Process for the preparation of pharmaceutically acceptable salts of (R,S)-S-adenosyl-L-methionine
AssigneeChementecno S.r.l.
InventorsMarco Berna, Lino Sivieri, Gianni Santambrogio, Ermanno Valoti
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Abstract
The present invention relates to a process for the preparation of pharmaceutically acceptable salts of (R,S)-S-adenosyl-L-methionine and allows to obtain the salified (R)-(+)-S-adenosyl-L-methionine diasteroisomer in amounts lower than or equal to 3% with respect to the salified (S)-(+)-S-adenosyl-L-methionine diastereoisomer; the salts that can be obtained by the process of the invention keep their configuration stable in time.
Claims9
A process for the preparation of a pharmaceutically acceptable salt of a mixture of (R)-S-adenosyl-L-methionine and (S)-S-adenosyl-L-methionine from enriched yeast containing at least 6 g/kg of (R)-S-adenosyl-L-methionine and (S)-S-adenosyl-L-methionine, wherein the process is performed at a temperature of 0-12° C., comprising:
- (a) adjusting the yeast to a pH of 1.0 to 3.5,
- (b) lysing the yeast to produce a lysate,
- (c) microfiltrating the lysate to produce a microfiltrate,
- (d) adsorbing the microfiltrate on a weak acid resin and eluting with 0.1-2 N inorganic acid to produce an eluate,
- (e) decolorizing the eluate to produce a decolorized eluate,
- (f) concentrating the decolorized eluate by reverse osmosis to 30-70% by volume to produce a concentrated, decolorized eluate,
- (g) adding stoichiometric amounts of a pharmaceutically acceptable acid to the concentrated, decolorized eluate to produce a pharmaceutically acceptable salt of the mixture of (R)-S-adenosyl-L-methionine and (S)-S-adenosyl-L-methionine, wherein the salified (R)-S-adenosyl-L-methionine is present in amounts lower than or equal to 3% with respect to the (S)-S-adenosyl-L-methionine.
Dependencies are inferred from the claim text.