JP5453280B2 - アセトアミノフェンおよびトラマドールを持続的に放出するための二層組成物 - Google Patents
アセトアミノフェンおよびトラマドールを持続的に放出するための二層組成物 Download PDFInfo
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- JP5453280B2 JP5453280B2 JP2010529201A JP2010529201A JP5453280B2 JP 5453280 B2 JP5453280 B2 JP 5453280B2 JP 2010529201 A JP2010529201 A JP 2010529201A JP 2010529201 A JP2010529201 A JP 2010529201A JP 5453280 B2 JP5453280 B2 JP 5453280B2
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Images
Classifications
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- 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
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- 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
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- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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- 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
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- 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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
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- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Description
幾つかの態様において、該アセトアミノフェンは、以下の表2に記載したように、第一層と第二層との間で分割することができる。
実施例1
実施例2
実施例3
実施例4
実施例5
以上、本発明をその好ましい態様によって例証してきたが、本発明は、添付した特許請求の範囲において規定した如き、本発明の精神並びに範囲を逸脱することなしに、その広い局面を網羅するものであると理解すべきである。
Claims (17)
- トラマドールおよびアセトアミノフェンを少なくとも12時間に渡って送達するための二層組成物であって、該二層組成物が、
a. 該組成物の迅速放出型部分を画成する、70質量%〜90質量%のアセトアミノフェンを含む第一層;および
b. 該組成物の持続放出型部分を画成する、40質量%〜60質量%のアセトアミノフェン、5質量%〜15質量%のトラマドール、および10質量%〜20質量%の架橋された高アミロースデンプンを含む第二層を含み、
ここで、全アセトアミノフェンの30-40%が該第一層に含まれることを特徴とする、前記二層組成物。 - 前記第二層が、更にヒドロキシプロピルメチルセルロースを含む、請求項1記載の組成物。
- 前記第一層が、造粒剤、フィラー、崩壊剤、潤滑剤、およびグリダントの1種またはそれ以上を含む、請求項1または2記載の組成物。
- 前記第二層が、造粒剤、フィラー、結合剤、潤滑剤、およびグリダントの1種またはそれ以上を含む、請求項1〜3の何れか1項に記載の組成物。
- 前記造粒剤が、コポビドンおよびデンプンからなる群から選択される、請求項3または4記載の組成物。
- 前記フィラーが、ラクトース、α-化デンプン、デキストリン、マルトースおよびマイクロクリスタリンセルロースからなる群から選択される、請求項3または4記載の組成物。
- 前記潤滑剤が、ステアリン酸マグネシウム、ステアリン酸カルシウム、ステアリン酸、ナトリウムステアリルフマレート、および水添植物油からなる群から選択される、請求項3または4記載の組成物。
- 前記グリダントが、タルクおよびコロイド状二酸化ケイ素からなる群から選択される、請求項3または4記載の組成物。
- 前記崩壊剤が、クロスポビドン、ナトリウムデンプングリコレート、アルギン酸ナトリウムおよびクロスカルメロースナトリウムからなる群から選択される、請求項3記載の組成物。
- 前記結合剤が、ポリエチレンオキサイド、メチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシエチルセルロース、ポリカルボフィルおよびコポビドンからなる群から選択される、請求項4記載の組成物。
- (i) 前記第一層がアセトアミノフェンの30%を含み、かつ前記第二層がアセトアミノフェンの70%を含み;(ii) 該第一層がアセトアミノフェンの35%を含み、かつ該第二層がアセトアミノフェンの65%を含み;または(iii) 該第一層がアセトアミノフェンの40%を含み、かつ該第二層がアセトアミノフェンの60%を含む、請求項1〜10の何れか1項に記載の組成物。
- (i) 前記第一層がトラマドールの50%を含み、かつ前記第二層がトラマドールの50%を含み;(ii) 該第一層がトラマドールの45%を含み、かつ該第二層がトラマドールの55%を含み;(iii) 該第一層がトラマドールの40%を含み、かつ該第二層がトラマドールの60%を含み;(iv) 該第一層がトラマドールの35%を含み、かつ該第二層がトラマドールの65%を含み;(v) 該第一層がトラマドールの30%を含み、かつ該第二層がトラマドールの70%を含み;(vi) 該第一層がトラマドールの25%を含み、かつ該第二層がトラマドールの75%を含み;(vii) 該第一層がトラマドールの20%を含み、かつ該第二層がトラマドールの80%を含み;(viii) 該第一層がトラマドールの15%を含み、かつ該第二層がトラマドールの85%を含み;(ix) 該第一層がトラマドールの10%を含み、かつ該第二層がアセトアミノフェンの90%を含み;(x) 該第一層がトラマドールの5%を含み、かつ該第二層がトラマドールの95%を含み;または(xi) 該第一層がトラマドールの0%を含み、かつ該第二層がトラマドールの100%を含む、請求項1〜11の何れか1項に記載の組成物。
- トラマドールおよびアセトアミノフェンを送達するための二層組成物であって、該二層組成物が、
a. 該組成物の迅速放出型部分を画成し、かつ70質量%〜90質量%のアセトアミノフェン、5質量%〜15質量%のデンプン、1質量%〜4質量%のマイクロクリスタリンセルロース、1質量%〜3質量%のクロスカルメロースナトリウム、0.5質量%〜2質量%のナトリウムステアリルフマレート、および0.1質量%〜1質量%のコロイド状二酸化ケイ素を含む第一層;および
