FR2781793B1 - Procede de fabrication de granules de gabapentine enrobes - Google Patents

Procede de fabrication de granules de gabapentine enrobes

Info

Publication number
FR2781793B1
FR2781793B1 FR9810091A FR9810091A FR2781793B1 FR 2781793 B1 FR2781793 B1 FR 2781793B1 FR 9810091 A FR9810091 A FR 9810091A FR 9810091 A FR9810091 A FR 9810091A FR 2781793 B1 FR2781793 B1 FR 2781793B1
Authority
FR
France
Prior art keywords
gabapentine
granules
producing coated
coated
producing
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.)
Expired - Lifetime
Application number
FR9810091A
Other languages
English (en)
Other versions
FR2781793A1 (fr
Inventor
Etienne Bruna
Edouard Gendrot
Charles Chauveau
Alain Gilles Demichelis
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.)
Laboratories Prographarm SA
Original Assignee
Laboratories Prographarm SA
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 FR9810091A priority Critical patent/FR2781793B1/fr
Application filed by Laboratories Prographarm SA filed Critical Laboratories Prographarm SA
Priority to NZ509980A priority patent/NZ509980A/en
Priority to PCT/FR1999/001811 priority patent/WO2000007568A1/fr
Priority to AU49160/99A priority patent/AU742701B2/en
Priority to EP99932956A priority patent/EP1100467A1/fr
Priority to CA002338173A priority patent/CA2338173A1/fr
Priority to CN99811672A priority patent/CN1321083A/zh
Priority to JP2000563254A priority patent/JP2002522375A/ja
Priority to PE1999000772A priority patent/PE20001030A1/es
Priority to ARP990103853A priority patent/AR021746A1/es
Publication of FR2781793A1 publication Critical patent/FR2781793A1/fr
Priority to ZA200100943A priority patent/ZA200100943B/en
Priority to US09/777,490 priority patent/US6488964B2/en
Application granted granted Critical
Publication of FR2781793B1 publication Critical patent/FR2781793B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
FR9810091A 1998-08-03 1998-08-03 Procede de fabrication de granules de gabapentine enrobes Expired - Lifetime FR2781793B1 (fr)

Priority Applications (12)

Application Number Priority Date Filing Date Title
FR9810091A FR2781793B1 (fr) 1998-08-03 1998-08-03 Procede de fabrication de granules de gabapentine enrobes
JP2000563254A JP2002522375A (ja) 1998-08-03 1999-07-23 被覆ギャバペンチンまたはプレギャバリン粒子の製造方法
AU49160/99A AU742701B2 (en) 1998-08-03 1999-07-23 Method for making coated gabapentine or pregabaline particles
EP99932956A EP1100467A1 (fr) 1998-08-03 1999-07-23 Procede de fabrication de particules de gabapentine ou de pregabaline enrobees
CA002338173A CA2338173A1 (fr) 1998-08-03 1999-07-23 Procede de fabrication de particules de gabapentine ou de pregabaline enrobees
CN99811672A CN1321083A (zh) 1998-08-03 1999-07-23 加巴喷丁或pregabaline包衣颗粒的制备方法
NZ509980A NZ509980A (en) 1998-08-03 1999-07-23 Method for making coated gabapentine or pregabaline particles
PCT/FR1999/001811 WO2000007568A1 (fr) 1998-08-03 1999-07-23 Procede de fabrication de particules de gabapentine ou de pregabaline enrobees
PE1999000772A PE20001030A1 (es) 1998-08-03 1999-08-02 Procedimiento de fabricacion de particulas de gabapentina o de pregabalina recubiertas
ARP990103853A AR021746A1 (es) 1998-08-03 1999-08-03 Procedimiento de fabricacion de particulas recubiertas de gabapentina o de pregabalina.
ZA200100943A ZA200100943B (en) 1998-08-03 2001-02-02 Method for making coated gabapentine or pregabaline particles.
US09/777,490 US6488964B2 (en) 1998-08-03 2001-02-05 Process for manufacturing coated gabapentin or pregabalin particles

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR9810091A FR2781793B1 (fr) 1998-08-03 1998-08-03 Procede de fabrication de granules de gabapentine enrobes

Publications (2)

Publication Number Publication Date
FR2781793A1 FR2781793A1 (fr) 2000-02-04
FR2781793B1 true FR2781793B1 (fr) 2001-07-20

Family

ID=9529443

Family Applications (1)

Application Number Title Priority Date Filing Date
FR9810091A Expired - Lifetime FR2781793B1 (fr) 1998-08-03 1998-08-03 Procede de fabrication de granules de gabapentine enrobes

