RU2007128767A - Способ стабилизации лекарственного средства против деменции - Google Patents
Способ стабилизации лекарственного средства против деменции Download PDFInfo
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- RU2007128767A RU2007128767A RU2007128767/15A RU2007128767A RU2007128767A RU 2007128767 A RU2007128767 A RU 2007128767A RU 2007128767/15 A RU2007128767/15 A RU 2007128767/15A RU 2007128767 A RU2007128767 A RU 2007128767A RU 2007128767 A RU2007128767 A RU 2007128767A
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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
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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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- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
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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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
-
- 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
-
- 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
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Hospice & Palliative Care (AREA)
- Psychiatry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (31)
1. Способ стабилизации лекарственного средства против деменции, включающий добавление высокомолекулярного кислого вещества в фармацевтическую композицию, содержащую лекарственное средство против деменции и высокомолекулярное основное вещество.
2. Способ по п.1, где высокомолекулярное кислое вещество добавляют в количестве, которое способно подавить образование продукта распада лекарственного средства против деменции, образующегося в результате контактирования лекарственного средства против деменции с высокомолекулярным основным веществом.
3. Способ по п. 1 или 2, где лекарственное средство против деменции представляет собой соединение, содержащее третичную аминогруппу.
4. Способ по п. 1, где лекарственное средство против деменции выбрано из группы, состоящей из ривастигмина, галантамина, донепезила, 3-[1-(фенилметил)пиперидин-4-ил]-1-(2,3,4,5-тетрагидро-1H-1-бензазепин-8-ил)-1-пропана и 5,7-дигидро-3-[2-[1-(фенилметил)-4-пиперидинил]этил]-6H-пирроло[4,5-f]-1,2-бензизоксазол-6-она и их фармацевтически приемлемых солей.
5. Способ по п. 4, где лекарственное средство против деменции представляет собой донепезил или его фармацевтически приемлемую соль.
6. Способ по п. 1, где высокомолекулярное основное вещество представляет собой не растворимое в воде полимерное вещество.
7. Способ по п. 6, где высокомолекулярное основное вещество представляет собой, по меньшей мере, одно вещество, выбранное из группы, состоящей из этилцеллюлозы, сополимера этилакрилата и метилметакрилата и полиэтиленоксида.
8. Способ по п. 1, где высокомолекулярное кислое вещество представляет собой энтеросолюбильное полимерное вещество.
9. Способ по п. 8, где высокомолекулярное кислое вещество представляет собой, по меньшей мере, одно вещество, выбранное из группы, состоящей из сополимера метакриловой кислоты и этилакрилата, сополимера метакриловой кислоты и метилметакрилата, фталата гидроксипропилметилцеллюлозы и сукцината ацетата гидроксипропилметилцеллюлозы.
10. Способ по п. 1, дополнительно включающий в себя добавление, по меньшей мере, одного вещества, выбранного из низкомолекулярного кислого вещества и антиоксиданта.
11. Способ по п. 10, где низкомолекулярное кислое вещество представляет собой, по меньшей мере, одно вещество, выбранное из группы, состоящей из карбоновых кислот, сульфоновых кислот, гидроксильных кислот, кислых аминокислот и неорганических кислот.
12. Способ по п. 10 или 11, где низкомолекулярное кислое вещество представляет собой, по меньшей мере, одно вещество, выбранное из группы, состоящей из гидроксильных кислот, кислых аминокислот и неорганических кислот.
13. Способ по п. 12, где низкомолекулярное кислое вещество представляет собой, по меньшей мере, одно вещество, выбранное из группы, состоящей из янтарной кислоты, винной кислоты, лимонной кислоты, фумаровой кислоты, малеиновой кислоты, яблочной кислоты, аспарагиновой кислоты, глутаминовой кислоты, гидрохлорида глутаминовой кислоты, хлористоводородной кислоты и фосфорной кислоты.
