Lamotrigine hydrate crystal form, preparation method therefor, and composition containing same

A pharmaceutical composition, comprising a therapeutically effective amount of anhydrous lamotrigine particles and one or more pharmaceutically acceptable excipients, wherein said anhydrous lamotrigine particles have a particle size D90 of about 4.5 to about 8 μm, and said excipients comprise a thickener and a pH modifier, wherein the pharmaceutical composition is in the form of a dry mixture, wherein said pH modifier provides a pH of about 4.6 to about 6.9 after said pharmaceutical composition is reconstituted with water to form a suspension, wherein the D90 of the anhydrous lamotrigine particles and the pH modifier are selected so that more than about 90% of lamotrigine from the anhydrous lamotrigine particles exists in lamotrigine hydrate form A in the suspension, wherein the hydrate form A has a particle size of 20-30 μm,

• wherein an XRPD pattern of said lamotrigine hydrate form A comprises characteristic peaks at diffraction angles 2θ of about 11.5±0.2, 13.4±0.2, 15.3±0.2, 16.5±0.2, 19.2±0.2, 26.9±0.2, and 27.7±0.2 degrees, and has no characteristic peak(s) at one or more of diffraction angles 2θ of about 15.9±0.2, 20.5±0.2, 23.5±0.2, 28.2±0.2, and 30.7±0.2 degrees;
• and/or, said XRPD pattern of said lamotrigine hydrate form A has no characteristic peaks at diffraction angles 2θ of about 15.9±0.2, 20.5±0.2, 23.5±0.2, 28.2±0.2 and 30.7±0.2 degrees;
• or
• wherein said XRPD pattern of said lamotrigine hydrate form A comprises characteristic peaks at diffraction angles 2θ substantially the same as diffraction angles shown in FIG. 1;
• or
• wherein said XRPD pattern of said lamotrigine hydrate form A has XRPD peak positions substantially the same as XRPD peak positions shown in FIG. 1;
• or
• wherein said XRPD pattern of said lamotrigine hydrate form A has XRPD peak positions the same as XRPD peak positions shown in FIG. 1.