Salt forms of [R-(R*,R*)]-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid

Abstract

Novel salt forms of [R—(R*,R*)]-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid characterized by their X-ray powder diffraction pattern and solid-state NMR spectra are described, as well as methods for the preparation and pharmaceutical composition of the same, which are useful as agents for treating hypedlipidemia, hypercholesterolemia, osteoporosis, benign prostatic hyperplasia, and Alzheimer's Disease.

1 . A crystalline form of atorvastatin sodium or a hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peak measured using CuK α  radiation: 8.0. 
     
     
         2 . A crystalline form of atorvastatin sodium or a hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peak measured using CuK α  radiation: 9.9. 
     
     
         3 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 1 , wherein said x-ray powder diffraction pattern also contains the following 2θ peak measured using CuK α  radiation: 9.9. 
     
     
         4 . A crystalline form of atorvastatin sodium or a hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peak measured using CuK α  is radiation: 19.7. 
     
     
         5 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 1 , wherein said x-ray powder diffraction pattern also contains the following 2θ peak measured using CuK α  radiation: 19.7. 
     
     
         6 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 2 , wherein said x-ray powder diffraction pattern also contains the following 2θ peak measured using CuK α  radiation: 19.7. 
     
     
         7 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 3 , wherein said x-ray powder diffraction pattern also contains the following 2θ peak measured using CuK α  radiation: 19.7. 
     
     
         8 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 1 , wherein said x-ray powder diffraction pattern also contains at least one of the following 2θ peaks measured using CuK α  radiation: 3.4, 4.9, 7.6 and 18.9. 
     
     
         9 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 2 , wherein said x-ray powder diffraction pattern also contains at least one of the following 2θ peaks measured using CuK α  radiation: 3.4, 4.9, 7.6 and 18.9. 
     
     
         10 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 3 , wherein said x-ray powder diffraction pattern also contains at least one of the following 2θ peaks measured using CuK α  radiation: 3.4, 4.9, 7.6 and 18.9. 
     
     
         11 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 4 , wherein said x-ray powder diffraction pattern also contains at least one of the following 2θ peaks measured using CuK α  radiation: 3.4, 4.9, 7.6 and 18.9. 
     
     
         12 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 5 , wherein said x-ray powder diffraction pattern also contains at least one of the following 2θ peaks measured using CuK α  radiation; 3.4, 4.9, 7.6 and 18.9. 
     
     
         13 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 6 , wherein said x-ray powder diffraction pattern also contains at least one of the following 2θ peaks measured using CuK α  radiation; 3.4, 4.9, 7.6 and 18.9. 
     
     
         14 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 1 , wherein said x-ray powder diffraction pattern also contains the following 2θ peaks measured using CuK α  radiation; 3.4, 4.9, 7.6, 9.9, 18.9 and 19.7. 
     
     
         15 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 1 , wherein said x-ray powder diffraction pattern also contains the following 2θ 1 peaks measured using CuK α  radiation, 3.4, 4.1, 4.9, 5.6, 6.8, 7.6, 8.5, 9.9, 10.4, 12.8, 18.9, 19.7, 21.2, 22.1, 22.9, 23.3, 24.0 and 25.2. 
     
     
         16 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 1 , wherein said x-ray powder diffraction pattern also contains the following 2θ peak measured using CuK α  radiation; 18.9. 
     
     
         17 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 2 , wherein said x-ray powder diffraction pattern also contains the following 2θ peak measured using CuK α  radiation, 18.9. 
     
     
         18 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 3 , wherein said x-ray powder diffraction pattern also contains the following 2θ peak measured using CuK α  radiation: 18.9. 
     
     
         19 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 7 , wherein said x-ray powder diffraction pattern also contains the following 2θ peak measured using CuK α  radiation; 18.9. 
     
     
         20 . A crystalline form of atorvastatin sodium or a hydrate thereof according to  claim 7 , wherein said x-ray powder diffraction pattern also contains the following 2θ peaks measured using CuK α  radiation: 7.6 and 18.9.