BRPI0721990B8 - composição farmacêutica de liberação controlada dependente de ph, e seu processo de preparação - Google Patents

composição farmacêutica de liberação controlada dependente de ph, e seu processo de preparação

Info

Publication number
BRPI0721990B8
BRPI0721990B8 BRPI0721990A BRPI0721990A BRPI0721990B8 BR PI0721990 B8 BRPI0721990 B8 BR PI0721990B8 BR PI0721990 A BRPI0721990 A BR PI0721990A BR PI0721990 A BRPI0721990 A BR PI0721990A BR PI0721990 B8 BRPI0721990 B8 BR PI0721990B8
Authority
BR
Brazil
Prior art keywords
weight
pharmaceutical composition
coating layer
controlled release
polymer blend
Prior art date
Application number
BRPI0721990A
Other languages
English (en)
Inventor
Petereit Hans-Ulrich
Ravishankar Hema
Samel Ashwini
Original Assignee
Evonik Roehm Gmbh
Roehm Gmbh
Evonik Degussa Gmbh
Evonik Operations Gmbh
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 Evonik Roehm Gmbh, Roehm Gmbh, Evonik Degussa Gmbh, Evonik Operations Gmbh filed Critical Evonik Roehm Gmbh
Publication of BRPI0721990A2 publication Critical patent/BRPI0721990A2/pt
Publication of BRPI0721990B1 publication Critical patent/BRPI0721990B1/pt
Publication of BRPI0721990B8 publication Critical patent/BRPI0721990B8/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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/501—Inorganic compounds
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

COMPOSIÇÃO OPIOIDE FARMACÊUTICA DE LIBERAÇÃO CONTROLADA DEPENDENTE DE PH COM RESISTÊNCIA CONTRA A INFLUÊNCIA DE ETANOL. A presente invenção refere-se a uma composição farmacêutica de liberação controlada dependente de pH, compreendendo um núcleo compreendendo pelo menos um ingrediente ativo farmacêutico, que é um opioide, em que o núcleo está revestido pelo menos por uma camada de revestimento, controlando a liberação da composição farmacêutica, em que a camada de revestimento compreende uma mistura de polímeros de i) 40-95% em peso, baseado no peso seco da mistura de polímero, de pelo menos um polímero vinila essencialmente neutro insolúvel em água, e ii)5-60% em peso, baseado em peso seco da mistura de polímeros, de pelo menos um polímero ou copolímero aniônico, que é insolúvel em um meio tamponado abaixo de pH 4,0 e solúvel pelo menos na faixa de pH 7,0 a pH 8,0, caracterizada pelo fato de que a camada de revestimento ainda contém 110 a 250% em peso, calculado em peso seco da mistura de polímeros, de um lubrificante inerte não-poroso e a camada de revstimento está presente em uma quantidade de pelo menos 6% em peso calculada sobre o peso do núcleo.
BRPI0721990A 2007-09-21 2007-09-25 composição farmacêutica de liberação controlada dependente de ph, e seu processo de preparação BRPI0721990B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN2130/CHE/2007 2007-09-21
IN2130CH2007 2007-09-21
PCT/EP2007/060131 WO2009036812A1 (en) 2007-09-21 2007-09-25 Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol

Publications (3)

Publication Number Publication Date
BRPI0721990A2 BRPI0721990A2 (pt) 2014-03-18
BRPI0721990B1 BRPI0721990B1 (pt) 2019-12-10
BRPI0721990B8 true BRPI0721990B8 (pt) 2022-07-05

Family

ID=39232916

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0721990A BRPI0721990B8 (pt) 2007-09-21 2007-09-25 composição farmacêutica de liberação controlada dependente de ph, e seu processo de preparação

Country Status (13)

Country Link
US (1) US9700520B2 (pt)
EP (1) EP2187876B1 (pt)
JP (1) JP5204847B2 (pt)
KR (1) KR101424653B1 (pt)
CN (1) CN101801357B (pt)
BR (1) BRPI0721990B8 (pt)
CA (1) CA2699227C (pt)
ES (1) ES2393934T3 (pt)
IL (1) IL203901A (pt)
MX (1) MX2010003032A (pt)
PL (1) PL2187876T3 (pt)
SI (1) SI2187876T1 (pt)
WO (1) WO2009036812A1 (pt)

