Polymorphic form of (-)-cibenzoline succinate
AssigneeCelltrion Inc.
InventorSander Brugman
Life of this patent
Estimating the term…
Abstract
The present invention relates to a crystalline form of (−)-cibenzoline succinate. The present invention also provides a process for preparing (−)-cibenzoline succinate and crystalline form thereof. The crystalline form of (−)-cibenzoline succinate according to the present invention has low hygroscopicity, and excellent stability under accelerated conditions and long-term storage conditions, and may be stably maintained without a change in content thereof for a long period of time.
Claims14
A crystalline form of (−)-cibenzoline succinate having an X-ray powder diffraction pattern (XRPD) selected from the group consisting of:
- i) a crystalline form 1 having an X-ray powder diffraction spectrum comprising diffraction peaks at 9.7°, 14.9°, 21.5°, 23.4° and 24.1° (2θ±0.2°);
- ii) a crystalline form 2 having an X-ray powder diffraction spectrum comprising diffraction peaks at 20.6°, 21.1°, 22.9°, 25.2° and 37.4° (2θ±0.2°);
- and
- iii) a crystalline form 3 having an X-ray powder diffraction spectrum comprising diffraction peaks at 13.0°, 14.8°, 23.3°, 25.5° and 26.1° (2θ±0.2°).
A crystalline form of (−)-cibenzoline succinate comprising a triclinic crystal system and has a space group of P1.
A process for preparing crystalline form 3 of (−)-cibenzoline succinate, comprising:
- forming a solution utilizing a polar solvent to dissolve (−)-cibenzoline succinate represented by Formula (IA)
- and
- precipitating crystalline form 3 of (−)-cibenzoline succinate by adding a hydrocarbon solvent having 6 or more carbon atoms to the solution.
Dependencies are inferred from the claim text.