Patent ID: 11883402
Assignee: SPECTRUM PHARMACEUTICALS, INC.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A  C | IPC A  C

Claim 18:
19. A method of preparing the crystalline form of the compound of Chemical formula of claim 1, comprising
(1) preparing the dihydrate (2H2O) of claim 3, comprising:
(a) adding the compound of Formula 1 to a mixture of acetone and water, wherein the acetone and the water are in such a ratio that the compound cannot completely dissolve in the mixture at room temperature;
(b) heating the mixture to a temperature wherein the compound completely dissolves; and
(c) cooling down the mixture and removing the acetone and water to obtain the dihydrate (2H2O) of the compound;

(2) preparing the anhydrous Form I of claim 4, comprising:
(a) mixing the dihydrate (2H2O) of the compound of claim 3 with acetone; and
(b) isolating the anhydrous Form I of the compound;

(3) preparing the anhydrous Form II of claim 5, comprising:
(a) mixing the anhydrous Form I of the compound of claim 4 with acetonitrile;
(b) heating to above about 80° C.; and
(c) cooling down and isolating the anhydrous Form II of the compound;

(4) preparing the monohydrochloride monohydrate (1HCl·1H2O) of claim 6, comprising:
(a) mixing the compound of Formula 1 with ethanol, water and aqueous hydrochloric acid; and
(b) isolating the monohydrochloride monohydrate (1HCl·1H2O) of the compound; or

(5) preparing the anhydrous monohydrochloride crystalline form of claim 7, comprising:
(a) mixing an anhydrous compound of formula 1 with a non-protic polar solvent and a hydrochloric acid having a concentration of about 30% or more; and
(b) isolating the anhydrous monohydrochloride of the compound.