AU2009206204B2 - Delayed release pharmaceutical composition of duloxetine - Google Patents

Delayed release pharmaceutical composition of duloxetine Download PDF

Info

Publication number
AU2009206204B2
AU2009206204B2 AU2009206204A AU2009206204A AU2009206204B2 AU 2009206204 B2 AU2009206204 B2 AU 2009206204B2 AU 2009206204 A AU2009206204 A AU 2009206204A AU 2009206204 A AU2009206204 A AU 2009206204A AU 2009206204 B2 AU2009206204 B2 AU 2009206204B2
Authority
AU
Australia
Prior art keywords
duloxetine
enteric
particle size
coat
composition according
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.)
Ceased
Application number
AU2009206204A
Other languages
English (en)
Other versions
AU2009206204A1 (en
Inventor
Phillip John Ferguson
Panagiotis Keramidas
Brett Antony Mooney
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.)
Alphapharm Pty Ltd
Original Assignee
Alphapharm Pty 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
Priority claimed from AU2008900332A external-priority patent/AU2008900332A0/en
Application filed by Alphapharm Pty Ltd filed Critical Alphapharm Pty Ltd
Priority to AU2009206204A priority Critical patent/AU2009206204B2/en
Publication of AU2009206204A1 publication Critical patent/AU2009206204A1/en
Application granted granted Critical
Publication of AU2009206204B2 publication Critical patent/AU2009206204B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/38Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/381Heterocyclic compounds having sulfur as a ring hetero atom having five-membered rings
    • 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
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • 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]
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2009206204A 2008-01-25 2009-01-09 Delayed release pharmaceutical composition of duloxetine Ceased AU2009206204B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2009206204A AU2009206204B2 (en) 2008-01-25 2009-01-09 Delayed release pharmaceutical composition of duloxetine

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
AU2008900332A AU2008900332A0 (en) 2008-01-25 Delayed Release Composition and Compound
AU2008900332 2008-01-25
AU2009206204A AU2009206204B2 (en) 2008-01-25 2009-01-09 Delayed release pharmaceutical composition of duloxetine
PCT/AU2009/000028 WO2009092129A1 (en) 2008-01-25 2009-01-09 Delayed release pharmaceutical composition of duloxetine

Publications (2)

Publication Number Publication Date
AU2009206204A1 AU2009206204A1 (en) 2009-07-30
AU2009206204B2 true AU2009206204B2 (en) 2015-03-19

Family

ID=40900727

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2009206204A Ceased AU2009206204B2 (en) 2008-01-25 2009-01-09 Delayed release pharmaceutical composition of duloxetine

Country Status (7)

Country Link
US (1) US20110070299A1 (https=)
EP (1) EP2240173A4 (https=)
JP (1) JP2011510024A (https=)
CN (1) CN101939004A (https=)
AU (1) AU2009206204B2 (https=)
CA (1) CA2712282A1 (https=)
WO (1) WO2009092129A1 (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8663661B2 (en) 2009-12-23 2014-03-04 Ratiopharm Gmbh Solid pharmaceutical dosage form of ticagrelor
CN102908331A (zh) * 2011-08-01 2013-02-06 浙江九洲药物科技有限公司 一种盐酸度洛西汀肠溶胶囊及其制备方法
EP2567959B1 (en) 2011-09-12 2014-04-16 Sanofi 6-(4-hydroxy-phenyl)-3-styryl-1h-pyrazolo[3,4-b]pyridine-4-carboxylic acid amide derivatives as kinase inhibitors
CN102579403B (zh) * 2011-12-26 2013-08-21 天津市嵩锐医药科技有限公司 盐酸度洛西汀药物组合物
US8313774B1 (en) * 2012-06-26 2012-11-20 Magnifica Inc. Oral solid composition
CN103127023B (zh) * 2013-03-01 2014-08-27 河北天成药业股份有限公司 一种盐酸度洛西汀肠溶片及其制备方法
GR1008228B (el) * 2013-04-23 2014-06-16 "Φαρματεν Α.Β.Ε.Ε.", Φαρμακευτικο σκευασμα περιεχον ενα διπλο αναστολεα επαναπροσληψης και μεθοδος για την παρασκευη αυτου
CN103393615B (zh) * 2013-07-24 2015-07-15 海南华益泰康药业有限公司 一种度洛西汀肠溶小丸及其制备方法
CN104414993A (zh) * 2013-08-20 2015-03-18 天津药物研究院 一种盐酸度洛西汀肠溶微丸胶囊及其制备方法
JP6815109B2 (ja) * 2016-06-23 2021-01-20 キョーリンリメディオ株式会社 デュロキセチンまたは薬学的に許容されるその塩を有効成分とする医薬組成物
JP6972674B2 (ja) * 2017-06-06 2021-11-24 ニプロ株式会社 経口医薬製剤
JP7046323B2 (ja) * 2017-09-13 2022-04-04 アリメント工業株式会社 多層被覆製剤
JP2020029447A (ja) * 2018-06-25 2020-02-27 大原薬品工業株式会社 腸溶性高分子及び抗付着剤を含有する顆粒
WO2021126098A1 (en) * 2019-12-18 2021-06-24 Santa Farma İlaç Sanayi̇ A.Ş. Gastro-resistant pellet comprising duloxetine
CN116617189B (zh) * 2023-07-26 2023-09-26 四川尚锐生物医药有限公司 一种盐酸度洛西汀缓释胶囊及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5508276A (en) * 1994-07-18 1996-04-16 Eli Lilly And Company Duloxetine enteric pellets
WO2002024160A2 (en) * 2000-09-21 2002-03-28 Phase 2 Discovery, Inc. Long acting antidepressant microparticles
WO2003094900A1 (en) * 2002-05-13 2003-11-20 Alexza Molecular Delivery Corporation Delivery of drug amines through an inhalation route
US20040058896A1 (en) * 2000-12-07 2004-03-25 Rango Dietrich Pharmaceutical preparation comprising an active dispersed on a matrix
WO2008077939A2 (en) * 2006-12-27 2008-07-03 Lek Pharmaceuticals D.D. Duloxetine composition

