JP2003535885A - 制御された範囲内にpHを持つ安定なギャバペンチン - Google Patents

制御された範囲内にpHを持つ安定なギャバペンチン

Info

Publication number
JP2003535885A
JP2003535885A JP2002503259A JP2002503259A JP2003535885A JP 2003535885 A JP2003535885 A JP 2003535885A JP 2002503259 A JP2002503259 A JP 2002503259A JP 2002503259 A JP2002503259 A JP 2002503259A JP 2003535885 A JP2003535885 A JP 2003535885A
Authority
JP
Japan
Prior art keywords
gabapentin
suspension
methanol
added
weight
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.)
Pending
Application number
JP2002503259A
Other languages
English (en)
Japanese (ja)
Other versions
JP2003535885A5 (enExample
Inventor
シンガー,クロード
ピラースキ,ギデオン
ペサチョビッチ,マイケル
Original Assignee
テバ ファーマシューティカル インダストリーズ リミティド
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 テバ ファーマシューティカル インダストリーズ リミティド filed Critical テバ ファーマシューティカル インダストリーズ リミティド
Publication of JP2003535885A publication Critical patent/JP2003535885A/ja
Publication of JP2003535885A5 publication Critical patent/JP2003535885A5/ja
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate 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
    • A61K9/145Intimate 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
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00Anaesthetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/08Antiepileptics; Anticonvulsants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/38Separation; Purification; Stabilisation; Use of additives
    • C07C227/40Separation; Purification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/38Separation; Purification; Stabilisation; Use of additives
    • C07C227/44Stabilisation; Use of additives
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D209/00Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D209/56Ring systems containing three or more rings
    • C07D209/96Spiro-condensed ring systems
    • 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
    • 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
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C2601/00Systems containing only non-condensed rings
    • C07C2601/12Systems containing only non-condensed rings with a six-membered ring
    • C07C2601/14The ring being saturated

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Anesthesiology (AREA)
  • Biophysics (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)
JP2002503259A 2000-06-16 2001-06-15 制御された範囲内にpHを持つ安定なギャバペンチン Pending JP2003535885A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US21196600P 2000-06-16 2000-06-16
US60/211,966 2000-06-16
PCT/US2001/019427 WO2001097782A1 (en) 2000-06-16 2001-06-15 Stable gabapentin having ph within a controlled range

Publications (2)

Publication Number Publication Date
JP2003535885A true JP2003535885A (ja) 2003-12-02
JP2003535885A5 JP2003535885A5 (enExample) 2006-01-19

Family

ID=22788986

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2002503259A Pending JP2003535885A (ja) 2000-06-16 2001-06-15 制御された範囲内にpHを持つ安定なギャバペンチン

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) AU6699201A (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)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008519834A (ja) * 2004-11-10 2008-06-12 テバ ファーマシューティカル インダストリーズ リミティド 低水溶性薬物とともに使用することによく適した圧縮固体状投与形態の製造方法およびそれにより製造された圧縮固体状投与形態
US8367106B2 (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

Families Citing this family (13)

* 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
EP1494996A1 (en) * 2002-04-16 2005-01-12 Taro Pharmaceutical Industries Limited Process for preparing gabapentin
KR20050084445A (ko) * 2002-12-20 2005-08-26 다이노젠 파마세우티컬스, 인코포레이티드 α₂δ 서브유닛 칼슘 채널 모듈레이터를 이용한 무통증방광 질환의 치료방법
ES2275229T3 (es) * 2003-03-21 2007-06-01 Dynogen Pharmaceuticals, Inc. Metodos para el tratamiento de desordenes del tracto urinario iferior utilizando antimuscarinos y moduladores de la subunidad alfa-2-delta del canal de calcio.
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
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
WO2008106217A1 (en) * 2007-02-28 2008-09-04 Teva Pharmaceutical Industries Ltd. Preparation of gabapentin by liquid-liquid extraction

