RU2007118726A - Фармацевтическая композиция, включающая диклофенак - Google Patents
Фармацевтическая композиция, включающая диклофенак Download PDFInfo
- Publication number
- RU2007118726A RU2007118726A RU2007118726/15A RU2007118726A RU2007118726A RU 2007118726 A RU2007118726 A RU 2007118726A RU 2007118726/15 A RU2007118726/15 A RU 2007118726/15A RU 2007118726 A RU2007118726 A RU 2007118726A RU 2007118726 A RU2007118726 A RU 2007118726A
- Authority
- RU
- Russia
- Prior art keywords
- food film
- film according
- food
- diclofenac
- flavoring
- Prior art date
Links
- DCOPUUMXTXDBNB-UHFFFAOYSA-N diclofenac Chemical compound OC(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl DCOPUUMXTXDBNB-UHFFFAOYSA-N 0.000 title claims 6
- 229960001259 diclofenac Drugs 0.000 title claims 6
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- 235000013305 food Nutrition 0.000 claims 17
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 239000000203 mixture Substances 0.000 claims 4
- 239000004014 plasticizer Substances 0.000 claims 4
- 229920000642 polymer Polymers 0.000 claims 4
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 3
- 239000002253 acid Substances 0.000 claims 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 3
- 230000000873 masking effect Effects 0.000 claims 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 2
- 240000000560 Citrus x paradisi Species 0.000 claims 2
- 235000006679 Mentha X verticillata Nutrition 0.000 claims 2
- 235000002899 Mentha suaveolens Nutrition 0.000 claims 2
- 235000001636 Mentha x rotundifolia Nutrition 0.000 claims 2
- 239000003963 antioxidant agent Substances 0.000 claims 2
- 230000003078 antioxidant effect Effects 0.000 claims 2
- 235000006708 antioxidants Nutrition 0.000 claims 2
- 235000011187 glycerol Nutrition 0.000 claims 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims 2
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims 1
- WBZFUFAFFUEMEI-UHFFFAOYSA-M Acesulfame k Chemical compound [K+].CC1=CC(=O)[N-]S(=O)(=O)O1 WBZFUFAFFUEMEI-UHFFFAOYSA-M 0.000 claims 1
- 108010011485 Aspartame Proteins 0.000 claims 1
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims 1
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims 1
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 239000004376 Sucralose Substances 0.000 claims 1
- 239000000619 acesulfame-K Substances 0.000 claims 1
- 229940087168 alpha tocopherol Drugs 0.000 claims 1
- 239000011668 ascorbic acid Substances 0.000 claims 1
- 235000010323 ascorbic acid Nutrition 0.000 claims 1
- 229960005070 ascorbic acid Drugs 0.000 claims 1
- 239000000605 aspartame Substances 0.000 claims 1
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims 1
- 235000010357 aspartame Nutrition 0.000 claims 1
- 229960003438 aspartame Drugs 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 235000010980 cellulose Nutrition 0.000 claims 1
- 229960004106 citric acid Drugs 0.000 claims 1
- 235000015165 citric acid Nutrition 0.000 claims 1
- 239000000796 flavoring agent Substances 0.000 claims 1
- 235000013355 food flavoring agent Nutrition 0.000 claims 1
- 235000003599 food sweetener Nutrition 0.000 claims 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
- 229940041616 menthol Drugs 0.000 claims 1
- 210000000214 mouth Anatomy 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 235000019408 sucralose Nutrition 0.000 claims 1
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims 1
- 239000003765 sweetening agent Substances 0.000 claims 1
- 229960000984 tocofersolan Drugs 0.000 claims 1
- 239000002076 α-tocopherol Substances 0.000 claims 1
- 235000004835 α-tocopherol Nutrition 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- 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
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
-
- 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]
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Zoology (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
Claims (17)
1. Фармацевтическая композиция, предназначенная для перорального введения, в форме пищевой пленки, включающей диклофенак, которая быстро и полностью разлагается в ротовой полости пациента в течение менее 60 с.
2. Пищевая пленка по п.1 толщиной 250 мкм или менее.
3. Пищевая пленка по п.1, включающая диклофенак в форме свободной кислоты.
4. Пищевая пленка по п.2, включающая диклофенак в форме свободной кислоты.
5. Пищевая пленка по п.4, включающая диклофенак в форме свободной кислоты со средним размером частиц 2 мкм или менее.
6. Пищевая пленка по любому из пп.1-5, включающая (А) по крайней мере один пленкообразующий полимер и (В) по крайней мере один пластификатор.
7. Пищевая пленка по п.6, включающая от 10 до 50 мас.% диклофенака, от 10 до 80 мас.% по крайней мере одного пленкообразующего полимера (А) и от 1 до 10 мас.% по крайней мере одного пластификатора (В) в расчете на массу конечной пищевой пленки (сухая масса).
