JP2011521999A - 抗生物質およびコルチコステロイドを含む組成物 - Google Patents
抗生物質およびコルチコステロイドを含む組成物 Download PDFInfo
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- JP2011521999A JP2011521999A JP2011512100A JP2011512100A JP2011521999A JP 2011521999 A JP2011521999 A JP 2011521999A JP 2011512100 A JP2011512100 A JP 2011512100A JP 2011512100 A JP2011512100 A JP 2011512100A JP 2011521999 A JP2011521999 A JP 2011521999A
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Abstract
Description
手短に言えば、本発明は一般に、コルチコステロイドおよび抗生物質を含む組成物(例えば懸濁液)を対象とする。これらの組成物は一般に、長時間(例えば5か月)にわたり室温またはより高温(例えば50℃)で安定である。このような安定な組成物の利点は、例えば、典型的には、冷蔵に関連する費用および人的資源の排除、冷蔵の失敗による製品の損失のリスクの排除、および冷蔵しない不注意な保存の後に投与される分解生成物のリスクの排除を含む。
本発明の医薬品組成物は、一般に、コルチコステロイド、抗生物質および有機酸を含む。最初に、この成分リストが完全ではないことが認識されなければならない。したがって、組成物は追加の成分を含んでいてもよい(通常、含む)。これらの追加の成分は例えば、1種または複数の追加のコルチコステロイド、抗生物質および/または有機酸を含むことができる。また、より詳細に以下に論じられるように、追加の成分は1種または複数の他の有効成分を含むことができる。また以下に論じられるように、追加の成分は1種または複数の賦形剤を含むことができる(通常、含む)。
コルチコステロイドは、視床下部の下垂体前葉副腎皮質の軸(脳下垂体としても知られている。)によって分泌されるホルモンの、通常、天然および合成類似体である。コルチコステロイド(特にグルココルチコイド)は、通常、強力な抗炎症剤であると知られている。これらはまた、通常、かゆみ止めおよび血管収縮作用を示す。様々なコルチコステロイドは、例えば、乾癬およびアトピー性皮膚炎などのコルチコステロイド反応性皮膚病を治療するために局所に用いられる。
いくつかの実施形態において、抗生物質はキノロンを含む。一般に、キノロンは、フルオロキノロン、フルオロキノロンの塩、またはフルオロキノロンもしくはこの塩の溶媒和物を含む。フルオロキノロン抗生物質は、例えば、6−フルオロキノリン−4(1H)−オン、6−フルオロキノリン−4(1H)−オンの塩、ならびに6−フルオロキノリン−4(1H)−オンおよびこれらの塩の溶媒和物を含む。6−フルオロキノリン−4(1H)−オンの例は、表3に示されているものを含む。
有機酸は、通常、脂肪酸を含む。脂肪酸は、好ましくは少なくとも約3個の炭素原子を含む。いくつかの実施形態において、例えば、脂肪酸は約3から約18個の炭素原子を含む。他の実施形態において、脂肪酸は約4から約18個の炭素原子を含む。さらに別の実施形態において、脂肪酸は約7から約18個の炭素原子を含む。
上に述べたように、本発明の組成物は他の成分を含むことができる(通常、含む)。これらの成分は、例えば、1種または複数の他の有効成分および/または1種または複数の賦形剤であってよい。
コルチコステロイドおよび抗生物質に加えて、様々な有効成分が本発明の組成物に組み入れられてよいことが企図される。いかなるこのような有効成分も、組成物が用いられている状況に対して好適であり、コルチコステロイドおよび抗生物質の活性に著しく有害でないことが好ましい。
A.クロラムフェニコール、チアンフェニコールおよびクロラムフェニコールおよびチアンフェニコール(例えばフロルフェニコールまたはD−(スレオ)−1−p−メチルスルホニルフェニル−2−ジフルオロアセトアミド−3−フルオロ−1−プロパノール)のフッ素含有類似体。
B.クロロテトラサイクリンおよびオキシテトラサイクリンなどのテトラサイクリン。
