WO2004071402A3 - STABLE PHARMACEUTICAL DOSAGE FORM COMPRISING HMG-CoA REDUCTASE INHIBITOR - Google Patents

STABLE PHARMACEUTICAL DOSAGE FORM COMPRISING HMG-CoA REDUCTASE INHIBITOR Download PDF

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Publication number
WO2004071402A3
WO2004071402A3 PCT/SI2004/000008 SI2004000008W WO2004071402A3 WO 2004071402 A3 WO2004071402 A3 WO 2004071402A3 SI 2004000008 W SI2004000008 W SI 2004000008W WO 2004071402 A3 WO2004071402 A3 WO 2004071402A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical dosage
stable pharmaceutical
environment
dosage form
hmg
Prior art date
Application number
PCT/SI2004/000008
Other languages
French (fr)
Other versions
WO2004071402A2 (en
Inventor
Mateja Burjak
Vlasta Humar
Rok Grahek
Mateja Salobir
Janez Kerc
Original Assignee
Lek Pharmaceuticals
Mateja Burjak
Vlasta Humar
Rok Grahek
Mateja Salobir
Janez Kerc
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 Lek Pharmaceuticals, Mateja Burjak, Vlasta Humar, Rok Grahek, Mateja Salobir, Janez Kerc filed Critical Lek Pharmaceuticals
Publication of WO2004071402A2 publication Critical patent/WO2004071402A2/en
Publication of WO2004071402A3 publication Critical patent/WO2004071402A3/en

Links

Classifications

    • 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
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Obesity (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention relates to stable pharmaceutical dosage forms comprising the active substances sensitive to environmental influences and pharmaceutical excipients which provide stability of one or more active substance to pH of the environment and do not contain alkalizing or buffering substances or combinations thereof. Said invention also discloses the stable pharmaceutical dosage forms comprising the active substances sensitive to pH of the environment, oxidation and/or environmental humidity, pharmaceutical excipients which provide stability of the active substance to pH of the environment and the coating which provides protection of the active substance from environment influences, in particular from oxidation and/or environmental humidity. Further the invention discloses the procedures for the preparation of the stable pharmaceutical dosage form and use of such active substances for the preparation of the pharmaceutical dosage forms for the treatment of dyslipidemias, cardiovascular disease and other diseases.
PCT/SI2004/000008 2003-02-12 2004-02-11 STABLE PHARMACEUTICAL DOSAGE FORM COMPRISING HMG-CoA REDUCTASE INHIBITOR WO2004071402A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SI200300040A SI21400A (en) 2003-02-12 2003-02-12 Stable pharmaceutical form with hmg-coa reductase inhibitor
SIP-200300040 2003-02-12

Publications (2)

Publication Number Publication Date
WO2004071402A2 WO2004071402A2 (en) 2004-08-26
WO2004071402A3 true WO2004071402A3 (en) 2004-10-21

Family

ID=32867326

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SI2004/000008 WO2004071402A2 (en) 2003-02-12 2004-02-11 STABLE PHARMACEUTICAL DOSAGE FORM COMPRISING HMG-CoA REDUCTASE INHIBITOR

Country Status (2)

Country Link
SI (1) SI21400A (en)
WO (1) WO2004071402A2 (en)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090088465A1 (en) * 2004-12-02 2009-04-02 Stephen Craig Dyar Pharmaceutical Compositions of Amorphous Atorvastatin and Process for Preparing Same
ITMO20050157A1 (en) 2005-06-22 2006-12-23 New Photocatalyst Solution Ltd SUSPENSIONS OF TITANIUM DIOXIDE AND METHOD OF OBTAINING THEM.
EP1741427A1 (en) * 2005-07-06 2007-01-10 KRKA, D.D., Novo Mesto Pharmaceutical composition comprising simvastatin and ezetimibe
HU227610B1 (en) * 2006-09-18 2011-09-28 Richter Gedeon Nyrt Pharmaceutical compositions containing rosuvastatin potassium
GB0713707D0 (en) * 2007-07-13 2007-08-22 Generics Uk Ltd Stable compositions
DE102007052071A1 (en) * 2007-10-30 2009-05-07 Stada Arzneimittel Ag Stabilized atorvastatin
WO2011012848A1 (en) 2009-07-27 2011-02-03 Suresensors Ltd Improvements relating to sensor devices
WO2011077843A1 (en) * 2009-12-25 2011-06-30 沢井製薬株式会社 Atrovastatin-containing coated preparation
IN2014CN04119A (en) 2011-11-15 2015-07-10 Reddys Lab Ltd Dr
US20150164809A1 (en) * 2012-08-08 2015-06-18 Kowa Company, Ltd. Medicine
CN107982223B (en) * 2017-11-27 2020-08-28 诺唯德(天津)制药有限公司 Atorvastatin calcium tablet and preparation method thereof

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0375156A2 (en) * 1988-11-21 1990-06-27 Merck & Co. Inc. Plasma cholesterol level lowering medicaments
EP0465096A1 (en) * 1990-06-26 1992-01-08 Merck & Co. Inc. Plasma cholesterol level lowering composition
WO1998015264A1 (en) * 1996-10-08 1998-04-16 Astra Aktiebolag PHARMACEUTICAL COMPOSITIONS FOR SUSTAINED RELEASE OF THE HMG-CoA REDUCTASE INHIBITOR FLUVASTATIN
US5916595A (en) * 1997-12-12 1999-06-29 Andrx Pharmaceutials, Inc. HMG co-reductase inhibitor
WO2001037876A2 (en) * 1999-11-24 2001-05-31 Bayer Aktiengesellschaft Methods of ameliorating abnormal bone states
WO2001076566A1 (en) * 2000-04-10 2001-10-18 Teva Pharmaceutical Industries Ltd. Stable pharmaceutical compositions containing 7-substituted-3,5-dihydroxyheptanoic acids or 7-substituted-3,5-dihydroxyheptenoic acids
WO2003057195A1 (en) * 2002-01-11 2003-07-17 Athpharma Limited Pravastatin pharmaceutical formulations and methods of their use

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0375156A2 (en) * 1988-11-21 1990-06-27 Merck & Co. Inc. Plasma cholesterol level lowering medicaments
EP0465096A1 (en) * 1990-06-26 1992-01-08 Merck & Co. Inc. Plasma cholesterol level lowering composition
WO1998015264A1 (en) * 1996-10-08 1998-04-16 Astra Aktiebolag PHARMACEUTICAL COMPOSITIONS FOR SUSTAINED RELEASE OF THE HMG-CoA REDUCTASE INHIBITOR FLUVASTATIN
US5916595A (en) * 1997-12-12 1999-06-29 Andrx Pharmaceutials, Inc. HMG co-reductase inhibitor
WO2001037876A2 (en) * 1999-11-24 2001-05-31 Bayer Aktiengesellschaft Methods of ameliorating abnormal bone states
WO2001076566A1 (en) * 2000-04-10 2001-10-18 Teva Pharmaceutical Industries Ltd. Stable pharmaceutical compositions containing 7-substituted-3,5-dihydroxyheptanoic acids or 7-substituted-3,5-dihydroxyheptenoic acids
WO2003057195A1 (en) * 2002-01-11 2003-07-17 Athpharma Limited Pravastatin pharmaceutical formulations and methods of their use

Also Published As

Publication number Publication date
SI21400A (en) 2004-08-31
WO2004071402A2 (en) 2004-08-26

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