JP2010285451A5 - - Google Patents
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- JP2010285451A5 JP2010285451A5 JP2010178286A JP2010178286A JP2010285451A5 JP 2010285451 A5 JP2010285451 A5 JP 2010285451A5 JP 2010178286 A JP2010178286 A JP 2010178286A JP 2010178286 A JP2010178286 A JP 2010178286A JP 2010285451 A5 JP2010285451 A5 JP 2010285451A5
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Claims (12)
- 向かい合った主面表面を有し、
(a) 少なくとも1種の有効薬剤の粒子と;
(b) 少なくとも1種の薬学的に許容される水崩壊性または水溶性賦形剤とを含む急速崩壊固体投与剤型であって、
(i)該投与剤型が、水性媒質と接触して約3分以内に崩壊または溶解し;
(ii) 該投与剤型が、約2%以下の脆砕性を有し;かつ(iii)投与剤型の主面表面の各々が二重凸形状を形成する、上記投与剤型。 - 前記投与剤型が、水性媒質と接触して、約2分以内、約1分以内、約45秒以内、約30秒以内、約20秒以内、約15秒以内、約10秒以内、並びに約5秒以内からなる群より選択される時間内に実質的に崩壊または溶解する、請求項1に記載の投与剤型。
- 脆砕性が約1%以下である、請求項1または2に記載の投与剤型。
- (a) 前記二重凸形状表面が、投与剤型直径の約100〜約400%の長軸カップ半径と、投与剤型直径の約5〜約50%の短軸カップ半径を有する;または
(b) 前記二重凸形状表面が、投与剤型直径の約240〜約290%の長軸カップ半径と、投与剤型直径の約16〜約28%の短軸カップ半径を有する、
請求項1〜3のいずれか1項に記載の投与剤型。 - (a) 前記少なくとも1種の有効薬剤の濃度が、約0.1%〜99.9%(w/w)、約5%〜約70%(w/w)、並びに約20%〜約50%(w/w)からなる群より選択される;および/または、
(b) 前記少なくとも1種の薬学的に許容される水崩壊性または水溶性賦形剤の濃度が、約99.9%〜約0.1%(w/w)、約95%〜約30%(w/w)、並びに約85%〜約60%(w/w)からなる群より選択される、
請求項1〜4のいずれか1項に記載の投与剤型。 - (a) 前記少なくとも1種の薬学的に許容される水崩壊性または水溶性賦形剤が、糖、糖アルコール、デンプン、天然ゴム、天然ポリマー、天然ポリマーの合成誘導体、合成ポリマー、及びこれらの混合物からなる群より選択される;または、
(b) 前記少なくとも1種の薬学的に許容される水崩壊性または水溶性賦形剤が、ラクトース、グルコース、マンノース、マンニトール、ソルビトール、キシリトール、エリトリトール、ラクチトール、マルチトール、コーンデンプン、ジャガイモデンプン、トウモロコシデンプン、ゼラチン、カラギーナン、アルギン酸塩、デキストラン、マルトデキストラン、アラビアゴム、キサンタンゴム、ポリエチレングリコール、ポリビニルピロリドン、ポリビニルアルコール、ポリオキシエチレンコポリマー、ポリオキシプロピレンコポリマー、ポリエチレンオキシド、及びこれらの混合物からなる群より選択される、
請求項1〜5のいずれか1項に記載の投与剤型:。 - (a) 有効薬剤の粒子が、コーティング剤でコーティングされている;または
(b) 有効薬剤の粒子が、コーティング剤でコーティングされ、前記コーティング剤が約5〜約60%(w/w)の量で存在する、
請求項1〜6のいずれかに記載の投与剤型。 - 前記少なくとも1種の有効薬剤が、
(a) 難溶性であり;
(b) 約2,000 nm以下の有効平均粒径を有し、
(c) 有効薬剤の粒子の表面に結合する少なくとも1種の表面安定剤を有する、
請求項1〜7のいずれか1項に記載の投与剤型。 - 前記表面安定剤が、非イオン表面安定剤、アニオン表面安定剤、カチオン表面安定剤、イオン性表面安定剤、および双性イオン表面安定剤からなる群より選択される、請求項8に記載の投与剤型。
- 前記少なくとも1種の有効薬剤が、タンパク質、ペプチド、栄養剤、カロチノイド、抗肥満薬、コルチコステロイド、エラスターゼ阻害剤、鎮痛薬、抗真菌薬、腫瘍治療薬、制吐薬、鎮痛薬、心臓血管薬、抗炎症薬、駆虫薬、抗不整脈薬、抗生物質、抗凝固薬、抗うつ薬、抗糖尿病薬、鎮痙薬、抗ヒスタミン薬、抗高血圧薬、抗ムスカリン薬、抗ミコバクテリウム薬、抗新生物薬、免疫抑制薬、抗甲状腺薬、抗ウイルス薬、抗不安鎮静薬、収れん薬、β-アドレナリン受容体遮断剤、血液産物および置換物、強心薬、造影剤、咳抑制薬、診断薬、診断用撮像剤、利尿薬、ドーパミン作用薬、止血薬、免疫薬、脂質調節薬、筋弛緩薬、副交感神経刺激作用薬、上皮小体カルシトニンおよびビホスホネート、プロスタグランジン、放射性薬品、性ホルモン、抗アレルギー薬、興奮薬および食欲抑制薬、交感神経刺激作用薬、甲状腺薬、血管拡張薬、キサンチン、ニキビ治療薬、α-ヒドロキシ製剤、嚢胞性繊維症治療薬、喘息治療薬、気腫治療薬、呼吸窮迫症候群治療薬、慢性気管支炎治療薬、慢性閉塞性肺疾患治療薬、器官移植拒絶治療薬、結核症およびその他の肺感染症の治療薬、並びに後天性免疫不全症候群に関連する呼吸疾患治療薬からなる群より選択される、請求項1〜9のいずれか1項に記載の投与剤型。
