BI-MODAL HYALURONATE

• US 20070059276A1
• Filed: 09/07/2006
• Published: 03/15/2007
• Est. Priority Date: 09/07/2005
• Status: Abandoned Application

• Current Assignee: AMO Regional Holdings (Abbott Laboratories), Abbott Medical Optics Incorporated (Johnson & Johnson)
• Original Assignee: AMO Regional Holdings (Abbott Laboratories)
• Inventors: Bergman, Rolf, Lundgren, Bjorn, Lundqvist, Maria, Shimizu, Robert, Mannberg, Stig
• Application Number:
  US11/470,988
• Publication Number:
  US 20070059276A1
• Time in Patent Office: Days
• US Class Current: 424/78.270
• CPC Class Codes: A61K 31/717 Celluloses
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 31/737 Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate A61K31/727 takes precedence
• CPC Class Codes: A61K 31/785 Polymers containing nitrogen
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

Formulations and methods for protecting cell layers and tissues exposed to trauma are disclosed. Different molecular mass fractions of the same polymer can be used to better control the physical and chemical properties of the formulation. In this manner the benefits of both fractions, and not just the benefits of the average of the fractions, can be seen in the formulation.

Claims

1. A formulation comprising a first fraction of a first ophthalmically acceptable compound and a second fraction of a second ophthalmically acceptable compound, wherein the first and second fractions are present in a total concentration of at least 10 mg/ml, and the first and second fractions have average molecular mass that differ by at least 4 million.

2. The formulation of claim 1 wherein the first compound has an average molecular mass of at least 5 million.

3. The formulation of claim 1 wherein the second compound has an average molecular mass of less than 1.5 million.

4. The formulation of claim 1 wherein the first compound has an average molecular mass of at least 5 million and the second compound has an average molecular mass of at least 0.75 million.

5. The formulation of claim 1 wherein the first and second fractions have average molecular mass that differ by at least five million.

6. The formulation of claim 1 wherein the first compound comprises a hyaluronate.

7. The formulation of claim 1 wherein each of the first and second compounds comprises a hyaluronate.

8. The formulation of claim 1 wherein one of the first and second compounds is selected from the group comprising hydroxyl propyl methyl cellulose, carrageenan, chondroitin sulfate and polyacrylamide.

9. The formulation of claim 1, further comprising a third fraction of a third ophthalmically acceptable compound, present in a concentration of at least 5 mg/ml, and wherein the average molecular mass of the third fraction differs from the average molecular mass of at least one of the first and second fractions by at least one million

10. A method of performing surgery using the formulation of claim 1.

11. A formulation comprising at least 5 mg/ml each of first and second ophthalmically acceptable, viscoelastic compounds, the first compound having an average molecular mass of less than 150,000, and the second compound having an average molecular mass of at least 2 million.

12. The formulation of claim 11 wherein the second compound has an average molecular mass of at least 3 million.

13. A formulation comprising at least 5 mg/ml each of first and second ophthalmically acceptable, viscoelastic compounds, the first compound having an average molecular mass of less than 2 million, and the second compound having an average molecular mass of at least 5 million.

14. The formulation of claim 13 wherein the first compound has an average molecular mass of less than 400,000.

15. The formulation of claim 13 wherein the first compound has an average molecular mass of less than 300,000.

16. A formulation comprising at least 5 mg/ml each of first and second ophthalmically acceptable, viscoelastic compounds, the concentrations and average molecular mass of the compounds selected such that at a shear rate of 1, the viscosity of the formulation is between 0, 1 and 10 Pas, and at zero shear, the viscosity of the formulation is between 50 and 100,000 Pas.

17. The formulation of claim 16, wherein the formulation has an apparent molecular mass M_app of between at least 1,500,000 and 7,000,000.

18. The formulation of claim 16, wherein the formulation has an apparent molecular mass M_app of between at least 3,000,000 and 7,000,000.

19. The formulation of claim 16, wherein the formulation has an apparent molecular mass M_app of between at least 4,500,000 and 7,000,000.

20. The formulation of claim 16, wherein the first compound is present at a concentration of 1-4% wt/wt.

21. The formulation of claim 16, wherein the first compound is present at a concentration of 2-3% wt/wt.

22. The formulation of claim 16, wherein the formulation is clear to visual inspection.

23. A formulation comprising a first fraction of a first ophthalmically acceptable compound and a second fraction of a second ophthalmically acceptable compound, wherein the first and second fractions have average molecular masses that differ by at least 4 million, and wherein the difference in average molecular mass accentuates the desirable characteristics of the OVD.

24. The formulation according to claim 23, wherein the average molecular masses differ by more than 4.5 million.

25. The formulation according to claim 23, wherein the desirable characteristic is the ability to coat a tissue,

26. A formulation comprising a first fraction of a first ophthalmically acceptable compound and a second fraction of a second ophthalmically acceptable compound, wherein the first and second fractions have average molecular masses that differ by at least 4 million, and wherein the difference in average molecular mass accentuates characteristics of one of the fractions.

27. The formulation according to claim 26, wherein the average molecular masses differ by more than 4.5 million.

28. The formulation according to claim 26, wherein the desirable characteristic is the ability to coat a tissue.