JP5350388B2 - 単位用量薬物パッケージの粉体調整 - Google Patents
単位用量薬物パッケージの粉体調整 Download PDFInfo
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- JP5350388B2 JP5350388B2 JP2010531047A JP2010531047A JP5350388B2 JP 5350388 B2 JP5350388 B2 JP 5350388B2 JP 2010531047 A JP2010531047 A JP 2010531047A JP 2010531047 A JP2010531047 A JP 2010531047A JP 5350388 B2 JP5350388 B2 JP 5350388B2
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Images
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
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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
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0005—Details of inhalators; Constructional features thereof with means for agitating the medicament
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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
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0005—Details of inhalators; Constructional features thereof with means for agitating the medicament
- A61M15/0006—Details of inhalators; Constructional features thereof with means for agitating the medicament using rotating 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
- A61M15/0005—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
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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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Anesthesiology (AREA)
- Biomedical Technology (AREA)
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- Hematology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
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- Veterinary Medicine (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Basic Packing Technique (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Description
本出願は、米国特許法第119条(e)に基づき、2007年10月25日に出願された米国仮出願番号第61/000,627号の利益を主張し、これは参照により全体が本願明細書に組み込まれる。
特に明記しない限り、本開示で使用する用語を以下の通りに定義する。標準的な用語は、本願明細書において明白に定義されない限り、当業者によって理解されるようなこれらの通常で通例の意味を示すこととする。
調整後、単位用量の薬物パッケージは、末端のユーザ用に仕上げ工程で処理される。単位用量の薬物パッケージを仕上げする工程は、少なくとも1つの単位用量の薬物パッケージを穿孔すること、又は少なくとも一つの単位用量の薬物パッケージを打ち抜いて、個々の単位用量の薬物パッケージを形成することを含む。仕上げ工程はまた、単位用量の薬物パッケージを二次容器(例えば耐水性のパウチ)にパッケージすることを含む。
本発明の1つ以上の実施形態の組成物は、当業者に知られていて利用可能である種々の方法および技術によって投与することができる。
レン、エクリズマブ、アンブリセンタン、アルモダフィニル、ランレオチド、サプロプテリン、リマンチジン(rimantidine)、および、適用する場合には、上記のアナログ、アゴニスト、アンタゴニスト、インヒビター、および薬学的に許容され得る塩形態。ペプチドおよびタンパク質に関して、本発明は、合成、天然、グリコシル化、非グリコシル化、ペグ化形態、ならびに生物活性フラグメントおよびそのアナログを包含することを意図するものである。
Claims (15)
- 少なくとも1つの単位用量の薬物パッケージの内容物を、単位用量の薬物パッケージの仕上げステップの前に調整する方法であって、
少なくとも1つの超音波プローブおよび少なくとも1つの単位用量の薬物パッケージを接触させて、振動を発生させ、少なくとも1つの単位用量の薬物パッケージの内容物を少なくとも部分的に解凝集する工程を含み、
前記一つの単位用量の薬物パッケージは、5マイクロメートル未満の空気動力学的直径を有する粒子を含み、
前記粒子は、活性薬剤、リン脂質、及び多価陽イオンを含み、
前記少なくとも1つの単位用量の薬物パッケージはタブを有し、
前記超音波プローブが前記タブ以外の前記少なくとも1つの単位用量の薬物パッケージの一部分に接触し、
前記超音波プローブが、約5kHz〜約100kHzの範囲にある振動数を発生させる、方法。 - 前記超音波プローブが、約0.00127cm〜約0.127cmの振動振幅を発生させる、請求項1に記載の方法。
- 前記超音波プローブからの振動が不定期間印加される、請求項1に記載の方法。
- 前記超音波プローブの周波数および振幅のうちの少なくとも1つをチューニングすることによって、前記振動が調整される、請求項1に記載の方法。
- 少なくとも1つの単位用量の薬物パッケージが、部材によって前記超音波プローブと強制的に接触する、請求項1に記載の方法。
- 前記超音波プローブが、少なくとも1つの単位用量の薬物パッケージの下方、上部、または側部に配置されている、請求項1に記載の方法。
- 前記接触工程が、
抑制装置を、前記抑制装置が直接的または間接的に少なくとも1つの単位用量の薬物パッケージと接触する係合位置と、前記抑制装置が1つの単位用量の薬物パッケージと接触しない非係合位置との間で作動させる工程を含む、請求項1に記載の方法。 - 前記接触工程が、
抑制装置を、前記抑制装置が直接的または間接的に少なくとも1つの単位用量の薬物パッケージと接触する係合位置と、前記抑制装置が1つの単位用量の薬物パッケージと接触しない非係合位置との間で垂直方向に作動させる工程を含む、請求項1に記載の方法。 - 前記内容物が、乾燥粉末薬物を含む、請求項1に記載の方法。
