AR074739A1 - Comprimidos de capecitabina de disgregacion rapida - Google Patents
Comprimidos de capecitabina de disgregacion rapidaInfo
- Publication number
- AR074739A1 AR074739A1 ARP090104855A ARP090104855A AR074739A1 AR 074739 A1 AR074739 A1 AR 074739A1 AR P090104855 A ARP090104855 A AR P090104855A AR P090104855 A ARP090104855 A AR P090104855A AR 074739 A1 AR074739 A1 AR 074739A1
- Authority
- AR
- Argentina
- Prior art keywords
- pharmaceutical composition
- crospovidone
- less
- composition
- capecitabine
- Prior art date
Links
- GAGWJHPBXLXJQN-UORFTKCHSA-N Capecitabine Chemical compound C1=C(F)C(NC(=O)OCCCCC)=NC(=O)N1[C@H]1[C@H](O)[C@H](O)[C@@H](C)O1 GAGWJHPBXLXJQN-UORFTKCHSA-N 0.000 title abstract 3
- 239000000203 mixture Substances 0.000 abstract 4
- 239000008194 pharmaceutical composition Substances 0.000 abstract 4
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 3
- 229960000913 crospovidone Drugs 0.000 abstract 3
- 239000007884 disintegrant Substances 0.000 abstract 3
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 abstract 3
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 abstract 3
- GAGWJHPBXLXJQN-UHFFFAOYSA-N Capecitabine Natural products C1=C(F)C(NC(=O)OCCCCC)=NC(=O)N1C1C(O)C(O)C(C)O1 GAGWJHPBXLXJQN-UHFFFAOYSA-N 0.000 abstract 2
- 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 abstract 2
- 229930195725 Mannitol Natural products 0.000 abstract 2
- 229960004117 capecitabine Drugs 0.000 abstract 2
- 238000009472 formulation Methods 0.000 abstract 2
- 239000000594 mannitol Substances 0.000 abstract 2
- 235000010355 mannitol Nutrition 0.000 abstract 2
- 239000002245 particle Substances 0.000 abstract 2
- 229920002689 polyvinyl acetate Polymers 0.000 abstract 2
- 239000011118 polyvinyl acetate Substances 0.000 abstract 2
- 229920002785 Croscarmellose sodium Polymers 0.000 abstract 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 abstract 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 abstract 1
- 229960001681 croscarmellose sodium Drugs 0.000 abstract 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 abstract 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 abstract 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 1
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 1
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 1
- 229940079832 sodium starch glycolate Drugs 0.000 abstract 1
- 239000008109 sodium starch glycolate Substances 0.000 abstract 1
- 229920003109 sodium starch glycolate Polymers 0.000 abstract 1
- 150000005846 sugar alcohols Polymers 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
-
- 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
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Saccharide Compounds (AREA)
Abstract
Reivindicación 1: Una composición farmacéutica recubierta por una película que comprende capecitabina y al menos un disgregante que consiste de una formulación de manitol (90%), crospovidona (5%) y acetato de polivinilo (5%), dicha composición se caracteriza porque se disgrega en agua a 37°C en un aparato de disgregación USP en menos de 2,5 minutos y tiene una dureza de alrededor de 8 - 23 SCU. Reivindicación 3: La composición de la reivindicación 2 que comprende entre alrededor de 50 mg y