JP2016519128A5 - - Google Patents
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- JP2016519128A5 JP2016519128A5 JP2016511088A JP2016511088A JP2016519128A5 JP 2016519128 A5 JP2016519128 A5 JP 2016519128A5 JP 2016511088 A JP2016511088 A JP 2016511088A JP 2016511088 A JP2016511088 A JP 2016511088A JP 2016519128 A5 JP2016519128 A5 JP 2016519128A5
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- JP
- Japan
- Prior art keywords
- composition
- composition according
- snac
- peptide
- ethoxy
- Prior art date
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- 239000000203 mixture Substances 0.000 claims 40
- UOENJXXSKABLJL-UHFFFAOYSA-M sodium;8-[(2-hydroxybenzoyl)amino]octanoate Chemical compound [Na+].OC1=CC=CC=C1C(=O)NCCCCCCCC([O-])=O UOENJXXSKABLJL-UHFFFAOYSA-M 0.000 claims 11
- DLSWIYLPEUIQAV-CCUURXOWSA-N Semaglutide Chemical group C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CC[C@@H](NC(=O)CCCCCCCCCCCCCCCCC(O)=O)C(O)=O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)C(C)(C)NC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 DLSWIYLPEUIQAV-CCUURXOWSA-N 0.000 claims 5
- 229950011186 Semaglutide Drugs 0.000 claims 5
- 108010060325 semaglutide Proteins 0.000 claims 5
- DTHNMHAUYICORS-KTKZVXAJSA-N 107444-51-9 Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCCN)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C)NC(=O)[C@@H](N)CC=1N=CNC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 DTHNMHAUYICORS-KTKZVXAJSA-N 0.000 claims 3
- 101710042131 GCG Proteins 0.000 claims 3
- 102100003818 GCG Human genes 0.000 claims 3
- 101700071595 GRZ1 Proteins 0.000 claims 3
- 230000037289 Plasma half life Effects 0.000 claims 3
- 230000037240 Plasma half-life Effects 0.000 claims 3
- 101700078733 ZGLP1 Proteins 0.000 claims 3
- 239000003623 enhancer Substances 0.000 claims 3
- 230000002708 enhancing Effects 0.000 claims 3
- 125000001301 ethoxy group Chemical group [H]C([H])([H])C([H])([H])O* 0.000 claims 3
- 230000002265 prevention Effects 0.000 claims 3
- 150000003839 salts Chemical group 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- -1 4-carboxyphenoxy Chemical group 0.000 claims 2
- GHVNFZFCNZKVNT-UHFFFAOYSA-N Decanoic acid Chemical compound CCCCCCCCCC(O)=O GHVNFZFCNZKVNT-UHFFFAOYSA-N 0.000 claims 2
- 208000008589 Obesity Diseases 0.000 claims 2
- 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 235000020824 obesity Nutrition 0.000 claims 2
- 239000005632 Capric acid (CAS 334-48-5) Substances 0.000 claims 1
- 206010012601 Diabetes mellitus Diseases 0.000 claims 1
- 108010090776 Glucagon-like peptide 1(7-37) Proteins 0.000 claims 1
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 claims 1
- 229940057948 Magnesium stearate Drugs 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinylpyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 1
- 229940069328 Povidone Drugs 0.000 claims 1
- 208000001072 Type 2 Diabetes Mellitus Diseases 0.000 claims 1
- 125000000738 acetamido group Chemical group [H]C([H])([H])C(=O)N([H])[*] 0.000 claims 1