Country Status (12)

Country Link
US (1) US6488964B2 (fr)
EP (1) EP1100467A1 (fr)
JP (1) JP2002522375A (fr)
CN (1) CN1321083A (fr)
AR (1) AR021746A1 (fr)
AU (1) AU742701B2 (fr)
CA (1) CA2338173A1 (fr)
FR (1) FR2781793B1 (fr)
NZ (1) NZ509980A (fr)
PE (1) PE20001030A1 (fr)
WO (1) WO2000007568A1 (fr)
ZA (1) ZA200100943B (fr)

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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
EP1384473A1 (fr) * 2000-06-16 2004-01-28 Teva Pharmaceutical Industries Ltd. Gabapentin stable contenant plus de 20 ppm d'ions chlore
KR100667721B1 (ko) * 2000-06-16 2007-01-15 테바 파마슈티컬 인더스트리즈 리미티드 제어 범위 내의 ph를 갖는 안정한 가바펜틴
EP1430893A1 (fr) * 2000-06-16 2004-06-23 Teva Pharmaceutical Industries Ltd. Gabapentin stable contenant plus de 20 ppm d'ions chlore
PT1289364E (pt) 2000-06-16 2004-04-30 Teva Pharma Gabapentina estavel contendo mais do que 20 ppm de iao cloreto
US7056951B2 (en) 2000-09-26 2006-06-06 Mutual Pharmaceutical Co., Inc. Stable solid dosage forms of amino acids and processes for producing same
US7022678B2 (en) * 2001-03-30 2006-04-04 Warner-Lambert Company Pregabalin lactose conjugates
US7612112B2 (en) 2001-10-25 2009-11-03 Depomed, Inc. Methods of treatment using a gastric retained gabapentin dosage
US20070184104A1 (en) * 2001-10-25 2007-08-09 Depomed, Inc. Gastric retentive gabapentin dosage forms and methods for using same
US20060159743A1 (en) * 2001-10-25 2006-07-20 Depomed, Inc. Methods of treating non-nociceptive pain states with gastric retentive gabapentin
TWI312285B (en) * 2001-10-25 2009-07-21 Depomed Inc Methods of treatment using a gastric retained gabapentin dosage
WO2003103634A1 (fr) * 2002-06-07 2003-12-18 Ranbaxy Laboratories Limited Formes posologiques orales a liberation prolongee de gabapentine
FR2851734B1 (fr) * 2003-02-28 2006-06-09 Galenix Innovations Procede pour la fabrication d'une composition pharmaceutique sous la forme de comprimes contenant un fibrate et comprimes obtenus selon le procede
ATE465718T1 (de) 2003-05-02 2010-05-15 Globopharm Pharmazeutische Pro Feste pharmazeutische zubereitung enthaltend levothyroxin- und/oder liothyroninsalze
WO2005046566A2 (fr) * 2003-08-04 2005-05-26 Sun Pharmaceutical Industries Limited Composition pharmaceutique stable
WO2005020978A1 (fr) * 2003-09-03 2005-03-10 Ranbaxy Laboratories Limited Comprimes de gabapentine a liberation prolongee et a administration par voie orale et leurs procedes de preparation
ITMI20032399A1 (it) * 2003-12-09 2005-06-10 Zambon Spa Composizione farmaceutica contenente gabapentina.
KR20070116588A (ko) * 2005-01-21 2007-12-10 파마노바 인코포레이티드 약제학적 제형 및 이용 방법
CN101160281A (zh) * 2005-04-06 2008-04-09 特瓦制药工业有限公司 结晶形态的普瑞巴林
US7488846B2 (en) * 2005-04-11 2009-02-10 Teva Pharmaceuical Industries Ltd. Pregabalin free of lactam and a process for preparation thereof
WO2006110783A2 (fr) * 2005-04-11 2006-10-19 Teva Pharmaceutical Industries Ltd. Procede de fabrication de (s)-pregabaline
ATE486841T1 (de) * 2005-05-10 2010-11-15 Teva Pharma Verfahren zur herstellung von pregabalin und salzen daraus
MX2007000525A (es) * 2005-05-10 2007-03-28 Teva Pharma Pregabalina libre de acido isobutilglutarico y un proceso para la preparacion de ella.
WO2006121557A1 (fr) * 2005-05-10 2006-11-16 Teva Pharmaceutical Industries Ltd. Pregabaline exempte de lactame et son procede de preparation