alrededor de 1500 mg de capecitabina. Reivindicación 6: La composición farmacéutica de la reivindicación 1, en la que además de una formulación de manitol (90%), crospovidona (5%) y acetato de polivinilo (5%), se selecciona otro disgregante del grupo que consiste en crospovidona con un tamano de partícula inferior a 15 micras en el rango de un 90% a un tamano de partícula inferior a 400 micras en el rango de un 90%, croscarmelosa sódica, glicolato de almidón sódico y hidroxipropilcelulosa poco sustituida o cualquier combinación de dichos disgregantes. Reivindicación 10: La composición farmacéutica de la reivindicación 1 que contiene además un alcohol polihídrico directamente comprimible. Reivindicación 14: La composición farmacéutica de la reivindicación 1 que contiene entre alrededor del 4% y alrededor del 30% de celulosa microcristalina de cada forma de dosificación unitaria.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US12276608P | 2008-12-16 | 2008-12-16 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR074739A1 true AR074739A1 (es) | 2011-02-09 |
Family
ID=41600677
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP090104855A AR074739A1 (es) | 2008-12-16 | 2009-12-14 | Comprimidos de capecitabina de disgregacion rapida |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US20110027374A1 (es) |
| EP (1) | EP2379065A2 (es) |
| JP (1) | JP2012512142A (es) |
| KR (1) | KR20110086857A (es) |
| CN (1) | CN102369002A (es) |
| AR (1) | AR074739A1 (es) |
| AU (1) | AU2009328348A1 (es) |
| BR (1) | BRPI0922983A2 (es) |
| CA (1) | CA2745279A1 (es) |
| IL (1) | IL212735A0 (es) |
| MX (1) | MX2011006026A (es) |
| PE (1) | PE20110583A1 (es) |
| RU (1) | RU2011129205A (es) |
| SG (1) | SG172191A1 (es) |
| TW (1) | TW201028156A (es) |
| WO (1) | WO2010069795A2 (es) |
| ZA (1) | ZA201103986B (es) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8715729B2 (en) | 2010-12-22 | 2014-05-06 | Basf Se | Rapidly disintegrating, solid coated dosage form |
| JP6521564B2 (ja) | 2010-12-22 | 2019-05-29 | ビーエーエスエフ ソシエタス・ヨーロピアＢａｓｆ Ｓｅ | 速崩性の固体被覆剤形 |
| CN102266303A (zh) * | 2011-07-07 | 2011-12-07 | 程雪翔 | 一种卡培他滨药用组合物及其制备方法 |
| US20140309183A1 (en) * | 2011-08-24 | 2014-10-16 | David Kerr | Low-Dose Combination Chemotherapy |
| CN102988320B (zh) * | 2012-12-13 | 2014-04-16 | 哈药集团技术中心 | 一种卡培他滨分散片及其制备方法 |
| CN104337783B (zh) * | 2013-08-02 | 2018-06-22 | 山东新时代药业有限公司 | 一种卡培他滨片剂及其制备方法 |
| CN104997744B (zh) * | 2015-08-04 | 2018-01-23 | 青岛市中心医院 | 一种高稳定性卡培他滨片剂及其制备方法 |
| JP6673798B2 (ja) * | 2016-10-12 | 2020-03-25 | 日本化薬株式会社 | カペシタビンを有効成分とするフィルムコート医薬製剤 |
| JP6866113B2 (ja) * | 2016-11-01 | 2021-04-28 | 日本化薬株式会社 | カペシタビンを有効成分とする医薬製剤 |
| JP6792418B2 (ja) * | 2016-11-08 | 2020-11-25 | 日本化薬株式会社 | カペシタビンを有効成分とする医薬製剤の製造方法 |
| PL3720424T3 (pl) * | 2017-12-08 | 2022-12-27 | F. Hoffmann-La Roche Ag | Preparat farmaceutyczny |
| WO2021033144A1 (en) * | 2019-08-20 | 2021-02-25 | Intas Pharmaceuticals Ltd. | Oral suspension of capecitabine |
| MX2022014094A (es) * | 2020-05-19 | 2022-12-08 | Cellix Bio Private Ltd | Formulaciones farmaceuticas y sus preparaciones para el tratamiento del cancer. |
| CN115666516A (zh) * | 2020-06-01 | 2023-01-31 | 希尔帕医疗保健有限公司 | 包括卡培他滨的快速分散药物组合物 |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB8628359D0 (en) * | 1986-11-27 | 1986-12-31 | Zyma Sa | Galenical formulation |
