JP2019089843A - 乾燥粉末配合および使用方法 - Google Patents
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
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- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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Abstract
Description
この出願は、2013年4月30日付で出願された米国仮出願第61/817,435号の利益を主張し、この参照によりその全体が組み込まれる。
血栓塞栓性の兆候および事象
血栓塞栓症、例えば、心筋梗塞、深部静脈血栓症、肺血栓症、脳血栓症等は、患者または臨床医が、前記イベントについての初期治療または処置を提供するのを可能にする特定の兆候を提供し得る。一部の状況では、81mgの低用量または低用量(baby)のアスピリンまたは通常のアスピリン(330mg)が、患者の初期処置を提供するために、経口投与される場合がある。
薬剤は、種々の方法、例えば、液体、カプセル、錠剤またはチュアブル錠において、経口投与され得る。ほとんどの場合、前記経口経路が使用される。最も都合がよく、最も安全で、最も安価であるためである。ただし、経口薬剤送達は、薬剤が典型的に消化管を通って移動する方法であるため限界を有する。
アスピリンは、サリチル酸のアセチル化型であり、アスピリンにおける活性な化学は、アセチルサリチル酸(ASA)と呼ばれる。アスピリンは、多数の人々により使用されて、所望の効果を達成しており、多くの人々により、低用量アスピリンが、多くの場合、毎日使用されている。アスピリンの原理的作用は、シクロオキシゲナーゼ酵素(具体的には、COX1およびCOX2の酵素)の機能を障害することである。
上記されたように、アスピリンの経口送達は、疼痛、消化不良をもたらす胃壁に対する傷害のリスクおよび出血の高いリスクを生じさせる場合がある。さらに、本願明細書に記載された実施形態の少なくとも1つの態様に基づいて、血栓塞栓症に関係するか、または、血栓塞栓症をもたらし得る緊急事態中に、多くの場合、薬剤を経口投与するのが困難であると認識される。例えば、患者は、嘔吐を起こすか、またはそうでなければ経口的に薬剤を摂取できない場合がある。さらに、薬剤の経口投与は、薬剤が直ちに全身性血流に達さないため、薬剤の重要な作用が遅延するために、望ましくない場合がある。全身性血流に達したとしても、肝臓および消化管における初回通過効果のために、全身性循環に達する薬剤量は、投与量より非常に少なくなる。したがって、本願明細書に開示された種々の実施形態の態様に基づいて、投与の代替経路は、これらの望ましくない副作用を避け得ると認識される。
ここで使用する場合、「約」の用語は、+/−5%の値を意味する。
NSAIDs、例えば、アスピリンは、種々の有益な効果を提供し、心血管疾患(例えば血栓症)のリスクを低下させるのに寄与する。しかしながら、臨床設定におけるNSAIDs、例えば、アスピリンの使用は、伝統的には、経口投与に限定されてきた。アスピリンの経口投与は、例えば、消化管および肝臓における初回通過効果により、経口用量の約2/3の損失または不活性化をもたらし得る。一方、前記用量の1/3は、全身性血流に達し、所望の作用を提供し、十分な用量により生じるネガティブな副作用により、多くの場合、患者が定期的または毎日アスピリンを使用するのを妨げる。
主題となる技術は、活性成分として、NSAID、例えば、アセチルサリチル酸を有する吸入用乾燥粉末および乾燥粒子に関する。
本願明細書に開示された一部の実施形態を通して、出願人は、従来の教示により認識されている課題を克服した。特に、出願人は、薬剤が肺に吸入された場合、前記薬剤が肺胞に向かって分散され得ることを認識した。肺胞は、主に、二酸化炭素を酸素に交換するのに機能し、肺胞は、酵素も産生する。このため、吸入された物質、例えば、病原体、薬剤または他の化学物質は、肺胞で処理され得る。
