JP6050758B2 - 乾燥粉末吸入器及びその作動方法 - Google Patents
乾燥粉末吸入器及びその作動方法 Download PDFInfo
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- JP6050758B2 JP6050758B2 JP2013543324A JP2013543324A JP6050758B2 JP 6050758 B2 JP6050758 B2 JP 6050758B2 JP 2013543324 A JP2013543324 A JP 2013543324A JP 2013543324 A JP2013543324 A JP 2013543324A JP 6050758 B2 JP6050758 B2 JP 6050758B2
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- Prior art keywords
- chamber
- actuator
- dry powder
- powder inhaler
- inhaler
- Prior art date
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- PNVNVHUZROJLTJ-UHFFFAOYSA-N venlafaxine Chemical compound C1=CC(OC)=CC=C1C(CN(C)C)C1(O)CCCCC1 PNVNVHUZROJLTJ-UHFFFAOYSA-N 0.000 description 1
- 229940000146 vicodin Drugs 0.000 description 1
- 229960003048 vinblastine Drugs 0.000 description 1
- JXLYSJRDGCGARV-XQKSVPLYSA-N vincaleukoblastine Chemical compound C([C@@H](C[C@]1(C(=O)OC)C=2C(=CC3=C([C@]45[C@H]([C@@]([C@H](OC(C)=O)[C@]6(CC)C=CCN([C@H]56)CC4)(O)C(=O)OC)N3C)C=2)OC)C[C@@](C2)(O)CC)N2CCC2=C1NC1=CC=CC=C21 JXLYSJRDGCGARV-XQKSVPLYSA-N 0.000 description 1
- 229960004528 vincristine Drugs 0.000 description 1
- OGWKCGZFUXNPDA-XQKSVPLYSA-N vincristine Chemical compound C([N@]1C[C@@H](C[C@]2(C(=O)OC)C=3C(=CC4=C([C@]56[C@H]([C@@]([C@H](OC(C)=O)[C@]7(CC)C=CCN([C@H]67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)C[C@@](C1)(O)CC)CC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-XQKSVPLYSA-N 0.000 description 1
- OGWKCGZFUXNPDA-UHFFFAOYSA-N vincristine Natural products C1C(CC)(O)CC(CC2(C(=O)OC)C=3C(=CC4=C(C56C(C(C(OC(C)=O)C7(CC)C=CCN(C67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)CN1CCC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-UHFFFAOYSA-N 0.000 description 1
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- MECHNRXZTMCUDQ-RKHKHRCZSA-N vitamin D2 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)/C=C/[C@H](C)C(C)C)=C\C=C1\C[C@@H](O)CCC1=C MECHNRXZTMCUDQ-RKHKHRCZSA-N 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0003—Details of inhalators; Constructional features thereof with means for dispensing more than one drug
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0005—Details of inhalators; Constructional features thereof with means for agitating the medicament
