JP2018196746A - 薬物送達デバイス内で使用するためのカートリッジ用のピストン - Google Patents
薬物送達デバイス内で使用するためのカートリッジ用のピストン Download PDFInfo
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- JP2018196746A JP2018196746A JP2018144747A JP2018144747A JP2018196746A JP 2018196746 A JP2018196746 A JP 2018196746A JP 2018144747 A JP2018144747 A JP 2018144747A JP 2018144747 A JP2018144747 A JP 2018144747A JP 2018196746 A JP2018196746 A JP 2018196746A
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- 239000004026 insulin derivative Substances 0.000 description 1
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- GFIJNRVAKGFPGQ-LIJARHBVSA-N leuprolide Chemical compound CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@@H](NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1N=CNC=1)NC(=O)[C@H]1NC(=O)CC1)CC1=CC=C(O)C=C1 GFIJNRVAKGFPGQ-LIJARHBVSA-N 0.000 description 1
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- 108010004367 lixisenatide Proteins 0.000 description 1
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- RWHUEXWOYVBUCI-ITQXDASVSA-N nafarelin Chemical compound C([C@@H](C(=O)N[C@H](CC=1C=C2C=CC=CC2=CC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1[C@@H](CCC1)C(=O)NCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H]1NC(=O)CC1)C1=CC=C(O)C=C1 RWHUEXWOYVBUCI-ITQXDASVSA-N 0.000 description 1
- 229960002333 nafarelin Drugs 0.000 description 1
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- 230000002093 peripheral effect Effects 0.000 description 1
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- 229920000642 polymer Polymers 0.000 description 1
- 229920001184 polypeptide Polymers 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 125000001500 prolyl group Chemical group [H]N1C([H])(C(=O)[*])C([H])([H])C([H])([H])C1([H])[H] 0.000 description 1
- 230000013777 protein digestion Effects 0.000 description 1
- 235000018102 proteins Nutrition 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
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- 229910052708 sodium Inorganic materials 0.000 description 1
- 241000894007 species Species 0.000 description 1
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- 229960004824 triptorelin Drugs 0.000 description 1
- VXKHXGOKWPXYNA-PGBVPBMZSA-N triptorelin Chemical compound C([C@@H](C(=O)N[C@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1[C@@H](CCC1)C(=O)NCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1N=CNC=1)NC(=O)[C@H]1NC(=O)CC1)C1=CC=C(O)C=C1 VXKHXGOKWPXYNA-PGBVPBMZSA-N 0.000 description 1
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Images
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Abstract
Description
る。
r)に動作可能に係合されるように直接適合される。第2のピストン部材の近位方向に誘導される端面は、ピストンの外側からアクセス可能であることが明らかである。したがって、第2のピストン部材は、第1のピストン部材によって完全に埋め込まれ、または取り囲まれるのではなく、たとえば薬物送達デバイスのピストンロッドに直接係合するように設計および適合される。第2のピストン部材は、ピストンの近位端面を少なくとも部分的に提供する。
化合物を含む医薬製剤を意味し、
ここで、一実施形態において、薬学的に活性な化合物は、最大1500Daまでの分子量を有し、および/または、ペプチド、タンパク質、多糖類、ワクチン、DNA、RNA、酵素、抗体もしくはそのフラグメント、ホルモンもしくはオリゴヌクレオチド、または上述の薬学的に活性な化合物の混合物であり、
ここで、さらなる実施形態において、薬学的に活性な化合物は、糖尿病、または糖尿病性網膜症などの糖尿病関連の合併症、深部静脈血栓塞栓症または肺血栓塞栓症などの血栓塞栓症、急性冠症候群(ACS)、狭心症、心筋梗塞、がん、黄斑変性症、炎症、枯草熱、アテローム性動脈硬化症および/または関節リウマチの処置および/または予防に有用であり、
ここで、さらなる実施形態において、薬学的に活性な化合物は、糖尿病または糖尿病性網膜症などの糖尿病に関連する合併症の処置および/または予防のための少なくとも1つのペプチドを含み、
