SAXAGLIPTIN CRYSTALLINE FORM AND METHOD FOR PRODUCING THE SAME

摘要

PROBLEM TO BE SOLVED: To provide a polymorphism crystalline structure of saxagliptin which is a reversible dipeptidyl peptidase-4 (DPP4) inhibitor, a pharmaceutical composition thereof, a method for producing said crystalline structure, and a method for treating disorders such as diabetes using the same.SOLUTION: A pharmaceutical composition containing a structure of substantially pure form of saxagliptin, or its free base monohydrate (H-1 type) and its hydrochloride, HBr salt, HI salt, ammonium sulfate, benzoate, tartrate, fumarate, trifluoroacetate and so on. Also, a method for producing the same, an intermediate used in producing the same, and a method for treating diseases such as diabetes using said structure are provided.