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

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)

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Publication number Priority date Publication date Assignee Title
KR101571198B1 (ko) 2009-03-18 2015-11-23 에보니크 룀 게엠베하 중성 비닐 중합체 및 부형제를 포함하는 코팅을 이용하는, 에탄올의 영향에 대한 내성을 갖는 제어 방출 제약 조성물
NZ603170A (en) 2010-05-10 2015-04-24 Euro Celtique Sa Combination of active loaded granules with additional actives
PE20130657A1 (es) 2010-05-10 2013-06-15 Euro Celtique Sa Composiciones farmaceuticas que comprenden hidromorfona y naloxona
NZ603173A (en) 2010-05-10 2014-10-31 Euro Celtique Sa Manufacturing of active-free granules and tablets comprising the same
BR112013027484A8 (pt) 2011-06-17 2022-07-05 Evonik Roehm Gmbh Composição farmacêutica ou nutracêutica com resistência gástrica, e uso de um polímero de (met)acrilato
ES2617402T3 (es) 2011-06-17 2017-06-19 Evonik Röhm Gmbh Composición de recubrimiento adecuada para formas farmacéuticas o nutracéuticas
RU2606588C2 (ru) 2011-06-17 2017-01-10 Эвоник Рем ГмбХ Композиция покрытия, подходящая для фармацевтических или нутрицевтических дозированных форм
WO2015023675A2 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US9814710B2 (en) 2013-11-13 2017-11-14 Euro-Celtique S.A. Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
WO2015095391A1 (en) 2013-12-17 2015-06-25 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
WO2016046817A1 (en) * 2014-09-24 2016-03-31 Vital Beverages Global Inc. Compositions and methods for selective gi tract delivery
JP2017531026A (ja) 2014-10-20 2017-10-19 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 徐放性乱用抑止性液体充填剤形
CA2978593A1 (en) * 2015-01-12 2016-07-21 Nano Pharmaceutical Laboratories Llc Layered sustained-release microbeads and methods of making the same
EP3288556A4 (en) 2015-04-29 2018-09-19 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
HUE057718T2 (hu) 2017-09-14 2022-06-28 Evonik Operations Gmbh Nyújtott felszabadulási tulajdonságú és etanol hatásával szemben ellenálló polimer és dózisforma
US20210007995A1 (en) 2018-03-09 2021-01-14 Evonik Operations 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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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
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DE10250543A1 (de) 2002-10-29 2004-05-19 Röhm GmbH & Co. KG Mehrschichtige Arzneiform
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EP2187876B1 (en) * 2007-09-21 2012-08-22 Evonik Röhm GmbH Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol

Also Published As

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

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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.