RU2017118329A - Частицы кадотрила - Google Patents
Частицы кадотрила Download PDFInfo
- Publication number
- RU2017118329A RU2017118329A RU2017118329A RU2017118329A RU2017118329A RU 2017118329 A RU2017118329 A RU 2017118329A RU 2017118329 A RU2017118329 A RU 2017118329A RU 2017118329 A RU2017118329 A RU 2017118329A RU 2017118329 A RU2017118329 A RU 2017118329A
- Authority
- RU
- Russia
- Prior art keywords
- cadotril
- wax
- parts
- pharmaceutical composition
- particles
- Prior art date
Links
- ODUOJXZPIYUATO-UHFFFAOYSA-N 2-[[2-[(acetylthio)methyl]-1-oxo-3-phenylpropyl]amino]acetic acid (phenylmethyl) ester Chemical compound C=1C=CC=CC=1COC(=O)CNC(=O)C(CSC(=O)C)CC1=CC=CC=C1 ODUOJXZPIYUATO-UHFFFAOYSA-N 0.000 title claims 26
- 229960002281 racecadotril Drugs 0.000 title claims 26
- 239000002245 particle Substances 0.000 title claims 10
- 239000008194 pharmaceutical composition Substances 0.000 claims 9
- 238000000034 method Methods 0.000 claims 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 6
- 239000002552 dosage form Substances 0.000 claims 5
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 5
- 239000000203 mixture Substances 0.000 claims 5
- 239000012798 spherical particle Substances 0.000 claims 4
- 239000006185 dispersion Substances 0.000 claims 2
- 239000010419 fine particle Substances 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 108700040249 racecadotril Proteins 0.000 claims 2
- 238000003756 stirring Methods 0.000 claims 2
- 238000013268 sustained release Methods 0.000 claims 2
- 239000012730 sustained-release form Substances 0.000 claims 2
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical group CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims 1
- ODUOJXZPIYUATO-IBGZPJMESA-N benzyl 2-[[(2r)-2-(acetylsulfanylmethyl)-3-phenylpropanoyl]amino]acetate Chemical compound C([C@@H](CSC(=O)C)C(=O)NCC(=O)OCC=1C=CC=CC=1)C1=CC=CC=C1 ODUOJXZPIYUATO-IBGZPJMESA-N 0.000 claims 1
- 239000007910 chewable tablet Substances 0.000 claims 1
- 229940068682 chewable tablet Drugs 0.000 claims 1
- 239000007891 compressed tablet Substances 0.000 claims 1
- 108700010883 dexecadotril Proteins 0.000 claims 1
- 229950008996 dexecadotril Drugs 0.000 claims 1
- ODUOJXZPIYUATO-LJQANCHMSA-N ecadotril Chemical compound C([C@H](CSC(=O)C)C(=O)NCC(=O)OCC=1C=CC=CC=1)C1=CC=CC=C1 ODUOJXZPIYUATO-LJQANCHMSA-N 0.000 claims 1
- 229950001184 ecadotril Drugs 0.000 claims 1
- 229940049654 glyceryl behenate Drugs 0.000 claims 1
- 210000000214 mouth Anatomy 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
Classifications
-
- 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
- A61K9/16—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
-
- 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
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
-
- 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
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- 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
-
- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Emergency Medicine (AREA)
- Molecular Biology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dispersion Chemistry (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Cosmetics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (26)
1. Способ изготовления частиц кадотрила, содержащий этапы, на которых:
плавят кадотрил и воск при перемешивании;
диспергируют расплавленную смесь кадотрила/воска в горячей воде;
переносят горячую дисперсию кадотрила/воска/воды в другой контейнер, содержащий холодную воду, причем диспергированные капли смеси кадотрила/воска застывают и образуют мелкодисперсные/сферические частицы; и
фильтруют и сушат мелкодисперсные/сферические частицы.
2. Способ по п. 1, в котором указанный кадотрил выбирают из группы, состоящей из рацекадотрила, дексекадотрила и экадотрила.
3. Способ по п. 1, в котором указанный воск представляет собой глицерилбегенат.
4. Способ изготовления дозированной формы, содержащий этапы, на которых:
смешивают частицы кадотрила по п. 1 с эксципиентами дозированной формы; и
прессуют смесь в дозированную форму.
5. Частица кадотрила, полученная способом по п. 1.
6. Дозированная форма, полученная способом по п. 2.
7. Способ лечения, включающий введение дозированной формы по п. 6.
8. Фармацевтический состав с немедленным высвобождением, содержащий частицу кадотрила по п. 5.
