RU2017136567A - Фармацевтическая композиция с замедленным высвобождением, содержащая ривастигмин - Google Patents
Фармацевтическая композиция с замедленным высвобождением, содержащая ривастигмин Download PDFInfo
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- RU2017136567A RU2017136567A RU2017136567A RU2017136567A RU2017136567A RU 2017136567 A RU2017136567 A RU 2017136567A RU 2017136567 A RU2017136567 A RU 2017136567A RU 2017136567 A RU2017136567 A RU 2017136567A RU 2017136567 A RU2017136567 A RU 2017136567A
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- RU
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- Prior art keywords
- pharmaceutical composition
- rivastigmine
- dependent
- release
- mass
- Prior art date
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- 239000008194 pharmaceutical composition Substances 0.000 title claims 8
- 239000000203 mixture Substances 0.000 claims 10
- XSVMFMHYUFZWBK-NSHDSACASA-N Rivastigmine Chemical compound CCN(C)C(=O)OC1=CC=CC([C@H](C)N(C)C)=C1 XSVMFMHYUFZWBK-NSHDSACASA-N 0.000 claims 7
- 229960004136 rivastigmine Drugs 0.000 claims 7
- 230000001419 dependent effect Effects 0.000 claims 6
- 238000009472 formulation Methods 0.000 claims 6
- 230000003111 delayed effect Effects 0.000 claims 4
- 238000013268 sustained release Methods 0.000 claims 4
- 239000012730 sustained-release form Substances 0.000 claims 4
- 229920000642 polymer Polymers 0.000 claims 3
- 239000008187 granular material Substances 0.000 claims 2
- 239000008188 pellet Substances 0.000 claims 2
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims 1
- 229920000623 Cellulose acetate phthalate Polymers 0.000 claims 1
- 229940114077 acrylic acid Drugs 0.000 claims 1
- 229940081734 cellulose acetate phthalate Drugs 0.000 claims 1
- 229920001577 copolymer Polymers 0.000 claims 1
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 claims 1
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 claims 1
- 239000011159 matrix material Substances 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
Classifications
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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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/27—Esters, e.g. nitroglycerine, selenocyanates of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
-
- 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
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
-
- 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
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
-
- 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)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Emergency Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Psychiatry (AREA)
- Hospice & Palliative Care (AREA)
- Psychology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (7)
1. Фармацевтическая композиция с замедленным высвобождением, содержащая ривастигмин, для схемы приема один раз в сутки, при этом фармацевтическая композиция содержит: рH-зависимый состав с отсроченным высвобождением; и рН-независимый состав с замедленным высвобождением совместно с рН-зависимым составом с отсроченным высвобождением или отдельно от него,
где рН-зависимый состав с отсроченным высвобождением содержит 25-90 масс. % ривастигмина в общем содержании ривастигмина, и где рН-независимый состав с замедленным высвобождением содержит 10-75 масс. % ривастигмина в общем содержании ривастигмина.
2. Фармацевтическая композиция по п. 1, в которой рН-зависимый состав с отсроченным высвобождением содержит полимер, имеющий свойство растворяться при рН 5,0 или выше, и изготавливается в форме гранулы, пеллета или таблетки с сердцевиной.
3. Фармацевтическая композиция по п. 2, где полимер, имеющий свойство растворяться при рН 5,0 или выше, представляет собой по меньшей мере один полимер, выбранный из группы, состоящей из сополимера на основе акриловой кислоты, фталата гидроксипропилметилцеллюлозы и ацетатфталата целлюлозы, и их смесь.
4. Фармацевтическая композиция по п. 1 или 2, дополнительно содержащая в рН-зависимом составе с отсроченным высвобождением рН-независимую основу с замедленным высвобождением.
5. Фармацевтическая композиция по п. 1, в которой рН-независимый состав с замедленным высвобождением содержится в форме матрицы, гранулы или пеллета.
6. Фармацевтическая композиция по п. 1, где ривастигмин высвобождается в количестве, относительно общего содержания ривастигмина, равном или больше 10 масс. % и меньше 40 масс. % в течение 120 минут, равном или больше 40 масс. % и меньше 70 масс. % в течение 6 часов, и равном или больше 70 масс. % в течение 12 часов.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2015-0058759 | 2015-04-27 | ||
| KR1020150058759A KR101990951B1 (ko) | 2015-04-27 | 2015-04-27 | 리바스티그민 함유 서방출 의약조성물 |
