HUP0301919A2 - Szabályozott pH tartományban levż stabil gabapentin - Google Patents

Szabályozott pH tartományban levż stabil gabapentin

Info

Publication number
HUP0301919A2
HUP0301919A2 HU0301919A HUP0301919A HUP0301919A2 HU P0301919 A2 HUP0301919 A2 HU P0301919A2 HU 0301919 A HU0301919 A HU 0301919A HU P0301919 A HUP0301919 A HU P0301919A HU P0301919 A2 HUP0301919 A2 HU P0301919A2
Authority
HU
Hungary
Prior art keywords
gabapentin
stable
controlled range
stable gabapentin
weight
Prior art date
Application number
HU0301919A
Other languages
English (en)
Inventor
Mihael Pesachovich
Gideon Pilarski
Claude Singer
Original Assignee
Teva Pharmaceutical Industries Ltd.
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 Pharmaceutical Industries Ltd. filed Critical Teva Pharmaceutical Industries Ltd.
Publication of HUP0301919A2 publication Critical patent/HUP0301919A2/hu
Publication of HUP0301919A3 publication Critical patent/HUP0301919A3/hu

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)
  • Molecular Biology (AREA)
  • Anesthesiology (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)

Abstract

Gyakorlatilag tiszta és stabil gabapentint tartalmazó olyangyógyszerkészítmény, amelynek a kezdeti időpontban a megfelelőlaktámból kisebb, mint 0,5 tömeg%-nyi mennyiséget tartalmaz, a pH-ja6,8 és 7,3 közötti tartományban van, és egy évig 25 °C-on, 60%páratartalom mellett történő tárolás után a gabapentinnek a megfelelőlaktámmá történő konverziója nem lépi túl a gabapentinrevonatkoztatott 0,2 tömeg% értéket. Ó
HU0301919A 2000-06-16 2001-06-15 Stable gabapentin having ph within a controlled range HUP0301919A3 (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 (2)

Publication Number Publication Date
HUP0301919A2 true HUP0301919A2 (hu) 2003-09-29
HUP0301919A3 HUP0301919A3 (en) 2006-01-30

Family

ID=22788986

Family Applications (1)

Application Number Title Priority Date Filing Date
HU0301919A HUP0301919A3 (en) 2000-06-16 2001-06-15 Stable gabapentin having ph within a controlled range

Country Status (18)

Country Link
US (4) US20020045662A1 (hu)
EP (1) EP1294364A4 (hu)
JP (1) JP2003535885A (hu)
KR (2) KR100667721B1 (hu)
CN (1) CN1447684A (hu)
AU (2) AU2001266992B8 (hu)
CA (1) CA2411787C (hu)
CZ (1) CZ200339A3 (hu)
HR (1) HRP20030002A2 (hu)
HU (1) HUP0301919A3 (hu)
IL (1) IL153441A0 (hu)
IS (1) IS6654A (hu)
NZ (1) NZ523546A (hu)
PL (1) PL363155A1 (hu)
SK (1) SK302003A3 (hu)
WO (1) WO2001097782A1 (hu)
YU (1) YU95302A (hu)
ZA (1) ZA200210144B (hu)

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
TWI312285B (en) 2001-10-25 2009-07-21 Depomed Inc Methods of treatment using a gastric retained gabapentin dosage
US7612112B2 (en) 2001-10-25 2009-11-03 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
US20040034248A1 (en) * 2002-04-16 2004-02-19 Taro Pharmaceutical Industries, Ltd. Process for preparing gabapentin
JP2006511624A (ja) * 2002-12-20 2006-04-06 ダイノジェン ファーマシューティカルズ， インコーポレイテッド α２δサブユニット・カルシウム・チャンネル調節因子を使用する無痛性膀胱障害を処置するための方法
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
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
WO2006052254A2 (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

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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
US4960931A (en) * 1988-05-02 1990-10-02 Warner-Lambert Company Gabapentin mohohydrate and a process for producing the same
US4894476A (en) * 1988-05-02 1990-01-16 Warner-Lambert Company Gabapentin monohydrate and a process for producing the same
DE3928183A1 (de) * 1989-08-25 1991-02-28 Goedecke Ag Lactamfreie cyclische aminosaeuren
US5319135A (en) * 1989-08-25 1994-06-07 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
US5132451A (en) * 1989-08-25 1992-07-21 Warner-Lambert Company Process for cyclic amino acid anticonvulsant compounds
DE3928184A1 (de) * 1989-08-25 1991-02-28 Goedecke Ag Verfahren zur herstellung von cyclischen aminosaeurederivaten sowie zwischenprodukte
FI107914B (fi) * 1989-08-25 2001-10-31 Warner Lambert Co Parannettu menetelmä syklisten aminohappoyhdisteiden valmistamiseksi ja menetelmässä käytettävä välituote
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
FI905584A (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
AU9318398A (en) * 1997-10-07 1999-04-27 Warner-Lambert Company Process for preparing a cyclic amino acid anticonvulsant compound
BR9910508B1 (pt) * 1998-05-15 2012-01-24 preparações farmacêuticas estabilizadas de derivados de ácido gama-aminobutìrico.
AU769038B2 (en) * 1998-05-15 2004-01-15 Warner-Lambert Company Llc Gamma-aminobutyric acid derivatives containing, solid compositions 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
PT1289364E (pt) * 2000-06-16 2004-04-30 Teva Pharma Gabapentina estavel contendo mais do que 20 ppm de iao cloreto

Also Published As

Publication number Publication date
AU2001266992B8 (en) 2005-12-01
HUP0301919A3 (en) 2006-01-30
CZ200339A3 (cs) 2003-06-18
US20060122271A1 (en) 2006-06-08
KR20060123782A (ko) 2006-12-04
CN1447684A (zh) 2003-10-08
CA2411787C (en) 2007-03-20
SK302003A3 (en) 2003-07-01
WO2001097782A1 (en) 2001-12-27
KR20030010700A (ko) 2003-02-05
CA2411787A1 (en) 2001-12-27
US20020045662A1 (en) 2002-04-18
EP1294364A4 (en) 2004-06-16
NZ523546A (en) 2005-04-29
US20040147607A1 (en) 2004-07-29
YU95302A (sh) 2006-05-25
EP1294364A1 (en) 2003-03-26
IL153441A0 (en) 2003-07-06
KR100667721B1 (ko) 2007-01-15
PL363155A1 (en) 2004-11-15
ZA200210144B (en) 2004-10-08
AU2001266992B2 (en) 2005-08-04
US20030055109A1 (en) 2003-03-20
HRP20030002A2 (en) 2005-10-31
JP2003535885A (ja) 2003-12-02
AU6699201A (en) 2002-01-02
IS6654A (is) 2002-12-11

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Legal Events

Date Code Title Description
FD9A Lapse of provisional protection due to non-payment of fees