JP2006508052A - 筋肉及び骨障害治療用薬を含有する口腔内極性及び非極性噴霧剤又はカプセル剤 - Google Patents
筋肉及び骨障害治療用薬を含有する口腔内極性及び非極性噴霧剤又はカプセル剤 Download PDFInfo
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Abstract
Description
本出願は、1997年10月1日に出願されたPCT/US97/17899の米国国際段階指定の一部継続である2000年3月29日に出願された第09/537,118号の一部継続であり、その開示を参照により全部取り入れる。
ある種の生物活性化合物は、粘膜を通る方が胃又は腸を通るなどの他の投与経路を通るより良好に吸収される。しかしながら、これらの後者の経路によるそのような投与に好適な製剤は、自身の問題を有する。例えば、生物活性化合物は、噴射剤や溶媒などの他の組成物成分と適合しなければならない。そのような製剤が多数提案されている。例えば、Dvorskyらによる米国特許第4,689,233号は、ポリエーテルアルコールの混合物に溶解した抗冠状動脈薬(anti-coronary drug)であるニフェジピン投与用の軟ゼラチンカプセル剤を記載し、Jonesらの米国特許第4,755,389号は、ニフェジピンを含有する硬ゼラチン咀嚼カプセル剤を記載している。薬物の溶液又は分散液を含有する咀嚼ゼラチンカプセル剤は、Borkanらの米国特許第4,935,243号、Aoudaらによる米国特許第4,919,919号に記載され、Klokkers-Bethkeによる米国特許第5,370,862号は、ニトログリセリン、エタノール、及びその他の成分を含有する口腔粘膜投与用のニトログリセリン噴霧剤を記載する。経口投与されるポンプ式噴霧剤は、Cholchaによる米国特許第5,186,925号に記載されている。炭化水素噴射剤及び粘膜表面への投与用薬物を含有するエアゾール組成物は、Suによる英国特許第2,082,457号、Silsonらによる米国特許第3,155,574号、Wangらによる米国特許第5,011,678号、及びParnellによる米国特許第5,128,132号に記載されている。これらの参照は、投与される膜を通るのではなく吸入による溶液の生物利用可能性を論じていることは注目すべきである。
効果の早期開始をもたらす口腔粘膜を通る速やかな吸収のための生物活性化合物を提供する極性又は非極性溶媒を用いた口腔内エアゾール噴霧剤又は軟バイトゼラチンカプセル剤(soft bite gelatin capsules)を開発した。
好ましい本発明の活性化合物は、イオン化された塩の形態であるか、薬学的に許容できる塩の遊離塩基としてである(但し、エアゾール又はポンプ式噴霧組成物では、それらは噴霧溶媒に可溶である)。これらの化合物は、有用な濃度で本発明の非極性溶媒に可溶であるか、有用な濃度でペーストとして調製することができる。口腔粘膜を通る化合物の吸収は増大するので、これらの濃度は、これらの化合物に対する標準的な容認されている用量未満であることができる。本発明のこの態様は、大きな(40〜99.99%)初回通過効果があるときに特に重要である。
CNS活性アミン及びその塩:三環式アミン、GABAアナログ、チアジド、フェノチアジン誘導体、セロトニンアンタゴニスト、及びセロトニン再取込み阻害剤を含むが、限定するものではない
Claims (11)
- 抗筋けいれん剤、筋肉弛緩剤、及びその混合物から成る群から選択され、全組成物の0.001〜60重量パーセントの間の量の活性化合物;及び全組成物の30〜99重量パーセントの間の量の極性溶媒を含有する、薬理活性化合物の経粘膜投与用の無噴射剤口腔内噴霧組成物。
- 抗筋けいれん剤、筋肉弛緩剤、及びそれらの混合物から成る群から選択され、全組成物の0.1〜25重量パーセントの間の量の活性化合物;全組成物の10及び97重量パーセントの間の量の極性溶媒;及び直鎖状又は分枝状立体配置のC3〜C8炭化水素であって、組成物の2及び10重量パーセントの間の量の噴射剤、を含有する、薬理活性化合物の経粘膜投与用の口腔内噴霧組成物。
- 抗筋けいれん剤、筋肉弛緩剤、及びその混合物から成る群から選択され、全組成物の0.005〜55重量パーセントの間の量の活性化合物;及び全組成物の30〜99重量パーセントの間の量の非極性溶媒を含有する、薬理活性化合物の経粘膜投与用の無噴射剤口腔内噴霧組成物。
- 抗筋けいれん剤、筋肉弛緩剤、及びそれらの混合物から成る群から選択され、全組成物の0.05〜50重量パーセントの間の量の活性化合物;全組成物の19〜85重量パーセントの間の量の非極性溶媒;及び直鎖状又は分枝状立体配置のC3〜C8炭化水素であって、組成物の5〜80重量パーセントの間の量の噴射剤、を含有する、薬理活性化合物の経粘膜投与用の口腔内噴霧組成物。
- 抗筋けいれん剤、筋肉弛緩剤、及びそれらの混合物から成る群から選択され、全組成物の0.01〜40重量パーセントの間の量の活性化合物;全組成物の25〜89重量パーセントの間の量の非極性溶媒;直鎖状又は分枝状立体配置のC3〜C8炭化水素であって、組成物の10〜70重量パーセントの間の量の噴射剤を含有し、香味剤が全組成物の1〜8重量パーセントの間の量で存在する、薬理活性化合物の経粘膜投与用の口腔内噴霧組成物。
