Claims for Patent: 7,918,814

Summary for Patent: 7,918,814

Title:	Method for drug delivery to ocular tissue using microneedle
Abstract:	Methods and devices are provided for administering a drug to a patient\'s eye. The methods include (a) inserting a hollow microneedle into the sclera or corneal stroma without penetrating across the sclera or corneal stroma; and (b) infusing a fluid drug formulation through the microneedle and into the sclera or cornea. It further may include partially retracting the microneedle before infusion to enhance delivery. Alternatively, the methods may include (a) inserting a solid microneedle into the sclera or corneal stroma without penetrating across the sclera or corneal stroma, wherein the solid microneedle comprises a first quantity of a drug formulation and inserting causes the solid microneedle to form a pocket in the sclera or corneal stroma; and (b) releasing the drug formulation into the pocket to form a drug depot, whereby a drug is released from the depot. The methods and devices may include an array of multiple microneedles.
Inventor(s):	Prausnitz; Mark R. (Atlanta, GA), Jiang; Ninghao (Alexandria, VA), Edelhauser; Henry F. (Atlanta, GA)
Assignee:	Georgia Tech Research Corporation (Atlanta, GA) Emory University (Atlanta, GA)
Application Number:	11/743,535
Patent Claims:	1. A method of administering a drug to an eye of a patient, comprising: inserting at least one hollow microneedle into the sclera or corneal stroma of the eye without penetrating across the sclera or corneal stroma; and infusing a fluid drug formulation through the at least one hollow microneedle and into the sclera or cornea, wherein the fluid drug formulation comprises a drug. 2. The method of claim 1, further comprising, after the insertion step and before and/or during the step of infusing, partially retracting the at least one hollow microneedle from the sclera or corneal stroma. 3. The method of claim 2, wherein the step of infusing is performed after the step of retracting the at least one microneedle out of the sclera or corneal stroma. 4. The method of claim 1, wherein the step of inserting further comprises substantially simultaneously inserting a second hollow microneedle into the sclera or corneal stroma without penetrating across the sclera or corneal stroma, and the step of infusing further comprises infusing the fluid drug formulation through the second hollow microneedle and into the sclera or corneal stroma, wherein the at least one hollow microneedle and the second hollow microneedle are part of a device which comprises an array of two or more microneedles. 5. The method of claim 1, wherein the fluid drug formulation comprises a suspension of microparticles or nanoparticles for controlled release of the drug. 6. The method of claim 1, wherein the at least one hollow microneedle is inserted into the surface of the sclera or corneal stroma at an angle of about 90 degrees. 7. The method of claim 1, wherein the at least one hollow microneedle comprises a metal. 8. The method of claim 1, wherein the at least one hollow microneedle is rotated or vibrated during the step of inserting. 9. The method of claim 1, wherein the step of infusing comprises driving the fluid drug formulation using a pressure gradient or an electric field. 10. The method of claim 1, for use in the treatment of uveitis, glaucoma, diabetic macular edema, age-related macular degeneration, corneal infection, or cytomegalovirus retinitis. 11. The method of claim 1, wherein the fluid drug formulation further comprises an agent effective to degrade collagen or glycosaminoglycan fibers in the sclera or corneal stroma. 12. The method of claim 11, wherein the agent comprises an enzyme selected from the group consisting of a hyaluronidase, a collagenase, or a combination thereof. 13. The method of claim 2, wherein the steps of inserting and retracting the at least one hollow microneedle form a pocket in the sclera or corneal stroma. 14. The method of claim 1, wherein the step of infusing creates a drug depot in the sclera or corneal stroma for sustained release of the drug from the drug depot after the step of infusion is completed. 15. A method of administering a drug to an eye of a patient, comprising: inserting at least one solid microneedle into the sclera or corneal stroma of the eye without penetrating across the sclera or corneal stroma, wherein the at least one solid microneedle comprises a first quantity of a drug formulation and the step of inserting causes the at least one solid microneedle to form a pocket in the sclera or corneal stroma; and releasing at least part of the first quantity of the drug formulation into the pocket to form a drug depot in the sclera or corneal stroma, whereby a drug in the drug formulation subsequently is released from the drug depot. 16. The method of claim 15, wherein the step of inserting further comprises substantially simultaneously inserting a second solid microneedle into the sclera or corneal stroma without penetrating across the sclera or corneal stroma, the second solid microneedle comprising a second quantity of the drug formulation, and wherein the step of inserting causes the second solid microneedle to form a second pocket in the sclera or corneal stroma, wherein the step of releasing further comprises releasing the second quantity of the drug formulation into the second pocket to form a second drug depot in the sclera or corneal stroma, whereby subsequently the drug is released from the second drug depot into the eye, wherein the at least one solid microneedle and the second solid microneedle are part of a device which comprises an array of two or more microneedles. 17. The method of claim 15, further comprising completely withdrawing the at least one solid microneedle from the sclera or corneal stroma after the step of inserting, wherein the drug depot provides sustained release of the drug after the at least one solid microneedle has been completely withdrawn. 18. The method of claim 15, wherein the at least one solid microneedle comprises a solid or semi-solid coating which comprises the drug formulation. 