PRODUCTION OF AGGLOMERATES OF INOGATRAN AND THE COMPOUND INOGATRAN ANHYDRATE

摘要

The invention relates to a process for producing compact, spherical agglomerates of inogatran having a narrow size distribution and to the compound inogatran anhydrate. The process comprises the following consecutive steps: dissolving inogatran in one of its stable, hygroscopic, hydrate forms in a mixture of a good solvent for inogatran (L1) and a poor solvent for inogatran (L3) to form a concentrated solution; optionally filtering the solution; concentrating the concentrated solution further; adding a non-solvent for inogatran (L2) to obtain supersaturation; adding further (L2) when nucleation has started.