BR112013020537A2 - suspensão aquosa e pó de liberação prolongada que compreendem metilfenidato - Google Patents

suspensão aquosa e pó de liberação prolongada que compreendem metilfenidato

Info

Publication number
BR112013020537A2
BR112013020537A2 BR112013020537A BR112013020537A BR112013020537A2 BR 112013020537 A2 BR112013020537 A2 BR 112013020537A2 BR 112013020537 A BR112013020537 A BR 112013020537A BR 112013020537 A BR112013020537 A BR 112013020537A BR 112013020537 A2 BR112013020537 A2 BR 112013020537A2
Authority
BR
Brazil
Prior art keywords
methylphenidate
powder
suspension
aqueous
oral
Prior art date
Application number
BR112013020537A
Other languages
English (en)
Other versions
BR112013020537B1 (pt
Inventor
Perumal Ashok
Mehta Ketan
Tu Yu-Hsing
Original Assignee
Tris Pharma 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 Tris Pharma Inc filed Critical Tris Pharma Inc
Publication of BR112013020537A2 publication Critical patent/BR112013020537A2/pt
Publication of BR112013020537B1 publication Critical patent/BR112013020537B1/pt

Links

Classifications

    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4458—Non condensed piperidines, e.g. piperocaine only substituted in position 2, e.g. methylphenidate
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

suspensão aquosa e pó de liberação prolongada que compreendem metilfenidato a presente invenção refere-se a um pó de metilfenidato oral que é reconstituível em uma formulação de liberação contínua aquosa oral final que contém pelo menos cerca de 50% ou pelo menos cerca de 80% em peso de água com base no peso total da suspensão. o pó é uma mescla que contém uma combinação de um complexo de resina de troca de íons de metifelnidato não revestido, uma matriz de complexo de resina de troca de íons de metilfenidadto revestido de barreira e um agente de tamponamento solúvel em água de tal forma que depois de formado como uma formulação líquida aquosa, a formulação tem um ph na faixa de cerca de 3,5 a cerca 5 ou cerca de 4 a cerca de 4,5. após administração de uma única dose da suspensão de metilfenidato aquosa oral, uma quantidade de metilfenidato terapeuticamente eficaz é alcançada em menos que uma hora e a composição fornece um perfil de liberação prolongada de doze horas.
BR112013020537-7A 2011-02-15 2011-02-15 Suspensão oral e mescla de pó de liberação prolongada aquosa de metilfenidato, método para fornecer um produto em suspensão líquida de metilfenidato, e formulação BR112013020537B1 (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2011/024873 WO2012112140A1 (en) 2011-02-15 2011-02-15 Extended release powder and aqueous suspension comprising methylphenidate

Publications (2)

Publication Number Publication Date
BR112013020537A2 true BR112013020537A2 (pt) 2017-09-26
BR112013020537B1 BR112013020537B1 (pt) 2021-09-08

Family

ID=44625199

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013020537-7A BR112013020537B1 (pt) 2011-02-15 2011-02-15 Suspensão oral e mescla de pó de liberação prolongada aquosa de metilfenidato, método para fornecer um produto em suspensão líquida de metilfenidato, e formulação

Country Status (8)

Country Link
EP (1) EP2675438B1 (pt)
AU (2) AU2011359405A1 (pt)
BR (1) BR112013020537B1 (pt)
CA (1) CA2825991C (pt)
DK (1) DK2675438T3 (pt)
ES (1) ES2721900T3 (pt)
IL (1) IL227734B (pt)
WO (1) WO2012112140A1 (pt)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11400065B2 (en) 2019-03-01 2022-08-02 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11839597B2 (en) 2016-07-22 2023-12-12 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101495146B1 (ko) 2006-03-16 2015-02-24 트리스 파마 인코포레이티드 약물 - 이온교환 수지 복합체를 함유하는 변형 방출 제제
US8287903B2 (en) 2011-02-15 2012-10-16 Tris Pharma Inc Orally effective methylphenidate extended release powder and aqueous suspension product
EP2726066B1 (en) * 2011-06-28 2021-03-31 Neos Therapeutics, LP Dosage forms of amphetamine for oral administration
WO2014028610A1 (en) 2012-08-15 2014-02-20 Tris Pharma, Inc. Methylphenidate extended release chewable tablet
US11590228B1 (en) 2015-09-08 2023-02-28 Tris Pharma, Inc Extended release amphetamine compositions
US11590081B1 (en) 2017-09-24 2023-02-28 Tris Pharma, Inc Extended release amphetamine tablets

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT946145E (pt) * 1996-12-20 2008-10-17 Mcneil Ppc Inc Fármacos antitússicos libertados por resinas de troca iónica
US7083808B2 (en) * 1998-12-17 2006-08-01 Euro-Celtique S.A. Controlled/modified release oral methylphenidate formulations
EP1140037A1 (en) * 1999-01-07 2001-10-10 ELAN CORPORATION, Plc Multiparticulate oral dosage forms
EP1429728A1 (en) * 2001-08-29 2004-06-23 SRL Technologies, Inc. Sustained release preparations
AU2003297736A1 (en) * 2002-12-23 2004-07-29 Celltech Americas, Inc. Acid labile drug compositions
US20050181050A1 (en) * 2004-01-28 2005-08-18 Collegium Pharmaceutical, Inc. Dosage forms using drug-loaded ion exchange resins
KR101495146B1 (ko) 2006-03-16 2015-02-24 트리스 파마 인코포레이티드 약물 - 이온교환 수지 복합체를 함유하는 변형 방출 제제
US20080118570A1 (en) * 2006-11-20 2008-05-22 Zhi Liu Polymer coated drug-ion exchange resins and methods

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11826335B2 (en) 2016-07-22 2023-11-28 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11839597B2 (en) 2016-07-22 2023-12-12 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11896572B2 (en) 2016-07-22 2024-02-13 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11400065B2 (en) 2019-03-01 2022-08-02 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

Also Published As

Publication number Publication date
IL227734B (en) 2018-08-30
CA2825991C (en) 2019-03-12
EP2675438B1 (en) 2019-04-10
IL227734A0 (en) 2013-09-30
ES2721900T3 (es) 2019-08-06
EP2675438A1 (en) 2013-12-25
DK2675438T3 (da) 2019-05-20
WO2012112140A1 (en) 2012-08-23
CA2825991A1 (en) 2012-08-23
AU2011359405A1 (en) 2013-08-22
AU2017202955A1 (en) 2017-05-25
AU2017202955B2 (en) 2019-01-03
BR112013020537B1 (pt) 2021-09-08

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Legal Events

Date Code Title Description
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]
B08G Application fees: restoration [chapter 8.7 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B350 Update of information on the portal [chapter 15.35 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 15/02/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO.