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PE20081364A1 - PHARMACEUTICAL COMPOSITION INCLUDING VALSARTAN - Google Patents

PHARMACEUTICAL COMPOSITION INCLUDING VALSARTAN

Info

Publication number
PE20081364A1
PE20081364A1 PE2007001173A PE2007001173A PE20081364A1 PE 20081364 A1 PE20081364 A1 PE 20081364A1 PE 2007001173 A PE2007001173 A PE 2007001173A PE 2007001173 A PE2007001173 A PE 2007001173A PE 20081364 A1 PE20081364 A1 PE 20081364A1
Authority
PE
Peru
Prior art keywords
modifier
pharmaceutical composition
valsartan
composition including
acid
Prior art date
Application number
PE2007001173A
Other languages
Spanish (es)
Inventor
Dieter Becker
Barbara Luckel
Stefanie Siepe
Jorg Ogorka
Bruno Galli
Original Assignee
Novartis Ag
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39047776&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20081364(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from EP06120038A external-priority patent/EP1897537A1/en
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of PE20081364A1 publication Critical patent/PE20081364A1/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
    • A61K9/2072—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • 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
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Cardiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

SE REFIERE A UNA COMPOSICION FARMACEUTICA SOLIDA, QUE COMPRENDE i) UN COMPUESTO DE FARMACO ACIDO TAL COMO UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA II SIENDO PEREFERIDO VALSARTAN; ii) AL MENOS UN MODIFICADOR DE pH QUE TIENE UN pKa MAYOR DE 2 SIENDO SELECCIONADO DE ACIDO CITRICO, FUMARICO, SUCCINICO, ADIPICO Y MALEICO, DONDE LA PROPORCION PESO/PESO DEL MODIFICADOR DE pH AL FARMACO ACIDO ES ENTRE 0.01:1 Y 10:1; Y iii) AL MENOS UN EXCIPIENTE; ADEMAS COMPRENDE UN POLIMERO DE MATRIZ QUE COMPRENDE HIDROXI-PROPIL-CELULOSA QUE CONTIENE UNA DISPERSION SUSTANCIALMENTE UNIFORME DEL FARMACO ACIDO Y EL MODIFICADOR DE pH. ESTA COMPOSICION SE ADAPTA PARA PROPORCIONAR UN pH MICRO-AMBIENTAL DE 5 O MENOS EN CUANDO MENOS UNA REGION DEL TRACTO GASTRO INTESTINAL; SIENDO UTIL EN EL TRATAMIENTO DE HIPERTENSION, INSUFICIENCIA CARDIACA O INFARTO DE MIOCARDIOREFERS TO A SOLID PHARMACEUTICAL COMPOSITION, WHICH INCLUDES i) A COMPOUND OF ACID PHARMACEUTICAL SUCH AS AN ANTAGONIST OF THE ANGIOTENSIN II RECEPTOR BEING PEREFERED VALSARTAN; ii) AT LEAST ONE pH MODIFIER THAT HAS A pKa GREATER THAN 2 BEING SELECTED FROM CITRIC, FUMARIC, SUCCINIC, ADIPIC AND MALEIC ACIDS, WHERE THE WEIGHT / WEIGHT RATIO OF THE pH MODIFIER TO THE ACID DRUG IS BETWEEN 10: 0.01: 1 AND one; AND iii) AT LEAST ONE EXCIPIENT; IT ALSO INCLUDES A MATRIX POLYMER THAT INCLUDES HYDROXY-PROPYL-CELLULOSE THAT CONTAINS A SUBSTANTIALLY UNIFORM DISPERSION OF THE ACID DRUG AND THE pH MODIFIER. THIS COMPOSITION IS ADAPTED TO PROVIDE A MICRO-ENVIRONMENTAL pH OF 5 OR LESS IN AT LEAST ONE REGION OF THE GASTRO INTESTINAL TRACT; BEING USEFUL IN THE TREATMENT OF HYPERTENSION, HEART FAILURE OR MYOCARDIAL INFARCTION

PE2007001173A 2006-09-04 2007-08-29 PHARMACEUTICAL COMPOSITION INCLUDING VALSARTAN PE20081364A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP06120038A EP1897537A1 (en) 2006-09-04 2006-09-04 Composition comprising an angiotensin II receptor antagonist
EP07103396 2007-03-02

Publications (1)

Publication Number Publication Date
PE20081364A1 true PE20081364A1 (en) 2008-12-04

Family

ID=39047776

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2007001173A PE20081364A1 (en) 2006-09-04 2007-08-29 PHARMACEUTICAL COMPOSITION INCLUDING VALSARTAN

Country Status (5)

Country Link
AR (1) AR062613A1 (en)
CL (1) CL2007002553A1 (en)
PE (1) PE20081364A1 (en)
TW (1) TW200817054A (en)
WO (1) WO2008028885A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0715628D0 (en) * 2007-08-10 2007-09-19 Generics Uk Ltd Solid valsartan composition
EP2916828A1 (en) * 2012-11-07 2015-09-16 Nazura Biohealth Inc. Gras enteric coating formulations and methods of making and using same

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9613470D0 (en) * 1996-06-27 1996-08-28 Ciba Geigy Ag Small solid oral dosage form
CA2318446C (en) * 1998-03-04 2008-09-23 Takeda Chemical Industries, Ltd. Sustained-release preparation for aii antagonist, production and use thereof
CA2400845A1 (en) * 2000-02-21 2001-08-23 Takeda Chemical Industries, Ltd. Sustained-release preparation of physiologically active compound slightly soluble in water and production process and use of the same
WO2003090723A1 (en) * 2002-04-23 2003-11-06 Bristol-Myers Squibb Company Modified-release vasopeptidase inhibitor formulation, combinations and method
WO2005089720A1 (en) * 2004-03-10 2005-09-29 Ranbaxy Laboratories Limited Valsartan tablets and the process for the preparation thereof
RS52607B (en) * 2004-12-24 2013-04-30 Krka Tovarna Zdravil D.D., Novo Mesto SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING VALSARTAN

Also Published As

Publication number Publication date
AR062613A1 (en) 2008-11-19
CL2007002553A1 (en) 2008-05-16
WO2008028885A3 (en) 2008-05-02
TW200817054A (en) 2008-04-16
WO2008028885A2 (en) 2008-03-13

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