Erythropoietin composition
First Claim
Patent Images
1. A liquid pharmaceutical composition in the form of an aqueous solution comprising an amount of a human erythropoietin glycoprotein product providing from about 10 μ
- g to about 10,000 μ
g of erythropoietin protein per mL of solution, from about 10 to about 200 mmol per liter of said solution of a multiple charged inorganic anion selected from a sulfate or phosphate anion, an antioxidant, and a pharmaceutically acceptable buffer, said anion and said buffer being present in said solution in an amount such as to provide the solution with a pH of from about 5.5 to about 7.0.
0 Assignments
0 Petitions
Accused Products
Abstract
The present invention relates to a liquid pharmaceutical composition consisting essentially of an erythropoietin protein, a multiple charged inorganic anion in a pharmaceutically acceptable buffer suitable to keep the solution pH in the range from about 5.5 to about 7.0, and optionally one or more pharmaceutically acceptable excipients. This composition is especially useful for the prophylaxis and treatment of diseases related to erythropoiesis.
122 Citations
55 Claims
-
1. A liquid pharmaceutical composition in the form of an aqueous solution comprising an amount of a human erythropoietin glycoprotein product providing from about 10 μ
- g to about 10,000 μ
g of erythropoietin protein per mL of solution, from about 10 to about 200 mmol per liter of said solution of a multiple charged inorganic anion selected from a sulfate or phosphate anion, an antioxidant, and a pharmaceutically acceptable buffer, said anion and said buffer being present in said solution in an amount such as to provide the solution with a pH of from about 5.5 to about 7.0. - 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)
- g to about 10,000 μ
-
40. A liquid pharmaceutical composition in the form of an aqueous solution comprising a therapeutically effective amount of a pegylated erythropoietin glycoprotein product of formula
P—- (NHCO—
(CH2)x—
(OCH2CH2)m—
OR)n
(I)wherein P is an erythropoietin glycoprotein having the sequence SEQ ID NO;
1, SEQ ID NO;
2, or either of these sequences modified by the addition of from 1 to 6 glycosylation sites or by rearrangement of at least one glycosylation site, minus the amino group of said glycoprotein which forms an amide linkage;R is lower alkyl; x is 2 or 3; m is from about 450 to about 900; n is from 1 to 3; and wherein the values of n and m are such that the molecular weight of the conjugate minus the erythropoietin glycoprotein is from 20 kilodaltons to 100 kilodaltons; an antioxidant, from about 10 to about 2000 mmol/L of a multiple charged inorganic anion selected from a sulfate or phosphate anion, and a pharmaceutically acceptable buffer, said anion and said buffer being present in said solution in an amount such that the pH of the solution is from about 5.5 to about 7.0. - View Dependent Claims (41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55)
- (NHCO—
Specification