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 (SS,RS)-S-adenosyl-L-methionine and allows to obtain the salified (RS)-(+)-S-adenosyl-L-methionine diastereoisomer in amounts lower than or equal to 3% with respect to the salified (SS)-(+)-S-adenosyl-L-methionine diastereoisomer; the salts that can be obtained by the process of the invention keep their configuration stable in time.
Claims8
A process for the preparation of pharmaceutically acceptable salts of (SS,RS)-SAMe, wherein the salified (RS)-(+)-SAMe diastereoisomer is present in amounts lower than or equal to 3% with respect to the salified (SS)-(+)-SAMe diastereoisomer, which, at a temperature of 0-12° C., comprises:
- the purification of (SS,RS)-S-adenosyl-L-methionine from enriched yeast, which shall contain at least 6 g/l thereof, which comprises:
- (a) the adjustment of the pH value to 1.2-3.5;
- (b) the preparation of an aqueous lysate of (SS,RS)-SAMe from the enriched yeast;
- (c) the microfiltration of the resulting lysate;
- (d) the absorption of the resulting microfiltrate on a weak acid resin, by eluting with a 0.1-2 N inorganic acid solution;
- (e) the decolouration of the resulting eluate;
- the concentration of the decolourised eluate by reverse osmosis, from 30 to 70% by volume;
- the addition of stoichiometric amounts of at least a pharmaceutically acceptable acid to the concentrated eluate, so as to obtain the corresponding pharmaceutically acceptable salt of (SS,RS)-SAMe.
Process according to any of the preceding claims, wherein the preparation of the lysate in step (b) takes place by passing the yeast through a cell-breaking equipment.
Process according to any of the preceding claims, wherein the temperature is 2-5° C.
Process according to any of the preceding claims, wherein the enriched yeast contains at least 8-10 g/l of (SS,RS)-S-adenosyl-L-methionine.
Process according to any of the preceding claims, wherein the pharmaceutically acceptable acid is selected from sulphuric acid and paratoluensulphonic acid.
A pharmaceutically acceptable salt of (SS,RS)-S-adenosyl-L-methionine obtainable by the process according to any of the preceding claims.
Dependencies are inferred from the claim text.