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)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (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 |
|---|---|---|---|---|
| US20040253310A1 (en) | 2001-09-21 | 2004-12-16 | Gina Fischer | Morphine polymer release system |
| WO2003024429A1 (en) | 2001-09-21 | 2003-03-27 | Egalet A/S | Polymer release system |
| US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
| US8877241B2 (en) | 2003-03-26 | 2014-11-04 | Egalet Ltd. | 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 |
| 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 |
| 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 |
| US8821928B2 (en) | 2007-06-04 | 2014-09-02 | Egalet Ltd. | Controlled release pharmaceutical compositions for prolonged effect |
| TWI454288B (zh) | 2008-01-25 | 2014-10-01 | Gruenenthal Chemie | 藥物劑型 |
| ES2599031T3 (es) | 2008-05-09 | 2017-01-31 | Grünenthal GmbH | Proceso para la preparación de una formulación de polvo intermedia y una forma de dosificación solida final utilizando un paso de congelación por pulverización |
| NZ594207A (en) | 2009-02-06 | 2013-03-28 | Egalet Ltd | Immediate release composition resistant to abuse by intake of alcohol |
| AU2010265213B2 (en) | 2009-06-24 | 2012-08-23 | Egalet Ltd. | Controlled release formulations |
| BR112012001466A2 (pt) * | 2009-07-22 | 2020-08-11 | Grünenthal GmbH | forma de dosagem resistente à falsificação para opioides sensíveis à oxidação, seu processo de fabricação, e embalagem |
| ES2534908T3 (es) | 2009-07-22 | 2015-04-30 | Grünenthal GmbH | Forma de dosificación de liberación controlada extruida por fusión en caliente |
| WO2011141490A1 (en) | 2010-05-10 | 2011-11-17 | Euro-Celtique S.A. | Combination of active loaded granules with additional actives |
| MX340188B (es) | 2010-05-10 | 2016-06-30 | Euro-Celtique S A * | Elaboracion de granulos sin activos y tabletas que comprenden los mismos. |
| WO2012028318A1 (en) | 2010-09-02 | 2012-03-08 | Grünenthal GmbH | Tamper resistant dosage form comprising an anionic polymer |
| CA2808219C (en) | 2010-09-02 | 2019-05-14 | Gruenenthal Gmbh | Tamper resistant dosage form comprising inorganic salt |
| BR112014002022A2 (pt) | 2011-07-29 | 2017-02-21 | Gruenenthal Gmbh | comprimido resistente à violação proporcionando liberação de fármaco imediata |
| JP6063462B2 (ja) | 2011-07-29 | 2017-01-18 | 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 | 即時薬剤放出を提供するタンパーレジスタント錠剤 |
| KR20140096062A (ko) * | 2011-11-17 | 2014-08-04 | 그뤼넨탈 게엠베하 | 약리학적 활성 성분, 오피오이드 길항제 및/또는 혐오제, 폴리알킬렌 옥사이드 및 음이온성 중합체를 포함하는 탬퍼-저항성 경구 약제학적 투여형 |
| BR112014019988A8 (pt) | 2012-02-28 | 2017-07-11 | Gruenenthal Gmbh | Forma de dosagem resistente a socamento compreendendo um composto farmacologicamente ativo e um polímero aniônico |
| LT2838512T (lt) | 2012-04-18 | 2018-11-12 | Grünenthal GmbH | Pažeidimui atspari ir dozės atpalaidavimo nuokrypiui atspari farmacinė vaisto forma |
| US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
| JP2015521988A (ja) | 2012-07-06 | 2015-08-03 | イガレット・リミテッド | 制御放出用乱用防止性医薬組成物 |
| CA2881144A1 (en) * | 2012-11-09 | 2014-05-09 | Purdue Pharma | Pharmaceutical compositions comprising hydromorphone and naloxone |