- A61M15/001—Details of inhalators; Constructional features thereof with means for agitating the medicament using ultrasonic means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
- A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
- A61M15/0033—Details of the piercing or cutting means
- A61M15/0035—Piercing means
- A61M15/0036—Piercing means hollow piercing means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
- A61M15/0063—Storages for pre-packed dosages
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/10—Preparation of respiratory gases or vapours
- A61M16/12—Preparation of respiratory gases or vapours by mixing different gases
- A61M16/122—Preparation of respiratory gases or vapours by mixing different gases with dilution
- A61M16/125—Diluting primary gas with ambient air
- A61M16/127—Diluting primary gas with ambient air by Venturi effect, i.e. entrainment mixers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/43—General characteristics of the apparatus making noise when used correctly
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- Engineering & Computer Science (AREA)
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- Pulmonology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
Description
粉末および液体の経鼻送達システムはいずれも現在市場に出回っている。液体の送達技術は、鼻腔内への製剤の迅速な噴射のために、噴霧ポンプに由来する技術または加圧型計量式吸入器(pMDI)を利用してきた。一般に、鼻腔投与製剤は溶媒または安定化剤を必要とする溶液または懸濁液ベースの製剤である。これらは典型的にはスプレーとして投与される。計量式スプレーおよびポンプスプレーにはいくつかの短所があり、該短所は例えば:
・「用量均一性」を確保するためにプライミングが必要であること
・異なる材料の多数のデバイス部品を伴う複雑かつ高価な設計物であること
・該デバイスの製造が困難であること
・製剤があまり安定でないこと
・鼻腔内の沈着部位に関する制御が不十分であること
・製剤の沈着が一定の組織に集中することが多くそのエリアに刺激をもたらす一方で鼻腔内の他の場所は治療をなさないこと
・使用時のデバイスの位置決めが重要でありかつ患者の使用法に強く依存することから、標的組織への投薬における変動が大きいこと
である。
医薬品原薬;活性作用薬:
医薬品原薬(API)、すなわち活性作用薬には、鎮痛性の抗炎症剤、例えば、アセトアミノフェン、アスピリン、サリチル酸、サリチル酸メチル、サリチル酸コリン、サリチル酸グリコール、l−メントール、カンフル、メフェナム酸、フルフェナム酸(fluphenamic acid)、インドメタシン、ジクロフェナク、アルクロフェナク、イブプロフェン、ケトプロフェン、ナプロキセン(naproxene)、プラノプロフェン、フェノプロフェン、スリンダク、フェンブフェン、クリダナク、フルルビプロフェン、インドプロフェン、プロチジン酸(protizidic acid)、フェンチアザク、トルメチン、チアプロフェン酸、ベンダザック、ブフェキサマク、ピロキシカム、フェニルブタゾン、オキシフェンブタゾン、クロフェゾン、ペンタゾシン、メピリゾールなどが挙げられる。
食欲抑制薬、例えば、デキストロアンフェタミン、メタンフェタミン、フェニルプロパノラミン、フェンフルラミン、ジエチルプロピオン、マジンドール、フェンテルミン、など。
