CA2581143C - Long acting sustained-release formulation containing dopamine receptor agonist and the preparation method thereof - Google Patents

Long acting sustained-release formulation containing dopamine receptor agonist and the preparation method thereof Download PDF

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Publication number
CA2581143C
CA2581143C CA2581143A CA2581143A CA2581143C CA 2581143 C CA2581143 C CA 2581143C CA 2581143 A CA2581143 A CA 2581143A CA 2581143 A CA2581143 A CA 2581143A CA 2581143 C CA2581143 C CA 2581143C
Authority
CA
Canada
Prior art keywords
microspheres
release
pharmaceutically acceptable
acid
rotigotine
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 - Fee Related
Application number
CA2581143A
Other languages
English (en)
French (fr)
Other versions
CA2581143A1 (en
Inventor
Luping Zhang
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.)
Shandong Luye Pharmaceutical Co Ltd
Original Assignee
Shandong Luye Pharmaceutical Co 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 Shandong Luye Pharmaceutical Co Ltd filed Critical Shandong Luye Pharmaceutical Co Ltd
Publication of CA2581143A1 publication Critical patent/CA2581143A1/en
Application granted granted Critical
Publication of CA2581143C publication Critical patent/CA2581143C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Psychology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA2581143A 2004-09-21 2005-09-21 Long acting sustained-release formulation containing dopamine receptor agonist and the preparation method thereof Expired - Fee Related CA2581143C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN200410077961.9 2004-09-21
CN200410077961 2004-09-21
PCT/CN2005/001521 WO2006032202A1 (fr) 2004-09-21 2005-09-21 Formulation à libération lente et prolongée contenant un agoniste du récepteur de la dopamine et son procédé de préparation

Publications (2)

Publication Number Publication Date
CA2581143A1 CA2581143A1 (en) 2006-03-30
CA2581143C true CA2581143C (en) 2015-03-31

Family

ID=36089849

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2581143A Expired - Fee Related CA2581143C (en) 2004-09-21 2005-09-21 Long acting sustained-release formulation containing dopamine receptor agonist and the preparation method thereof

Country Status (9)

Country Link
US (2) US8691277B2 (enExample)
EP (1) EP1797871B1 (enExample)
JP (1) JP5081622B2 (enExample)
KR (1) KR20070059161A (enExample)
AU (1) AU2005287743B2 (enExample)
CA (1) CA2581143C (enExample)
ES (1) ES2536460T3 (enExample)
PL (1) PL1797871T3 (enExample)
WO (1) WO2006032202A1 (enExample)

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US7435738B2 (en) 2003-08-18 2008-10-14 Solvay Pharmaceuticals, Inc. Stable crystalline form of bifeprunox mesylate (7-[4-([1,1′-biphenyl]-3-ylmethyl)-1-piperazinyl]-2(3H)-benzoxazolone monomethanesulfonate)
US7405216B2 (en) 2004-08-18 2008-07-29 Solvay Pharmaceuticals, B.V. Stable crystalline form of bifeprunox mesylate (7-[4-([1,1′-biphenyl]-3-ylmethyl)-1-piperazinyl]-2(3H)-benzoxazolone monomethanesulfonate)
US7964604B2 (en) 2005-02-18 2011-06-21 Solvay Pharmaceuticals B.V. Bifeprunox mesylate maintenance dose compositions and methods for using the same
US7423040B2 (en) 2005-02-18 2008-09-09 Irene Eijgendaal Stable crystalline form of bifeprunox mesylate, dosage forms thereof and methods for using same
US8475829B2 (en) * 2006-04-06 2013-07-02 Nupathe Inc. Implants for the treatment of dopamine associated states
US7786126B2 (en) 2006-06-16 2010-08-31 Solvay Pharmaceuticals B.V. Combination preparations comprising SLV308 and a dopamine agonist
CA2654719A1 (en) * 2006-06-16 2007-12-21 Solvay Pharmaceuticals B.V. Combination preparations comprising slv308 and a l-dopa
US8106056B2 (en) 2006-06-16 2012-01-31 Solvay Pharmaceuticals B.V. Combination preparations comprising bifeprunox and a dopamine agonist
TWI392670B (zh) 2006-06-22 2013-04-11 Ucb Pharma Gmbh 經取代的2-胺基萘滿之於製造用於預防、減緩及/或治療各種類型疼痛之藥物上的用途
WO2008009665A1 (en) * 2006-07-19 2008-01-24 Boehringer Ingelheim International Gmbh Treatment of pain
US20090304794A1 (en) * 2008-06-09 2009-12-10 Supernus Pharmaceuticals, Inc. Controlled release formulations of pramipexole
EP2452677A1 (en) 2008-09-29 2012-05-16 Wockhardt Limited Extended release dosage form of ropinirole
FR2936710B1 (fr) * 2008-10-07 2011-01-07 Ceva Sante Animale Composition veterinaire antiprolactinique destinee aux ruminants
AU2010266285A1 (en) * 2009-07-02 2012-02-09 Supernus Pharmaceuticals, Inc. A method of treatment of a neurological disorder
WO2011012721A1 (en) 2009-07-31 2011-02-03 Ascendis Pharma As Carrier linked pramipexole prodrugs
WO2011012723A1 (en) 2009-07-31 2011-02-03 Ascendis Pharma As Injectable sustained release compositions comprising a pramipexole prodrug
DE102010014113A1 (de) * 2010-04-07 2011-10-13 Acino Ag Freisetzungsverfahren für Implantate
AU2011334494B2 (en) * 2010-11-25 2015-11-05 Geneora Pharma (Shijiazhuang) Co., Ltd. Compositions of rotigotine, derivatives thereof, or pharmaceutically acceptable salts of rotigotine or its derivative
EA201300607A8 (ru) * 2010-12-02 2014-02-28 Ратиофарм Гмбх Ионная жидкость ротиготина
US9956201B2 (en) 2014-07-21 2018-05-01 Spriaso Llc Compositions comprising bioreversible derivatives of hydroxy N-substituted-2-aminotetralins, and related dosage forms
WO2018096560A1 (en) 2016-11-23 2018-05-31 Cipla Limited Long acting depot formulation for the continuous dopaminergic stimulation
WO2019234069A1 (en) 2018-06-08 2019-12-12 Boehringer Ingelheim Vetmedica Gmbh Liquid pharmaceutical compositions comprising pergolide
KR102212722B1 (ko) * 2019-12-23 2021-02-08 환인제약 주식회사 로피니롤을 포함하는 마이크로스피어 및 이를 함유하는 주사제 조성물

