JP2022517091A - 薬剤を凍結乾燥、再構成、及び送達するためのシステム、並びに関連する方法 - Google Patents
薬剤を凍結乾燥、再構成、及び送達するためのシステム、並びに関連する方法 Download PDFInfo
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Abstract
Description
本出願は、2019年1月11日に出願された米国仮出願第62/791,182号の優先権を主張するものであり、その全容が参照により本明細書に組み込まれる。
本発明は、液体又は粉末などの2つ又は3つ以上の物質を混合するためのモジュール式システムに関する。より詳細には、本発明は、薬剤を凍結乾燥、再構成、及び送達する際に使用することができるモジュール式システム、並びに関連する同システムを使用する方法に関する。
Claims (25)
- モジュール式注射器組立体であって、
近位端及び遠位端を有する管状注射器筒であって、長手方向軸を画定する、管状注射器筒と、
前記管状注射器筒内で摺動可能なプランジャと、
停止部分及びルアーチップを含むキャップ組立体であって、前記停止部分が、前記管状注射器筒の前記遠位端に受け入れ可能であり、通気窓を画定する、キャップ組立体と、を備え、
前記キャップ組立体は、前記キャップ組立体と前記管状注射器筒との間の通気を防止するために前記通気窓が前記管状注射器筒によって覆われている密封位置と、前記キャップ組立体と前記管状注射器筒との間に前記通気窓が通気を形成する通気位置との間で、前記長手方向軸に沿って前記管状注射器筒内を摺動可能である、モジュール式注射器組立体。 - 前記停止部分が、フランジを画定する遠位端と、前記遠位端の反対側にある近位端と、を更に備え、前記通気窓が、前記停止部分の前記近位端と交差する、請求項1に記載のモジュール式注射器組立体。
- 前記キャップ組立体が前記密封位置にあるとき、前記フランジが前記管状注射器筒の前記遠位端に接触し、前記キャップ組立体が前記通気位置にあるとき、前記フランジが前記管状注射器筒の前記遠位端から離隔される、請求項1に記載のモジュール式注射器組立体。
- 前記キャップ組立体が、前記停止部分と、前記管状注射器筒の前記遠位端との間に適合する密封リングを備える、請求項1に記載のモジュール式注射器組立体。
- 前記通気窓が、前記密封リング内に位置している、請求項4に記載のモジュール式注射器組立体。
- 前記通気窓が、前記停止部分に成形されている、請求項1に記載のモジュール式注射器組立体。
- 前記ルアーチップ上に位置するOVS閉鎖部を更に備える、請求項1に記載のモジュール式注射器組立体。
- 前記プランジャが、プランジャロッドへの取り外し可能な取り付けのための連結具を含む、請求項1に記載のモジュール式注射器組立体。
- 前記連結具を介して前記プランジャに取り外し可能に連結されたプランジャロッドを更に備える、請求項8に記載のモジュール式注射器組立体。
- 前記管状注射器筒内に位置する凍結乾燥された薬剤を更に含む、請求項1に記載のモジュール式注射器組立体。
- 前記凍結乾燥された薬剤が、インフリキシマブを含む、請求項10に記載のモジュール式注射器組立体。
- 薬剤を凍結乾燥する方法であって、
前記薬剤を収容するモジュール式注射器組立体を提供することであって、前記モジュール式注射器組立体が、管状注射器筒と、前記管状注射器筒内で摺動可能なプランジャと、前記管状注射器筒上で密封位置と通気位置との間を移動可能なキャップ組立体と、を含む、提供することと、
前記キャップ組立体が前記通気位置にある状態で前記薬剤を凍結乾燥させることであって、それにより、蒸気が前記キャップ組立体を通して通気される、凍結乾燥させることと、
前記キャップ組立体を前記通気位置から前記密封位置まで移動させることと、を含む、方法。 - 前記プランジャを前記管状注射器筒の近位端に挿入することと、
前記管状注射器筒を前記薬剤で充填することと、
前記キャップ組立体が前記通気位置に位置する状態で、前記キャップ組立体を前記管状注射器筒の遠位端に挿入することと、を更に含む、請求項12に記載の方法。 - 前記キャップ組立体を前記通気位置から前記密封位置まで移動させることが、前記キャップ組立体を前記管状注射器筒の前記遠位端に押し込むことを含む、請求項12に記載の方法。
- 前記キャップ組立体を前記管状注射器筒の前記遠位端に押し込むことが、前記キャップ組立体内に位置している通気窓を密封する、請求項14に記載の方法。
- 前記キャップ組立体を前記通気位置から前記密封位置まで移動させることが、凍結乾燥棚を使用して前記キャップ組立体に力を加えることを含む、請求項12に記載の方法。
- 前記凍結乾燥棚を使用して前記キャップ組立体に力を加えることが、前記凍結乾燥棚と前記キャップ組立体との間に位置する圧縮治具に力を加えることを含む、請求項16に記載の方法。
- 前記密封位置に位置するときに、前記キャップ組立体の上に圧着リングを適用することを更に含む、請求項12に記載の方法。
- プランジャロッドを前記プランジャに取り付けることを更に含む、請求項12に記載の方法。
- 前記薬剤が、インフリキシマブを含む、請求項12に記載の方法。
- 凍結乾燥された薬剤を再構成する方法であって、
前記凍結乾燥された薬剤を収容するモジュール式注射器組立体を提供することであって、前記モジュール式注射器組立体が、管状注射器筒と、前記管状注射器筒内で摺動可能なプランジャと、ルアーチップを含むキャップ組立体と、を含む、提供することと、
プランジャロッドを前記プランジャに連結することと、
前記ルアーチップを希釈剤の供給源に連結することと、
