BRPI0823096B8 - composição farmacêutica de opióide de liberação controlada, dependente do ph, com resistência contra a influência do etanol, processo para sua preparação, e seu uso - Google Patents
composição farmacêutica de opióide de liberação controlada, dependente do ph, com resistência contra a influência do etanol, processo para sua preparação, e seu usoInfo
- Publication number
- BRPI0823096B8 BRPI0823096B8 BRPI0823096A BRPI0823096A BRPI0823096B8 BR PI0823096 B8 BRPI0823096 B8 BR PI0823096B8 BR PI0823096 A BRPI0823096 A BR PI0823096A BR PI0823096 A BRPI0823096 A BR PI0823096A BR PI0823096 B8 BRPI0823096 B8 BR PI0823096B8
- Authority
- BR
- Brazil
- Prior art keywords
- weight
- dependent
- pharmaceutical composition
- ethanol
- polymer blend
- Prior art date
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
-
- 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
-
- 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
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/32—Alcohol-abuse
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
Abstract
COMPOSIÇÃO DE OPIOIDE FARMACÊUTICA DE LIBERAÇÃO CONTROLADA, DEPENDENTE DO PH, COM RESISTÊNCIA CONTRA A INFLUÊNCIA DO ETANOL. A presente invenção refere-se a uma composição farmacêutica de liberação controlada, dependente do pH, compreendendo um núcleo, e um opioide, onde o núcleo está revestido pelo menos por uma camada de revestimento, controlando a liberação da composição farmacêutica, onde a camada de revestimento compreende uma mistura de polímeros de i) 40 - 95% em peso, com base no peso seco da mistura de polímeros, de pelo menos um polímero de vinila essencialmente netro, insolúvel em água, e ii) 5 - 60% em peso, com base no peso seco da mistura de polímeros, de pelo menos um polímero ou copolímero aniônico, o qual 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 adicionalmente compreende 110 a 250% em peso de um lubrificante inerte não poroso, 1 a 35% em peso de composto celulósico neutro e 1 a 25% em peso de um emulsificante, cada um calculado sobre o peso seco da mistura de polímeros.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/EP2008/062761 WO2010034342A1 (en) | 2008-09-24 | 2008-09-24 | Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BRPI0823096A2 BRPI0823096A2 (pt) | 2015-06-16 |
| BRPI0823096B1 BRPI0823096B1 (pt) | 2019-07-02 |
| BRPI0823096B8 true BRPI0823096B8 (pt) | 2022-07-05 |
Family
ID=40691361
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0823096A BRPI0823096B8 (pt) | 2008-09-24 | 2008-09-24 | composição farmacêutica de opióide de liberação controlada, dependente do ph, com resistência contra a influência do etanol, processo para sua preparação, e seu uso |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US9757343B2 (pt) |
| EP (1) | EP2341899B1 (pt) |
| JP (1) | JP5453433B2 (pt) |
| KR (1) | KR101528957B1 (pt) |
| CN (1) | CN102164588B (pt) |
| BR (1) | BRPI0823096B8 (pt) |
| CA (1) | CA2738078C (pt) |
| ES (1) | ES2532877T3 (pt) |
| IL (1) | IL211306A (pt) |
| MX (1) | MX2011003047A (pt) |
| PL (1) | PL2341899T3 (pt) |
| SI (1) | SI2341899T1 (pt) |
