JP2022507528A - 皮下投与のための医薬製剤 - Google Patents

皮下投与のための医薬製剤 Download PDF

Info

Publication number
JP2022507528A
JP2022507528A JP2021526553A JP2021526553A JP2022507528A JP 2022507528 A JP2022507528 A JP 2022507528A JP 2021526553 A JP2021526553 A JP 2021526553A JP 2021526553 A JP2021526553 A JP 2021526553A JP 2022507528 A JP2022507528 A JP 2022507528A
Authority
JP
Japan
Prior art keywords
pharmaceutical composition
levodopa
carbidopa
stable liquid
liquid aqueous
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
JP2021526553A
Other languages
English (en)
Japanese (ja)
Other versions
JP2022507528A5 (enExample
Inventor
ムーサ，エハブ
ローズブロー，マシュー
ジャミール，フェロズ
セバー，ナンシー
ファケリス，マウリツィオ・エフ
ロビーソン，ワイニング・ゼット
ロック，チャールズ・エス
シュトットマン，スベン
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 JP2022507528A publication Critical patent/JP2022507528A/ja
Publication of JP2022507528A5 publication Critical patent/JP2022507528A5/ja
Priority to JP2024140691A priority Critical patent/JP2024174894A/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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/661—Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • 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
    • A61K9/08—Solutions
    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Psychology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2021526553A 2018-11-15 2019-11-15 皮下投与のための医薬製剤 Pending JP2022507528A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024140691A JP2024174894A (ja) 2018-11-15 2024-08-22 皮下投与のための医薬製剤

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US201862767546P 2018-11-15 2018-11-15
US62/767,546 2018-11-15
US201962843945P 2019-05-06 2019-05-06
US62/843,945 2019-05-06
US201962863113P 2019-06-18 2019-06-18
US201962863101P 2019-06-18 2019-06-18
US201962863093P 2019-06-18 2019-06-18
US62/863,101 2019-06-18
US62/863,093 2019-06-18
US62/863,113 2019-06-18
US201962898214P 2019-09-10 2019-09-10
US62/898,214 2019-09-10
PCT/US2019/061626 WO2020102628A1 (en) 2018-11-15 2019-11-15 Pharmaceutical formulations for subcutaneous administration

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2024140691A Division JP2024174894A (ja) 2018-11-15 2024-08-22 皮下投与のための医薬製剤

Publications (2)

Publication Number Publication Date
JP2022507528A true JP2022507528A (ja) 2022-01-18
JP2022507528A5 JP2022507528A5 (enExample) 2022-11-29

Family

ID=68835352

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2021526553A Pending JP2022507528A (ja) 2018-11-15 2019-11-15 皮下投与のための医薬製剤
JP2024140691A Pending JP2024174894A (ja) 2018-11-15 2024-08-22 皮下投与のための医薬製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2024140691A Pending JP2024174894A (ja) 2018-11-15 2024-08-22 皮下投与のための医薬製剤

Country Status (14)

Country Link
US (3) US12251365B2 (enExample)
EP (1) EP3880210A1 (enExample)
JP (2) JP2022507528A (enExample)
KR (1) KR20210091139A (enExample)
CN (1) CN113015531A (enExample)
AU (2) AU2019379806B2 (enExample)
BR (1) BR112021009353A2 (enExample)
CA (1) CA3117983A1 (enExample)
IL (1) IL282842A (enExample)
MX (1) MX2021005776A (enExample)
SG (1) SG11202104499RA (enExample)
TW (1) TW202031265A (enExample)
UY (1) UY38473A (enExample)
WO (1) WO2020102628A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UY38473A (es) 2018-11-15 2020-06-30 Abbvie Inc Formulaciones farmacéuticas para una administración subcutánea
AU2022352845A1 (en) * 2021-10-27 2024-04-11 Abbvie Inc. Subcutaneously administered foslevodopa/foscarbidopa treatments for advanced parkinson's disease

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017537066A (ja) * 2014-10-21 2017-12-14 アッヴィ・インコーポレイテッド カルビドパおよびｌ−ドーパプロドラッグならびにそれらの使用方法