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US4166800A (en) * 1977-08-25 1979-09-04 Sandoz, Inc. Processes for preparation of microspheres
JP2651320B2 (ja) 1992-07-16 1997-09-10 田辺製薬株式会社 徐放性マイクロスフェア製剤の製造方法
DE69734060T2 (de) * 1996-05-24 2006-06-29 Angiotech Pharmaceuticals, Inc., Vancouver Zubereitungen und verfahren zur behandlung oder prävention von krankheiten der körperpassagewege
EP0930874A2 (en) 1996-10-09 1999-07-28 Takeda Chemical Industries, Ltd. A method for producing a microparticle
JPH10167968A (ja) * 1996-10-09 1998-06-23 Takeda Chem Ind Ltd マイクロパーティクルの製造法
PT949905E (pt) * 1996-12-20 2001-12-28 Alza Corp Composicao de gel injectavel de efeito retardado e processo para a sua preparacao
JP3663271B2 (ja) * 1997-01-24 2005-06-22 シュバルツ ファルマ アクチェンゲゼルシャフト 新規の分枝鎖エステル及びその製法
ATE428371T1 (de) * 1998-07-17 2009-05-15 Pacira Pharmaceuticals Inc Biologisch abbaubare anordnungen zur kontrollierten freigabe eingeschlossener substanzen
US6455526B1 (en) * 1998-12-16 2002-09-24 Aventis Pharmaceuticals, Inc. Biodegradable polymer encapsulated pharmaceutical compositions and method for preparing the same
MEP19408A (en) * 1998-12-16 2010-06-10 Aventis Pharma Inc Biodegradable polymer encapsulated serotonin receptor antagonist and method for preparing the same
GB9828861D0 (en) * 1998-12-31 1999-02-17 Danbiosyst Uk Compositions
JP4540280B2 (ja) 1999-07-09 2010-09-08 ベーテーエス ホールディング インターナショナル ベー ヴィ 光学走査装置
JP4287613B2 (ja) 2000-04-28 2009-07-01 田辺三菱製薬株式会社 マイクロスフェアの製法
DE10041479A1 (de) * 2000-08-24 2002-03-14 Sanol Arznei Schwarz Gmbh Neue pharmazeutische Zusammensetzung zur Verabreichung von N-0923
DE10055742B4 (de) * 2000-11-10 2006-05-11 Schwarz Pharma Ag Neue Polyester, Verfahren zu ihrer Herstellung und aus den Polyestern hergestellte Depot-Arzneiformen
KR20040005936A (ko) * 2001-04-26 2004-01-16 컨트롤 딜리버리 시스템즈 인코포레이티드 공동약물을 함유하는 서방 약물 전달 시스템
EP1572154B1 (en) * 2002-11-18 2012-02-01 Rutgers, The State University of New Jersey Medical devices employing novel polymers
EP1610791B1 (en) * 2003-03-31 2011-02-23 Titan Pharmaceuticals, Inc. Implantable polymeric device for sustained release of dopamine agonist
DE10334188B4 (de) * 2003-07-26 2007-07-05 Schwarz Pharma Ag Verwendung von Rotigotin zur Behandlung von Depressionen

Also Published As

Publication number Publication date
EP1797871A4 (en) 2012-11-28
WO2006032202A1 (fr) 2006-03-30
US20080260846A1 (en) 2008-10-23
US8691277B2 (en) 2014-04-08
ES2536460T3 (es) 2015-05-25
US9220782B2 (en) 2015-12-29
JP2008513524A (ja) 2008-05-01
CA2581143A1 (en) 2006-03-30
JP5081622B2 (ja) 2012-11-28
EP1797871A1 (en) 2007-06-20
KR20070059161A (ko) 2007-06-11
HK1107012A1 (en) 2008-03-28
AU2005287743B2 (en) 2011-09-29
EP1797871B1 (en) 2015-02-25
PL1797871T3 (pl) 2015-07-31
AU2005287743A1 (en) 2006-03-30
US20140255488A1 (en) 2014-09-11

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Effective date: 20210921