b. 該第一層と隣接し、該組成物の持続放出型部分を画成し、かつ40質量%〜60質量%のアセトアミノフェン、5質量%〜15質量%のトラマドール、5質量%〜25質量%の架橋された高アミロースデンプン、10質量%〜20質量%の架橋された高アミロースデンプン、5質量%〜10質量%のデンプン、1質量%〜6質量%のマイクロクリスタリンセルロース、5質量%〜15質量%のヒドロキシプロピルメチルセルロース、0質量%〜5質量%のコポビドン、0.5質量%〜2質量%のナトリウムステアリルフマレート、および0.1質量%〜1質量%のコロイド状二酸化ケイ素を含有する第二層を含み、
ここで、全アセトアミノフェンの30-40%が該第一層に含まれることを特徴とする、前記組成物。 - 前記二層組成物の溶媒と接触可能な表面が切込みを画成し、該切込みが、該組成物を該切込みに沿って分割して2つのサブユニットを生成することを可能とする、請求項1〜13の何れか1項に記載の組成物。
- 650mgのアセトアミノフェンを含む、請求項1〜14の何れか1項に記載の組成物。
- 少なくとも12時間に渡り、哺乳動物に鎮痛作用を及ぼすために使用するための、請求項1〜15の何れか1項に記載の組成物。
- 少なくとも12時間に渡り、哺乳動物に鎮痛作用を及ぼすための医薬の製造における、請求項1〜15の何れか1項に記載の組成物の使用。
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US98020307P | 2007-10-16 | 2007-10-16 | |
US60/980,203 | 2007-10-16 | ||
PCT/CA2008/001799 WO2009049405A1 (en) | 2007-10-16 | 2008-10-15 | Bilayer composition for the sustained release of acetaminophen and tramadol |
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KR (1) | KR20100069685A (ja) |
CN (1) | CN101827590A (ja) |
AR (1) | AR068891A1 (ja) |
AU (1) | AU2008314454A1 (ja) |
BR (1) | BRPI0818762B8 (ja) |
CA (1) | CA2678092C (ja) |
CO (1) | CO6270218A2 (ja) |
ES (1) | ES2541809T3 (ja) |
MX (1) | MX336494B (ja) |
RU (1) | RU2469718C2 (ja) |
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2008
- 2008-10-15 KR KR1020107008205A patent/KR20100069685A/ko not_active Application Discontinuation
- 2008-10-15 RU RU2010119463/15A patent/RU2469718C2/ru not_active IP Right Cessation
- 2008-10-15 JP JP2010529201A patent/JP5453280B2/ja active Active
- 2008-10-15 BR BRPI0818762A patent/BRPI0818762B8/pt active IP Right Grant
- 2008-10-15 US US12/252,117 patent/US8895066B2/en active Active
- 2008-10-15 MX MX2010004236A patent/MX336494B/es unknown
- 2008-10-15 CA CA2678092A patent/CA2678092C/en active Active
- 2008-10-15 CN CN200880112295A patent/CN101827590A/zh active Pending
- 2008-10-15 AU AU2008314454A patent/AU2008314454A1/en not_active Abandoned
- 2008-10-15 WO PCT/CA2008/001799 patent/WO2009049405A1/en active Application Filing
- 2008-10-15 EP EP20080839570 patent/EP2203166B1/en active Active
- 2008-10-15 ES ES08839570.2T patent/ES2541809T3/es active Active
- 2008-10-16 TW TW097139684A patent/TW200927196A/zh unknown
- 2008-10-16 AR ARP080104506A patent/AR068891A1/es not_active Application Discontinuation
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MX336494B (es) | 2016-01-21 |
BRPI0818762A2 (pt) | 2015-04-07 |
WO2009049405A1 (en) | 2009-04-23 |
CA2678092A1 (en) | 2009-04-23 |
ES2541809T3 (es) | 2015-07-24 |
EP2203166A4 (en) | 2012-07-04 |
EP2203166A1 (en) | 2010-07-07 |
BRPI0818762A8 (pt) | 2017-09-19 |
BRPI0818762B8 (pt) | 2021-05-25 |
BRPI0818762B1 (pt) | 2019-07-02 |
RU2010119463A (ru) | 2011-11-27 |
AR068891A1 (es) | 2009-12-16 |
RU2469718C2 (ru) | 2012-12-20 |
CN101827590A (zh) | 2010-09-08 |
TW200927196A (en) | 2009-07-01 |
AU2008314454A1 (en) | 2009-04-23 |
CA2678092C (en) | 2013-07-30 |
MX2010004236A (es) | 2010-09-07 |
EP2203166B1 (en) | 2015-05-06 |
US8895066B2 (en) | 2014-11-25 |
JP2011500607A (ja) | 2011-01-06 |
CO6270218A2 (es) | 2011-04-20 |
US20090130183A1 (en) | 2009-05-21 |
KR20100069685A (ko) | 2010-06-24 |
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