ECSP14013269A - Forma de dosificación resistente a la alteración comprendiendo agonista opioide y antagonista opioide - Google Patents
Forma de dosificación resistente a la alteración comprendiendo agonista opioide y antagonista opioideInfo
- Publication number
- ECSP14013269A ECSP14013269A ECSP14013269A ECSP14013269A EC SP14013269 A ECSP14013269 A EC SP14013269A EC SP14013269 A ECSP14013269 A EC SP14013269A EC SP14013269 A ECSP14013269 A EC SP14013269A
- Authority
- EC
- Ecuador
- Prior art keywords
- opioid
- dosage form
- alteration
- understanding
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Emergency Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Neurosurgery (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
La invención se refiere a una forma de dosificación farmacéutica para administración oral que tiene una resistencia a rompimiento de al menos 300 N y que comprende un agonista opioide, un antagonista opioide, y un óxido de polialquileno que tiene un peso molecular promedio de al menos 200,000 g/mol, en donde de acuerdo con Ph. Eur. el perfil de liberación in vitro del agonista opioide esencialmente corresponde al perfil de liberación in vitro del antagonista opioide, y en donde el agonista opioide y el antagonista opioide se mezclan íntimamente entre sí y se mezclan de manera homogénea en el óxido de polialquileno.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11008131 | 2011-10-06 | ||
| EP11009090 | 2011-11-16 | ||
| EP12001297 | 2012-02-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ECSP14013269A true ECSP14013269A (es) | 2014-12-30 |
Family
ID=47018994
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ECSP14013269 ECSP14013269A (es) | 2011-10-06 | 2014-03-25 | Forma de dosificación resistente a la alteración comprendiendo agonista opioide y antagonista opioide |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US20130090349A1 (es) |
| EP (1) | EP2763664A2 (es) |
| JP (1) | JP2014528437A (es) |
| KR (1) | KR20140075704A (es) |
| CN (1) | CN103998025A (es) |
| AR (1) | AR088250A1 (es) |
| AU (1) | AU2012320496C1 (es) |
| BR (1) | BR112014008120A2 (es) |
| CA (1) | CA2850853A1 (es) |
| CL (1) | CL2014000361A1 (es) |
| CO (1) | CO6950467A2 (es) |
| EA (1) | EA029508B1 (es) |
| EC (1) | ECSP14013269A (es) |
| HK (1) | HK1200741A1 (es) |
| IL (1) | IL230819A0 (es) |
| MX (1) | MX2014003973A (es) |
| PE (1) | PE20141171A1 (es) |
| WO (1) | WO2013050539A2 (es) |
Families Citing this family (58)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1429744A1 (en) | 2001-09-21 | 2004-06-23 | Egalet A/S | Morphine polymer release system |
| US20040234602A1 (en) | 2001-09-21 | 2004-11-25 | Gina Fischer | Polymer release system |
| US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
| WO2004084868A1 (en) | 2003-03-26 | 2004-10-07 | Egalet A/S | Morphine controlled release system |
| 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 |
| 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 |
| EP2155167A2 (en) | 2007-06-04 | 2010-02-24 | Egalet A/S | Controlled release pharmaceutical compositions for prolonged effect |
| CA2713128C (en) | 2008-01-25 | 2016-04-05 | Gruenenthal Gmbh | Pharmaceutical dosage form |
| AU2009243681B2 (en) | 2008-05-09 | 2013-12-19 | Grunenthal Gmbh | Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step |
| NZ594207A (en) | 2009-02-06 | 2013-03-28 | Egalet Ltd | Immediate release composition resistant to abuse by intake of alcohol |
