WO2001044180 A FACTORY SCALE PROCESS FOR PRODUCING CRYSTALLINE ATORVASTATIN TRIHYDRATE HEMI CALCIUM SALT

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Publication Number WO/2001/044180

Publication Date 21.06.2001

International Application No. PCT/IE2000/000150

International Filing Date 18.12.2000

Chapter 2 Demand Filed 13.06.2001

IPC

CPC

Applicants

WARNER LAMBERT RESEARCH AND DEVELOPMENT IRELAND LIMITED [IE]/[IE] (AllExceptUS)
TULLY, William [IE]/[IE] (UsOnly)

Inventors

TULLY, William

Agents

O'BRIEN, John, A.

Priority Data

PCT/IE99/00132

17.12.1999

Publication Language English (en)

Filing Language English (EN)

Designated States

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Title

(EN) A FACTORY SCALE PROCESS FOR PRODUCING CRYSTALLINE ATORVASTATIN TRIHYDRATE HEMI CALCIUM SALT

(FR) PROCEDE DE PRODUCTION A L'ECHELLE INDUSTRIELLE DE SEL D'HEMI-CALCIUM TRIHYDRATE D'ATORVASTATINE CRISTALLISE

Abstract

(EN) A factory scale process for producing crystalline atorvastatin trihydrate hemi calcium salt includes the addition of extra methyl tert-butyl ether to the reaction mixture to supersaturate the crystallisation matrix. A seed slurry is made up in a make-up/delivery vessel and delivered, under pressure, to the reaction mixture. The process produces crystalline atorvastatin calcium, having structure (I) within a consistent size range on a factory scale.

(FR) La présente invention concerne un procédé de production à l'échelle industrielle de sel d'hémi-calcium trihydraté d'atorvastatine cristallisé, comprenant l'adjonction de méthyl tert-butyl éther supplémentaire au mélange réactionnel pour sursaturer la matrice de cristallisation. Une suspension de germe est préparée dans un récipient de préparation et de distribution, puis ajoutée, sous pression, au mélange réactionnel. Le procédé permet d'obtenir du calcium d'atorvastatine cristallisé, de structure (I), à grande échelle industrielle.

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
D	HETEROCYCLIC COMPOUNDS
207	Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
02	with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
30	having two double bonds between ring members or between ring members and non-ring members
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

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
D	HETEROCYCLIC COMPOUNDS
207	Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
02	with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
30	having two double bonds between ring members or between ring members and non-ring members
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

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
D	HETEROCYCLIC COMPOUNDS
207	Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
02	with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
30	having two double bonds between ring members or between ring members and non-ring members
34	with heteroatoms 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

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
D	HETEROCYCLIC COMPOUNDS
405	Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom
02	containing two hetero rings
06	linked by a carbon chain containing only aliphatic carbon atoms

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
D	HETEROCYCLIC COMPOUNDS
207	Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
02	with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
30	having two double bonds between ring members or between ring members and non-ring members
34	with heteroatoms 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

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1. WO2001044180 - A FACTORY SCALE PROCESS FOR PRODUCING CRYSTALLINE ATORVASTATIN TRIHYDRATE HEMI CALCIUM SALT