Pharmaceutical composition
AssigneeadvanceCOR GmbH
InventorsGötz Münch, Kristin Adler, Meinrad Gawaz
Life of this patent
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Abstract
A pharmaceutical composition for parenteral application. comprising (a) more than 2.4 mg/ml of a collagen-binding dimeric fusion protein comprising an extracellular domain of glycoprotein VI, the fusion protein having an amino acid sequence of SEQ ID NO: 1, or an amino acid sequence that is at least 99% homologous to the amino acid sequence of SEQ ID NO: 1; and (b) a pharmaceutically acceptable buffer, the buffer comprising (b1) a buffering component in combination with a ph adjusting agent, which is 10 mM His/HCl, and (b2) 4 percent by weight of mannitol and (b3) 2.5 percent by weight of saccharose as stabilizing agents, and which has a pH of 7
Claims10
A pharmaceutical composition for parenteral application, comprising
- (a) more than 2.4 mg/ml of a collagen-binding dimeric fusion protein comprising an extracellular domain of glycoprotein VI, the fusion protein having an amino acid sequence of SEQ ID NO:
- 1, or an amino acid sequence that is at least 99% homologous to the amino acid sequence of SEQ ID NO:
- 1;
- and
- (b) a pharmaceutically acceptable buffer, the buffer comprising
- (b1) a buffering component in combination with a pH adjusting agent, which is 10 mM His/HCl, and
- (b2) mannitol as a stabilizing agent in an amount of 4 percent by weight based on the total weight of the pharmaceutical composition and
- (b3) saccharose in an amount of 2.5 percent by weight based on the total weight of the pharmaceutical composition as a stabilizing agent, and
- which has a pH of 7.
A diagnostic method for selecting a patient benefitting from administration of a dimeric fusion protein comprising an extracellular domain of glycoprotein VI for preventing bleeding complications, which method comprises
- (a) determining a soluble GPVI concentration in blood plasma of the patient;
- and
- (b) selecting the patient if the soluble GPVI concentration is above 22.8 ng/ml.
Dependencies are inferred from the claim text.