WO2009056288A3 - Stabilized statins - Google Patents

Stabilized statins Download PDF

Info

Publication number
WO2009056288A3
WO2009056288A3 PCT/EP2008/009123 EP2008009123W WO2009056288A3 WO 2009056288 A3 WO2009056288 A3 WO 2009056288A3 EP 2008009123 W EP2008009123 W EP 2008009123W WO 2009056288 A3 WO2009056288 A3 WO 2009056288A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutically acceptable
stabilized
statins
pharmaceutical composition
rosuvastatin
Prior art date
Application number
PCT/EP2008/009123
Other languages
German (de)
French (fr)
Other versions
WO2009056288A2 (en
Inventor
Renz Jessica
Thomas Rillmann
Christof Schumann
Original Assignee
Stada Arzneimittel Ag
Renz Jessica
Thomas Rillmann
Christof Schumann
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 Stada Arzneimittel Ag, Renz Jessica, Thomas Rillmann, Christof Schumann filed Critical Stada Arzneimittel Ag
Priority to EP08843504A priority Critical patent/EP2214648A2/en
Publication of WO2009056288A2 publication Critical patent/WO2009056288A2/en
Publication of WO2009056288A3 publication Critical patent/WO2009056288A3/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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Abstract

Disclosed is a pharmaceutical composition comprising a mixture of a basic granulate made of at least one pharmaceutically acceptable adjuvant, atorvastatin or rosuvastatin or pharmaceutically acceptable salts thereof, and other optional pharmaceutically acceptable adjuvants. Said pharmaceutical composition is characterized, inter alia, in that the active substance contained therein is stabilized in an amorphous or metastable crystalline form.
PCT/EP2008/009123 2007-10-30 2008-10-29 Stabilized statins WO2009056288A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP08843504A EP2214648A2 (en) 2007-10-30 2008-10-29 Stabilized statins

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102007052071.0 2007-10-30
DE200710052071 DE102007052071A1 (en) 2007-10-30 2007-10-30 Stabilized atorvastatin

Publications (2)

Publication Number Publication Date
WO2009056288A2 WO2009056288A2 (en) 2009-05-07
WO2009056288A3 true WO2009056288A3 (en) 2009-06-18

Family

ID=40427352

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2008/009123 WO2009056288A2 (en) 2007-10-30 2008-10-29 Stabilized statins

Country Status (3)

Country Link
EP (1) EP2214648A2 (en)
DE (1) DE102007052071A1 (en)
WO (1) WO2009056288A2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7316345B2 (en) 2020-11-30 2023-07-27 財團法人工業技術研究院 anti curling film

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004071402A2 (en) * 2003-02-12 2004-08-26 Lek Pharmaceuticals D.D. STABLE PHARMACEUTICAL DOSAGE FORM COMPRISING HMG-CoA REDUCTASE INHIBITOR
WO2004110409A1 (en) * 2003-06-12 2004-12-23 Warner-Lambert Company Llc Pharmaceutical compositions comprising atorvastatin manufactured without granulation
EP1532975A1 (en) * 2003-11-18 2005-05-25 Helm AG Process for the manufacture of free-flowing, powdery atorvastatin adsorbates
WO2005084670A1 (en) * 2004-03-01 2005-09-15 Lek Pharmaceuticals D.D. Pharmaceutical formulation

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE178794T1 (en) 1993-01-19 1999-04-15 Warner Lambert Co STABILIZED ORAL COMPOSITION CONTAINING THE COMPOUND CI-981 AND METHOD
PT1148049E (en) 1995-07-17 2005-02-28 Warner Lambert Co [R- (R *, R *)] - 2- (4-FLUOROPHENYL) -BETA, DELTA-DIHYDROXY-5- (1-METHYLETHYL) -3-PHENYL-4-PHARMACEUTICAL CRYSTALLINES OF CALCIUM HEMI- [(PHENYLAMINO) -CARBONYL) -1H-PYRROLE-1-HEPTANOIC ACID (ATORVASTATIN)
HRP960313B1 (en) 1995-07-17 2002-08-31 Warner Lambert Co Form iii crystalline (r- (r*, r*)-2- (4-fluorophenyl) -beta-delta-hydroxy-5-(1-methylethyl) -3-phenyl-4- ((phenylamino) carbonyl -1h-pyrrole-1-heptanoic acid calcium salt (2:1)
SI20109A (en) 1998-12-16 2000-06-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. Stable pharmaceutical formulation
BR0009557A (en) * 1999-04-06 2002-05-28 Ethypharm Lab Prod Ethiques Pharmaceutical suspension for ibuprofen drinking
AU2000249434B2 (en) 2000-06-09 2006-02-02 Lek Pharmaceuticals D.D. Stabilized pharmaceutically effective composition and pharmaceutical formulation comprising the same
CA2450111C (en) 2001-06-29 2006-02-07 Warner-Lambert Company Llc Crystalline forms of [r-(r*,r*)]-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid calcium salt(2:1)(atorvastatin)
US20080242725A1 (en) * 2004-03-01 2008-10-02 Janez Kerc Pharmaceutical Composition
JP2008506764A (en) 2004-07-20 2008-03-06 ワーナー−ランバート カンパニー リミテッド ライアビリティー カンパニー [R- (R *, R *)]-2- (4-fluorophenyl) -β, δ-dihydroxy-5- (1-methylethyl) -3-phenyl-4-[(phenylamino) carbonyl]- Novel form of 1H-pyrrole-1-heptanoic acid calcium salt (2: 1)
US20080305158A1 (en) * 2004-12-28 2008-12-11 Ranbaxy Laboratories Limited Methods For the Preparation of Stable Pharmaceutical Solid Dosage Forms of Atorvastatin and Amlodipine
MY149865A (en) 2006-03-10 2013-10-31 Stc Unm Pulsed growth of gan nanowires and applications in group iii nitride semiconductor substrate materials and devices
WO2008048705A2 (en) 2006-03-10 2008-04-24 Goodrich Corporation Low density lightning strike protection for use in airplanes

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004071402A2 (en) * 2003-02-12 2004-08-26 Lek Pharmaceuticals D.D. STABLE PHARMACEUTICAL DOSAGE FORM COMPRISING HMG-CoA REDUCTASE INHIBITOR
WO2004110409A1 (en) * 2003-06-12 2004-12-23 Warner-Lambert Company Llc Pharmaceutical compositions comprising atorvastatin manufactured without granulation
EP1532975A1 (en) * 2003-11-18 2005-05-25 Helm AG Process for the manufacture of free-flowing, powdery atorvastatin adsorbates
WO2005084670A1 (en) * 2004-03-01 2005-09-15 Lek Pharmaceuticals D.D. Pharmaceutical formulation

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
MICHRAFY ET AL: "Predictions of tensile strength of binary tablets using linear and power law mixing rules", INTERNATIONAL JOURNAL OF PHARMACEUTICS, ELSEVIER BV, NL, vol. 333, no. 1-2, 24 February 2007 (2007-02-24), pages 118 - 126, XP005904210, ISSN: 0378-5173 *
ROWE R C ET AL: "CELLULOSE, MICROCRYSTALLINE", HANDBOOK OF PHARMACEUTICAL EXCIPIENTS, LONDON : PHARMACEUTICAL PRESS.; GB, 1 January 2006 (2006-01-01), pages 132 - 135, XP002520963, ISBN: 978-1-58212-058-4 *

Also Published As

Publication number Publication date
WO2009056288A2 (en) 2009-05-07
DE102007052071A1 (en) 2009-05-07
EP2214648A2 (en) 2010-08-11

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