Patent EA-005317-B1 (EA)
Title: Crystalline forms of [r-(r(, r()]-2-(4fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)3-phenyl-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid calcium salt (2:1) (atorvastatin)
Inventor: BYRN STEPHEN ROBERT
IPC: A61P25/28
Filed: 2002-05-21
Abstract: 1. A crystalline Form V atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa a radiation: 4.9 (broad), 6.0, 7.0, 8.0 (broad), 8.6, 9.9, 16.6, 19.0, and 21.1. 2. A crystalline Form VI atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 7.2, 8.3, 11.0, 12.4, 13.8, 16.8, 18.5, 19.7 (broad), 20.9, and 25.0. 3. A crystalline Form VII atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 8.6, 10.2, 12.4 (broad), 12.8 (broad), 17.6, 18.3 (broad), 19.3, 22.2 (broad), 23.4 (broad), 23.8 (broad), and 25.5 (broad). 4. A crystalline Form VIII atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 7.5, 9.2, 10.0, 12.1, 12.8, 13.8, 15.1, 16.7 (broad), 18.6 (broad), 20.3 (broad), 21.2, 21.9, 22.4, 25.8, 26.5, 27.4 (broad), and 30.5. 5. A crystalline Form IX atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 8.8, 9.4 (broad), 11.2-11.7 (broad), 16.7, 17.5 (broad), 19.3 (broad), 21.4 (broad), 22.4 (broad), 23.2 (broad), and 29.0 (broad). 6. A crystalline Form X atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 4.7, 5.2, 5.8, 6.9, 7.9, 9.2, 9.5, 10.3 (broad), 11.8, 16.1, 16.9, 19.1, 19.8, 21.4, 22.3 (broad), 23.7 (broad), 24.4, and 28.7. 7. A crystalline Form XI atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 10.8 (broad), 12.0, 13.5, 16.5, 17.6-18.0 (broad), 19.7, 22.3, 23.2, 24.4, 25.8, 26.5, 27.3, 28.7, 29.5, 30.9 (broad), 32.8 (broad), 33.6 (broad), 36.0 (broad), and 38.5 (broad). 8. A crystalline Form XII atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 5.4, 7.7, 8.0, 8.6, 8.9, 9.9, 10.4 (broad), 12.5, 13.9 (broad), 16.2, 17.8, 19.4, 20.8, 21.7, 22.4-22.6 (broad), 24.3, 25.5, 26.2, and 27.1. 9. A crystalline Form XIII atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 8.4, 8.9, 15.7 (broad), 16.4 (broad), 17.6 (broad), 18.1 (broad), 19.7 (broad), 20.8 (broad), and 23.8 (broad). 10. A crystalline Form XIV atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 5.4, 6.7, 7.7, 8.1, 9.0, 16.5 (broad), 17.6 (broad), 18.0-18.7 (broad), and 19.5 (broad). 11. A crystalline Form XV atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 5.7, 6.1, 6.8, 7.5, 8.1, 8.5, 9.5, 10.5 (broad), and 19.1-19.6 (broad). 12. A crystalline Form XVI atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 5.2, 6.4, 7.5, 8.7, 10.5 (broad), 12.0 (broad), 12.7 (broad), 16.7, 18.3 (broad), 19.5, 20.1-20.4 (broad), 21.2-21.9 (broad), 22.9-23.3 (broad), and 24.4-25.0 (broad). 13. A crystalline Form XVII atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 5.0, 6.1, 7.3, 7.9, 8.5, 9.1, 10.0, 12.1 (broad), 14.8, 16.0-16.5 (broad), 17.5 (broad), 19.0 (broad), 19.5, 20.2 (broad), 21.3, 21.6, and 22.0. 14. A crystalline Form XVIII atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 8.0, 9.2 (broad), 9.7 (broad), 12.1, 16.6 (broad), and 18.5. 15. A crystalline Form XIX atorvastatin or a hydrate thereof having an X-ray powder diffraction containing the following 2theta values measured using CuKa radiation: 5.2, 6.3, 7.0, 8.6, 10.5, 11.6 (broad), 12.7 (broad), 14.0, 16.7 (broad), 18.9, 20.8, 23.6 (broad), and 25.5 (broad).