JP5366549B2 - 即時放出特性及び/又は制御放出特性を有する薬学的剤形 - Google Patents
即時放出特性及び/又は制御放出特性を有する薬学的剤形 Download PDFInfo
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- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
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- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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Description
本願は、一部継続出願である2005年9月30日に出願された米国特許出願第11/239,249号の継続であり、米国特許法35巻第120条の下、2005年5月26日に出願された米国特許出願第11/138,008号、2004年4月
2日に出願された米国特許出願第10/815,924号、2004年4月2日に出願された米国特許出願第10,815,926号、2004年4月2日に出願された米国特許出願第10/815,929号、及び2004年4月2日に出願された米国特許出願第10/815,930号(これらの開示は全て、参照により本明細書に援用される)の有益性を主張する。
本発明は概して、(1)胃腸管において吸収ウィンドウを有する(例えば、胃及び/又は小腸で通常吸収される)か、(2)胃腸管(例えば、胃及び/又は小腸)におけるか又はそれに近接した治療位置を有するか、或いは(3)結腸で分解する吸収ウィンドウ活性物質の制御放出のための薬学的薬物送達系に関する。本発明はまた、哺乳動物における各種障害及び疾患の治療におけるこれらの制御放出送達系の使用に関する。
Claims (33)
- バクロフェン、ガバペンチン、レボドパ、α-メチルドパ、バラシクロビル又はそれらの任意の混合物からなる群より選択される、小腸における持続的な吸収を示す吸収ウィンドウ活性物質の薬学的剤形であって、複数の制御放出粒子からなり、各粒子が、
i.バクロフェン、ガバペンチン、レボドパ、α-メチルドパ、バラシクロビル又はそれらの任意の混合物からなる群から選択される吸収ウィンドウ活性物質、
ii.該吸収ウィンドウ活性物質を少なくとも80%封入するように包み込む内部pH感受性ポリマー層、及び
iii.該吸収ウィンドウ活性物質及び内部pH感受性ポリマー層を少なくとも80%封入するように包み込む外部pH感受性ポリマー層を含んでなり、
該剤形が該吸収ウィンドウ活性物質の小腸における持続的放出をもたらし、該外部pH感受性ポリマー層が該内部pH感受性ポリマー層より低いpHで溶解し、前記外部pH感受性ポリマー層が5.5以上のpHで溶解し、内部pH感受性ポリマー層が6以上のpHで溶解する、薬学的剤形。 - 即時放出成分をさらに含む、請求項1に記載の薬学的剤形。
- 前記即時放出成分が、即時放出粒子を含む、請求項2に記載の薬学的剤形。
- 可塑剤をさらに含む、請求項1に記載の薬学的剤形。
- 前記可塑剤が、1,2−プロピレングリコール、アセチル化モノグリセリド、ヒマシ油、セバシン酸ジブチル、フタル酸ジエチル、フタル酸エステル、ポリエチレングリコール、プロピレングリコール、トリアセチン、クエン酸トリブチル、クエン酸トリエチル、又はそれらの任意の混合物から成る群から選択される、請求項4に記載の薬学的剤形。
- 前記内部pH感受性ポリマー層及び/又は前記外部pH感受性ポリマー層が、カルボキシメチルエチルセルロース、酢酸フタル酸セルロース、酢酸トリメリット酸セルロース、フタル酸ヒドロキシプロピルメチルセルロース、共重合されたメタクリル酸/メタクリル酸メチルエステル、ポリ酢酸フタル酸ビニル、又はそれらの任意の混合物から成る群から選択されるpH感受性ポリマーから成る、請求項1に記載の薬学的剤形。
- 前記外部pH感受性ポリマー層が、共重合されたメタクリル酸/メタクリル酸メチルエステルポリマーを含む、請求項6に記載の薬学的剤形。
- 前記即時放出成分対前記制御放出成分の比が、1:4〜4:1である、請求項2に記載の薬学的剤形。
- 前記即時放出成分対前記制御放出成分の比が、1:2〜2:1である、請求項8に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、1mg〜1000mgの量で存在する、請求項1に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、1.5mg〜500mgの量で存在する、請求項10に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、2mg〜250mgの量で存在する、請求項11に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、2.5mg〜200mgの量で存在する、請求項12に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、10mg〜100mgの量で存在する、請求項13に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、15mg〜50mgの量で存在する、請求項14に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、300mg〜900mgの量で存在する、請求項10に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、400mg〜800mgの量で存在する、請求項16に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、450mg〜750mgの量で存在する、請求項17に記載の薬学的剤形。
- 前記薬学的剤形が錠剤である、請求項1に記載の薬学的剤形。
- 前記薬学的剤形がカプセル剤である、請求項1に記載の薬学的剤形。
- 前記カプセル剤が、ビーズ、顆粒、粒子、錠剤又はそれらの混合物から成る群から選択される別個のユニットをさらに含む、請求項20に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、バクロフェンである、請求項1に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質がラセミ混合物である、請求項1に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、光学的に純粋な異性体混合物である、請求項1に記載の薬学的剤形。
- 前記吸収ウィンドウ活性物質が、胃及び小腸で放出される、請求項1に記載の薬学的剤形。
- 前記バクロフェンが、上部小腸で放出される、請求項22に記載の薬学的剤形。