| CA2440361A1 (en) * | 2001-03-06 | 2002-09-12 | Kyowa Hakko Kogyo Co. Ltd. | Intraorally rapidly disintegrable preparation |
| US7118765B2 (en) * | 2001-12-17 | 2006-10-10 | Spi Pharma, Inc. | Co-processed carbohydrate system as a quick-dissolve matrix for solid dosage forms |
| PT1634586E (pt) * | 2004-09-09 | 2007-04-30 | Medinfar Produtos Farmaceutico | Comprimidos de domperidona rapidamente dispersíveis em água. |
| JP5209876B2 (ja) * | 2004-12-28 | 2013-06-12 | エーザイ・アール・アンド・ディー・マネジメント株式会社 | 速崩壊性錠剤及びその製造方法 |
| WO2006110800A1 (en) * | 2005-04-12 | 2006-10-19 | Elan Pharma International Limited | Modified release compositions comprising a fluorocytidine derivative for the treatment of cancer |
| EP1965761B1 (de) * | 2005-12-21 | 2015-07-01 | Basf Se | Pharmazeutische formulierung für die herstellung von schnell zerfallenden tabletten |
| CA2665343C (en) * | 2006-10-05 | 2014-12-16 | The Johns Hopkins University | Water-dispersible oral, parenteral, and topical formulations for poorly water soluble drugs using smart polymeric nanoparticles |
| US20080085310A1 (en) * | 2006-10-06 | 2008-04-10 | Maria Oksana Bachynsky | Capecitabine rapidly disintegrating tablets |
-
2009
- 2009-11-17 US US12/619,918 patent/US20110027374A1/en not_active Abandoned
- 2009-12-07 RU RU2011129205/15A patent/RU2011129205A/ru not_active Application Discontinuation
- 2009-12-07 CA CA2745279A patent/CA2745279A1/en not_active Abandoned
- 2009-12-07 BR BRPI0922983A patent/BRPI0922983A2/pt not_active Application Discontinuation
- 2009-12-07 CN CN2009801497682A patent/CN102369002A/zh active Pending
- 2009-12-07 SG SG2011044047A patent/SG172191A1/en unknown
- 2009-12-07 KR KR1020117013740A patent/KR20110086857A/ko not_active Ceased
- 2009-12-07 AU AU2009328348A patent/AU2009328348A1/en not_active Abandoned
- 2009-12-07 JP JP2011540038A patent/JP2012512142A/ja active Pending
- 2009-12-07 PE PE2011001070A patent/PE20110583A1/es not_active Application Discontinuation
- 2009-12-07 WO PCT/EP2009/066490 patent/WO2010069795A2/en not_active Ceased
- 2009-12-07 MX MX2011006026A patent/MX2011006026A/es not_active Application Discontinuation
- 2009-12-07 EP EP09768524A patent/EP2379065A2/en not_active Withdrawn
- 2009-12-14 TW TW098142783A patent/TW201028156A/zh unknown
- 2009-12-14 AR ARP090104855A patent/AR074739A1/es unknown
-
2011
- 2011-05-05 IL IL212735A patent/IL212735A0/en unknown
- 2011-05-30 ZA ZA2011/03986A patent/ZA201103986B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP2379065A2 (en) | 2011-10-26 |
| TW201028156A (en) | 2010-08-01 |
| RU2011129205A (ru) | 2013-01-27 |
| MX2011006026A (es) | 2011-06-21 |
| WO2010069795A3 (en) | 2010-10-07 |
| ZA201103986B (en) | 2012-02-29 |
| IL212735A0 (en) | 2011-07-31 |
| KR20110086857A (ko) | 2011-08-01 |
| WO2010069795A2 (en) | 2010-06-24 |
| CA2745279A1 (en) | 2010-06-24 |
| AU2009328348A1 (en) | 2010-06-24 |
| PE20110583A1 (es) | 2011-08-17 |
| CN102369002A (zh) | 2012-03-07 |
| US20110027374A1 (en) | 2011-02-03 |
| SG172191A1 (en) | 2011-07-28 |
| BRPI0922983A2 (pt) | 2016-01-26 |
| JP2012512142A (ja) | 2012-05-31 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FB | Suspension of granting procedure |