前記希釈剤を前記管状注射器筒内に引き込むために、前記プランジャロッドを後退させることと、を含む、方法。 - 前記再構成された薬剤を送達することであって、
前記希釈剤の供給源を前記ルアーチップから分離することと、
前記ルアーチップを通して前記凍結乾燥された薬剤を排出するために、前記プランジャを押下することと、によって、送達することを更に含む、請求項21に記載の方法。 - 前記再構成された薬剤を送達することが、
針、バイアル、バイアルアダプタ、又はIVバッグのうちの少なくとも1つを前記ルアーチップに連結することを更に含む、請求項22に記載の方法。 - 前記ルアーチップを露出させるために、OVS閉鎖部の一次閉鎖部分を取り外すことを更に含む、請求項21に記載の方法。
- 前記凍結乾燥された薬剤が、インフリキシマブを含む、請求項21に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201962791182P | 2019-01-11 | 2019-01-11 | |
US62/791,182 | 2019-01-11 | ||
PCT/IB2020/050183 WO2020144640A1 (en) | 2019-01-11 | 2020-01-10 | System for lyophilizing, reconstituting, and delivering a medication, and related methods |
Publications (1)
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US (1) | US20220110829A1 (ja) |
EP (1) | EP3886951A1 (ja) |
JP (1) | JP2022517091A (ja) |
CN (1) | CN113271994A (ja) |
AU (1) | AU2020206879A1 (ja) |
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US11536512B1 (en) * | 2021-09-16 | 2022-12-27 | Thomas John Harkins, JR. | Apparatus and method for lyophilization |
WO2023095094A1 (en) * | 2021-11-29 | 2023-06-01 | University Of Miami | Ocular drug transfer and dispensing device |
US11723870B1 (en) | 2022-01-31 | 2023-08-15 | Thomas John Harkins, JR. | Assembly, apparatus and method for lyophilization |
US11957790B1 (en) | 2022-01-31 | 2024-04-16 | Thomas John Harkins, JR. | Combination lyophilization and dispensing syringe assembly and methods of using same |
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US5871110A (en) * | 1996-09-13 | 1999-02-16 | Grimard; Jean-Pierre | Transfer assembly for a medicament container having a splashless valve |
AT500930B1 (de) * | 2004-10-25 | 2007-03-15 | Pharma Consult Ges M B H & Co | Verfahren und vorrichtung zum lyophilisieren, rekonstituieren und verabreichen eines rekonstituierten wirkstoffes |
KR20160045740A (ko) * | 2013-08-07 | 2016-04-27 | 유니트랙트 시린지 피티와이 엘티디 | 후퇴가능한 바늘 주사기를 위한 루어 연결 어댑터 |
WO2018035047A1 (en) * | 2016-08-15 | 2018-02-22 | Genentech, Inc. | Vial assembly with luer fitting |
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- 2020-01-10 AU AU2020206879A patent/AU2020206879A1/en active Pending
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CN113271994A (zh) | 2021-08-17 |
CA3126373A1 (en) | 2020-07-16 |
EP3886951A1 (en) | 2021-10-06 |
WO2020144640A1 (en) | 2020-07-16 |
US20220110829A1 (en) | 2022-04-14 |
BR112021013076A2 (pt) | 2021-09-21 |
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