| WO (1) | WO2010034342A1 (pt) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2904546T3 (es) | 2006-02-03 | 2022-04-05 | Opko Renal Llc | Tratamiento de la insuficiencia y deficiencia de vitamina D con 25-hidroxivitamina D2 y 25-hidroxivitamina D3 |
| WO2008008608A2 (en) | 2006-06-21 | 2008-01-17 | Proventiv Therapeutics, Llc | Method of treating and preventing secondary hyperparathyroidism |
| PL2148661T3 (pl) | 2007-04-25 | 2013-07-31 | Cytochroma Inc | Doustne kompozycje o kontrolowanym uwalnianiu zawierające związek będący witaminą D i woskowy nośnik |
| JP5444212B2 (ja) | 2007-04-25 | 2014-03-19 | シトクロマ インコーポレイテッド | ビタミンｄ不足および欠乏症の治療方法 |
| US20100144684A1 (en) | 2007-04-25 | 2010-06-10 | Proventiv Therapeutics, Inc. | Method of Safely and Effectively Treating and Preventing Secondary Hyperparathyroidism in Chronic Kidney Disease |
| KR101852042B1 (ko) | 2008-04-02 | 2018-04-25 | 사이토크로마 인코포레이티드 | 비타민 ｄ 결핍 및 관련 장애에 유용한 방법, 조성물, 용도 및 키트 |
| SI2408436T1 (sl) | 2009-03-18 | 2017-06-30 | Evonik Roehm Gmbh | Farmacevtski sestavek z nadzorovanim sproščanjem z odpornostjo na vpliv etanola, ki uporablja oplaščenje, ki vsebuje nevtralne vinil polimere in ekscipiente |
| ES2783980T3 (es) | 2010-03-29 | 2020-09-21 | Opko Ireland Global Holdings Ltd | Métodos y composiciones para la reducción de niveles de paratiroides |
| JP5840201B2 (ja) | 2010-05-10 | 2016-01-06 | ユーロ−セルティーク エス．エイ． | 活性剤を負荷した顆粒と追加の活性剤の組合せ |
| GB2492037A (en) | 2010-05-10 | 2012-12-19 | Euro Celtique Sa | Pharmaceutical compositions comprising hydromorphone and naloxone |
| KR20130030261A (ko) | 2010-05-10 | 2013-03-26 | 유로-셀티큐 에스.에이. | 활성제-무함유 과립 및 그를 포함하는 정제의 제조 |
| MX356579B (es) | 2011-06-17 | 2018-06-05 | Evonik Roehm Gmbh | Composicion farmaceutica o nutraceutica de resistencia gastrica con resistencia contra la influenza de etanol. |
| WO2012171575A1 (en) | 2011-06-17 | 2012-12-20 | Evonik Röhm Gmbh | Coating composition suitable for pharmaceutical or nutraceutical dosage forms |
| KR101799625B1 (ko) * | 2011-06-17 | 2017-11-20 | 에보니크 룀 게엠베하 | 제약 또는 기능식품 투여 형태에 적합한 코팅 조성물 |
| US9155734B2 (en) * | 2012-03-07 | 2015-10-13 | Mallinckrodt Llc | Stability of hydromorphone hydrochloride solutions |
| KR101847947B1 (ko) | 2013-03-15 | 2018-05-28 | 옵코 아이피 홀딩스 Ⅱ 인코포레이티드 | 안정화되고 변형된 비타민 ｄ 방출 제형 |
| CN103271940B (zh) * | 2013-05-03 | 2014-03-12 | 湖北新济药业有限公司 | 复方金属离子补充剂及其制备方法 |
| CN112716955A (zh) | 2013-11-13 | 2021-04-30 | 欧洲凯尔特公司 | 用于治疗疼痛和阿片样物质肠功能障碍综合征的氢吗啡酮和纳洛酮 |
| KR20160115995A (ko) * | 2014-02-17 | 2016-10-06 | 에보니크 룀 게엠베하 | 지속 방출 특성을 가지며 에탄올의 영향에 대한 저항성을 갖는 약제학적 또는 건강기능성 조성물 |
| SG11201700858RA (en) | 2014-08-07 | 2017-03-30 | Opko Ireland Global Holdings Ltd | Adjunctive therapy with 25-hydroxyvitamin d |
| WO2016046817A1 (en) * | 2014-09-24 | 2016-03-31 | Vital Beverages Global Inc. | Compositions and methods for selective gi tract delivery |
| TWI747893B (zh) | 2016-03-28 | 2021-12-01 | 愛爾蘭商歐科愛爾蘭全球控股股份有限公司 | 維生素ｄ治療之方法 |
| KR101942922B1 (ko) | 2017-01-20 | 2019-01-30 | 한국해양대학교 산학협력단 | 실리콘 나노입자를 포함하는 리튬이차전지용 음극활물질 및 그 제조방법 |
| CN111356709A (zh) | 2017-09-14 | 2020-06-30 | 赢创运营有限公司 | 具有缓释性质并耐受乙醇影响的聚合物和剂型 |
| WO2019170485A1 (en) | 2018-03-09 | 2019-09-12 | Evonik Röhm Gmbh | Polymer mixture with resistance against the influence of ethanol |
