IP Library › Granted Patent US 8,236,966
Granted Patent B2
US 8,236,966 · App. 12/966,488 · Granted Aug 7, 2012

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

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Quick Facts
Patent No.
US 8,236,966
App. No.
12/966,488
Granted
Aug 7, 2012
Kind
B2
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.

Claims (8)

1. A Form A atorvastatin benethamine having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuK α radiation: 4.7, 5.3, 9.5, 12.0, 15.6, 18.1, and 19.9, or a solid state 19 F nuclear magnetic resonance having the following chemical shifts expressed in parts per million: −113.2 and −114.2.

2. A Form B atorvastatin benethamine having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuK α radiation: 5.0, 7.1, 8.4, 10.0, 11.6, 12.6, 14.8, and 20.2, or a solid state 19 F nuclear magnetic resonance having the following chemical shifts expressed in parts per million: −113.7 and −114.4.

3. A Form A atorvastatin benethamine characterized by solid state 13 C nuclear magnetic resonance having the following chemical shifts expressed in parts per million: 180.1, 178.8, 165.1, 164.1, 161.7, 160.7, 26.5, 25.1, 23.5, 23.1, 19.7, and 19.1.

4. A Form A atorvastatin benethamine characterized by solid state 13 C nuclear magnetic resonance having the following chemical shifts expressed in parts per million: 180.1, 178.8, 165.1, 164.1, 162.8, 161.7, 160.7, 140.6, 139.6, 137.9, 136.1, 133.0, 129.6, 127.3, 126.4, 125.4, 123.1, 122.5, 121.6, 121.1, 119.9, 116.4, 115.4, 114.5, 114.0, 66.0, 65.5, 64.6, 53.6, 51.5, 51.0, 47.8, 44.6, 43.3, 41.4, 40.9, 38.5, 37.7, 36.8, 34.0, 32.7, 26.5, 25.1, 23.5, 23.1, 19.7, and 19.1.

5. A Form B atorvastatin benethamine characterized by solid state 13 C nuclear magnetic resonance having the following chemical shifts expressed in parts per million: 179.4, 165.6, 26.5, 23.5, and 19.6.

6. A Form B atorvastatin benethamine characterized by solid state 13 C nuclear magnetic resonance having the following chemical shifts expressed in parts per million: 179.4, 165.6, 162.4, 140.1, 138.6, 133.6, 132.8, 129.9, 128.2, 125.7, 123.6, 114.8, 69.6, 69.0, 52.3, 49.8, 43.1, 42.2, 39.6, 38.9, 31.5, 26.5, 23.5, and 19.6.

7. A Form A atorvastatin benethamine having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuK α radiation: 4.7, 5.3, 6.0, 7.8, 8.9, 9.5, 10.5, 12.0, 13.8, 14.3, 15.6, 16.7, 16.9, 17.6, 17.8, 18.1, 18.8, 19.1, 19.9, 21.3, 21.9, 22.7, 23.6, 24.3, 25.9, 26.3, 27.0, 27.9, 28.8, and 29.6.

8. A Form B atorvastatin benethamine having an x-ray powder diffraction pattern containing the following 2θ peaks measured using CuK α radiation: 4.1, 5.0, 5.8, 7.1, 8.4, 8.9, 10.0, 11.6, 12.6, 14.4, 14.8, 16.5, 17.7, 18.6, 20.2, 21.4, 21.6, 22.3, 22.7, 23.4, 23.6, 25.0, 25.2, 25.9, 26.2, 28.0, 28.3, 29.3, 29.7, 31.8, 33.5, 35.2, and 35.8.

Assignments (2)
CHANGE OF NAME Recorded Oct 31, 2022
From: UPJOHN US 1 LLC
To: VIATRIS SPECIALTY LLC.
Reel/Frame 061808/0420 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2020
From: PFIZER INC.
To: UPJOHN US 1 LLC
Reel/Frame 054293/0154 →