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AssigneeAzurity Pharmaceuticals Ireland Limited
InventorsJordan R. Hunt, Gerold Mosher, Paras P. Jain, Krishna Mohan Lakshmipathula
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The present disclosure relates to novel lamotrigine salts, co-crystals, and compositions. In some embodiments, the lamotrigine salt is a lamotrigine dicarboxylic acid salt or hydrate or solvate thereof. In some embodiments, the lamotrigine co-crystal is a co-crystal of lamotrigine and a dicarboxylic acid, or a hydrate or solvate thereof. In some embodiments, the compositions comprise lamotrigine or a salt or co-crystal thereof, or a hydrate or solvate thereof. In some embodiments, the composition is in the form of a powder. In some embodiments, the composition is in the form of a liquid. The present disclosure also relates to methods of preparation and use in medical therapy, for example, for the treatment of a subject with epilepsy or bipolar disorder.
A stable oral suspension comprising lamotrigine hemifumarate anhydrate, wherein the amount of lamotrigine hemifumarate anhydrate is equivalent to from 1 mg/mL to 50 mg/mL of lamotrigine (free base), wherein the stable oral suspension is in the form of a liquid, and wherein the lamotrigine hemifumarate anhydrate has an x-ray powder diffraction pattern comprising one or more peaks at 7.0°±0.2° 2θ, 13.4°±0.2° 2θ, 14.1°±0.2° 2θ, 15.1°±0.2° 2θ, 17.5°±0.2° 2θ, 22.1°±0.2° 2θ, and 24.9°±0.2° 2θ.
Dependencies are inferred from the claim text.