JP2015530200A - 薬物流体を含む送達装置 - Google Patents
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- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
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- B65D81/26—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
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Abstract
Description
総厚:500μm、DIN 53370;基本重量:646g/m2、ISO 2286−2;
酸素透過率:1cm3/m2 d bar未満、23℃/35% r.h.、DIN 53380;
水蒸気透過率:1g/m2 d未満、23℃/85% r.h.、DIN 53122。
総厚:100μm、DIN 53370;基本重量:107.5g/m2、ISO 2286−2;縦方向引張強度:40N/mm2〜60N/mm2、ISO 527−3;横方向引張強度:35N/mm2〜55N/mm2、ISO 527−3;縦方向破断伸び:40%〜120%、ISO 527−3;横方向破断伸び:40%〜120%、ISO 527−3;酸素透過率:1cm3/m2 d bar、23℃/35% r.h.、DIN 53380;CO2透過率:4cm3/m2 d bar未満、23℃/35% r.h.、DIN 53380;N2透過率:1cm3/m2 d bar未満、23℃/35% r.h.、DIN 53380。
101 プラスチック容器
103 プラスチックプランジャーロッド
105 インサート
107 医薬有効成分の流体
109 ノズル
111 クロージャ
113 プラスチックプランジャー
115 サイドウィング
117 サイドウィング
119 酸素密封エンベロープ
121 シェル
123 フィルム
125 縁
127 送達シリンジの収容凹部
129 プランジャーロッドの収容凹部
130 送達シリンジの収容凹部とプランジャーロッドの収容凹部との間のスペーサ又は壁部
131 クランプ凸部
133 クランプ凸部
135 酸素吸収剤
300 方法
301 準備する工程
303 満たす工程
305 酸素を密封して覆う工程
Claims (18)
- プラスチック容器(101)を含む送達シリンジ(100)であって、該プラスチック容器(101)が酸素感受性の医薬有効成分の流体(107)で満たされている、送達シリンジと、
酸素を密封するように前記送達シリンジ(100)を覆う酸素密封エンベロープ(119)と、
を備える送達装置であって、
前記プラスチック容器(101)の内表面の少なくとも一部がシリコン処理されている、送達装置。 - 前記酸素感受性の医薬有効成分の流体(107)が医薬有効成分のエマルションである、請求項1に記載の送達装置。
- 前記医薬有効成分の流体(107)が、1gの医薬有効成分を溶解するのに少なくとも30mlの水が要求される水溶性を有する医薬有効成分を含む、請求項1又は2に記載の送達装置。
- 前記医薬有効成分の流体(107)がプロポフォールを含む、請求項1から3のいずれか一項に記載の送達装置。
- 前記プラスチック容器(101)が、下記のポリマー:環状オレフィンコポリマー、環状オレフィンポリマー、又はCrystal Clear Polymerの少なくとも1つを含むプラスチックから作製されている、請求項1から4のいずれか一項に記載の送達装置。
- 前記送達シリンジ(100)が、前記プラスチック容器(101)内においてシフト可能なように収納可能なプラスチックプランジャーロッド(103)、より詳細には前記プラスチック容器(101)内においてシフト可能なように収納可能であり、該プラスチック容器(101)のそばに配置され、前記酸素密封エンベロープ(119)によって酸素を密封するように覆われているプラスチックプランジャーロッド(103)を含む、請求項1から5のいずれか一項に記載の送達装置。
- 前記プラスチックプランジャーロッド(103)が、下記のポリマー:環状オレフィンコポリマー、環状オレフィンポリマー、若しくはCrystal Clear Polymerの少なくとも1つを含むプラスチックから作製されているか、又はポリプロピレンから作製されている、請求項6に記載の送達装置。
- 前記プラスチック容器(101)及び/又は前記プラスチックプランジャーロッド(103)が、前記酸素密封エンベロープ(119)内において少なくとも軸方向にシフト可能なように収納されている、請求項1から7のいずれか一項に記載の送達装置。
- 前記プラスチック容器(101)及び/又は前記プラスチックプランジャーロッド(103)が、少なくとも1つの可撓性のスペーサ(130)によって少なくとも別々に収納されている、請求項1から8のいずれか一項に記載の送達装置。
- 前記酸素密封エンベロープ(119)が、エチレン−ビニルアルコールコポリマー障壁、より詳細にはエチレン−ビニルアルコールコポリマー層を含む、請求項1から9のいずれか一項に記載の送達装置。
- 前記酸素密封エンベロープ(119)が、熱可塑性物質から作製される、より詳細には熱成形されるシェル(121)を含み、及び/又は該シェル(121)が、前記送達シリンジ(100)を嵌合収容する成形物を形成する、請求項1から10のいずれか一項に記載の送達装置。
- 前記熱可塑性物質が、エチレン−ビニルアルコールコポリマー障壁を含むアモルファスポリエチレンテレフタレートフィルム又はエチレン−ビニルアルコールコポリマー障壁を含む二軸配向ポリエステルを含む、請求項11に記載の送達装置。
- 前記シェル(121)が、剥離可能なポリエチレンフィルム又はエチレン−ビニルアルコールコポリマー障壁を含むポリエチレンフィルムによって酸素を密封するように封止されている、請求項11又は12に記載の送達装置。
- 前記酸素密封エンベロープ(119)が、熱可塑性物質から作製される更なるシェル、より詳細には熱可塑性物質から作製されるシェルを含み、該更なるシェルがエチレン−ビニルアルコールコポリマー障壁を含み、該更なるシェルは、酸素を密封するように前記シェル(121)に接合、より詳細には溶接又は接着結合している、請求項11〜13のいずれか一項に記載の送達装置。
- 前記プラスチック容器(101)が、遠位端及び近位端で流体を密封するように、それぞれの場合で取り外し可能なクロージャ(111、113)により封止されている、請求項1から14のいずれか一項に記載の送達装置。
