RU2018131133A - Фармацевтическая композиция, содержащая рацекадотрил, и способ ее получения - Google Patents
Фармацевтическая композиция, содержащая рацекадотрил, и способ ее получения Download PDFInfo
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- RU2018131133A RU2018131133A RU2018131133A RU2018131133A RU2018131133A RU 2018131133 A RU2018131133 A RU 2018131133A RU 2018131133 A RU2018131133 A RU 2018131133A RU 2018131133 A RU2018131133 A RU 2018131133A RU 2018131133 A RU2018131133 A RU 2018131133A
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- Prior art keywords
- pharmaceutical composition
- racecadotril
- crystallized
- crystallized sugar
- weight
- Prior art date
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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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
-
- 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
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/223—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of alpha-aminoacids
-
- 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
- A61K31/265—Esters, e.g. nitroglycerine, selenocyanates of carbonic, thiocarbonic, or thiocarboxylic acids, e.g. thioacetic acid, xanthogenic acid, trithiocarbonic acid
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/009—Sachets, pouches characterised by the material or function of the envelope
-
- 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
-
- 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
-
- 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
- A61K9/1611—Inorganic 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/12—Antidiarrhoeals
-
- 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
- A61K9/1682—Processes
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Emergency Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (24)
1. Фармацевтическая композиция, содержащая рацекадотрил, сокристаллизованный сахар и фармацевтически приемлемые инертные вспомогательные вещества, где соотношение рацекадотрила к сокристаллизованному сахару составляет от приблизительно 1:10 до приблизительно 1:150.
2. Фармацевтическая композиция по п. 1, где композиция является непокрытой.
3. Фармацевтическая композиция по п. 1, где фармацевтически приемлемые инертные вспомогательные вещества включают разбавители, связующие вещества, подсластитель, разрыхлители, растворители, смазывающее вещество, способствующие скольжению вещества и ароматизаторы.
4. Фармацевтическая композиция по п. 1, где сокристаллизованным сахаром является сокристаллизованная сахароза.
5. Фармацевтическая композиция, содержащая:
от приблизительно 0,5% до приблизительно 2% по массе рацекадотрила;
от приблизительно 40% до приблизительно 99% по массе сокристаллизованного сахара;
от приблизительно 0,1% до приблизительно 5% по массе разрыхлителя;
от приблизительно 0,05% до приблизительно 2% по массе способствующего скольжению вещества.
6. Фармацевтическая композиция по п. 5, где композиция представляет собой твердую лекарственную форму.
7. Фармацевтическая композиция по п. 5, где композиция представлена в виде саше.
8. Фармацевтическая композиция по п. 5, где сокристаллизованным сахаром является сокристаллизованная сахароза.
9. Фармацевтическая композиция по п. 5, где разрыхлителем является поливинилпирролидон.
10. Фармацевтическая композиция по п. 5, где способствующим скольжению веществом является коллоидный диоксид кремния.
11. Способ получения фармацевтической композиции, содержащей рацекадотрил, причем способ включает стадии:
(a) просеивания рацекадотрила, части сокристаллизованного сахара и фармацевтически приемлемых инертных вспомогательных веществ с получением смеси;
(b) добавления растворителя в поливинилпирролидон с получением раствора или суспензии;
(c) гранулирования смеси, полученной на стадии (а), с раствором или суспензией, полученной на стадии (b), с получением гранул;
(d) сушки гранул, полученных на стадии (с);
(e) смешивания другой части сокристаллизованного сахара с диоксидом кремния с получением промежуточной смеси;
(f) смешивания высушенных гранул, полученных на стадии (d), и промежуточной смеси, полученной на стадии (е), с получением конечной смеси;
(g) заполнения конечной смеси, полученной на стадии (f), в саше подходящего размера.
12. Способ по п. 11, где способ гранулирования представляет собой водное гранулирование.
13. Способ по п. 11, где способ гранулирования представляет собой безводное гранулирование.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN201721007797 | 2017-03-06 | ||
| IN201721007797 | 2017-03-06 | ||
| PCT/IN2018/050085 WO2018163195A1 (en) | 2017-03-06 | 2018-02-20 | A pharmaceutical composition comprising racecadotril and process for preparing the same |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2018131133A true RU2018131133A (ru) | 2021-01-22 |
| RU2018131133A3 RU2018131133A3 (ru) | 2021-01-22 |
| RU2749949C2 RU2749949C2 (ru) | 2021-06-21 |
Family
ID=63447638
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2018131133A RU2749949C2 (ru) | 2017-03-06 | 2018-02-20 | Фармацевтическая композиция, содержащая рацекадотрил, и способ ее получения |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20200061014A1 (ru) |
| EP (1) | EP3592333B1 (ru) |
| KR (1) | KR102195776B1 (ru) |
| CN (1) | CN108834401A (ru) |
| BR (1) | BR112018069973A2 (ru) |
| MX (1) | MX2018014260A (ru) |
| RU (1) | RU2749949C2 (ru) |
| WO (1) | WO2018163195A1 (ru) |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2480747A1 (fr) | 1980-04-17 | 1981-10-23 | Roques Bernard | Derives d'acides amines et leur application therapeutique |
| US6214402B1 (en) * | 1998-09-17 | 2001-04-10 | The Nutrasweet Company | Co-crystallization of sugar and n-[n-(3,3-dimethylbutyl)-l αaspartyl]-l-phenylalanine 1-methyl ester |
| DE60112756T2 (de) * | 2000-06-23 | 2006-06-08 | Bioprojet | Racecadotril enthaltende trockene pulverformulierung |
| GB0015490D0 (en) * | 2000-06-23 | 2000-08-16 | Smithkline Beecham Lab | Novel formulations |
| KR20120048046A (ko) * | 2004-02-06 | 2012-05-14 | 세파론, 인코포레이티드 | 모다피닐 조성물 |
| US20070254050A1 (en) * | 2006-05-01 | 2007-11-01 | Quart Barry D | Method for treatment of diarrhea-predominant irritable bowel syndrome |
| FR2900823B1 (fr) * | 2006-05-15 | 2009-02-13 | Bioprojet Soc Civ Ile | Nouvelle forme d'administration du racecadotril. |
| US8404297B2 (en) * | 2006-06-13 | 2013-03-26 | Ingenio del Cauca S.A.—Incauca S.A. | Process for co-crystallizing sucrose and a natural sweetener and the product thereof |
| US20090004248A1 (en) * | 2007-06-29 | 2009-01-01 | Frank Bunick | Dual portion dosage lozenge form |
| US9084721B2 (en) * | 2012-06-28 | 2015-07-21 | Mcneil-Ppc, Inc. | Racecadotril liquid compositions |
| EP2749270B1 (en) | 2012-12-26 | 2018-01-17 | ILKO Ilaç Sanayi ve Ticaret A.S. | Racecadotril and pharmaceutical compositions thereof |
| CN104224724A (zh) * | 2013-06-08 | 2014-12-24 | 北京韩美药品有限公司 | 一种消旋卡多曲颗粒剂及其制备工艺 |
| CN103565750A (zh) * | 2013-09-30 | 2014-02-12 | 北京德众万全药物技术开发有限公司 | 消旋卡多曲颗粒及其制备方法 |
| EP2949318A1 (en) * | 2014-05-26 | 2015-12-02 | Galenicum Health S.L. | Pharmaceutical compositions comprising racecadotril |
| MA40859A (fr) * | 2014-10-29 | 2017-09-05 | Johnson & Johnson Consumer Inc | Particules de cadotril |
-
2018
- 2018-02-20 BR BR112018069973A patent/BR112018069973A2/pt active Search and Examination
- 2018-02-20 WO PCT/IN2018/050085 patent/WO2018163195A1/en unknown
- 2018-02-20 EP EP18763649.3A patent/EP3592333B1/en active Active
- 2018-02-20 CN CN201880000987.3A patent/CN108834401A/zh active Pending
- 2018-02-20 MX MX2018014260A patent/MX2018014260A/es unknown
- 2018-02-20 KR KR1020187028565A patent/KR102195776B1/ko active IP Right Grant
- 2018-02-20 RU RU2018131133A patent/RU2749949C2/ru active
- 2018-02-20 US US16/081,634 patent/US20200061014A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| CN108834401A (zh) | 2018-11-16 |
| KR102195776B1 (ko) | 2020-12-29 |
| BR112018069973A2 (pt) | 2019-09-17 |
| EP3592333B1 (en) | 2024-04-03 |
| KR20180129807A (ko) | 2018-12-05 |
| EP3592333A1 (en) | 2020-01-15 |
| EP3592333A4 (en) | 2020-08-19 |
| WO2018163195A1 (en) | 2018-09-13 |
| EP3592333C0 (en) | 2024-04-03 |
| MX2018014260A (es) | 2019-04-29 |
| RU2749949C2 (ru) | 2021-06-21 |
| US20200061014A1 (en) | 2020-02-27 |
| RU2018131133A3 (ru) | 2021-01-22 |
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