WO2008078341A3 - Stable pharmaceutical formulations of atorvastatin magnesium salt - Google Patents

Stable pharmaceutical formulations of atorvastatin magnesium salt Download PDF

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Publication number
WO2008078341A3
WO2008078341A3 PCT/IS2007/000024 IS2007000024W WO2008078341A3 WO 2008078341 A3 WO2008078341 A3 WO 2008078341A3 IS 2007000024 W IS2007000024 W IS 2007000024W WO 2008078341 A3 WO2008078341 A3 WO 2008078341A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical formulations
stable pharmaceutical
atorvastatin magnesium
magnesium salt
crystallised
Prior art date
Application number
PCT/IS2007/000024
Other languages
French (fr)
Other versions
WO2008078341A2 (en
Inventor
Fjalar Johannsson
Original Assignee
Actavis Group Hf
Fjalar Johannsson
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Actavis Group Hf, Fjalar Johannsson filed Critical Actavis Group Hf
Priority to EP07849693A priority Critical patent/EP2124899A2/en
Publication of WO2008078341A2 publication Critical patent/WO2008078341A2/en
Publication of WO2008078341A3 publication Critical patent/WO2008078341A3/en

Links

Classifications

    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • 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

Abstract

Stable pharmaceutical formulations are provided comprising atorvastatin magnesium as active ingredient. The atorvastatin magnesium is preferably in crystallised form, fully crystallised or partially crystallised. The crystallised material may comprise one or more polymorphic forms, which have characterised powder X-ray diffraction spectra.
PCT/IS2007/000024 2006-12-27 2007-12-21 Stable pharmaceutical formulations of atorvastatin magnesium salt WO2008078341A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP07849693A EP2124899A2 (en) 2006-12-27 2007-12-21 Stable pharmaceutical formulations of atorvastatin magnesium salt

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IS8587 2006-12-27
IS8587A IS8587A (en) 2006-12-27 2006-12-27 Atorvastatin pharmaceutical combination

Publications (2)

Publication Number Publication Date
WO2008078341A2 WO2008078341A2 (en) 2008-07-03
WO2008078341A3 true WO2008078341A3 (en) 2008-12-24

Family

ID=39473858

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IS2007/000024 WO2008078341A2 (en) 2006-12-27 2007-12-21 Stable pharmaceutical formulations of atorvastatin magnesium salt

Country Status (3)

Country Link
EP (1) EP2124899A2 (en)
IS (1) IS8587A (en)
WO (1) WO2008078341A2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2130819A3 (en) * 2008-04-10 2009-12-23 Ranbaxy Laboratories Limited Crystalline forms of atorvastatin magnesium

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1336405A1 (en) * 2002-02-14 2003-08-20 Ranbaxy Laboratories, Ltd. Formulations of atorvastatin stabilized with alkali metal additions
WO2006054308A2 (en) * 2004-11-22 2006-05-26 Dexcel Pharma Technologies Ltd. Stable atorvastatin formulations
WO2006070248A1 (en) * 2004-12-28 2006-07-06 Ranbaxy Laboratories Limited Methods for the preparation of stable pharmaceutical solid dosage forms of atorvastatin and amlodipine
WO2006117761A2 (en) * 2005-05-03 2006-11-09 Ranbaxy Laboratories Limited Magnesium salts of hmg-coa reductase inhibitors
WO2007063551A1 (en) * 2005-11-29 2007-06-07 Biocon Limited POLYMORPHS OF [R-(R*, R*)]-2-(4-FLUOROPHENYL)-β,δ-DIHYDROXY-5-(l-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-lH-PYRROLE-l-HEPTANOIC ACID MAGNESIUM SALT (2: 1)
WO2007118873A2 (en) * 2006-04-14 2007-10-25 Krka, Tovarna Zdravil, D.D., Novo Mesto Polymorphs of atorvastatin sodium and magnesium salts
WO2007132472A1 (en) * 2006-05-11 2007-11-22 Biocon Limited A crystalline form b4 of atorvastatin magnesium and a process thereof

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1336405A1 (en) * 2002-02-14 2003-08-20 Ranbaxy Laboratories, Ltd. Formulations of atorvastatin stabilized with alkali metal additions
WO2006054308A2 (en) * 2004-11-22 2006-05-26 Dexcel Pharma Technologies Ltd. Stable atorvastatin formulations
WO2006070248A1 (en) * 2004-12-28 2006-07-06 Ranbaxy Laboratories Limited Methods for the preparation of stable pharmaceutical solid dosage forms of atorvastatin and amlodipine
WO2006117761A2 (en) * 2005-05-03 2006-11-09 Ranbaxy Laboratories Limited Magnesium salts of hmg-coa reductase inhibitors
WO2007063551A1 (en) * 2005-11-29 2007-06-07 Biocon Limited POLYMORPHS OF [R-(R*, R*)]-2-(4-FLUOROPHENYL)-β,δ-DIHYDROXY-5-(l-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-lH-PYRROLE-l-HEPTANOIC ACID MAGNESIUM SALT (2: 1)
WO2007118873A2 (en) * 2006-04-14 2007-10-25 Krka, Tovarna Zdravil, D.D., Novo Mesto Polymorphs of atorvastatin sodium and magnesium salts
WO2007132472A1 (en) * 2006-05-11 2007-11-22 Biocon Limited A crystalline form b4 of atorvastatin magnesium and a process thereof

Also Published As

Publication number Publication date
EP2124899A2 (en) 2009-12-02
IS8587A (en) 2008-06-28
WO2008078341A2 (en) 2008-07-03

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