ここで、さらなる実施形態において、薬学的に活性な化合物は、少なくとも1つのヒトインスリンもしくはヒトインスリン類似体もしくは誘導体、グルカゴン様ペプチド(GLP−1)もしくはその類似体もしくは誘導体、またはエキセンジン−3もしくはエキセンジン−4もしくはエキセンジン−3もしくはエキセンジン−4の類似体もしくは誘導体を含む。
H−(Lys)4−desPro36,desPro37エキセンジン−4(1−39)−NH2、
H−(Lys)5−desPro36,desPro37エキセンジン−4(1−39
)−NH2、
desPro36エキセンジン−4(1−39)、
desPro36[Asp28]エキセンジン−4(1−39)、
desPro36[IsoAsp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,Asp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,IsoAsp28]エキセンジン−(1−39)、
desPro36[Trp(O2)25,Asp28]エキセンジン−4(1−39)、
desPro36[Trp(O2)25,IsoAsp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)、
desPro36[Met(O)14Trp(O2)25,IsoAsp28]エキセンジン−4(1−39);または
desPro36[Asp28]エキセンジン−4(1−39)、
desPro36[IsoAsp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,Asp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,IsoAsp28]エキセンジン−(1−39)、
desPro36[Trp(O2)25,Asp28]エキセンジン−4(1−39)、
desPro36[Trp(O2)25,IsoAsp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)、
desPro36[Met(O)14,Trp(O2)25,IsoAsp28]エキセンジン−4(1−39)、
(ここで、基−Lys6−NH2が、エキセンジン−4誘導体のC−末端に結合していてもよい);
desPro36エキセンジン−4(1−39)−Lys6−NH2(AVE0010)、
H−(Lys)6−desPro36[Asp28]エキセンジン−4(1−39)−Lys6−NH2、
desAsp28Pro36,Pro37,Pro38エキセンジン−4(1−39)−NH2、
H−(Lys)6−desPro36,Pro38[Asp28]エキセンジン−4(1−39)−NH2、
H−Asn−(Glu)5desPro36,Pro37,Pro38[Asp28]エキセンジン−4(1−39)−NH2、
desPro36,Pro37,Pro38[Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36[Trp(O2)25,Asp28]エキセンジン−4(1−39)−Lys6−NH2、
H−desAsp28Pro36,Pro37,Pro38[Trp(O2)25]エキセンジン−4(1−39)−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Trp(O2)25,Asp28]エキセンジン−4(1−39)−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Trp(O2)25,Asp28]エキセンジン−4(1−39)−NH2、
desPro36,Pro37,Pro38[Trp(O2)25,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Trp(O2)25,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Trp(O2)25,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36[Met(O)14,Asp28]エキセンジン−4(1−39)−Lys6−NH2、
desMet(O)14,Asp28Pro36,Pro37,Pro38エキセンジン−4(1−39)−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−NH2;
desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−Asn−(Glu)5desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−Lys6−desPro36[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)−Lys6−NH2、
H−desAsp28,Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]エキセンジン−4(1−39)−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Met(O)14,Asp28]エキセンジン−4(1−39)−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)−NH2、
desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2、
H−(Lys)6−desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(S1−39)−(Lys)6−NH2、
H−Asn−(Glu)5−desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]エキセンジン−4(1−39)−(Lys)6−NH2;
または前述のいずれか1つのエキセンジン−4誘導体の薬学的に許容される塩もしくは溶媒和化合物
から選択される。
下垂体ホルモンまたは視床下部ホルモンまたは調節性活性ペプチドおよびそれらのアンタゴニストである。
L)について3つおよび重鎖(HV)に3つの可変ループが、抗原との結合、すなわちその抗原特異性に関与する。これらのループは、相補性決定領域(CDR)と呼ばれる。VHドメインおよびVLドメインの両方からのCDRが抗原結合部位に寄与するので、最終的な抗原特異性を決定するのは重鎖と軽鎖の組合せであり、どちらか単独ではない。
を特色とする第1のピストン部材12は、ピストン10の近位端からアクセスできる実質上円筒形の形状のカップ状のレセプタクル16を有する。
2 近位方向
10 ピストン
12 第1のピストン部材
13 底部部分
14 第2のピストン部材
15 横方向の側壁
16 カップ状のレセプタクル
18 底面
20 側壁
22 遠位面
24 近位面
25 推力を受ける面
26 封止リップ
27 近位面
28 封止リップ
30 電子回路
40 カートリッジ
42 本体
44 内側容積
46 出口端
48 封止
50 キャップ
52 針
Claims (14)
- 薬剤で充填されるカートリッジ用のピストンであって:
第1の材料を含み、該ピストンの遠位端面(22)を形成する第1のピストン部材(12)と、