- さらに、全組成物の0.1〜10重量パーセントの間の量の香味剤を含有する請求項1〜4項のいずれか1項に記載の組成物。
- 前記極性溶媒が、400〜1000の間の分子量を有するポリエチレングリコール、C2〜C8モノアルコール及びポリアルコール、及び直鎖状又は分枝状立体配置のC7〜C18アルコールから成る群から選択される請求項1又は2に記載の組成物。
- 前記噴射剤が、プロパン、N−ブタン、イソ−ブタン、N−ペンタン、イソ−ペンタン、ネオ−ペンタン、及びそれらの混合物から成る群から選択される請求項2、4又は5のいずれか1項に記載の組成物。
- 前記溶媒が、(C2〜C24)脂肪酸(C2〜C6)エステル、直鎖状又は分枝状立体配置のC7〜C18炭化水素、C2〜C6アルカノイルエステル、及びC2〜C6カルボン酸のトリグリセリドから成る群から選択される請求項3〜5のいずれか1項に記載の組成物。
- 前記活性化合物が、バクロフェン、ボツリヌス毒素、カリソプロドール、クロルフェネシン、クロロゾキサゾン、シクロベンザプリン、ダントロレン、ジアゼパム、メタキサロン、メトカルバモール、オルフェナドリン、チザニジンからなる群から選択される抗筋肉けいれん剤、又は、バクロフェン、カリソプロドール、クロルフェネシン、クロロゾキサゾン、シクロベンザプリン、ダントロレン、ジアゼパム、メタキサロン、メトカルバモール、オルフェナドリンからなる群から選択される筋肉弛緩剤である請求項1〜5のいずれか1項に記載の組成物。
- 哺乳類の口腔粘膜へ薬剤的活性物質を噴霧することからなる先行するいずれか1項に記載の組成物の使用方法。
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US10/230,086 US20030095927A1 (en) | 1997-10-01 | 2002-08-29 | Buccal, polar and non-polar spray or capsule containing drugs for treating muscular and skeletal disorders |
PCT/US2003/026858 WO2004019905A1 (en) | 2002-08-29 | 2003-08-27 | Buccal, polar and non-polar spray or capsule containing drugs for treating muscular and skeletal disorders |
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US20050180923A1 (en) * | 1997-10-01 | 2005-08-18 | Dugger Harry A.Iii | Buccal, polar and non-polar spray containing testosterone |
US20030095926A1 (en) * | 1997-10-01 | 2003-05-22 | Dugger Harry A. | Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the gastrointestinal tract or urinary tract |
US20030095925A1 (en) * | 1997-10-01 | 2003-05-22 | Dugger Harry A. | Buccal, polar and non-polar spray or capsule containing drugs for treating metabolic disorders |
US20030077228A1 (en) * | 1997-10-01 | 2003-04-24 | Dugger Harry A. | Buccal, polar and non-polar spray or capsule containing drugs for treating endocrine disorders |
US7632517B2 (en) * | 1997-10-01 | 2009-12-15 | Novadel Pharma Inc. | Buccal, polar and non-polar spray containing zolpidem |
US20050281752A1 (en) * | 1997-10-01 | 2005-12-22 | Dugger Harry A Iii | Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system |
US6212227B1 (en) * | 1997-12-02 | 2001-04-03 | Conexant Systems, Inc. | Constant envelope modulation for splitterless DSL transmission |