抗潰瘍性作用薬、例えば、ミソプロストール、オメプラゾール、エンプロスチル、など。抗潰瘍薬、例えば、アラントイン、アルジオキサ、アルクロキサ、メチル硫酸N−メチルスコポラミン(N−methylscopolamine methylsuflate)、など。抗糖尿病薬、例えばインスリン、など。
上述の活性作用薬は、必要に応じて組み合わせて使用されうる。さらに、上記薬物は、遊離形態で使用されてもよいし、塩を形成しうる場合は適切な酸または塩基との塩の形態で使用されてもよい。薬物がカルボキシル基を有する場合、該薬物のエステルが使用されてもよい。
Fadhesive=(AHd1d2)/{12D2(d1+d2)}
によって近似可能であり、上記式中、AHはハマカー(Hamaker)定数であって典型的には10−19Jの範囲にあり、Dは粒子間距離であって一般に4オングストローム(10−10m)として与えられ、d1およびd2はそれぞれ薬剤および担体粒子の直径である。作動器201の振動によって生成される離脱力は、一般に作動器201の直径の3乗に比例する。したがって、大きな作動器については、図3において領域301に示されるように、付着力を上回る離脱力を生成することが可能である。
吸入器の実施形態
図4Aは、本発明の実施形態による乾燥粉末吸入器(DPI)400の斜視図を示す。DPI400は、出口流路402が貫通しているマウスピース401を備えている。DPI400はさらに、マウスピース401と係合したチャンバ部分403を備えている。DPI400はさらに、マウスピース401およびチャンバ部分403をともに固定するための保持機構404を備えていてもよい。連結機構404は、例えばDPI400の装填を行うために、マウスピース401およびチャンバ部分403を分離および再結合可能とするために、着脱式であってもよい。任意の適切な連結機構が使用されうる。図4BはDPI400の側面図を示し、図4CはDPI400の断面図であっていくつかの内部詳細を示している。
患者の吸気努力のみによって駆動される吸入器は受動吸入器として知られている。本発明は受動吸入器において具体化されてもよいし、空気流を推進するために少なくとも部分的に別のエネルギー源を使用する吸入器において具体化されてもよいことが認識されるであろう。
別の態様によれば、予め装填された作動器を備えたカートリッジが提供される。そのようなカートリッジは、1回量の粉末状の薬剤を包含することが可能であり、かつ本発明の原理に従って作動する再使用可能なDPIに装填されうる。
別の態様によれば、連用式吸入器が提供される。図13はある実施形態による連用式吸入器1300を示す。連用式吸入器1300は、マウスピース部分1301および丸形の基部1302を備えている。回転式キャリッジ1303が基部1302の内部に配置され、カートリッジ、例えば上述のカートリッジ1000に類似のカートリッジを受承するように構成された1組のスロット1304を備えている。カートリッジはそれぞれ、粉末状の薬剤が付着せしめられた作動器1006を備えている。
試験により、実施形態によるデバイスが、従来のデバイスと比較して、少ない空気流量でもなお効果的に薬剤を送達しうることが示された。下記の表4は、本発明を具体化したDPIによって生産された粒子の吸入性画分を、ラクトース担体粒子を用いる従来の吸入器によって生産されたものと比較している。肺疾患について一般に処方される異なる2つの薬剤、すなわちコルチコステロイドであるブデソニドおよびβアゴニストであるサルブタモールについて、3種類の異なる流量において試験を行った。
Claims (31)
- 乾燥粉末吸入器であって、
該吸入器に入る空気を通す入口流路と、
該入口流路から空気を受け取るチャンバであって、粉末状の薬剤が付着せしめられた単一の作動器を包含するサイズおよび形状であるチャンバと、
入口流路と相対向する側のチャンバ端部に配置された保持部材であって、空気および粉末状の薬剤が該保持部材を通り抜けるのを可能にするとともに作動器が該保持部材を通り抜けるのを防止するサイズに形成されている1以上の開口部を有する保持部材と、
患者に送達されるべく吸入器から出る空気および粉末状の薬剤を通す出口流路と
を含んでなり、
前記チャンバは長手軸を有し、前記入口流路は前記長手軸とほぼ同軸であり、かつ前記出口流路は前記チャンバの前記長手軸とほぼ同軸であり、
吸入器の幾何学的構造は、前記単一の作動器を前記長手軸とほぼ同軸方向に繰り返し振動させる流れプロファイルがチャンバ内部で生成され、その繰り返される振動により粉末状の薬剤が作動器の表面から離脱せしめられて空気に巻き込まれ、かつ出口流路を通して患者に送達されるようになっている、乾燥粉末吸入器。 - 吸入器を通る流れ経路の断面積はチャンバの入口で一段階大きくなる、請求項1に記載の乾燥粉末吸入器。
- チャンバの入口において、チャンバの直径は入口流路の直径の少なくとも1.5倍である、請求項2に記載の乾燥粉末吸入器。
- 入口流路はテーパ状チューブを含んでなる、請求項1に記載の乾燥粉末吸入器。
- 出口流路は長さに沿って断面積が変化するチューブを含んでなる、請求項1に記載の乾燥粉末吸入器。
- 出口流路は、患者の口内に配置されるようになされたマウスピース内に含められる、請求項1に記載の乾燥粉末吸入器。
