RU2012106167A - Стабильная при окислении, устойчивая к взлому лекарственная форма - Google Patents
Стабильная при окислении, устойчивая к взлому лекарственная форма Download PDFInfo
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- RU2012106167A RU2012106167A RU2012106167/15A RU2012106167A RU2012106167A RU 2012106167 A RU2012106167 A RU 2012106167A RU 2012106167/15 A RU2012106167/15 A RU 2012106167/15A RU 2012106167 A RU2012106167 A RU 2012106167A RU 2012106167 A RU2012106167 A RU 2012106167A
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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- 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
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- 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
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Abstract
1. Устойчивая к взлому фармацевтическая лекарственная форма в форме таблетки, которая имеет сопротивление разрушению по крайней мере 300 Н, термоформируемая путем экструзии горячего расплава смеси, которая включает- фармакологически активный ингредиент (А),- свободную физиологически приемлемую многоосновную карбоновую кислоту (В) в количестве от 0,001 мас.% до 5,0 мас.% в пересчете на общую массу фармацевтической лекарственной формы, и- антиоксидант, выбранный из группы, включающей аскорбиновую кислоту или ее соли, аскорбилпальмитат, α-токоферол, витамин Е-сукцинат, витамин Е-пальмитат, бутилгидроксианизол, бутилгидрокситолуол, монотиоглицерин, конифериловый бензоат, нордигидрогваяретовую кислоту, сложные эфиры галловой кислоты, фосфорную кислоту и бисульфит натрия; в количестве от 0,001 мас.% до 5,0 мас.% в пересчете на общую массу фармацевтической лекарственной формы; и- полиалкиленоксид (С), который имеет среднемассовую молекулярную массу Mпо крайней мере 200,000 г/моль.2. Фармацевтическая лекарственная форма по п.1, в которой фармакологически активный ингредиент (А) представляет собой опиоид.3. Фармацевтическая лекарственная форма по п.1 или 2, в которой многоосновная карбоновая кислота выбрана из группы, включающей малеиновую кислоту, фумаровую кислоту, пентандиовую кислоту, малоновую кислоту и лимонную кислоту.4. Фармацевтическая лекарственная форма по п.1 или 2, в которой содержание кислоты (В) находится в диапазоне от 0,005 до 2,5 мас.% в пересчете на общую массу фармацевтической лекарственной формы.5. Фармацевтическая лекарственная форма по п.1 или 2, в которой антиоксидант представляет собой α-токоферол.6. Фармацевтическа�
Claims (14)
1. Устойчивая к взлому фармацевтическая лекарственная форма в форме таблетки, которая имеет сопротивление разрушению по крайней мере 300 Н, термоформируемая путем экструзии горячего расплава смеси, которая включает
- фармакологически активный ингредиент (А),
- свободную физиологически приемлемую многоосновную карбоновую кислоту (В) в количестве от 0,001 мас.% до 5,0 мас.% в пересчете на общую массу фармацевтической лекарственной формы, и
- антиоксидант, выбранный из группы, включающей аскорбиновую кислоту или ее соли, аскорбилпальмитат, α-токоферол, витамин Е-сукцинат, витамин Е-пальмитат, бутилгидроксианизол, бутилгидрокситолуол, монотиоглицерин, конифериловый бензоат, нордигидрогваяретовую кислоту, сложные эфиры галловой кислоты, фосфорную кислоту и бисульфит натрия; в количестве от 0,001 мас.% до 5,0 мас.% в пересчете на общую массу фармацевтической лекарственной формы; и
- полиалкиленоксид (С), который имеет среднемассовую молекулярную массу Mw по крайней мере 200,000 г/моль.
2. Фармацевтическая лекарственная форма по п.1, в которой фармакологически активный ингредиент (А) представляет собой опиоид.
3. Фармацевтическая лекарственная форма по п.1 или 2, в которой многоосновная карбоновая кислота выбрана из группы, включающей малеиновую кислоту, фумаровую кислоту, пентандиовую кислоту, малоновую кислоту и лимонную кислоту.
