JPH11500127A - 保護被膜を有する再分散性超微粒状フィルムマトリックス - Google Patents
保護被膜を有する再分散性超微粒状フィルムマトリックスInfo
- Publication number
- JPH11500127A JPH11500127A JP8525046A JP52504696A JPH11500127A JP H11500127 A JPH11500127 A JP H11500127A JP 8525046 A JP8525046 A JP 8525046A JP 52504696 A JP52504696 A JP 52504696A JP H11500127 A JPH11500127 A JP H11500127A
- Authority
- JP
- Japan
- Prior art keywords
- drug
- film
- composition
- matrix
- weight
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- 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
- A61K9/1676—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 having a drug-free core with discrete complete coating layer containing drug
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
Landscapes
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Paints Or Removers (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.立体安定剤及びフィルム分散剤により会合される、低溶解性薬物の超微粒 子を含んで成る医薬フィルムマトリックスであって、前記フィルムの溶解が前記 薬物超微粒子の実質的な再分散をもたらすことを特徴とするマトリックス。 2.前記低溶解性薬物が、周囲温度で、約500 〜1,000,000 重量部超の媒体に おける1重量部未満の薬物の水における溶解性を有する請求の範囲第1項記載の マトリックス。 3.前記薬物が、鎮痛剤、抗炎症剤、駆虫薬、抗不整脈薬、抗生物物質、抗凝 固剤、抗うつ剤、抗糖尿病剤、抗てんかん薬、抗ヒスタミン、抗高血圧薬、抗ム スカリン剤、抗マイコバクテリア剤、抗腫瘍剤、免疫抑制剤、抗甲状腺薬、抗ウ ィルス剤、不安緩和性鎮静薬、収れん薬、β−アドレナリン受容体遮断薬、心筋 変力作用剤、造影剤、コルチコステロイド、咳抑制剤、診断剤、診断用イメージ ング剤、利尿剤、ドパミン作用剤、血止め薬、脂質調整剤、筋肉弛緩薬、副交感 神経作用薬、甲状腺カルシトニン及びビホスホネート、プロスタグラジン、放射 性医薬、性ホルモン、抗アレルギー薬、刺激剤、食欲抑制剤、交感神経作用薬、 甲状腺剤、血管拡張剤、及びキサンテンから成る群から選択される請求の範囲第 2項記載のマトリックス。 4.前記薬物がダナゾーム、ナプロキセン又はシクロスポリンである請求の範 囲第3項記載のマトリックス。 5.前記立体安定剤が、立体安定化性質を有する、親水性又は両梁性化合物で ある請求の範囲第1項記載のマトリックス。 6.前記立体安定剤が、ゼラチン、カゼイン、レシチン、アラビアゴム、コレ ステロール、トラガカント、ソルビタンエステル、ポ リオキシエチレンアルオルエステル、ポリオキシエチレンヒマシ油誘導体、ポリ オキシエチレン、ソルビタン脂肪酸エステル、ポリエチレングリコール、ポリオ キシエチレンステアレート、カルボキシメチルセルロースカルシウム、カルボキ シメチルセルロースナトリウム、メチルセルロース、ヒドロキシエチルセルロー ス、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、フ タレート、非結晶性セルロース、ポリビニルアルコール及びポリビニルピロリド ンから成る群から選択される請求の範囲第5項記載のマトリックス。 7.前記立体安定剤がポリビニルピロリドンである請求の範囲第6項記載のマ トリックス。 8.前記フィルム分散剤が、前記超微粒子の表面により会合される水溶性化合 物である請求の範囲第1項記載のマトリックス。 9.前記フィルム分散剤が、マンニトール、ラウリル硫酸ナトリウム、単糖類 及び二糖類から成る群から選択される請求の範囲第8項記載のマトリックス。 10.前記フィルム分散剤がラウリル硫酸ナトリウムである請求の範囲第9項記 載のマトリックス。 11.