| NZ597283A (en) | 2009-06-24 | 2013-07-26 | Egalet Ltd | Controlled release formulations |
| KR101738369B1 (ko) | 2009-07-22 | 2017-05-22 | 그뤼넨탈 게엠베하 | 핫 멜트 압출된 제어 방출 투여형 |
| CN102639118B (zh) | 2009-07-22 | 2015-07-29 | 格吕伦塔尔有限公司 | 氧化稳定的抗干扰剂型 |
| PH12012502083A1 (en) | 2010-05-10 | 2017-07-26 | Euro Celtique Sa | Manufacturing of active-free granules and tablets comprising the same |
| EP2568965A1 (en) | 2010-05-10 | 2013-03-20 | Euro-Celtique S.A. | Combination of active loaded granules with additional actives |
| TWI516286B (zh) | 2010-09-02 | 2016-01-11 | 歌林達股份有限公司 | 含陰離子聚合物之抗破碎劑型 |
| BR112013005194A2 (pt) | 2010-09-02 | 2016-05-03 | Gruenenthal Gmbh | forma de dosagem resistente à violação compreendendo sal inorgânico |
| BR112014001091A2 (pt) | 2011-07-29 | 2017-02-14 | Gruenenthal Gmbh | comprimido resistente à adulteração que fornece liberação imediata do fármaco |
| EA201400172A1 (ru) | 2011-07-29 | 2014-06-30 | Грюненталь Гмбх | Устойчивая к разрушению таблетка, которая обеспечивает немедленное высвобождение лекарственного средства |
| PE20141671A1 (es) * | 2011-11-17 | 2014-11-22 | Gruenenthal Chemie | Forma de dosis farmaceutica oral a prueba de manipulacion que comprende un agente antagonista y/o repelente opioide, oxido de polialquileno y un polimero anionico |
| MX356421B (es) | 2012-02-28 | 2018-05-29 | Gruenenthal Gmbh | Forma de dosificacion resistente a la manipulacion indebida que comprende un compuesto farmacologicamente activo y un polimero anionico. |
| EP2838512B1 (en) | 2012-04-18 | 2018-08-22 | Grünenthal 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 |
| BR112015000150A2 (pt) | 2012-07-06 | 2017-06-27 | Egalet Ltd | composições farmacêuticas dissuasoras de abuso de liberação controlada |
| CA2881144A1 (en) * | 2012-11-09 | 2014-05-09 | Purdue Pharma | Pharmaceutical compositions comprising hydromorphone and naloxone |
| EP3003279A1 (en) | 2013-05-29 | 2016-04-13 | Grünenthal GmbH | Tamper-resistant dosage form containing one or more particles |
| US9737490B2 (en) | 2013-05-29 | 2017-08-22 | Grünenthal GmbH | Tamper resistant dosage form with bimodal release profile |
| BR112016000194A8 (pt) | 2013-07-12 | 2019-12-31 | Gruenenthal Gmbh | forma de dosagem resistente à violação contendo o polímero de acetato de etileno-vinila |
| CA3042642A1 (en) | 2013-08-12 | 2015-02-19 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| WO2015071380A1 (en) | 2013-11-13 | 2015-05-21 | Euro-Celtique S.A. | Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome |
| EP3073994A1 (en) | 2013-11-26 | 2016-10-05 | Grünenthal GmbH | Preparation of a powdery pharmaceutical composition by means of cryo-milling |
| US10105360B2 (en) | 2013-12-11 | 2018-10-23 | Develco Pharma Schweiz Ag | Method and composition for the treatment of opioid induced constipation |
| US9456986B2 (en) | 2013-12-11 | 2016-10-04 | Develco Pharma Schweiz Ag | Naloxone mono preparation and multilayer tablet |
| 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 |
| MX2016008361A (es) * | 2013-12-23 | 2016-10-14 | Purdue Pharma Lp | Formulaciones de antagonista de opioides. |
| CA2847781C (en) * | 2014-03-28 | 2019-03-12 | Purdue Pharma | Reducing drug liking in a subject |
| WO2015173195A1 (en) | 2014-05-12 | 2015-11-19 | Grünenthal GmbH | Tamper resistant immediate release capsule formulation comprising tapentadol |