4. Фармацевтическая лекарственная форма по п.1 или 2, в которой содержание кислоты (В) находится в диапазоне от 0,005 до 2,5 мас.% в пересчете на общую массу фармацевтической лекарственной формы.
5. Фармацевтическая лекарственная форма по п.1 или 2, в которой антиоксидант представляет собой α-токоферол.
6. Фармацевтическая лекарственная форма по п.1 или 2, в которой после хранения на протяжении 4 недель при 40°С и 75% отн. влажности, содержание фармакологически активного ингредиента (А) составляет, по крайней мере, 98,0% его первоначального содержания перед хранением.
7. Фармацевтическая лекарственная форма по п.1 или 2, в которой после хранения на протяжении 4 недель при 40°С и 75% отн. влажности, содержание полиэтиленоксида (С) составляет, по крайней мере, 98,0% его первоначального содержания перед хранением.
8. Фармацевтическая лекарственная форма по п.1 или 2, в которой фармакологически активный ингредиент (А) внедрен в матрицу, включающую полиалкиленоксид (С), где указанная матрица регулирует высвобождение фармакологически активного ингредиента (А) из фармацевтической лекарственной формы.
9. Фармацевтическая лекарственная форма по п.1 или 2, в которой фармакологически активный ингредиент (А) выбран из группы, включающей оксиморфон, оксикодон, гидроморфон, и их физиологически приемлемые соли.
10. Фармацевтическая лекарственная форма по п.1 или 2, в которой относительное соотношение массы полиалкиленоксида (С) к фармакологически активному ингредиенту (А) составляет по крайней мере 1:1.
11. Фармацевтическая лекарственная форма по п.1 или 2, которая является адаптированной для введения один раз в сутки или два раза в сутки.
12. Фармацевтическая лекарственная форма по п.1 или 2, которая имеет сопротивление разрушению, по крайней мере, 500 Н.
13. Упаковка, содержащая фармацевтическую лекарственную форму по любому из пп.1-12 и поглотитель кислорода.
14. Способ получения фармацевтической лекарственной формы по любому из пп.1-12, который включает этапы:
a) смешивание всех компонентов;
b) нагревание получившейся в результате смеси в экструдере по крайней мере до точки размягчения полиэтилеоксида (С) и выдавливание через выходное отверстие экструдера с применением силы,
c) отделение еще пластичного экструдата и формирование в фармацевтическую лекарственную форму или
d) охлаждение и необязательно повторный нагрев отеленного экструдата и формирование его в фармацевтическую лекарственную форму.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09009480.6 | 2009-07-22 | ||
| EP09009480 | 2009-07-22 | ||
| PCT/EP2010/004461 WO2011009604A1 (en) | 2009-07-22 | 2010-07-21 | Oxidation-stabilized tamper-resistant dosage form |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015138422A Division RU2015138422A (ru) | 2009-07-22 | 2010-07-21 | Стабильная при окислении, прочная на излом лекарственная форма |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2012106167A true RU2012106167A (ru) | 2013-08-27 |
| RU2567723C2 RU2567723C2 (ru) | 2015-11-10 |
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Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2012106166/15A RU2555531C2 (ru) | 2009-07-22 | 2010-07-21 | Защищенная от применения не по назначению лекарственная форма для чувствительных к окислению опиоидов |
| RU2012106167/15A RU2567723C2 (ru) | 2009-07-22 | 2010-07-21 | Стабильная при окислении, прочная на излом лекарственная форма |
| RU2015138422A RU2015138422A (ru) | 2009-07-22 | 2010-07-21 | Стабильная при окислении, прочная на излом лекарственная форма |
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| RU2012106166/15A RU2555531C2 (ru) | 2009-07-22 | 2010-07-21 | Защищенная от применения не по назначению лекарственная форма для чувствительных к окислению опиоидов |