前記マトリックスが前記薬物の重量に基づいて、約0.1 〜約60重量%の立 体安定剤及びまた、0.05〜約60重量%のフィルム分散剤を含んで成る請求の範囲 第1項記載のマトリックス。 12.立体安定剤及びフィルム分散剤により会合される、低溶解性薬物の超微粒 子を含んで成るフィルムを、その表面上に有する担体粒子を含んで成る医薬組成 物であって、前記フィルムの溶解が前記薬物超微粒子の実質的な再分散をもたら すことを特徴とする医薬組成物。 13.前記フィルムが前記組成物の約1〜1200重量%を含む請求の 範囲第12項記載の組成物。 14.前記フィルムが、前記薬物の重量に基づいて、約0.1 〜約60重量%の立体 安定剤及び約0.5 〜約60重量%のフィルム分散剤を含んで成る請求の範囲第13項 記載の組成物。 15.前記担体粒子が、糖球体、マルトデキストリン、微結晶性セルロース、微 結晶セルロース/ナトリウムカルボキシメチルセルロース、粒状デキストロース 、リン酸二カルシウム、リン酸三カルシウム、単糖類及び二糖類から成る群から 選択される請求の範囲第12項記載の組成物。 16.前記担体粒子が、糖球体(40〜45メッシュ、30〜35メッシュ、20〜25メッ シュ、18〜20メッシュ、16〜18メッシュ)、マルトデキストリン、デキストロー ス、Avicel マンニトール、ラクトース、及びリン酸二カルシウムから成る群か ら選択される請求の範囲第15項記載の組成物。 17.前記担体粒子が、20〜25メッシュを有する糖球体を含んで成る請求の範囲 第16項記載の組成物。 18.立体安定化剤及びフィルム分散剤により会合される、低溶解性薬物の超微 粒子を含んで成るフィルムを、その表面上に有する担体粒子、ここで前記フィル ムの溶解が前記薬物超微粒子の実質的な再分散をもたらし、及びPVP/PEG を含ん で成る前記フィルム上に適用される被膜を含んで成る医薬組成物。 19.前記低溶解性薬物が、周囲温度で、約500 〜1,000,000 重量部超の媒体に おける1重量部未満の薬物の水における溶解性を有する請求の範囲第18項記載の 組成物。 20.前記薬物が、鎮痛剤、抗炎症剤、駆虫薬、抗不整脈薬、抗生物質、抗凝固 剤、抗うつ剤、抗糖尿病剤、抗てんかん薬、抗ヒスタミン、抗高血圧薬、抗ムス カリン剤、抗マイコバクテリア剤、抗腫 瘍剤、免疫抑制剤、抗甲状腺薬、抗ウィルス剤、不安緩和性鎮静薬、収れん薬、 β−アドレナリン受容体遮断薬、心筋変力作用剤、造影剤、コルチコステロイド 、咳抑制剤、診断剤、診断用イメージング剤、利尿剤、ドパミン作用剤、血止め 薬、脂質調整剤、筋肉弛緩薬、副交感神経作用薬、甲状腺カルシトニン及びビホ スホネート、プロスタグラジン、放射性医薬、性ホルモン、抗アレルギー薬、刺 激剤、食欲抑制剤、交感神経作用薬、甲状腺剤、血管拡張剤、及びキサンテンか ら成る群から選択される請求の範囲第18項記載の組成物。 21.前記薬物がダナゾール、ナプロキセン又はシクロスポリンである請求の範 囲第18項記載の組成物。 22.前記立体安定剤が、立体安定化性質を有する、親水性又は両染性化合物で ある請求の範囲第18項記載の組成物。 23.前記立体安定剤が、ゼラチン、カゼイン、レシチン、アラビアゴム、コレ ステロール、トラガカント、ソルビタンエステル、ポリオキシエチレンアルキル エステル、ポリオキシエチレンヒマシ油誘導体、ポリオキシエチレン、ソルビタ ン脂肪酸エステル、ポリエチレングリコール、ポリオキシエチレンステアレート 、カルボキシメチルセルロースカルシウム、カルボキシメチルセルロースナトリ ウム、メチルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルセ ルロース、ヒドロキシプロピルメチルセルロース、フタレート、非結晶性セルロ ース、ポリビニルアルコール及びポリビニルピロリドンから成る群から選択され る請求の範囲第18項記載の組成物。 24.前記立体安定剤がポリビニルピロリドンである請求の範囲第18項記載の組 成物。 25.前記フィルム分散剤が、前記超微粒子の表面により会合され る水溶性化合物である請求の範囲18項記載の組成物。 26.前記フィルム分散剤が、マンニトール、ラウリル硫酸ナトリウム、単糖類 及び二糖類から成る群から選択される請求の範囲第18項記載の組成物。 27.前記フィルム分散剤がラウリル硫酸ナトリウムである請求の範囲第18項記 載の組成物。 28.前記マトリックスが前記薬物の重量に基づいて、約0.1 〜約60重量%の立 体安定剤及びまた、0.05〜約60重量%のフィルム分散剤を含んで成る請求の範囲 第18項記載の組成物。 29.哺乳類を治療するための方法であって、請求の範囲第18項記載の医薬組成 物の有効量を前記哺乳類に投与するステップを含んで成る方法。 30.前記フィルムマトリックスがPVP/PEG により被覆される請求の範囲第29項 記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/387,651 US5573783A (en) | 1995-02-13 | 1995-02-13 | Redispersible nanoparticulate film matrices with protective overcoats |