Family Cites Families (62)

* 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
US3939253A (en) 1973-11-02 1976-02-17 Interx Research Corporation Novel, transient pro-drug forms of l-dopa useful in the treatment of parkinson's disease
US3891696A (en) 1973-11-02 1975-06-24 Interx Research Corp Novel, transient pro-drug forms of l-dopa
US3998799A (en) 1973-11-02 1976-12-21 Interx Research Corporation Novel, transient pro-drug forms of l-dopa
US4035507A (en) 1975-04-17 1977-07-12 Interx Research Corporation Novel, transient pro-drug forms of L-DOPA to treat Parkinson's disease
US4065566A (en) 1975-04-17 1977-12-27 Interx Research Corporation N-Nicotinoyl-3,4-dinicotinoyloxy-L-phenylalanine and derivatives pharmaceutical compositions and methods containing same
US4163058A (en) 1977-04-22 1979-07-31 Interx Research Corporation Derivatives of 5,5-diphenylhydantoin exhibiting enhanced solubility and the therapeutic use thereof
US4618484A (en) 1983-03-30 1986-10-21 Yale University Composition and method for treatment of melanomas
US4508706A (en) 1983-03-30 1985-04-02 Yale University Composition for increasing melanin in mammalian skin and hair
IT1213182B (it) 1984-06-25 1989-12-14 Simes Derivati di composti a struttura catecolamminica.
IT1200427B (it) 1985-03-22 1989-01-18 Afros Spa Procedimento ed impianto per lo stampaggio di pezzi in materiale plastico espanso,con parti o inserti preformati a spruzzo nello stesso stampo di formatura
JPH02138A (ja) 1987-09-18 1990-01-05 Banyu Pharmaceut Co Ltd Ｌ‐ドーパ誘導体
IT1226727B (it) 1988-07-29 1991-02-05 Simes Farmaci precursori della dopamina.
DE69016688T2 (de) 1989-04-20 1995-10-05 Zambon Spa Dopamin-Medikament-Vorstufe.
GB9102812D0 (en) 1991-02-11 1991-03-27 Enzymatix Ltd Compounds
IT1255471B (it) 1992-07-30 1995-11-02 Zambon Spa Derivati di catecolammine,processo per la loro preparazione e composizioni farmaceutiche che li contengono
SE9203594D0 (sv) 1992-11-30 1992-11-30 Christer Nystroem Laekemedel i dispersa system
US5874468A (en) * 1996-12-26 1999-02-23 Yissum Brain targeted low molecular weight hydrophobic antioxidant compounds
AU1457299A (en) 1997-11-12 1999-05-31 Ariad Pharmaceuticals, Inc. Novel signal transduction inhibitors, compositions containing them
US6365180B1 (en) 1998-01-20 2002-04-02 Glenn A. Meyer Oral liquid compositions
US6204257B1 (en) 1998-08-07 2001-03-20 Universtiy Of Kansas Water soluble prodrugs of hindered alcohols
CA2490626A1 (en) 2002-06-20 2003-12-31 Nippon Suisan Kaisha, Ltd. Prodrug, medicinal utilization thereof and process for producing the same
AU2003293423A1 (en) 2002-12-06 2004-06-30 Xenoport, Inc. Carbidopa prodrugs and uses thereof
EP1596808A4 (en) 2003-02-07 2007-04-04 Yissum Res Dev Co L-DOPA AMID DERIVATIVES AND THEIR USE
CN1845728B (zh) 2003-08-29 2013-06-19 转化医药公司 包含左旋多巴和卡比多巴的药物组合物
JP5160786B2 (ja) 2003-08-29 2013-03-13 トランスフォーム・ファーマシューティカルズ・インコーポレイテッド 医薬組成物及びレボドパ及びカルビドパの使用方法
WO2005041925A2 (en) 2003-10-31 2005-05-12 Alza Corporation Compositions and dosage forms for enhanced absorption
US7342131B2 (en) 2004-06-04 2008-03-11 Xenoport, Inc. Levodopa prodrugs, and compositions and uses thereof
ES2402552T3 (es) 2004-07-06 2013-05-06 Abbott Laboratories Profármacos de inhibidores de proteasa de VIH
SE0401842D0 (sv) 2004-07-12 2004-07-12 Dizlin Medical Design Ab Infusion and injection solution of levodopa
EP1959948B1 (en) 2005-12-05 2012-07-18 XenoPort, Inc. Levodopa prodrug mesylate, compositions thereof, and uses thereof
