JP2012532638A - 酸素吸収材を含むプレフィルドシリンジ - Google Patents
酸素吸収材を含むプレフィルドシリンジ Download PDFInfo
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- 239000001301 oxygen Substances 0.000 title claims abstract description 145
- 229910052760 oxygen Inorganic materials 0.000 title claims abstract description 145
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 title claims abstract description 144
- 239000006096 absorbing agent Substances 0.000 title claims abstract description 50
- 229940071643 prefilled syringe Drugs 0.000 title description 3
- 239000003814 drug Substances 0.000 claims abstract description 127
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- 238000004519 manufacturing process Methods 0.000 claims description 4
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- 238000004891 communication Methods 0.000 claims description 3
- RZXDTJIXPSCHCI-UHFFFAOYSA-N hexa-1,5-diene-2,5-diol Chemical compound OC(=C)CCC(O)=C RZXDTJIXPSCHCI-UHFFFAOYSA-N 0.000 claims description 3
- 230000035699 permeability Effects 0.000 claims description 3
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- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 2
- 229910052782 aluminium Inorganic materials 0.000 claims description 2
- NBVXSUQYWXRMNV-UHFFFAOYSA-N fluoromethane Chemical compound FC NBVXSUQYWXRMNV-UHFFFAOYSA-N 0.000 claims description 2
- 230000000717 retained effect Effects 0.000 claims description 2
- 230000001419 dependent effect Effects 0.000 claims 1
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- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 4
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 4
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- WKBPZYKAUNRMKP-UHFFFAOYSA-N 1-[2-(2,4-dichlorophenyl)pentyl]1,2,4-triazole Chemical compound C=1C=C(Cl)C=C(Cl)C=1C(CCC)CN1C=NC=N1 WKBPZYKAUNRMKP-UHFFFAOYSA-N 0.000 description 2
- 238000012371 Aseptic Filling Methods 0.000 description 2
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- 150000001875 compounds Chemical class 0.000 description 2
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- 150000002894 organic compounds Chemical class 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
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- 235000010378 sodium ascorbate Nutrition 0.000 description 2
- 229960005055 sodium ascorbate Drugs 0.000 description 2
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 description 2
- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 0.000 description 2
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- 206010002199 Anaphylactic shock Diseases 0.000 description 1
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- 125000002066 L-histidyl group Chemical group [H]N1C([H])=NC(C([H])([H])[C@](C(=O)[*])([H])N([H])[H])=C1[H] 0.000 description 1
- 208000012266 Needlestick injury Diseases 0.000 description 1
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- JRZJOMJEPLMPRA-UHFFFAOYSA-N olefin Natural products CCCCCCCC=C JRZJOMJEPLMPRA-UHFFFAOYSA-N 0.000 description 1
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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- A—HUMAN NECESSITIES
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- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
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- B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
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- B65B31/025—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas specially adapted for rigid or semi-rigid containers
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Abstract
【選択図】図1
Description
・ユーザが薬物を投与する際に必要な手順が増える。
・シリンジまたは自己注射器の保管中、薬物がエンベロープで見えにくくなることがあるため、使用前の薬物の品質検査がより困難または不可能になる。