| PCT/KR2016/004380 WO2016175546A2 (ko) | 2015-04-27 | 2016-04-27 | 리바스티그민 함유 서방출 의약조성물 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2017136567A true RU2017136567A (ru) | 2019-05-27 |
| RU2017136567A3 RU2017136567A3 (ru) | 2019-09-19 |
| RU2727721C2 RU2727721C2 (ru) | 2020-07-23 |
Family
ID=57199589
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2017136567A RU2727721C2 (ru) | 2015-04-27 | 2016-04-27 | Фармацевтическая композиция с замедленным высвобождением, содержащая ривастигмин |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US10835497B2 (ru) |
| EP (1) | EP3290023B1 (ru) |
| JP (1) | JP6787928B2 (ru) |
| KR (1) | KR101990951B1 (ru) |
| CN (1) | CN107530290B (ru) |
| AU (1) | AU2016255302B2 (ru) |
| BR (1) | BR112017022478B1 (ru) |
| CA (1) | CA2984235C (ru) |
| CY (1) | CY1124339T1 (ru) |
| DK (1) | DK3290023T3 (ru) |
| ES (1) | ES2860694T3 (ru) |
| HR (1) | HRP20210434T1 (ru) |
| HU (1) | HUE053816T2 (ru) |
| LT (1) | LT3290023T (ru) |
| MX (1) | MX380909B (ru) |
| PL (1) | PL3290023T3 (ru) |
| PT (1) | PT3290023T (ru) |
| RS (1) | RS61548B1 (ru) |
| RU (1) | RU2727721C2 (ru) |
| SI (1) | SI3290023T1 (ru) |
| SM (1) | SMT202100208T1 (ru) |
| WO (1) | WO2016175546A2 (ru) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR102209420B1 (ko) * | 2019-03-08 | 2021-01-29 | 에이치엘비제약 주식회사 | 리바스티그민의 일정한(0-차) 방출형 경구용 서방성 정제 조성물 |
| CN112546037A (zh) * | 2020-12-08 | 2021-03-26 | 苏州大学 | 卡巴拉汀在制备抗辐射药中的应用 |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL141762A0 (en) | 1998-10-01 | 2002-03-10 | Novartis Ag | New oral formulations |
| AU6715600A (en) | 1999-08-26 | 2001-03-19 | Elan Corporation, Plc | Pharmaceutical formulations |
| JP2003507416A (ja) * | 1999-08-26 | 2003-02-25 | エラン コーポレイション ピーエルスィー | 医薬製剤 |
| GB9923045D0 (en) | 1999-09-29 | 1999-12-01 | Novartis Ag | New oral formulations |
| US20050163847A1 (en) * | 2004-01-21 | 2005-07-28 | Andrx Pharmaceuticals, Llc | Pharmaceutical formulations containing a non-steroidal antiinflammatory drug and an antiulcerative drug |
| KR100866720B1 (ko) * | 2004-12-27 | 2008-11-05 | 에자이 알앤드디 매니지먼트 가부시키가이샤 | 항치매 약물의 안정화 방법 |
| RU2390354C2 (ru) * | 2004-12-27 | 2010-05-27 | Эйсай Ар Энд Ди Менеджмент Ко., Лтд. | Препарат матричного типа с замедленным высвобождением, содержащий основное лекарственное средство или его соль, и способ его получения |
| MX2007012220A (es) * | 2005-04-06 | 2007-12-06 | Mallinckrodt Inc | Formulacion farmaceutica de liberacion por pulsos a base de matriz. |
| CA2911569C (en) * | 2005-11-29 | 2019-11-26 | Children's Hospital Medical Center | Optimization and individualization of medication selection and dosing |
| US8846100B2 (en) * | 2006-05-12 | 2014-09-30 | Shire Llc | Controlled dose drug delivery system |
| MX2008014455A (es) | 2006-05-12 | 2008-11-27 | Shire Llc | Sistema de suministro de farmaco de dosis controlada. |
| US8632805B2 (en) | 2008-06-20 | 2014-01-21 | Mutual Pharmaceutical Company, Inc. | Controlled-release formulations, method of manufacture, and use thereof |
| US20100159001A1 (en) * | 2008-12-19 | 2010-06-24 | Cardinal John R | Extended-Release Pharmaceutical Formulations |
| CN102548544B (zh) * | 2009-10-09 | 2015-01-21 | 永进药品工业株式会社 | 同时具有速效特性和长效特性的药物组合物 |
| MX344189B (es) | 2010-03-31 | 2016-12-08 | Supernus Pharmaceuticals Inc | Formulaciones de mazindol. |
| CN108653226A (zh) | 2013-03-15 | 2018-10-16 | 韩国联合制药株式会社 | 提供药理及临床效应的莫沙必利每日单次施用缓释制剂 |
-
2015
- 2015-04-27 KR KR1020150058759A patent/KR101990951B1/ko active Active
-
2016
- 2016-04-27 PT PT167867324T patent/PT3290023T/pt unknown
- 2016-04-27 MX MX2017013481A patent/MX380909B/es unknown
- 2016-04-27 HU HUE16786732A patent/HUE053816T2/hu unknown
- 2016-04-27 DK DK16786732.4T patent/DK3290023T3/da active
- 2016-04-27 SM SM20210208T patent/SMT202100208T1/it unknown
- 2016-04-27 RU RU2017136567A patent/RU2727721C2/ru active
- 2016-04-27 WO PCT/KR2016/004380 patent/WO2016175546A2/ko not_active Ceased
- 2016-04-27 JP JP2017555575A patent/JP6787928B2/ja active Active
- 2016-04-27 HR HRP20210434TT patent/HRP20210434T1/hr unknown
- 2016-04-27 LT LTEP16786732.4T patent/LT3290023T/lt unknown
- 2016-04-27 RS RS20210290A patent/RS61548B1/sr unknown
- 2016-04-27 SI SI201631161T patent/SI3290023T1/sl unknown
- 2016-04-27 ES ES16786732T patent/ES2860694T3/es active Active
- 2016-04-27 CN CN201680024737.4A patent/CN107530290B/zh active Active
- 2016-04-27 US US15/569,693 patent/US10835497B2/en active Active
- 2016-04-27 AU AU2016255302A patent/AU2016255302B2/en active Active
- 2016-04-27 PL PL16786732T patent/PL3290023T3/pl unknown
- 2016-04-27 BR BR112017022478-0A patent/BR112017022478B1/pt active IP Right Grant
- 2016-04-27 EP EP16786732.4A patent/EP3290023B1/en active Active
- 2016-04-27 CA CA2984235A patent/CA2984235C/en active Active
-
2021
- 2021-04-14 CY CY20211100324T patent/CY1124339T1/el unknown
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