Lamotrigine hydrate crystal form, preparation method therefor, and composition containing same
AssigneeShanghai Aucta Pharmaceuticals Co., Ltd.
InventorsShoufeng Li, Yong Wang, Boli Li
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Abstract
The present invention relates to a crystalline form of a 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.
Claims18
A pharmaceutical composition, comprising a therapeutically effective amount of lamotrigine particles and one or more pharmaceutically acceptable excipients, wherein said lamotrigine particles have a particle size D90 of about 1-30 μm, and said excipients comprise a thickener and a pH modifier, wherein the pharmaceutical composition is in the form of a dry suspension.
A suspension comprising a lamotrigine hydrate form A, wherein said suspension comprises said lamotrigine hydrate form A, a thickener, and a pH modifier, and wherein said lamotrigine hydrate form A in said suspension has a particle size being at least one selected from the group consisting of:
- 20-80 μm, 20-70 μm, 20-60 μm, 20-50 μm, 20-40 μm, 20-30 μm, 30-80 μm, 30-70 μm, 30-60 μm, 30-50 μm, 30-40 μm, 40-80 μm, 40-70 μm, 40-60 μm, 40-50 μm, 50-80 μm, 50-70 μm, 50-60 μm, 60-80 μm, 60-70 μm, and 70-80 μm, and said pH modifier provides a pH of 4.6-6.9 for said suspension.
Dependencies are inferred from the claim text.