NOVEL CRYSTALLINE FORM OF AMLODIPINE NICOTINATE AND ITS PREPARATION METHOD

摘要

PURPOSE: A new crystalline form of amlodipine nicotinate and a manufacturing method thereof are provided to improve the solubility of the conventional amlodipine nicotinate for using as a pharmaceutical composition. CONSTITUTION: A new crystalline form of amlodipine nicotinate is defined as a powder X-ray diffraction pattern showing the peak at the diffraction angle of (2-Theta)8.6 and 13.0+/-0.1. The crystalline form of the amlodipine nicotinate is an anhydrous form of S-(-)- amlodipine nicotinate. The crystalline form is manufactured by crystallizing the amlodipine nicotinate with a THF solvent. The THF solvent is a mixed solvent of THF and an inactive organic solvent. A pharmaceutical composition including the crystalline form of the amlodipine nicotinate includes the crystalline form more than 90% of crystal purity.