JP2021090759A - 膣用薬物送達デバイス - Google Patents
膣用薬物送達デバイス Download PDFInfo
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Abstract
Description
本発明は、女性における様々な医学的状態の処置に使用するための膣用薬物送達デバイスに関する。デバイスは、「個別化医療」または「テーラーメイド医療」を可能にする。
膣用リングシステムは通常、避妊およびホルモン補充療法のために使用される。これらの応用に関して異なるリングシステムが先行技術分野で公知である。
本発明に従って、現在、ホルモン薬以外の薬剤も同様に膣を通して投与および吸収され得ることが見出されている。膣を通しての投与は、例えば不十分な吸収、胃腸(GI)管での分解(例えば、ペプチドおよびタンパク質)、もしくは他の要因により、経口生物学的利用率が比較的低いもしくはわずかである化合物、望ましくないGI副作用を有する化合物、治療範囲が狭い化合物、頻回投与もしくは高用量を必要とする半減期(t1/2)が短い化合物、適切な効能を得るために複雑な時間的および/または投与スケジュールを必要とする化合物等にとって特に有用である。そのような化合物は、処方箋なしの(OTC)化合物ならびに処方薬であり得る。
このように、本発明は、膣に留置されて、化合物が制御された方法で放出されるデバイスを通して、特定の生物活性化合物、特に薬物を投与する新規手段に関する。化合物は、通常は膣を通して投与されない薬物および他の化合物である。
に加えて、異なる形状および機能を有し得る。デバイスは、例えば、好ましくはリングの上部に可撓性部分と剛性部分とを有するリングであり得る。デバイスは、より厚みのある剛性部分を圧縮することができ、これを最初に挿入して、次にリングが挿入後に展開して剛性部分が膣の最も深い部分(後円蓋)でなめらかに定着して、排出を防止して吸収を増強するためにリングの外側部分が膣壁に柔軟に接触するように構成される。
バイスの使用に関する。違いは投与経路である。
用する場合、デバイスはニコチンを含み、例えば、持続的に放出されるようにプログラムされる。服薬を順守しない患者における高血圧症の処置に使用する場合、デバイスにクロニジンを充填する。糖尿病性ニューロパシー性疼痛の処置に使用する場合も、デバイスは、クロニジンを含み、持続的に放出されるようにプログラムされる。
し、このようにして愁訴および問題を回避し得る。
らびに通信およびデータ転送手段を含有する。
本発明を、さらに以下の実施例において例証する。実施例は、単なる例証目的のために示され、本発明をいかなるようにも制限しないと意図される。実施例に記述した実験は、図1および2に示されるデバイスによって実施した。
Claims (24)
- ハウジングと、通常は膣を通して投与されない生物活性化合物を含む少なくとも1つのリザーバーと、リザーバーから化合物を膣内に制御放出する手段とを含む、膣内に留置するように構成された膣用薬物送達デバイス。
- 自身の膣に前記デバイスを有する人の生理学データを収集する手段をさらに含む、請求項1に記載の膣用デバイス。
- 前記リザーバーから前記化合物を制御放出する前記手段が、自身の膣に前記デバイスを有する人の生理学データに応答して作用するように構成される、請求項1または2に記載の膣用デバイス。
- 前記リザーバーから前記化合物を制御放出する前記手段が、特に自身の膣に前記デバイスを有する人、看護師、または医師によって遠隔操作される、請求項1または2に記載の膣用デバイス。
- 前記リザーバーから前記化合物を制御放出する前記手段が、定義された放出パターンで予めプログラムされる、請求項1または2に記載の膣用デバイス。
- 前記定義された放出パターンが、持続的放出、パルス状放出、スパイク状放出、遅延放出、間欠的放出、またはそれらの組み合わせを含む、請求項4に記載の膣用デバイス。
- 前記放出が、請求項6に記載の放出パターンと必要に応じて組み合わせて、オンデマンドである、請求項6に記載の膣用デバイス。
