CA2429590A1 - Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms - Google Patents

Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms Download PDF

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Publication number
CA2429590A1
CA2429590A1 CA002429590A CA2429590A CA2429590A1 CA 2429590 A1 CA2429590 A1 CA 2429590A1 CA 002429590 A CA002429590 A CA 002429590A CA 2429590 A CA2429590 A CA 2429590A CA 2429590 A1 CA2429590 A1 CA 2429590A1
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CA
Canada
Prior art keywords
processes
forms
novel
preparation
preparing
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CA002429590A
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French (fr)
Other versions
CA2429590C (en
Inventor
Judith Aronhime
Ramy Lidor-Hadas
Valerie Niddam
Revital Lifshitz
Eti Ishai
Guy Sambursky
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Teva Pharmaceutical Industries Ltd
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Individual
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Application filed by Individual filed Critical Individual
Priority to CA002625277A priority Critical patent/CA2625277A1/en
Publication of CA2429590A1 publication Critical patent/CA2429590A1/en
Application granted granted Critical
Publication of CA2429590C publication Critical patent/CA2429590C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D207/00—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D207/02—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D207/30—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
    • C07D207/34—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D405/00—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
    • C07D405/02—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 containing two hetero rings
    • C07D405/06—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 containing two hetero rings linked by a carbon chain containing only aliphatic carbon atoms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds

Abstract

The present invention provides novel forms of atorvastatin designated Forms VI, VIII, IX, X, XI and XII and novel processes for their preparation as well as processes for preparing atorvastatin Forms, I, II, IV, V and amorphous atorvastatin.
CA002429590A 2000-11-30 2001-11-29 Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms Expired - Fee Related CA2429590C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA002625277A CA2625277A1 (en) 2000-11-30 2001-11-29 Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US25007200P 2000-11-30 2000-11-30
US60/250,072 2000-11-30
US26789701P 2001-02-09 2001-02-09
US60/267,897 2001-02-09
US28187201P 2001-04-05 2001-04-05
US60/281,872 2001-04-05
US31214401P 2001-08-13 2001-08-13
US60/312,144 2001-08-13
US32652901P 2001-10-01 2001-10-01
US60/326,529 2001-10-01
PCT/US2001/044636 WO2002043732A1 (en) 2000-11-30 2001-11-29 Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA002625277A Division CA2625277A1 (en) 2000-11-30 2001-11-29 Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms

Publications (2)

Publication Number Publication Date
CA2429590A1 true CA2429590A1 (en) 2002-06-06
CA2429590C CA2429590C (en) 2008-06-10

Family

ID=27540285

Family Applications (3)

Application Number Title Priority Date Filing Date
CA2689915A Abandoned CA2689915A1 (en) 2000-11-30 2001-11-29 Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms
CA002429590A Expired - Fee Related CA2429590C (en) 2000-11-30 2001-11-29 Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms
CA002625277A Abandoned CA2625277A1 (en) 2000-11-30 2001-11-29 Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2689915A Abandoned CA2689915A1 (en) 2000-11-30 2001-11-29 Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA002625277A Abandoned CA2625277A1 (en) 2000-11-30 2001-11-29 Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms

Country Status (23)

Country Link
US (15) US20020183378A1 (en)
EP (5) EP2194041A1 (en)
JP (2) JP2004514694A (en)
KR (1) KR100765871B1 (en)
CN (1) CN1489463A (en)
AU (1) AU2002217927A1 (en)
BG (1) BG107856A (en)
BR (1) BR0115892A (en)
CA (3) CA2689915A1 (en)
CZ (1) CZ20031766A3 (en)
DE (1) DE01998348T1 (en)
ES (2) ES2215495T1 (en)
HR (2) HRP20030523A2 (en)
HU (1) HUP0600538A3 (en)
IL (2) IL156055A0 (en)
IS (1) IS6829A (en)
MX (1) MXPA03004844A (en)
NO (1) NO20032425L (en)
PL (1) PL363228A1 (en)
SK (1) SK8062003A3 (en)
TR (1) TR200400815T3 (en)
WO (1) WO2002043732A1 (en)
YU (1) YU42803A (en)

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