Method for forming contact lenses comprising therapeutic agents

• US 20060100408A1
• Filed: 10/07/2005
• Published: 05/11/2006
• Est. Priority Date: 03/11/2002
• Status: Abandoned Application

• Current Assignee: Johnson & Johnson Vision Care Incorporated (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Vision Care Incorporated (Johnson & Johnson)
• Inventors: Powell, P. Mark, Rooney, Thomas R., Molock, Frank F., Mahadevan, Shivkumar, Martin, W. Anthony, Rathore, Osman, Raja, Ranganath, Grammer, Holly L., Bhat, Ram
• Application Number:
  US11/246,771
• Publication Number:
  US 20060100408A1
• Time in Patent Office: Days
• US Class Current: 526/320
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: B29D 11/00038 Production of contact lenses
• CPC Class Codes: C08F 220/20 of polyhydric alcohols or phenols , e.g. 2-hydroxyethyl (meth)acrylate or glycerol mono-(meth)acrylate
• CPC Class Codes: G02B 1/043 Contact lenses

Abstract

The present invention relates to a process comprising (a) dosing a reactive mixture comprising at least one crosslinkable prepolymer into a mold; (b) curing said reactive mixture to form a medical device; (c) contacting, said medical device with no more than about 500 mL of solution per medical device; and (d) incorporating, prior to or during said contacting step (c), at least one therapeutic agent.

Claims

1. A process comprising

a. Dosing a reactive mixture comprising at least one crosslinkable prepolymer into a mold;

b. Curing said reactive mixture to form a medical device;

c. Contacting, said medical device with no more than about 500 mL of solution per medical device after said curing step (b); and

d. Incorporating, prior to or during said contacting step (c), at least one therapeutic, agent.

2. The process of claim 1 wherein said medical device is an ophthalmic device.

9. The process of claim 2 or 3 wherein said solution comprises water.

10. The process of claim 2 or 3 wherein said solution is contact lens packing solution.

11. The process of claim 2 or 3 wherein said solution is borate buffered saline solution.

13. The process of claim 1, 2 or 3 wherein said therapeutic agent is incorporated into the prepolymer during dosing step (a).

14. The process of claim 1, 2 or 3 wherein said therapeutic agent is incorporated into the prepolymer during contacting step (c).

15. The process of claim 1, 2 or 3 wherein said therapeutic agent is incorporated into said reactive mixture via compounding.

16. The process of claim 9 wherein said solution comprises a therapeutically effective amount of said therapeutic agent.

23. The process of claim 1, 2 or 3 further comprising the step of (e) sterilizing said medical device lens after incorporating step (d).

24. The process of claim 23 wherein said sterilizing step is conducted via autoclaving, microwave irradiation, UV light irradiation, chemical sterilization, asceptic packaging or a combination thereof.

3. A process comprising

e. Dosing a reactive mixture comprising at least one crosslinkable prepolymer into a mold;

f. Curing said reactive mixture to form a contact lens;

g. Contacting, said contact lens with no more than about 500 mL of solution per contact lens after said curing step (b); and

h. Incorporating, prior to or during said contacting step (c), at least one therapeutic agent.

4. The process of claim 3 wherein said contacting step uses between about 0.005 and about 100 mL solution per lens.

5. The process of claim 3 wherein said contacting step uses between about 0.1 and about 50 mL solution per lens.

6. The process of claim 3 wherein said contacting step uses between about 0.5 and about 10 mL solution per lens.

7. The process of claim 3 wherein said contacting step uses between about 0.5 and about 5 mL solution per lens.

8. The process of claim 3 wherein said prepolymer is formed from urethanes, methacrylates, silicones, vinyl alcohol and mixtures thereof.

12. The process of claim 3 wherein said therapeutic agent is incorporated into the reactive mixture.

17. The process of claim 3 wherein said reaction mixture further comprises at least one diluent which is displaceable by said solution.

18. The process of claim 17 wherein said diluent is compatible with the human eye.

19. The process of claim 17 wherein said therapeutic agent is soluble in said diluent during curing and storage conditions.

20. The process of claim 17 wherein said diluent is selected from the group consisting of water, polyethylene glycol, polypropylene glycol and combinations thereof.

21. The process of claim 3 wherein said mold comprises a front mold half and a back mold half and at least one mold half is used to form at least a part of a contact lens package.

22. The process of claim 3 wherein said mold comprises a front mold half and a back mold half and at least one mold half is reusable.

25. The process of claim 3 wherein said therapeutic agent is selected from the group consisting of pharmaceutical agents, nutraceuticals combinations thereof and the like.

26. The process of claim 3 wherein said therapeutic agent comprises at least one pharmaceutical agent selected from the group consisting of antihistamines, antibiotics, glaucoma medication, carbonic anhydrase inhibitors, anti-viral agents, anti-inflammatory agents, non-steroid anti-imflammatory drugs, antifungal drugs, anesthetic agents, miotics, mydriatics, immunosuppressive agents, antiparasitic drugs, anti-protozoal drugs and combinations thereof.

27. The process of claim 3 wherein said therapeutic agent comprises at least one pharmaceutical agent selected from the group consisting of acycylovir, adrenalone, aminocaproic acid, amoxicillin, amotriphene, amoxecaine, amodiaquin, antazoline, atrophine, betaxolol, bupivacaine, carbachol, carteolol, chlorampenicol, chlortetracycline, clemastine, corynathine, cromalyn sodium, cyclopentolate, demecarium, dexamethasone, dichlorphenamide, dibutoline, diclophenac, dipivefrin, ephedrine, erythromycin, ethambutol, eucatropine, fluoromethalone, gentamycin, gramicidin, homatropine, indomethacin, ketotifen, levallorphan, levobunolol, levocabastine, lidocaine, lignocaine, lomefloxacin, loratidine, medrysone, mepivacaine, methazolamide, naphazoline, natamycin, natamycin, neomycin, noradrenaline, ofloxacin, oxybuprocaine, oxymetazoline, pheniramine, phenylephrine, physostigmine, pilocarpine, polymyxin B, prednisolone, proparacaine, pyrilamine, scopolamine, sorbinil, sulfacetamide, tamoxifen, tetracaine, tetracycline, tetrahydozoline, timolol, trifluridine, tropicamide, vidarabine, and salts and mixtures thereof. In yet another embodiment the OIOC comprises at least one therapeutic agent selected from ketotifen fumarate, nor ketotifen fumarate, 11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-imidazo[2,1-b][3]benzazepine-3-carboxaldehyde (CAS# 147084-10-4, olapatadine and mixtures thereof.

28. The process of claim 3 wherein said therapeutic agent is selected from the group consisting of ketotifen fumarate, pheniramine maleate, clemastine, loratidine, 11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-imidazo[2,1-b][3]benzazepine-3-carboxaldehyde (CAS# 147084-10-4, olapatadine and mixtures thereof.

29. The process of claim 25 wherein said therapeutic agent comprises at least one nutraceutical compounds selected from the group consisting of vitamins A, D, E, lutein, zeaxanthin, lipoic acid, flavonoids, ophthalmicially compatible fatty acids and combinations thereof

30. The process of claim 3 wherein said process is conducted without an extraction step.

31. The process of claim 3 wherein said contacting step (c) comprises at least one step selected from the group consisting of releasing said lens from said mold, extracting unreacted components from said lens, hydrating said lens and combinations thereof.