8. Пищевая пленка по п.7, в которой по крайней мере один пленкообразующий полимер (А) выбирают из группы, включающей гидроксипропилметилцеллюлозу, гидроксиэтилцеллюлозу, гидроксипропилцеллюлозу, фталат целлюлозы или их смесь.
9. Пищевая пленка по п.7, в которой пленкообразующий полимер (А) означает гидроксипропилметилцеллюлозу.
10. Пищевая пленка по любому из пп.1-5 или 7-9, в которой по крайней мере один пластификатор (В) выбирают из группы, включающей глицерин, полиэтиленгликоль, этиленгликоль, пропиленгликоль или их смеси.
11. Пищевая пленка по п.10, в которой пластификатор (В) означает глицерин.
12. Пищевая пленка по любому из пп.1-5, 7-9 или 11, включающая по крайней мере один антиоксидант (С).
13. Пищевая пленка по п.12, в которой по крайней мере один антиоксидант (С) выбирают из группы, включающей альфа-токоферол, аскорбиновую кислоту, лимонную кислоту или их смеси.
14. Пищевая пленка по любому из пп.1-5, 7-9, 11 или 13, включающая по крайней мере один ароматизатор (D), выбранный из группы, включающей грейпфрутовый, мятный ароматизаторы и маскирующий вкус ароматизатор.
15. Пищевая пленка по п.14, включающая маскирующий вкус ароматизатор, грейпфрутовый ароматизатор и хлорид натрия.
16. Пищевая пленка по п.14, включающая маскирующий вкус ароматизатор, мятный ароматизатор, хлорид натрия и ментол.
17. Пищевая пленка по любому из пп.1-5, 7-9, 11,13 или 15 и 16, включающая по крайней мере один подсластитель (Е), выбранный из группы, включающей сукралозу, ацесульфам К, аспартам и любую их смесь.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US62070604P | 2004-10-21 | 2004-10-21 | |
| US60/620,706 | 2004-10-21 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2007118726A true RU2007118726A (ru) | 2008-11-27 |
| RU2424793C2 RU2424793C2 (ru) | 2011-07-27 |
Family
ID=35840581
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2007118726/15A RU2424793C2 (ru) | 2004-10-21 | 2005-10-20 | Фармацевтическая композиция, включающая диклофенак |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US8911769B2 (ru) |
| EP (1) | EP1804777B1 (ru) |
| JP (1) | JP5213446B2 (ru) |
| KR (1) | KR101288162B1 (ru) |
| CN (1) | CN101043880B (ru) |
| AR (1) | AR051397A1 (ru) |
| AU (1) | AU2005299741B2 (ru) |
| BR (1) | BRPI0516238A (ru) |
| CA (1) | CA2577862C (ru) |
| IL (1) | IL182020A0 (ru) |
| MX (1) | MX2007004736A (ru) |
| NO (1) | NO20072262L (ru) |
| NZ (1) | NZ553475A (ru) |
| PE (1) | PE20060935A1 (ru) |
| PL (1) | PL1804777T3 (ru) |
| RU (1) | RU2424793C2 (ru) |
| TW (1) | TWI406680B (ru) |
| WO (1) | WO2006047365A1 (ru) |
| ZA (1) | ZA200701557B (ru) |
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| WO2010086989A1 (ja) | 2009-01-29 | 2010-08-05 | 日東電工株式会社 | 口腔内フィルム状基剤及び製剤 |
| US20120328675A1 (en) * | 2010-03-03 | 2012-12-27 | Kowa Co., Ltd. | Film preparation containing medicament with unpleasant taste |
| US20120076865A1 (en) | 2010-03-24 | 2012-03-29 | Jazz Pharmaceuticals, Inc. | Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances |
| JP2011207847A (ja) * | 2010-03-30 | 2011-10-20 | Nitto Denko Corp | フィルム状製剤及びその製造方法 |
| JP5751868B2 (ja) | 2010-03-30 | 2015-07-22 | 日東電工株式会社 | フィルム状製剤及びその製造方法 |
| JP5555148B2 (ja) * | 2010-12-10 | 2014-07-23 | 日東電工株式会社 | シート状製剤及びシート状製剤の製造方法 |
| JP6067687B2 (ja) * | 2011-06-08 | 2017-01-25 | エルテーエス ローマン テラピー−ジステーメ アーゲー | 味覚マスキングのためのイオン交換樹脂を含有する可食性経口ストリップ又はウエハース剤形 |
| JP5841433B2 (ja) | 2012-01-11 | 2016-01-13 | 日東電工株式会社 | 口腔内フィルム状基剤及び製剤 |
| EA033893B1 (ru) * | 2013-04-11 | 2019-12-06 | СиТиСи БАЙО, ИНК. | Лекарственная форма в виде пленки, содержащей свободное основание тадалафила и полимер на основе полиэтиленгликоля и/или полимер на основе винилпирролидона в качестве агента, стабилизирующего дисперсию, раствор для получения пленки и способ получения пленки |