EP1879854B1 (fr) * 2005-05-10 2011-09-07 Teva Pharmaceutical Industries Ltd Resolution optique de l'acide 3-carbamoylmethyl-5-methyl hexanoique
KR20080034205A (ko) * 2005-09-19 2008-04-18 테바 파마슈티컬 인더스트리즈 리미티드 (s)-프레가발린의 신규한 합성을 위한 주요 중간체인 키랄3-카르바모일메틸-5-메틸 헥산산
US20090176882A1 (en) * 2008-12-09 2009-07-09 Depomed, Inc. Gastric retentive gabapentin dosage forms and methods for using same
EP2019817A2 (fr) * 2006-05-24 2009-02-04 Teva Pharmaceutical Industries Ltd. Procédés pour la préparation d'acide r-(+)-3-(carbamoyl méthyl)-5-méthylhexanoïque et de sels de celui-ci
WO2007143113A2 (fr) * 2006-05-31 2007-12-13 Teva Pharmaceutical Industries Ltd. Utilisation de la résolution enzymatique pour la préparation d'intermédiaires de prégabaline
US20080015385A1 (en) * 2006-05-31 2008-01-17 Lilach Hedvati Preparation of (S)-pregabalin-nitrile
GB0616794D0 (en) * 2006-08-24 2006-10-04 Arrow Int Ltd Solid dosage form
TW200846308A (en) * 2007-03-22 2008-12-01 Teva Pharma Synthesis of (s)-(+)-3-(aminomethyl)-5-methyl hexanoic acid
CA2682661C (fr) 2007-03-22 2017-03-14 Dendreon Corporation Procedes d'induction d'une reponse immunitaire mediee par des cellules tueuses naturelles (nk) et d'augmentation de l'activite des cellules nk
US20090137842A1 (en) * 2007-10-03 2009-05-28 Vollerner Yuri Pregabalin -4-eliminate, pregabalin 5-eliminate, their use as reference marker and standard, and method to produce pregabalin containing low levels thereof
WO2009066325A1 (fr) * 2007-11-23 2009-05-28 Lupin Limited Compositions pharmaceutiques de prégabaline à libération contrôlée
EP2116618A1 (fr) 2008-05-09 2009-11-11 Agency for Science, Technology And Research Diagnostic et traitement de la maladie de Kawasaki
KR20100107500A (ko) * 2008-06-23 2010-10-05 테바 파마슈티컬 인더스트리즈 리미티드 (s) 또는 (r)-이소-부틸-글루타릭 에스테르의 입체선택적 효소 합성방법
WO2010150221A1 (fr) 2009-06-25 2010-12-29 Wockhardt Research Centre Compositions pharmaceutiques de prégabaline de saveur masquée
TR200909613A1 (tr) * 2009-12-22 2011-07-21 Sanovel İlaç San. Ve Ti̇c. A.Ş. Pregabalinin farmasötik bileşimleri.
HU230031B1 (hu) 2010-03-01 2015-05-28 Egis Gyógyszergyár Nyilvánosan Működő Részvénytársaság Pregabalint és izomaltot tartalmazó stabilizált gyógyszerkészítmény
WO2013100873A1 (fr) * 2011-12-19 2013-07-04 Mahmut Bilgic Formulation pharmaceutique de prégabaline (taille de particules 300-2500 micromètres)
KR102221846B1 (ko) * 2014-04-07 2021-02-26 영진약품 주식회사 안정성이 개선된 프레가발린을 함유하는 약제학적 조성물 및 이의 제조방법
JP6919119B2 (ja) * 2017-01-23 2021-08-18 日新製薬株式会社 3位が置換されたγ−アミノ酪酸誘導体を含有する圧縮固形医薬組成物。
DK3760190T3 (da) 2019-07-03 2023-09-04 Alvogen Inc Tabletter af pregabalin med forlænget frigivelse, fremgangsmåde til fremstilling og fremgangsmåde til anvendelse deraf
CN112843015A (zh) * 2021-04-08 2021-05-28 海南鑫开源医药科技有限公司 一种加巴喷丁胶囊制剂及其制备方法

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Also Published As

Publication number Publication date
ZA200100943B (en) 2001-09-05
PE20001030A1 (es) 2000-10-12
AU742701B2 (en) 2002-01-10
AR021746A1 (es) 2002-08-07
JP2002522375A (ja) 2002-07-23
WO2000007568A1 (fr) 2000-02-17
US20020012679A1 (en) 2002-01-31
FR2781793A1 (fr) 2000-02-04
NZ509980A (en) 2003-07-25
CA2338173A1 (fr) 2000-02-17
AU4916099A (en) 2000-02-28
EP1100467A1 (fr) 2001-05-23
US6488964B2 (en) 2002-12-03
CN1321083A (zh) 2001-11-07

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