EA201400413A1 - Защищенная от применения не по назначению пероральная фармацевтическая лекарственная форма, содержащая опиоидный агонист и опиоидный антагонист - Google Patents
Защищенная от применения не по назначению пероральная фармацевтическая лекарственная форма, содержащая опиоидный агонист и опиоидный антагонистInfo
- Publication number
- EA201400413A1 EA201400413A1 EA201400413A EA201400413A EA201400413A1 EA 201400413 A1 EA201400413 A1 EA 201400413A1 EA 201400413 A EA201400413 A EA 201400413A EA 201400413 A EA201400413 A EA 201400413A EA 201400413 A1 EA201400413 A1 EA 201400413A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- opioid
- protected
- opioid agonist
- oral pharmaceutical
- form containing
- 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; 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
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
Изобретение относится к фармацевтической лекарственной форме для перорального применения, имеющей предел прочности на разрыв, который составляет по меньшей мере 300 Н, и содержащей опиоидный агонист, опиоидный антагонист, а также полиалкиленоксид, имеющий среднюю молекулярную массу, которая составляет по меньшей мере 200000 г/моль, где в соответствии с Европейской Фармакопеей профиль высвобождения опиоидного агониста in vitro в основном соответствует профилю высвобождения опиоидного антагониста in vitro и где опиоидный агонист и опиоидный антагонист тщательно смешаны друг с другом и гомогенно диспергированы в полиалкиленоксиде.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11008131 | 2011-10-06 | ||
EP11009090 | 2011-11-16 | ||
EP12001297 | 2012-02-28 | ||
PCT/EP2012/069735 WO2013050539A2 (en) | 2011-10-06 | 2012-10-05 | Tamper-resistant oral pharmaceutical dosage form comprising opioid agonist and opioid antagonist |
Publications (2)
Publication Number | Publication Date |
---|---|
EA201400413A1 true EA201400413A1 (ru) | 2014-11-28 |
EA029508B1 EA029508B1 (ru) | 2018-04-30 |
Family
ID=47018994
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA201400413A EA029508B1 (ru) | 2011-10-06 | 2012-10-05 | Защищенная от применения не по назначению пероральная фармацевтическая лекарственная форма, содержащая опиоидный агонист и опиоидный антагонист |
Country Status (18)
Country | Link |
---|---|
US (1) | US20130090349A1 (ru) |
EP (1) | EP2763664A2 (ru) |
JP (1) | JP2014528437A (ru) |
KR (1) | KR20140075704A (ru) |
CN (1) | CN103998025A (ru) |
AR (1) | AR088250A1 (ru) |
AU (1) | AU2012320496C1 (ru) |
BR (1) | BR112014008120A2 (ru) |
CA (1) | CA2850853A1 (ru) |
CL (1) | CL2014000361A1 (ru) |
CO (1) | CO6950467A2 (ru) |
EA (1) | EA029508B1 (ru) |
EC (1) | ECSP14013269A (ru) |
HK (1) | HK1200741A1 (ru) |
IL (1) | IL230819A0 (ru) |
MX (1) | MX2014003973A (ru) |
PE (1) | PE20141171A1 (ru) |
WO (1) | WO2013050539A2 (ru) |
Families Citing this family (56)
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WO2003024430A1 (en) | 2001-09-21 | 2003-03-27 | Egalet A/S | Morphine polymer release system |
EP1429739A1 (en) | 2001-09-21 | 2004-06-23 | Egalet A/S | Polymer release system |
US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
ATE495732T1 (de) | 2003-03-26 | 2011-02-15 | Egalet As | Morphin-system mit kontrollierter freisetzung |
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 |
US20070048228A1 (en) | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
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 |
AU2008258596B2 (en) | 2007-06-04 | 2013-02-14 | Egalet Ltd | Controlled release pharmaceutical compositions for prolonged effect |
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 |
CA2723438C (en) | 2008-05-09 | 2016-10-11 | Gruenenthal Gmbh | Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step |
AU2010211220B2 (en) | 2009-02-06 | 2013-08-01 | Egalet Ltd. | Immediate release composition resistant to abuse by intake of alcohol |
NZ603579A (en) | 2009-06-24 | 2014-02-28 | Egalet Ltd | Controlled release formulations |
MX2012000369A (es) | 2009-07-22 | 2012-02-01 | Gruenenthal Gmbh | Forma de dosificacion resistente a la manipulacion para opioides sensibles a la oxidacion. |
MX2012000317A (es) | 2009-07-22 | 2012-02-08 | Gruenenthal Gmbh | Forma de dosificacion de liberacion controlada extruida por fusion en caliente. |
AU2011252040C1 (en) | 2010-05-10 | 2015-04-02 | Euro-Celtique S.A. | Manufacturing of active-free granules and tablets comprising the same |
NZ603170A (en) | 2010-05-10 | 2015-04-24 | Euro Celtique Sa | Combination of active loaded granules with additional actives |
RU2604676C2 (ru) | 2010-09-02 | 2016-12-10 | Грюненталь Гмбх | Устойчивая к разрушению лекарственная форма, содержащая неорганическую соль |
ES2487244T3 (es) | 2010-09-02 | 2014-08-20 | Grünenthal GmbH | Forma de dosificación resistente a la manipulación que comprende un polímero aniónico |
