JP2009102405A - 乱用防止制御放出オピオイド投薬形態 - Google Patents
乱用防止制御放出オピオイド投薬形態 Download PDFInfo
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Abstract
【解決手段】組み合わせ物が破壊されて、制御放出特性が崩壊し、オピオイドおよびオピオイドアンタゴニストが、1用量として、即時的放出産物として放出されるのを引き起こす場合にオピオイドの陶酔効果を抑制するのに必要とされるよりも高いレベルで、オピオイドアンタゴニスト(例えば、ナロキソン)を組み合わせて含む乱用防止制御放出オピオイド錠剤。錠剤の制御放出の性質は、通常に摂取した場合に、経口での有効量のオピオイドアンタゴニストの蓄積を防ぐ。このオピオイドアンタゴニストは、制御放出マトリクス中に含有され、そして経時的にオピオイドと共に放出される。
【選択図】なし
Description
本発明は、制御放出される鎮痛性薬学的処方物に関する。より詳細には、本発明は、乱用を抑止する制御放出された鎮痛性錠剤に関する。
オピオイド化合物は、長い間、それらの強力な鎮痛特性と、それらの乱用についての高い可能性との両方について知られてきた。疼痛の制御には非常に効果的であるが、オピオイドはまた、依存性でもあり得る。オピオイド(特に、ヘロインだが、モルフィン、コデイン、オキシコドン、ヒドロモルフォン、オキシモルフォンなども含む)の乱用は、現代社会における問題である。オピオイド常用者は、種々の違法な供給源から薬物を得ることができる。これらのストリートドラッグは、疑わしい品質のものである。従って、潜在的乱用者にとって、処方された薬学的オピオイドは、特に、それらの高い純度および信頼性の有る投薬量に起因して、薬物供給源として魅力的であり得る。
乱用防止制御放出オピオイド錠剤は、高い経口:非経口の効力比(すなわち経口:非経口>1)を有するオピオイドアンタゴニスト(例えば、ナロキソン)を、長期にわたり投与された制御放出処方物においては、オピオイドの効果をブロックするのにも、オピオイドの副作用を弱めるのにも不充分なレベルであるが、全てを一度に投与された場合、そのオピオイドの陶酔効果を抑制するのに必要とされるより高いレベルで含む、組み合わせである。組み合わせ錠剤が破壊されて、制御放出特性が崩壊した場合、オピオイドおよびオピオイドアンタゴニストは、1用量の即時放出産物として放出され、そしてこのアンタゴニストは、このアゴニストの陶酔効果をブロックする。このオピオイドアンタゴニストは、制御放出マトリクス中に含まれ、そして経時的に、このオピオイドアゴニストと共に放出される。
上記に加えて、本発明は、以下の手段を提供する:
(項目1)
経口用薬学的組成物であって、該薬学的組成物は、以下:
制御放出マトリクス;
オピオイドアゴニスト;
オピオイドアンタゴニスト、
を含み、
該オピオイドアンタゴニストは、非経口投与されたときに、経口投与されたときより高い拮抗効果を有し;
ここで、該オピオイドアンタゴニストは、該制御放出マトリクスが破壊されて、該組成物が即時放出のために不適切に投与された場合に、オピオイドの効果をブロックし、そして/または使用中止を誘導するのに、有効な経口量で該組成物中に存在し;
ここで、アンタゴニストレベルが、適切な経口投与レジメの下では、阻害性レセプターおよび興奮性レセプターの両方をブロックすることによりオピオイドの効果をブロックするにも、該興奮性レセプターを選択的にブロックすることによりオピオイドの副作用を弱めるにも有効でないように、該制御放出マトリクスが、該オピオイドアンタゴニストの放出速度を制御するように選択され、そして組み込まれている、経口用薬学的組成物。
(項目2)
前記オピオイドアンタゴニストの放出速度が、前記オピオイドアゴニストの放出速度の約100%〜約25%である、項目1に記載の薬学的組成物。
(項目3)
前記オピオイドアンタゴニストの放出速度が、前記オピオイドアゴニストの放出速度の約100%である、項目1に記載の薬学的組成物。
(項目4)
前記オピオイドアンタゴニストの放出速度が、前記オピオイドアゴニストの放出速度の約50%である、項目1に記載の薬学的組成物。
(項目5)
前記オピオイドアンタゴニストの放出速度が、前記オピオイドアゴニストの放出速度の約25%である、項目1に記載の薬学的組成物。
(項目6)
前記オピオイドアンタゴニストの経口:非経口の効力比が、少なくとも約10:1である、項目1に記載の薬学的組成物。
(項目7)
