Patent ID: 9212233
Filing Date: 2015-12-15
Classification: A61K,A61P,C08B

Abstract:
1. A pharmaceutical composition comprising a low molecular weight heparin preparation produced by a process comprising: depolymerization of unfractionated heparin to produce a depolymerized polysaccharide preparation, oxidation of the depolymerized polysaccharide preparation to produce an oxidized polysaccharide preparation, and reduction of the oxidized polysaccharide preparation to produce the low molecular weight heparin preparation, wherein the low molecular weight heparin preparation has the following characteristics (a) a weight average chain molecular weight between 5,000 and 8,000 Da; (b) anti-Xa activity of less than 20 IU/mg and anti-IIa activity of 1 IU/mg or less; (c) greater than 5% and less than 25% glycol split uronic acid residues; (d) a molecular weight distribution such that 10-30% of the oligosaccharides have a molecular weight <3000 Da; 55-65% of the oligosaccharides have a molecular weight between 3000-8000 Da, and 15-30% of the oligosaccharides have a molecular weight >8000 Da; and wherein the preparation comprises polysaccharides comprising the structure: [U wherein each occurrence of U indicates a uronic acid residue and each occurrence of H indicates a hexosamine residue; wherein m and n are integers such that m=4-15, and n=1-3; each of w, x, y and z can, independently, be the same or different for each occurrence of [U w=−2OS or −2OH; x=—NS or —NAc; y=−3OS or −3OH; z=−6OS or −6OH; and wherein the symbol ˜ indicates that the units marked m and n are distributed along the polysaccharide chain and are not necessarily in sequence.