US20130028972A1 (en) | 2011-07-29 | 2013-01-31 | Grunenthal Gmbh | Tamper-resistant tablet providing immediate drug release |
PT2736495T (pt) | 2011-07-29 | 2017-11-30 | Gruenenthal Gmbh | Comprimido resistente à adulteração proporcionando libertação imediata de fármaco |
CA2855718A1 (en) * | 2011-11-17 | 2013-05-23 | Anja Geissler | Tamper-resistant oral pharmaceutical dosage form comprising a pharmacologically active ingredient, an opioid antagonist and/or aversive agent, polyalkylene oxide and anionic polymer |
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 |
JP6282261B2 (ja) | 2012-04-18 | 2018-02-21 | 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 | 不正使用防止および過量放出防止医薬剤形 |
US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
KR20150059167A (ko) | 2012-07-06 | 2015-05-29 | 에갈렛 리미티드 | 제어된 방출을 위한 남용 제지 약학적 조성물 |
CA2795324C (en) * | 2012-11-09 | 2015-07-14 | Purdue Pharma | Pharmaceutical compositions comprising hydromorphone and naloxone |
BR112015029616A2 (pt) | 2013-05-29 | 2017-07-25 | Gruenenthal Gmbh | forma de dosagem resistente à adulteração com perfil de liberação bimodal |
CA2907950A1 (en) | 2013-05-29 | 2014-12-04 | Grunenthal Gmbh | Tamper-resistant dosage form containing one or more particles |
KR20160031526A (ko) | 2013-07-12 | 2016-03-22 | 그뤼넨탈 게엠베하 | 에틸렌-비닐 아세테이트 중합체를 함유하는 템퍼 내성 투여형 |
CA3042642A1 (en) | 2013-08-12 | 2015-02-19 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
AU2014350135B2 (en) | 2013-11-13 | 2017-08-31 | Euro-Celtique S.A. | Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome |
MX371372B (es) | 2013-11-26 | 2020-01-28 | Gruenenthal Gmbh | Preparacion de una composicion farmaceutica en polvo por medio de criomolienda. |
WO2015086528A1 (de) | 2013-12-11 | 2015-06-18 | Develco Pharma Schweiz Ag | Naloxon-monopräparat und mehrschichttablette |
US10105360B2 (en) | 2013-12-11 | 2018-10-23 | Develco Pharma Schweiz Ag | Method and composition for the treatment of opioid induced constipation |
US10172797B2 (en) | 2013-12-17 | 2019-01-08 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
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CA2964628A1 (en) | 2014-10-20 | 2016-04-28 | Pharmaceutical Manufacturing Research Services, Inc. | Extended release abuse deterrent liquid fill dosage form |
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DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
WO2005102286A1 (de) | 2004-04-22 | 2005-11-03 | Grünenthal GmbH | Verfahren zur herstellung einer gegen missbrauch gesicherten, festen darreinchungsform |
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US20070190142A1 (en) * | 2006-01-21 | 2007-08-16 | Abbott Gmbh & Co. Kg | Dosage forms for the delivery of drugs of abuse and related methods |
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GB0909680D0 (en) * | 2009-06-05 | 2009-07-22 | Euro Celtique Sa | Dosage form |
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-
2012
- 2012-10-05 AR ARP120103721A patent/AR088250A1/es unknown
- 2012-10-05 PE PE2014000279A patent/PE20141171A1/es not_active Application Discontinuation
- 2012-10-05 WO PCT/EP2012/069735 patent/WO2013050539A2/en active Application Filing
- 2012-10-05 CN CN201280049146.4A patent/CN103998025A/zh active Pending
- 2012-10-05 AU AU2012320496A patent/AU2012320496C1/en not_active Ceased
- 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 US US13/645,595 patent/US20130090349A1/en not_active Abandoned
- 2012-10-05 KR KR1020147009106A patent/KR20140075704A/ko not_active Application Discontinuation
- 2012-10-05 CA CA2850853A patent/CA2850853A1/en not_active Abandoned
- 2012-10-05 BR BR112014008120A patent/BR112014008120A2/pt not_active IP Right Cessation
- 2012-10-05 EA EA201400413A patent/EA029508B1/ru not_active IP Right Cessation
- 2012-10-05 MX MX2014003973A patent/MX2014003973A/es 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
-
2015
- 2015-02-11 HK HK15101501.3A patent/HK1200741A1/xx unknown
Also Published As
Publication number | Publication date |
---|---|
AU2012320496B2 (en) | 2017-05-18 |
CA2850853A1 (en) | 2013-04-11 |
EA029508B1 (ru) | 2018-04-30 |
AU2012320496C1 (en) | 2017-09-28 |
NZ620252A (en) | 2015-09-25 |
JP2014528437A (ja) | 2014-10-27 |
ECSP14013269A (es) | 2014-12-30 |
WO2013050539A3 (en) | 2013-05-30 |
CL2014000361A1 (es) | 2014-06-20 |
IL230819A0 (en) | 2014-03-31 |
WO2013050539A2 (en) | 2013-04-11 |
PE20141171A1 (es) | 2014-09-21 |
US20130090349A1 (en) | 2013-04-11 |
AU2012320496A1 (en) | 2014-02-13 |
CO6950467A2 (es) | 2014-05-20 |
KR20140075704A (ko) | 2014-06-19 |
MX2014003973A (es) | 2014-05-07 |
CN103998025A (zh) | 2014-08-20 |
HK1200741A1 (en) | 2015-08-14 |
AR088250A1 (es) | 2014-05-21 |
EP2763664A2 (en) | 2014-08-13 |
BR112014008120A2 (pt) | 2017-04-11 |
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