BRPI0823128B8 - composição farmacêutica de liberação controlada dependente do ph para não opioides com resistência contra a influência de etanol, e processo para sua preparação - Google Patents

composição farmacêutica de liberação controlada dependente do ph para não opioides com resistência contra a influência de etanol, e processo para sua preparação

Info

Publication number
BRPI0823128B8
BRPI0823128B8 BRPI0823128A BRPI0823128A BRPI0823128B8 BR PI0823128 B8 BRPI0823128 B8 BR PI0823128B8 BR PI0823128 A BRPI0823128 A BR PI0823128A BR PI0823128 A BRPI0823128 A BR PI0823128A BR PI0823128 B8 BRPI0823128 B8 BR PI0823128B8
Authority
BR
Brazil
Prior art keywords
weight
pharmaceutical composition
opioids
controlled release
ethanol
Prior art date
Application number
BRPI0823128A
Other languages
English (en)
Inventor
Bär Hans
Fürst Thomas
Renner Gerhard
Gottschalk Michael
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 BRPI0823128A2 publication Critical patent/BRPI0823128A2/pt
Publication of BRPI0823128B1 publication Critical patent/BRPI0823128B1/pt
Publication of BRPI0823128B8 publication Critical patent/BRPI0823128B8/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
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/06—Antiarrhythmics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

COMPOSIÇÃO FARMACÊUTICA DE LIBERAÇÃO CONTROLADA DEPENDENTE DO PH PARA NÃO OPIOIDES COM RESISTÊNCIA CONTRA A INFLUÊNCIA DE ETANOL. A presente invenção refere-se a uma composição a uma composição farmacêutica de liberação controladas dependente do pH, compreendendo pelo menos um ingrediente ativo farmacêutico, com a exceção de opioides, em que o núcleo é revestido pelo menos por uma camada de revestimento, que controla a liberação da composição farmacêutica em que a camada de revestimento compreende uma mistura de polímero de i) 40-95% em peso, com base no peso seco da mistura de polímero, do pelo menos um polímero ou copolímero de vinila essencialmente neutro insolúvel em água e ii) 5-60% em peso, com base no peso seco da mistura de polímero, 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 a partir de pH 7,0 a pH 8,0, caracterizada pelo fato de que a camada de revestimento compreende ainda 110 a 250% em peso de um lubrificante inerte não poroso, 1 a 35% em peso menos um composto celulósico neutro e 1 a 25% em peso de pelo menos um emulsificante, cada um calculado sobre peso seco da mistura de polímero.
BRPI0823128A 2008-09-24 2008-09-24 composição farmacêutica de liberação controlada dependente do ph para não opioides com resistência contra a influência de etanol, e processo para sua preparação BRPI0823128B8 (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2008/062767 WO2010034344A1 (en) 2008-09-24 2008-09-24 Ph-dependent controlled release pharmaceutical composition for non-opioids with resistance against the influence of ethanol

Publications (3)

Publication Number Publication Date
BRPI0823128A2 BRPI0823128A2 (pt) 2015-06-16
BRPI0823128B1 BRPI0823128B1 (pt) 2019-05-07
BRPI0823128B8 true BRPI0823128B8 (pt) 2022-07-05

Family

ID=40756228

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0823128A BRPI0823128B8 (pt) 2008-09-24 2008-09-24 composição farmacêutica de liberação controlada dependente do ph para não opioides com resistência contra a influência de etanol, e processo para sua preparação

Country Status (14)