- 前記バクロフェンが、十二指腸で放出される、請求項22に記載の薬学的剤形。
- 前記バクロフェンが、空腸で放出される、請求項22に記載の薬学的剤形。
- 前記外部ポリマー層が、前記粒子に対して5重量パーセント〜50重量パーセントの量で存在する、請求項1に記載の薬学的剤形。
- 前記外部ポリマー層が、前記粒子に対して15重量パーセント〜35重量パーセントの量で存在する、請求項29に記載の薬学的剤形。
- 前記内部ポリマー層が、前記粒子に対して5重量パーセント〜50重量パーセントの量で存在する、請求項1に記載の薬学的剤形。
- 前記外部ポリマー層が、前記粒子に対して20重量パーセント〜30重量パーセントの量で存在する、請求項31に記載の薬学的剤形。
- 前記内部pH感受性ポリマー層が前記粒子を包み込み、前記外部pH感受性ポリマー層が前記粒子及び前記内部pH感受性ポリマー層を包み込んでいる請求項1記載の薬学的剤形。
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Application Number | Priority Date | Filing Date | Title |
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US11/239,249 US8007827B2 (en) | 2004-04-02 | 2005-09-30 | Pharmaceutical dosage forms having immediate release and/or controlled release properties |
US11/239,249 | 2005-09-30 | ||
PCT/US2006/036694 WO2007040997A2 (en) | 2005-09-30 | 2006-09-20 | Pharmaceutical dosage forms having immediate release and/or controlled release properties |
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JP2009510065A JP2009510065A (ja) | 2009-03-12 |
JP5366549B2 true JP5366549B2 (ja) | 2013-12-11 |
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US (1) | US8007827B2 (ja) |
EP (1) | EP1940361B1 (ja) |
JP (1) | JP5366549B2 (ja) |
KR (1) | KR20080059409A (ja) |
CN (1) | CN101312716A (ja) |
AU (1) | AU2006297477B2 (ja) |
BR (1) | BRPI0616703A2 (ja) |
CA (1) | CA2625481C (ja) |
ES (1) | ES2561585T3 (ja) |
TR (1) | TR200804209T1 (ja) |
TW (1) | TW200735899A (ja) |
WO (1) | WO2007040997A2 (ja) |
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2005
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2006
- 2006-09-20 JP JP2008533447A patent/JP5366549B2/ja not_active Expired - Fee Related
- 2006-09-20 AU AU2006297477A patent/AU2006297477B2/en not_active Ceased
- 2006-09-20 CN CNA2006800432865A patent/CN101312716A/zh active Pending
- 2006-09-20 TR TR2008/04209T patent/TR200804209T1/xx unknown
- 2006-09-20 EP EP06825042.2A patent/EP1940361B1/en not_active Not-in-force
- 2006-09-20 CA CA2625481A patent/CA2625481C/en not_active Expired - Fee Related
- 2006-09-20 WO PCT/US2006/036694 patent/WO2007040997A2/en active Application Filing
- 2006-09-20 BR BRPI0616703A patent/BRPI0616703A2/pt not_active IP Right Cessation
- 2006-09-20 KR KR1020087010287A patent/KR20080059409A/ko not_active Application Discontinuation
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Also Published As
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CN101312716A (zh) | 2008-11-26 |
TW200735899A (en) | 2007-10-01 |
ES2561585T3 (es) | 2016-02-29 |
AU2006297477B2 (en) | 2011-02-10 |
AU2006297477A1 (en) | 2007-04-12 |
EP1940361B1 (en) | 2015-11-04 |
CA2625481C (en) | 2012-01-03 |
US8007827B2 (en) | 2011-08-30 |
WO2007040997A3 (en) | 2007-09-27 |
JP2009510065A (ja) | 2009-03-12 |
US20060057197A1 (en) | 2006-03-16 |
WO2007040997A2 (en) | 2007-04-12 |
BRPI0616703A2 (pt) | 2016-09-06 |
EP1940361A4 (en) | 2011-03-02 |
TR200804209T1 (tr) | 2008-08-21 |
CA2625481A1 (en) | 2007-04-12 |
EP1940361A2 (en) | 2008-07-09 |
KR20080059409A (ko) | 2008-06-27 |
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