Formulations
First Claim
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1. A formulation comprising a glutamic acid or aspartic acid buffer having a pH from about 4.0 to about 6.0, proline at a concentration of about 2% to about 10%, and an antibody or antigen-binding fragment.
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Abstract
The invention provides a formulation comprising a buffer with a pH from about 4.0 to about 6.0, proline and an effective amount of a polypeptide. The polypeptide can be an antibody. The specification also provides methods of preparing the formulation, a kit containing the formulation and methods of using the formulation.
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Citations
50 Claims
- 1. A formulation comprising a glutamic acid or aspartic acid buffer having a pH from about 4.0 to about 6.0, proline at a concentration of about 2% to about 10%, and an antibody or antigen-binding fragment.
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12. A method of preparing a formulation comprising combining a glutamic acid or aspartic acid buffer having a pH from about 4.0 to about 6.0, proline and an effective amount of an antibody or antigen-binding fragment.
- 13. A container containing a formulation comprising an aqueous solution having between about 3 to about 50 mM glutamic acid or aspartic acid with a pH from about 4.0 to about 6.0, proline from about 2% to about 10% and an antibody or antigen-binding fragment.
- 16. A method of treating a condition caused by increased expression of nerve growth factor or increased sensitivity to nerve growth factor in a patient, comprising administering to a patient a pharmaceutically effective amount of a formulation comprising a glutamic acid buffer or aspartic acid buffer having a pH from about 4.0 to about 6.0, proline at a concentration of about 2% to about 10%, and an effective amount of an antibody or antigen-binding fragment to nerve-growth factor.
- 18. A formulation comprising an acetic buffer having a pH from about 4.0 to about 6.0, proline at a concentration of about 2% to about 10%, and an antibody or antigen-binding fragment, wherein the formulation does not further comprise both a polyol and a surfactant.
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29. A method of preparing a formulation comprising combining a acetic acid buffer having a pH from about 4.0 to about 6.0, proline and an effective amount of an antibody or antigen-binding fragment, wherein the formulation does not further comprise both a polyol and a surfactant.
- 30. A container containing a formulation comprising an aqueous solution having between about 3 to about 50 mM acetic acid with a pH from about 4.0 to about 6.0, proline from about 2% to about 10% and an antibody or antigen-binding fragment, wherein the aqueous solution does not further comprise both a polyol and a surfactant.
- 33. A method of treating a condition caused by increased expression of nerve growth factor or increased sensitivity to nerve growth factor in a patient, comprising administering to a patient a pharmaceutically effective amount of a formulation comprising an acetic acid buffer having a pH from about 4.0 to about 6.0, proline at a concentration of about 2% to about 10%, and an effective amount of an antibody or antigen-binding fragment to nerve-growth factor, wherein the formulation does not further comprise both a polyol and a surfactant.
- 35. A formulation consisting essentially of proline and an antibody or antigen-binding fragment at a concentration wherein the formulation maintains a selected pH during storage.
- 40. A method of treating a condition caused by increased expression of nerve growth factor or increased sensitivity to nerve growth factor in a patient, comprising administering to a patient a pharmaceutically effective amount of a formulation consisting essentially of proline and an antibody or antigen-binding fragment at a concentration wherein the formulation maintains a selected pH during storage.
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42. A formulation comprising an acetic acid buffer having a pH from about 4.0 to about 6.0, proline at a concentration of about 2% to about 10%, and an antibody or antigen-binding fragment.
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43. A kit comprising in one or more containers a glutamic acid or aspartic acid buffer having a pH from about 4.0 to about 6.0 or an appropriate glutamate or aspartate salt to prepare such a buffer, proline at a concentration of about 2% to about 10%, and an antibody or antigen-binding fragment, and instructions regarding the use thereof.
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44. A kit comprising in one or more containers proline at a concentration of about 2% to about 10% and an antibody or antigen-binding fragment at a concentration wherein when mixed together, the proline and antibody or antigen-binding fragment maintain a selected pH during storage of the mixture, and instructions regarding the use thereof.
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45. A kit comprising in one or more containers an acetic buffer having a pH from about 4.0 to about 6.0 or an appropriate acetate salt to prepare such a buffer, proline at a concentration of about 2% to about 10%, and an antibody or antigen-binding fragment, wherein the kit does not further comprise both a polyol and a surfactant, and instructions regarding the use thereof.
Specification