7. Фармацевтический состав с немедленным высвобождением по п. 8, который представляет собой жевательную таблетку.
8. Фармацевтический состав с немедленным высвобождением по п. 8, который представляет собой таблетку, распадающуюся в полости рта.
9. Фармацевтический состав с немедленным высвобождением по п. 8, который представляет собой прессованную таблетку.
10. Фармацевтический состав с немедленным высвобождением по п. 8, в котором указанные частицы кадотрила содержат от около 50 частей кадотрила/около 50 частей воска до около 95 частей кадотрила/около 5 частей воска.
11. Фармацевтический состав с немедленным высвобождением по п. 9, в котором указанные частицы кадотрила содержат от около 85 частей кадотрила/около 15 частей воска.
11. Фармацевтический состав с замедленным высвобождением, содержащий частицу кадотрила, полученную способом, включающим этапы, на которых:
плавят кадотрил и воск при перемешивании;
диспергируют расплавленную смесь кадотрила/воска в горячей воде;
переносят горячую дисперсию кадотрила/воска/воды в другой контейнер, содержащий холодную воду, причем диспергированные капли смеси кадотрила/воска застывают и образуют мелкодисперсные/сферические частицы; и
фильтруют и сушат мелкодисперсные/сферические частицы.
12. Фармацевтический состав с замедленным высвобождением по п. 11, в котором указанные частицы кадотрила содержат от около 30 частей кадотрила/более чем около 70 частей воска до около 5 частей кадотрила/около 95 частей воска.
13. Фармацевтический состав с замедленным высвобождением по п. 12, в котором указанные частицы кадотрила содержат от около 15 частей кадотрила: 85 частей воска.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462069902P | 2014-10-29 | 2014-10-29 | |
| US62/069,902 | 2014-10-29 | ||
| PCT/US2015/058007 WO2016069871A1 (en) | 2014-10-29 | 2015-10-29 | Cadotril particles |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2017118329A true RU2017118329A (ru) | 2018-11-29 |
Family
ID=54478279
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2017118329A RU2017118329A (ru) | 2014-10-29 | 2015-10-29 | Частицы кадотрила |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US10022349B2 (ru) |
| EP (1) | EP3212179A1 (ru) |
| CN (1) | CN107072952A (ru) |
| BR (1) | BR112017008854A2 (ru) |
| CA (1) | CA2965685A1 (ru) |
| MA (1) | MA40859A (ru) |
| RU (1) | RU2017118329A (ru) |
| WO (1) | WO2016069871A1 (ru) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017123485A1 (en) * | 2016-01-13 | 2017-07-20 | Johnson & Johnson Consumer Inc. | New improved composition comprising at least one cadotril |
| EP3503926B1 (en) | 2016-08-23 | 2023-06-07 | Johnson & Johnson Consumer Inc. | New improved composition of racecadotril |
| EP3592333B1 (en) * | 2017-03-06 | 2024-04-03 | Athena Pharmaceutiques SAS | A pharmaceutical composition comprising racecadotril and process for preparing the same |
| US20210145730A1 (en) * | 2017-04-20 | 2021-05-20 | Zeenar Enterprises Pty Ltd | Process for preparing an oral disintegrating dosage form |
| EP3612166A4 (en) | 2017-04-20 | 2020-11-04 | Zeenar Enterprises Pty Ltd | LIQUID CRYSTAL GALENIC FORM FOR THE ADMINISTRATION OF STATIN |
| WO2018191793A1 (en) * | 2017-04-20 | 2018-10-25 | Zeenar Enterprises Pty Ltd | Fast disintegrating tablet |
Family Cites Families (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3485719A (en) | 1967-10-13 | 1969-12-23 | Us Agriculture | Continuous process for producing xanthomonas heteropolysaccharide |
| FR2480747A1 (fr) | 1980-04-17 | 1981-10-23 | Roques Bernard | Derives d'acides amines et leur application therapeutique |
| GB8317696D0 (en) | 1983-06-29 | 1983-08-03 | Shell Int Research | Preparing xanthomonas heteroplysaccharide |
