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Last Updated: March 29, 2024

Claims for Patent: 8,173,138


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Summary for Patent: 8,173,138
Title:Stable liquid formulations of botulinum toxin
Abstract: The invention includes liquid formulations of botulinum toxin that are stable to storage in liquid form at standard refrigerator temperatures for at least 1-2 years and to storage at higher temperatures for at least 6 months. The invention also includes methods of treatment using such formulations for various therapeutic and cosmetic purposes.
Inventor(s): Moyer; Elizabeth (Mill Valley, CA), Hirtzer; Pamela (Piedmont, CA)
Assignee: Solstice Neurosciences, LLC (Louisville, KY)
Application Number:11/683,628
Patent Claims:1. A stable liquid pharmaceutical botulinum toxin formulation for therapeutic use in humans, comprising a pharmaceutically acceptable buffer capable of providing a buffered pH range to the formulation of between about pH 5 and about pH 6; sodium chloride; a therapeutic concentration of a purified botulinum toxin suitable for use in humans, wherein said purified botulinum toxin has not been dried or lyophilized; and serum albumin; wherein the formulation is stable as a liquid when stored for at least one year at a temperature of about 5 degrees centigrade, or for at least 6 months at a temperature between about 10 and about 30 degrees centigrade.

2. The formulation of claim 1, wherein said buffered pH is between about pH 5.4 and about pH 5.8.

3. The formulation of claim 1, wherein said formulation is stable in liquid form for at least two years at a temperature of about 5 degrees centigrade.

4. The formulation of claim 1, wherein said buffer is selected from the group consisting of phosphate buffer, phosphate-citrate buffer, and succinate buffer.

5. The formulation of claim 1, wherein said botulinum toxin is a botulinum toxin serotype selected from the group consisting of serotypes A, B, C, D, E, F and G.

6. The formulation of claim 5, wherein said botulinum toxin is botulinum toxin Type B present at said therapeutic concentration in the range of about 100 to about 20,000 U/ml.

7. The formulation of claim 6, wherein said botulinum toxin Type B is present in a high molecular weight complex of about 700 kilodaltons (kD).

8. The formulation of claim 6, wherein said botulinum toxin Type B is present at said therapeutic concentration between about 1000 to about 5000 U/ml.

9. The formulation of claim 5, wherein said botulinum toxin is botulinum toxin Type A, present at said therapeutic concentration in the range of about 20-2000 U/ml.

10. The formulation of claim 9, wherein said botulinum toxin Type A is present at said therapeutic concentration in the range of about 100-1000 U/ml.

11. A stable liquid pharmaceutical botulinum toxin formulation for therapeutic use in humans, comprising about 0.5 mg/mL human serum albumin, a pharmaceutically acceptable buffer capable of providing a buffered pH range between about pH 5 and about pH 6; sodium chloride; and botulinum toxin type B, wherein said botulinum type B is present at a concentration of about 5,000.+-.1000 U/ml in said formulation; wherein said botulinum toxin is stable in said formulation for at least about 6 months at a temperature between about 10 and about 30 degrees centigrade; and wherein the stable liquid pharmaceutical botulinum toxin formulation is suitable for use without reconstitution of said botulinum toxin from a dried or lyophilized state prior to administration.

12. A stable liquid pharmaceutical botulinum toxin formulation for therapeutic use in humans, comprising a pharmaceutically acceptable buffer capable of providing a buffered pH range to the formulation of between about pH 5 and pH 6; sodium chloride; a therapeutic concentration of a purified botulinum toxin suitable for use in humans, wherein said purified botulinum toxin has not been dried or lyophilized; and serum albumin; wherein said formulation is stable as a liquid when stored for at least one year at a temperature of between about 0 and 10 degrees centigrade, or for at least 6 months at a temperature of between about 10 and 30 degrees centigrade.

13. The formulation of claim 12, wherein said buffer is selected from the group consisting of phosphate buffer, phosphate-citrate buffer, and succinate buffer.

14. The formulation of claim 12, wherein said botulinum toxin comprises botulinum serotype B.

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