otherwise identical IOL lacking the decomposable film.

34. The methods of claim 32, wherein the at least one or more releasable agents comprise an antibiotic, such that infection after the IOL implantation is reduced as compared with that observed for an otherwise identical IOL lacking the decomposable film.

35. The methods of claim 32, further comprising no substantive alternation/modification of the IOL.

36. The methods of claim 32, further comprising no substantive alternation/modification of the IOL implantation.

37. A method of making a coated system comprising steps of:

associating one or more releasable agents within a decomposable film comprising a plurality of multi-layers of alternating first and second charges,

wherein the multi-layers comprise polyelectrolyte layers; and

wherein decomposition of the film is characterized by sequential removal of at least a portion of the polyelectrolyte layers by alternating delamination of polyelectrolyte layers having the first charge and degradation of polyelectrolyte layers having the second charge; and

depositing the film on a substrate.

38-44. -44. (canceled)

45. A method of using a coated system comprising steps of:

providing a coated system comprising one or more decomposable films on a substrate

wherein each decomposable film comprises a plurality of multi-layers of alternating first and second charges, and wherein the multi-layers comprise polyelectrolyte layers and one or more releasable agents;

wherein decomposition of the film is characterized by sequential removal of at least a portion of the polyelectrolyte layers by alternating delamination of polyelectrolyte layers having the first charge and degradation of polyelectrolyte layers having the second charge; and

releasing the one or more releasable agents from the film.

46-51. -51. (canceled)