AU2016209420B2 - Levodopa and carbidopa intestinal gel and methods of use - Google Patents

Levodopa and carbidopa intestinal gel and methods of use Download PDF

Info

Publication number
AU2016209420B2
AU2016209420B2 AU2016209420A AU2016209420A AU2016209420B2 AU 2016209420 B2 AU2016209420 B2 AU 2016209420B2 AU 2016209420 A AU2016209420 A AU 2016209420A AU 2016209420 A AU2016209420 A AU 2016209420A AU 2016209420 B2 AU2016209420 B2 AU 2016209420B2
Authority
AU
Australia
Prior art keywords
pharmaceutical composition
active agent
carbidopa
levodopa
less
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.)
Active
Application number
AU2016209420A
Other languages
English (en)
Other versions
AU2016209420A1 (en
Inventor
Rajkumar Conjeevaram
Alexandru Deac
Ye Huang
Sean E. MACKEY
Randy A. Menges
Jayne B. ZIMMERMAN
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.)
AbbVie Inc
Original Assignee
AbbVie Inc
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 AbbVie Inc filed Critical AbbVie Inc
Publication of AU2016209420A1 publication Critical patent/AU2016209420A1/en
Application granted granted Critical
Publication of AU2016209420B2 publication Critical patent/AU2016209420B2/en
Active 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
    • A61K9/10Dispersions; Emulsions
    • 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
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physiology (AREA)
  • Dispersion Chemistry (AREA)
  • Nutrition Science (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Psychology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
AU2016209420A 2015-01-20 2016-01-20 Levodopa and carbidopa intestinal gel and methods of use Active AU2016209420B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562105565P 2015-01-20 2015-01-20
US62/105,565 2015-01-20
US201562272922P 2015-12-30 2015-12-30
US62/272,922 2015-12-30
PCT/US2016/014005 WO2016118556A1 (en) 2015-01-20 2016-01-20 Levodopa and carbidopa intestinal gel and methods of use

Publications (2)

Publication Number Publication Date
AU2016209420A1 AU2016209420A1 (en) 2017-08-03
AU2016209420B2 true AU2016209420B2 (en) 2021-05-20

Family

ID=55410198

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2016209420A Active AU2016209420B2 (en) 2015-01-20 2016-01-20 Levodopa and carbidopa intestinal gel and methods of use

Country Status (16)

Country Link
US (3) US10117843B2 (enExample)
EP (2) EP3247330A1 (enExample)
JP (4) JP2018503686A (enExample)
KR (1) KR20170103967A (enExample)
CN (2) CN107427463A (enExample)
AU (1) AU2016209420B2 (enExample)
BR (1) BR112017015613B1 (enExample)
CA (1) CA2974203A1 (enExample)
IL (1) IL253487A0 (enExample)
MA (1) MA41377A (enExample)
MX (1) MX384262B (enExample)
PH (1) PH12017501304A1 (enExample)
RU (1) RU2017129375A (enExample)
SG (1) SG11201705964YA (enExample)
TW (1) TW201639556A (enExample)
WO (1) WO2016118556A1 (enExample)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI755257B (zh) 2014-10-21 2022-02-11 美商艾伯維有限公司 卡比多巴及左旋多巴之前藥及使用方法
MA41377A (fr) * 2015-01-20 2017-11-28 Abbvie Inc Gel intestinal de lévodopa et de carbidona et procédés d'utilisation
KR20180004756A (ko) 2015-05-06 2018-01-12 신애질 코포레이션 약물 입자를 함유하는 제약 현탁액, 그의 투여를 위한 장치, 및 그의 사용 방법
WO2018017850A1 (en) * 2016-07-20 2018-01-25 Abbvie Inc. Levodopa and carbidopa intestinal gel and methods of use
EP3880210A1 (en) 2018-11-15 2021-09-22 Abbvie Inc. Pharmaceutical formulations for subcutaneous administration
CN119510592A (zh) * 2023-08-22 2025-02-25 上海汉都医药科技有限公司 一种含有卡比多巴的药物中肼含量的检测方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994012153A1 (en) * 1992-11-30 1994-06-09 Nystroem Christer A pharmaceutical formulation
WO2007138086A1 (en) * 2006-05-31 2007-12-06 Solvay Pharmaceuticals Gmbh Long term 24 hour intestinal administration of levodopa/carbidopa
WO2012066538A1 (en) * 2010-11-15 2012-05-24 Neuroderm Ltd Continuous administration of l-dopa, dopa decarboxylase inhibitors, catechol-o-methyl transferase inhibitors and compositions for same
WO2015069773A1 (en) * 2013-11-05 2015-05-14 Synagile Corporation Devices and methods for continuous drug delivery via the mouth