C.単独でまたはクラブラン酸、クラブラン酸カリウム、スルバクタムロドペニシラン酸、6−ブロモペニシラン酸、オリバン酸およびタゾバクタムなどのβラクタマーゼ阻害剤と組み合わせて、アモキシシリン、アンピシリン、アンピシリン三水和物、アンピシリンナトリウム、アパルシリン、アスポキシシリン、アズロシリン、バカンピシリン、カルベニシリン、カルベニシリンナトリウム、カルフェシリン、カリンダシリン、シクラシリン、クロキサシリンナトリウム、クロキサシリンベンザチン、ジクロキサシリン、ジクロキサシリンナトリウム、フルクロキサシリン、ヘタシリン、レナムピシリン、メシリナム、メタンピシリン、メチシリン、メズロシリン、ナフシリン、ナフシリンナトリウム、オキサシリン、ペニシリン酸、ペニシリンG、ペニシリンGベンザチン、ペニシリンGカリウム、ペニシリンGナトリウム、ペニシリンV、フェネチシリン、フェネチシリンカリウム、ピペラシリン、ピペラシリンナトリウム、ピバンピシリン、スルベニシリン、スルタミシリン、タランピシリン、チカルシリン、セファクロル、セファドロキシル、セファドロキシル一水和物、セファマンドール、セファマンドールリチウム、セファマンドールナンフェート、セファマンドールナトリウム、セファザフルール、セファゼドン、セファゾリン、セファゾリンナトリウム、セフクリジン、セフジニル、セフェピム、セフェタメト、セフィキシム、セフルプレナム、セフメノキシム、セフメタゾールナトリウム、セフォジジム、セフォニシド、セフォペラゾン、セフォペラゾンナトリウム、セフォラニド、セフォセリス、セフォタキシム、セフォタキシムナトリウム、セフォチアム、セフォゾプラン、セフピミゾール、セフピミゾールナトリウム、セフピラミド、セフピロム、セフポドキシム、セフプロジル、セフキノム、セフロキサジン、セフスロジン、セフスロジンナトリウム水和物、セフタジジム、セフタジジム五水和物、セフテゾール、セフチブテン、セフチオレン、セフチゾキシム、セフトリアキソン、セフトリアキソンジナトリウム塩、セフトリアキソンナトリウム、セフロキシム、セフゾナム、セファセトリル、セファレキシン、セファロリジン、セファロスポリンC、セファロチン、セファロチンナトリウム、セファピリン、セファピリンナトリウム、セフラジン、ロラカルベフ、セフブペラゾン、セホキシチン、セフォキシチンナトリウム、セフミノックス、セフメタゾール、セフォテタン。
D.アジスロマイシン、ブレフェルジン、クラリスロマイシン、エリスロマイシン、エリスロマイシンエストレート、エチルコハク酸エリスロマイシン、ステアリン酸エリスロマイシン、ジョサマイシン、キタサマイシン、ツラスロマイシンおよびチルミコシンなどのマクロライド抗生物質。
本発明の組成物中の企図される賦形剤は、例えば、液状媒体、粘度上昇剤、界面活性剤、防腐剤、安定剤、樹脂、充填剤、結合剤、潤滑油、流動促進剤、崩壊剤、共溶媒、および製薬グレードの染料または顔料を含む。
上に述べたように、本発明の組成物中に存在する多くの化合物が塩の形態をしていてよい。例えば、上記抗生物質、コルチコステロイドおよび抗真菌剤の多くは、塩の形態をしていてよい。温度および湿度の差における製薬の安定性;結晶性;および/または水、油もしくは他の溶媒への望ましい溶解性などの1種または複数の物理的性質により、塩は有利であり得る。酸および塩基の塩は、当業界で既知の様々な方法を使用することによって、例えば、化合物を酸または塩基とそれぞれ混合して、通常形成することができる。一般に、本発明の組成物が治療の恩恵のためにインビボ(すなわち動物に対して)投与されるように意図される場合、組成物中のすべての塩は薬学的に許容できることが好ましい。
本発明の組成物は、一般に、例えば、当業界で周知の技術を使用して調製することができる。通常、組成物(またはこのような媒体(複数可)の一部)中で使用される任意の媒体(複数可)、続いて、残りの賦形剤、有効成分および脂肪酸を調剤容器に加える。一般に、成分が容器に加えられる順序は重要ではない。
本発明の組成物は、一般に、動物の感染を治療するために使用することができる。本組成物は、ある範囲の動物(特に哺乳動物)を治療するために使用され得ることが企図される。このような哺乳動物は例えば、ヒトを含む。他の哺乳動物は、例えば、農場すなわち家畜哺乳動物(例えばブタ、ウシ、ヒツジ、ヤギなど)、実験哺乳動物(例えばマウス、ラット、スナネズミなど)、伴侶哺乳動物(例えばイヌ、ネコ、ウマなど)ならびに野生および動物園の哺乳動物(例えばスイギュウ、シカなど)を含む。いくつかの実施形態において、組成物はイヌ科の動物(例えばイヌ)を治療するために使用される。他の実施形態において、組成物はネコ科の動物(例えば家ネコ)を治療するために使用される。組成物はまた、鳥(例えばシチメンチョウ、ニワトリなど)および魚(例えばサケ、マス、コイなど)などの非哺乳動物を治療するのに適切であることが企図される。