US08/387,651 | 1995-02-13 | ||
PCT/US1996/001845 WO1996025150A1 (en) | 1995-02-13 | 1996-02-09 | Redispersible nanoparticulate film matrices with protective overcoats |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007025659A Division JP2007112816A (ja) | 1995-02-13 | 2007-02-05 | 保護被膜を有する再分散性超微粒状フィルムマトリックス |
Publications (1)
Publication Number | Publication Date |
---|---|
JPH11500127A true JPH11500127A (ja) | 1999-01-06 |
Family
ID=23530812
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP8525046A Ceased JPH11500127A (ja) | 1995-02-13 | 1996-02-09 | 保護被膜を有する再分散性超微粒状フィルムマトリックス |
JP2007025659A Withdrawn JP2007112816A (ja) | 1995-02-13 | 2007-02-05 | 保護被膜を有する再分散性超微粒状フィルムマトリックス |
JP2010145720A Withdrawn JP2010241820A (ja) | 1995-02-13 | 2010-06-28 | 保護被膜を有する再分散性超微粒状フィルムマトリックス |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007025659A Withdrawn JP2007112816A (ja) | 1995-02-13 | 2007-02-05 | 保護被膜を有する再分散性超微粒状フィルムマトリックス |
JP2010145720A Withdrawn JP2010241820A (ja) | 1995-02-13 | 2010-06-28 | 保護被膜を有する再分散性超微粒状フィルムマトリックス |
Country Status (8)
Country | Link |
---|---|
US (1) | US5573783A (ja) |
EP (1) | EP0812187B1 (ja) |
JP (3) | JPH11500127A (ja) |
AT (1) | ATE238770T1 (ja) |
AU (1) | AU4866996A (ja) |
CA (1) | CA2212803C (ja) |
DE (1) | DE69627835T2 (ja) |
WO (1) | WO1996025150A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2011526598A (ja) * | 2008-07-02 | 2011-10-13 | ビーエーエスエフ ソシエタス・ヨーロピア | 錠剤のコーティング方法 |
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DE69627835D1 (de) | 2003-06-05 |
JP2010241820A (ja) | 2010-10-28 |
CA2212803A1 (en) | 1996-08-22 |
ATE238770T1 (de) | 2003-05-15 |
AU4866996A (en) | 1996-09-04 |
WO1996025150A1 (en) | 1996-08-22 |
EP0812187B1 (en) | 2003-05-02 |
CA2212803C (en) | 2003-10-07 |
US5573783A (en) | 1996-11-12 |
EP0812187A1 (en) | 1997-12-17 |
JP2007112816A (ja) | 2007-05-10 |
DE69627835T2 (de) | 2004-02-19 |
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