Submicron suspensions with polymorph control
OwnerJane Werling, James Kipp +2inventors
InventorsJane Werling, James Kipp, Rajaram Sriram, Mark Doty
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Abstract
The present invention provides a method for preparing a suspension of a pharmaceutically active compound, the solubility of which is greater in a water miscible first organic solvent than in a second solvent which is aqueous, The process includes the steps of: (i) dissolving a first quantity of the pharmaceutically active compound in the water miscible first organic solvent to form a first solution; (ii) mixing the first solution with the second solvent to precipitate the pharmaceutically active compound; and (iii) seeding the first solution or the second solvent or the presuspension.
Claims66
A method for preparing a suspension of a pharmaceutically-active compound, the solubility of which is greater in a water miscible first organic solvent than in a second solvent which is aqueous, the process comprising the steps of:
- (i) dissolving a first quantity of the pharmaceutically-active compound in the water-miscible first organic solvent to form a first solution;
- (ii) mixing the first solution with the second solvent to precipitate the pharmaceutically-active compound to create a presuspension;
- and
- (iii) seeding the first solution or the second solvent prior to the or the presuspension after the mixing step.
A method for preparing a suspension of a pharmaceutically-active compound, the solubility of which is greater in a water-miscible first organic solvent than in a second solvent which is aqueous, the process comprising the steps of:
- (i) dissolving a first quantity of the pharmaceutically-active compound in the water-miscible first organic solvent to form a first solution;
- (ii) mixing the first solution with the second solvent to precipitate the pharmaceutically active compound to create a presuspension;
- and
- (iii) providing a seed compound to the first solution or the second solvent or the presuspension.
A method for preparing a suspension of a pharmaceutically-active compound, the solubility of which is greater in a water-miscible first organic solvent than in a second solvent which is aqueous, the process comprising the steps of:
- (i) adding a quantity of the pharmaceutically-active compound to the first organic solvent to create a supersaturated solution;
- (ii) aging the supersaturated solution to form detectable crystals to create a seeding mixture;
- and
- (iii) mixing the seeding mixture with the second solvent to precipitate the pharmaceutically-active compound to create a presuspension.
A method for preparing a suspension of a pharmaceutically-active compound, the solubility of which is greater in a water-miscible first organic solvent than in a second solvent which is aqueous, the process comprising the steps of:
- (i) adding a quantity of the pharmaceutically-active compound to the first organic solvent to create a supersaturated solution;
- (ii) treating the supersaturated solution to form a detectable crystal to create a seeding mixture;
- and
- (iii) mixing the seeding mixture with the second solvent to precipitate the pharmaceutically-active compound.
A composition of matter of a polymorphic pharmaceutically-active compound in a desired polymorphic form essentially free of an unspecified polymorphic form.
Dependencies are inferred from the claim text.