| AU2014273227B2 (en) * | 2013-05-29 | 2019-08-15 | Grunenthal Gmbh | Tamper-resistant dosage form containing one or more particles |
| MX2015016254A (es) | 2013-05-29 | 2016-04-20 | Gruenenthal Gmbh | Forma de dosificacion resistente al uso indebido con perfil de liberacion bimodal. |
| AU2014289187B2 (en) | 2013-07-12 | 2019-07-11 | Grunenthal Gmbh | Tamper-resistant dosage form containing ethylene-vinyl acetate polymer |
| CA3042642A1 (en) | 2013-08-12 | 2015-02-19 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| JP6232135B2 (ja) | 2013-11-13 | 2017-11-15 | ユーロ−セルティーク エス.エイ. | 疼痛およびオピオイドによる腸機能障害症候群の治療のためのヒドロモルホンおよびナロキソン |
| HK1224189A1 (zh) | 2013-11-26 | 2017-08-18 | Grünenthal GmbH | 通过低温研磨制备粉状药物组合物 |
| 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 |
| WO2015095391A1 (en) | 2013-12-17 | 2015-06-25 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| EP3086789A4 (en) * | 2013-12-23 | 2017-08-02 | Purdue Pharma L.P. | Opioid antagonist formulations |
| 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 |
| US9872835B2 (en) | 2014-05-26 | 2018-01-23 | Grünenthal GmbH | Multiparticles safeguarded against ethanolic dose-dumping |
| DK3169315T3 (da) | 2014-07-17 | 2020-08-10 | Pharmaceutical Manufacturing Res Services In | Væskefyldt doseringsform til forhindring af misbrug med øjeblikkelig frigivelse |
| 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 |
| WO2016170097A1 (en) | 2015-04-24 | 2016-10-27 | Grünenthal GmbH | Tamper-resistant dosage form with immediate release and resistance against solvent extraction |
| BR112017022856A2 (pt) | 2015-04-24 | 2018-07-17 | Gruenenthal Gmbh | combinação de dose fixa inviolável que proporciona rápida liberação de duas drogas a partir de partículas |
| WO2016170093A1 (en) | 2015-04-24 | 2016-10-27 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix |
| US20160310428A1 (en) | 2015-04-24 | 2016-10-27 | Grunenthal Gmbh | Tamper-resistant fixed dose combination providing fast release of two drugs from different particles |
| CA2998259A1 (en) | 2015-09-10 | 2017-03-16 | Grunenthal Gmbh | Protecting oral overdose with abuse deterrent immediate release formulations |
| 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 |
| US12161754B2 (en) | 2017-12-20 | 2024-12-10 | Purdue Pharma L.P. | Abuse deterrent morphine sulfate dosage forms |
| CA3195386A1 (en) * | 2020-10-16 | 2022-04-21 | Qi Fang | 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 |
| DK1416842T3 (da) * | 2001-07-18 | 2009-03-16 | Euro Celtique Sa | Farmaceutiske kombinationer af oxycodon og naloxon |
| AU2002321879A1 (en) | 2001-08-06 | 2003-03-03 | Thomas Gruber | Pharmaceutical formulation containing dye |
| US7141250B2 (en) | 2001-08-06 | 2006-11-28 | Euro-Celtique S.A. | Pharmaceutical formulation containing bittering agent |
| LT2425821T (lt) * | 2002-04-05 | 2017-07-25 | Euro-Celtique S.A. | Farmacinis preparatas, turintis oksikodono ir naloksono |
| 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 |
| PT1842533E (pt) * | 2003-08-06 | 2013-05-17 | Gruenenthal Gmbh | Forma de dosagem protegida contra abuso |
| 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 |