- 薬剤の調製のための、請求項1〜10のいずれかに記載の投与剤型の使用。
- (a) 少なくとも1種の有効薬剤の粒子と少なくとも1種の薬学的に許容される水崩壊性または水溶性賦形剤とを含む組成物を用意し、
(b) 固体投与剤型を形成する
工程を含む、請求項1〜10のいずれかに記載の急速崩壊固体投与剤型を製造する方法であって、
該投与剤型が、(i) 水性媒質と接触して約3分以内に実質的に崩壊または溶解し;(ii) 約2%以下の脆砕性を有し;かつ(iii) 上記投与剤型が、各々二重凸形状を形成する、向かい合った主面表面を備える、上記方法。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US36552602P | 2002-03-20 | 2002-03-20 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2003577853A Division JP2005526095A (ja) | 2002-03-20 | 2003-03-20 | 脆砕性の低い急速溶解投与剤型 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2010285451A JP2010285451A (ja) | 2010-12-24 |
JP2010285451A5 true JP2010285451A5 (ja) | 2011-11-04 |
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Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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JP2003577853A Withdrawn JP2005526095A (ja) | 2002-03-20 | 2003-03-20 | 脆砕性の低い急速溶解投与剤型 |
JP2010178286A Pending JP2010285451A (ja) | 2002-03-20 | 2010-08-09 | 脆砕性の低い急速溶解投与剤型 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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JP2003577853A Withdrawn JP2005526095A (ja) | 2002-03-20 | 2003-03-20 | 脆砕性の低い急速溶解投与剤型 |
Country Status (6)
Country | Link |
---|---|
US (1) | US20030215502A1 (ja) |
EP (1) | EP1487419A2 (ja) |
JP (2) | JP2005526095A (ja) |
AU (1) | AU2003222027A1 (ja) |
CA (1) | CA2479735C (ja) |
WO (1) | WO2003080023A2 (ja) |
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-
2003
- 2003-03-20 JP JP2003577853A patent/JP2005526095A/ja not_active Withdrawn
- 2003-03-20 US US10/392,383 patent/US20030215502A1/en not_active Abandoned
- 2003-03-20 CA CA2479735A patent/CA2479735C/en not_active Expired - Fee Related
- 2003-03-20 EP EP03718010A patent/EP1487419A2/en not_active Withdrawn
- 2003-03-20 WO PCT/US2003/008544 patent/WO2003080023A2/en active Application Filing
- 2003-03-20 AU AU2003222027A patent/AU2003222027A1/en not_active Abandoned
-
2010
- 2010-08-09 JP JP2010178286A patent/JP2010285451A/ja active Pending
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