該第1の材料と比較するとより低い圧縮率の第2の材料を含む第2のピストン部材(14)とを備え、
ここで、該第2のピストン部材(14)は、該第1のピストン部材(12)のカップ状のレセプタクル(16)内に配置され、該ピストンの近位端(24)に推力を受ける面(25)を提供する、上記ピストン。 - 第1の材料および/または第2の材料はポリマー材料を含む、請求項1に記載のピストン。
- 第1の材料は天然および/または合成ゴムを含む、請求項1または2に記載のピストン。
- 第2の材料は環状オレフィンコポリマー(COC)を含む、請求項1〜3のいずれか1項に記載のピストン。
- 第1のピストン部材(12)および/または第2のピストン部材(14)は、円筒形または管状の形状であり、第1のピストン部材(12)は、第2のピストン部材(14)を横方向に取り巻く、請求項1〜4のいずれか1項に記載のピストン。
- 第2のピストン部材(14)は、軸方向(1、2)で第1のピストン部材(12)の底面(18)に当接する、請求項1〜5のいずれか1項に記載のピストン。
- 第2のピストン部材(14)の推力を受ける面(25)は、ピストンの平滑または平坦な形状の近位面(24)を形成するように、第1のピストン部材(12)の近位端面(27)に同一平面に取り付けられる、請求項1〜6のいずれか1項に記載のピストン。
- 第2のピストン部材(14)は、第1のピストン部材(12)のレセプタクル(16)内にプレス嵌めされる、請求項1〜7のいずれか1項に記載のピストン。
- 第1のピストン部材(12)と第2のピストン部材(14)との間に配置された電子回路(30)をさらに備える、請求項1〜8のいずれか1項に記載のピストン。
- 第2のピストン部材(14)の遠位端面および/または第1のピストン部材(12)の底面(18)は、電子回路(30)を受けるための凹部を含む、請求項9に記載のピストン。
- 第2のピストン部材(14)は、ピストンの全体的な軸方向の伸長の少なくとも80%、90%、または少なくとも95%の軸方向の伸長を含む、請求項1〜10のいずれか1項に記載のピストン。
- 薬物送達デバイスとともに使用されるカートリッジであって、薬剤で少なくとも部分的に充填された内側容積(44)を閉じ込める管形状の本体(42)を備え、請求項1〜11のいずれか1項に記載のピストン(10)が軸方向(1、2)で該管状の本体(42)内に変位可能に配置されることによって封止される、上記カートリッジ。
- 請求項1〜11のいずれか1項に記載のピストンを製造する方法であって:
カップ状のレセプタクル(16)を有する第1の材料の第1のピストン部材(12)を設ける工程と、
該第1の材料より低い圧縮率の第2の材料の第2のピストン部材(14)を該レセプタクル(16)内へ挿入する工程とを含む、上記方法。 - 第1のピストン部材(12)のレセプタクル(16)内への第2のピストン部材(14)の挿入前に、第1のピストン部材(12)のレセプタクル(16)内または第2のピストン部材の凹部内に電子回路(13)を配置する工程をさらに含む、請求項13に記載の方法。
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JP2017006352A Active JP6383017B2 (ja) | 2011-11-02 | 2017-01-18 | 薬物送達デバイス内で使用するためのカートリッジ用のピストン |
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JP2017006352A Active JP6383017B2 (ja) | 2011-11-02 | 2017-01-18 | 薬物送達デバイス内で使用するためのカートリッジ用のピストン |
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US (2) | US9572939B2 (ja) |
EP (2) | EP4015016A1 (ja) |
JP (3) | JP6082016B2 (ja) |
KR (1) | KR20140094582A (ja) |
CN (2) | CN106943646B (ja) |
AU (2) | AU2012331147B2 (ja) |
BR (1) | BR112014010467A2 (ja) |
DK (1) | DK2773397T3 (ja) |
IL (1) | IL231884A0 (ja) |
IN (1) | IN2014CN02800A (ja) |
MX (1) | MX346268B (ja) |
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- 2012-11-01 KR KR1020147014330A patent/KR20140094582A/ko unknown
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JP2014534027A (ja) | 2014-12-18 |
AU2017200276A1 (en) | 2017-02-02 |
JP6622362B2 (ja) | 2019-12-18 |
BR112014010467A2 (pt) | 2017-04-18 |
IN2014CN02800A (ja) | 2015-07-03 |
JP6082016B2 (ja) | 2017-02-15 |
AU2012331147A1 (en) | 2014-04-24 |
JP2017094151A (ja) | 2017-06-01 |
US10751474B2 (en) | 2020-08-25 |
RU2631207C2 (ru) | 2017-09-19 |
KR20140094582A (ko) | 2014-07-30 |
AU2012331147B2 (en) | 2016-11-24 |
CN104023765B (zh) | 2016-11-09 |
CN106943646A (zh) | 2017-07-14 |
CN106943646B (zh) | 2020-04-14 |
US9572939B2 (en) | 2017-02-21 |
RU2014122196A (ru) | 2015-12-10 |
MX2014005413A (es) | 2014-10-17 |
US20140303567A1 (en) | 2014-10-09 |
RU2017130667A3 (ja) | 2019-02-05 |
DK2773397T3 (da) | 2022-05-02 |
MX346268B (es) | 2017-03-13 |
EP2773397A1 (en) | 2014-09-10 |
WO2013064590A1 (en) | 2013-05-10 |
US20170128671A1 (en) | 2017-05-11 |
EP4015016A1 (en) | 2022-06-22 |
EP2773397B1 (en) | 2022-02-23 |
RU2017130667A (ru) | 2019-02-05 |
JP6383017B2 (ja) | 2018-08-29 |
IL231884A0 (en) | 2014-05-28 |
CN104023765A (zh) | 2014-09-03 |
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