| EA201692388A1 (ru) | 2014-05-26 | 2017-05-31 | Грюненталь Гмбх | Лекарственная форма в виде множества частиц, защищенная от вызываемого этанолом сброса дозы |
| CA2955229C (en) | 2014-07-17 | 2020-03-10 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
| AU2015336065A1 (en) | 2014-10-20 | 2017-05-04 | Pharmaceutical Manufacturing Research Services, Inc. | Extended release abuse deterrent liquid fill dosage form |
| EP3229785A2 (de) * | 2014-12-08 | 2017-10-18 | Develco Pharma Schweiz AG | Naloxon-monopräparat und mehrschichttablette |
| AU2016251851A1 (en) | 2015-04-24 | 2017-11-09 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from particles |
| EP3285744A1 (en) | 2015-04-24 | 2018-02-28 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix |
| WO2016170097A1 (en) | 2015-04-24 | 2016-10-27 | Grünenthal GmbH | Tamper-resistant dosage form with immediate release and resistance against solvent extraction |
| WO2016170096A1 (en) | 2015-04-24 | 2016-10-27 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from different particles |
| JP2018526414A (ja) | 2015-09-10 | 2018-09-13 | 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 | 乱用抑止性の即放性製剤を用いた経口過剰摂取に対する保護 |
| US9943513B1 (en) | 2015-10-07 | 2018-04-17 | Banner Life Sciences Llc | Opioid abuse deterrent dosage forms |
| US10335405B1 (en) | 2016-05-04 | 2019-07-02 | Patheon Softgels, Inc. | Non-burst releasing pharmaceutical composition |
| EP3290027A1 (en) * | 2016-09-02 | 2018-03-07 | Develco Pharma Schweiz AG | Method and composition for the treatment of opioid induced constipation |
| US10335375B2 (en) | 2017-05-30 | 2019-07-02 | Patheon Softgels, Inc. | Anti-overingestion abuse deterrent compositions |
| EP3473246A1 (en) | 2017-10-19 | 2019-04-24 | Capsugel Belgium NV | Immediate release abuse deterrent formulations |
| EP3727384A4 (en) | 2017-12-20 | 2021-11-03 | Purdue Pharma L.P. | ABUSE-DISSUASIVE MORPHINE SULPHATE FORMES |
| NZ799086A (en) * | 2020-10-16 | 2026-02-27 | Scherer Technologies Llc R P | Controlled release fill compositions and capsules containing same |
Family Cites Families (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19710008A1 (de) * | 1997-03-12 | 1998-09-17 | Basf Ag | Feste, mindestens zweiphasige Zubereitungsformen eines Opioid-Analgeticums mit verzögerter Freisetzung |
| SI1416842T1 (sl) * | 2001-07-18 | 2009-06-30 | Euro Celtique Sa | Farmacevtske kombinacije oksikodona in naloksona |
| US7141250B2 (en) | 2001-08-06 | 2006-11-28 | Euro-Celtique S.A. | Pharmaceutical formulation containing bittering agent |
| WO2003015531A2 (en) | 2001-08-06 | 2003-02-27 | Thomas Gruber | Pharmaceutical formulation containing dye |
| EP1492505B1 (en) | 2002-04-05 | 2015-06-03 | Euro-Celtique S.A. | Pharmaceutical preparation containing oxycodone and naloxone |
| EP1658054B1 (de) | 2003-08-06 | 2007-06-27 | Grünenthal GmbH | Gegen missbrauch gesicherte darreichungsform |
| DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
| DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
| DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| PL1740156T3 (pl) | 2004-04-22 | 2011-12-30 | Gruenenthal Gmbh | Sposób wytwarzania zabezpieczonej przed nadużyciem, stałej postaci aplikacyjnej |
| PL1765298T3 (pl) | 2004-07-01 | 2013-01-31 | Gruenenthal Gmbh | Sposób wytwarzania stałej postaci dawkowania, która jest zabezpieczona przez nadużywaniem, wykorzystujący wytłaczarkę z przekładnią planetarną |
