Stable formulations of a hyaluronan-degrading enzyme
First Claim
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1. A composition, comprising:
- a therapeutically effective amount of a soluble PH20 polypeptide, wherein the soluble PH20 polypeptide is active at neutral pH; and
lysyl lysine (Lys-Lys) at a concentration that is about 10 mM to about 200 mM, inclusive, whereby the soluble PH20 polypeptide in the composition, when incubated at a temperature of 37°
C. to 42°
C., inclusive, exhibits greater hyaluronidase activity than a composition that is identical, except that the composition does not contain the Lys-Lys.
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Abstract
Provided are compositions that are stable formulations of a hyaluronan-degrading enzyme or are stable co-formulations of a fast-acting insulin and a hyaluronan degrading enzyme, including a recombinant human PH20 (rHuPH20).
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Citations
55 Claims
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1. A composition, comprising:
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a therapeutically effective amount of a soluble PH20 polypeptide, wherein the soluble PH20 polypeptide is active at neutral pH; and lysyl lysine (Lys-Lys) at a concentration that is about 10 mM to about 200 mM, inclusive, whereby the soluble PH20 polypeptide in the composition, when incubated at a temperature of 37°
C. to 42°
C., inclusive, exhibits greater hyaluronidase activity than a composition that is identical, except that the composition does not contain the Lys-Lys. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 55)
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50. A composition, comprising:
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a soluble PH20 polypeptide at a concentration of between 10 U/mL to 5000 U/mL, inclusive, wherein the soluble PH20 polypeptide is active at neutral pH; lysyl lysine (Lys-Lys) at a concentration of about 10 mM to 200 mM, inclusive, wherein the pH of the composition is between about 6.5 to 8.0, inclusive. - View Dependent Claims (51, 52, 53, 54)
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Specification