| CA2572491A1 (en) | 2004-07-01 | 2006-01-12 | Gruenenthal Gmbh | Oral dosage form safeguarded against abuse |
| AR053304A1 (es) | 2004-07-01 | 2007-05-02 | Gruenenthal Gmbh | Formas farmaceuticas orales protegidas frente al abuso con liberacion controlada de (1r,2r)-3-(3 dimetilamino-1-etil-2metil-propil)fenol y procedimiento para su produccion. |
| BRPI0513608A (pt) * | 2004-07-27 | 2008-05-13 | Unilever Nv | composição para o cuidado dos cabelos, processo para a preparação de uma composição para o cuidado dos cabelos e método para o tratamento dos cabelos |
| 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 |
| RU2433817C2 (ru) * | 2006-01-21 | 2011-11-20 | Эбботт Гмбх Унд Ко.Кг | Лекарственная форма и способ для доставки вызывающих зависимость лекарственных веществ |
| DE102007011485A1 (de) | 2007-03-07 | 2008-09-11 | Grünenthal GmbH | Darreichungsform mit erschwertem Missbrauch |
| HUE028066T2 (en) | 2008-07-31 | 2016-11-28 | Anglo Netherlands Grain Bv | Herbicide-resistant sunflower plants |
| GB0909680D0 (en) | 2009-06-05 | 2009-07-22 | Euro Celtique Sa | Dosage form |
| BR112012001466A2 (pt) * | 2009-07-22 | 2020-08-11 | Grünenthal GmbH | forma de dosagem resistente à falsificação para opioides sensíveis à oxidação, seu processo de fabricação, e embalagem |
-
2012
- 2012-10-05 CA CA2850853A patent/CA2850853A1/en not_active Abandoned
- 2012-10-05 CN CN201280049146.4A patent/CN103998025A/zh active Pending
- 2012-10-05 US US13/645,595 patent/US20130090349A1/en not_active Abandoned
- 2012-10-05 PE PE2014000279A patent/PE20141171A1/es not_active Application Discontinuation
- 2012-10-05 MX MX2014003973A patent/MX2014003973A/es unknown
- 2012-10-05 KR KR1020147009106A patent/KR20140075704A/ko not_active Withdrawn
- 2012-10-05 AR ARP120103721A patent/AR088250A1/es unknown
- 2012-10-05 JP JP2014533921A patent/JP2014528437A/ja active Pending
- 2012-10-05 EP EP12772756.8A patent/EP2763664A2/en not_active Withdrawn
- 2012-10-05 BR BR112014008120A patent/BR112014008120A2/pt not_active IP Right Cessation
- 2012-10-05 AU AU2012320496A patent/AU2012320496C1/en not_active Ceased
- 2012-10-05 WO PCT/EP2012/069735 patent/WO2013050539A2/en not_active Ceased
- 2012-10-05 EA EA201400413A patent/EA029508B1/ru not_active IP Right Cessation
- 2012-10-05 HK HK15101501.3A patent/HK1200741A1/xx unknown
-
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 |
|---|---|
| EA029508B1 (ru) | 2018-04-30 |
| EP2763664A2 (en) | 2014-08-13 |
| NZ620252A (en) | 2015-09-25 |
| KR20140075704A (ko) | 2014-06-19 |
| WO2013050539A2 (en) | 2013-04-11 |
| US20130090349A1 (en) | 2013-04-11 |
| AU2012320496B2 (en) | 2017-05-18 |
| CL2014000361A1 (es) | 2014-06-20 |
| CA2850853A1 (en) | 2013-04-11 |
| AU2012320496A1 (en) | 2014-02-13 |
| IL230819A0 (en) | 2014-03-31 |
| JP2014528437A (ja) | 2014-10-27 |
| AU2012320496C1 (en) | 2017-09-28 |
| CO6950467A2 (es) | 2014-05-20 |
| AR088250A1 (es) | 2014-05-21 |
| WO2013050539A3 (en) | 2013-05-30 |
| PE20141171A1 (es) | 2014-09-21 |
| BR112014008120A2 (pt) | 2017-04-11 |
| MX2014003973A (es) | 2014-05-07 |
| EA201400413A1 (ru) | 2014-11-28 |
| CN103998025A (zh) | 2014-08-20 |
| HK1200741A1 (en) | 2015-08-14 |
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