NZ523546A - Stable pharmaceutical compositions of gabapentin having PH within the range 6.8 to 7.3 comprising less than 0.5% by weight of a corresponding lactum - Google Patents

Stable pharmaceutical compositions of gabapentin having PH within the range 6.8 to 7.3 comprising less than 0.5% by weight of a corresponding lactum

Info

Publication number
NZ523546A
NZ523546A NZ523546A NZ52354601A NZ523546A NZ 523546 A NZ523546 A NZ 523546A NZ 523546 A NZ523546 A NZ 523546A NZ 52354601 A NZ52354601 A NZ 52354601A NZ 523546 A NZ523546 A NZ 523546A
Authority
NZ
New Zealand
Prior art keywords
gabapentin
weight
pharmaceutical composition
ppm
year
Prior art date
Application number
NZ523546A
Other languages
English (en)
Inventor
Claude Singer
Gideon Pilarski
Michael Pesachovich
Eduard Schwartz
Original Assignee
Teva Pharma
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 Teva Pharma filed Critical Teva Pharma
Publication of NZ523546A publication Critical patent/NZ523546A/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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/38—Separation; Purification; Stabilisation; Use of additives
    • C07C227/40—Separation; Purification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/38—Separation; Purification; Stabilisation; Use of additives
    • C07C227/44—Stabilisation; Use of additives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D209/56—Ring systems containing three or more rings
    • C07D209/96—Spiro-condensed ring systems
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C2601/00—Systems containing only non-condensed rings
    • C07C2601/12—Systems containing only non-condensed rings with a six-membered ring
    • C07C2601/14—The ring being saturated

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Biophysics (AREA)
  • Anesthesiology (AREA)
  • Molecular Biology (AREA)
  • Pain & Pain Management (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
NZ523546A 2000-06-16 2001-06-15 Stable pharmaceutical compositions of gabapentin having PH within the range 6.8 to 7.3 comprising less than 0.5% by weight of a corresponding lactum NZ523546A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US21196600P 2000-06-16 2000-06-16
PCT/US2001/019427 WO2001097782A1 (en) 2000-06-16 2001-06-15 Stable gabapentin having ph within a controlled range

Publications (1)

Publication Number Publication Date
NZ523546A true NZ523546A (en) 2005-04-29

Family

ID=22788986

Family Applications (1)

Application Number Title Priority Date Filing Date
NZ523546A NZ523546A (en) 2000-06-16 2001-06-15 Stable pharmaceutical compositions of gabapentin having PH within the range 6.8 to 7.3 comprising less than 0.5% by weight of a corresponding lactum

Country Status (18)

Country Link
US (4) US20020045662A1 (enExample)
EP (1) EP1294364A4 (enExample)
JP (1) JP2003535885A (enExample)
KR (2) KR20060123782A (enExample)
CN (1) CN1447684A (enExample)
AU (2) AU2001266992B8 (enExample)
CA (1) CA2411787C (enExample)
CZ (1) CZ200339A3 (enExample)
HR (1) HRP20030002A2 (enExample)
HU (1) HUP0301919A3 (enExample)
IL (1) IL153441A0 (enExample)
IS (1) IS6654A (enExample)
NZ (1) NZ523546A (enExample)
PL (1) PL363155A1 (enExample)
SK (1) SK302003A3 (enExample)
WO (1) WO2001097782A1 (enExample)
YU (1) YU95302A (enExample)
ZA (1) ZA200210144B (enExample)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7056951B2 (en) * 2000-09-26 2006-06-06 Mutual Pharmaceutical Co., Inc. Stable solid dosage forms of amino acids and processes for producing same
US7612112B2 (en) 2001-10-25 2009-11-03 Depomed, Inc. Methods of treatment using a gastric retained gabapentin dosage
TWI312285B (en) 2001-10-25 2009-07-21 Depomed Inc Methods of treatment using a gastric retained gabapentin dosage
US20030119908A1 (en) * 2001-12-21 2003-06-26 Zambon Group S.P.A. Stable gabapentin compositions
CA2478471A1 (en) * 2002-04-16 2003-10-30 Taro Pharmaceutical Industries Ltd. Process for preparing gabapentin
CA2510292A1 (en) * 2002-12-20 2004-07-15 Dynogen Pharmaceuticals, Inc. Methods of treating non-painful bladder disorders using .alpha.2.delta. subunit calcium channel modulators
KR100742001B1 (ko) * 2003-03-21 2007-07-23 다이노젠 파마세우티컬스, 인코포레이티드 평활근 모듈레이터 및 알파2 델타 서브유닛 칼슘 채널모듈레이터를 이용한 하부 요로 질환의 치료 방법
WO2005046566A2 (en) * 2003-08-04 2005-05-26 Sun Pharmaceutical Industries Limited Stable gabapentin containing composition
US20050187295A1 (en) * 2004-02-19 2005-08-25 Surendra Kalyan Processes for the preparation of gabapentin
WO2005117526A2 (en) * 2004-06-03 2005-12-15 Matrix Laboratories Ltd An improved process for the purification of gabapentin
US8367105B2 (en) 2004-11-10 2013-02-05 Teva Pharmaceutical Industries, Ltd. Compressed solid dosage form manufacturing process well-suited for use with drugs of low aqueous solubility and compressed solid dosage forms made thereby
CA2587295A1 (en) * 2004-11-10 2006-05-18 Teva Pharmaceutical Industries Ltd. Compressed solid dosage form manufacturing process well-suited for use with drugs of low aqueous solubility and compressed solid dosage forms made thereby
US20090176882A1 (en) 2008-12-09 2009-07-09 Depomed, Inc. Gastric retentive gabapentin dosage forms and methods for using same
US20080103334A1 (en) * 2006-10-26 2008-05-01 Ipca Laboratories Ltd Process For Synthesis Of Gabapentin
EP2007710A1 (en) * 2007-02-28 2008-12-31 Teva Pharmaceutical Industries Ltd. Preparation of gabapentin by liquid-liquid extraction

