RU2015138710A - Жевательная композиция для перорального приема и способ ее получения - Google Patents
Жевательная композиция для перорального приема и способ ее получения Download PDFInfo
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- RU2015138710A RU2015138710A RU2015138710A RU2015138710A RU2015138710A RU 2015138710 A RU2015138710 A RU 2015138710A RU 2015138710 A RU2015138710 A RU 2015138710A RU 2015138710 A RU2015138710 A RU 2015138710A RU 2015138710 A RU2015138710 A RU 2015138710A
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- 239000000203 mixture Substances 0.000 title claims 17
- 238000000034 method Methods 0.000 title claims 6
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 6
- 239000013543 active substance Substances 0.000 claims 4
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 3
- 238000010438 heat treatment Methods 0.000 claims 3
- 238000000465 moulding Methods 0.000 claims 3
- 239000001814 pectin Substances 0.000 claims 3
- 235000010987 pectin Nutrition 0.000 claims 3
- 229920001277 pectin Polymers 0.000 claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 3
- 239000002253 acid Substances 0.000 claims 2
- 239000003086 colorant Substances 0.000 claims 2
- 239000000796 flavoring agent Substances 0.000 claims 2
- 235000019634 flavors Nutrition 0.000 claims 2
- 235000021092 sugar substitutes Nutrition 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- 239000003765 sweetening agent Substances 0.000 claims 2
- 238000005266 casting Methods 0.000 claims 1
- 230000001055 chewing effect Effects 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- 238000000151 deposition Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 238000001879 gelation Methods 0.000 claims 1
- 239000012907 medicinal substance Substances 0.000 claims 1
- 238000010979 pH adjustment Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 229940124531 pharmaceutical excipient Drugs 0.000 claims 1
Classifications
-
- 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
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
- A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
- A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
- A23G3/364—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
- A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
- A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
- A23G3/48—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing plants or parts thereof, e.g. fruits, seeds, extracts
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
- A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
- A23L29/231—Pectin; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic 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
- A61K31/33—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
-
- 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
- A61K31/47—Quinolines; Isoquinolines
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
-
- 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
- A61P1/06—Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Nutrition Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Zoology (AREA)
- Physiology (AREA)
- Botany (AREA)
- Microbiology (AREA)
- Dispersion Chemistry (AREA)
- Mycology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Confectionery (AREA)
Claims (23)
1. Композиция для перорального приема, содержащая:
- 0,5-3,5 вес. % высокометилированного пектина,
- 40-70 вес. % глицерина,
- 16-30 вес. % воды,
- 0-2,5 вес. % по меньшей мере одного ПАВа,
- 1,5-40 вес. % по меньшей мере одного другого компонента, выбранного из группы, состоящей из: заменителей сахара, ароматизаторов, красителей и/или активных веществ,
где весовые процентные доли относятся к полному весу композиции, и рН композиции находится в диапазоне от приблизительно 2,8 до приблизительно 3,2.
2. Композиция по п. 1, имеющая активность воды менее 0,61.
3. Композиция по п. 1 или 2, где рН композиции регулируют добавлением в композицию кислоты.
4. Композиция по п. 1, являющаяся жевательной.
5. Фармацевтическая композиция, содержащая композицию по любому из пп. 1-4, содержащая по меньшей мере одно активное вещество, где указанное активное вещество является лекарственным веществом, факультативно с по меньшей мере одним фармацевтическим эксципиентом.
6. Фармацевтическая композиция по п. 5 для применения в качестве лекарственного средства.
7. Способ получения композиции по любому из пп. 1-4 или фармацевтической композиции по любому из пп. 5 или 6, включающий следующие стадии:
(i) смешение глицерина, воды, факультативно с, одним или несколькими, активными веществами и/или ПАВами,
(ii) после нагревания, добавление высокометилированного пектина,
(iii) добавление одного или нескольких заменителей сахара, ароматизаторов и/или красителей, если таковые применяются,
(iv) нагревание смеси, полученной на стадии (ii), до температуры в интервале от 60°С до 90°С,
(v) корректировка рН кислотой,
(vi) формование и охлаждение композиции до наступления желирования.
8. Способ по п. 7, где добавление высокометилированного пектина на стадии (ii) осуществляют после нагревания смеси со стадии (i) до температуры в диапазоне 35-45°С.
9. Способ по п. 7 или 8, где рН корректируют лимонной кислотой.
10. Способ по любому из пп. 7 или 8, где стадию формования осуществляют, разливая композицию по формам.
11. Способ по любому из пп. 7 или 8, где стадию формования осуществляют, осаждая каплю композиции на охлаждаемую ленту конвейера.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13305172.2 | 2013-02-14 | ||
| EP13305172 | 2013-02-14 | ||
| PCT/EP2014/052746 WO2014124981A1 (en) | 2013-02-14 | 2014-02-12 | Chewable composition for oral administration and process for preparing thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2015138710A true RU2015138710A (ru) | 2017-03-20 |
Family
ID=47739180
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015138710A RU2015138710A (ru) | 2013-02-14 | 2014-02-12 | Жевательная композиция для перорального приема и способ ее получения |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US9474713B2 (ru) |
| EP (1) | EP2956011B1 (ru) |
| JP (1) | JP6346623B2 (ru) |
| KR (1) | KR20150116861A (ru) |
| CN (1) | CN105007750A (ru) |
| AR (1) | AR094770A1 (ru) |
| AU (1) | AU2014217965B2 (ru) |
| BR (1) | BR112015018200B1 (ru) |
| CA (1) | CA2900597C (ru) |
| HU (1) | HUE038489T2 (ru) |
| IL (1) | IL239958A (ru) |
| MX (1) | MX359887B (ru) |
| PL (1) | PL2956011T3 (ru) |
| RU (1) | RU2015138710A (ru) |
| SG (1) | SG11201505541VA (ru) |
| TW (1) | TWI622408B (ru) |
| WO (1) | WO2014124981A1 (ru) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2999937B1 (fr) | 2012-12-21 | 2015-01-09 | Sanofi Sa | Unite solide a haute teneur en fexofenadine et son procede de preparation |
| US20180263904A1 (en) * | 2017-03-20 | 2018-09-20 | Bayer Healthcare Llc | Chewable gel products for active pharmaceutical ingredients |
| BR112020008653A2 (pt) * | 2017-11-02 | 2020-10-27 | Zambon S.P.A. | composições farmacêuticas compreendendo safinamida |
| EP3549579A1 (en) | 2018-04-03 | 2019-10-09 | Sanofi Winthrop Industrie | Oral gum formulation and fabrication process thereof |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6723348B2 (en) * | 2001-11-16 | 2004-04-20 | Ethypharm | Orodispersible tablets containing fexofenadine |
| JP5133244B2 (ja) * | 2005-08-05 | 2013-01-30 | ルピン・リミテッド | フェキソフェナジンの経口用医薬懸濁組成物 |
| US9155772B2 (en) * | 2008-12-08 | 2015-10-13 | Philip Morris Usa Inc. | Soft, chewable and orally dissolvable and/or disintegrable products |
| CN101628117B (zh) * | 2009-08-18 | 2011-02-16 | 北京航洋胶囊技术有限公司 | 一种咀嚼软胶囊皮、咀嚼软胶囊药物及其制备方法 |
| JP2013514347A (ja) * | 2009-12-16 | 2013-04-25 | シャスン ファーマシューティカルズ リミテッド | デクスイブプロフェン経皮ヒドロゲルの組成物 |
| US20120251484A1 (en) * | 2011-03-31 | 2012-10-04 | Cp Kelco Aps | Cold prepared gel and method for making same |
| KR101303479B1 (ko) | 2011-07-28 | 2013-09-06 | (주)씨엘팜 | 가식성 필름형성 조성물 및 약물이 함유된 가식성 필름형 제제 |
| FR2999937B1 (fr) | 2012-12-21 | 2015-01-09 | Sanofi Sa | Unite solide a haute teneur en fexofenadine et son procede de preparation |
-
2014
- 2014-02-12 WO PCT/EP2014/052746 patent/WO2014124981A1/en active Application Filing
- 2014-02-12 EP EP14703892.1A patent/EP2956011B1/en active Active
- 2014-02-12 JP JP2015557416A patent/JP6346623B2/ja active Active
- 2014-02-12 KR KR1020157022247A patent/KR20150116861A/ko not_active Application Discontinuation
- 2014-02-12 MX MX2015010486A patent/MX359887B/es active IP Right Grant
- 2014-02-12 AU AU2014217965A patent/AU2014217965B2/en active Active
- 2014-02-12 CA CA2900597A patent/CA2900597C/en active Active
- 2014-02-12 US US14/767,527 patent/US9474713B2/en active Active
- 2014-02-12 PL PL14703892T patent/PL2956011T3/pl unknown
- 2014-02-12 BR BR112015018200-3A patent/BR112015018200B1/pt active IP Right Grant
- 2014-02-12 CN CN201480008792.5A patent/CN105007750A/zh active Pending
- 2014-02-12 SG SG11201505541VA patent/SG11201505541VA/en unknown
- 2014-02-12 RU RU2015138710A patent/RU2015138710A/ru not_active Application Discontinuation
- 2014-02-12 HU HUE14703892A patent/HUE038489T2/hu unknown
- 2014-02-13 AR ARP140100449A patent/AR094770A1/es unknown
- 2014-02-14 TW TW103104989A patent/TWI622408B/zh not_active IP Right Cessation
-
2015
- 2015-07-15 IL IL239958A patent/IL239958A/en not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| KR20150116861A (ko) | 2015-10-16 |
| IL239958A0 (en) | 2015-08-31 |
| TWI622408B (zh) | 2018-05-01 |
| PL2956011T3 (pl) | 2018-09-28 |
| SG11201505541VA (en) | 2015-08-28 |
| AR094770A1 (es) | 2015-08-26 |
| HUE038489T2 (hu) | 2018-10-29 |
| US20150374622A1 (en) | 2015-12-31 |
| AU2014217965B2 (en) | 2017-03-23 |
| CA2900597A1 (en) | 2014-08-21 |
| CA2900597C (en) | 2021-11-02 |
| EP2956011B1 (en) | 2018-03-28 |
| BR112015018200B1 (pt) | 2020-11-03 |
| JP2016507579A (ja) | 2016-03-10 |
| CN105007750A (zh) | 2015-10-28 |
| TW201440821A (zh) | 2014-11-01 |
| MX2015010486A (es) | 2015-10-26 |
| WO2014124981A1 (en) | 2014-08-21 |
| MX359887B (es) | 2018-10-15 |
| AU2014217965A1 (en) | 2015-08-20 |
| JP6346623B2 (ja) | 2018-06-20 |
| EP2956011A1 (en) | 2015-12-23 |
| IL239958A (en) | 2017-11-30 |
| US9474713B2 (en) | 2016-10-25 |
| BR112015018200A2 (pt) | 2017-07-18 |
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