Tartrate salt of isofagomine and methods of use
View Patent ↗A novel tartaric acid salt of Isofagomine (Isofagomine tartrate) that can be used for the treatment of Gaucher disease is provided. The invention also provides a crystalline form of isofagomine tartrate, method for preparing the salt, a pharmaceutical composition containing the salt, and a method of treating Gaucher disease.
1. A L-(+) tartaric acid salt of isofagomine represented by the structure:
2. A pharmacuetical composition comprising the L-(+) tartaric acid salt of isofagomine of claim 1 .
3. The pharmaceutical composition of claim 2 , wherein the purity of the L-(+) tartaric acid salt of isofagomine present in the pharmaceutical composition is at least 98%.
4. The pharmaceutical composition of claim 2 , wherein the purity of the L-(+) tartaric acid salt of isofagomine present in the pharmaceutical composition is at least 99%.
5. The pharmaceutical composition of claim 2 , wherein the amount of L-(+) tartaric acid salt of isofagomine ranges from about 5 to about 300 mg per unit dose.
6. The pharmaceutical composition of claim 5 , wherein the amount of L-(+) tartaric acid salt of isofagomine ranges from about 10 to about 100 mg per unit dose.
7. The pharmaceutical composition of claim 6 further comprising a pharmaceutically acceptable excipient.
8. A method of treating Gaucher disease comprising administering to an individual in need thereof an effective amount of the pharmaceutical composition as in any one of claims 2 - 7 .
9. The method of claim 8 further comprising administering to the individual a functional glucocerebrosidase enzyme.