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| RU2015138422A RU2015138422A (ru) | 2009-07-22 | 2010-07-21 | Стабильная при окислении, прочная на излом лекарственная форма |
Country Status (26)
| Country | Link |
|---|---|
| US (7) | US20110020451A1 (ru) |
| EP (4) | EP2997965B1 (ru) |
| JP (2) | JP2012533586A (ru) |
| KR (2) | KR101747156B1 (ru) |
| CN (2) | CN102639118B (ru) |
| AR (1) | AR077420A1 (ru) |
| AU (2) | AU2010275755B2 (ru) |
| BR (2) | BR112012001466A2 (ru) |
| CA (2) | CA2766172C (ru) |
| CL (2) | CL2011002970A1 (ru) |
| CO (2) | CO6470798A2 (ru) |
| EC (2) | ECSP12011591A (ru) |
| ES (3) | ES2428938T3 (ru) |
| HK (3) | HK1167810A1 (ru) |
| HU (1) | HUE042987T2 (ru) |
| IL (3) | IL216522A (ru) |
| MX (2) | MX2012000369A (ru) |
| NZ (2) | NZ596668A (ru) |
| PE (2) | PE20120631A1 (ru) |
| PL (2) | PL2456424T3 (ru) |
| PT (1) | PT2456424E (ru) |
| RU (3) | RU2555531C2 (ru) |
| SI (1) | SI2456424T1 (ru) |
| TW (1) | TWI473628B (ru) |
| WO (2) | WO2011009603A1 (ru) |
| ZA (2) | ZA201109447B (ru) |
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| EP1429744A1 (en) | 2001-09-21 | 2004-06-23 | Egalet A/S | Morphine 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 |
| 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 |
| US20070048228A1 (en) * | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
| US8075872B2 (en) | 2003-08-06 | 2011-12-13 | Gruenenthal Gmbh | Abuse-proofed dosage form |
| DE10361596A1 (de) * | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| DE102004032051A1 (de) * | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten, festen Darreichungsform |
| DE102004032049A1 (de) * | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Gegen Missbrauch gesicherte, orale Darreichungsform |
| DE102004032103A1 (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 |
| DE102007011485A1 (de) | 2007-03-07 | 2008-09-11 | Grünenthal GmbH | Darreichungsform mit erschwertem Missbrauch |
| AU2008258596B2 (en) | 2007-06-04 | 2013-02-14 | Egalet Ltd | Controlled release pharmaceutical compositions for prolonged effect |
| US20090052818A1 (en) * | 2007-07-10 | 2009-02-26 | Jason Matthew Mitmesser | Hybrid bearing |
| CN102014877B (zh) | 2008-01-25 | 2017-06-06 | 格吕伦塔尔有限公司 | 药物剂型 |
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| DK2736495T3 (da) | 2011-07-29 | 2017-11-13 | Gruenenthal Gmbh | Misbrugsbestandig tablet som tilvejebringer øjeblikkelig frigivelse af lægemiddel |
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2012
- 2012-01-05 US US13/343,846 patent/US20120136021A1/en not_active Abandoned
- 2012-01-11 EC EC2012011591A patent/ECSP12011591A/es unknown
- 2012-01-11 EC EC2012011590A patent/ECSP12011590A/es unknown
- 2012-08-30 HK HK12108485.1A patent/HK1167810A1/xx not_active IP Right Cessation
- 2012-08-30 HK HK12108484.2A patent/HK1167809A1/xx not_active IP Right Cessation
- 2012-08-30 HK HK16104042.2A patent/HK1216296A1/zh unknown
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2014
- 2014-02-28 US US14/192,916 patent/US20140194455A1/en not_active Abandoned
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2015
- 2015-09-01 US US14/841,829 patent/US9925146B2/en active Active
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2017
- 2017-02-28 IL IL250841A patent/IL250841A0/en unknown
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2018
- 2018-02-21 US US15/901,063 patent/US10493033B2/en active Active
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2019
- 2019-10-15 US US16/653,186 patent/US20200038329A1/en not_active Abandoned
- 2019-12-03 US US16/701,921 patent/US20200101020A1/en not_active Abandoned
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| Date | Code | Title | Description |
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| MM4A | The patent is invalid due to non-payment of fees |
Effective date: 20200722 |