US6375975B1 (en) * | 1998-12-21 | 2002-04-23 | Generex Pharmaceuticals Incorporated | Pharmaceutical compositions for buccal and pulmonary application |
CO5271697A1 (es) * | 2000-01-12 | 2003-04-30 | Pfizer Prod Inc | Composiciones y procedimientos para el tratamiento de afecciones que responden a un aumento de testosterona |
ATE353629T1 (de) * | 2000-03-09 | 2007-03-15 | Gw Pharma Ltd | Cannabis enthaltende pharmazeutische zusammensetzungen |
AU4866001A (en) * | 2000-03-28 | 2001-10-08 | Farmarc Nederland Bv | Alprazolam inclusion complexes and pharmaceutical compositions thereof |
EP1343521A2 (en) * | 2000-12-01 | 2003-09-17 | Battelle Memorial Institute | Method for the stabilizing biomolecules (e.g. insulin) in liquid formulations |
-
2002
- 2002-08-29 US US10/230,086 patent/US20030095927A1/en not_active Abandoned
-
2003
- 2003-08-27 JP JP2004531574A patent/JP2006508052A/ja active Pending
- 2003-08-27 CA CA002497121A patent/CA2497121A1/en not_active Abandoned
- 2003-08-27 AU AU2003270018A patent/AU2003270018A1/en not_active Abandoned
- 2003-08-27 NZ NZ539280A patent/NZ539280A/en not_active IP Right Cessation
- 2003-08-27 WO PCT/US2003/026858 patent/WO2004019905A1/en active Application Filing
- 2003-08-27 EP EP03751912A patent/EP1534236A1/en not_active Withdrawn
-
2004
- 2004-08-27 US US10/928,997 patent/US20050025717A1/en not_active Abandoned
Patent Citations (4)
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WO1993015724A1 (en) * | 1992-02-18 | 1993-08-19 | Nippon Shinyaku Co., Ltd. | Fast soluble tablet |
JP2000510841A (ja) * | 1996-05-14 | 2000-08-22 | バイオゾーン ラボラトリーズ,インコーポレイテッド | 口への投与のためのリポソーム処方物での生物学的活性物質の送達 |
JP2001517689A (ja) * | 1997-10-01 | 2001-10-09 | フレミントン ファーマシューティカル コーポレイション | 極性または非極性の、バッカルスプレーまたはカプセル |
JP2002531393A (ja) * | 1998-12-01 | 2002-09-24 | コントロールド セラピューティックス (スコットランド) リミテッド | 口内経粘膜投与材 |
Also Published As
Publication number | Publication date |
---|---|
US20050025717A1 (en) | 2005-02-03 |
EP1534236A1 (en) | 2005-06-01 |
NZ539280A (en) | 2007-12-21 |
WO2004019905A1 (en) | 2004-03-11 |
AU2003270018A1 (en) | 2004-03-19 |
CA2497121A1 (en) | 2004-03-11 |
US20030095927A1 (en) | 2003-05-22 |
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