JP2018503686A - 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 - Google Patents

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 Download PDF

Info

Publication number
JP2018503686A
JP2018503686A JP2017556790A JP2017556790A JP2018503686A JP 2018503686 A JP2018503686 A JP 2018503686A JP 2017556790 A JP2017556790 A JP 2017556790A JP 2017556790 A JP2017556790 A JP 2017556790A JP 2018503686 A JP2018503686 A JP 2018503686A
Authority
JP
Japan
Prior art keywords
pharmaceutical composition
carbidopa
levodopa
activator
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.)
Pending
Application number
JP2017556790A
Other languages
English (en)
Japanese (ja)
Inventor
カンジーバラム，ラジクマール
ディーク，アレクサンドル
ホワン，イエ
マッキー，シーン・イー
メンジス，ランディー・エイ
ジンマーマン，ジェイン・ビー
Original Assignee
アッヴィ・インコーポレイテッド
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 アッヴィ・インコーポレイテッド filed Critical アッヴィ・インコーポレイテッド
Publication of JP2018503686A publication Critical patent/JP2018503686A/ja
Pending legal-status Critical Current

Links

Images

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
    • A61K31/197—Carboxylic 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
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures 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)
JP2017556790A 2015-01-20 2016-01-20 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 Pending JP2018503686A (ja)

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2020214665A Division JP7232235B2 (ja) 2015-01-20 2020-12-24 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

Publications (1)

Publication Number Publication Date
JP2018503686A true JP2018503686A (ja) 2018-02-08

Family

ID=55410198

Family Applications (4)

Application Number Title Priority Date Filing Date
JP2017556790A Pending JP2018503686A (ja) 2015-01-20 2016-01-20 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
JP2020214665A Active JP7232235B2 (ja) 2015-01-20 2020-12-24 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
JP2023022208A Ceased JP2023058678A (ja) 2015-01-20 2023-02-16 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
JP2024107963A Pending JP2024129122A (ja) 2015-01-20 2024-07-04 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

Family Applications After (3)

Application Number Title Priority Date Filing Date
JP2020214665A Active JP7232235B2 (ja) 2015-01-20 2020-12-24 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
JP2023022208A Ceased JP2023058678A (ja) 2015-01-20 2023-02-16 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
JP2024107963A Pending JP2024129122A (ja) 2015-01-20 2024-07-04 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

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)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024129122A (ja) * 2015-01-20 2024-09-26 アッヴィ・インコーポレイテッド 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

Families Citing this family (5)

* 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
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
JPH08504764A (ja) * 1992-11-30 1996-05-21 ニストレム，クリスター 製薬学的製剤
JP2009543761A (ja) * 2006-05-31 2009-12-10 ゾルファイ ファーマスーティカルズ ゲゼルシャフト ミット ベシュレンクテル ハフツング レボドパ／カルビドパの長期間２４時間腸内投与
JP2013545745A (ja) * 2010-11-15 2013-12-26 ニューロダーム リミテッド Ｌ−ドーパ、ドーパデカルボキシラーゼ阻害剤、カテコール−ｏ−メチルトランスフェラーゼ阻害剤、およびそれらのための組成物の継続的投与
JP2014508113A (ja) * 2010-12-10 2014-04-03 シンアジャイル コーポレーション 皮下注入可能なレボドパプロドラッグ組成物及び注入方法

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
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
KR102457026B1 (ko) * 2013-11-05 2022-10-21 신애질 코포레이션 입을 통한 연속적 약물 전달
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
JPH08504764A (ja) * 1992-11-30 1996-05-21 ニストレム，クリスター 製薬学的製剤
JP2009543761A (ja) * 2006-05-31 2009-12-10 ゾルファイ ファーマスーティカルズ ゲゼルシャフト ミット ベシュレンクテル ハフツング レボドパ／カルビドパの長期間２４時間腸内投与
JP2013545745A (ja) * 2010-11-15 2013-12-26 ニューロダーム リミテッド Ｌ−ドーパ、ドーパデカルボキシラーゼ阻害剤、カテコール−ｏ−メチルトランスフェラーゼ阻害剤、およびそれらのための組成物の継続的投与
JP2014508113A (ja) * 2010-12-10 2014-04-03 シンアジャイル コーポレーション 皮下注入可能なレボドパプロドラッグ組成物及び注入方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024129122A (ja) * 2015-01-20 2024-09-26 アッヴィ・インコーポレイテッド 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

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
AU2016209420B2 (en) 2021-05-20
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
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
JP6889231B2 (ja) レボドパ、ドーパミン脱炭酸酵素阻害薬およびｃｏｍｔ阻害薬を含む医薬組成物ならびにその投与方法
US20230129413A1 (en) Levodopa and Carbidopa Intestinal Gel and Methods of Use
JP2024129122A5 (enExample)
WO2017039525A1 (en) Method of treating a dopamine related disorder in a subject by administering levodopa, in combination with a dopamine decarboxylase inhibitor and a catechol-o-methyltransferase inhibitor
US20060105036A1 (en) Threo-dops controlled release formulation
EP3338802B1 (en) Biphasic creatine nutraceutic composition
CN100544720C (zh) 安全稳定的帕洛诺司琼组合物
ES2733113T3 (es) Composición farmacéutica estable de una sal de vinorelbina soluble en agua
KR20250110202A (ko) 변형-방출 실로도신 조성물 및 남성 피임 방법에서 이의 용도
GB2634647A (en) An oral liquid formulation of methocarbamol
US20070122479A1 (en) Threo-DOPS controlled release formulation
EP2943186A1 (en) Controlled release formulations of lorazepam
EP2446879A2 (en) Pharmaceutical composition containing carboxylosartan and a production method therefor

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20190118

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20191029

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20200123

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200430

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20200901

C60 Trial request (containing other claim documents, opposition documents)

Free format text: JAPANESE INTERMEDIATE CODE: C60

Effective date: 20201224

C116 Written invitation by the chief administrative judge to file amendments

Free format text: JAPANESE INTERMEDIATE CODE: C116

Effective date: 20210112

C22 Notice of designation (change) of administrative judge

Free format text: JAPANESE INTERMEDIATE CODE: C22

Effective date: 20210112

C22 Notice of designation (change) of administrative judge

Free format text: JAPANESE INTERMEDIATE CODE: C22

Effective date: 20210907

C22 Notice of designation (change) of administrative judge

Free format text: JAPANESE INTERMEDIATE CODE: C22

Effective date: 20211005

C13 Notice of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: C13

Effective date: 20211102

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20220127

C22 Notice of designation (change) of administrative judge

Free format text: JAPANESE INTERMEDIATE CODE: C22

Effective date: 20220412

C23 Notice of termination of proceedings

Free format text: JAPANESE INTERMEDIATE CODE: C23

Effective date: 20220802

C03 Trial/appeal decision taken

Free format text: JAPANESE INTERMEDIATE CODE: C03

Effective date: 20220913

C30A Notification sent

Free format text: JAPANESE INTERMEDIATE CODE: C3012

Effective date: 20220913