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 preparaçãoInfo
- 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
Links
Classifications
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- 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.
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)
| 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 |
| EP2568968B1 (en) | 2010-05-10 | 2017-07-12 | Euro-Celtique S.A. | Manufacturing of active-free granules and tablets comprising the same |
| BR112012028656A2 (pt) | 2010-05-10 | 2016-08-09 | Euro Celtique Sa | combinação de grânulos carregados ativos com ativos adicionais |
| SE1251371A1 (sv) | 2010-05-10 | 2012-12-27 | Euro Celtique Sa | Farmaceutiska kompositioner innefattande hydromorfon och naloxon |
| AU2012269187A1 (en) | 2011-06-17 | 2013-09-26 | Evonik Rohm Gmbh | Gastric resistant pharmaceutical or nutraceutical composition with resistance against the influence of ethanol |
| BR112013028453B8 (pt) | 2011-06-17 | 2022-07-05 | Evonik Roehm Gmbh | Uso de uma composição de revestimento, formas de dosagem farmacêuticas ou nutracêuticas gastrorresistentes, e composição do polímero do núcleo/invólucro |
| BR112013032095A8 (pt) | 2011-06-17 | 2022-07-05 | Evonik Roehm Gmbh | Composição de revestimento adequada para formas de dosagem farmacêuticas ou nutracêuticas |
| CA2919892C (en) | 2013-08-12 | 2019-06-18 | 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 |
| 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 |
| ES2919874T3 (es) * | 2014-09-24 | 2022-07-28 | Vital Beverages Global Inc | Composiciones y métodos para el suministro selectivo en el tubo gastrointestinal |
| AU2015336065A1 (en) | 2014-10-20 | 2017-05-04 | 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 |
| CA3075204A1 (en) | 2017-09-14 | 2019-03-21 | Thomas Endres | Polymer and dosage form with sustained release properties and resistance against the influence of ethanol |
| KR20200130369A (ko) | 2018-03-09 | 2020-11-18 | 에보니크 오퍼레이션즈 게엠베하 | 에탄올의 영향에 대한 내성을 갖는 중합체 혼합물 |
| 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 |
Family Cites Families (12)
| 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 |
| CN1248689C (zh) | 1999-08-27 | 2006-04-05 | 南方研究所 | 可注射的美沙酮、丁丙诺啡微粒组合物及其用途 |
| 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 |
| AU2007205866B2 (en) * | 2006-01-21 | 2012-11-29 | Abbott Gmbh & Co. Kg | Dosage form and method for the delivery of drugs of abuse |
| PL2034975T3 (pl) * | 2006-06-19 | 2012-09-28 | Alpharma Pharmaceuticals Llc | Kompozycje farmaceutyczne |
| 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 |
| BRPI0722042B8 (pt) | 2007-09-21 | 2022-07-05 | Evonik Roehm Gmbh | composição farmacêutica de liberação controlada dependente do ph, e seu processo de preparação |
| JP5204847B2 (ja) * | 2007-09-21 | 2013-06-05 | 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して耐性を有するｐｈ依存性制御放出医薬オピオイド組成物 |
-
2008
- 2008-09-24 SI SI200831431T patent/SI2326313T1/sl unknown
- 2008-09-24 PL PL08804672T patent/PL2326313T3/pl unknown
- 2008-09-24 CN CN2008801312249A patent/CN102164589A/zh active Pending
- 2008-09-24 BR BRPI0823128A patent/BRPI0823128B8/pt not_active IP Right Cessation
- 2008-09-24 EP EP08804672.7A patent/EP2326313B1/en active Active
- 2008-09-24 MX MX2011003050A patent/MX2011003050A/es active IP Right Grant
- 2008-09-24 JP JP2011528192A patent/JP5453434B2/ja not_active Expired - Fee Related
- 2008-09-24 WO PCT/EP2008/062767 patent/WO2010034344A1/en active Application Filing
- 2008-09-24 KR KR1020117006639A patent/KR101535701B1/ko active IP Right Grant
- 2008-09-24 ES ES08804672.7T patent/ES2537622T3/es active Active
- 2008-09-24 CA CA2738197A patent/CA2738197C/en not_active Expired - Fee Related
- 2008-09-24 US US13/120,112 patent/US10933024B2/en active Active
-
2011
- 2011-02-20 IL IL211305A patent/IL211305A/en active IP Right Grant
-
2015
- 2015-12-17 HK HK15112452.9A patent/HK1211491A1/xx not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| IL211305A0 (en) | 2011-04-28 |
| IL211305A (en) | 2015-01-29 |
| KR20110058836A (ko) | 2011-06-01 |
| CA2738197A1 (en) | 2010-04-01 |
| KR101535701B1 (ko) | 2015-07-09 |
| PL2326313T3 (pl) | 2015-08-31 |
| BRPI0823128A2 (pt) | 2015-06-16 |
| EP2326313B1 (en) | 2015-03-04 |
| SI2326313T1 (sl) | 2015-06-30 |
| BRPI0823128B1 (pt) | 2019-05-07 |
| EP2326313A1 (en) | 2011-06-01 |
| CN102164589A (zh) | 2011-08-24 |
| JP5453434B2 (ja) | 2014-03-26 |
| HK1211491A1 (en) | 2016-05-27 |
| US20110229562A1 (en) | 2011-09-22 |
| US10933024B2 (en) | 2021-03-02 |
| ES2537622T3 (es) | 2015-06-10 |
| WO2010034344A1 (en) | 2010-04-01 |
| CA2738197C (en) | 2016-01-05 |
| MX2011003050A (es) | 2011-04-11 |
| JP2012503609A (ja) | 2012-02-09 |
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| B07A | Application suspended after technical examination (opinion) [chapter 7.1 patent gazette] | ||
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| 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 |
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| B25A | Requested transfer of rights approved |
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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. |