| US4851226A (en) | 1987-11-16 | 1989-07-25 | Mcneil Consumer Products Company | Chewable medicament tablet containing means for taste masking |
| FR2623498B1 (fr) | 1987-11-24 | 1990-04-06 | Bioprojet Soc Civ | Nouveaux composes enantiomeres derives d'amino-acides, leur procede de preparation et leurs applications therapeutiques |
| US5136076A (en) | 1987-11-24 | 1992-08-04 | Societe Civile Bioprojet | Process for the preparation of amino acid-derived enatiomeric compounds |
| US5075114A (en) | 1990-05-23 | 1991-12-24 | Mcneil-Ppc, Inc. | Taste masking and sustained release coatings for pharmaceuticals |
| CA2068402C (en) | 1991-06-14 | 1998-09-22 | Michael R. Hoy | Taste mask coatings for preparation of chewable pharmaceutical tablets |
| US5250236A (en) * | 1991-08-05 | 1993-10-05 | Gasco Maria R | Method for producing solid lipid microspheres having a narrow size distribution |
| WO1997033571A1 (fr) | 1996-03-14 | 1997-09-18 | Shionogi & Co., Ltd. | Preparation d'ecadotril a microdispersion et liberation rapides |
| GB0015490D0 (en) | 2000-06-23 | 2000-08-16 | Smithkline Beecham Lab | Novel formulations |
| DE60112756T2 (de) | 2000-06-23 | 2006-06-08 | Bioprojet | Racecadotril enthaltende trockene pulverformulierung |
| EP1563848A1 (en) | 2004-02-12 | 2005-08-17 | Bioprojet | New combinations of an anti-emetic agent and an enkephalinase inhibitor |
| FR2900823B1 (fr) | 2006-05-15 | 2009-02-13 | Bioprojet Soc Civ Ile | Nouvelle forme d'administration du racecadotril. |
| CN101103960B (zh) | 2006-07-14 | 2010-12-08 | 海南盛科生命科学研究院 | 一种含有消旋卡多曲的干混悬剂及其制备方法 |
| CN101264065A (zh) | 2008-04-18 | 2008-09-17 | 盐城苏海制药有限公司 | 消旋卡多曲滴丸及其制备方法 |
| US8313768B2 (en) * | 2009-09-24 | 2012-11-20 | Mcneil-Ppc, Inc. | Manufacture of tablet having immediate release region and sustained release region |
| ES2384060B1 (es) * | 2010-03-24 | 2013-09-23 | Lipotec S.A. | Cápsulas de nanopartículas lipídicas. |
| EP2462922A1 (en) | 2010-12-10 | 2012-06-13 | Bioprojet | New form of administration of enkephalinase inhibitor |
| CN102133186B (zh) | 2011-03-18 | 2012-08-01 | 海南美大制药有限公司 | 一种消旋卡多曲脂质体固体制剂 |
| CN102327234B (zh) | 2011-09-28 | 2017-04-12 | 海南康芝药业股份有限公司 | 一种消旋卡多曲干混悬剂 |
| US10039712B2 (en) | 2012-06-28 | 2018-08-07 | Johnson & Johnson Consumer Inc. | Racecadotril lipid compositions |
| US9084721B2 (en) | 2012-06-28 | 2015-07-21 | Mcneil-Ppc, Inc. | Racecadotril liquid compositions |
| US20140213653A1 (en) * | 2012-09-18 | 2014-07-31 | Mcneil-Ppc, Inc. | Directly compressible proprionic acid derivative particles |
| EP2749270B1 (en) | 2012-12-26 | 2018-01-17 | ILKO Ilaç Sanayi ve Ticaret A.S. | Racecadotril and pharmaceutical compositions thereof |
-
2015
- 2015-10-28 MA MA040859A patent/MA40859A/fr unknown
- 2015-10-29 EP EP15791182.7A patent/EP3212179A1/en not_active Withdrawn
- 2015-10-29 RU RU2017118329A patent/RU2017118329A/ru unknown
- 2015-10-29 BR BR112017008854A patent/BR112017008854A2/pt not_active Application Discontinuation
- 2015-10-29 CA CA2965685A patent/CA2965685A1/en not_active Abandoned
- 2015-10-29 CN CN201580059479.9A patent/CN107072952A/zh not_active Withdrawn
- 2015-10-29 US US14/926,533 patent/US10022349B2/en not_active Expired - Fee Related
- 2015-10-29 WO PCT/US2015/058007 patent/WO2016069871A1/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| EP3212179A1 (en) | 2017-09-06 |
| WO2016069871A1 (en) | 2016-05-06 |
| BR112017008854A2 (pt) | 2017-12-19 |
| CA2965685A1 (en) | 2016-05-06 |
| CN107072952A (zh) | 2017-08-18 |
| US10022349B2 (en) | 2018-07-17 |
| US20160120834A1 (en) | 2016-05-05 |
| MA40859A (fr) | 2017-09-05 |
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