Claims
- 1. A process for the preparation of a stable, non-hygroscopic salt of L(−)-carnitine selected from the group consisting of L(−)-carnitine acid fumarate (1:1) and L(−)-carnitine L(+)-tartrate (2:1), comprising:a) mixing at room temperature, in any desired order, (1) L(−)-carnitine inner salt; (2) fumaric acid or L(+)-tartaric acid, respectively in equimolar amount or in half the equimolar amount to L(−)-carnitine inner salt; and (3) 5-9%, preferably 6-8%, by weight of water calculated on the weight of the (1)+(2)+(3) mixture; (b) heating under stirring the above mixture at a temperature of 100-120° C. to obtain a substantially colourless, transparent molten mass; (c) cooling the molten mass until complete solidification; and (d) grinding the solidified mass to obtain a granulate or powder having the desired particle size.
- 2. A process as claimed in claim 1, in which in step (c) the cooling mass is added with 1-2% by weight, calculated on the mass weight, of a crystallization initiator consisting of a fine powder of L(−)-carnitine acid fumarate (1:1) or of L(−)-carnitine L(+)-tartrate (2:1), respectively.
- 3. A process as claimed in claim 2, in which the addition of the crystallization initiator is carried out when the cooling mass has a temperature of 60-90° C.
- 4. A process according to claim 1, in which the grinding step (d) comprises:(d. 1) a first coarse grinding, optionally under vacuum and at 50-60° C., to promote drying of the solidified mass; and (d. 2) a further grinding of the dried product to obtain the granulate or powder of the desired particle size.
- 5. A granulate or powder substantially comprising L(−)-carnitine acid fumarate (1.1), whose tapped density is at least 0.8 g/mL.
- 6. A granulate or powder as claimed in claim 5, whose tapped density is 0.82-0.86 g/mL.
Priority Claims (1)
Number |
Date |
Country |
Kind |
MI99A0551 |
Mar 1999 |
IT |
|
Parent Case Info
This application is a 371 of PCT IEP00/02349 filed Mar. 16,2000, now WO 00/56701.
PCT Information
Filing Document |
Filing Date |
Country |
Kind |
PCT/EP00/02344 |
|
WO |
00 |
Publishing Document |
Publishing Date |
Country |
Kind |
WO00/56701 |
9/28/2000 |
WO |
A |
Foreign Referenced Citations (2)
Number |
Date |
Country |
0 434 088 |
Jun 1991 |
EP |
WO9838157 |
Sep 1998 |
WO |