吸入用乾燥粒子および乾燥粉末は、任意の適切な方法を使用して調製され得る。吸入用乾燥粉末および粒子を調製するための多くの適切な方法が、当該分野において従来からあり、単独および二重の乳化溶媒蒸発法、スプレー乾燥、粉砕(例えば、ジェット粉砕)、ブレンド、溶媒抽出、溶媒蒸発、相分離、単独および複雑なコアセルベーション、界面重合、超臨界二酸化炭素(CO2)の使用を含む適切な方法ならびに他の適切な方法を含む。吸入用乾燥粒子は、当該分野において公知のマイクロスフェアまたはマイクロカプセルを調製するための方法を使用して調製され得る。これらの方法は、所望の空気力学的特性(例えば、空気力学的直径および幾何学的直径)を有する吸入用乾燥粒子の形成をもたらす条件下で使用され得る。必要に応じて、所望の特性、例えば、サイズおよび密度を有する吸入用乾燥粒子は、適切な方法、例えば、ふるい分けを使用して選択され得る。
他の態様では、主題となる技術は、心血管疾患(例えば、血栓症)を処置(例えば、予防的処置またはリスクの低下)するための方法であって、それを必要とする対象の気道に、有効量の本願明細書に記載された吸入用乾燥粒子または乾燥粉末を投与することを有する方法である。
Claims (23)
- アセチルサリチル酸またはその薬学的に許容され得る塩を有する吸入用乾燥粒子を有する吸入用乾燥粉末であって、
前記乾燥粉末は、(i)約5μm以下の体積メジアン幾何学的直径(VMGD)を有する乾燥粒子と、(ii)約15μm以上の体積メジアン幾何学的直径(VMGD)を有する乾燥粒子との混合物を有する、吸入用乾燥粉末。 - 請求項1記載の吸入用乾燥粉末において、少なくとも50%の前記乾燥粒子は、約5μm以下の体積メジアン幾何学的直径(VMGD)を有する、吸入用乾燥粉末。
- 請求項1または2記載の吸入用乾燥粉末において、少なくとも70%の前記乾燥粒子は、約5μm以下の体積メジアン幾何学的直径(VMGD)を有する、吸入用乾燥粉末。
- アセチルサリチル酸またはその薬学的に許容され得る塩を有する吸入用乾燥粒子を有する吸入用乾燥粉末であって、
前記乾燥粉末は、(i)約5μm以下の質量メジアン空気力学的直径(MMAD)を有する乾燥粒子と、(ii)約15μm以上の質量メジアン空気力学的直径(MMAD)を有する乾燥粒子との混合物を有する、吸入用乾燥粉末。 - 請求項1記載の吸入用乾燥粉末において、少なくとも50%の前記乾燥粒子は、約5μm以下の質量メジアン空気力学的直径(MMAD)を有する、吸入用乾燥粉末。
- 請求項1または2記載の吸入用乾燥粉末において、少なくとも70%の前記乾燥粒子は、約5μm以下の質量メジアン空気力学的直径(MMAD)を有する、吸入用乾燥粉末。
- 請求項1〜6のいずれか一項に記載の吸入用乾燥粉末において、前記乾燥粉末は、賦形剤を有さない、吸入用乾燥粉末。
- 請求項1〜7のいずれか一項に記載の吸入用乾燥粉末において、前記乾燥粉末は、ナノ粒子の凝集体を有し、前記ナノ粒子の平均径は、約5nmから約500nmである、吸入用乾燥粉末。
- 請求項8記載の吸入用乾燥粉末において、前記ナノ粒子は、約1μmから約25μmの体積メジアン幾何学的直径(VMGD)を有する中空の凝集体を形成する、吸入用乾燥粉末。
- 血栓症を治療するための薬剤送達システムであって、前記システムは、請求項1〜9のいずれか一項に記載の吸入用乾燥粉末を有し、アセチルサリチル酸は、約40mg以下の用量で存在する、薬剤送達システム。
- 請求項10記載の薬剤送達システムにおいて、アセチルサリチル酸は、約40mg以下の用量で存在する、薬剤送達システム。
- 血栓症を治療し、または血栓塞栓症のリスクを低下させる方法であって、
それを必要とする対象に、治療的に有効量のアセチルサリチル酸を投与する工程を有し、前記アセチルサリチル酸は、請求項1〜9のいずれか一項に記載の吸入用乾燥粉末を有する乾燥粉末吸入器によって送達され、前記対象に投与されるアセチルサリチル酸の用量は、約40mg以下である、方法。 - 請求項12記載の方法において、アセチルサリチル酸は、約40mg以下の用量で存在する、方法。
