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OwnerBrian Lobo, Sabrina Lo +5inventors
InventorsBrian Lobo, Sabrina Lo, Aditya Wakankar, Yuchang John Wang, Rita L. Wong, Pierre Goldbach, Hanns-Christian Mahler
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The invention provides a method for reducing aggregation and inhibiting flocculation of a macromolecule, such as a protein, under physiological conditions, by the addition of 5% to 20% polyvinylpyrrolidone (PVP) with a molecular weight range of 2000 to 54,000 daltons. The invention further provides a method to minimize inflammation at the injection site during subcutaneous administration of a macromolecule. In further aspects, the invention provides pharmaceutical formulations for subcutaneous administration of a macromolecule, and methods of treating a CD20 positive cancer or an autoimmune disease, comprising administering a humanized anti-CD20 antibody in a pharmaceutical formulation of the invention. The invention further provides an in vitro dialysis method to evaluate the ability of an excipient to reduce aggregation of an antibody or other macromolecule under physiological conditions.
A method to minimize inflammation at the injection site during subcutaneous administration of a macromolecule, comprising adding to a formulation containing the macromolecule 5% to 20% polyvinylpyrrolidone (PVP) having a molecular weight range of 2000 to 54,000 daltons.
A pharmaceutical formulation for subcutaneous administration of an antibody, comprising an antibody at a concentration range of 10 mg/ml to 200 mg/ml, and 5% to 20% polyvinylpyrrolidone (PVP) with a molecular weight range of 2000 to 54,000 daltons.
A method of treating a CD20 positive B cell cancer, comprising administering to a patient having the cancer a therapeutically effective amount of a humanized 2H7 antibody of Table 1 in a pharmaceutical formulation comprising 5% to 20% polyvinylpyrrolidone (PVP) having a molecular weight range of 2000 to 54,000 daltons.
A method of treating an autoimmune disease, comprising administering to a patient having the autoimmune disease a therapeutically effective amount of a humanized 2H7 antibody of Table 1 in a pharmaceutical formulation comprising 5% to 20% polyvinylpyrrolidone (PVP) having a molecular weight range of 2000 to 54,000 daltons.
A method of improving or maintaining solubilization of or minimizing precipitation of an antibody in an aqueous subcutaneous formulation upon injection at the injection site of a patient, comprising adding 5% to 20% polyvinylpyrrolidone (PVP) having a molecular weight range of 2000 to 54,000 daltons to the aqueous subcutaneous formulation.
A method of increasing the bioavailability of an antibody to be administered subcutaneously, comprising adding 5% to 20% polyvinylpyrrolidone (PVP) having a molecular weight range of 2000 to 54,000 daltons to an aqueous subcutaneous formulation comprising the antibody.
An in vitro dialysis method for evaluating the ability of an excipient to reduce aggregation of an antibody or other macromolecule under physiological conditions, comprising:
Dependencies are inferred from the claim text.