Solid dispersion comprising an orexin receptor antagonist
AssigneeSandoz Ltd.
InventorsVerena Adamer, Andreas Krekeler, Michael Sedlmayr
Life of this patent
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Abstract
A solid dispersion comprising suvorexant or a salt thereof in amorphous form and at least one pharmaceutically acceptable matrix compound, wherein the matrix compound is (i) a polymer and wherein the solid dispersion contains the suvorexant or salt thereof in an 5 amount of at least 50 weight-% based on the combined weight of the suvorexant or salt thereof and the at least one matrix compound, or (ii) a silicon-based inorganic adsorbent.
Claims17
A solid dispersion comprising suvorexant ([(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone) or a salt thereof in amorphous form and at least one pharmaceutically acceptable matrix compound,
- wherein the at least one matrix compound is
- (i) a polymer and wherein the solid dispersion contains the suvorexant or salt thereof in an amount of at least 50 weight-% based on the combined weight of the suvorexant or salt thereof and the at least one matrix compound, or
- (ii) a silicon-based inorganic adsorbent.
A process for preparing a solid dispersion comprising suvorexant or a salt thereof in amorphous form and at least one pharmaceutically acceptable matrix compound, the process comprising
- (a) providing suvorexant or a salt thereof
- (b) dissolving or dispersing suvorexant provided in (a) and the at least one matrix compound in a solvent to form a mixture
- (c) removing at least part-of the solvent
- to give the solid dispersion, and wherein the matrix compound is
- (i) a polymer and wherein the solid dispersion contains the suvorexant or salt thereof in an amount of at least 50 weight-% based on the combined weight of the suvorexant or salt thereof and the at least one matrix compound, or a silicon-based inorganic adsorbent.
A process for the preparation of suvorexant of which at least 95 weight-%-are present in its amorphous form, comprising
- (a1) providing suvorexant of which at least 95 weight-% are present in at least one crystalline form;
- (a2) dissolving at least a portion of the suvorexant provided according to (a1) in at least one solvent, obtaining a solution comprising the suvorexant;
- (a3) subjecting at least a portion of the solution obtained according to (a2), optionally after concentrating, to rapid-drying, obtaining the suvorexant of which at least 95 weight-% are present in its amorphous form.
Dependencies are inferred from the claim text.