Abstract: The present invention relates to a liquid pharmaceutical composition comprising a granulocyte colony stimulating factor polypeptide conjugated with a polymer. In various embodiments, the composition has a pH value in the range of 4.5 to 5.5. Exemplary compositions further comprise a surfactant and optionally one or more other pharmaceutically acceptable excipients. The invention provides, inter alia, formulations free from tartaric acid or salts thereof and/or from succinic acid and salts thereof as buffering agents. Exemplary formulations are essentially devoid of not amino acids as stabilizers. The composition has good storage stability and is especially useful for the prophylaxis and treatment of disorders and medical indications where granulocyte colony stimulating factor preparations are considered as useful remedies.
Type:
Application
Filed:
August 29, 2008
Publication date:
June 4, 2009
Applicants:
Neose Technologies, Inc., BioGeneriX AG
Inventors:
Walter Hinderer, Christian Scheckermann
Abstract: A stable pharmaceutical formulation of erythropoietin is disclosed which contains tris-(hydnox-ymethyl)-aminomethane as stabilizer, whereby the formulation does not contain amino acids or human serumalbumin.
Type:
Application
Filed:
December 1, 2004
Publication date:
June 7, 2007
Applicant:
BIOGENERIX AG
Inventors:
Stefan Arnold, Okke Franssen, Albert Mekking