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| EP2995301B1 (en) * | 2013-05-10 | 2019-08-07 | CTC Bio, Inc. | Film preparation containing donepezil-free base and method for producing same |
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| US12186296B1 (en) | 2016-07-22 | 2025-01-07 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
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| KR20110004921A (ko) | 2002-05-16 | 2011-01-14 | 규큐 야쿠힝 고교 가부시키가이샤 | 속용성 필름형상 제제 |
| JP2004043450A (ja) * | 2002-05-16 | 2004-02-12 | Kyukyu Yakuhin Kogyo Kk | 速溶性フィルム状製剤 |
| DE10224612A1 (de) * | 2002-06-04 | 2003-12-24 | Lohmann Therapie Syst Lts | Wirkstoffhaltige filmförmige Zubereitungen mit verbesserter chemischer Stabilität, und Verfahren zu deren Herstellung |
| FR2840221B1 (fr) * | 2002-06-04 | 2006-01-13 | Backert Marie Elisabeth Cuine | Film polymerique contenant des "actifs" destines a etre liberes dans un liquide |
| US20040202698A1 (en) * | 2003-04-02 | 2004-10-14 | The Procter & Gamble Company | Drug delivery systems comprising an encapsulated active ingredient |
| ITMI20032087A1 (it) * | 2003-10-27 | 2005-04-28 | Pharmafilm S R L | Film autosupportanti per uso farmaceutico ed alimentare. |
-
2005
- 2005-10-19 PE PE2005001228A patent/PE20060935A1/es not_active Application Discontinuation
- 2005-10-19 AR ARP050104366A patent/AR051397A1/es unknown
- 2005-10-20 RU RU2007118726/15A patent/RU2424793C2/ru not_active IP Right Cessation
- 2005-10-20 WO PCT/US2005/038090 patent/WO2006047365A1/en not_active Ceased
- 2005-10-20 US US11/666,086 patent/US8911769B2/en not_active Expired - Fee Related
- 2005-10-20 JP JP2007538108A patent/JP5213446B2/ja not_active Expired - Fee Related
- 2005-10-20 TW TW094136742A patent/TWI406680B/zh not_active IP Right Cessation
- 2005-10-20 AU AU2005299741A patent/AU2005299741B2/en not_active Ceased
- 2005-10-20 CN CN2005800360078A patent/CN101043880B/zh not_active Expired - Fee Related
- 2005-10-20 KR KR1020077008968A patent/KR101288162B1/ko not_active Expired - Fee Related
- 2005-10-20 PL PL05816335T patent/PL1804777T3/pl unknown
- 2005-10-20 NZ NZ553475A patent/NZ553475A/en not_active IP Right Cessation
- 2005-10-20 BR BRPI0516238-6A patent/BRPI0516238A/pt not_active Application Discontinuation
- 2005-10-20 EP EP05816335.3A patent/EP1804777B1/en not_active Expired - Lifetime
- 2005-10-20 CA CA2577862A patent/CA2577862C/en not_active Expired - Fee Related
- 2005-10-20 MX MX2007004736A patent/MX2007004736A/es active IP Right Grant
-
2007
- 2007-02-22 ZA ZA200701557A patent/ZA200701557B/xx unknown
- 2007-03-19 IL IL182020A patent/IL182020A0/en unknown
- 2007-05-02 NO NO20072262A patent/NO20072262L/no not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| CA2577862A1 (en) | 2006-05-04 |
| MX2007004736A (es) | 2007-06-18 |
| PL1804777T3 (pl) | 2018-09-28 |
| US8911769B2 (en) | 2014-12-16 |
| JP5213446B2 (ja) | 2013-06-19 |
| JP2008517935A (ja) | 2008-05-29 |
| PE20060935A1 (es) | 2006-10-26 |
| EP1804777A1 (en) | 2007-07-11 |
| EP1804777B1 (en) | 2018-05-09 |
| AU2005299741B2 (en) | 2009-03-12 |
| TW200621317A (en) | 2006-07-01 |
| NZ553475A (en) | 2010-10-29 |
| WO2006047365A1 (en) | 2006-05-04 |
| US20080003267A1 (en) | 2008-01-03 |
| KR101288162B1 (ko) | 2013-07-18 |
| ZA200701557B (en) | 2008-08-27 |
| TWI406680B (zh) | 2013-09-01 |
| CA2577862C (en) | 2013-06-04 |
| IL182020A0 (en) | 2007-07-24 |
| CN101043880A (zh) | 2007-09-26 |
| AU2005299741A1 (en) | 2006-05-04 |
| RU2424793C2 (ru) | 2011-07-27 |
| NO20072262L (no) | 2007-05-14 |
| KR20070065890A (ko) | 2007-06-25 |
| CN101043880B (zh) | 2011-08-10 |
| BRPI0516238A (pt) | 2008-08-26 |
| AR051397A1 (es) | 2007-01-10 |
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Legal Events
| Date | Code | Title | Description |
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| MM4A | The patent is invalid due to non-payment of fees |
Effective date: 20171021 |