BR112017015613A2 - gel intestinal de levodopa e carbidopa e métodos de utilização - Google Patents

gel intestinal de levodopa e carbidopa e métodos de utilização

Info

Publication number
BR112017015613A2
BR112017015613A2 BR112017015613A BR112017015613A BR112017015613A2 BR 112017015613 A2 BR112017015613 A2 BR 112017015613A2 BR 112017015613 A BR112017015613 A BR 112017015613A BR 112017015613 A BR112017015613 A BR 112017015613A BR 112017015613 A2 BR112017015613 A2 BR 112017015613A2
Authority
BR
Brazil
Prior art keywords
methods
levodopa
pharmaceutical composition
intestinal gel
carbidopa
Prior art date
Application number
BR112017015613A
Other languages
English (en)
Other versions
BR112017015613B1 (pt
Inventor
Deac Alexandru
B Zimmerman Jayne
Conjeevaram Rajkumar
A Menges Randy
E Mackey Sean
Huang Ye
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 BR112017015613A2 publication Critical patent/BR112017015613A2/pt
Publication of BR112017015613B1 publication Critical patent/BR112017015613B1/pt

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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Physiology (AREA)
  • Dispersion Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (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)

Abstract

a presente invenção refere-se a (a) uma composição farmacêutica melhorada que compreende um agente ativo levodopa, e um agente ativo carbidopa (b) métodos para produzir a composição farmacêutica e (c) métodos para tratar a doença de parkinson e condições associadas, os quais compreendem administrar a composição farmacêutica a um indivíduo com doença de parkinson.
BR112017015613-0A 2015-01-20 2016-01-20 Composição farmacêutica compreendendo um agente ativo levodopa e um agente ativo carbidopa suspensos em um veículo aquoso, método para prepará-la, uso da mesma para tratar doença de parkinson, forma de dosagem farmacêutica compreendendo dita composição e kit BR112017015613B1 (pt)

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
BR112017015613A2 true BR112017015613A2 (pt) 2018-03-13
BR112017015613B1 BR112017015613B1 (pt) 2023-11-28

Family

ID=55410198

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017015613-0A BR112017015613B1 (pt) 2015-01-20 2016-01-20 Composição farmacêutica compreendendo um agente ativo levodopa e um agente ativo carbidopa suspensos em um veículo aquoso, método para prepará-la, uso da mesma para tratar doença de parkinson, forma de dosagem farmacêutica compreendendo dita composição e kit

Country Status (16)

Country Link
US (3) US10117843B2 (pt)
EP (1) EP3247330A1 (pt)
JP (3) JP2018503686A (pt)
KR (1) KR20170103967A (pt)
CN (2) CN116036064A (pt)
AU (1) AU2016209420B2 (pt)
BR (1) BR112017015613B1 (pt)
CA (1) CA2974203A1 (pt)
IL (1) IL253487A0 (pt)
MA (1) MA41377A (pt)
MX (1) MX2017009325A (pt)
PH (1) PH12017501304A1 (pt)
RU (1) RU2017129375A (pt)
SG (1) SG11201705964YA (pt)
TW (1) TW201639556A (pt)
WO (1) WO2016118556A1 (pt)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2743347C2 (ru) 2014-10-21 2021-02-17 Эббви Инк. Пролекарства карбидопа и l-dopa и их применение для лечения болезни паркинсона
CN113197851A (zh) 2015-05-06 2021-08-03 辛纳吉勒公司 包含药物粒子的药用悬浮液、用于其配给的装置、以及其使用方法
EP3487479A1 (en) * 2016-07-20 2019-05-29 AbbVie Inc. Levodopa and carbidopa intestinal gel and methods of use
JP7314871B2 (ja) 2020-07-09 2023-07-26 新東工業株式会社 強度計測装置及び強度計測方法

Family Cites Families (17)

* 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
DE69016688T2 (de) 1989-04-20 1995-10-05 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
SE9203594D0 (sv) * 1992-11-30 1992-11-30 Christer Nystroem Laekemedel i dispersa system
US6365180B1 (en) 1998-01-20 2002-04-02 Glenn A. Meyer Oral liquid compositions
WO2004069146A2 (en) 2003-02-07 2004-08-19 Yissum Research Development Company Of The Hebrew University Of Jerusalem L-dopa amide derivatives and uses thereof
EP2063865A1 (en) * 2006-05-31 2009-06-03 Solvay Pharmaceuticals GmbH Long term 24 hour intestinal administration of levodopa/carbidopa
LT2432454T (lt) 2009-05-19 2017-07-10 Neuroderm Ltd Kompozicijos, skirtos nepertraukiamam dopa dekarboksilazės inhibitorių vartojimui
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
NZ610911A (en) * 2010-11-15 2015-02-27 Neuroderm Ltd Continuous administration of l-dopa, dopa decarboxylase inhibitors, catechol-o-methyl transferase inhibitors and compositions for same
WO2012079072A2 (en) 2010-12-10 2012-06-14 Synagile Corporation 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
ES2833276T3 (es) * 2011-08-31 2021-06-14 Abbvie Inc Disposión de sellado para jeringa
HRP20211442T1 (hr) 2013-03-13 2022-02-04 Neuroderm Ltd Kombinacija za liječenje parkinsonove bolesti
AU2014346855B2 (en) 2013-11-05 2019-07-18 Synagile Corporation Devices and methods for continuous drug delivery via the mouth

Also Published As

Publication number Publication date
RU2017129375A (ru) 2019-02-21
US20210046029A1 (en) 2021-02-18
AU2016209420A1 (en) 2017-08-03
CN116036064A (zh) 2023-05-02
TW201639556A (zh) 2016-11-16
US20190142777A1 (en) 2019-05-16
KR20170103967A (ko) 2017-09-13
MA41377A (fr) 2017-11-28
JP2023058678A (ja) 2023-04-25
EP3247330A1 (en) 2017-11-29
SG11201705964YA (en) 2017-08-30
IL253487A0 (en) 2017-09-28
JP2018503686A (ja) 2018-02-08
JP2021073186A (ja) 2021-05-13
CA2974203A1 (en) 2016-07-28
US20160206584A1 (en) 2016-07-21
US10117843B2 (en) 2018-11-06
BR112017015613B1 (pt) 2023-11-28
MX2017009325A (es) 2018-02-09
JP7232235B2 (ja) 2023-03-02
RU2017129375A3 (pt) 2019-08-05
CN107427463A (zh) 2017-12-01
PH12017501304A1 (en) 2018-02-05
WO2016118556A1 (en) 2016-07-28
AU2016209420B2 (en) 2021-05-20

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 20/01/2016, OBSERVADAS AS CONDICOES LEGAIS