14. Способ по п. 13, где низкомолекулярное кислое вещество представляет собой, по меньшей мере, одно вещество, выбранное из группы, состоящей из янтарной кислоты, винной кислоты, лимонной кислоты, яблочной кислоты, аспарагиновой кислоты, глутаминовой кислоты, гидрохлорида глутаминовой кислоты, хлористоводородной кислоты и фосфорной кислоты.
15. Способ по п. 10, где антиоксидант представляет собой, по меньшей мере, одно вещество, выбранное из группы, состоящей из аскорбиновых кислот, серосодержащих аминокислот, производных гидрохинона и токоферолов.
16. Применение высокомолекулярного кислого вещества для подавления образования продуктов распада лекарственного средства против деменции, образующегося в результате контактирования лекарственного средства против деменции с высокомолекулярным основным веществом.
17. Применение высокомолекулярного кислого вещества и, по меньшей мере, одного вещества, выбранного из низкомолекулярного кислого вещества и антиоксиданта, для подавления образования продукта распада лекарственного средства против деменции в результате контактирования лекарственного средства против деменции с высокомолекулярным основным веществом.
18. Фармацевтическая композиция, содержащая лекарственное средство против деменции и высокомолекулярное основное вещество, где композиция дополнительно содержит высокомолекулярное кислое вещество для стабилизации лекарственного средства против деменции.
19. Фармацевтическая композиция по п. 18, дополнительно содержащая, по меньшей мере, одно из веществ, выбранных из низкомолекулярного кислого вещества и антиоксиданта, для стабилизации лекарственного средства против деменции.
20. Фармацевтическая композиция по п. 18, где композиция включает в себя матрикс, содержащий смесь лекарственного средства против деменции, высокомолекулярного основного вещества и высокомолекулярного кислого вещества для стабилизации лекарственного средства против деменции.
21. Фармацевтическая композиция по п.20, где, по меньшей мере, одно вещество, выбранное из низкомолекулярного кислого вещества и антиоксиданта, для стабилизации лекарственного средства против деменции смешивают в матриксе.
22. Фармацевтическая композиция по п.18, где фармацевтическая композиция включает в себя центральное ядро, содержащее лекарственное средство против деменции и наружный слой, содержащий высокомолекулярное основное вещество, который покрывает ядро, и где высокомолекулярное кислое вещество добавляют, по меньшей мере, в ядро или покрывающий слой.
23. Фармацевтическая композиция по п.22, где, по меньшей мере, одно вещество, выбранное из низкомолекулярного кислого вещества и антиоксиданта, для стабилизации лекарственного средства против деменции также добавляют, по меньшей мере, в ядро или покрывающий слой.
24. Фармацевтическая композиция по любому из пп.18-23, где фармацевтическая композиция представляет собой препарат с замедленным высвобождением.
25. Фармацевтическая композиция по п. 24, где высокомолекулярное кислое вещество представляет собой энтеросолюбильное полимерное вещество.
26. Матриксный препарат с замедленным высвобождением, содержащий: донепезил или его фармацевтически приемлемую соль; высокомолекулярное основное вещество; и высокомолекулярное кислое вещество.
27. Матриксный препарат с замедленным высвобождением по п.26, дополнительно содержащий, по меньшей мере, одно вещество, выбранное из низкомолекулярного кислого вещества и антиоксиданта.
28. Способ промышленного получения фармацевтической композиции, включающий в себя стадии:
смешивания лекарственного средства против деменции и высокомолекулярного основного вещества; и
гранулирования смеси, где высокомолекулярное кислое вещество для стабилизации лекарственного средства против деменции добавляют к смеси лекарственного средства против деменции и высокомолекулярного основного вещества в процессе, по меньшей мере, одной из стадий смешивания и гранулирования.
29. Способ по п.28, где высокомолекулярное кислое вещество добавляют в виде порошка.
30. Способ по п. 28 или 29, где, по меньшей мере, одно вещество, выбранное из низкомолекулярного кислого вещества и антиоксиданта, для стабилизации лекарственного средства против деменции также добавляют к смеси лекарственного средства против деменции и высокомолекулярного основного вещества в процессе, по меньшей мере, одной из стадий смешивания и гранулирования.
31. Способ по п.29, где, по меньшей мере, одно вещество, выбранное из низкомолекулярного кислого вещества и антиоксиданта, добавляют в виде раствора или суспензии.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2004-376770 | 2004-12-27 | ||
| JP2004376770 | 2004-12-27 | ||
| JP2005041492 | 2005-02-18 | ||
| JP2005-041492 | 2005-02-18 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2007128767A true RU2007128767A (ru) | 2009-02-10 |
| RU2401125C2 RU2401125C2 (ru) | 2010-10-10 |
Family
ID=36615033
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2007128767/15A RU2401125C2 (ru) | 2004-12-27 | 2005-12-27 | Способ стабилизации лекарственного средства против деменции |
Country Status (14)
| Country | Link |
|---|---|
| US (2) | US8481565B2 (ru) |
| EP (1) | EP1830886B1 (ru) |
| JP (2) | JP2008525313A (ru) |
| KR (1) | KR100866720B1 (ru) |
| AU (1) | AU2005320547B2 (ru) |
| BR (1) | BRPI0518396A2 (ru) |
| CA (1) | CA2592605C (ru) |
| HK (1) | HK1112399A1 (ru) |
| IL (1) | IL183650A (ru) |
| MX (1) | MX2007007836A (ru) |
| NO (1) | NO20073482L (ru) |
| NZ (1) | NZ555693A (ru) |
| RU (1) | RU2401125C2 (ru) |
| WO (1) | WO2006070930A1 (ru) |
Families Citing this family (30)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US20090208579A1 (en) * | 2004-12-27 | 2009-08-20 | Eisai R & D Management Co., Ltd. | Matrix Type Sustained-Release Preparation Containing Basic Drug or Salt Thereof, and Method for Manufacturing the Same |
| RU2401125C2 (ru) | 2004-12-27 | 2010-10-10 | Эйсай Ар Энд Ди Менеджмент Ко., Лтд. | Способ стабилизации лекарственного средства против деменции |
| US20070129402A1 (en) * | 2004-12-27 | 2007-06-07 | Eisai Research Institute | Sustained release formulations |
| WO2006118265A1 (ja) * | 2005-04-28 | 2006-11-09 | Eisai R & D Management Co., Ltd. | 抗痴呆薬を含有する組成物 |
| KR101408500B1 (ko) * | 2006-12-01 | 2014-06-17 | 닛토덴코 가부시키가이샤 | 안정화된 도네페질 함유 접착 제제 |
| WO2008066179A1 (fr) * | 2006-12-01 | 2008-06-05 | Nitto Denko Corporation | Préparation d'absorption percutanée |
| CA2671000C (en) * | 2006-12-01 | 2014-01-21 | Nitto Denko Corporation | Method for suppressing coloring of adhesive preparation containing donepezil and method for reducing amounts of donepezil-related substances formed |
| KR20090086565A (ko) * | 2006-12-01 | 2009-08-13 | 닛토덴코 가부시키가이샤 | 안정화된 도네페질 함유 접착 제제 |
| EP2127651A4 (en) * | 2007-01-19 | 2012-08-01 | Eisai R&D Man Co Ltd | STABILIZED MEDICINAL COMPOSITION COMPRISING DONEEPZIL, PROCESS FOR PRODUCING AND STABILIZING SUCH A COMPOSITION |
| GR20070100405A (el) * | 2007-06-26 | 2009-01-20 | Genepharm �.�. | Βελτιωμενες φαρμακοτεχνικες μορφες που περιεχουν αναστολεις της ακετυλοχοληνεστερασης και μεθοδοι παρασκευης αυτων |
| AU2009229372C1 (en) | 2008-03-27 | 2017-02-02 | Chase Pharmaceuticals Corporation | Use and composition for treating dementia |
| DE102009041839A1 (de) * | 2009-09-18 | 2011-03-24 | Dolorgiet Gmbh & Co. Kg | Donepezil-haltige Tabletten |