Families Citing this family (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
ATE526950T1 (de) 1999-10-29 2011-10-15 Euro Celtique Sa Hydrocodon-formulierungen mit gesteuerter freisetzung
EP2283829A1 (en) 2000-10-30 2011-02-16 Euro-Celtique S.A. Controlled release hydrocodone formulations
US20080069891A1 (en) 2006-09-15 2008-03-20 Cima Labs, Inc. Abuse resistant drug formulation
US8445018B2 (en) 2006-09-15 2013-05-21 Cima Labs Inc. Abuse resistant drug formulation
CA2923102C (en) 2007-08-13 2019-10-15 Omeho Life Sciences Inc. Abuse resistant drugs, method of use and method of making
JP5453434B2 (ja) * 2008-09-24 2014-03-26 エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング エタノールの影響に対する耐性を有するオピオイドではないｐＨ依存の制御放出の医薬組成物
US9757343B2 (en) * 2008-09-24 2017-09-12 Evonik Röhm Gmbh PH-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol
US9730899B2 (en) * 2009-03-18 2017-08-15 Evonik Roehm Gmbh Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising neutral vinyl polymers and excipients
WO2010105673A1 (en) * 2009-03-18 2010-09-23 Evonik Röhm Gmbh Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising a polymer mixture and excipients
US9107451B2 (en) 2009-07-29 2015-08-18 Evonik Röhm Gmbh Coating composition for the dip coating of capsule halves
DE102009028076A1 (de) * 2009-07-29 2011-02-03 Evonik Röhm Gmbh Beschichtungsmittel zum Tauchbeschichten von Kapselhälften
FR2951378B1 (fr) * 2009-10-16 2012-06-01 Flamel Tech Sa Forme pharmaceutique orale solide anti-mesusage et dotee d'un profil specifique de liberation modifiee
EP2371356B1 (en) 2010-03-12 2012-12-19 Phoeme GmbH Multi-particle pharmaceutical formulation for colon absorption
CA2798702A1 (en) 2010-05-11 2011-11-17 Cima Labs Inc. Alcoholresistant metoprolol-containing extended-release oral dosage forms
MX360389B (es) * 2010-08-18 2018-10-31 Evonik Roehm Gmbh Formulacion farmaceutica o nutraceutica resistente a fluidos gastricos que comprende una o mas sales de acido alginico.
CN103501768B (zh) * 2011-06-17 2016-11-09 赢创罗姆有限公司 具有抗乙醇影响抗性的抗胃酸的药物或营养组合物
MX353427B (es) 2011-06-17 2018-01-12 Evonik Roehm Gmbh Composicion de recubrimiento adecuada para formas de dosis farmaceuticas o nutraceuticas.
JP5832645B2 (ja) 2011-06-17 2015-12-16 エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツングＥｖｏｎｉｋ Ｒｏｅｈｍ ＧｍｂＨ 医薬剤形又は栄養補助剤形に適したコーティング組成物
ES2616115T3 (es) * 2011-06-30 2017-06-09 Develco Pharma Schweiz Ag Forma farmacéutica oral de liberación controlada que comprende oxicodona
BR112014009033A2 (pt) * 2011-10-18 2017-10-17 Purdue Pharma Lp formulações de polímero acrílico
WO2014146093A2 (en) 2013-03-15 2014-09-18 Inspirion Delivery Technologies, Llc Abuse deterrent compositions and methods of use
AU2014306759B2 (en) 2013-08-12 2018-04-26 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US20150118300A1 (en) 2013-10-31 2015-04-30 Cima Labs Inc. Immediate Release Abuse-Deterrent Granulated Dosage Forms
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
GB201411704D0 (en) * 2014-07-01 2014-08-13 Lucideon Ltd Coated particles
EP3169315B1 (en) 2014-07-17 2020-06-24 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
US10729685B2 (en) 2014-09-15 2020-08-04 Ohemo Life Sciences Inc. Orally administrable compositions and methods of deterring abuse by intranasal administration
US20160106737A1 (en) 2014-10-20 2016-04-21 Pharmaceutical Manufacturing Research Services, Inc. Extended Release Abuse Deterrent Liquid Fill Dosage Form
CA2936741C (en) 2014-10-31 2018-11-06 Purdue Pharma Methods and compositions particularly for treatment of attention deficit disorder
WO2018044895A1 (en) * 2016-08-29 2018-03-08 Cima Labs Inc. Immediate release dosage forms with abuse deterrence and alcohol resistance
KR20200057019A (ko) 2017-09-14 2020-05-25 에보닉 오퍼레이션스 게엠베하 서방성 및 에탄올의 영향에 대한 내성을 갖는 중합체 및 투여 형태
JP2021515778A (ja) 2018-03-09 2021-06-24 エボニック オペレーションズ ゲーエムベーハー エタノールの影響に対する耐性を有するポリマー混合物
CN108822816A (zh) * 2018-06-25 2018-11-16 中国石油集团渤海钻探工程有限公司 一种疏松砂岩用可酸溶凝胶堵漏剂及其制备方法
US10722473B2 (en) 2018-11-19 2020-07-28 Purdue Pharma L.P. Methods and compositions particularly for treatment of attention deficit disorder
EP3965733A4 (en) 2019-05-07 2023-01-11 Clexio Biosciences Ltd. ABUSE DETERRENT DOSAGE FORMS CONTAINING ESKETAMINE
US12589083B2 (en) 2019-05-07 2026-03-31 Clexio Biosciences Ltd. Abuse-deterrent dosage forms containing esketamine

