Abstract: New polymorphic forms of pravastatin sodium are provided. Each of the new forms is selectively obtained by crystallization from different solvent systems, each solvent system having a protic component, and by controlling the rate of crystallization through temperature. The new polymorphic forms are suitable for use as active substances of pharmaceutical dosage forms for reduction of serum cholesterol levels in the bloodstream.
Type:
Grant
Filed:
December 14, 2000
Date of Patent:
February 21, 2006
Assignee:
Teva Gyogyszergyar Reszvenytarsasag
Inventors:
Vilmos Keri, Csaba Szabo, Edit Nagyne Arvai, Judith Aronhime
Abstract: The present invention provides pravastatin sodium substantially free of pravastatin lactone and epiprava, the C-6 epimer of pravastatin. The present invention further provides a novel process for recovering pravastatin sodium from a fermentation broth in such high purity. The process includes the stages of forming an solution of the compound by extraction, obtaining an ammonium salt of pravastatin from the solution, purifying the ammonium salt of the compound and transposing the salt of the compound to pravastatin sodium.
Type:
Grant
Filed:
October 5, 2001
Date of Patent:
August 30, 2005
Assignee:
TEVA Gyógyszergyár Részvénytársaság
Inventors:
Vilmos Keri, Lajos Deak, Ilona Forgacs, Csaba Szabo, Arvai Edit Nagyne
Abstract: A process for the production of N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide (zaleplon) that involves reacting N-[3-[3-(dimethylamino)-1-oxo-2-propenyl]phenyl]-N-ethylacetamide or a salt thereof with 3-amino-4-cyanopyrazole or a salt thereof under acidic conditions in a reaction medium comprising a mixture of water and a water-miscible organic compound produces zaleplon in high yield and high purity. A regioisomer of zaleplon (N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-5-yl)phenyl]-N-ethylacetamide) is useful as a reference standard for monitoring the composition of production batches of zaleplon.
Type:
Grant
Filed:
June 12, 2002
Date of Patent:
April 26, 2005
Assignee:
Teva Gyogyszergyar Reszvenytarsasag
Inventors:
Ferenc Korodi, Erika Feher, Erika Magyar