| KR101674240B1 (ko) * | 2009-12-22 | 2016-11-08 | 아시노 아게 | 리바스티그민 또는 그의 유도체 투여용 경피 치료 시스템 |
| US10076502B2 (en) | 2009-12-22 | 2018-09-18 | Luye Pharma Ag | Transdermal therapeutic system for administering rivastigmine or derivatives thereof |
| EP2524689B1 (en) * | 2009-12-28 | 2016-10-05 | Nipro Corporation | Method for producing donepezil tablets |
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| JP2011213606A (ja) * | 2010-03-31 | 2011-10-27 | Sawai Pharmaceutical Co Ltd | ドネペジルを含有する固形製剤の製造方法 |
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| JP5656258B2 (ja) * | 2011-03-09 | 2015-01-21 | 塩野義製薬株式会社 | ガランタミンを含有する口腔内崩壊錠剤 |
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| CN103417490B (zh) * | 2012-05-21 | 2015-06-17 | 成都康弘药业集团股份有限公司 | 一种含有盐酸多奈哌齐的颗粒剂及其制备方法 |
| WO2014132218A1 (en) | 2013-02-28 | 2014-09-04 | Lupin Limited | Pharmaceutical compositions of donepezil having specific in vitro dissolution profile or pharmacokinetics parameters |
| CA2902697A1 (en) | 2013-02-28 | 2014-09-04 | Lupin Limited | Pharmaceutical compositions of donepezil having specific in vitro dissolution profile or pharmacokinetics parameters |
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- 2005-12-27 AU AU2005320547A patent/AU2005320547B2/en not_active Ceased
- 2005-12-27 JP JP2007529288A patent/JP2008525313A/ja not_active Withdrawn
- 2005-12-27 US US11/793,722 patent/US8481565B2/en active Active
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- 2005-12-27 WO PCT/JP2005/024254 patent/WO2006070930A1/en active Application Filing
- 2005-12-27 MX MX2007007836A patent/MX2007007836A/es active IP Right Grant
- 2005-12-27 KR KR1020077014535A patent/KR100866720B1/ko active IP Right Grant
- 2005-12-27 CA CA2592605A patent/CA2592605C/en not_active Expired - Fee Related
- 2005-12-27 EP EP05824466.6A patent/EP1830886B1/en active Active
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Also Published As
| Publication number | Publication date |
|---|---|
| EP1830886A4 (en) | 2012-10-10 |
| RU2401125C2 (ru) | 2010-10-10 |
| BRPI0518396A2 (pt) | 2008-11-18 |
| MX2007007836A (es) | 2007-08-20 |
| NO20073482L (no) | 2007-09-27 |
| AU2005320547A1 (en) | 2006-07-06 |
| EP1830886A1 (en) | 2007-09-12 |
| AU2005320547B2 (en) | 2009-02-05 |
| IL183650A (en) | 2013-12-31 |
| KR100866720B1 (ko) | 2008-11-05 |
| NZ555693A (en) | 2010-10-29 |
| WO2006070930A1 (en) | 2006-07-06 |
| CA2592605A1 (en) | 2006-07-06 |
| US20080213368A1 (en) | 2008-09-04 |
| HK1112399A1 (zh) | 2008-09-05 |
| JP2008525313A (ja) | 2008-07-17 |
| CA2592605C (en) | 2010-12-07 |
| JP2012144568A (ja) | 2012-08-02 |
| JP5514249B2 (ja) | 2014-06-04 |
| KR20070086667A (ko) | 2007-08-27 |
| US8507527B2 (en) | 2013-08-13 |
| IL183650A0 (en) | 2007-09-20 |
| US20100152164A1 (en) | 2010-06-17 |
| EP1830886B1 (en) | 2016-04-13 |
| US8481565B2 (en) | 2013-07-09 |
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