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08143476A (ja) * 1994-11-18 1996-06-04 Japan Tobacco Inc 薬物放出制御膜及び固形製剤
FR2759293B1 (fr) * 1997-02-11 1999-04-30 Ethypharm Lab Prod Ethiques Microgranules contenant du cisplatine, procede de fabrication, preparation pharmaceutique et utilisation en polychimiotherapie ou en association avec une radiotherapie
CN1204890C (zh) * 1997-12-22 2005-06-08 欧罗赛铁克股份有限公司 防止阿片样物质滥用的方法
US7374779B2 (en) 1999-02-26 2008-05-20 Lipocine, Inc. Pharmaceutical formulations and systems for improved absorption and multistage release of active agents
US6623758B2 (en) * 2000-02-24 2003-09-23 Advancis Pharmaceutical Corp. Cephalosporin-metronidazole antibiotic composition
WO2003024430A1 (en) 2001-09-21 2003-03-27 Egalet A/S Morphine polymer release system
DE10211289A1 (de) * 2002-03-14 2003-09-25 Basf Ag Kombination von Polyvinylacetat von wasserunlöslichen, säureunlöslichen oder alkaliunlöslichen Polymeren zur Hestellung von Filmüberzügen mit sehr kontrollierter Freisetzung und hoher Stabilität
BR0312445A (pt) 2002-06-07 2005-05-10 Ranbaxy Lab Ltd Sistemas multiunitários para disponibilização de fármaco de liberação modificada
CA2543689A1 (en) * 2003-10-31 2005-05-12 Hexal Ag Pharmaceutical actve-ingredient-containing formulation with coating
WO2006079550A2 (en) * 2005-01-28 2006-08-03 Euro-Celtique S.A. Alcohol resistant dosage forms
WO2005107716A1 (en) 2004-03-25 2005-11-17 Cadila Healthcare Limited Controlled release paroxetine-containing tablets based on a core and a coating
DE102005024614A1 (de) * 2005-05-25 2006-11-30 Röhm Gmbh Verwendung von Polymermischungen zur Herstellung von überzogenen Arzneiformen sowie Arzneiform mit polymerem Mischüberzug
HU227490B1 (en) 2005-08-26 2011-07-28 Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszvenytarsasag Sustained release pharmaceutical preparation containing carvedilol

Also Published As

Publication number Publication date
MX2010003032A (es) 2010-04-09
IL203901A (en) 2015-03-31
CA2699227A1 (en) 2009-03-26
EP2187876A1 (en) 2010-05-26
BRPI0721990B1 (pt) 2019-12-10
US20100226978A1 (en) 2010-09-09
KR101424653B1 (ko) 2014-08-06
EP2187876B1 (en) 2012-08-22
KR20100059885A (ko) 2010-06-04
JP2010539197A (ja) 2010-12-16
PL2187876T3 (pl) 2013-01-31
WO2009036812A1 (en) 2009-03-26
CN101801357A (zh) 2010-08-11
BRPI0721990A2 (pt) 2014-03-18
CA2699227C (en) 2014-12-02
SI2187876T1 (sl) 2012-12-31
JP5204847B2 (ja) 2013-06-05
US9700520B2 (en) 2017-07-11
CN101801357B (zh) 2013-08-07
ES2393934T3 (es) 2013-01-02

