RU2016127361A - Гастроретентивные фармацевтические композиции для перорального введения - Google Patents
Гастроретентивные фармацевтические композиции для перорального введения Download PDFInfo
- Publication number
- RU2016127361A RU2016127361A RU2016127361A RU2016127361A RU2016127361A RU 2016127361 A RU2016127361 A RU 2016127361A RU 2016127361 A RU2016127361 A RU 2016127361A RU 2016127361 A RU2016127361 A RU 2016127361A RU 2016127361 A RU2016127361 A RU 2016127361A
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- RU
- Russia
- Prior art keywords
- tablet
- mass
- tablet according
- total weight
- agent
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000003349 gelling agent Substances 0.000 claims 4
- KPYSYYIEGFHWSV-UHFFFAOYSA-N Baclofen Chemical compound OC(=O)CC(CN)C1=CC=C(Cl)C=C1 KPYSYYIEGFHWSV-UHFFFAOYSA-N 0.000 claims 3
- 229960000794 baclofen Drugs 0.000 claims 3
- 239000004604 Blowing Agent Substances 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 239000008187 granular material Substances 0.000 claims 2
- 239000011159 matrix material Substances 0.000 claims 2
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims 1
- 208000007848 Alcoholism Diseases 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 201000007930 alcohol dependence Diseases 0.000 claims 1
- 238000013270 controlled release Methods 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 230000002496 gastric effect Effects 0.000 claims 1
- 230000014759 maintenance of location Effects 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 235000010413 sodium alginate Nutrition 0.000 claims 1
- 239000000661 sodium alginate Substances 0.000 claims 1
- 229940005550 sodium alginate Drugs 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic 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
-
- 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
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
-
- 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
- A61K9/2009—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
- A61K9/20—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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
-
- 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
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/32—Alcohol-abuse
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Addiction (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Psychiatry (AREA)
- Neurosurgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (10)
1. Фармацевтическая таблетка матричного типа, предназначенная для введения перорально один или два раза в сутки, которая обеспечивает контролируемое высвобождение баклофена за счет удержания в желудке, включающая гранулы баклофена и один или более разбавителей в матрице, включающей по меньшей мере гелеобразующий агент, газообразующий агент и суперразрыхлитель.
2. Таблетка по п. 1, включающая гранулы баклофена и маннит в матрице, включающей по меньшей мере гелеобразующий агент, газообразующий агент и суперразрыхлитель.
3. Таблетка по п. 1, включающая от 1% масс. до 30% масс. суперразрыхлителя в пересчете на общую массу таблетки.
4. Таблетка по п. 1, включающая от 5% масс. до 50% масс. гелеобразующего агента в пересчете на общую массу таблетки.
5. Таблетка по п. 1, включающая от 2% масс. до 25% масс. газообразующего агента в пересчете на общую массу таблетки.
6. Таблетка по п. 5, включающая 5% масс. генератора газа в пересчете на общую массу таблетки.
7. Таблетка по п. 1, не содержащая альгината натрия.
8. Таблетка по п. 1, в которой массовое отношение количества гелеобразующего агента к количеству газообразующего агента составляет от 1:10 до 10:1.
9. Таблетка по любому из пп. 1-8, предназначенная для применения в качестве лекарственного средства.