Country Link
US (1) US10933024B2 (pt)
EP (1) EP2326313B1 (pt)
JP (1) JP5453434B2 (pt)
KR (1) KR101535701B1 (pt)
CN (1) CN102164589A (pt)
BR (1) BRPI0823128B8 (pt)
CA (1) CA2738197C (pt)
ES (1) ES2537622T3 (pt)
HK (1) HK1211491A1 (pt)
IL (1) IL211305A (pt)
MX (1) MX2011003050A (pt)
PL (1) PL2326313T3 (pt)
SI (1) SI2326313T1 (pt)
WO (1) WO2010034344A1 (pt)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2408436B1 (en) 2009-03-18 2017-02-22 Evonik Röhm GmbH Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising neutral vinyl polymers and excipients
SE1251371A1 (sv) 2010-05-10 2012-12-27 Euro Celtique Sa Farmaceutiska kompositioner innefattande hydromorfon och naloxon
CN103002881B (zh) 2010-05-10 2015-09-02 欧洲凯尔特公司 载有活性剂的颗粒与额外活性剂的组合
ES2642788T3 (es) 2010-05-10 2017-11-20 Euro-Celtique S.A. Fabricación de gránulos sin principio activo y de comprimidos que comprenden los mismos
CN103501767A (zh) 2011-06-17 2014-01-08 赢创罗姆有限公司 适合于药物或营养制品剂型的包衣组合物
CA2839689C (en) 2011-06-17 2018-05-01 Evonik Roehm Gmbh Coating composition suitable for pharmaceutical or nutraceutical dosage forms
KR101902602B1 (ko) 2011-06-17 2018-09-28 에보니크 룀 게엠베하 에탄올의 영향에 대해 내성을 갖는 위 내성 제약 또는 기능식품 조성물
JP6539274B2 (ja) 2013-08-12 2019-07-03 ファーマシューティカル マニュファクチュアリング リサーチ サービシズ，インコーポレーテッド 押出成形された即放性乱用抑止性丸剤
EP3068397A1 (en) 2013-11-13 2016-09-21 Euro-Celtique S.A. Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
DK3169315T3 (da) 2014-07-17 2020-08-10 Pharmaceutical Manufacturing Res Services In Væskefyldt doseringsform til forhindring af misbrug med øjeblikkelig frigivelse
US11229600B2 (en) * 2014-09-24 2022-01-25 Vital Beverages Global Inc. Compositions and methods for selective GI tract delivery
US20160106737A1 (en) 2014-10-20 2016-04-21 Pharmaceutical Manufacturing Research Services, Inc. Extended Release Abuse Deterrent Liquid Fill Dosage Form
AU2015377223A1 (en) 2015-01-12 2017-08-31 Nano Pharmaceutical Laboratories Llc Layered sustained-release microbeads and methods of making the same
US20170042806A1 (en) 2015-04-29 2017-02-16 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
EP3681918B1 (en) 2017-09-14 2022-01-12 Evonik Operations GmbH Polymer and dosage form with sustained release properties and resistance against the influence of ethanol
WO2019170485A1 (en) 2018-03-09 2019-09-12 Evonik Röhm Gmbh Polymer mixture with resistance against the influence of ethanol
CN114983973B (zh) * 2022-05-31 2023-05-05 石家庄四药有限公司 一种乌拉地尔缓释胶囊及其制备方法

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Publication number Priority date Publication date Assignee Title
US4996047A (en) * 1988-11-02 1991-02-26 Richardson-Vicks, Inc. Sustained release drug-resin complexes
FR2655266B1 (fr) 1989-12-05 1992-04-03 Smith Kline French Lab Compositions pharmaceutiques a base de cimetidine.
US7374779B2 (en) 1999-02-26 2008-05-20 Lipocine, Inc. Pharmaceutical formulations and systems for improved absorption and multistage release of active agents
US20030118641A1 (en) 2000-07-27 2003-06-26 Roxane Laboratories, Inc. Abuse-resistant sustained-release opioid formulation
WO2001015699A1 (en) 1999-08-27 2001-03-08 Southern Research Institute Injectable buprenorphine microparticle compositions and their use
DE10250543A1 (de) * 2002-10-29 2004-05-19 Röhm GmbH & Co. KG Mehrschichtige Arzneiform
DE102005024614A1 (de) 2005-05-25 2006-11-30 Röhm Gmbh Verwendung von Polymermischungen zur Herstellung von überzogenen Arzneiformen sowie Arzneiform mit polymerem Mischüberzug
WO2007085024A2 (en) 2006-01-21 2007-07-26 Abbott Gmbh & Co. Kg Dosage form and method for the delivery of drugs of abuse
KR20140079441A (ko) * 2006-06-19 2014-06-26 알파마 파머슈티컬스 엘엘씨 약제학적 조성물
DE102006051020A1 (de) 2006-10-26 2008-04-30 Evonik Röhm Gmbh Verwendung von (Meth)acrylat-Copolymeren in Retard-Arzneiformen zur Verringerung des Einflusses von Ethanol auf die Wirkstofffreisetzung
CA2699227C (en) 2007-09-21 2014-12-02 Evonik Roehm Gmbh Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol
BRPI0722042B8 (pt) 2007-09-21 2022-07-05 Evonik Roehm Gmbh composição farmacêutica de liberação controlada dependente do ph, e seu processo de preparação

Also Published As

Publication number Publication date
ES2537622T3 (es) 2015-06-10
KR20110058836A (ko) 2011-06-01
SI2326313T1 (sl) 2015-06-30
JP2012503609A (ja) 2012-02-09
US20110229562A1 (en) 2011-09-22
CN102164589A (zh) 2011-08-24
CA2738197A1 (en) 2010-04-01
MX2011003050A (es) 2011-04-11
EP2326313A1 (en) 2011-06-01
JP5453434B2 (ja) 2014-03-26
KR101535701B1 (ko) 2015-07-09
HK1211491A1 (en) 2016-05-27
BRPI0823128A2 (pt) 2015-06-16
WO2010034344A1 (en) 2010-04-01
CA2738197C (en) 2016-01-05
IL211305A (en) 2015-01-29
BRPI0823128B1 (pt) 2019-05-07
IL211305A0 (en) 2011-04-28
PL2326313T3 (pl) 2015-08-31
US10933024B2 (en) 2021-03-02
EP2326313B1 (en) 2015-03-04

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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]
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]
B07A Application suspended after technical examination (opinion) [chapter 7.1 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 07/05/2019, OBSERVADAS AS CONDICOES LEGAIS. (CO) 10 (DEZ) ANOS CONTADOS A PARTIR DE 07/05/2019, 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 24/09/2008 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 15A 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.