MX2011009667A - Composición farmacéutica de liberación controlada con resistencia a la influencia de etanol mediante el uso de un revestimiento compuesto de polímeros de vinilo neutrales y excipientes. - Google Patents
Composición farmacéutica de liberación controlada con resistencia a la influencia de etanol mediante el uso de un revestimiento compuesto de polímeros de vinilo neutrales y excipientes.Info
- Publication number
- MX2011009667A MX2011009667A MX2011009667A MX2011009667A MX2011009667A MX 2011009667 A MX2011009667 A MX 2011009667A MX 2011009667 A MX2011009667 A MX 2011009667A MX 2011009667 A MX2011009667 A MX 2011009667A MX 2011009667 A MX2011009667 A MX 2011009667A
- Authority
- MX
- Mexico
- Prior art keywords
- excipients
- weight
- influence
- pharmaceutical composition
- controlled release
- Prior art date
Links
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 title abstract 8
- 239000000546 pharmaceutical excipient Substances 0.000 title abstract 6
- 238000013270 controlled release Methods 0.000 title abstract 2
- 230000007935 neutral effect Effects 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 229920002554 vinyl polymer Polymers 0.000 title abstract 2
- 239000011248 coating agent Substances 0.000 title 1
- 238000000576 coating method Methods 0.000 title 1
- 239000004480 active ingredient Substances 0.000 abstract 2
- 239000011247 coating layer Substances 0.000 abstract 2
- 150000001875 compounds Chemical class 0.000 abstract 1
- 230000000694 effects Effects 0.000 abstract 1
- 239000003995 emulsifying agent Substances 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000004014 plasticizer Substances 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 229920006163 vinyl copolymer Polymers 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Rheumatology (AREA)
- Inorganic Chemistry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
La invención trata sobre una composición farmacéutica que consta de un núcleo, que consta de un ingrediente farmacéutico activo, donde el núcleo está revestido por una capa de revestimiento que proporciona resistencia que tiene el efecto de proporcionar el perfil de liberación del ingrediente farmacéutico activo para que sea resistente contra la influencia del etanol en donde la capa de revestimiento que proporciona resistencia al etanol consta de al menos 70% por peso de una mezcla de una porción polimérica a) y una porción de excipientes b), con la porción polimérica a) que consta de un polímero de vinilo o copolímero de vinilo esencialmente neutral insoluble en agua y la porción de excipientes b) que consta de los excipientes b1) 100 a 250% por peso de un lubricante inherente no poroso, b2) 1 - 35% por peso de un compuesto celulósico, b3) 0.1 a 25% por peso de un emulsionante y además o de manera alternativa a b3), b4) 0.1 a 30% por peso de un plastificante donde los excipientes de la porción de excipientes b) se calculan en peso en seco de la porción polimérica a).
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/EP2009/053176 WO2010105672A1 (en) | 2009-03-18 | 2009-03-18 | Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising neutral vinyl polymers and excipients |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2011009667A true MX2011009667A (es) | 2011-12-14 |
Family
ID=40694515
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2011009667A MX2011009667A (es) | 2009-03-18 | 2009-03-18 | Composición farmacéutica de liberación controlada con resistencia a la influencia de etanol mediante el uso de un revestimiento compuesto de polímeros de vinilo neutrales y excipientes. |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US9730899B2 (es) |
| EP (1) | EP2408436B1 (es) |
| JP (1) | JP5619130B2 (es) |
| KR (1) | KR101571198B1 (es) |
| CN (1) | CN102355893A (es) |
| BR (1) | BRPI0924543B8 (es) |
| CA (1) | CA2755808C (es) |
| ES (1) | ES2624719T3 (es) |
| HK (1) | HK1214182A1 (es) |
| HU (1) | HUE032817T2 (es) |
| IL (1) | IL214570A (es) |
| MX (1) | MX2011009667A (es) |
| PL (1) | PL2408436T3 (es) |
| SI (1) | SI2408436T1 (es) |
| WO (1) | WO2010105672A1 (es) |
Families Citing this family (59)
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| US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
| US20070048228A1 (en) | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
| DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
| DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
| DE102004032049A1 (de) | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Gegen Missbrauch gesicherte, orale Darreichungsform |
| DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| JP5774853B2 (ja) | 2008-01-25 | 2015-09-09 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 医薬投薬形 |
| NZ588863A (en) | 2008-05-09 | 2012-08-31 | Gruenenthal Chemie | Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step |
| PL2456424T3 (pl) | 2009-07-22 | 2013-12-31 | Gruenenthal Gmbh | Stabilizowana przed utlenianiem odporna na naruszenie postać dawkowania |
| PL2456427T3 (pl) | 2009-07-22 | 2015-07-31 | Gruenenthal Gmbh | Wytłaczana na gorąco postać dawki o kontrolowanym uwalnianiu |
| EP2506709B2 (en) | 2009-12-02 | 2019-10-09 | Adamas Pharmaceuticals, Inc. | Amantadine compositions and methods of use |
| SG184523A1 (en) | 2010-05-10 | 2012-11-29 | Euro Celtique Sa | Pharmaceutical compositions comprising hydromorphone and naloxone |
| AU2011252040C1 (en) | 2010-05-10 | 2015-04-02 | Euro-Celtique S.A. | Manufacturing of active-free granules and tablets comprising the same |
| WO2011141490A1 (en) | 2010-05-10 | 2011-11-17 | Euro-Celtique S.A. | Combination of active loaded granules with additional actives |
| KR20130137627A (ko) | 2010-09-02 | 2013-12-17 | 그뤼넨탈 게엠베하 | 음이온성 중합체를 포함하는 내변조성 투여형 |
| AU2011297901B2 (en) | 2010-09-02 | 2014-07-31 | Grunenthal Gmbh | Tamper resistant dosage form comprising inorganic salt |
| KR101799625B1 (ko) | 2011-06-17 | 2017-11-20 | 에보니크 룀 게엠베하 | 제약 또는 기능식품 투여 형태에 적합한 코팅 조성물 |
| RU2606588C2 (ru) | 2011-06-17 | 2017-01-10 | Эвоник Рем ГмбХ | Композиция покрытия, подходящая для фармацевтических или нутрицевтических дозированных форм |
| JP6099638B2 (ja) | 2011-06-17 | 2017-03-22 | 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 | エタノールの影響に耐性のある胃液抵抗性の医薬又は栄養補助組成物 |
| PT2736495T (pt) | 2011-07-29 | 2017-11-30 | Gruenenthal Gmbh | Comprimido resistente à adulteração proporcionando libertação imediata de fármaco |
| ES2648129T3 (es) | 2011-07-29 | 2017-12-28 | Grünenthal GmbH | Pastilla a prueba de manipulación que proporciona una liberación inmediata de un medicamento |
| EP2819656A1 (en) | 2012-02-28 | 2015-01-07 | Grünenthal GmbH | Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer |
| AR090695A1 (es) | 2012-04-18 | 2014-12-03 | Gruenenthal Gmbh | Forma de dosificacion farmaceutica resistente a la adulteracion y resistente a la liberacion inmediata de la dosis |
| US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
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| US10835495B2 (en) | 2012-11-14 | 2020-11-17 | W. R. Grace & Co.-Conn. | Compositions containing a biologically active material and a non-ordered inorganic oxide material and methods of making and using the same |
| JP2016507576A (ja) | 2013-02-13 | 2016-03-10 | 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 | 多数の２種類のペレットを含む多粒子医薬組成物 |
| MX2015013231A (es) * | 2013-03-15 | 2016-06-07 | Inspirion Delivery Technologies Llc | Composiciones que disuaden el abuso y metodos de utilizacion. |
| US10064826B2 (en) * | 2013-03-15 | 2018-09-04 | Navinta, Llc | Direct compression and dry granulation processes for preparing carglumic acid tablets having less impurities than those produced by wet granulation process |
| US10420729B2 (en) | 2013-03-15 | 2019-09-24 | R.P. Scherer Technologies, Llc | Abuse resistant capsule |
| MX2015016254A (es) | 2013-05-29 | 2016-04-20 | Gruenenthal Gmbh | Forma de dosificacion resistente al uso indebido con perfil de liberacion bimodal. |
| EP3003279A1 (en) | 2013-05-29 | 2016-04-13 | Grünenthal GmbH | Tamper-resistant dosage form containing one or more particles |
| TWI649100B (zh) * | 2013-06-17 | 2019-02-01 | 地平線罕見醫學製藥有限責任公司 | 延遲釋放型半胱胺珠粒調配物，以及其製備及使用方法 |
| US10154971B2 (en) | 2013-06-17 | 2018-12-18 | Adamas Pharma, Llc | Methods of administering amantadine |
| KR20160031526A (ko) | 2013-07-12 | 2016-03-22 | 그뤼넨탈 게엠베하 | 에틸렌-비닐 아세테이트 중합체를 함유하는 템퍼 내성 투여형 |
| WO2015023675A2 (en) | 2013-08-12 | 2015-02-19 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| SG11201602884WA (en) | 2013-11-13 | 2016-05-30 | Euro Celtique Sa | Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome |
| AU2014356581C1 (en) | 2013-11-26 | 2020-05-28 | Grunenthal Gmbh | Preparation of a powdery pharmaceutical composition by means of cryo-milling |
| 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 |
| MX2016014738A (es) | 2014-05-12 | 2017-03-06 | Gruenenthal Gmbh | Formulacion en capsula de liberacion inmediata resistente a alteraciones que comprende tapentadol. |
| AU2015266117A1 (en) | 2014-05-26 | 2016-11-24 | Grunenthal Gmbh | Multiparticles safeguarded against ethanolic dose-dumping |
| AU2015290098B2 (en) | 2014-07-17 | 2018-11-01 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
| WO2016042565A1 (en) * | 2014-09-16 | 2016-03-24 | Suresh Pareek | Extended release 'formulation of metoprolol |
| 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 |
| EP3229785A2 (de) * | 2014-12-08 | 2017-10-18 | Develco Pharma Schweiz AG | Naloxon-monopräparat und mehrschichttablette |
| JP2018517676A (ja) | 2015-04-24 | 2018-07-05 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 即時放出および溶媒抽出に対する耐性を有する改変防止製剤 |
| US20170042806A1 (en) | 2015-04-29 | 2017-02-16 | Dexcel Pharma Technologies Ltd. | Orally disintegrating compositions |
| ES2838816T3 (es) * | 2015-06-05 | 2021-07-02 | Evonik Operations Gmbh | Composición farmacéutica o nutracéutica con resistencia contra la influencia de etanol |
| US10842750B2 (en) | 2015-09-10 | 2020-11-24 | Grünenthal GmbH | Protecting oral overdose with abuse deterrent immediate release formulations |
| US10143665B2 (en) | 2015-11-17 | 2018-12-04 | Horizon Orphan Llc | Methods for storing cysteamine formulations and related methods of treatment |
| US10076494B2 (en) | 2016-06-16 | 2018-09-18 | Dexcel Pharma Technologies Ltd. | Stable orally disintegrating pharmaceutical compositions |
| CN117860718A (zh) | 2017-08-24 | 2024-04-12 | 阿达玛斯药物有限责任公司 | 金刚烷胺组合物、其制备和使用方法 |
| US20200289423A1 (en) | 2017-09-14 | 2020-09-17 | Evonik Operations Gmbh | Polymer and dosage form with sustained release properties and resistance against the influence of ethanol |
| EP3727384A4 (en) | 2017-12-20 | 2021-11-03 | Purdue Pharma L.P. | ABUSE-DISSUASIVE MORPHINE SULPHATE FORMES |
| KR20200130369A (ko) | 2018-03-09 | 2020-11-18 | 에보니크 오퍼레이션즈 게엠베하 | 에탄올의 영향에 대한 내성을 갖는 중합체 혼합물 |
| CN113195090B (zh) | 2018-10-16 | 2023-06-20 | 硅胶实验室制药公司 | 二氧化硅胶囊/球制备的可调方法及其用途 |
| CN114948898B (zh) * | 2022-03-28 | 2024-04-30 | 深圳善康医药科技股份有限公司 | 一种用于治疗肿瘤的盐酸纳曲酮微丸及其制备方法 |
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| DE10250543A1 (de) | 2002-10-29 | 2004-05-19 | Röhm GmbH & Co. KG | Mehrschichtige Arzneiform |
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| AU2006208627B8 (en) * | 2005-01-28 | 2009-08-13 | Mundipharma Pty Limited | Alcohol resistant dosage forms |
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| PL2187876T3 (pl) | 2007-09-21 | 2013-01-31 | Evonik Roehm Gmbh | Farmaceutyczna kompozycja opioidowa o zależnym od pH kontrolowanym uwalnianiu z odpornością przed wpływem etanolu |
| WO2010034342A1 (en) | 2008-09-24 | 2010-04-01 | Evonik Röhm Gmbh | Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol |
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-
2009
- 2009-03-18 SI SI200931651A patent/SI2408436T1/sl unknown
- 2009-03-18 US US13/256,694 patent/US9730899B2/en active Active
- 2009-03-18 ES ES09779169.3T patent/ES2624719T3/es active Active
- 2009-03-18 BR BRPI0924543A patent/BRPI0924543B8/pt not_active IP Right Cessation
- 2009-03-18 CN CN2009801581042A patent/CN102355893A/zh active Pending
- 2009-03-18 KR KR1020117021576A patent/KR101571198B1/ko not_active Expired - Fee Related
- 2009-03-18 EP EP09779169.3A patent/EP2408436B1/en active Active
- 2009-03-18 PL PL09779169T patent/PL2408436T3/pl unknown
- 2009-03-18 CA CA2755808A patent/CA2755808C/en active Active
- 2009-03-18 MX MX2011009667A patent/MX2011009667A/es active IP Right Grant
- 2009-03-18 HU HUE09779169A patent/HUE032817T2/en unknown
- 2009-03-18 JP JP2012500078A patent/JP5619130B2/ja not_active Expired - Fee Related
- 2009-03-18 WO PCT/EP2009/053176 patent/WO2010105672A1/en active Application Filing
-
2011
- 2011-08-09 IL IL214570A patent/IL214570A/en active IP Right Grant
-
2016
- 2016-03-02 HK HK16102434.2A patent/HK1214182A1/zh unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA2755808A1 (en) | 2010-09-23 |
| JP2012520831A (ja) | 2012-09-10 |
| BRPI0924543A2 (pt) | 2015-06-30 |
| SI2408436T1 (sl) | 2017-06-30 |
| KR20110128869A (ko) | 2011-11-30 |
| HUE032817T2 (en) | 2017-11-28 |
| IL214570A (en) | 2016-05-31 |
| WO2010105672A1 (en) | 2010-09-23 |
| EP2408436A1 (en) | 2012-01-25 |
| US9730899B2 (en) | 2017-08-15 |
| HK1214182A1 (zh) | 2016-07-22 |
| KR101571198B1 (ko) | 2015-11-23 |
| BRPI0924543B1 (pt) | 2021-02-02 |
| BRPI0924543B8 (pt) | 2022-07-05 |
| JP5619130B2 (ja) | 2014-11-05 |
| EP2408436B1 (en) | 2017-02-22 |
| US20120045506A1 (en) | 2012-02-23 |
| CN102355893A (zh) | 2012-02-15 |
| PL2408436T3 (pl) | 2017-08-31 |
| CA2755808C (en) | 2016-01-19 |
| IL214570A0 (en) | 2011-09-27 |
| ES2624719T3 (es) | 2017-07-17 |
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