# US 7,411,075 B1 · Polymorphic form of atorvastatin calcium

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- Number: US 7,411,075 B1
- Document ID: US7411075B1
- Status: Granted
- Kind: B1
- Application number: 09/714,351
- Filed: 2000-11-16
- Granted: 2008-08-12
- Earliest claimed: 2000-11-16
- Assignees: Teva Pharmaceutical Industries Ltd.
- Inventors: Ari Ayalon; Michal Levinger; Sofia Roytblat; Valerie Niddam; Revital Lifshitz; Judith Aronhime
- Web page: https://patentgrep.com/patent/US7411075B1

## CPC

- C07D 207/34: with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)

## Abstract

The present invention relates to atorvastatin calcium, a useful agent for lowering serum cholesterol levels. New atorvastatin calcium Form V, processes for preparing the new form, and pharmaceutical compositions and dosage forms containing the new form are disclosed.

## Claims

### Claim 1

Atorvastatin calcium Form V having an X-ray powder diffractogram substantially as depicted in FIG. 1.

### Claim 2

Atorvastatin calcium Form V characterized by X-ray powder diffraction peaks at 5.3±0.2 and 8.3±0.2 degrees 2θ and a broad peak at 18-23±0.2 degrees 2θ with a maximum at 18.3±0.2 degrees 2θ.

### Claim 3

Atorvastatin calcium Form V having a solid state 13C NMR spectrum substantially as depicted in FIG. 2.

### Claim 4

Atorvastatin calcium Form V characterized by solid state 13C NMR signals at 21.9, 25.9, 118.9, 122.5, 128.7, 161.0 and 167.1 ppm.

### Claim 5

Atorvastatin calcium Form V characterized by X-ray powder diffraction peaks at 5.3±0.2 and 8.3±0.2 degrees 2θ and solid state 13C NMR signals at 21.9, 25.9, 118.9, 122.5, 128.7, 161.0 and 167.1 ppm.

### Claim 6 (depends on 1, 3, 4, 5)

Atorvastatin calcium Form V according to any one of claims 1, 3, 4 or 5 produced by a process comprising the steps of
a) dissolving a metal, ammonium or alkylammonium salt of atorvastatin in a solvent to form an atorvastatin salt solution,
b) contacting the atorvastatin salt solution with a calcium salt, and
c) isolating atorvastatin calcium Form V.