RU2484815C2 (ru) 2006-05-31 2013-06-20 Зольвай Фармасьютиклз Гмбх Продолжительное 24-часовое введение в кишечник леводопа/карбидопа
KR20090033871A (ko) 2006-06-16 2009-04-06 솔베이 파마슈티칼스 비. 브이 비페프루녹스 및 ｌ-ｄｏｐａ를 포함하는 병용 제제
TW200843732A (en) 2006-12-21 2008-11-16 Xenoport Inc Levodopa dimethyl-substituted diester prodrugs, compositions, and methods of use
GB0713189D0 (en) 2007-07-06 2007-08-15 Proximagen Ltd Amino acid derivatives
AU2009211028B2 (en) * 2008-02-06 2013-12-05 Wockhardt Research Centre Pharmaceutical compositions of entacapone, levodopa and carbidopa with improved bioavailability
JP5757864B2 (ja) 2008-05-20 2015-08-05 ニューロジェシックス， インコーポレイテッド 水溶性アセトアミノフェン類似体
US20130253056A1 (en) 2009-05-19 2013-09-26 Neuroderm, Ltd. Continuous Administration of Levodopa and/or Dopa Decarboxylase Inhibitors and Compositions for Same
RU2559083C9 (ru) 2009-05-19 2016-01-20 Неуродерм Лтд Композиции для непрерывного введения ингибиторов допа-декарбоксилазы
AU2010291927A1 (en) 2009-09-14 2012-04-12 AbbVie Deutschland GmbH & Co. KG Methods for treating psoriasis
WO2011056240A2 (en) 2009-11-09 2011-05-12 Xenoport, Inc. Pharmaceutical compositions and oral dosage forms of a levodopa prodrug and methods of use
KR101868326B1 (ko) 2010-03-04 2018-06-19 오리온 코포레이션 파킨슨병의 치료를 위한 레보도파, 카르비도파 및 엔타카폰의 용도
WO2011109767A2 (en) 2010-03-04 2011-09-09 University Of Notre Dame Du Lac Gelatinase inhibitors and prodrugs
CA2801917C (en) 2010-06-03 2017-04-25 Abbvie Biotechnology Ltd Uses and compositions for treatment of hidradenitis suppurativa (hs)
CN110123743A (zh) 2010-11-15 2019-08-16 纽罗德姆有限公司 L-多巴、多巴脱羧酶抑制剂、儿茶酚-o-甲基转移酶抑制剂及其组合物的连续施用
CA2818161A1 (en) 2010-12-02 2012-06-07 Ono Pharmaceutical Co., Ltd. Novel compound and medical use thereof
BR112013014304A2 (pt) 2010-12-10 2016-07-19 Synagile Corp composições de pró-fármaco levodopa infundíveis subcutaneamente e método de infusão
US8765189B2 (en) 2011-05-13 2014-07-01 Howmedica Osteonic Corp. Organophosphorous and multivalent metal compound compositions and methods
RU2677278C2 (ru) 2013-03-13 2019-01-16 Неуродерм Лтд Способ лечения болезни паркинсона
BR112015022896B1 (pt) 2013-03-15 2022-08-23 Chongxi Yu Composto de fármacos de alta penetração, composição farmacêutica e seus usos para o tratamento de doenças de parkinson
US10258585B2 (en) 2014-03-13 2019-04-16 Neuroderm, Ltd. DOPA decarboxylase inhibitor compositions
EP3116475B1 (en) 2014-03-13 2020-11-04 Neuroderm Ltd Dopa decarboxylase inhibitor compositions
MA41377A (fr) 2015-01-20 2017-11-28 Abbvie Inc Gel intestinal de lévodopa et de carbidona et procédés d'utilisation
JP2019515908A (ja) 2016-04-20 2019-06-13 アッヴィ・インコーポレイテッド カルビドパ及びｌ−ドパプロドラッグ並びに使用方法
US20240024338A1 (en) 2016-04-20 2024-01-25 Abbvie Inc. Carbidopa and l-dopa prodrugs and methods of use
EP3487843A1 (en) 2016-07-22 2019-05-29 Syngenta Participations AG Microbiocidal oxadiazole derivatives
EP3518920A1 (en) 2016-09-29 2019-08-07 Berlirem GmbH L-dopa derivatives for the treatment of neurological diseases
WO2018154447A1 (en) 2017-02-21 2018-08-30 Neuroderm Ltd Dopa decarboxylase inhibitor compositions
UY38473A (es) 2018-11-15 2020-06-30 Abbvie Inc Formulaciones farmacéuticas para una administración subcutánea
US11331293B1 (en) 2020-11-17 2022-05-17 Neuroderm, Ltd. Method for treatment of Parkinson's disease
US11213502B1 (en) 2020-11-17 2022-01-04 Neuroderm, Ltd. Method for treatment of parkinson's disease
AU2022352845A1 (en) 2021-10-27 2024-04-11 Abbvie Inc. Subcutaneously administered foslevodopa/foscarbidopa treatments for advanced parkinson's disease

