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US 6,271,258 B1Granted
Process for the preparation of stable, non-hygroscopic salts of L(-)carnitine
AssigneeSigma-Tau Industrie Farmaceutiche Riunite S.p.A.
InventorAldo Fassi
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Abstract
An improved process for producing stable, non-hygroscopic salts of l(−)carnitine is disclosed, which comprises preparing at room temperature a pasty/semiliquid slurry of L(−)carnitine inner salt and water and adding to the slurry an organic dicarboxylic acid suitable for the formation of such salts
Claims3
A process for preparing a stable, non-hygroscopic salt of L(−)carnitine selected from the group consisting of L(−)carnitine, L(+) tartrate (2:1) and L(−)carnitine acid fumarate (1:1), which process comprises the successive steps of:
- (a) mixing at room temperature L(−)carnitine inner salt with the least amount of water necessary to obtain a paste or semiliquid slurry;
- (b) adding to the slurry produced in step (a) at room temperature an equimolar amount of fumaric acid with respect to L(−)-carnitine inner salt or one-half of the molar amount of L(+) tartaric acid and thoroughly blending the resulting reaction mixture;
- (c) solidifying/dehydrating the reaction mixture of step (b) by allowing the reaction mixture to stand in the open air at relative humidity not higher than 50% or optionally accelerating the solidification/dehydration by drying;
- and
- (d) optionally grinding the solidified reaction mixture to provide the L(−)carnitine salt as a granulate or powder product.
2 more elements
Dependencies are inferred from the claim text.