10. Таблетка по любому из пп. 1-8, предназначенная для применения при лечении алкогольной зависимости или при поддержании отказа от приема алкоголя.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR1362916 | 2013-12-18 | ||
| FR1362916A FR3014692B1 (fr) | 2013-12-18 | 2013-12-18 | Compositions pharmaceutiques orales a retention gastrique. |
| PCT/EP2014/078597 WO2015091874A1 (fr) | 2013-12-18 | 2014-12-18 | Compositions pharmaceutiques orales à rétention gastrique |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2016127361A true RU2016127361A (ru) | 2018-01-23 |
| RU2666996C1 RU2666996C1 (ru) | 2018-09-13 |
Family
ID=50624693
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2016127361A RU2666996C1 (ru) | 2013-12-18 | 2014-12-18 | Гастроретентивные фармацевтические композиции для перорального введения |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20160310434A1 (ru) |
| EP (1) | EP3082791B1 (ru) |
| JP (1) | JP6585053B2 (ru) |
| KR (1) | KR102336819B1 (ru) |
| CN (1) | CN105828812B (ru) |
| AU (1) | AU2014368504B2 (ru) |
| CA (1) | CA2933738C (ru) |
| FR (1) | FR3014692B1 (ru) |
| IL (1) | IL246197B (ru) |
| RU (1) | RU2666996C1 (ru) |
| WO (1) | WO2015091874A1 (ru) |
| ZA (1) | ZA201604100B (ru) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11491125B1 (en) * | 2021-09-29 | 2022-11-08 | Amneal Pharmaceuticals Llc | Baclofen formulations and methods of minimizing patient exposure to metabolite variations |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4406424A1 (de) * | 1994-02-28 | 1995-08-31 | Bayer Ag | Expandierbare Arzneiformen |
| CN1520286B (zh) * | 2001-07-04 | 2010-12-01 | 太阳医药工业有限公司 | 胃滞留控制药物释出系统 |
| US20050090554A1 (en) * | 2003-09-12 | 2005-04-28 | John Devane | Treatment of gastroparesis and nonulcer dyspepsia with GABAB agonists |
| DE602005007205D1 (de) * | 2005-07-19 | 2008-07-10 | Ethypharm Sa | Gastroretentive Zusammensetzungen und Verfahren zur Herstellung |
| AU2007201808B8 (en) * | 2006-04-26 | 2013-09-05 | Sun Pharmaceutical Advanced Research Company Ltd | A method for alleviating signs and symptoms of spasticity |
| PL2378883T3 (pl) * | 2008-12-04 | 2016-06-30 | Intec Pharma Ltd | SYSTEM DOSTARCZANIA LEKU ZATRZYMYWANEGO W ŻOŁĄDKU dLA ZALEPLONU |
| CA2790164A1 (en) * | 2010-02-17 | 2011-08-25 | Sun Pharma Advanced Research Company Ltd. | Method of treating a disease condition susceptible to baclofen therapy |
| US20130078290A1 (en) * | 2010-06-01 | 2013-03-28 | Rubicon Research Private Limited | Gastroretentive Dosage Forms Of GABA Analogs |
-
2013
- 2013-12-18 FR FR1362916A patent/FR3014692B1/fr active Active
-
2014
- 2014-12-18 EP EP14827204.0A patent/EP3082791B1/fr active Active
- 2014-12-18 AU AU2014368504A patent/AU2014368504B2/en active Active
- 2014-12-18 US US15/104,698 patent/US20160310434A1/en not_active Abandoned
- 2014-12-18 CA CA2933738A patent/CA2933738C/fr active Active
- 2014-12-18 JP JP2016541030A patent/JP6585053B2/ja active Active
- 2014-12-18 RU RU2016127361A patent/RU2666996C1/ru active
- 2014-12-18 WO PCT/EP2014/078597 patent/WO2015091874A1/fr active Application Filing
- 2014-12-18 KR KR1020167019221A patent/KR102336819B1/ko active IP Right Grant
- 2014-12-18 CN CN201480069688.7A patent/CN105828812B/zh active Active
-
2016
- 2016-06-14 IL IL246197A patent/IL246197B/en active IP Right Grant
- 2016-06-17 ZA ZA2016/04100A patent/ZA201604100B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA2933738C (fr) | 2023-07-04 |
| CA2933738A1 (fr) | 2015-06-25 |
| AU2014368504A1 (en) | 2016-07-07 |
| KR102336819B1 (ko) | 2021-12-07 |
| CN105828812B (zh) | 2019-08-09 |
| JP2016540814A (ja) | 2016-12-28 |
| US20160310434A1 (en) | 2016-10-27 |
| JP6585053B2 (ja) | 2019-10-02 |
| IL246197B (en) | 2021-04-29 |
| WO2015091874A1 (fr) | 2015-06-25 |
| KR20160095162A (ko) | 2016-08-10 |
| FR3014692B1 (fr) | 2016-01-29 |
| EP3082791A1 (fr) | 2016-10-26 |
| EP3082791B1 (fr) | 2024-03-20 |
| RU2666996C1 (ru) | 2018-09-13 |
| AU2014368504B2 (en) | 2019-12-19 |
| FR3014692A1 (fr) | 2015-06-19 |
| IL246197A0 (en) | 2016-07-31 |
| ZA201604100B (en) | 2017-08-30 |
| CN105828812A (zh) | 2016-08-03 |
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