前記オピオイドアンタゴニストの経口:非経口の効力比が、少なくとも約25:1である、項目1に記載の薬学的組成物。
(項目8)
前記オピオイドアンタゴニストの経口:非経口の効力比が、少なくとも約100:1である、項目1に記載の薬学的組成物。
(項目9)
項目1に記載の薬学的組成物であって、前記オピオイドアゴニストが、モルフィン、オキシコドン、レボルフェノール、メペルジン、ヒドロコドン、コデイン、ジヒドロコデイン、ヒドロモルフォン、プロポキシフォン、メタドン、およびオキシモルフォンからなる群より選択される、薬学的組成物。
(項目10)
項目1に記載の薬学的組成物であって、前記オピオイドアンタゴニストが、ナロキソン;ナルトレキソン;N−シクロプロピルメチル−7,8−ジヒドロ−14−ヒドロキシノルモルフィノン;および21−シクロプロピルz,−(1−ヒドロキシ−1−メチルエチル)−6,14−エンド−エタノ−テトラヒドロオリパビン(またはジフェノルフィン)およびそれらの薬学的に受容可能な塩からなる群より選択される、薬学的組成物。
(項目11)
前記オピオイドアンタゴニストが、ナロキソンである、項目1に記載の薬学的組成物。
(項目12)
前記オピオイドアゴニストが、オキシコドンである、項目1に記載の薬学的組成物。
(項目13)
前記オピオイドアゴニストが、約10mg〜160mgのオキシコドン用量と薬学的に等価な濃度で存在する、項目1に記載の薬学的組成物。
(項目14)
項目1に記載の薬学的組成物であって、前記アンタゴニストの前記放出速度が、1用量の該組成物では、経口有効量のアンタゴニストを利用可能にしないが、2以上の用量の該組成物が、破壊されてかまたは破壊されずに組み合わせられて、乱用用量の前記オピオイドアゴニストを達成する場合、該オピオイドアンタゴニストが、経口有効ブロックレベルで利用可能である速度である、薬学的組成物。
(項目15)
薬学的組成物であって、以下:
制御放出マトリクス;
オピオイドアゴニスト;
オピオイドアンタゴニスト、
を含み、
該オピオイドアンタゴニストは、非経口投与されたときに、経口投与されたときより高い拮抗効果を有し;
ここで、該オピオイドアンタゴニストは、該制御放出マトリクスが破壊され、2以上の用量の該組成物が組み合わせられて乱用用量の該オピオイドアゴニストをもたらす場合、オピオイドアンタゴニストの量が、経口で服用された際に、該オピオイドの効果をブロックし、そして/または使用中止を誘導するのに十分であるように該組成物中の該オピオイドアゴニストの乱用用量数に比例した量で該組成物中に存在し;
ここで、アンタゴニストレベルが、適切な経口投与レジメの下で、阻害性レセプターおよび興奮性レセプターをブロックすることにより該オピオイドの作用をブロックするにも、興奮性レセプターを選択的にブロックすることによりオピオイドの副作用を弱めるにも、有効でないように、該制御放出マトリクスは、該オピオイドアンタゴニストの放出速度を制御するために選択され、そして組み込まれる、薬学的組成物。
(項目16)
項目15に記載の薬学的組成物であって、前記アンタゴニストの前記放出速度は、1用量の該組成物では、経口有効量のアンタゴニストを利用可能にしないが、2以上の用量の該組成物が、破壊されてかまたは破壊されずに組み合わせられて、前記オピオイドアゴニストの乱用用量を可能にする際に、該オピオイドアンタゴニストは、経口で有効なブロックレベルで利用可能である速度である、薬学的組成物。
(項目17)
経口用薬学的組成物であって、該薬学的組成物は、以下:
制御放出マトリクス;
約10mg〜160mgのオキシコドン;
約2mg〜160mgのナロキソン、
を含み、
ここで、オキシコドンのナロキソンに対する比率は、約4〜5:1から1:1であり;
ここで該制御放出マトリクスは、12時間までの期間にわたり薬学的有効性を維持するようにオキシコドンの放出速度を制御するため、およびナロキソンレベルが、適切な経口投与レジメの下で、阻害レセプターおよび興奮性レセプターの両方をブロックすることにより該オピオイドの効果をブロックするにも、興奮性レセプターを選択的にブロックすることによりオピオイド副作用を弱めるにも有効でないように、該ナロキソンの放出速度を制御するために選択されそして組み込まれている、薬学的組成物。
(項目18)
経口用薬学的組成物であって、該経口用薬学的組成物は、重量%で以下:
約3〜35%のオピオイドアゴニスト;
約2〜20%のオピオイドアンタゴニスト;
約10〜50%の微結晶セルロース(NF);