- 酸素吸収剤(135)を含む、請求項1から15のいずれか一項に記載の送達装置。
- プラスチック容器(101)を含む送達シリンジ(100)であって、該プラスチック容器(101)が酸素感受性の医薬有効成分の流体(107)で満たされている、送達シリンジと、
酸素を密封するように前記送達シリンジ(100)を覆う酸素密封エンベロープ(119)と、
を備える送達装置であって、
前記酸素感受性の医薬有効成分の流体(107)が医薬有効成分のエマルションであり、プロポフォールを含むものであり、
前記プラスチック容器(101)が、少なくとも1つの環状オレフィンコポリマーを含むプラスチックから作製されており、
前記プラスチック容器(101)の内表面の少なくとも一部がシリコン処理されている、送達装置。 - 請求項1〜17のいずれか一項に記載の送達装置を作製する方法であって、
プラスチック容器(101)を含む送達シリンジを準備すること(301)と、
前記プラスチック容器(101)の内表面の少なくとも一部をシリコン処理することと、
前記プラスチック容器を、酸素感受性の医薬有効成分の流体、より詳細にはプロポフォールで満たすこと(303)と、
充填されたプラスチック容器を含む前記送達シリンジを、酸素密封エンベロープによって酸素を密封して覆うこと(305)と、
を含む、方法。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261709657P | 2012-10-04 | 2012-10-04 | |
EP12187273.3 | 2012-10-04 | ||
EP12187273 | 2012-10-04 | ||
US61/709,657 | 2012-10-04 | ||
PCT/EP2013/070570 WO2014053560A1 (de) | 2012-10-04 | 2013-10-02 | Applikationsanordnung mit einem arzneistofffluid |
Publications (2)
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JP2015530200A true JP2015530200A (ja) | 2015-10-15 |
JP2015530200A5 JP2015530200A5 (ja) | 2017-03-09 |
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Application Number | Title | Priority Date | Filing Date |
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JP2015535010A Pending JP2015530200A (ja) | 2012-10-04 | 2013-10-02 | 薬物流体を含む送達装置 |
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Country | Link |
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US (3) | US9522222B2 (ja) |
EP (1) | EP2903660B1 (ja) |
JP (1) | JP2015530200A (ja) |
KR (1) | KR101954486B1 (ja) |
CN (1) | CN204798474U (ja) |
AU (1) | AU2013326538B2 (ja) |
BR (1) | BR112015007018B1 (ja) |
CA (1) | CA2887095C (ja) |
HK (1) | HK1213208A1 (ja) |
IN (1) | IN2015DN03179A (ja) |
PT (1) | PT2903660T (ja) |
WO (1) | WO2014053560A1 (ja) |
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Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9656016B2 (en) * | 2014-01-29 | 2017-05-23 | Beckton, Dickinson And Company | Syringe packaging system including oxygen absorber |
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CA2887095A1 (en) | 2014-04-10 |
CN204798474U (zh) | 2015-11-25 |
US20170182240A1 (en) | 2017-06-29 |
EP2903660B1 (de) | 2020-11-25 |
BR112015007018B1 (pt) | 2021-12-28 |
AU2013326538A1 (en) | 2015-04-09 |
EP2903660A1 (de) | 2015-08-12 |
PT2903660T (pt) | 2020-12-04 |
KR20150065828A (ko) | 2015-06-15 |
HK1213208A1 (zh) | 2016-06-30 |
BR112015007018A8 (pt) | 2018-05-08 |
AU2013326538B2 (en) | 2017-09-14 |
IN2015DN03179A (ja) | 2015-10-02 |
US20150273133A1 (en) | 2015-10-01 |
CA2887095C (en) | 2021-02-16 |
KR101954486B1 (ko) | 2019-03-05 |
US11452811B2 (en) | 2022-09-27 |
US20190321541A1 (en) | 2019-10-24 |
WO2014053560A1 (de) | 2014-04-10 |
US9522222B2 (en) | 2016-12-20 |
US10350346B2 (en) | 2019-07-16 |
BR112015007018A2 (pt) | 2017-07-04 |
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