- 前記単位用量の薬物パッケージが、少なくとも1つのブリスターパックを備える、請求項1に記載の方法。
- 少なくとも1つの単位用量の薬物パッケージのキャビティを前記内容物で充填する工程;および
前記充填された単位用量の薬物パッケージのキャビティを密封して、前記単位用量の薬物パッケージを形成する工程、
をさらに含む、請求項1に記載の方法。 - 充填された単位用量の薬物パッケージのキャビティを密封する工程が、前記単位用量の薬物パッケージのキャビティに蓋を密封して、前記単位用量の薬物パッケージを形成する工程を含む、請求項11に記載の方法。
- 少なくとも1つの単位用量の薬物パッケージの内容物を、単位用量の薬物パッケージの仕上げステップの前に調整する装置であって、
少なくとも1つの単位用量の薬物パッケージを振動させて、前記単位用量の薬物パッケージの内容物を少なくとも部分的に解凝集する少なくとも1つの超音波プローブを備え、 前記一つの単位用量の薬物パッケージは、5マイクロメートル未満の空気動力学的直径を有する粒子を含み、
前記粒子は、活性薬剤、リン脂質、及び多価陽イオンを含み、
前記少なくとも1つの単位用量の薬物パッケージはタブを有し、
前記超音波プローブが前記タブ以外の前記少なくとも1つの単位用量の薬物パッケージの一部分に接触し、
前記超音波プローブが、約5kHz〜約100kHzの範囲にある振動数を発生させる、装置。 - 少なくとも一つの単位用量の薬物パッケージは、少なくとも50%の放出薬用量を有する、請求項1に記載の方法。
- 前記超音波プローブは、固定周波数に対して40%の振幅で動作される、請求項1に記載の方法。
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US62707P | 2007-10-25 | 2007-10-25 | |
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PCT/US2008/012117 WO2009055030A2 (en) | 2007-10-25 | 2008-10-23 | Powder conditioning of unit dose drug packages |
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JP5350388B2 true JP5350388B2 (ja) | 2013-11-27 |
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EP (1) | EP2207584A2 (ja) |
JP (1) | JP5350388B2 (ja) |
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AU (1) | AU2008317307A1 (ja) |
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MX (1) | MX2010004507A (ja) |
RU (1) | RU2517140C2 (ja) |
WO (1) | WO2009055030A2 (ja) |
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US9006175B2 (en) | 1999-06-29 | 2015-04-14 | Mannkind Corporation | Potentiation of glucose elimination |
DE60318938T2 (de) | 2002-03-20 | 2009-01-22 | Mannkind Corp., Valencia | Inhalationsgerät |
EP1786784B1 (en) | 2004-08-20 | 2010-10-27 | MannKind Corporation | Catalysis of diketopiperazine synthesis |
CA2578175C (en) | 2004-08-23 | 2014-10-14 | Mannkind Corporation | Diketopiperazine salts, diketomorpholine salts or diketodioxane salts for drug delivery |
US7803404B2 (en) | 2005-09-14 | 2010-09-28 | Mannkind Corporation | Method of drug formulation based on increasing the affinity of active agents for crystalline microparticle surfaces |
BRPI0707991B8 (pt) | 2006-02-22 | 2021-05-25 | Mannkind Corp | métodos de preparação de um medicamento em pó seco com uma propriedade farmacêutica melhorada, dito pó seco e uso de uma quantidade efetiva do pó seco |
US8485180B2 (en) | 2008-06-13 | 2013-07-16 | Mannkind Corporation | Dry powder drug delivery system |
EP2570147B1 (en) | 2008-06-13 | 2017-10-18 | MannKind Corporation | A dry powder inhaler and system for drug delivery |
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2008
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- 2008-10-23 AU AU2008317307A patent/AU2008317307A1/en not_active Abandoned
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- 2008-10-23 KR KR1020107011222A patent/KR20100098610A/ko not_active Application Discontinuation
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KR20100098610A (ko) | 2010-09-08 |
US20100287884A1 (en) | 2010-11-18 |
MX2010004507A (es) | 2010-07-05 |
WO2009055030A3 (en) | 2009-06-18 |
JP2011500268A (ja) | 2011-01-06 |
CN101835508A (zh) | 2010-09-15 |
EP2207584A2 (en) | 2010-07-21 |
WO2009055030A2 (en) | 2009-04-30 |
AU2008317307A1 (en) | 2009-04-30 |
BRPI0818818A2 (pt) | 2015-04-22 |
CA2703597A1 (en) | 2009-04-30 |
RU2517140C2 (ru) | 2014-05-27 |
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