BR9815548A - Composição farmacêutica para administração em dose única diária para alteração de lipìdios num indivìduo sem causar hepatotoxicidade induzida por drogas, miopatia ou rabdomiólise, comprimido revestido para administração oral e método para administração de dita composição - Google Patents

Composição farmacêutica para administração em dose única diária para alteração de lipìdios num indivìduo sem causar hepatotoxicidade induzida por drogas, miopatia ou rabdomiólise, comprimido revestido para administração oral e método para administração de dita composição

Info

Publication number
BR9815548A
BR9815548A BR9815548-2A BR9815548A BR9815548A BR 9815548 A BR9815548 A BR 9815548A BR 9815548 A BR9815548 A BR 9815548A BR 9815548 A BR9815548 A BR 9815548A
Authority
BR
Brazil
Prior art keywords
composition
nicotinamide
methyl
administration
rhabdomyolysis
Prior art date
Application number
BR9815548-2A
Other languages
English (en)
Inventor
David J Bova
Josephine Dunne
Original Assignee
Kos Pharma Inc
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 Kos Pharma Inc filed Critical Kos Pharma Inc
Publication of BR9815548A publication Critical patent/BR9815548A/pt

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

<B>"COMPOSIçãO FARMACêUTICA PARA ADMINISTRAçãO EM DOSE úNICA DIáRIA PARA ALTERAçãO DE LIPìDIOS NUM INDIVìDUO SEM CAUSAR HEPATOTOXICIDADE INDUZIDA POR DROGAS, MIOPATIA OU RABDOMIóLISE, COMPRIMIDO REVESTIDO PARA ADMINISTRAçãO ORAL E MéTODO PARA ADMINISTRAçãO DE DITA COMPOSIçãO"<D> A presente invenção está relacionada com combinações farmacêuticas sólidas para administração por via oral administração por via oral compreendendo ácido nicotínico ou compostos do ácido nicotínico ou misturas dos mesmos numa forma de liberação prolongada e um inibidor de HMG-CoA redutase, que servem para alterar os níveis de lipídios em indivíduos sofrendo de, por exemplo, hiperlipidemia e arteriosclerose, sem causar hepatotoxicidade induzida por drogas, miopatia ou rabdomiólise. A presente invenção está também relacionada aos métodos de alteração de lipídios séricos em indivíduos para tratar, por exemplo, hiperlipidemia em hiperlipidêmicos, lipidemia em normolipidêmicos com diagnóstico ou predisposição a doenças cardiovasculares, e aretereoesclerose, administrando a referida composição farmacêutica sólida por via oral uma vez por dia como dose única durante o horário noturno, sem causar hepatotoxicidade induzida por drogas, miopatias ou rabdomiólise, ou sem causar, pelo menos num número apreciável de pacientes, hepatotoxicidade induzida por drogas, miopatias ou rabdomiólise de tal gravidade que imponha a suspensão do referido tratamento. Mais particularmente, a presente invenção diz respeito a composição farmacêutica sólida oral composta de, por exemplo, (1) um inibidor de HMG-CoA redutase para liberação imediata ou prolongada, (2) ácido nicotínico, um composto de ácido nicotínico ou misturas dos mesmos, e (3) um agente expansor para formar uma composição de liberação continuada para a liberação prolongada do ácido nicotínico ou composto de ácido nicotínico ou misturas dos mesmos para dosagem noturna ou vespertina para redução do percentual de lipídios séricos e aumento do colesterol HDL. De acordo com a presente invenção, e como forma de exemplo, apresenta-se uma composição para administração oral durante o horário noturno para alterar os lipídios séricos compreendendo ácido nicotínico e hidroxipropil metilcelulose na forma de um comprimido ou drágea de liberação prolongada ou continuada revestido de um revestimento composto de um inibidor de HMG-CoA redutase numa forma de liberação imediata. Também de acordo com a presente invenção, as composições farmacêuticas podem incluir um agente anti-inflamatório não-esteróidico para redução da capacidade do ácido nicotínico ou compostos de ácido nicotínico para provocar reações de rubor em indivíduos.
BR9815548-2A 1997-07-31 1998-07-31 Composição farmacêutica para administração em dose única diária para alteração de lipìdios num indivìduo sem causar hepatotoxicidade induzida por drogas, miopatia ou rabdomiólise, comprimido revestido para administração oral e método para administração de dita composição BR9815548A (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US90375297A 1997-07-31 1997-07-31
PCT/US1998/015990 WO1999006035A2 (en) 1997-07-31 1998-07-31 COMBINATIONS OF HMG-CoA REDUCTASE INHIBITORS AND NICOTINIC ACID COMPOUNDS AND METHODS FOR TREATING HYPERLIPIDEMIA ONCE A DAY AT NIGHT

Publications (1)

Publication Number Publication Date
BR9815548A true BR9815548A (pt) 2000-11-07

Family

ID=25418027

Family Applications (1)

Application Number Title Priority Date Filing Date
BR9815548-2A BR9815548A (pt) 1997-07-31 1998-07-31 Composição farmacêutica para administração em dose única diária para alteração de lipìdios num indivìduo sem causar hepatotoxicidade induzida por drogas, miopatia ou rabdomiólise, comprimido revestido para administração oral e método para administração de dita composição

Country Status (17)

Country Link
US (3) US20040053975A1 (pt)
EP (2) EP1792616B1 (pt)
JP (2) JP4870869B2 (pt)
AT (2) ATE359785T1 (pt)
AU (1) AU752673B2 (pt)
BR (1) BR9815548A (pt)
CA (1) CA2298549C (pt)
CY (1) CY1107057T1 (pt)
DE (2) DE69837610T2 (pt)
DK (1) DK1017390T3 (pt)
ES (2) ES2336492T3 (pt)
HK (1) HK1106153A1 (pt)
IL (2) IL134271A0 (pt)
NO (1) NO20000439L (pt)
NZ (1) NZ520176A (pt)
PT (1) PT1017390E (pt)
WO (1) WO1999006035A2 (pt)

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Also Published As

Publication number Publication date
ES2283067T3 (es) 2007-10-16
WO1999006035A3 (en) 1999-04-22
US20040053975A1 (en) 2004-03-18
AU752673B2 (en) 2002-09-26
JP2001511444A (ja) 2001-08-14
CA2298549A1 (en) 1999-02-11
HK1106153A1 (en) 2008-03-07
DE69841395D1 (de) 2010-01-28
DK1017390T3 (da) 2007-06-11
EP1017390B1 (en) 2007-04-18
IL134271A0 (en) 2001-04-30
NO20000439D0 (no) 2000-01-27
PT1017390E (pt) 2007-07-24
EP1792616B1 (en) 2009-12-16
ATE451926T1 (de) 2010-01-15
CY1107057T1 (el) 2012-10-24
EP1017390A2 (en) 2000-07-12
ES2336492T3 (es) 2010-04-13
WO1999006035A2 (en) 1999-02-11
NO20000439L (no) 2000-03-22
US20120164221A1 (en) 2012-06-28
NZ520176A (en) 2005-02-25
EP1792616A1 (en) 2007-06-06
DE69837610T2 (de) 2008-01-03
AU8680198A (en) 1999-02-22
DE69837610D1 (de) 2007-05-31
JP2009235105A (ja) 2009-10-15
IL134271A (en) 2006-07-05
ATE359785T1 (de) 2007-05-15
US20090226518A1 (en) 2009-09-10
JP4870869B2 (ja) 2012-02-08
CA2298549C (en) 2006-01-10

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