・エンベロープにより、薬物の包装が全体として大きくなる。
・ユーザがエンベロープから薬物容器を取り出すのが早すぎて薬物を酸素に汚染させてしまう危険性がある。これは特に、薬物を酸素から保護するにあたってのエンベロープの機能と重要性をユーザが理解していない場合に起こりやすい。
・ユーザ、特に身体障害または認識障害を有するユーザにとって、エンベロープを開けることが難しい場合がある。
・酸素不浸透性の第2のシール21は、酸素不浸透性の外部容器3の開口部を完全に封止している。
・第1の酸素浸透性シール4は、プランジャー15を封止している。
・プランジャー15は、1以上の通路または表面溝部29を含んでおり、酸素がプランジャー15と酸素不浸透性の第2のシール21との間の空間内を自在に移動できるようになっている。
・酸素が、プランジャー15と酸素不浸透性の第2のシール21との間の空間から酸素吸収材14まで、自由に酸素浸透性の内部容器2の外側を通ることができるように、1以上の開口部28が酸素浸透性の内部容器2に形成されている。
Claims (26)
- 薬物投薬用シリンジであって、
薬物を収容する硬質のシリンジ本体と、
酸素吸収材と、
前記薬物および前記酸素吸収材の間に位置し、前記薬物が酸素吸収材に接触することを防ぐとともに酸素が前記薬物から前記酸素吸収材へ通ることができるようにする分離要素と、
前記薬物および前記酸素吸収材の両方を取り囲む酸素不浸透性エンクロージャーとを備え、
前記酸素不浸透性エンクロージャーは、前記硬質のシリンジ本体の一部もしくは全部をなす、または前記硬質のシリンジ本体内に保持される、薬物投薬用シリンジ。 - 前記酸素不浸透性エンクロージャーは、完全に前記硬質のシリンジ本体の外表面の内部にある、請求項1に記載のシリンジ。
- 前記薬物に接触しこれを包む内部容器をさらに備え、
前記内部容器は前記酸素不浸透性エンクロージャーよりも酸素浸透性が高い、請求項1または2に記載のシリンジ。 - 前記内部容器は前記分離要素である、請求項3に記載のシリンジ。
- 前記酸素吸収材は、実質的に前記内部容器の外表面全体と気体連結状態にある、請求項4に記載のシリンジ。
- 前記内部容器に取り囲まれたプランジャーをさらに備える、請求項3から5のいずれか一つに記載のシリンジ。
- 前記酸素吸収材は、前記薬物の前記プランジャーとは反対側に位置している、請求項6に記載のシリンジ。
- 前記内部容器は環状オレフィン重合体材料からなる、請求項3から7のいずれか一つに記載のシリンジ。
- 前記シリンジは自己注射器である、先行する請求項のいずれか一つに記載のシリンジ。
- 前記薬物を前記シリンジから投薬する針をさらに備え、
前記薬物の投薬の前には、前記針が前記酸素不浸透性エンクロージャーの外部に格納されている、先行する請求項のいずれか一つに記載のシリンジ。 - 前記薬物を前記シリンジから投薬する針をさらに備え、
前記薬物の投薬の前には、前記針が前記酸素不浸透性エンクロージャーの内部に格納されている、先行する請求項のいずれか一つに記載のシリンジ。 - 前記酸素吸収材は、前記薬物の前記針とは反対側に位置している、請求項10から11のいずれか一つに記載のシリンジ。
- 前記酸素不浸透性エンクロージャーは、少なくとも部分的に透明である、先行する請求項のいずれか一つに記載のシリンジ。
- 前記硬質のシリンジ本体の一部をなす穿孔メカニズムをさらに備え、
前記穿孔メカニズムはユーザ作動要素を含み、前記ユーザ作動要素が作動すると前記酸素不浸透性エンクロージャーに穿孔して前記薬物が前記シリンジから投薬されるよう構成されている、先行する請求項のいずれか一つに記載のシリンジ。 - 前記穿孔メカニズムは、前記穿孔メカニズムの動作により前記薬物が前記シリンジから投薬されるよう構成されている、請求項14に記載のシリンジ。
- 前記薬物を前記シリンジから投薬する針をさらに備え、
前記穿孔メカニズムは、前記穿孔メカニズムの動作により前記針を前記硬質のシリンジ本体から押し出すよう構成されている、請求項14または15に記載のシリンジ。 - 前記薬物を前記シリンジから投薬する針をさらに備え、
前記穿孔メカニズムは、前記穿孔メカニズムの動作により前記針を前記薬物と流体連結した状態にするよう構成されている、請求項14、15、または16に記載のシリンジ。 - 前記穿孔メカニズムは、前記ユーザ作動要素が作動すると前記内部容器に穿孔するよう構成されている、請求項3に従属する場合における、請求項14から17のいずれか一つに記載のシリンジ。
- 前記酸素吸収材は、前記穿孔メカニズムの一部がその内部を通過できるような形状をしている、請求項14から18のいずれか一つに記載のシリンジ。
- 前記酸素不浸透性エンクロージャーは酸素不浸透性のシールを含み、
前記穿孔メカニズムは、前記ユーザ作動要素が作動すると前記シールに穿孔するよう構成される、請求項14から19のいずれか一つに記載のシリンジ。 - 前記酸素不浸透性のシールは、アルミニウム、ポリアミド、フッ化炭素、またはエチレンビニルアルコールからなる、請求項20に記載のシリンジ。
- 硬質のシリンジ本体と、酸素吸収材と、薬物を包み前記酸素吸収材が前記薬物と接触することを防ぐとともに酸素が前記薬物から前記酸素吸収材へ通ることができるようにする内部容器と、前記内部容器および前記酸素吸収材の両方を取り囲む酸素不浸透性エンクロージャーとを備え、前記酸素不浸透性エンクロージャーは前記硬質のシリンジ本体の一部もしくは全部をなすまたは前記硬質のシリンジ本体内に保持される、シリンジの製造方法であって、
無菌環境または低微粒子環境において、前記内部容器に前記薬物を充填し、前記内部容器を封止するステップと、
前記第1の環境から隔離された異なる環境において、前記酸素吸収材および前記内部容器を前記酸素不浸透性エンクロージャー内に設置するステップと、
前記酸素不浸透性エンクロージャーを封止するステップとを備える、シリンジの製造方法。 - 前記酸素吸収材は、前記内部容器が前記充填および封止された後に前記酸素不浸透性エンクロージャー内に設置される、請求項22に記載の方法。
- 前記内部容器を充填し封止するステップの前に、前記内部容器内にプランジャーを設置するステップを備える、請求項22または23に記載の方法。
- 実質的に添付の図面を参照して本明細書に記載されるシリンジ。
- 実質的に添付の図面を参照して本明細書に記載されるシリンジの製造方法。
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GB0912073.4A GB2471726B (en) | 2009-07-10 | 2009-07-10 | A pre-filled syringe including an oxygen absorber |
PCT/GB2010/001244 WO2011004137A1 (en) | 2009-07-10 | 2010-06-23 | A pre-filled syringe including an oxygen absorber |
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BR112012000619A2 (pt) | 2019-09-24 |
KR20120041216A (ko) | 2012-04-30 |
GB2471726A (en) | 2011-01-12 |
US8679068B2 (en) | 2014-03-25 |
GB0912073D0 (en) | 2009-08-19 |
IN2012DN00467A (ja) | 2015-06-05 |
CA2804580A1 (en) | 2011-01-13 |
EP2451505A1 (en) | 2012-05-16 |
CN102470212B (zh) | 2014-08-27 |
EP2451505B1 (en) | 2016-05-04 |
CN102470212A (zh) | 2012-05-23 |
AU2010270005A1 (en) | 2012-02-02 |
US20120143144A1 (en) | 2012-06-07 |
GB2471726B (en) | 2013-09-11 |
WO2011004137A1 (en) | 2011-01-13 |
ZA201200784B (en) | 2012-10-31 |
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