Ophthalmic drug delivery system

• US 8,273,366 B2
• Filed: 03/17/2004
• Issued: 09/25/2012
• Est. Priority Date: 06/05/2002
• Status: Active Grant

• Current Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Inventors: Chauhan, Anuj, Gulsen, Derya
• Primary Examiner(s): Vivlemore, Tracy
• Assistant Examiner(s): BERRIOS, JENNIFER A
• Application Number:
  US10/802,058
• Publication Number:
  US 20040241207A1
• Time in Patent Office: 3,114 Days
• Field of Search: None
• US Class Current: 424/429
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 31/41 having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/1075 Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers A61K9/0026 takes precedence
• CPC Class Codes: A61K 9/5115 Inorganic compounds
• CPC Class Codes: A61K 9/5138 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/5192 Processes
• CPC Class Codes: G02C 7/04 Contact lenses for the eyes disinfection or sterilisation of contact lenses A61L12/00

Abstract

A drug delivery system comprising a contact lens having dispersed therein as nanoparticles having a particle size less than about 200 nm, an ophthalmic drug nanoencapsulated in a material from which said ophthalmic drug is capable of diffusion into and migration through said contact lens and into the post-lens tear film when said contact lens is placed on the eye.

Claims

1. A drug delivery system comprising a contact lens having dispersed throughout as nanoparticles an ophthalmic drug nanoencapsulated with an encapsulation material, wherein said encapsulation material is selected dependent upon ophthalmic drug characteristics wherein a hydrophobic encapsulation material is selected for a hydrophobic ophthalmic drug and a hydrophilic encapsulation material is selected for a hydrophilic ophthalmic drug;

wherein said ophthalmic drug is capable of diffusion into and migration through said contact lens and into the post-lens tear film when said contact lens is placed on the eye;

wherein said diffusion results in extended or time-release delivery of said ophthalmic drug; and

wherein said nanoparticles are dispersed within said contact lens in an amount such that said contact lens remains optically transparent, wherein optically transparent is a degree of transparency equal to that of p-HEMA or other material employed as a contact lens.

2. The drug delivery system of claim 1, each said nanoparticles having a particle size less than about 50 nm.

3. The drug delivery system of claim 2 wherein said amount of nanoparticles is from about 1 to about 5%, by weight, based on the weight of the contact lens.

4. The drug delivery system of claim 1 wherein said contact lens comprises poly 2-hydroxyethylmethacrylate, and wherein the transmittance of visible light through said contact lens is at least 66%.

5. The drug delivery system of claim 1, wherein said hydrophilic encapsulation material is a liposome.

6. The drug delivery system of claim 1 wherein said ophthalmic drug is an antiparisitic, a steroid, a non-steroidal anti-inflammatory, an antibiotic or mixtures thereof.

7. The drug delivery system of claim 1 wherein said ophthalmic drug is nanoencapsulated with an encapsulation material in an oil-in-water emulsion hydrophobic encapsulation material is a microemulsion.

8. The drug delivery system of claim 7, wherein said encapsulation material comprises:

chitosan, human serum albumin, biodegradable poly(alkylcynoacrylates), polybutylcyanoacrylate, polyhexylcyanoacrylate, polyethylcyanoacrylate, (polyisobutylcyanoacrylate), polycyanoacylate, silica, PEG'"'"'ylated core-shell, biodegradable PLGA (poly(D,L-lactide-co-glycolide)), (poly lactic acid), PGA, PLG (poly(D,L-glycolide))polymeric, microemulsion, liposomes, biocompatible gliadin, low pH sensitive PEG stabilized plasmid-lipid, biodegradable calcium phosphate, legumin, tocopherol derivatives stabilized emulsion, polysaccherides grafted with Polyesthers (amphyphilic copolymers), PLA-PEG, hydrophilic proteins coupled with apolipoprotein E, biodegradable poly(vepsiln-caprolactone), poly(methylidene malonate), gelatin, poly(E-caprolactone), sodium alginate, agarose hydrogel, PMMA, biotinylated poly(ethylene glycol) conjugated with lactobionic acid, carboxylmethyl dextran magnetic, poly(vinyl alcohol)hydrogel, biotinylated pullulan acetate, diblock copolymers or mixtures thereof.

9. A method of administering an ophthalmic drug to a patient in need thereof comprising placing on the eye thereof the drug delivery system of claim 1.

10. A kit comprising:

a) a first component containing the drug delivery system of claim 1, and

b) a second component containing at least one storage container for said first component, said storage container additionally containing a material that substantially prevents said diffusion and migration of said ophthalmic drug during storage.

11. The kit of claim 10 wherein said material that substantially prevents said diffusion and migration of said ophthalmic drug is substantially saturated with an aqueous solution of said ophthalmic drug.

12. The kit of claim 11, wherein the kit is used for the storage and delivery of ophthalmic drugs to the eye of a patient in need thereof.

13. A method of preparing the drug delivery system of claim 1 comprising:

a) providing said nanoencapsulated ophthalmic drug, and

b) preparing said contact lens from materials that incorporate the nanoencapsulated ophthalmic drug, such that the nanoencapsulated ophthalmic drug is substantially uniformly dispersed throughout said contact lens.

14. An article of manufacture comprising packaging material and the ophthalmic drug delivery system of claim 1 contained within said packaging material, wherein said packaging material comprises a label which indicates that said ophthalmic drug delivery system can be used for ameliorating symptoms associated with pathologic conditions of the eye.

15. An article of manufacture comprising packaging material and the kit of claim 12 contained within said packaging material, wherein said packaging material comprises a label which indicates that said first component of said kit can be used for ameliorating symptoms associated with pathologic conditions of the eye and that said second component of said kit can be used for storage of said first component.

16. The drug delivery system of claim 6 wherein said antiparisitic drug is ivermectin, pyrimethamine or mixtures thereof.

17. The drug delivery system of claim 6 wherein said steroid is prednisilone acetate.

18. The drug delivery system of claim 6 wherein said non-steroidal anti inflammatory drug is acular, voltaren, or mixtures thereof.

19. The drug delivery system of claim 6 wherein said antibiotic drug is ciloxan, gentamycin, cephlosporin or mixtures thereof.

20. The drug delivery system of claim 1 wherein said ophthalmic drug is lidocaine, timolol, ciproflaxin, cyclosporin A, or pilocarpine.

21. The drug delivery system of claim 2 wherein said nanoparticles are dispersed within said contact lens from about 5 to about 20%, by weight, based on the weight of the contact lens.