Chemi S.p.a.

Italfarmaco Spa

Barbara Pinto

Lorenzo De Ferra

Annamaria Naggi

Maurizio Zenoni

Ettore Ammirati

Andrea Stevenazzi

Luca Mandelli

Felice Stracqualursi

Simona Andreassi

Mauro Annibaldi

A method for the qualification and selection of manufacturing processes, raw materials, intermediates and batch production of pentosan polysulfate based on the identification of acetylated monosaccharide units, including units of xylose substituted with 4-O-methyl-glucuronic which also lead the acetyl group, as structural characterizing units, is disclosed.

Method for the qualification of preparations of pentosan polysulfate, raw materials and production processes thereof

The present invention relates to a process for the preparation of a polysaccharide composed of D-xylose units of formula (III) linked together via beta 1,4 glycosidic bonds wherein Ris hydrogen or acetyl, Ris hydrogen, acetyl or a 4-O-methyl glucuronic acid unit, wherein, when Ris a 4-O-methyl glucuronic acid unit, the Rgroup on the same saccharide unit is defined as G, wherein G is hydrogen or acetyl, and wherein the sugar unit at the reducing end of sun such polysaccharide is xylose, lyxose or xylulose, said process comprising the following steps: selective deacetylation of xylan extracted from beech wood; and isomerization of the selectively deacetylated xylan achieved in step or the following steps: isomerization of xylan extracted from beech wood; and selective deacetylation of isomerized xylan achieved in step. The process is useful for the preparation of pentosan polysulfate or pharmaceutically acceptable salts thereof for pharmaceutical use.

Process for the preparation of polysaccharides

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Patrica, Italy

Barbara Pinto