JP2012528620A - 薬物送達デバイスをプライミングするための用量設定機構 - Google Patents
薬物送達デバイスをプライミングするための用量設定機構 Download PDFInfo
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- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31525—Dosing
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- A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
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- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
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Abstract
【選択図】図2
Description
薬物送達デバイスをプライミングすることである。
ここで一実施態様において、薬学的に活性な化合物は、最大で1500Daまでの分子量を有し、及び/又は、ペプチド、蛋白質、多糖類、ワクチン、DNA、RNA、抗体、酵素、抗体、ホルモン若しくはオリゴヌクレオチド、又は上述の薬学的に活性な化合物の混合物であり、
ここで、更なる実施態様において、薬学的に活性な化合物は、糖尿病、又は糖尿病性網膜症などの糖尿病関連の合併症、深部静脈又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、癌、黄斑変性症、炎症、枯草熱、アテローム性動脈硬化症、及び/又は、関節リウマチの処置、及び/又は、予防に有用であり、
ここで、更なる実施態様において、薬学的に活性な化合物は、糖尿病、又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、及び/又は、予防のための少なくとも1つのペプチドを含み、
ここで、更なる実施態様において、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、又はヒトインスリン類似体若しくは誘導体、グルカゴン様ペプチド(GLP−1)、又はその類似体若しくは誘導体、又はエキセジン−3又はエキセジン−4、若しくはエキセジン−3又はエキセジン−4の類似体若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[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−4(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)14Trp(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);又は
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は、エキセンジン−4誘導体のC−末端と結合してもよく;
H−(Lys)6−desPro36[Asp28]エキセンジン−4(1−39)−Lys6−NH2、
desAsp28,Pro36,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−desAsp28 Pro36,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−des Pro36,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,Asp28,Pro36,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)5,desPro36,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−des Pro36,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;
又は前述のエキセンジン−4誘導体のいずれか1つの薬学的に許容される塩若しくは溶媒和物;
から選択される。
Publishing社,Easton, Pa., U.S.A.,1985 及び Encyclopedia of Pharmaceutical Technologyに記載されている。
Claims (15)
- ダイアルスリーブ(56、84)及び内部ハウジング部分(58、70)を含んでなる薬物送達デバイス用の用量設定機構であって、
ここで、ダイアルスリーブ(56、84)は、内部ハウジング部分(58、70)に連結され、
ここで、ダイアルスリーブ(56、84)は、薬物送達デバイスのプライミング中、実質的に回転経路(74)に沿って回転し、そして
ここで、ダイアルスリーブ(56、84)は、薬物送達デバイスの用量設定中、ラセン経路(76)に沿って並進移動する、
上記用量設定機構。 - 内部ハウジング(58、70)がネジ山部分(72)を含んでなり、ここで、ネジ山部分は回転ネジ山部分(74)及びラセンネジ山部分(76)を含んでなる、請求項1に記載の用量設定機構。
- ダイアルスリーブ(56、84)が、薬物送達デバイスをプライミングする前にラセン経路(76)上を回転することを阻止される、請求項1又は2に記載の用量設定機構。
- ダイアルスリーブ(56、84)上に配置された少なくとも1つの逆止エレメント(88)、及びダイアルスリーブ(56、84)上に配置された少なくとも1つの逆止エレメント(88)に相補的な内部ハウジング(58、70)部分上に配置された少なくとも1つの相補的逆止エレメント(82)を更に含んでなる、請求項1〜3のいずれか1項に記載の用量設定機構。
- 実質的回転経路(74)は回転経路の末端を含んでなり、ここで、ダイアルスリーブ(56、84)が回転経路(74)の末端に到達するとき、少なくとも1つ逆止エレメント(88)及び少なくとも1つの相補的逆止エレメント(82)が、相互作用して回転経路(74)に沿って戻るダイアルスリーブ(56、84)の実質的な移動を阻止する、請求項4に記載の用量設定機構。
- 逆止エレメント(88)がダイアルスリーブ(56、84)からの突起であり、そしてここで、相補的逆止エレメント(82)が内部ハウジング(58、70)からの突起である、請求項4又は5に記載の用量設定機構。