- 出口流路は、患者の鼻孔に合うようになされた鼻アダプタ内に含められる、請求項1に記載の乾燥粉末吸入器。
- 吸入器の外から補給空気を受け取って、該補給空気を、チャンバを通過させずに患者に送達する1以上のバイパス流路をさらに含んでなる、請求項1に記載の乾燥粉末吸入器。
- 入口流路は第1入口流路でありかつチャンバは第1チャンバであって、乾燥粉末吸入器は第2入口流路および第2チャンバをさらに含んでなる、請求項1に記載の乾燥粉末吸入器。
- 第1および第2チャンバから出る空気および粉末状の薬剤は出口流路に送達される、請求項9に記載の乾燥粉末吸入器。
- 出口流路は第1出口流路であり、乾燥粉末吸入器は第2出口流路をさらに含んでなり、第1チャンバから出る空気および粉末状の薬剤は第1出口流路に送達され、かつ、第2チャンバから出る空気および粉末状の薬剤は第2出口流路に送達される、請求項9に記載の乾燥粉末吸入器。
- 第1および第2のチャンバは同じ寸法のものである、請求項9に記載の乾燥粉末吸入器。
- 乾燥粉末吸入器は、作動器を包含しているカプセルをチャンバ内に挿入することができるように分離可能である、請求項1に記載の乾燥粉末吸入器。
- カプセル端部の封止部を穿刺するための機構をさらに含んでなる、請求項13に記載の乾燥粉末吸入器。
- 吸入器を通る空気流は患者の吸気努力によって駆動される、請求項1に記載の乾燥粉末吸入器。
- 作動器と組み合わされている、請求項1に記載の乾燥粉末吸入器。
- 作動器は発泡ポリスチレン製である、請求項16に記載の乾燥粉末吸入器。
- 作動器は0.001〜0.50g/cm3の密度を有する、請求項16に記載の乾燥粉末吸入器。
- 作動器は少なくとも1000μmの直径を有する、請求項16に記載の乾燥粉末吸入器。
- 作動器は1000〜6000μmの直径を有する、請求項16に記載の乾燥粉末吸入器。
- 作動器は0.1〜5.0ミリグラムの質量を有する、請求項16に記載の乾燥粉末吸入器。
- 作動器は0.5〜2.5ミリグラムの質量を有する、請求項16に記載の乾燥粉末吸入器。
- 薬剤の組み合わせが作動器に付着せしめられる、請求項16に記載の乾燥粉末吸入器。
- 複数のチャンバであって、該チャンバのうちいずれかを選択的に出口流路に合わせて位置調整するための回転要素上に配置された同複数のチャンバを含んでなる、請求項1に記載の乾燥粉末吸入器。
- 入口流路、チャンバ、および出口流路を備えた乾燥粉末吸入器であって、前記チャンバは長手軸を有し、前記入口流路は前記長手軸とほぼ同軸であり、前記チャンバは単一の作動器を収容しており、1以上の粉末状の薬剤が前記作動器の外側表面に付着せしめられている、乾燥粉末吸入器を得るステップと;
前記長手軸とほぼ同軸である出口流路を通して吸入が行われて、空気を入口流路内に流入させ、チャンバを通過させ、かつ出口チャンバを通過させて、空気流によりさらに作動器が前記長手軸とほぼ同軸方向に繰り返し振動せしめられて該作動器の表面から粉末状の薬剤が容易に追い出されて空気流に巻き込まれ、かつ出口流路を通して運搬されるステップと
を含んでなる方法。 - チャンバを含んでなる吸入器の部分と出口流路を含んでなる吸入器の部分とを分離するステップと、
チャンバに作動器を装填するステップと、
チャンバを含んでなる吸入器の部分と出口流路を含んでなる吸入器の部分とを再係合するステップと
をさらに含んでなる、請求項25に記載の方法。 - 粉末状の薬剤の組み合わせが作動器に付着せしめられる、請求項25に記載の方法。
- 乾燥粉末吸入器は、各々が薬剤が付着せしめられた単一の作動器を収容する少なくとも2個のチャンバを備え、空気流は各作動器を振動させて吸入されるべき粉末状の薬剤を容易に追い出す、請求項25に記載の方法。
- 各作動器には同じ粉末状の薬剤が付着せしめられる、請求項28に記載の方法。
- 各作動器には異なる粉末状の薬剤が付着せしめられる、請求項28に記載の方法。
- 乾燥粉末吸入器であって、
該吸入器に入る空気を通す入口流路と、
該入口流路から空気を受け取るチャンバであって、単一の作動器を包含するサイズおよび形状であるチャンバと、
入口流路と相対向する側のチャンバ端部に配置された保持部材であって、空気および粉末が該保持部材を通り抜けるのを可能にするとともに作動器が該保持部材を通り抜けるのを防止するサイズに形成されている1以上の開口部を有する保持部材と、
患者に送達されるべく吸入器から出る空気および粉末を通す出口流路と、
を含んでなり、
前記チャンバは長手軸を有し、前記入口流路は前記長手軸とほぼ同軸であり、かつ前記出口流路は前記チャンバの前記長手軸とほぼ同軸であり、
吸入器の幾何学的構造は、前記単一の作動器を前記長手軸とほぼ同軸方向に繰り返し振動させる流れプロファイルがチャンバ内部で生成され、その繰り返される振動により前記粉末が出口流路を通して患者に送達されるようになっている、乾燥粉末吸入器。
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US8651104B2 (en) | 2014-02-18 |
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