約30〜70%のアンモニオメタクリレートコポリマー(NF);および
少なくとも1つの賦形剤を含み、
該少なくとも1つの賦形剤は、以下:
約5%までのコロイド状二酸化ケイ素(NF);
約5%までのラウリル硫酸ナトリウム(NF);
約2%までの水酸化マグネシウム(USP);
約15%までのポビドン(USP);
約5%までのステアリン酸、NF;および
約5%までのステアリン酸マグネシウム、NF、
からなる群より選択され、ここで該制御放出組成物は、インタクトな形態で経口服用された場合、治療有効速度で該オキシコドンを放出し、かつ該オピオイドの効果をブロックし、そして/または使用中止を誘導するのに有効でない速度で該ナロキソンを放出するように適合させた制御放出処方物である、経口用薬学的組成物
(項目19)
項目18に記載の経口用薬学的組成物であって、前記オピオイドアゴニストが、モルフィン、オキシコドン、レボルフェノール、メペルジン、ヒドロコドン、コデイン、ジヒドロコデイン、ヒドロモルフィン、プロポキシフェン、メタドン、およびオキシモルフォンからなる群より選択され、そして前記オピオイドアンタゴニストが、ナロキソン;ナルトレキソン;N−シクロプロピルメチル−7,8−ジヒドロ−14−ヒドロキシノルモルフィノン;および21−シクロプロピルz,−(1−ヒドロキシ−1−メチルエチル)−6,14−エンド−エタノ−テトラヒドロオリパビン(またはジフェノルフィン)およびそれらの薬学的に受容可能な塩からなる群より選択される、経口用薬学的組成物。
(項目20)
前記オピオイドアゴニストが、塩酸オキシコドンであり、かつ前記オピオイドアンタゴニストがナロキソンである、項目18に記載の経口用薬学的組成物。
本発明は、特定のオピオイドアンタゴニストが経口での低用量では効果的でないという原理を使用する。従って、オピオイドの作用に有害な影響を与えることなく、経口有効量の大量のアンタゴニストを含む錠剤から長期間にわたり経口低用量を投与し得る(制御放出)。しかし、アンタゴニストが一度に全て投与される場合、それは、オピオイドの効果をブロックし、そして依存症の個体における使用中止を誘導し得る。
溶解を、処方物1〜3について、USP XXIV装置3(往復シリンダー(Reciprocating Cylinder)に従い実施した。装置3は、ヒトの胃腸の条件をシュミレートする。最初の1時間は、pH1.2の0.1NのHClである。次の1時間(2時間目)およびさらに次の1時間(3時間目)は、pH4.5の10mMのリン酸一カリウムである。3時間目より後の条件は、pH6.8の10mMのリン酸一カリウムである。全ての溶解容器は、250mLの溶解溶液を含む。浸漬速度を、1分間あたり10回の浸漬(dip)に設定する。浴の温度を、37.5℃に設定する。HPLCパラメーターを、以下のように設定する:カラム−Inertsil ODS 3、50mm×4.6mm、3μm粒子サイズ、移動相:80% 30mMヘキサンスルホン酸ナトリウムpH3.0±1、20%アセトニトリル。注入容量は、75μLである。カラム温度は、35℃であり、流動速度を、1.0mL/分に設定する。波長を、225nmに設定する。稼動時間は、5.5分間である。
これらの試験から、通常の、破壊しない使用の下で、経時的に放出されたアンタゴニストの量(ここでは、ナロキソンである)は、オピオイドの効果をブロックするには不充分であることが明らかである。アンタゴニストの最も高い放出初速度を有する、実施例3でさえ、たった約5mgのナロキソンしか、1時間目において利用可能でない。ナロキソンの短い半減期、および徐放速度に起因して、アンタゴニストは、体内で、オピオイドの効果をブロックするレベルまで蓄積しない。一方、破壊された錠剤において、実質的に全てのアンタゴニストは、最初の1時間において利用可能である。従って、オピオイドをブロックする量のアンタゴニストは、経口および他の形態の乱用を抑止するために容易に利用可能である。使用されるアンタゴニストに拘わらず、アンタゴニストの含量、放出速度、およびアンタゴニストの半減期の組み合わせは、制御放出処方物として意図されかつ推薦されたとおりに投与された場合にオピオイドの効果をなおブロックせずに、即時放出のためとして投与された場合にオピオイドの効果をブロックする本発明の目的を達成する。
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- 明細書に記載の発明。
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