http://rdf.ncbi.nlm.nih.gov/pubchem/patent/AR-080427-A1

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filingDate 2011-01-19-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_f39f23772a8d30587a3cb14a68b4d84e
http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_e194ab025b22266e880a9d8f3d93352c
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publicationDate 2012-04-11-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber AR-080427-A1
titleOfInvention LIQUID FORMULATION FOR A G-CSF PROLONGED ACTION CONJUGATE
abstract Liquid formulation that gives long-acting conjugates of G-CSF stability for extended periods of time, which have improved durability and stability in vivo. It comprises a stabilizing composition characterized by a buffer and mannitol. Because it is free of human serum albumin and other factors potentially harmful to the body, the formulation does not present risks related to viral infections, while ensuring excellent stability during storage of long-acting G-conjugates. CSF Claim 2: The liquid formulation according to claim 1, characterized in that the concentration of mannitol varies between 1 and 20% (w / v), based on the total volume of the liquid formulation. Claim 5: The liquid formulation according to claim 1, characterized in that the pH of the buffer varies between 4 and 8. Claim 6: The liquid formulation according to claim 1, characterized in that the albumine free stabilizer also comprises a selected ingredient from the group consisting of an isotonic agent, a polyhydric alcohol, a sugar, a non-ionic surfactant, a neutral amino acid and a combination thereof. Claim 12: The liquid formulation according to claim 6, characterized in that the sugar is selected from the group consisting of mannose, glucose, fucose, xylose, lactose, maltose, sucrose, raffinose, dextran and a combination of these. Claim 18: The liquid formulation according to claim 1, characterized in that the albumine-free stabilizer comprises a citrate buffer with a pH ranging between 5 and 8, in a concentration of between 5 and 100, mannitol in a concentration of between 1 and 20% (w / v), sodium chloride in a concentration between 5 and 200 mM and polysorbate 80 in a concentration between 0.001 and 0.05%. Claim 19: The liquid formulation according to claim 1, characterized in that the G-CSF is a mutant G-CSF protein modified from the wild G-CSF by substitution, deletion or insertion of one or more amino acids, or either an analog peptide with an activity similar to that of wild G-CSF. Claim 20: The liquid formulation according to claim 19, characterized in that the G-CSF derivative is a mutant derivative (17Ser-G-CSF) in which there is a serine residue located at position 17, instead of the residue of cysteine from wild G-CSF. Claim 22: The liquid formulation according to claim 1, characterized in that the immunoglobulin Fc fragment is selected from the group consisting of lgG, IgA, IgD, IgE, lgM and a combination thereof. Claim 27: The liquid formulation according to claim 1, characterized in that the non-peptide polymer is selected from the group consisting of a biodegradable polymer, a lipid polymer, chitin, hyaluronic acid and a combination thereof. Claim 28: The liquid formulation according to claim 27, characterized in that the biodegradable polymer is selected from the group consisting of polyethylene glycol, polypropylene glycol, a copolymer of ethylene glycol and propylene glycol, polyoxyethylated polyols, polyvinyl alcohol, polysaccharides, dextran, polyvinyl ethyl ether, PLA (polylactic acid) and PLGA (polylactic-glycolic acid).
priorityDate 2010-01-19-04:00^^<http://www.w3.org/2001/XMLSchema#date>
type http://data.epo.org/linked-data/def/patent/Publication

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