WO1999006035A3 - COMBINATIONS OF HMG-CoA REDUCTASE INHIBITORS AND NICOTINIC ACID COMPOUNDS AND METHODS FOR TREATING HYPERLIPIDEMIA ONCE A DAY AT NIGHT - Google Patents

COMBINATIONS OF HMG-CoA REDUCTASE INHIBITORS AND NICOTINIC ACID COMPOUNDS AND METHODS FOR TREATING HYPERLIPIDEMIA ONCE A DAY AT NIGHT Download PDF

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Publication number
WO1999006035A3
WO1999006035A3 PCT/US1998/015990 US9815990W WO9906035A3 WO 1999006035 A3 WO1999006035 A3 WO 1999006035A3 US 9815990 W US9815990 W US 9815990W WO 9906035 A3 WO9906035 A3 WO 9906035A3
Authority
WO
WIPO (PCT)
Prior art keywords
nicotinic acid
hmg
coa reductase
present
pharmaceutical combinations
Prior art date
Application number
PCT/US1998/015990
Other languages
French (fr)
Other versions
WO1999006035A2 (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
Priority to BR9815548-2A priority Critical patent/BR9815548A/en
Priority to AU86801/98A priority patent/AU752673B2/en
Priority to DK98938228T priority patent/DK1017390T3/en
Priority to DE69837610T priority patent/DE69837610T2/en
Priority to JP2000504849A priority patent/JP4870869B2/en
Priority to CA002298549A priority patent/CA2298549C/en
Application filed by Kos Pharma Inc filed Critical Kos Pharma Inc
Priority to EP98938228A priority patent/EP1017390B1/en
Priority to IL13427198A priority patent/IL134271A0/en
Publication of WO1999006035A2 publication Critical patent/WO1999006035A2/en
Publication of WO1999006035A3 publication Critical patent/WO1999006035A3/en
Priority to NO20000439A priority patent/NO20000439L/en
Priority to IL134271A priority patent/IL134271A/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • 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
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (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)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Pain & Pain Management (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Child & Adolescent Psychology (AREA)
  • Vascular Medicine (AREA)
  • Rheumatology (AREA)
  • Urology & Nephrology (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)
  • Enzymes And Modification Thereof (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

The present invention relates to solid pharmaceutical combinations for oral administration comprising nicotinic acid or a nicotinic acid compound or mixtures thereof in an extended release form and an HMG-CoA reductase inhibitor, which are useful for altering lipid levels in subjects suffering from, for example, hyperlipidemia and atherosclerosis, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis. The present invention also relates to methods of altering serum lipids in subjects to treat, for example, hyperlipidemia in hyperlipidemics, lipidemia in normolipidemics diagnosed with or predisposed to cardiovascular disease, and atherosclerosis, by administering such oral solid pharmaceutical combinations once per day as a single dose during the evening hours, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, or without causing in at least an appreciable number of individuals drug-induced hepatotoxicity, myopathy or rhabdomyolysis to such a level that discontinuation of such therapy would be required. More particularly, the present invention concerns oral solid pharmaceutical combinations comprised of, for example, (1) an HMG-CoA reductase inhibitor for immediate or extended release, (2) nicotinic acid, a nicotinic acid compound or mixtures thereof, and (3) a swelling agent to form a sustained release composition for extended release of the nicotinic acid or nicotinic acid compound or mixtures thereof for nocturnal or evening dosing for reducing serum lipids and increasing HDL-cholesterol. In accordance with the present invention, and by way of example, a composition for oral administration during the evening hours to alter serum lipids comprised of nicotinic acid and hydroxypropyl methylcellulose in the form of an extended or sustained release tablet or caplet coated with a coating comprising an HMG-CoA reductase inhibitor in immediate release form is disclosed. Also in accordance with the present invention, the pharmaceutical combinations may include a nonsteroidal anti-inflammatory agent for reducing the capacity of nicotinic acid or nicotinic acid compounds to provoke flushing reactions in individuals.
PCT/US1998/015990 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 WO1999006035A2 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
AU86801/98A AU752673B2 (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
DK98938228T DK1017390T3 (en) 1997-07-31 1998-07-31 Coated tablet comprising nicotinic acid or a compound metabolized to nicotinic acid in a sustained-release form and an HMG-CoA reductase inhibitor in an immediate-release form
DE69837610T DE69837610T2 (en) 1997-07-31 1998-07-31 COAT COMPARTMENT CONTAINING NICOTIC ACID OR A SUBSTANCE FOR METABOLISING TO NICOTIC ACID IN DELAYED FORM AND AN HMG-COA REDUCTASE IN THE COAT FOR IMMEDIATE RELEASE
JP2000504849A JP4870869B2 (en) 1997-07-31 1998-07-31 Combination of HMG-CoA reductase inhibitor and nicotinic acid compound, and method for treating hyperlipidemia once a day at night
CA002298549A CA2298549C (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
BR9815548-2A BR9815548A (en) 1997-07-31 1998-07-31 Pharmaceutical composition for administration in a single daily dose to change lipids in an individual without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, coated tablet for oral administration and method for administering said composition
EP98938228A EP1017390B1 (en) 1997-07-31 1998-07-31 Coated tablet comprising nicotinic acid or a compound metabolized to nicotinic acid in an extended release form, and a coating containing an hmg-coa reductase inhibitor in an immediate release form
IL13427198A IL134271A0 (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
NO20000439A NO20000439L (en) 1997-07-31 2000-01-27 Combinations of HMG-COA reductase inhibitors and nicotinic acid compounds as well as methods for treating hyperlipidemia
IL134271A IL134271A (en) 1997-07-31 2000-01-27 Pharmaceutical compositions for altering lipids comprising nicotinic acid compounds and hmg-coa reductase inhibitors

