CA2343376A1 - Sustained release ranolazine formulations - Google Patents

Sustained release ranolazine formulations Download PDF

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Publication number
CA2343376A1
CA2343376A1 CA002343376A CA2343376A CA2343376A1 CA 2343376 A1 CA2343376 A1 CA 2343376A1 CA 002343376 A CA002343376 A CA 002343376A CA 2343376 A CA2343376 A CA 2343376A CA 2343376 A1 CA2343376 A1 CA 2343376A1
Authority
CA
Canada
Prior art keywords
ranolazine
sustained release
release ranolazine
aqueous media
ranolazine formulations
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002343376A
Other languages
French (fr)
Other versions
CA2343376C (en
Inventor
Andrew A. Wolff
Fiona Baker
John Langridge
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gilead Sciences Inc
Original Assignee
Cv Therapeutics, Inc.
Andrew A. Wolff
Fiona Baker
John Langridge
Roche Palo Alto Llc
Gilead Sciences, 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26796494&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2343376(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Cv Therapeutics, Inc., Andrew A. Wolff, Fiona Baker, John Langridge, Roche Palo Alto Llc, Gilead Sciences, Inc. filed Critical Cv Therapeutics, Inc.
Publication of CA2343376A1 publication Critical patent/CA2343376A1/en
Application granted granted Critical
Publication of CA2343376C publication Critical patent/CA2343376C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • 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
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
    • 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
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • 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
    • 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
    • A61P9/06—Antiarrhythmics
    • 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

Landscapes

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

Abstract

A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng basNmL.
CA002343376A 1998-09-10 1999-09-09 Sustained release ranolazine formulations Expired - Lifetime CA2343376C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US9980498P 1998-09-10 1998-09-10
US60/099,804 1998-09-10
US09/321,522 US6303607B1 (en) 1998-09-10 1999-05-27 Method for administering a sustained release ranolanolazine formulation
US09/321,522 1999-05-27
PCT/US1999/020968 WO2000013687A2 (en) 1998-09-10 1999-09-09 Sustained release ranolazine formulations

Publications (2)

Publication Number Publication Date
CA2343376A1 true CA2343376A1 (en) 2000-03-16
CA2343376C CA2343376C (en) 2007-01-09

Family

ID=26796494

Family Applications (2)

Application Number Title Priority Date Filing Date
CA002342390A Expired - Lifetime CA2342390C (en) 1998-09-10 1999-09-09 Sustained release ranolazine formulations
CA002343376A Expired - Lifetime CA2343376C (en) 1998-09-10 1999-09-09 Sustained release ranolazine formulations

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA002342390A Expired - Lifetime CA2342390C (en) 1998-09-10 1999-09-09 Sustained release ranolazine formulations

Country Status (33)

Country Link
US (14) US6303607B1 (en)
EP (3) EP1527779A1 (en)
JP (2) JP3745621B2 (en)
KR (1) KR100475759B1 (en)
CN (2) CN1193757C (en)
AR (3) AR022085A1 (en)
AT (2) ATE285774T1 (en)
AU (4) AU760435B2 (en)
BR (2) BR9913553A (en)
CA (2) CA2342390C (en)
CY (1) CY2008020I1 (en)
CZ (2) CZ301341B6 (en)
DE (3) DE69922964T2 (en)
DK (2) DK1096937T3 (en)
ES (2) ES2177346T3 (en)
FR (1) FR09C0001I2 (en)
GE (1) GEP20053420B (en)
HK (2) HK1040060A1 (en)
HU (2) HUP0104088A3 (en)
IL (6) IL141893A0 (en)
LU (1) LU91504I2 (en)
MX (2) MXPA01002599A (en)
NL (1) NL300371I2 (en)
NO (4) NO319434B1 (en)
NZ (2) NZ510386A (en)
PL (3) PL202207B1 (en)
PT (2) PT1096937E (en)
RU (2) RU2207856C2 (en)
SI (2) SI1109558T1 (en)
TR (2) TR200101262T2 (en)
TW (1) TWI241911B (en)
UA (2) UA75027C2 (en)
WO (2) WO2000013687A2 (en)

