JP2014012712A - 小分子薬の持続放出製剤 - Google Patents
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Abstract
【解決手段】生体適合性ポリマー、生体適合性ポリマーに配合されて粘性ゲルを形成している有機溶媒、および粘性ゲルに組み込まれた小分子薬を含んでいる注入可能なデポ製剤であって、Cmax対Cmin比が200未満、かつラグタイムが0.2未満のin vivo放出プロファイルを示す製剤。
【選択図】図4
Description
Claims (20)
- 生体適合性ポリマー、生体適合性ポリマーに配合されて粘性ゲルを形成している有機溶媒、および粘性ゲルに組み込まれた小分子薬を含んでいる注入可能なデポ製剤であって、Cmax対Cmin比が200未満、かつラグタイムが0.2未満のin vivo放出プロファイルを示す製剤。
- in vivo放出プロファイルのCmax対Cmin比が30未満である、請求項1に記載の製剤。
- 小分子薬が水に難溶性である、請求項1に記載の製剤。
- 小分子の水への溶解度が1 mg/ml未満である、請求項1に記載の製剤。
- ポリマーがポリラクチドである、請求項1に記載の製剤。
- ポリマーの乳酸対グリコール酸のモノマー比が100:0〜15:85の範囲である、請求項5に記載の製剤。
- ポリマーが以下からなる群から選択される、請求項1に記載の製剤: ポリラクチド、ポリグリコリド、ポリカプロラクトン、ポリ無水物、ポリアミン、ポリウレタン、ポリエステルアミド、ポリオルトエステル、ポリジオキサノン、ポリアセタール、ポリケタール、ポリカルボナート、ポリオルトカルボナート、ポリホスファゼン、コハク酸、ポリ(リンゴ酸)、ポリ(アミノ酸)、ポリビニルピロリドン、ポリエチレングリコール、ポリヒドロキシセルロース、多糖類、キチン、キトサン、ならびにこれらのコポリマー、ターポリマーおよび混合物。
- 溶媒が以下からなる群から選択される、請求項1に記載の製剤: ベンジルアルコール、安息香酸ベンジル、安息香酸エチル、エタノール、トリアセチン、N-メチル-2-ピロリドン、およびこれらの混合物。
- 小分子薬が抗精神病薬を含んでいる、請求項1に記載の製剤。
- 小分子薬が以下からなる群から選択される、請求項1に記載の製剤: ドーパミン受容体作動薬、ドーパミン受容体拮抗薬、セロトニン受容体作動薬、セロトニン受容体拮抗薬、セロトニン取り込み阻害薬、およびこれらの組み合わせ。
- 小分子薬がR209130およびリスペリドンの塩基ならびに塩形態からなる群から選択される、請求項1に記載の製剤。
- 小分子薬の分子量が200〜2,000ダルトンの範囲である、請求項1に記載の製剤。
- 溶媒の水との混和性が7重量%未満である、請求項1に記載の製剤。
- 小分子薬が、平均粒子サイズが0.1〜125μmの範囲の粒子形態である、請求項1に記載の製剤。
- 少なくとも1週間にわたって目標の速度または目標に近い速度で小分子薬を放出する、請求項1に記載の製剤。
- 1ヶ月にわたって目標の速度または目標に近い速度で小分子薬を放出する、請求項1に記載の製剤。
- 生体適合性ポリマー、生体適合性ポリマーに配合されて粘性ゲルを形成している有機溶媒、および粘性ゲルに組み込まれた小分子薬を含んでいる、Cmax対Cmin比が200未満、かつラグタイムが0.2未満のin vivo放出プロファイルを示す注入可能なデポ製剤の有効量を被験体にインプラントすることを含む、被験体に小分子薬を制御された様相で投与する方法。
- 小分子薬が放出期間にわたって制御された様相で全身に送達される、請求項17に記載の方法。
- 放出期間が少なくとも1週間である、請求項17に記載の方法。
- 小分子薬が抗精神病薬を含んでいる、請求項17に記載の方法。
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US72284505P | 2005-09-30 | 2005-09-30 | |
US60/722,845 | 2005-09-30 |
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JP2008533726A Division JP2009510116A (ja) | 2005-09-30 | 2006-09-28 | 小分子薬の持続放出製剤 |
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JP2014012712A true JP2014012712A (ja) | 2014-01-23 |
JP5934685B2 JP5934685B2 (ja) | 2016-06-15 |
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JP2008533726A Pending JP2009510116A (ja) | 2005-09-30 | 2006-09-28 | 小分子薬の持続放出製剤 |
JP2013183886A Expired - Fee Related JP5934685B2 (ja) | 2005-09-30 | 2013-09-05 | 小分子薬の持続放出製剤 |
JP2015241816A Expired - Fee Related JP6216364B2 (ja) | 2005-09-30 | 2015-12-11 | 小分子薬の持続放出製剤 |
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US (6) | US8852638B2 (ja) |
EP (2) | EP2361609B1 (ja) |
JP (3) | JP2009510116A (ja) |
CN (1) | CN101365423B (ja) |
AR (1) | AR056554A1 (ja) |
AT (1) | ATE551989T1 (ja) |
AU (1) | AU2006299657B2 (ja) |
CA (1) | CA2624088C (ja) |
DK (2) | DK1940351T3 (ja) |
ES (2) | ES2385384T3 (ja) |
IL (1) | IL190499A (ja) |
PL (1) | PL2361609T3 (ja) |
TW (1) | TW200803920A (ja) |
WO (1) | WO2007041410A2 (ja) |
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