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3132171A (en) 1962-06-18 1964-05-05 Strong Cobb Arner Inc 3, 4-diphosphatophenyl-alanine and process for making same
US4618484A (en) 1983-03-30 1986-10-21 Yale University Composition and method for treatment of melanomas
ATE118216T1 (de) 1989-04-20 1995-02-15 Zambon Spa Dopamin-medikament-vorstufe.
IT1255471B (it) 1992-07-30 1995-11-02 Zambon Spa Derivati di catecolammine,processo per la loro preparazione e composizioni farmaceutiche che li contengono
US6365180B1 (en) 1998-01-20 2002-04-02 Glenn A. Meyer Oral liquid compositions
EP1596808A4 (en) 2003-02-07 2007-04-04 Yissum Res Dev Co L-DOPA AMID DERIVATIVES AND THEIR USE
RU2678839C2 (ru) 2009-05-19 2019-02-04 Неуродерм Лтд Композиции для непрерывного введения ингибиторов допа-декарбоксилазы
US20130253056A1 (en) 2009-05-19 2013-09-26 Neuroderm, Ltd. Continuous Administration of Levodopa and/or Dopa Decarboxylase Inhibitors and Compositions for Same
NZ601747A (en) 2009-11-09 2014-08-29 Xenoport Inc Pharmaceutical compositions and oral dosage forms of a levodopa prodrug and methods of use
SG191090A1 (en) 2010-12-10 2013-07-31 Synagile Corp Subcutaneously infusible levodopa prodrug compositions and methods of infusion
US8765189B2 (en) 2011-05-13 2014-07-01 Howmedica Osteonic Corp. Organophosphorous and multivalent metal compound compositions and methods
HK1199624A1 (en) * 2011-08-31 2015-07-10 Abbvie Inc. Sealing arrangement for syringe
BR112015022390A8 (pt) 2013-03-13 2019-11-26 Neuroderm Ltd uso de carbidopa, levodopa e um inibidor de comt para a preparação de uma composição para tratamento de doença de parkinson
MA41377A (fr) * 2015-01-20 2017-11-28 Abbvie Inc Gel intestinal de lévodopa et de carbidona et procédés d'utilisation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994012153A1 (en) * 1992-11-30 1994-06-09 Nystroem Christer A pharmaceutical formulation
WO2007138086A1 (en) * 2006-05-31 2007-12-06 Solvay Pharmaceuticals Gmbh Long term 24 hour intestinal administration of levodopa/carbidopa
WO2012066538A1 (en) * 2010-11-15 2012-05-24 Neuroderm Ltd Continuous administration of l-dopa, dopa decarboxylase inhibitors, catechol-o-methyl transferase inhibitors and compositions for same
WO2015069773A1 (en) * 2013-11-05 2015-05-14 Synagile Corporation Devices and methods for continuous drug delivery via the mouth

Also Published As

Publication number Publication date
TW201639556A (zh) 2016-11-16
US20210046029A1 (en) 2021-02-18
JP7232235B2 (ja) 2023-03-02
US20190142777A1 (en) 2019-05-16
BR112017015613B1 (pt) 2023-11-28
CN116036064A (zh) 2023-05-02
IL253487A0 (en) 2017-09-28
BR112017015613A2 (en) 2018-03-13
EP4470611A3 (en) 2025-02-19
SG11201705964YA (en) 2017-08-30
AU2016209420A1 (en) 2017-08-03
US10117843B2 (en) 2018-11-06
KR20170103967A (ko) 2017-09-13
CN107427463A (zh) 2017-12-01
CA2974203A1 (en) 2016-07-28
EP3247330A1 (en) 2017-11-29
RU2017129375A (ru) 2019-02-21
WO2016118556A1 (en) 2016-07-28
JP2024129122A (ja) 2024-09-26
JP2021073186A (ja) 2021-05-13
US20160206584A1 (en) 2016-07-21
MX384262B (es) 2025-03-14
JP2023058678A (ja) 2023-04-25
MX2017009325A (es) 2018-02-09
MA41377A (fr) 2017-11-28
JP2018503686A (ja) 2018-02-08
EP4470611A2 (en) 2024-12-04
RU2017129375A3 (enExample) 2019-08-05
PH12017501304A1 (en) 2018-02-05

Similar Documents

Publication Publication Date Title
JP7232235B2 (ja) レボドパおよびカルビドパ経腸用ゲル剤ならびに使用方法
US20250041257A1 (en) Pharmaceutical compositions comprising levodopa, a dopamine decarboxylase inhibitor and a comt inhibitor and method of administration thereof
US20230129413A1 (en) Levodopa and Carbidopa Intestinal Gel and Methods of Use
US20140005269A1 (en) Polymeric matrix of polymer-lipid nanoparticles as a pharmaceutical dosage form
SE538425C2 (en) Pharmaceutical compositions comprising levodopa, carbidopa and a comt inhibitor and method of administration thereof
US20060105036A1 (en) Threo-dops controlled release formulation
EP3338802B1 (en) Biphasic creatine nutraceutic composition
US20070122479A1 (en) Threo-DOPS controlled release formulation
GB2634647A (en) An oral liquid formulation of methocarbamol
EP2446879B1 (en) Pharmaceutical composition containing carboxylosartan and a production method therefor
WO2020216450A1 (en) Pharmaceutical composition comprising amorphous sunitinib
CN105769809A (zh) 提高生物利用度的雷尼司他及其制备方法
WO2016042566A1 (en) Extended release formulation of trimetazidine

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)