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
AssigneePfizer Inc.
InventorsAnthony Michael Campeta, Joseph Francis Krzyzaniak, Jason Albert Leonard
Life of this patent
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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 hyperlipidemia, hypercholesterolemia, osteoporosis, benign prostatic hyperplasia, and Alzheimer's Disease.
Claims15
An atorvastatin ammonium or hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuKα radiation:
- 7.8, 8.8, 9.3, 9.9, 10.6, 12.4, and 19.5.
(canceled)
(canceled)
A Form A atorvastatin benzathine or hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuKα radiation:
- 14.0 and 15.1.
A Form B atorvastatin benzathine or hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuKα radiation:
- 8.3, 10.2, 14.4, 15.8, 18.6, 21.8, and 23.3.
A Form C atorvastatin benzathine or hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuKα radiation:
- 3.9, 6.9, 7.9, 9.7, and 12.8.
(canceled)
(canceled)
An atorvastatin erbumine or hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuKα radiation:
- 5.4, 7.3, 9.5, 17.8, 19.2, 20.0, 22.2, and 24.2, or a solid state 19F nuclear magnetic resonance having the following chemical shifts expressed in parts per million:
- −110.4.
An atorvastatin L-lysine or hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuKα radiation:
- 6.7, 9.8, 17.1, and 24.0.
An atorvastatin morpholine or hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuKα radiation:
- 9.7, 16.0, 18.9, 19.6, 20.8, 22.1, 23.9, and 25.0, or a solid state 19F nuclear magnetic resonance having the following chemical shifts expressed in parts per million:
- −117.6.
An atorvastatin olamine or hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuKα radiation:
- 8.5, 9.8, 17.4, 18.6, 20.9, 22.5, and 24.1, or a solid state 19F nuclear magnetic resonance having the following chemical shifts measured in parts per million:
- −118.7.
An atorvastatin piperazine or hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuKα radiation:
- 7.8, 9.3, 11.8, 16.1, and 19.7.
An atorvastatin sodium or hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuKα radiation:
- 3.4, 4.9, 7.6, 8.0, 9.9, 18.9, and 19.7.
An atorvastatin 2-amino-2-methylpropan-1-ol or hydrate thereof having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuKα radiation:
- 4.2, 8.3, 16.0, 17.5, 18.3, 19.4, and 19.7, or a solid state 19F nuclear magnetic resonance having the following chemical shifts measured in parts per million:
- −113.6 and −116.5.
Dependencies are inferred from the claim text.