Back to results
US 11,447,456 B1Granted
Crystalline form of lamotrigine hydrate, method for preparing the same and composition comprising the same
AssigneeShanghai Aucta Pharmaceuticals Co., Ltd.
InventorsShoufeng Li, Sr., Yong Wang
Life of this patent
Estimating the term…
Abstract
The invention relates to a crystalline form of lamotrigine hydrate, a method for preparing the same and a composition comprising the same, and in particular, to a lamotrigine hydrate form A, a method for preparing the lamotrigine hydrate form A and a composition comprising the lamotrigine hydrate form A.
Claims19
A method for preparing lamotrigine hydrate form A in a suspension, comprising the steps of:
- adding lamotrigine particles and a thickener to an aqueous phase;
- dispersing the lamotrigine particles having a particle size (D90) ranging from about 8 to about 12 μm and the thickener uniformly in the aqueous phase;
- and cooling the aqueous phase at a temperature lower than 25° C. to obtain the suspension comprising the lamotrigine hydrate form A, wherein the form A has a particle size ranging from about 20 to about 30 μm in the suspension, wherein the term about indicates a range within ±1 of a given value,
- wherein an XRPD spectrum of the lamotrigine hydrate form A comprises characteristic peaks at diffraction angles (2θ) of about 11.5±0.2°, 13.4±0.2°, 15.0±0.2°, 16.5±0.2°, 19.2±0.2°, 26.9±0.2° and 27.7±0.2°, and has no characteristic peaks at one or more diffraction angles (2θ) of 15.9±0.2°, 20.5±0.2°, 23.5±0.2°, 28.2±0.2° and 30.7±0.2°,
- wherein the thickener comprises xanthan gum, povidone, colloidal microcrystalline cellulose, or sodium alginate,
- wherein more than 90% of lamotrigine in the suspension is present in the form of the lamotrigine hydrate form A.
3 more elements
Dependencies are inferred from the claim text.