JP2007524628A - In−Situゲル化薬物輸送システム - Google Patents
In−Situゲル化薬物輸送システム Download PDFInfo
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Abstract
Description
本出願は2003年6月26日出願の米国仮出願第60/482677号及び2004年5月28日出願の米国仮出願第60/575307号の利益を主張し、これらの明細書を本明細書に援用する。
(1)薬物の局所的輸送である。製品は薬の作用を必要とする部位に直接埋植することができ、従って薬物への全身暴露を軽減することができる。種々の全身性副作用に関連する(化学療法薬のような)毒性薬物に対してはこのことは特に重要となる。
(2)薬物の持続的放出である。薬物が長期間にわたって放出されるので、多数回の注射や経口投与が必要なくなる。特に、酵素やホルモン欠損症のための代償療法のような頻繁な投与を要する慢性病のための薬物、或いは結核のような頑固な病気のための抗生物質による長期治療のための薬物について患者のコンプライアンスを改善する。
(3)薬物の安定性である。ポリマーマトリクスは生理学的環境(特に循環している酵素)から薬物を保護するので、生体内(in vivo)での安定性を改善する。このことは不安定な蛋白質及びペプチドの輸送に関して本技術を特に魅力的にする。
異なるPLGA(70:30)の濃度としたときの、モルヒネ−ジクロフェナクのコドラッグの放出プロファイルを比較するために三つの処方物を評価した。処方物AはPLGA(70:30)/PEG400溶液(PEG中に約5%(w/v)のPLGA)中の約10mg/mLのモルヒネ−ジクロフェナクのコドラッグとして処方した。処方物BはPLGA(70:30)/PEG400溶液(PEG中に約10%(w/v)のPLGA)中の約10mg/mLのモルヒネ−ジクロフェナクのコドラッグとして処方した。処方物CはPLGA(70:30)/PEG400溶液(PEG中に約20%(w/v)のPLGA)中の約10mg/mLのモルヒネ−ジクロフェナクのコドラッグとして処方した。
PLGA(50:50)/PEG400溶液(PEG中に約5%(w/v)のPLGA)中のモルヒネ−ジクロフェナクのコドラッグ12mg/mLを用いて処方物を調製した。該処方物を1mLのシリンジ中に装填し、その100μLの分取量を、血漿を10%含むHA(ヒアルロン酸)ホスフェート緩衝液(pH7.4)を10mL含有する試験管に注入した。試料を37℃の水浴中に置いた。各時点にて、放出媒体全部を取り除いて新しい緩衝液10mLと交換した。取り除いた溶液に対しては、HPLCによってモルヒネ、ジクロフェナク及びコドラッグの含有量を分析した。
この試験には二種類の処方物を評価した。処方物AはPLGA(70:30)/DMA溶液(DMA中に40%(w/v)のPLGA)中の約8mg/mLのモルヒネ−ジクロフェナクのコドラッグとして処方した。処方物BはPLGA(70:30)/ベンジルベンゾアート溶液(ベンジルベンゾアート中に20%(w/v)のPLGA)中の約10mg/mLのモルヒネ−ジクロフェナクのコドラッグとして処方した。
Claims (31)
- (a)原薬と;
(b)ポリエチレングリコールと;
(c)生体適合性且つ生分解性のポリ(DL−ラクチド−グリコリド)(PLGA)ポリマーと;
を含む(該生分解性PLGAポリマーは該ポリエチレングリコール中に溶解、分散又は縣濁する。)注射可能な医薬組成物。 - 前記ポリエチレングリコールの平均分子量(MW)は約100〜約6000である請求項1に記載の組成物。
- 前記ポリエチレングリコールの平均分子量(MW)は約200〜約400である請求項2に記載の組成物。
- 前記原薬はポリエチレングリコール中に溶解する請求項1〜3の何れか一項に記載の組成物。
- 前記PLGAポリマーはポリエチレングリコール中に溶解する請求項1〜3の何れか一項に記載の組成物。
- 前記PLGAポリマーはポリエチレングリコール中に溶解する請求項4に記載の組成物。
- 前記原薬はペプチド、蛋白質、ペグ化したペプチド、及びペグ化した蛋白質よりなる群から選択される請求項1〜6の何れか一項に記載の組成物。
- 前記原薬はプロドラッグである請求項1〜6の何れか一項に記載の組成物。
- 前記原薬はコドラッグである請求項1〜6の何れか一項に記載の組成物。
- 前記コドラッグはジクロフェナクに連結したモルヒネを含む請求項9に記載の組成物。
- 請求項1〜10の何れか一項に記載の組成物を対象物に注射することを含む原薬の対象物への投与方法。
- 請求項1〜10の何れか一項に記載の組成物を対象物に注射することを含む徐放性薬物輸送ポリマーゲルの対象物中での形成方法。
- 請求項1〜10の何れか一項に記載の組成物を投与する方法であって、該組成物を水性流体と共に同時投与する方法。
- 前記水性流体が緩衝食塩水である請求項13に記載の方法。
- 前記水性流体がヒドロゲルである請求項13に記載の方法。
- 前記水性流体及び前記組成物がダブルルーメンニードルによって投与される請求項13に記載の方法。
- 前記水性流体及び前記組成物がダブルルーメンシリンジによって投与される請求項15に記載の方法。