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US90375297A 1997-07-31 1997-07-31
US08/903,752 1997-07-31

Publications (2)

Publication Number Publication Date
WO1999006035A2 WO1999006035A2 (en) 1999-02-11
WO1999006035A3 true WO1999006035A3 (en) 1999-04-22

Family

ID=25418027

Family Applications (1)

Application Number Title Priority Date Filing Date
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

Country Status (17)

Country Link
US (3) US20040053975A1 (en)
EP (2) EP1017390B1 (en)
JP (2) JP4870869B2 (en)
AT (2) ATE451926T1 (en)
AU (1) AU752673B2 (en)
BR (1) BR9815548A (en)
CA (1) CA2298549C (en)
CY (1) CY1107057T1 (en)
DE (2) DE69837610T2 (en)
DK (1) DK1017390T3 (en)
ES (2) ES2283067T3 (en)
HK (1) HK1106153A1 (en)
IL (2) IL134271A0 (en)
NO (1) NO20000439L (en)
NZ (1) NZ520176A (en)
PT (1) PT1017390E (en)
WO (1) WO1999006035A2 (en)

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HK1106153A1 (en) 2008-03-07
ES2336492T3 (en) 2010-04-13
DE69837610D1 (en) 2007-05-31
ATE359785T1 (en) 2007-05-15
JP4870869B2 (en) 2012-02-08
WO1999006035A2 (en) 1999-02-11
NZ520176A (en) 2005-02-25
ATE451926T1 (en) 2010-01-15
DE69837610T2 (en) 2008-01-03
CA2298549A1 (en) 1999-02-11
IL134271A0 (en) 2001-04-30
DK1017390T3 (en) 2007-06-11
DE69841395D1 (en) 2010-01-28
US20090226518A1 (en) 2009-09-10
US20040053975A1 (en) 2004-03-18
NO20000439L (en) 2000-03-22
BR9815548A (en) 2000-11-07
PT1017390E (en) 2007-07-24
EP1792616B1 (en) 2009-12-16
EP1017390B1 (en) 2007-04-18
EP1017390A2 (en) 2000-07-12
US20120164221A1 (en) 2012-06-28
NO20000439D0 (en) 2000-01-27
ES2283067T3 (en) 2007-10-16
AU752673B2 (en) 2002-09-26
IL134271A (en) 2006-07-05
JP2001511444A (en) 2001-08-14
JP2009235105A (en) 2009-10-15
EP1792616A1 (en) 2007-06-06
AU8680198A (en) 1999-02-22
CY1107057T1 (en) 2012-10-24
CA2298549C (en) 2006-01-10

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