Sterile hyaluronic acid solutions
First Claim
1. A process for sterilizing a solution, the process comprising:
- providing an aqueous solution of hyaluronic acid having a weight average molecular weight from 0.6 MDa to 3.6 MDa, and the concentration of the hyaluronic acid is from 0.04% to 0.8% by weight;
wherein the aqueous solution has an ionic strength equivalent to an aqueous concentration of sodium chloride from 3% to 30% by weight to provide a high salt, hyaluronic acid solution;
maintaining the aqueous high salt, hyaluronic acid solution at a temperature from 40°
C. to 80°
C. for at least 1 hour and not longer than six days; and
filtering the heated, high salt, hyaluronic acid solution through a sterilization filter medium, wherein the filter medium has an average pore size of 0.25 μ
m or less to provide a sterilized high salt, hyaluronic acid solution.
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Abstract
A process for sterilizing a solution comprising hyaluronic acid. The process comprises providing an aqueous solution of hyaluronic acid with a weight average molecular weight from 0.6 MDa to 3.6 MDa, and the concentration of the hyaluronic acid is from 0.04% to 0.8% by weight. The aqueous solution also has an ionic strength equivalent to an aqueous concentration of sodium chloride from 3% to 30% by weight. Once the aqueous, high salt, hyaluronic acid solution is prepared the solution is maintained at a temperature from 40° C. to 80° C. for at least 1 hour and not longer than six days. Following the heat treatment step, the aqueous solution is filtered through a sterilization filter medium to provide a sterilized high salt, hyaluronic acid solution.
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Citations
21 Claims
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1. A process for sterilizing a solution, the process comprising:
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providing an aqueous solution of hyaluronic acid having a weight average molecular weight from 0.6 MDa to 3.6 MDa, and the concentration of the hyaluronic acid is from 0.04% to 0.8% by weight;
wherein the aqueous solution has an ionic strength equivalent to an aqueous concentration of sodium chloride from 3% to 30% by weight to provide a high salt, hyaluronic acid solution;maintaining the aqueous high salt, hyaluronic acid solution at a temperature from 40°
C. to 80°
C. for at least 1 hour and not longer than six days; andfiltering the heated, high salt, hyaluronic acid solution through a sterilization filter medium, wherein the filter medium has an average pore size of 0.25 μ
m or less to provide a sterilized high salt, hyaluronic acid solution. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A process for sterilizing a solution comprising hyaluronic acid, the process comprising:
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providing an aqueous solution of hyaluronic acid with a weight average molecular weight from 0.6 MDa to 2.2 MDa, and the concentration of the hyaluronic acid is from 0.08% to 0.5% by weight;
wherein the aqueous solution has an ionic strength equivalent to an aqueous concentration of sodium chloride from 4% to 18% by weight to provide a high salt, hyaluronic acid solution;maintaining the aqueous high salt, hyaluronic acid solution at a temperature from 50°
C. to 75°
C. for at least 1 hour and not longer than 18 hours; andfiltering the heated, high salt, hyaluronic acid solution through a sterilization filter medium, wherein the filter medium has an average pore size of 0.25 μ
m or less to provide a sterilized high salt, hyaluronic acid solution. - View Dependent Claims (13, 14, 15, 16, 17)
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18. A process of preparing a production batch of a contact lens care solution, the process comprising:
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providing an aqueous solution of hyaluronic acid with a weight average molecular weight from 0.6 MDa to 3.6 MDa, and the concentration of the hyaluronic acid is from 0.04% to 0.8% by weight;
wherein the aqueous solution has an ionic strength equivalent to an aqueous concentration of sodium chloride from 2% to 30% by weight to provide a high salt, hyaluronic acid solution;maintaining the aqueous high salt, hyaluronic acid solution at a temperature from 55°
C. to 75°
C. for at least 1 hour and not longer than 12 hours;filtering the heated, high salt, hyaluronic acid solution through a sterilization filter medium, wherein the filter medium has an average pore size of 0.25 μ
m or less to provide a sterilized high salt, hyaluronic acid solution;combining the sterilized high salt, hyaluronic acid solution with an aqueous solution comprising buffer components and adjusting the pH from 6.4 to 7.2, and by the combining of the two aqueous solutions the sterilized high salt, hyaluronic acid solution is diluted by a factor of at least 10. - View Dependent Claims (19, 20, 21)
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Specification