RU2013114406A - Устойчивая к разрушению лекарственная форма, которая содержит анионный полимер - Google Patents
Устойчивая к разрушению лекарственная форма, которая содержит анионный полимер Download PDFInfo
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- RU2013114406A RU2013114406A RU2013114406/15A RU2013114406A RU2013114406A RU 2013114406 A RU2013114406 A RU 2013114406A RU 2013114406/15 A RU2013114406/15 A RU 2013114406/15A RU 2013114406 A RU2013114406 A RU 2013114406A RU 2013114406 A RU2013114406 A RU 2013114406A
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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
- A61K9/2022—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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- 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
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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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
- A61K9/14—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
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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
- 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
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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Abstract
1. Фармацевтическая лекарственная форма, проявляющая прочность на разрыв по меньшей мере 500 H, указанная лекарственная форма содержит- фармакологически активный компонент (A);- физиологически приемлемый полимер (B), получаемый путем полимеризации мономерной композиции, содержащей этиленненасыщенный мономер, несущий анионную функциональную группу, в протонированной форме или его физиологически приемлемой соли;- полиалкилен оксид (C), имеющий средневесовую молекулярную массу по меньшей мере 500,000 г/моль, где содержание полиалкилен оксида (C) составляет по меньшей мере 20 мас.%, исходя из общей массы лекарственной формы;где фармакологически активный компонент (A) присутствует в матриксе с контролируемым высвобождением, содержащем полимер (B) и полиалкилен оксид (C).2. Фармацевтическая лекарственная форма по п. 1, где фармакологически активный компонент (A) представляет собой опиоид.3. Фармацевтическая лекарственная форма по п. 1 или 2, где анионную функциональную группу выбирают из карбоксильных групп, сульфонильных групп, сульфатных групп, и фосфорильных групп.4. Фармацевтическая лекарственная форма по п. 1 или 2, где мономерная композиция содержит мономер, выбранный из акриловой кислоты, алкил акрилатов и алкил алкакрилатов, или их комбинацию.5. Фармацевтическая лекарственная форма по п. 1 или 2, где мономерная композиция дополнительно содержит перекрестносшивающий агент.6. Фармацевтическая лекарственная форма по п. 5, где перекрестносшивающий агент выбирают из группы, включающей аллил сахарозу, аллил пентаэритритол, дивинил гликоль, дивинил полиэтилен гликоль и сложные эфиры диолов и (мет)акриловой кислоты.7. Фармацевтич�
Claims (13)
1. Фармацевтическая лекарственная форма, проявляющая прочность на разрыв по меньшей мере 500 H, указанная лекарственная форма содержит
- фармакологически активный компонент (A);
- физиологически приемлемый полимер (B), получаемый путем полимеризации мономерной композиции, содержащей этиленненасыщенный мономер, несущий анионную функциональную группу, в протонированной форме или его физиологически приемлемой соли;
- полиалкилен оксид (C), имеющий средневесовую молекулярную массу по меньшей мере 500,000 г/моль, где содержание полиалкилен оксида (C) составляет по меньшей мере 20 мас.%, исходя из общей массы лекарственной формы;
где фармакологически активный компонент (A) присутствует в матриксе с контролируемым высвобождением, содержащем полимер (B) и полиалкилен оксид (C).
2. Фармацевтическая лекарственная форма по п. 1, где фармакологически активный компонент (A) представляет собой опиоид.
3. Фармацевтическая лекарственная форма по п. 1 или 2, где анионную функциональную группу выбирают из карбоксильных групп, сульфонильных групп, сульфатных групп, и фосфорильных групп.
4. Фармацевтическая лекарственная форма по п. 1 или 2, где мономерная композиция содержит мономер, выбранный из акриловой кислоты, алкил акрилатов и алкил алкакрилатов, или их комбинацию.
5. Фармацевтическая лекарственная форма по п. 1 или 2, где мономерная композиция дополнительно содержит перекрестносшивающий агент.
6. Фармацевтическая лекарственная форма по п. 5, где перекрестносшивающий агент выбирают из группы, включающей аллил сахарозу, аллил пентаэритритол, дивинил гликоль, дивинил полиэтилен гликоль и сложные эфиры диолов и (мет)акриловой кислоты.
7. Фармацевтическая лекарственная форма по п. 1 или 2, где относительное весовое соотношение полиалкилен оксида (C) к физиологически приемлемому полимеру (В) находится в диапазоне от 8:1 до 1,5:1
8. Фармацевтическая лекарственная форма по п. 1 или 2, где полиалкилен оксид (С) представляет собой полиэтилен оксид.
9. Фармацевтическая лекарственная форма по п. 8, где полиэтилен оксид (С) имеет молекулярную массу от приблизительно 500,000 г/моль до приблизительно 15,000,000 г/моль.
10. Фармацевтическая лекарственная форма по п. 1 или 2, которая приготовлена путем экструзии расплава.