| CN114949220B (zh) * | 2022-01-30 | 2023-09-22 | 浙江大学 | 一种靶向损伤节段背根神经节的pH响应镇痛药及其应用 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| AU765496C (en) | 1999-08-27 | 2005-08-25 | Brookwood Pharmaceuticals Inc. | Injectable buprenorphine microparticle compositions and their use |
| RU2245136C2 (ru) | 2001-07-27 | 2005-01-27 | Яманоути Фармасьютикал Ко., ЛТД | Композиция, включающая тонкодисперсные частицы с замедленным высвобождением для быстроразлагающихся в щечной полости таблеток, и способ ее получения |
| DE10250543A1 (de) | 2002-10-29 | 2004-05-19 | Röhm GmbH & Co. KG | Mehrschichtige Arzneiform |
| BRPI0606339A2 (pt) | 2005-01-28 | 2009-06-16 | Euro Celtique Sa | formas farmacêuticas resistentes a álcool |
| DE102005024614A1 (de) * | 2005-05-25 | 2006-11-30 | Röhm Gmbh | Verwendung von Polymermischungen zur Herstellung von überzogenen Arzneiformen sowie Arzneiform mit polymerem Mischüberzug |
| CA2637755A1 (en) * | 2006-01-21 | 2007-07-26 | Abbott Gmbh & Co. Kg | Dosage form and method for the delivery of drugs of abuse |
| 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 |
| PL2187875T3 (pl) * | 2007-09-21 | 2013-01-31 | Evonik Roehm Gmbh | Kompozycja farmaceutyczna o zależnym od pH kontrolowanym uwalnianiu dla nieopioidów z odpornością przed wpływem etanolu |
| MX2010003032A (es) * | 2007-09-21 | 2010-04-09 | Evonik R Hm Gmbh | Composicion farmaceutica opioide de liberacion controlada ph dependiente con resistencia contra la influencia del etanol. |
-
2008
- 2008-09-24 WO PCT/EP2008/062761 patent/WO2010034342A1/en active Application Filing
- 2008-09-24 KR KR1020117006638A patent/KR101528957B1/ko active IP Right Grant
- 2008-09-24 EP EP08804667.7A patent/EP2341899B1/en active Active
- 2008-09-24 MX MX2011003047A patent/MX2011003047A/es active IP Right Grant
- 2008-09-24 ES ES08804667.7T patent/ES2532877T3/es active Active
- 2008-09-24 BR BRPI0823096A patent/BRPI0823096B8/pt not_active IP Right Cessation
- 2008-09-24 CN CN200880131222.XA patent/CN102164588B/zh not_active Expired - Fee Related
- 2008-09-24 JP JP2011528191A patent/JP5453433B2/ja not_active Expired - Fee Related
- 2008-09-24 CA CA2738078A patent/CA2738078C/en active Active
- 2008-09-24 SI SI200831386T patent/SI2341899T1/sl unknown
- 2008-09-24 US US13/062,591 patent/US9757343B2/en active Active
- 2008-09-24 PL PL08804667T patent/PL2341899T3/pl unknown
-
2011
- 2011-02-20 IL IL211306A patent/IL211306A/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| US9757343B2 (en) | 2017-09-12 |
| ES2532877T3 (es) | 2015-04-01 |
| KR20110058835A (ko) | 2011-06-01 |
| IL211306A0 (en) | 2011-04-28 |
| CN102164588A (zh) | 2011-08-24 |
| CA2738078A1 (en) | 2010-04-01 |
| SI2341899T1 (sl) | 2015-04-30 |
| JP5453433B2 (ja) | 2014-03-26 |
| US20110217383A1 (en) | 2011-09-08 |
| PL2341899T3 (pl) | 2015-05-29 |
| WO2010034342A1 (en) | 2010-04-01 |
| EP2341899A1 (en) | 2011-07-13 |
| MX2011003047A (es) | 2011-04-14 |
| EP2341899B1 (en) | 2014-12-17 |
| KR101528957B1 (ko) | 2015-06-17 |
| BRPI0823096B1 (pt) | 2019-07-02 |
| JP2012503608A (ja) | 2012-02-09 |
| IL211306A (en) | 2015-01-29 |
| CA2738078C (en) | 2015-12-29 |
| CN102164588B (zh) | 2015-07-08 |
| BRPI0823096A2 (pt) | 2015-06-16 |
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