- 前記水性流体及び前記ポリマーゲルが投与の直前に混合される請求項13に記載の方法。
- 前記水性流体及び前記ポリマーゲルがそれぞれ別のシリンジに入っている請求項15に記載の方法。
- 請求項1〜10の何れか一項に組成物を含有する薬物輸送デバイス。
- 前記デバイスが少なくとも一つの開口部を有する請求項20に記載のデバイス。
- 前記デバイスが開管である請求項20に記載のデバイス。
- (a)ポリオキシエチレンエーテルに共有結合した原薬を含むプロドラッグと;
(b)生体適合性且つ生分解性のポリ(DL−ラクチド−グリコリド)(PLGA)ポリマーと;
を含む(該生分解性PLGAポリマーは該原薬−ポリオキシエチレンエーテル複合体中に溶解、分散又は縣濁する。)注射可能な医薬組成物。 - ポリエチレングリコールの平均分子量(MW)は約100〜約6000である請求項23に記載の組成物。
- ポリエチレングリコールの平均分子量(MW)は約200〜約400である請求項23に記載の組成物。
- 請求項23〜25の何れか一項に記載の組成物を対象物に注射することを含む、除放性薬物輸送ポリマーゲルの対象物内での形成方法。
- 請求項23〜25の何れか一項に記載の組成物を投与する方法であって、該組成物を水性流体と共に同時投与する方法。
- 前記水性流体が緩衝食塩水である請求項27に記載の方法。
- 請求項23〜25の何れか一項に記載の組成物を含有する薬物輸送デバイス。
- 前記デバイスが少なくとも一つの開口部を有する請求項29に記載のデバイス。
- 前記デバイスが開管である請求項29に記載のデバイス。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US48267703P | 2003-06-26 | 2003-06-26 | |
US60/482,677 | 2003-06-26 | ||
US57530704P | 2004-05-28 | 2004-05-28 | |
US60/575,307 | 2004-05-28 | ||
PCT/US2004/020369 WO2005002625A2 (en) | 2003-06-26 | 2004-06-25 | In-situ gelling drug delivery system |
Publications (2)
Publication Number | Publication Date |
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JP2007524628A true JP2007524628A (ja) | 2007-08-30 |
JP5229768B2 JP5229768B2 (ja) | 2013-07-03 |
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Application Number | Title | Priority Date | Filing Date |
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JP2006517646A Expired - Fee Related JP5229768B2 (ja) | 2003-06-26 | 2004-06-25 | In−Situゲル化薬物輸送システム |
Country Status (16)
Country | Link |
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US (4) | US20050048123A1 (ja) |
EP (2) | EP1635875B8 (ja) |
JP (1) | JP5229768B2 (ja) |
CN (2) | CN101862455A (ja) |
AR (1) | AR044926A1 (ja) |
AT (1) | ATE410186T1 (ja) |
CA (1) | CA2530136C (ja) |
CY (1) | CY1108685T1 (ja) |
DE (1) | DE602004016995D1 (ja) |
DK (1) | DK1635875T3 (ja) |
ES (1) | ES2315680T3 (ja) |
PL (1) | PL1635875T3 (ja) |
PT (1) | PT1635875E (ja) |
SI (1) | SI1635875T1 (ja) |
TW (1) | TWI377958B (ja) |
WO (1) | WO2005002625A2 (ja) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2011508791A (ja) * | 2008-04-18 | 2011-03-17 | ウォーソー・オーソペディック・インコーポレーテッド | 生物分解性ポリマー担体中のフルオシノロン製剤 |
JP2011513337A (ja) * | 2008-04-18 | 2011-04-28 | ウォーソー・オーソペディック・インコーポレーテッド | 椎間板ヘルニアを治療するための方法および組成物 |
JP2014521636A (ja) * | 2011-07-27 | 2014-08-28 | ポリピッド リミテッド | ペプチドおよびポリペプチド分子の制御放出のためのマトリクス組成物 |
