Atorvastatin hemi-calcium form VII
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsJudith Aronhime, Ramy Lidor-Hadas, Valerie Niddam, Revital Lifshitz
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Abstract
The present invention provides a novel form of atorvastatin hemi-calcium designated Form VII and novel processes for its preparation whereby another crystalline form of atorvastatin hemi-calcium is suspended in ethanol, preferably absolute ethanol, and is converted to the new form, which is then isolated. The present invention further provides a method of reducing the plasma low density lipoprotein level in patients suffering from or susceptible to hypercholesterolemia and compositions and dosage forms for practicing the invention.
Claims17
Atorvastatin hemi-calcium Form VII or a hydrate thereof having a powder X-ray diffraction pattern substantially as depicted in FIG. 1.
Atorvastatin hemi-calcium Form VII or a hydrate thereof characterized by a powder X-ray diffraction pattern having broad peaks in the range of 18.5-21.8 and 21.8-25.0 degrees two-theta.
A process for preparing atorvastatin hemi-calcium Form VII comprising the steps of:
- a) suspending atorvastatin hemi-calcium in ethanol for a period of time sufficient to convert it into Form VII and
- b) recovering Form VII from the suspension.
Dependencies are inferred from the claim text.