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4956388A (en) * 1986-12-22 1990-09-11 Eli Lilly And Company 3-aryloxy-3-substituted propanamines
US5009895A (en) * 1990-02-02 1991-04-23 Merck & Co., Inc. Sustained release with high and low viscosity HPMC
US5362886A (en) * 1993-10-12 1994-11-08 Eli Lilly And Company Asymmetric synthesis
ZA977967B (en) * 1996-09-23 1999-03-04 Lilly Co Eli Combination therapy for treatment of psychoses
CA2362185C (en) * 1999-04-09 2009-06-02 Eli Lilly And Company Methods for preparing 3-aryloxy-3-arylpropylamines and intermediates thereof
US6420473B1 (en) * 2000-02-10 2002-07-16 Bpsi Holdings, Inc. Acrylic enteric coating compositions
AU2003287499A1 (en) * 2002-11-19 2004-06-15 Eli Lilly And Company Treatment of gastrointestinal disorders with duloxetine
US7625932B2 (en) * 2003-10-08 2009-12-01 Eli Lilly And Company Pyrrole and pyrazole derivatives as potentiators of glutamate receptors
US20050250838A1 (en) * 2004-05-04 2005-11-10 Challapalli Prasad V Formulation for sustained delivery
KR20070087678A (ko) * 2004-12-20 2007-08-28 컬리지움 파마슈티칼, 인코포레이티드 수면 장애용 약제 조성물
US20100285123A1 (en) * 2005-06-20 2010-11-11 Rudresha Korlakunte Virupakshalah Prasad Controlled Release Dosage Formulation of Duloxetine
WO2007077580A2 (en) 2006-01-06 2007-07-12 Msn Laboratories Limited Improved process for pure duloxetine hydrochloride
EP1820800A1 (en) * 2006-02-17 2007-08-22 KRKA, tovarna zdravil, d.d., Novo mesto Crystalline forms of duloxetine hydrochloride and processes for their preparation
KR20090005237A (ko) * 2006-05-22 2009-01-12 테바 파마슈티컬 인더스트리즈 리미티드 둘록세틴 염산염 지연 방출형 제제

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5508276A (en) * 1994-07-18 1996-04-16 Eli Lilly And Company Duloxetine enteric pellets
WO2002024160A2 (en) * 2000-09-21 2002-03-28 Phase 2 Discovery, Inc. Long acting antidepressant microparticles
US20040058896A1 (en) * 2000-12-07 2004-03-25 Rango Dietrich Pharmaceutical preparation comprising an active dispersed on a matrix
WO2003094900A1 (en) * 2002-05-13 2003-11-20 Alexza Molecular Delivery Corporation Delivery of drug amines through an inhalation route
WO2008077939A2 (en) * 2006-12-27 2008-07-03 Lek Pharmaceuticals D.D. Duloxetine composition

Also Published As

Publication number Publication date
WO2009092129A8 (en) 2009-10-22
CN101939004A (zh) 2011-01-05
AU2009206204A1 (en) 2009-07-30
EP2240173A4 (en) 2013-07-17
WO2009092129A1 (en) 2009-07-30
US20110070299A1 (en) 2011-03-24
JP2011510024A (ja) 2011-03-31
CA2712282A1 (en) 2009-07-30
EP2240173A1 (en) 2010-10-20

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FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired