CO6220959A2 - Prevencion de la separacion del agonista opioide del antagonista opioide desde formas de dosificacion que comprenden el agonista opioide y el antagonista opioide - Google Patents
Prevencion de la separacion del agonista opioide del antagonista opioide desde formas de dosificacion que comprenden el agonista opioide y el antagonista opioideInfo
- Publication number
- CO6220959A2 CO6220959A2 CO09070292A CO09070292A CO6220959A2 CO 6220959 A2 CO6220959 A2 CO 6220959A2 CO 09070292 A CO09070292 A CO 09070292A CO 09070292 A CO09070292 A CO 09070292A CO 6220959 A2 CO6220959 A2 CO 6220959A2
- Authority
- CO
- Colombia
- Prior art keywords
- opioid
- amount
- opioid agonist
- dosage form
- opioid antagonist
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
- A61P25/36—Opioid-abuse
-
- 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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Emergency Medicine (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Addiction (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurology (AREA)
- Organic Chemistry (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
1.- El uso de una cantidad de un antagonista opioide en una cantidad que al menos sea suficiente para antagonizar sustancialmente una cantidad terapéutica de agonista opioide cuando ambos, el agonista opioide y el antagonista opioide se administran por vía intravenosa al mismo tiempo, en forma de una forma de dosificación de liberación controlada que comprende una formulación de matriz de liberación controlada homogénea que comprende un material hidrofóbico, incluyendo al menos un polímero hidrofóbico y al menos un alcohol graso o un ácido graso y la cantidad declarada terapéutica de un agonista opioide y la cantidad declarada suficiente de antagonista opioide, para prevenir la formación de una extracto de dicha formulación de matriz de liberación controlada que comprende el agonista opioide mediante el procedimiento de extracción de un solo paso que comprende los pasos de: a) triturar la formulación de una forma de dosificación usando un triturador de tabletas o un mortero, o usando dos cucharas, donde la trituración se lleva a cabo al menos 4 veces usando las cucharas, extraer la formulación triturada de una forma de dosificación en una cuchara usando 2 ml de agua de la llave hirviendo como agente extractor y un encendedor de cigarrillos como medio para calentar por un periodo necesario para hervir el agua, y filtrar la solución usando algodón, donde el antagonista opioide está presente en dicho extracto en una cantidad de peso porcentual basada en la cantidad total de antagonista opioide en la forma de dosificación, que es mayor que 20 puntos porcentuales menor que la cantidad de peso porcentual de agonista opioide presente en el extracto, basado en la cantidad total de agonista opioide en la forma de dosificación.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP06001754A EP1813276A1 (en) | 2006-01-27 | 2006-01-27 | Tamper resistant dosage forms |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO6220959A2 true CO6220959A2 (es) | 2010-11-19 |
Family
ID=35987132
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CO09070292A CO6220959A2 (es) | 2006-01-27 | 2009-07-08 | Prevencion de la separacion del agonista opioide del antagonista opioide desde formas de dosificacion que comprenden el agonista opioide y el antagonista opioide |
Country Status (32)
| Country | Link |
|---|---|
| US (4) | US20090169626A1 (es) |
| EP (4) | EP1813276A1 (es) |
| JP (2) | JP5714215B2 (es) |
| KR (2) | KR20110122775A (es) |
| CN (1) | CN101374521B (es) |
| AP (1) | AP2258A (es) |
| AR (1) | AR059194A1 (es) |
| AU (1) | AU2007209290B2 (es) |
| BR (1) | BRPI0706952A2 (es) |
| CA (1) | CA2640339C (es) |
| CO (1) | CO6220959A2 (es) |
| CY (1) | CY1113122T1 (es) |
| DE (1) | DE202007019381U1 (es) |
| DK (1) | DK1986650T3 (es) |
| EA (1) | EA017635B1 (es) |
| ES (1) | ES2389223T3 (es) |
| GE (1) | GEP20125578B (es) |
| HK (1) | HK1123748A1 (es) |
| HR (1) | HRP20120619T1 (es) |
| IL (1) | IL192973A (es) |
| MA (1) | MA30310B1 (es) |
| ME (1) | ME01437B (es) |
| NZ (1) | NZ570358A (es) |
| PL (1) | PL1986650T3 (es) |
| PT (1) | PT1986650E (es) |
| RS (1) | RS52428B (es) |
| SG (1) | SG169353A1 (es) |
| SI (1) | SI1986650T1 (es) |
| TN (1) | TNSN08313A1 (es) |
| TW (1) | TWI463983B (es) |
| WO (1) | WO2007085637A1 (es) |
| ZA (1) | ZA200806965B (es) |
Families Citing this family (59)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HU1500214D0 (hu) | 1997-12-22 | 2002-03-28 | Euro Celtique Sa | Opioid agonista és antagonista hatóanyagot tartalmazó gyógyszerkészítmény |
| US6375957B1 (en) | 1997-12-22 | 2002-04-23 | Euro-Celtique, S.A. | Opioid agonist/opioid antagonist/acetaminophen combinations |
| ES2361148T3 (es) | 2001-05-11 | 2011-06-14 | Endo Pharmaceuticals Inc. | Forma de dosificación de opioides de liberación controlada resistente al abuso. |
| EP2425823A1 (en) | 2002-04-05 | 2012-03-07 | Euro-Celtique S.A. | Pharmaceutical preparation containing oxycodone and naloxone |
| US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
| EP2316456B1 (en) | 2003-04-29 | 2017-06-14 | Orexigen Therapeutics, Inc. | Compositions for affecting weight loss comprising an opioid antagonist and bupropion |
| US20070048228A1 (en) | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
| DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
| 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 |
| EP1604666A1 (en) | 2004-06-08 | 2005-12-14 | Euro-Celtique S.A. | Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD) |
| 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 |
| EP1702558A1 (en) | 2005-02-28 | 2006-09-20 | Euro-Celtique S.A. | Method and device for the assessment of bowel function |
| EP1951212A2 (en) | 2005-11-22 | 2008-08-06 | Orexigen Therapeutics, Inc. | Compositions and methods for increasing insulin sensitivity |
| US8916195B2 (en) | 2006-06-05 | 2014-12-23 | Orexigen Therapeutics, Inc. | Sustained release formulation of naltrexone |
| KR20090090316A (ko) | 2006-11-09 | 2009-08-25 | 오렉시젠 세러퓨틱스 인크. | 체중 감량 약물을 투여하기 위한 단위 용량 팩키지 및 투여 방법 |
| BRPI0906467C1 (pt) | 2008-01-25 | 2021-05-25 | Gruenenthal Gmbh | forma de dosagem farmacêutica com formato exterior modificado resistente à ruptura e com liberação controlada |
| LT2273983T (lt) | 2008-05-09 | 2016-10-25 | Grünenthal GmbH | Tarpinės miltelių kompozicijos gamybos būdas ir galutinė kieta dozavimo forma naudojant purškalo kietinimo stadija |
| CA2725930A1 (en) | 2008-05-30 | 2009-12-30 | Orexigen Therapeutics, Inc. | Methods for treating visceral fat conditions |
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| GB0909680D0 (en) | 2009-06-05 | 2009-07-22 | Euro Celtique Sa | Dosage form |
| AU2010275754B2 (en) | 2009-07-22 | 2014-05-15 | Grünenthal GmbH | Tamper-resistant dosage form for oxidation-sensitive opioids |
| EP2456427B1 (en) | 2009-07-22 | 2015-03-04 | Grünenthal GmbH | Hot-melt extruded controlled release dosage form |
| ES2762113T3 (es) | 2010-01-11 | 2020-05-22 | Nalpropion Pharmaceuticals Inc | Métodos de proporcionar terapia de pérdida de peso en pacientes con depresión mayor |
| CN101768164B (zh) * | 2010-01-25 | 2011-09-14 | 海南数尔药物研究有限公司 | 一种高纯度的盐酸纳洛酮化合物 |
| WO2011095314A2 (en) | 2010-02-03 | 2011-08-11 | Grünenthal GmbH | Preparation of a powdery pharmaceutical composition by means of an extruder |
| CA2798884C (en) | 2010-05-10 | 2016-09-13 | Euro-Celtique S.A. | Manufacturing of active-free granules and tablets comprising the same |
| SE1251371A1 (sv) | 2010-05-10 | 2012-12-27 | Euro Celtique Sa | Farmaceutiska kompositioner innefattande hydromorfon och naloxon |
| US9901540B2 (en) | 2010-05-10 | 2018-02-27 | Euro-Celtique S.A. | Combination of active loaded granules with additional actives |
| WO2012028319A1 (en) | 2010-09-02 | 2012-03-08 | Grünenthal GmbH | Tamper resistant dosage form comprising inorganic salt |
| MX2013002293A (es) | 2010-09-02 | 2013-05-09 | Gruenenthal Gmbh | Forma de dosificacion resistente a alteracion que comprende un polimero anionico. |
| AT511581A1 (de) * | 2011-05-26 | 2012-12-15 | G L Pharma Gmbh | Orale retardierende formulierung |
| LT2736497T (lt) | 2011-07-29 | 2017-11-10 | Grünenthal GmbH | Sugadinimui atspari tabletė, pasižyminti greitu vaisto atpalaidavimu |
| BR112014002022A2 (pt) | 2011-07-29 | 2017-02-21 | Gruenenthal Gmbh | comprimido resistente à violação proporcionando liberação de fármaco imediata |
| US20130225697A1 (en) | 2012-02-28 | 2013-08-29 | Grunenthal Gmbh | Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer |
| AU2013248351B2 (en) | 2012-04-18 | 2018-04-26 | Grunenthal Gmbh | Tamper resistant and dose-dumping resistant pharmaceutical dosage form |
| US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
| ES2436344B1 (es) * | 2012-05-29 | 2014-08-07 | Onedose Pharma, S.L. | Composición farmacéutica de diacetilmorfina y naloxona para administración oral |
| EP4104824A1 (en) | 2012-06-06 | 2022-12-21 | Nalpropion Pharmaceuticals LLC | Composition for use in a method of treating overweight and obesity in patients with high cardiovascular risk |
| MX362838B (es) | 2012-07-12 | 2019-02-19 | SpecGx LLC | Composiciones farmacéuticas de liberación prolongada para disuadir el abuso de opioides que comprenden un plastómero, un elastómero y un plastificante delicuescente. |
| HU231191B1 (hu) | 2013-04-15 | 2021-08-30 | Szegedi Tudományegyetem | Izotóp tartalmú morfin molekulák |
| JP6466417B2 (ja) | 2013-05-29 | 2019-02-06 | 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 | 二峰性放出プロファイルを有する改変防止（ｔａｍｐｅｒ−ｒｅｓｉｓｔａｎｔ）剤形 |
| CA2907950A1 (en) | 2013-05-29 | 2014-12-04 | Grunenthal Gmbh | Tamper-resistant dosage form containing one or more particles |
| EA032465B1 (ru) | 2013-07-12 | 2019-05-31 | Грюненталь Гмбх | Защищенная от применения не по назначению пероральная фармацевтическая лекарственная форма, содержащая этиленвинилацетатный полимер, и способ ее изготовления |
| CN105517551A (zh) | 2013-07-23 | 2016-04-20 | 欧洲凯尔特公司 | 用于在患有疼痛和导致肠生态失调和/或提高肠细菌移位风险之疾病的患者中治疗疼痛的羟考酮与纳洛酮的组合 |
| WO2015023675A2 (en) | 2013-08-12 | 2015-02-19 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| BR112016009749A8 (pt) | 2013-11-13 | 2018-01-30 | Euro Celtique Sa | hidromorfona e naloxona para tratamento de dor e síndrome de disfunção intestinal opioide |
| AU2014356581C1 (en) | 2013-11-26 | 2020-05-28 | Grunenthal Gmbh | Preparation of a powdery pharmaceutical composition by means of cryo-milling |
| US8969371B1 (en) | 2013-12-06 | 2015-03-03 | Orexigen Therapeutics, Inc. | Compositions and methods for weight loss in at risk patient populations |
| 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 |
| CN106572980A (zh) | 2014-05-12 | 2017-04-19 | 格吕伦塔尔有限公司 | 包含他喷他多的防篡改即释胶囊制剂 |
| CN106456550A (zh) | 2014-05-26 | 2017-02-22 | 格吕伦塔尔有限公司 | 避免乙醇剂量倾泻的多颗粒 |
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| TW201613590A (en) * | 2014-09-12 | 2016-04-16 | Purdue Pharma Lp | Systems and methods for attenuating opioid-induced euphoria |
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-
2006
- 2006-01-27 EP EP06001754A patent/EP1813276A1/en not_active Withdrawn
-
2007
- 2007-01-25 KR KR1020117025761A patent/KR20110122775A/ko not_active Application Discontinuation
- 2007-01-25 CN CN200780003701.9A patent/CN101374521B/zh not_active Expired - Fee Related
- 2007-01-25 RS RS20120354A patent/RS52428B/en unknown
- 2007-01-25 SI SI200730994T patent/SI1986650T1/sl unknown
- 2007-01-25 US US12/162,390 patent/US20090169626A1/en not_active Abandoned
- 2007-01-25 SG SG201100593-1A patent/SG169353A1/en unknown
- 2007-01-25 KR KR1020087020932A patent/KR20080091265A/ko active Application Filing
- 2007-01-25 BR BRPI0706952-9A patent/BRPI0706952A2/pt not_active IP Right Cessation
- 2007-01-25 AU AU2007209290A patent/AU2007209290B2/en not_active Ceased
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