本発明はまた、上に記載された治療方法を実行する際に、例えば、使用に適するキットを対象とする。一般に、このようなキットは、治療上効果的な量の本発明の組成物および追加の要素(複数可)を含む。追加の要素(複数可)は、例えば、1種または複数の、診断ツール、組成物を投与するための説明書または組成物を投与するための機器(例えば注射器またはスクィーズボトル)であってよい。耳の治療のためのいくつかの実施形態において、キットは、例えば、耳を浄化するための機器および/または耳清浄液と組み合わせた本発明の組成物を含むことができる。耳を浄化するための企図された機器の例は、浄化布(例えば乾燥した布またはアルコールパッド)または動力付き耳浄化機(Schering−Plough Corpによって販売されているAuriflush(登録商標)Systemなどの)を含む。企図された耳清浄液の例は、Virbac Animal Health’s Cerulytic(登録商標)Solution(ジカプリル酸/ジカプリン酸プロピレングリコール、ベンジルアルコール、香料およびブチルヒドロキシトルエンを含む。)、Pfizer社のOti−Clens(登録商標)Solution(プロピレングリコールリンゴ酸、安息香酸およびサリチル酸を含む。)、Vet Solutions Ear Cleaning Solution(プロピレングリコール、アロエベラゲル、Sdアルコール40−2、乳酸、グリセリン、ジオクチルソジウムスルホサクシネート、サリチル酸、香料、安息香酸およびベンジルアルコールを含む。)、およびIVX Animal Health’s OtiRinse(登録商標)Solution(ジオクチルソジウムスルホサクシネート、サリチル酸、乳酸、安息香酸およびアロエベラを含む。)を含む。
以下の実施例は単に例示であり、本開示の残りを決して限定するものではない。
この実験の目的は、オルビフロキサシンと組み合わせたフランカルボン酸モメタゾン一水和物を含む懸濁液中の少なくとも1種のモメタゾン分解産物の形成を、オレイン酸またはラウリン酸が減少させることができることを実証することであった。この実験において、懸濁液は表8に示されている組成物を有していた。
以下の表10は、オレイン酸を含む本発明の組成物を例示する。
Claims (18)
- コルチコステロイド、
抗生物質、および
脂肪酸
を含み、
抗生物質が、
フルオロキノロン、フルオロキノロンの塩、またはフルオロキノロンもしくはこの塩の溶媒和物、または
フルオロナフチリジノン、フルオロナフチリジノンの塩、またはフルオロナフチリジノンもしくはこの塩の溶媒和物を含み、
脂肪酸が、
約3から約18個の炭素原子を含み、
約60℃以下の融点を有する、
医薬品組成物。 - 懸濁液の形態をしている、請求項1に記載の組成物。
- コルチコステロイドがモメタゾン、フランカルボン酸モメタゾン、またはモメタゾンもしくはフランカルボン酸モメタゾンの溶媒和物を含む、請求項1から2のいずれかに記載の組成物。
- コルチコステロイドがフランカルボン酸モメタゾン一水和物を含む、請求項3に記載の組成物。
- 抗生物質が6−フルオロキノリン−4(1H)−オン、6−フルオロキノリン−4(1H)−オンの塩、または6−フルオロキノリン−4(1H)−オンもしくはこの塩の溶媒和物を含む、請求項1から4のいずれか一項に記載の組成物。
- 6−フルオロキノリン−4(1H)−オンが、アミフロキサシン、バロフロキサシン、シプロフロキサシン、クリナフロキサシン、フレロキサシン、ガレノキサシン、ガチフロキサシン、グレパフロキサシン、ロメフロキサシン、モキシフロキサシン、ノルフロキサシン、ペフロキサシン、プラドフロキサシン、シタフロキサシン、スパルフロキサシン、テマフロキサシン、ダノフロキサシン、ジフロキサシン、エンロフロキサシン、サラフロキサシン、フルメキン、イバフロキサシン、レボフロキサシン、ナジフロキサシン、オフロキサシン、パズフロキサシン、プルリフロキサシン、ルフロキサシン、およびマルボフロキサシンからなる群から選択される6−フルオロキノリン−4(1H)−オンを含む、請求項5に記載の組成物。
- 6−フルオロキノリン−4(1H)−オンがオルビフロキサシンを含む、請求項5に記載の組成物。
- 抗真菌薬をさらに含む、請求項1から7のいずれか一項に記載の組成物。
- 抗真菌薬がトリアゾール、トリアゾールの塩またはトリアゾールもしくはこの塩の溶媒和物を含む、請求項8に記載の組成物。
- トリアゾールがフルコナゾール、イトラコナゾール、サペルコナゾール、テルコナゾールおよびボリコナゾールからなる群から選択されるトリアゾールを含む、請求項9に記載の組成物。
- トリアゾールがポサコナゾールを含む、請求項9に記載の組成物。
- 脂肪酸がラウリン酸を含む、請求項1から11のいずれか一項に記載の組成物。
- 脂肪酸がオレイン酸を含む、請求項1から11のいずれか一項に記載の組成物。
- 鉱油をさらに含む、請求項1から13のいずれか一項に記載の組成物。
- 請求項1から14のいずれか一項に記述された組成物を動物に投与することを含む、動物の感染を治療する方法。
- 感染がイヌの耳感染を含む、請求項15に記載の方法。
- 動物の感染の治療用の薬剤を調製するための、請求項1から14のいずれか一項に記載の組成物の使用。
- 請求項1から14のいずれか一項に記載の組成物、および
追加の要素を含み、追加の要素が、
診断ツール、
耳清浄液、
耳を浄化するための機器、
動物に組成物を投与するための説明書、および
動物に組成物を投与するためのデバイスからなる群から選択される追加の要素を含む
治療キット。
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