| BRPI0513300B1 (pt) | 2004-07-01 | 2018-11-06 | Gruenenthal Gmbh | forma farmacêutica oral, protegida frente ao abuso, contendo (1r, 2r)-3-(3-dimetilamino-1-etil-2- metil-lpropil)-fenol |
| AR049562A1 (es) * | 2004-07-01 | 2006-08-16 | Gruenenthal Gmbh | Formas farmaceuticas orales, con liberacion controlada de opioides, protegidas frente al abuso y procedimiento para su preparacion |
| JP2008508201A (ja) * | 2004-07-27 | 2008-03-21 | ユニリーバー・ナームローゼ・ベンノートシヤープ | ヘアケア組成物 |
| DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| US20060194759A1 (en) * | 2005-02-25 | 2006-08-31 | Eidelson Stewart G | Topical compositions and methods for treating pain and inflammation |
| KR20080089653A (ko) * | 2006-01-21 | 2008-10-07 | 애보트 게엠베하 운트 콤파니 카게 | 남용 약물의 전달을 위한 투여형 및 방법 |
| DE102007011485A1 (de) | 2007-03-07 | 2008-09-11 | Grünenthal GmbH | Darreichungsform mit erschwertem Missbrauch |
| HRP20160529T1 (hr) | 2008-07-31 | 2016-07-29 | Anglo Netherlands Grain Bv | Biljke suncokreta rezistentne na herbicide |
| GB0909680D0 (en) * | 2009-06-05 | 2009-07-22 | Euro Celtique Sa | Dosage form |
| CN102639118B (zh) * | 2009-07-22 | 2015-07-29 | 格吕伦塔尔有限公司 | 氧化稳定的抗干扰剂型 |
-
2012
- 2012-10-05 PE PE2014000279A patent/PE20141171A1/es not_active Application Discontinuation
- 2012-10-05 AR ARP120103721A patent/AR088250A1/es unknown
- 2012-10-05 WO PCT/EP2012/069735 patent/WO2013050539A2/en not_active Ceased
- 2012-10-05 BR BR112014008120A patent/BR112014008120A2/pt not_active IP Right Cessation
- 2012-10-05 HK HK15101501.3A patent/HK1200741A1/xx unknown
- 2012-10-05 AU AU2012320496A patent/AU2012320496C1/en not_active Ceased
- 2012-10-05 CA CA2850853A patent/CA2850853A1/en not_active Abandoned
- 2012-10-05 MX MX2014003973A patent/MX2014003973A/es unknown
- 2012-10-05 JP JP2014533921A patent/JP2014528437A/ja active Pending
- 2012-10-05 KR KR1020147009106A patent/KR20140075704A/ko not_active Withdrawn
- 2012-10-05 US US13/645,595 patent/US20130090349A1/en not_active Abandoned
- 2012-10-05 CN CN201280049146.4A patent/CN103998025A/zh active Pending
- 2012-10-05 EP EP12772756.8A patent/EP2763664A2/en not_active Withdrawn
- 2012-10-05 EA EA201400413A patent/EA029508B1/ru not_active IP Right Cessation
-
2014
- 2014-02-05 IL IL230819A patent/IL230819A0/en unknown
- 2014-02-12 CO CO14029690A patent/CO6950467A2/es not_active Application Discontinuation
- 2014-02-13 CL CL2014000361A patent/CL2014000361A1/es unknown
- 2014-03-25 EC ECSP14013269 patent/ECSP14013269A/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| AU2012320496C1 (en) | 2017-09-28 |
| CN103998025A (zh) | 2014-08-20 |
| MX2014003973A (es) | 2014-05-07 |
| IL230819A0 (en) | 2014-03-31 |
| AU2012320496A1 (en) | 2014-02-13 |
| EP2763664A2 (en) | 2014-08-13 |
| NZ620252A (en) | 2015-09-25 |
| HK1200741A1 (en) | 2015-08-14 |
| KR20140075704A (ko) | 2014-06-19 |
| BR112014008120A2 (pt) | 2017-04-11 |
| CO6950467A2 (es) | 2014-05-20 |
| EA201400413A1 (ru) | 2014-11-28 |
| CA2850853A1 (en) | 2013-04-11 |
| PE20141171A1 (es) | 2014-09-21 |
| EA029508B1 (ru) | 2018-04-30 |
| WO2013050539A2 (en) | 2013-04-11 |
| WO2013050539A3 (en) | 2013-05-30 |
| AR088250A1 (es) | 2014-05-21 |
| US20130090349A1 (en) | 2013-04-11 |
| JP2014528437A (ja) | 2014-10-27 |
| CL2014000361A1 (es) | 2014-06-20 |
| AU2012320496B2 (en) | 2017-05-18 |
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