Similar Documents

Publication Publication Date Title
BRPI0823128B8 (pt) composição farmacêutica de liberação controlada dependente do ph para não opioides com resistência contra a influência de etanol, e processo para sua preparação
BRPI0722042B8 (pt) composição farmacêutica de liberação controlada dependente do ph, e seu processo de preparação
BRPI0823096B8 (pt) composição farmacêutica de opióide de liberação controlada, dependente do ph, com resistência contra a influência do etanol, processo para sua preparação, e seu uso
MX2010003032A (es) Composicion farmaceutica opioide de liberacion controlada ph dependiente con resistencia contra la influencia del etanol.
BRPI0924543B8 (pt) composição farmacêutica de liberação controlada, e seu processo de preparação
BRPI0707465B8 (pt) composições farmacêuticas compreendendo misturas de polímeros e ingredientes ativos dificilmente solúveis em água, seu uso e seus processos de preparação, forma farmacêutica e seu processo de produção
BRPI0807569A8 (pt) Péletes compreendendo uma matriz de substância ativa resistentes ao suco gástrico
MX2011009669A (es) Composición farmacéutica de liberación controlada con resistencia a la influencia de etanol mediante un revestimiento compuesto de una mezcla polimérica y excipientes.
BR112012008626A2 (pt) forma farmacêutica oral sólida com liberação modificada de pelo menos um ingrediente ativo
BRPI0814502A2 (pt) uso de uma dispersão de polímero aquosa concentrada, método para a preparação de uma dispersão de polímero aquosa concentrada, composição cosmética, e, uso da composição cosmética
NO20080202L (no) Nanopartikulaere clopidogrel og aspirin kombinasjonsformuleringer
BRPI0703508A (pt) copolìmero em emulsão aquosa, anfifìlico, e, método para produzir copolìmero em emulsão, anfifìlico
MX339671B (es) Forma oral solida con perfil de liberacion dual que contiene particulas multiples.
BR112014019092A8 (pt) Uso de uma composição de polímero
BR0116842A (pt) Revestimentos para modificação de superfìcies duras e processos para a aplicação dos mesmos
BRPI0815424A2 (pt) particulando polimérico revestido e processo para revestir um particulado polimérico
BR112013027484A2 (pt) composição farmacêutica ou nutracêutica com resistência gástrica com resistência contra a influência do etanol
BRPI0508997A (pt) microcamada com siloxanas
WO2009034431A3 (en) Controlled-release dosage forms for varenicline
BRPI0810335A2 (pt) "pó depolímero redispersável, dispersão aquosa, composição de polímero e uso da composição de polímero"
BR112023000145A2 (pt) Dispersão aquosa de polímero, processo para preparar uma dispersão aquosa de polímero, uso de uma dispersão aquosa de polímero, formulação adesiva aquosa, e, uso da formulação adesiva aquosa
ATE552984T1 (de) Dunkelfarbige, lasermarkierbare polymerzusammensetzung
TW200714680A (en) Method for improving staining properties of aqueous coating compositions
BR0313610A (pt) Composições antimicrobianas sinérgicas, estáveis, de doadores de aldeìdo e ácido desidroacético, com baixo teor de formaldeìdo livre
KR101767530B1 (ko) 모발 화장료

Legal Events

Date Code Title Description
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

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: 10 (DEZ) ANOS CONTADOS A PARTIR DE 10/12/2019, OBSERVADAS AS CONDICOES LEGAIS. (CO) 10 (DEZ) ANOS CONTADOS A PARTIR DE 10/12/2019, OBSERVADAS AS CONDICOES LEGAIS

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 25/09/2007 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B25D Requested change of name of applicant approved

Owner name: ROEHM GMBH (DE)

B25G Requested change of headquarter approved

Owner name: ROEHM GMBH (DE)

B25A Requested transfer of rights approved

Owner name: EVONIK DEGUSSA GMBH (DE)

B25D Requested change of name of applicant approved

Owner name: EVONIK OPERATIONS GMBH (DE)

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 16A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2741 DE 18-07-2023 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.