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Publication number Publication date
SI1096937T1 (en) 2005-04-30
NO2009005I2 (en) 2010-06-28
BR9913553A (en) 2001-10-23
EP1096937A2 (en) 2001-05-09
IL175371A0 (en) 2006-09-05
NZ510384A (en) 2002-10-25
CZ301375B6 (en) 2010-02-03
US6503911B2 (en) 2003-01-07
EP1096937B1 (en) 2004-12-29
WO2000013686A3 (en) 2000-07-06
KR20010089874A (en) 2001-10-12
IL180864A0 (en) 2007-07-04
SI1109558T1 (en) 2002-10-31
PL347073A1 (en) 2002-03-11
WO2000013686A2 (en) 2000-03-16
US6525057B2 (en) 2003-02-25
US6369062B1 (en) 2002-04-09
TR200101261T2 (en) 2002-05-21
HUP0104088A2 (en) 2002-05-29
CZ2001879A3 (en) 2001-08-15
GEP20053420B (en) 2005-01-25
CA2342390A1 (en) 2000-03-16
ATE285774T1 (en) 2005-01-15
RU2214233C2 (en) 2003-10-20
HK1044284A1 (en) 2002-10-18
US20030166659A1 (en) 2003-09-04
NO320986B1 (en) 2006-02-20
US20040097514A1 (en) 2004-05-20
DK1096937T3 (en) 2005-05-09
AU760435B2 (en) 2003-05-15
RU2207856C2 (en) 2003-07-10
JP2006096757A (en) 2006-04-13
US20020090396A1 (en) 2002-07-11
HUP0103844A3 (en) 2002-11-28
IL141892A (en) 2006-08-20
PL202207B1 (en) 2009-06-30
US20050153982A1 (en) 2005-07-14
AR022085A1 (en) 2002-09-04
CN1193757C (en) 2005-03-23
NL300371I2 (en) 2009-10-01
AU6036499A (en) 2000-03-27
AR052921A1 (en) 2007-04-11
DK1109558T3 (en) 2002-08-26
PL196263B1 (en) 2007-12-31
US20020004506A1 (en) 2002-01-10
DE69901570D1 (en) 2002-06-27
AU744071B2 (en) 2002-02-14
US6864258B2 (en) 2005-03-08
UA67793C2 (en) 2004-07-15
HUP0104088A3 (en) 2002-12-28
WO2000013687A3 (en) 2000-06-29
CZ301341B6 (en) 2010-01-20
US20040029890A1 (en) 2004-02-12
TWI241911B (en) 2005-10-21
NO20011192D0 (en) 2001-03-08
HK1044284B (en) 2005-07-15
NO319434B1 (en) 2005-08-15
US20050059667A1 (en) 2005-03-17
US6620814B2 (en) 2003-09-16
TR200101262T2 (en) 2001-12-21
NO20011192L (en) 2001-04-30
DE69901570T2 (en) 2003-01-09
US20060217397A1 (en) 2006-09-28
DE69922964T2 (en) 2005-12-08
IL141893A (en) 2008-08-07
US20030100566A1 (en) 2003-05-29
HU224215B1 (en) 2005-06-28
MXPA01002598A (en) 2002-04-08
PL196668B1 (en) 2008-01-31
EP1527779A1 (en) 2005-05-04
NL300371I1 (en) 2009-02-02
AU2008207707A1 (en) 2008-09-25
PL348249A1 (en) 2002-05-20
EP1096937B9 (en) 2007-02-28
DE122008000065I1 (en) 2009-04-09
CN1354665A (en) 2002-06-19
CY2008020I2 (en) 2010-07-28
FR09C0001I1 (en) 2009-02-27
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US6852724B2 (en) 2005-02-08
FR09C0001I2 (en) 2009-12-18
US6617328B2 (en) 2003-09-09
EP1109558A2 (en) 2001-06-27
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CA2343376C (en) 2007-01-09
US20060147521A1 (en) 2006-07-06
EP1109558B1 (en) 2002-05-22
JP3745621B2 (en) 2006-02-15
AU6142599A (en) 2000-03-27
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US6562826B1 (en) 2003-05-13
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MXPA01002599A (en) 2005-02-17
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