Family Cites Families (25)

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Publication number Priority date Publication date Assignee Title
DE2460891C2 (de) * 1974-12-21 1982-09-23 Gödecke AG, 1000 Berlin 1-Aminomethyl-1-cycloalkanessigsäuren und deren Ester, Verfahren zu deren Herstellung und diese Verbindungen enthaltende Arzneimittel
US4087544A (en) * 1974-12-21 1978-05-02 Warner-Lambert Company Treatment of cranial dysfunctions using novel cyclic amino acids
DE2611690A1 (de) * 1976-03-19 1977-09-22 Goedecke Ag Cyclische sulfonyloxyimide
US4894476A (en) * 1988-05-02 1990-01-16 Warner-Lambert Company Gabapentin monohydrate and a process for producing the same
US4960931A (en) * 1988-05-02 1990-10-02 Warner-Lambert Company Gabapentin mohohydrate and a process for producing the same
US5319135A (en) * 1989-08-25 1994-06-07 Warner-Lambert Company Process for cyclic amino acid anticonvulsant compounds
PH27359A (en) * 1989-08-25 1993-06-21 Warner Lambert Co Process for cyclic amino acid anticonvulsant compounds
US5132451A (en) * 1989-08-25 1992-07-21 Warner-Lambert Company Process for cyclic amino acid anticonvulsant compounds
DE3928182A1 (de) * 1989-08-25 1991-02-28 Goedecke Ag Verfahren zur herstellung von gabapentin
DE3928184A1 (de) * 1989-08-25 1991-02-28 Goedecke Ag Verfahren zur herstellung von cyclischen aminosaeurederivaten sowie zwischenprodukte
DE3928183A1 (de) * 1989-08-25 1991-02-28 Goedecke Ag Lactamfreie cyclische aminosaeuren
US5149870A (en) * 1989-11-16 1992-09-22 Lonza Ltd. Process for the production of 1-(aminomethyl)cyclohexane acetic acid
US5136091A (en) * 1989-11-16 1992-08-04 Lonza Ltd. Process for the production of 1-(aminomethyl) cyclohexane acetic acid
FI905584L (fi) * 1989-11-16 1991-05-17 Lonza Ag Foerfarande foer framstaellning av 1-(aminometyl)cyklohexanaettikssyra.
US5084479A (en) * 1990-01-02 1992-01-28 Warner-Lambert Company Novel methods for treating neurodegenerative diseases
US5510381A (en) * 1995-05-15 1996-04-23 Warner-Lambert Company Method of treatment of mania and bipolar disorder
IL119890A (en) * 1996-12-24 2002-03-10 Teva Pharma Gabapentin form iii and preparation of gabapentin form ii
US6294690B1 (en) * 1997-10-07 2001-09-25 Warner-Lambert Company Process for preparing a cyclic amino acid anticonvulsant compound
WO1999059572A1 (en) * 1998-05-15 1999-11-25 Warner-Lambert Company Gamma-aminobutyric acid derivatives containing, solid compositions and process for preparing the same
CA2327285C (en) * 1998-05-15 2005-06-14 Warner-Lambert Company Stabilized pharmaceutical preparations of gamma-aminobutyric acid derivatives and process for preparing the same
FR2781793B1 (fr) * 1998-08-03 2001-07-20 Prographarm Lab Procede de fabrication de granules de gabapentine enrobes
HU225502B1 (en) * 1998-12-29 2007-01-29 Richter Gedeon Vegyeszet Process for producing 1-(amino-metyl)-cyclohexene-acetic-acid and intermediates
ES2164527B1 (es) * 1999-04-26 2003-04-01 Medichen S A Procedimiento de obtencion de gabapentina de calidad farmaceutica.
US6294198B1 (en) * 1999-08-24 2001-09-25 Purepac Pharmaceutical Co. Pharmaceutical tablet formulation containing gabapentin with improved physical and chemical characteristics and method of making the same
CA2410867C (en) * 2000-06-16 2003-12-09 Claude Singer Stable gabapentin containing more than 2o ppm of chlorine ion

Also Published As

Publication number Publication date
CA2411787C (en) 2007-03-20
PL363155A1 (en) 2004-11-15
YU95302A (sh) 2006-05-25
US20020045662A1 (en) 2002-04-18
EP1294364A1 (en) 2003-03-26
US20060122271A1 (en) 2006-06-08
KR20030010700A (ko) 2003-02-05
WO2001097782A1 (en) 2001-12-27
IL153441A0 (en) 2003-07-06
IS6654A (is) 2002-12-11
ZA200210144B (en) 2004-10-08
JP2003535885A (ja) 2003-12-02
CA2411787A1 (en) 2001-12-27
KR100667721B1 (ko) 2007-01-15
HRP20030002A2 (en) 2005-10-31
KR20060123782A (ko) 2006-12-04
AU2001266992B8 (en) 2005-12-01
HUP0301919A2 (hu) 2003-09-29
US20030055109A1 (en) 2003-03-20
EP1294364A4 (en) 2004-06-16
HUP0301919A3 (en) 2006-01-30
CZ200339A3 (cs) 2003-06-18
AU6699201A (en) 2002-01-02
SK302003A3 (en) 2003-07-01
AU2001266992B2 (en) 2005-08-04
US20040147607A1 (en) 2004-07-29
CN1447684A (zh) 2003-10-08

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