Hypertonic dextran solution and methods of treating and preventing recurrent corneal erosion

• US 9,636,355 B2
• Filed: 09/22/2011
• Issued: 05/02/2017
• Est. Priority Date: 09/22/2011
• Status: Expired due to Fees

• Current Assignee: Theo Holdings, LLC
• Original Assignee: Theo Holdings, LLC
• Inventors: Szabocsik, John M.
• Primary Examiner(s): Maier, Leigh C
• Application Number:
  US13/200,270
• Publication Number:
  US 20130079301A1
• Time in Patent Office: 2,049 Days
• Field of Search: None
• CPC Class Codes: A61J 1/067 Flexible ampoules, the contents of which are expelled by squeezing
• CPC Class Codes: A61K 31/715 Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• CPC Class Codes: A61K 31/721 Dextrans
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

An ophthalmic solution is provided. The ophthalmic solution is hypertonic. The ophthalmic solution includes a polysaccharide having an average molecular weight of between about 40,000 grams per mole and about 150,000 grams per mole. A packaged ophthalmic solution for preventing the ophthalmic solution from being exposed to CO₂ and other contaminants is also provided. The ophthalmic solution can be used to treat recurrent corneal erosion. The ophthalmic solution can also be used as a prophylactic to prevent recurrent corneal erosion.

Claims

1. An ophthalmic solution for treating and preventing recurrent corneal erosion consisting essentially of:

between about 5% and 25% by weight of non-substituted glucose polymer having an average molecular weight of between about 40,000 grams per mole and about 150,000 grams per mole;

between about 0.5% and 2% by weight NaCl;

between about 0.5% and 2% by weight hyaluronic acid;

between about 71% and 94% by weight H₂O; and

optionally an anesthetic;

wherein the ophthalmic solution is an aqueous solution having a viscosity of between about 6.5 and 7.5 centistokes, has a pH between about 6.5 and 7.5, has an osmolality of between about 320-350 mOsmol/kg solution and a colloidal osmolality at least equal to the colloidal osmolality of the deturgescent cornea.

2. The ophthalmic solution of claim 1 wherein the non-substituted glucose polymer is dextran and has an average molecular weight in the range of from about 60,000 to about 80,000 grams per mole.

3. The ophthalmic solution of claim 2 comprising between about 8% and 12% by weight of dextran.

4. The ophthalmic solution of claim 1 further consisting essentially of an effective amount of buffer to maintain the pH between about 6.5 and 7.5.

7. The ophthalmic solution of claim 1 wherein the at least one polymer of glucose is dextran, the solution further consisting essentially of one or more soluble salts other than NaCl, one or more preservatives, an effective amount of buffer to maintain the pH between about 6.5 and 7.5, and carbon dioxide.

11. The ophthalmic solution of claim 1 consisting of:

between about 5% and 25% by weight of non-substituted glucose polymer having an average molecular weight of between about 40,000 grams per mole and about 150,000 grams per mole;

between about 0.5% and 2% by weight NaCl;

between about 0.5% and 2% by weight hyaluronic acid;

between about 71% and 94% by weight H₂O; and

less than about 360 ppm carbon dioxide, wherein the ophthalmic solution has a pH between about 6.5 and 7.5 and has an osmolality of between about 320-350 mOsmol/kg solution.

13. The ophthalmic solution of claim 1 further consisting essentially of one or more preservatives.

14. The ophthalmic solution of claim 1 wherein the one or more preservatives are selected from the group of benzalkonium chloride, thimerosal, phenylmercuric nitrate, chlorobutanol, methyl paraben, propyl paraben, chlorhexidine digluconate, sorbic acid and edetate.

15. The ophthalmic solution of claim 1 further consisting essentially of an effective amount of buffer to maintain the pH between about 6.5 and 7.5.

16. The ophthalmic solution of claim 1 wherein the hyaluronic acid in the solution is between about 0.75% and 1.5% by weight.

18. The ophthalmic solution of claim 1 wherein the non-substituted glucose polymer is dextran.

5. A packaged ophthalmic solution for treating and preventing recurrent corneal erosion consisting essentially of:

a plastic ampoule, wherein the plastic ampoule contains an ophthalmic solution comprising between about 5% and 25% by weight of non-substituted glucose polymer having an average molecular weight of between about 40,000 grams per mole and about 150,000 grams per mole;

between about 0.5% and 2% by weight NaCl;

between about 0.5% and 2% by weight hyaluronic acid;

between about 71% and 94% by weight water; and

optionally an anesthetic;

wherein the ophthalmic solution has an osmolality of between about 320-350 mOsmol/kg, a viscosity of between about 6.5 and 7.5 centistokes and a colloidal osmolality at least equal to the colloidal osmolality of the deturgescent cornea; and

a sealed foil pouch, having an interior closed to the external atmosphere, the sealed foil pouch providing a carbon dioxide and oxygen barrier preventing atmospheric carbon dioxide from entering the interior of the sealed foil pouch;

the plastic ampoule contained within the foil pouch.

6. The packaged ophthalmic solution of claim 5 wherein the foil pouch prevents carbon dioxide from entering the plastic ampoule.

8. The packaged ophthalmic solution of claim 5 wherein the solution contains less than about 360 ppm carbon dioxide.

9. The packaged ophthalmic solution of claim 5 wherein the solution contains less than about 100 ppm carbon dioxide.

10. The packaged ophthalmic solution of claim 5 wherein the at least one polymer of glucose is dextran, the solution further consists essentially of one or more soluble salts other than NaCl, and one or more preservatives.

12. The packaged ophthalmic solution of claim 5 consisting of:

between about 5% and 25% by weight of non-substituted glucose polymer having an average molecular weight of between about 40,000 grams per mole and about 150,000 grams per mole;

between about 0.5% and 2% by weight NaCl;

between about 0.5% and 2% by weight hyaluronic acid;

between about 71% and 94% by weight water; and

less than about 360 ppm carbon dioxide, wherein the ophthalmic solution has a pH between about 6.5 and 7.5 and has an osmolality of between about 320-350 mOsmol/kg solution.

17. The ophthalmic solution of claim 5 wherein the hyaluronic acid in the solution is between about 0.75% and 1.5% by weight.

19. The packaged ophthalmic solution of claim 5 wherein the non-substituted glucose polymer is dextran.