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4087544A (en) * 1974-12-21 1978-05-02 Warner-Lambert Company Treatment of cranial dysfunctions using novel cyclic amino acids
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
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
DE3928183A1 (de) * 1989-08-25 1991-02-28 Goedecke Ag Lactamfreie cyclische aminosaeuren
US5132451A (en) * 1989-08-25 1992-07-21 Warner-Lambert Company Process for cyclic amino acid anticonvulsant compounds
MY106864A (en) * 1989-08-25 1995-08-30 Warner Lambert Co Improved 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
FI905584L (fi) * 1989-11-16 1991-05-17 Lonza Ag Foerfarande foer framstaellning av 1-(aminometyl)cyklohexanaettikssyra.
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
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
HU228772B1 (en) * 1998-05-15 2013-05-28 Warner Lambert Co Gamma-aminobutyric acid derivatives containing, solid compositions and process for preparing the same
DK1077692T3 (da) * 1998-05-15 2004-12-06 Warner Lambert Co Aminosyrestabiliserede gabapentin- og pregabalinpræparater og fremgangsmåder til fremstilling deraf
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
PT1289364E (pt) * 2000-06-16 2004-04-30 Teva Pharma Gabapentina estavel contendo mais do que 20 ppm de iao cloreto

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008519834A (ja) * 2004-11-10 2008-06-12 テバ ファーマシューティカル インダストリーズ リミティド 低水溶性薬物とともに使用することによく適した圧縮固体状投与形態の製造方法およびそれにより製造された圧縮固体状投与形態
JP4842960B2 (ja) * 2004-11-10 2011-12-21 テバ ファーマシューティカル インダストリーズ リミティド 低水溶性薬物とともに使用することによく適した圧縮固体状投与形態の製造方法およびそれにより製造された圧縮固体状投与形態
US8367106B2 (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
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
US8597666B2 (en) 2004-11-10 2013-12-03 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

Also Published As

Publication number Publication date
US20020045662A1 (en) 2002-04-18
US20060122271A1 (en) 2006-06-08
NZ523546A (en) 2005-04-29
US20030055109A1 (en) 2003-03-20
KR100667721B1 (ko) 2007-01-15
ZA200210144B (en) 2004-10-08
AU2001266992B8 (en) 2005-12-01
CZ200339A3 (cs) 2003-06-18
WO2001097782A1 (en) 2001-12-27
PL363155A1 (en) 2004-11-15
KR20060123782A (ko) 2006-12-04
EP1294364A1 (en) 2003-03-26
AU6699201A (en) 2002-01-02
IS6654A (is) 2002-12-11
HUP0301919A3 (en) 2006-01-30
IL153441A0 (en) 2003-07-06
HRP20030002A2 (en) 2005-10-31
EP1294364A4 (en) 2004-06-16
CN1447684A (zh) 2003-10-08
HUP0301919A2 (hu) 2003-09-29
KR20030010700A (ko) 2003-02-05
AU2001266992B2 (en) 2005-08-04
CA2411787C (en) 2007-03-20
SK302003A3 (en) 2003-07-01
CA2411787A1 (en) 2001-12-27
US20040147607A1 (en) 2004-07-29
YU95302A (sh) 2006-05-25

Similar Documents

Publication Publication Date Title
JP2003535885A (ja) 制御された範囲内にpHを持つ安定なギャバペンチン
AU689645B2 (en) Salts of nefazodone having improved dissolution rates
NO317371B1 (no) 4-Fenylpiperidinforbindelser
CA2410867C (en) Stable gabapentin containing more than 2o ppm of chlorine ion
AU2001266992A1 (en) Stable gabapentin having pH within a controlled range
JPH07598B2 (ja) 光学的に純粋な化合物およびその製造方法
KR102276281B1 (ko) 의약으로 사용하기 위한 펄린돌 광학이성질체의 약학적으로 허용가능한 염
US20080234323A1 (en) Amorphous and Three Crystalline Forms of Rimonabant Hydrochloride
TW200900392A (en) Novel crystalline bepotastine metal salt hydrate, method for preparing same, and pharmaceutical composition comprising same
CA2164296C (en) Heterocyclic chemistry
MXPA02000033A (es) Polimorfos de un diclorhidrato cristalino de azobiciclo (2, 2, 2)oct-3-ilamina y sus composiciones farmaceuticas.
EP1384473A1 (en) Stable gabapentin containing more than 20 ppm of chlorine ion
KR100295255B1 (ko) 피롤리디닐메틸인돌의염
EP1430893A1 (en) Stable gabapentin containing more than 20 ppm of chloride ion

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20040609

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20040906

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20040906

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20050126

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20080617

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20090106