- ハウジングと、自身の膣に前記デバイスを有する人の生理学データを収集する手段とを備える、膣内に留置するように構成された膣用薬物送達デバイス。
- 自身の膣に前記デバイスを有する人の診断データを収集する手段が、温度、グルコースレベル、子宮頚管粘液の物理化学特性、例えば透明度、水分および粘度などを測定する手段、薬剤レベルをモニターする手段、ホルモンレベル、特にホルモンFSH、LH、17−β−エストラジオールおよびプロゲステロン、またはその組み合わせを測定する手段、タンパク質またはDNAなどの核酸を分析する手段、分子、特にサイトカインなどのシグナル伝達分子を検出する手段、(無)排卵周期をモニターする手段、ヒアルロン酸を測定する手段、またはそれらの組み合わせを含む、請求項2〜7のいずれか1項に記載の膣用デバイス。
- 前記測定が前記膣粘膜滲出液および/または前記子宮頚管粘液において行われる、請求項9に記載の膣用デバイス。
- 前記生物活性化合物が充填される、請求項1〜10のいずれか1項に記載の膣用デバイス。
- 前記化合物が、比較的低いまたはわずかな経口生物学的利用率、短い半減期(t1/2)、強い初回通過効果、胃腸管での望ましくない副作用、狭い治療範囲、および/または複雑な時間的投与スケジュールに依存する効能を有する化合物である、請求項1〜11のいずれか1項に記載の膣用デバイス。
- 前記化合物が、精神科および神経科の薬物(例えば、エスシタロプラム、ハロペリドー
ル、プラミペキソール)、薬物依存の処置のための化合物(例えば、ニコチン、ナルトレキソン、ブプレノルフィン)、鎮痛剤(例えば、モルヒネ、ブプレノルフィン)、ホルモン(例えば、ゴナドレリン、インスリン、エストロゲン、プロゲストゲン)、心血管薬(例えば、クロニジン)および抗コリン作動薬(例えば、オキシブチニン、ソリフェナシン)からなる群より選択される、請求項1〜12のいずれか1項に記載の膣用デバイス。 - 化合物が、オキシブチニン、エスシタロプラム、プラミペキソール、ブプレノルフィン、クロニジン、ゴナドレリン、インスリン、ニコチン、プロゲストゲン、SPRM、またはそのアナログ、ホモログ、もしくはアゴニスト、または同じ化学クラス由来で同じ薬学的作用を有する関連化合物からなる群より選択される、請求項1〜13のいずれか1項に記載の膣用デバイス。
- 請求項1〜14のいずれか1項に記載される膣用デバイスによって、処置を必要とする人に投与される、尿および膀胱の問題、特に切迫尿失禁の処置に使用するためのオキシブチニン。
- 請求項1〜14のいずれか1項に記載される膣用デバイスによって投与される、うつ病の処置に使用するためのエスシタロプラム。
- 請求項1〜14のいずれか1項に記載される膣用デバイスによって、処置を必要とする人に投与される、パーキンソン病の処置に使用するためのプラミペキソール。
- 請求項1〜14のいずれか1項に記載される膣用デバイスによって、処置を必要とする人に投与される、オピオイド中毒または慢性疼痛の処置に使用するためのブプレノルフィン。
- 請求項1〜14のいずれか1項に記載される膣用デバイスによって、処置を必要とする人に投与される、閉経後愁訴または高血圧症の処置に使用するためのクロニジン。
- 請求項1〜14のいずれか1項に記載される膣用デバイスによって、処置を必要とする人に投与される、カルマン症候群の処置に使用するためのゴナドレリン。
- 請求項1〜14のいずれか1項に記載される膣用デバイスによって、処置を必要とする人に投与される、糖尿病の処置に使用するためのインスリン。
- 請求項1〜14のいずれか1項に記載される膣用デバイスによって、サポートまたは処置を必要とする人に投与される、禁煙サポートまたは軽度の認知障害の処置に使用するためのニコチン。
- 請求項1〜14のいずれか1項に記載される膣用デバイスによって、処置を必要とする人に投与される、避妊に使用するためのプロゲストゲン。
- 請求項1〜14のいずれか1項に記載される膣用デバイスによって、処置を必要とする人に投与される、避妊に使用するためのSPRM。
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