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017537066A (ja) * 2014-10-21 2017-12-14 アッヴィ・インコーポレイテッド カルビドパおよびｌ−ドーパプロドラッグならびにそれらの使用方法

Also Published As

Publication number Publication date
BR112021009353A2 (pt) 2021-11-23
TW202031265A (zh) 2020-09-01
EP3880210A1 (en) 2021-09-22
AU2019379806B2 (en) 2025-08-14
US20250186382A1 (en) 2025-06-12
AU2019379806A1 (en) 2021-05-27
MX2021005776A (es) 2021-07-02
AU2025256148A1 (en) 2025-11-13
US12251365B2 (en) 2025-03-18
US20200155578A1 (en) 2020-05-21
US20250325507A1 (en) 2025-10-23
KR20210091139A (ko) 2021-07-21
CA3117983A1 (en) 2020-05-22
SG11202104499RA (en) 2021-05-28
WO2020102628A1 (en) 2020-05-22
IL282842A (en) 2021-06-30
CN113015531A (zh) 2021-06-22
UY38473A (es) 2020-06-30
JP2024174894A (ja) 2024-12-17

Similar Documents

Publication Publication Date Title
US20250177292A1 (en) Method for treatment of parkinson's disease
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
RU2607497C2 (ru) Непрерывное введение l-допа, ингибиторов допа-декарбоксилазы, ингибиторов катехол-о-метилтрансферазы и предназначенные для этого композиции
US20250325507A1 (en) Pharmaceutical formulations for subcutaneous administration
JP2008505966A (ja) レボドパの輸液および注射液
JP2025072496A (ja) ジスキネジア治療薬
Torok Extended-release formulation of minocycline in the treatment of moderate-to-severe acne vulgaris in patients over the age of 12 years
AU2007259256A1 (en) Combination preparations comprising bifeprunox and L-DOPA
JP7485874B2 (ja) 神経変性障害の治療のための医薬組成物の連続的投与
JP2021519272A5 (enExample)
JP2024541978A (ja) 進行期パーキンソン病のためのホスレボドパ／ホスカルビドパ皮下投与治療
ES2593620T3 (es) Composiciones para tratar la anormalidad del reflejo postural causada por la enfermedad de Parkinson
HK40055589A (en) Pharmaceutical formulations for subcutaneous administration
US12161612B2 (en) Methods and compositions for reducing symptoms of Parkinson's disease
EP4694877A1 (en) Methods and compositions for reducing symptoms of parkinson's disease
HK40116609A (zh) 晚期帕金森病的皮下施用foslevodopa/foscarbidopa疗法
WO2024028863A1 (en) Therapeutic effect of molecules derived from probiotic milk-based fermentation microbial consortium ("kefir") on wounds healing

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20221115

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20221115

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20231011

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20231107

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20240201

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240304

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20240423

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20260416