JP2016518951A - 薬物送達デバイス用のアセンブリ、および薬物送達デバイス - Google Patents
薬物送達デバイス用のアセンブリ、および薬物送達デバイス Download PDFInfo
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- 108010004367 lixisenatide Proteins 0.000 description 1
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- 208000002780 macular degeneration Diseases 0.000 description 1
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- 239000007769 metal material Substances 0.000 description 1
- 208000010125 myocardial infarction Diseases 0.000 description 1
- 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
- 229940055729 papain Drugs 0.000 description 1
- 235000019834 papain Nutrition 0.000 description 1
- 229940111202 pepsin Drugs 0.000 description 1
- 239000008194 pharmaceutical composition Substances 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
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- 230000002040 relaxant effect Effects 0.000 description 1
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- 230000003248 secreting effect Effects 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 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
- 210000003462 vein Anatomy 0.000 description 1
Images
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- 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
- 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
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31545—Setting modes for dosing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- 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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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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- 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
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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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
- A61M5/178—Syringes
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- 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
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
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Abstract
Description
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。
2 アセンブリ
3 ピストンロッド
4 駆動要素
7 ハウジング
8 案内要素
12 圧縮ばね
13 アクチュエータ
14 カートリッジ
15 カートリッジホルダ
16 ピストン
17 ロッキング部材
18 最終用量部材
19 インジケータ
20 支承面
21 用量設定部材
22 リセットばね
23 駆動軸
24 ゼロ止め具
25 ピストンロッドの支承部
26 スプライン
27 回転部材
28 窓
29 止め具機能
30 スリーブ部材
Claims (15)
- 薬物送達デバイス(1)用のアセンブリ(2)であって、
薬物の用量の設定中に圧縮される圧縮ばね(12)と、
スリーブ部材(30)とを含み、
ここで、圧縮ばね(12)は、スリーブ部材(30)と直接接触し、圧縮ばね(12)およびスリーブ部材(30)は、圧縮ばね(12)の弛緩がデバイスの投薬端から離れた近位方向でスリーブ部材(30)の回転および軸方向運動を生じるように構成され、それにより、薬物送達デバイス(1)からの用量の投薬を引き起こす、前記アセンブリ。 - スリーブ部材(30)は、用量の設定中に回転され、スリーブ部材(30)の回転が、圧縮ばね(12)の圧縮を引き起こす請求項1に記載のアセンブリ。
- 圧縮ばね(12)は、近位方向に向けられたスリーブ部材(30)に対して力を及ぼす請求項1または2に記載のアセンブリ。
- 圧縮ばね(12)はコイルばねである請求項1〜3のいずれか1項に記載のアセンブリ。
- ハウジング(7)を含み、ここで、圧縮ばね(12)は、ハウジング(7)の支承面(20)とスリーブ部材(30)との間に配置される請求項1〜4のいずれか1項に記載のアセンブリ。
- スリーブ部材(30)はねじ山を含み、スリーブ部材(30)は、該スリーブ部材(30)の回転がハウジング(7)に対するスリーブ部材(30)の軸方向運動を引き起こすように、ねじ山によってハウジング(7)と係合する請求項5に記載のアセンブリ。
- ピストンロッド(3)を含み、ここで、圧縮ばね(12)の弛緩は、ピストンロッド(3)を遠位方向に移動させる請求項1〜6のいずれか1項に記載のアセンブリ。
- 回転部材(27)を含み、ここで、スリーブ部材(30)は、回転部材(27)に対して回転方向に固定され、軸方向に可動である請求項1〜7のいずれか1項に記載のアセンブリ。
- 用量の設定中の回転部材(27)の回転は、スリーブ部材(30)を回転させて遠位方向に軸方向移動させ、それにより圧縮ばね(12)が圧縮される請求項8に記載のアセンブリ。
- 用量を設定するために用量設定方向に回転するように構成された用量設定部材(21)を含み、用量設定方向での用量設定部材(21)の回転は、用量設定方向での回転部材(27)の回転を引き起こす請求項8または9に記載のアセンブリ。
- 回転部材(27)は、駆動軸(23)によって用量設定部材(21)に連結される請求項10に記載のアセンブリ。
- 薬物の用量を投薬するために動作されるように構成されたアクチュエータ(13)を含み、ここで、該アクチュエータ(13)が動作されるときに、圧縮ばね(12)が弛緩することが可能になる請求項1〜11のいずれか1項に記載のアセンブリ。
- 用量の設定中に用量投薬方向での回転部材(27)の回転を妨げ、それにより圧縮ばね(12)の弛緩を妨げるように構成されたロッキング部材(17)を含む請求項8〜12のいずれか1項に記載のアセンブリ。
- ロッキング部材(17)は、アクチュエータ(13)が作動されるときに、用量投薬方向で回転部材(27)の回転を可能にし、それにより圧縮ばね(12)の弛緩を可能にする請求項13に記載のアセンブリ。
- 請求項1〜14のいずれか1項に記載のアセンブリを含む薬物送達デバイス(1)。
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EP13169308.7 | 2013-05-27 | ||
EP13169308 | 2013-05-27 | ||
PCT/EP2014/059689 WO2014191189A1 (en) | 2013-05-27 | 2014-05-13 | Assembly for a drug delivery device and drug delivery device |
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EP (1) | EP3003439B1 (ja) |
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CN (1) | CN105246531B (ja) |
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IT201900019460A1 (it) * | 2019-10-21 | 2021-04-21 | Cane Spa | Pompa meccanica ad azionamento manuale per l’infusione di farmaci |
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US10137251B2 (en) | 2018-11-27 |
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