JP2018188457A (ja) * | 2010-11-24 | 2018-11-29 | デュレクト コーポレイション | 生分解性薬物送達組成物 |
JP2020523303A (ja) * | 2017-06-13 | 2020-08-06 | ザ・ユニバーシティ・オブ・ブリティッシュ・コロンビア | 薬物送達用のポリマーペースト組成物 |
Families Citing this family (36)
Publication number | Priority date | Publication date | Assignee | Title |
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US20040175410A1 (en) * | 2000-04-26 | 2004-09-09 | Control Delivery Systems, Inc. | Sustained release device and method for ocular delivery of carbonic anhydrase inhibitors |
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Cited By (6)
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JP2011508791A (ja) * | 2008-04-18 | 2011-03-17 | ウォーソー・オーソペディック・インコーポレーテッド | 生物分解性ポリマー担体中のフルオシノロン製剤 |
JP2011513337A (ja) * | 2008-04-18 | 2011-04-28 | ウォーソー・オーソペディック・インコーポレーテッド | 椎間板ヘルニアを治療するための方法および組成物 |
JP2018188457A (ja) * | 2010-11-24 | 2018-11-29 | デュレクト コーポレイション | 生分解性薬物送達組成物 |
JP2014521636A (ja) * | 2011-07-27 | 2014-08-28 | ポリピッド リミテッド | ペプチドおよびポリペプチド分子の制御放出のためのマトリクス組成物 |
JP2020523303A (ja) * | 2017-06-13 | 2020-08-06 | ザ・ユニバーシティ・オブ・ブリティッシュ・コロンビア | 薬物送達用のポリマーペースト組成物 |
JP7254719B2 (ja) | 2017-06-13 | 2023-04-10 | ザ・ユニバーシティ・オブ・ブリティッシュ・コロンビア | 薬物送達用のポリマーペースト組成物 |
Also Published As
Publication number | Publication date |
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CY1108685T1 (el) | 2014-04-09 |
CA2530136A1 (en) | 2005-01-13 |
AR044926A1 (es) | 2005-10-12 |
DE602004016995D1 (de) | 2008-11-20 |
CN1863557A (zh) | 2006-11-15 |
EP1635875B1 (en) | 2008-10-08 |
PL1635875T3 (pl) | 2009-03-31 |
EP1635875A2 (en) | 2006-03-22 |
US20050048123A1 (en) | 2005-03-03 |
WO2005002625A3 (en) | 2005-04-21 |
SI1635875T1 (sl) | 2009-04-30 |
CA2530136C (en) | 2012-10-16 |
JP5229768B2 (ja) | 2013-07-03 |
ATE410186T1 (de) | 2008-10-15 |
US20110165242A1 (en) | 2011-07-07 |
US20140336278A1 (en) | 2014-11-13 |
EP2044959A1 (en) | 2009-04-08 |
TWI377958B (en) | 2012-12-01 |
EP1635875B8 (en) | 2008-12-24 |
WO2005002625A2 (en) | 2005-01-13 |
PT1635875E (pt) | 2008-12-09 |
DK1635875T3 (da) | 2009-01-12 |
US20130101656A1 (en) | 2013-04-25 |
TW200514581A (en) | 2005-05-01 |
CN1863557B (zh) | 2010-06-16 |
ES2315680T3 (es) | 2009-04-01 |
CN101862455A (zh) | 2010-10-20 |
US9566336B2 (en) | 2017-02-14 |
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