11. Фармацевтическая лекарственная форма по п. 1 или 2, которая дополнительно содержит полиэтилен гликоль.
12. Фармацевтическая лекарственная форма по п. 1 или 2, которая приспособлена для введения один раз в сутки, два раза в сутки или три раза в сутки.
13. Фармацевтическая лекарственная форма по п. 1 или 2, которая представляет собой таблетку.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10009125 | 2010-09-02 | ||
| EP10009125.5 | 2010-09-02 | ||
| PCT/EP2011/004405 WO2012028318A1 (en) | 2010-09-02 | 2011-09-01 | Tamper resistant dosage form comprising an anionic polymer |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2013114406A true RU2013114406A (ru) | 2014-10-10 |
| RU2607499C2 RU2607499C2 (ru) | 2017-01-10 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2013114406A RU2607499C2 (ru) | 2010-09-02 | 2011-09-01 | Устойчивая к разрушению лекарственная форма, которая содержит анионный полимер |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US9636303B2 (ru) |
| EP (1) | EP2611425B1 (ru) |
| JP (1) | JP5933553B2 (ru) |
| KR (1) | KR20130137627A (ru) |
| CN (1) | CN103179954A (ru) |
| AR (1) | AR082862A1 (ru) |
| AU (1) | AU2011297892B2 (ru) |
| BR (1) | BR112013005234A2 (ru) |
| CA (1) | CA2808541C (ru) |
| CL (1) | CL2013000424A1 (ru) |
| CO (1) | CO6670590A2 (ru) |
| EC (1) | ECSP13012472A (ru) |
| ES (1) | ES2487244T3 (ru) |
| HK (1) | HK1184390A1 (ru) |
| MX (1) | MX2013002293A (ru) |
| NZ (1) | NZ608865A (ru) |
| PE (1) | PE20131126A1 (ru) |
| PL (1) | PL2611425T3 (ru) |
| RU (1) | RU2607499C2 (ru) |
| TW (1) | TWI516286B (ru) |
| WO (1) | WO2012028318A1 (ru) |
| ZA (1) | ZA201301181B (ru) |
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-
2011
- 2011-09-01 WO PCT/EP2011/004405 patent/WO2012028318A1/en active Application Filing
- 2011-09-01 NZ NZ608865A patent/NZ608865A/en not_active IP Right Cessation
- 2011-09-01 AR ARP110103192A patent/AR082862A1/es unknown
- 2011-09-01 RU RU2013114406A patent/RU2607499C2/ru not_active IP Right Cessation
- 2011-09-01 MX MX2013002293A patent/MX2013002293A/es active IP Right Grant
- 2011-09-01 CA CA2808541A patent/CA2808541C/en not_active Expired - Fee Related
- 2011-09-01 PL PL11760397T patent/PL2611425T3/pl unknown
- 2011-09-01 TW TW100131419A patent/TWI516286B/zh not_active IP Right Cessation
- 2011-09-01 KR KR1020137008509A patent/KR20130137627A/ko not_active Application Discontinuation
- 2011-09-01 BR BR112013005234A patent/BR112013005234A2/pt not_active IP Right Cessation
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- 2011-09-01 AU AU2011297892A patent/AU2011297892B2/en not_active Ceased
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Also Published As
| Publication number | Publication date |
|---|---|
| CN103179954A (zh) | 2013-06-26 |
| MX2013002293A (es) | 2013-05-09 |
| US20120065220A1 (en) | 2012-03-15 |
| CO6670590A2 (es) | 2013-05-15 |
| ECSP13012472A (es) | 2013-04-30 |
| CA2808541C (en) | 2019-01-08 |
| ZA201301181B (en) | 2013-10-30 |
| WO2012028318A1 (en) | 2012-03-08 |
| PL2611425T3 (pl) | 2014-09-30 |
| EP2611425B1 (en) | 2014-07-02 |
| KR20130137627A (ko) | 2013-12-17 |
| US9636303B2 (en) | 2017-05-02 |
| CL2013000424A1 (es) | 2013-04-12 |
| AU2011297892B2 (en) | 2014-05-29 |
| JP5933553B2 (ja) | 2016-06-15 |
| HK1184390A1 (en) | 2014-01-24 |
| CA2808541A1 (en) | 2012-03-08 |
| AR082862A1 (es) | 2013-01-16 |
| TWI516286B (zh) | 2016-01-11 |
| AU2011297892A1 (en) | 2013-04-18 |
| ES2487244T3 (es) | 2014-08-20 |
| RU2607499C2 (ru) | 2017-01-10 |
| BR112013005234A2 (pt) | 2016-05-03 |
| NZ608865A (en) | 2015-03-27 |
| EP2611425A1 (en) | 2013-07-10 |
| TW201217002A (en) | 2012-05-01 |
| JP2013536810A (ja) | 2013-09-26 |
| PE20131126A1 (es) | 2013-10-21 |
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