19. The method of claim 18, wherein the step of releasing comprises at least partially dissolving the coating off of the at least one solid microneedle into fluids present in the sclera or corneal stroma. 20. The method of claim 15, wherein the step of releasing comprises breaking or dissolving all or part of the at least one solid microneedle, which includes the drug formulation, off of a base to which the at least one solid microneedle is connected prior to said breaking or dissolving. 21. The method of claim 15, wherein the drug formulation comprises microparticles or nanoparticles which comprise a drug for controlled release. 22. The method of claim 15, wherein the at least one solid microneedle is inserted into the surface of the sclera or corneal stroma at an angle of about 90 degrees. 23. The method of claim 15, wherein the at least one solid microneedle comprises a metal. 24. The method of claim 15, wherein the at least one solid microneedle comprises a polymer. 25. The method of claim 15, wherein the at least one solid microneedle is rotated or vibrated during the step of inserting or during the step of releasing. 26. The method of claim 15, further comprising driving the drug into or through the sclera or corneal stroma using an electric field or acoustic energy. 27. The method of claim 15, for use in the treatment of uveitis, glaucoma, diabetic macular edema, age-related macular degeneration, corneal infection, or cytomegalovirus retinitis. 28. The method of claim 1 or 15, wherein the drug from the drug depot is delivered to choroidal or retinal tissues. 29. The method of claim 1 or 15, wherein the drug is delivered to the ciliary body or the trabecular meshwork. 30. The method of claim 1 or 15, wherein the drug is delivered to the aqueous humor or the vitreous humor. 31. A method of extraction from a tissue of the eye comprising: inserting at least one microneedle into the sclera or corneal stroma, without penetrating across the sclera or corneal stroma; and withdrawing a biological fluid, tissue, or molecule sample from the sclera or corneal stroma with the at least one microneedle. 32. A microneedle device for delivery of a drug to the eye comprising: an array of two or more microneedles extending from a base; means for controllably inserting the two or more microneedles into the sclera or corneal stroma without penetrating across the sclera or corneal stroma; and means for depositing a drug formulation in the sclera or corneal stroma to form a drug depot for subsequent release to an ocular tissue. 33. The device of claim 32, wherein the drug depot provides extended or sustained release of a drug after the two or more microneedles have been completely withdrawn from the sclera or corneal stroma. 34. The device of claim 33, wherein the drug formulation comprises microparticles or nanoparticles which provide controlled release of the drug. 35. The device of claim 32, wherein the two or more microneedles are solid. 36. The device of claim 35, wherein the means for depositing comprises a coating on the two or more microneedles, wherein the coating comprises the drug formulation. 37. The device of claim 36, wherein the coating is solid or semi-solid. 38. The device of claim 37, wherein the coating is at least partially soluble in fluids present in the sclera or corneal stroma. 39. The device of claim 32, wherein all or part of the two or more microneedles are adapted to break or dissolve off of the base in the sclera or cornea. 40. The device of claim 32, wherein the two or more microneedles comprise a metal. 41. The device of claim 32, wherein the two or more microneedles comprise a polymer. 42. The device of claim 32, wherein the two or more microneedles extend from the base at an angle of about 90 degrees to provide approximately perpendicular insertion of the microneedles into the surface of the sclera or corneal stroma. 43. The device of claim 32, wherein the base has either a fixed radius of curvature substantially the same as the radius of curvature of the surface of a sclera or corneal stroma, or is elastically deformable to fit the radius of curvature of the surface of a sclera or corneal stroma. 44. The device of claim 32, wherein the two or more microneedles are hollow. 45. The device of claim 44, wherein the means for depositing comprises a fluid drug formulation, a source reservoir for the fluid drug formulation, and an infusion means for driving the fluid drug formulation from the source reservoir into the pocket. 46. The device of claim 45, wherein the infusion means comprises a pump or syringe. 47. The device of claim 45, wherein the fluid drug formulation further comprises an agent effective to degrade collagen or glycosaminoglycan fibers in the sclera or corneal stroma. 48. The device of claim 47, wherein the agent comprises an enzyme selected from the group consisting of a hyaluronidase, a collagenase, or a combination thereof. 49. The device of claim 45, wherein the fluid drug formulation comprises a suspension of microparticles or nanoparticles which comprise a drug for controlled release. 50. The device of claim 32, wherein the portion of the microneedles that is designed to insert into the sclera or corneal stoma has a maximum cross-sectional width or diameter between 50 microns and 400 microns. 51. The device of claim 32, wherein the portion of the microneedles that is designed to insert into the sclera or corneal stoma has length between 50 microns and 1000 microns. 52. A microneedle device for delivery of a drug to the eye comprising: at least one solid microneedle extending from a base; means for controllably inserting the at least one solid microneedle into the sclera or corneal stroma without penetrating across the sclera or corneal stroma; and a drug formulation which comprises a drug, wherein the device is adapted to deposit the drug formulation into the sclera or corneal stroma to form a drug depot for controlled release of the drug to an ocular tissue.

Details for Patent 7,918,814

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	05/05/2004		2026-05-02
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	12/02/2004		2026-05-02
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10/26/2004		2026-05-02
Akorn, Inc.	HYDASE	hyaluronidase	Injection	021716	10/25/2005		2026-05-02