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AssigneeAzurity Pharmaceuticals Ireland Limited
InventorsJordan R. Hunt, Gerold Mosher, Paras P. Jain, Krishna Mohan Lakshmipathula
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The invention discloses a lamotrigine oral suspension and a preparation method thereof, the lamotrigine oral suspension is composed of lamotrigine and other pharmaceutic adjuvants, the pharmaceutic adjuvants are composed of a suspending aid, a wetting agent, a bacteriostatic agent, a flavoring agent, a defoaming agent, a pH regulator and a solvent, and the wetting agent is hydroxypropyl methylcellulose, glycerin, Tween 80 and the like. According to the invention, the suspending aid is adopted to increase the liquid viscosity and improve the stability of the suspension, and the wetting agent is adopted to improve the hydrophobicity of API, so that the stability and redispersibility of the suspension are improved, and the preparation process is simple and suitable for industrial mass production.
1-102. (canceled)
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, 14.10° 0.2° 2θ, 15.10° 0.2° 2θ, 17.5°±0.2° 2θ, 22.10° 0.2° 2θ, and 24.9°±0.2° 2θ.
108-110. (canceled)
114-116. (canceled)
120-127. (canceled)
Dependencies are inferred from the claim text.