- 逆止エレメント(88)が、ダイアルスリーブ(56、84)の可撓性エレメント部分(90)に連結され、ここで、可撓性エレメント(90)は、逆止エレメント(88)が回転移動中相補的逆止エレメント(82)上を通過するのを可能にし、そしてここで、実質的回転経路の末端で、可撓性エレメント(90)は、逆止エレメント(88)が相補的逆止エレメント(82)上を通過して戻ることを阻止するために作動する、請求項6に記載の用量設定機構。
- 用量設定機構が非可逆的連結を介してカートリッジハウジング(6)と連結する、請求項1〜7のいずれか1項に記載の用量設定機構。
- ダイアルスリーブ(58、70)がプライミング前に表示されるグラフを含んでなり、ここで、グラフは薬物送達デバイスがプライミングされていないことを示す、請求項1〜8のいずれか1項に記載の用量設定機構。
- 用量設定機構は、更に、以下:
ドライバ(53);及び
スピンドル(64)、ここで、ダイアルスリーブ(56、84)の回転が、ドライバ(53)を回転させ、そしてスピンドル(64)を遠位方向に並進移動させ、この並進移動が薬物送達デバイスをプライミングさせるように、ダイアルスリーブ(56、84)はドライバ(53)に操作可能に連結する、
を含んでなる、請求項1〜9のいずれか1項に記載の用量設定機構。 - 特に、再使用可能な薬物送達デバイス用、以下:
ダイアルスリーブ(56、84)上に配置された少なくとも1つの逆止エレメント(88);
用量ダイアルスリーブ(56、84)上に配置された少なくとも1つの逆止エレメント(88)に対して相補的な内部ハウジング(58)部分上に配置された少なくとも1つの相補的逆止エレメント(82)を更に含んでなり、
ここで、使用者が用量を設定するとき、逆止エレメント(88)及び相補的逆止エレメント(82)が、実質的円周回転経路(74)に沿った実質的回転移動を阻止し、
ここで、使用者が用量を設定しないとき、逆止エレメント(88)及び相補的逆止エレメント(82)が、デバイスの使用者によって克服され得る、
請求項1〜10のいずれか1項に記載の用量設定機構。 - 薬物送達デバイスをプライミングする方法であって、以下:
薬物送達デバイスの内部ハウジング(58、70)と係合する用量ダイアルスリーブ(56、84)を備える工程;
用量ダイアルスリーブ(56、84)を、内部ハウジング(58、70)の周囲の実質的円周回転経路(74)上で回転させる工程であって、ここで、用量ダイアルスリーブ(56、84)を回転させることが、薬物送達デバイスをプライミングする、該工程;
を含んでなる、上記方法。 - 薬物送達デバイスのプライミングに応答して、用量ダイアルスリーブ(56、84)が円周方向に回転するのを阻止する工程を更に含んでなる、請求項12に記載の用量設定機構。
- 用量ダイアルスリーブ(56、84)が円周方向に回転するのを阻止する工程が、内部ハウジング(58、70)上の対応する逆止機構(82)と相互作用する用量ダイアルスリーブ(56、84)上に、逆止機構(88)を備える工程を含む、請求項13に記載の用量設定機構。
- 内部ハウジング(58、70)上に実質的円周回転ネジ山(74)を備える工程を更に含んでなり、ここで、用量ダイアルスリーブ(56、84)を、内部ハウジング(58,70)の周囲の実質的円周回転経路(74)上で回転させる工程が、用量ダイアルスリーブ(56、84)を実質的円周回転ネジ山(74)に沿って回転させる工程を含む、請求項14に記載の用量設定機構。
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- 2010-05-28 US US13/321,310 patent/US9408978B2/en active Active
- 2010-05-28 DK DK10722346.3T patent/DK2437824T3/en active
- 2010-05-28 EP EP10722346.3A patent/EP2437824B1/en active Active
- 2010-05-28 BR BRPI1014727A patent/BRPI1014727A2/pt not_active IP Right Cessation
- 2010-05-28 WO PCT/EP2010/057467 patent/WO2010139631A1/en active Application Filing
- 2010-05-28 CA CA2762414A patent/CA2762414A1/en not_active Abandoned
- 2010-05-28 CN CN201080032166.1A patent/CN102458529B/zh active Active
- 2010-05-28 JP JP2012513561A patent/JP5820808B2/ja active Active
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Also Published As
Publication number | Publication date |
---|---|
IL216480A0 (en) | 2012-01-31 |
CN102458529A (zh) | 2012-05-16 |
US20130218130A1 (en) | 2013-08-22 |
AU2010255806A1 (en) | 2011-12-22 |
US10279116B2 (en) | 2019-05-07 |
US8585656B2 (en) | 2013-11-19 |
EP2437824A1 (en) | 2012-04-11 |
US20120172813A1 (en) | 2012-07-05 |
JP5820808B2 (ja) | 2015-11-24 |
BRPI1014727A2 (pt) | 2016-04-12 |
US9408978B2 (en) | 2016-08-09 |
US20100324528A1 (en) | 2010-12-23 |
CN102458529B (zh) | 2014-11-05 |
DK2437824T3 (en) | 2019-01-28 |
WO2010139631A1 (en) | 2010-12-09 |
EP2437824B1 (en) | 2018-10-03 |
AU2010255806B2 (en) | 2014-12-18 |
CA2762414A1 (en) | 2010-12-09 |
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