CRYSTALS OF LAQUINIMOD SODIUM, AND PROCESS FOR THE MANUFACTURE THEREOF
0 Assignments
0 Petitions
Accused Products
Abstract
Disclosed is a process for the preparation of laguinimod sodium which removes the impurities after the salt formation step, thus resulting in crystals of higher purity as well as crystals having improved crystalline characteristics.
-
Citations
53 Claims
-
1-40. -40. (canceled)
-
41. A process of recrystallization of laquinimod sodium comprising:
-
a) dissolving laquinimod sodium in water to form an aqueous solution; b) concentrating the aqueous solution to form a concentrated solution; c) adding a water-miscible anti-solvent to the concentrated solution to form laquinimod sodium crystals; and d) isolating the laquinimod sodium crystals. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49, 50, 51)
-
-
52. A process for making a pharmaceutical composition comprising laquinimod sodium comprising:
-
a) obtaining a batch of laquinimod sodium; b) determining whether insoluble matter is present in the batch of step a) by mixing a sample from the batch in deionized water at room temperature at a ratio of at least 110 mg of sample to 1.0 ml of water, and inspecting the resulting mixture for the presence of insoluble matter; and c) mixing the batch of step a) with at least one pharmaceutically acceptable carrier if in step b) insoluble matter is determined to be present below a predetermined amount. - View Dependent Claims (53)
-
Specification