Crystals of laquinimod sodium, and process for the manufacture thereof
First Claim
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1. A mixture of crystalline laquinimod sodium particles, wherein 10% or more of the total amount by volume of the laquinimod sodium particles have a size of greater than 40 microns.
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Abstract
Disclosed is a process for the preparation of laquinimod 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.
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Citations
40 Claims
- 1. A mixture of crystalline laquinimod sodium particles, wherein 10% or more of the total amount by volume of the laquinimod sodium particles have a size of greater than 40 microns.
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8-10. -10. (canceled)
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11. A mixture of crystalline laquinimod sodium particles, having a tapped density of at least 0.6 g/mL.
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12-18. -18. (canceled)
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21. A composition comprising laquinimod sodium and no more than 2 ppm of a heavy metal calculated based on the total amount of laquinimod sodium in the composition.
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22-28. -28. (canceled)
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29. A process of recrystallization of laquinimod sodium comprising:
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a) dissolving laquinimod sodium in water to form an aqueous solution;
b) filtering the aqueous solution to remove solid impurities;
c) concentrating the aqueous solution to form a concentrated solution;
d) adding a water-miscible anti-solvent to the concentrated solution to form laquinimod sodium crystals; and
e) isolating the laquinimod sodium crystals. - View Dependent Claims (30, 31, 32, 33, 34, 35, 36, 37, 38)
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39. A process for making a pharmaceutical composition comprising laquinimod sodium comprising:
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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 (40)
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Specification