- アセチルサリチル酸またはその薬学的に許容され得る塩を有する吸入用乾燥粒子を有する吸入用乾燥粉末であって、
前記吸入用乾燥粒子は、約10μm以下の体積メジアン幾何学的直径(VMGD)を有する、吸入用乾燥粉末。 - 請求項14記載の吸入用乾燥粉末において、前記吸入用乾燥粒子は、約5.0μm以下の体積メジアン幾何学的直径(VMGD)を有する、吸入用乾燥粉末。
- アセチルサリチル酸またはその薬学的に許容され得る塩を有する吸入用乾燥粒子を有する吸入用乾燥粉末であって、
前記吸入用乾燥粒子は、約10μm以下の質量メジアン空気力学的直径(MMAD)を有する、吸入用乾燥粉末。 - 請求項16記載の吸入用乾燥粉末において、前記吸入用乾燥粒子は、約5.0μm以下の質量メジアン空気力学的直径(MMAD)を有する、吸入用乾燥粉末。
- 薬学的に許容され得る賦形剤によって実質的に封入されている、アセチルサリチル酸またはその薬学的に許容され得る塩を有する吸入用乾燥粒子を有する吸入用乾燥粉末であって、
前記吸入用乾燥粒子は、約10μm以下の体積メジアン幾何学的直径(VMGD)を有する、吸入用乾燥粉末。 - 薬学的に許容され得る賦形剤によって実質的に封入されている、アセチルサリチル酸またはその薬学的に許容され得る塩を有する吸入用乾燥粒子を有する吸入用乾燥粉末であって、
前記吸入用乾燥粒子は、約10μm以下の質量メジアン空気力学的直径(MMAD)を有する、吸入用乾燥粉末。 - 請求項18または19記載の吸入用乾燥粉末において、約25%から約50%(重量パーセント)の前記乾燥粉末は、アセチルサリチル酸である、吸入用乾燥粉末。
- 請求項18〜20のいずれか一項に記載の吸入用乾燥粉末において、前記賦形剤は、クエン酸ナトリウムまたはラクトースである、吸入用乾燥粉末。
- 血栓症を治療するための薬剤送達システムであって、
前記システムは、請求項14〜21のいずれか一項に記載の吸入用乾燥粉末を有し、アセチルサリチル酸は、約40mg以下の用量で存在する、薬剤送達システム。 - 血栓症を治療する方法であって、
それを必要とする対象に、治療的に有効量のアセチルサリチル酸を投与する工程を有し、前記アセチルサリチル酸は、請求項14〜21のいずれか一項に記載の吸入用乾燥粉末を有する乾燥粉末吸入器によって送達され、前記対象に投与されるアセチルサリチル酸の用量は、約40mg以下である、方法。
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WO2015127315A1 (en) * | 2014-02-20 | 2015-08-27 | Otitopic Inc. | Dry powder formulations for inhalation |
CA2991760A1 (en) * | 2014-07-31 | 2016-02-04 | Otitopic Inc. | Dry powder formulations for inhalation |
WO2017100656A1 (en) * | 2015-12-11 | 2017-06-15 | Otitopic Inc. | Dry powder formulations of aspirin for inhalation |
AU2016378478B2 (en) * | 2015-12-22 | 2021-11-25 | Aspiair Gmbh | Treatment of moderate to severe influenza |
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CA2910766C (en) | 2020-12-15 |
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JP2023086774A (ja) | 2023-06-22 |
CN105473133A (zh) | 2016-04-06 |
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