- 239000000654 additive Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 239000008247 solid mixture Substances 0.000 claims 1
Claims (24)
- 経口投与による医薬として使用するためのGLP-1ペプチド及びエンハンサーを含む固体組成物であって、
a)前記ペプチドは、ヒトにおいて少なくとも60時間の血漿内半減期を有し、
b)前記組成物は、少なくとも3回投与され、
c)前記組成物は、ヒトにおける前記ペプチドの日数での血漿内半減期と前記組成物の日数での投薬間隔との間の比が2:1超であるように投与される、組成物。 - 前記組成物が、1日おき又はそれ超の頻度で投与される、請求項1に記載の組成物。
- 前記組成物が、1日2回、1日1回、又は1日おきに投与される、請求項2に記載の組成物。
- 前記組成物が、錠剤の形態である、請求項1から3のいずれか一項に記載の組成物。
- 前記組成物が、少なくとも5回投与される、請求項1から4のいずれか一項に記載の組成物。
- 前記エンハンサーが、N-(8-(2-ヒドロキシベンゾイル)アミノ)カプリル酸の塩である、請求項1から5のいずれか一項に記載の組成物。
- 前記N-(8-(2-ヒドロキシベンゾイル)アミノ)カプリル酸の塩が、SNACである、請求項6に記載の組成物。
- SNACの量が、100〜500mgのSNACであり、又はSNACの量が、前記組成物の50〜90%(w/w)である、請求項7に記載の組成物。
- SNACの量が、200〜400mgである、請求項8に記載の組成物。
- SNACの量が、300mgである、請求項9に記載の組成物。
- 前記エンハンサーが、カプリン酸の塩である、請求項1から10のいずれか一項に記載の組成物。
- 前記ペプチドが、ヒトにおいて少なくとも72時間の血漿内半減期を有する、請求項1から11のいずれか一項に記載の組成物。
- 前記ペプチドが、0.01〜100mgの量で投与される、請求項1から12のいずれか一項に記載の組成物。
- 前記組成物が、1〜100mgのGLP-1ペプチド及び100〜500mg又は50〜90%(w/w)のSNACを含む、請求項1から13のいずれか一項に記載の組成物。
- 前記組成物が、1〜100mgのGLP-1ペプチド、100〜500mgのSNAC、微結晶性セルロース、ポビドン、及びステアリン酸マグネシウムを含む、請求項1から14のいずれか一項に記載の組成物。
- 前記ペプチドが、セマグルチドまたはNε26{2-[2-(2-{2-[2-(2-{(S)-4-カルボキシ-4-[10-(4-カルボキシフェノキシ)デカノイル-アミノ]ブチリルアミノ}エトキシ)エトキシ]アセチルアミノ}エトキシ)エトキシ]アセチル}、Nε37{2-[2-(2-{2-[2-(2-{(S)-4-カルボキシ-4-[10-(4-カルボキシフェノキシ)デカノイルアミノ]ブチリルアミノ}エトキシ)エトキシ]アセチルアミノ}エトキシ)エトキシ]アセチル}-[Aib8,Arg34,Lys37]GLP-1(7-37)-OHである、請求項1から15のいずれか一項に記載の組成物。
- 前記ペプチドが、セマグルチドである、請求項16に記載の組成物。
- 前記組成物が、1〜100mgのセマグルチド及び100〜500mg若しくは50〜90%(w/w)のSNACを含み、又は前記組成物が、2〜60mgのセマグルチド及び200〜400mgのSNACを含む、請求項1から17のいずれか一項に記載の組成物。
- 前記組成物が、2〜40mgのセマグルチド及び200〜400mgのSNACを含む、請求項1から18のいずれか一項に記載の組成物。
- 前記組成物が、1種又は複数の薬学的に許容される添加剤を更に含む、請求項1から19のいずれか一項に記載の組成物。
- 前記錠剤の重量が、150mg〜1000mgの範囲、例えば、300〜600mg又は例えば、300〜500mgの範囲である、請求項4から20のいずれか一項に記載の組成物。
- 前記組成物が、糖尿病及び/又は肥満症の治療又は予防における使用のためのものである、請求項1から21のいずれか一項に記載の組成物。
- 前記組成物が、2型糖尿病の治療又は予防における使用のためのものである、請求項22に記載の組成物。
- 前記組成物が、肥満症の治療又は予防における使用のためのものである、請求項22に記載の組成物。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13166205.8 | 2013-05-02 | ||
| EP13166205 | 2013-05-02 | ||
| PCT/EP2014/058974 WO2014177683A1 (en) | 2013-05-02 | 2014-05-02 | Oral dosing of glp-1 compounds |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019235054A Division JP2020073533A (ja) | 2013-05-02 | 2019-12-25 | Ｇｌｐ−１化合物の経口投薬 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016519128A JP2016519128A (ja) | 2016-06-30 |
| JP2016519128A5 true JP2016519128A5 (ja) | 2017-06-15 |
| JP6672140B2 JP6672140B2 (ja) | 2020-03-25 |
Family
ID=48190381
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016511088A Active JP6672140B2 (ja) | 2013-05-02 | 2014-05-02 | Ｇｌｐ−１化合物の経口投薬 |
| JP2019235054A Pending JP2020073533A (ja) | 2013-05-02 | 2019-12-25 | Ｇｌｐ−１化合物の経口投薬 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019235054A Pending JP2020073533A (ja) | 2013-05-02 | 2019-12-25 | Ｇｌｐ−１化合物の経口投薬 |
Country Status (24)
| Country | Link |
|---|---|
| US (3) | US20160067184A1 (ja) |
| EP (2) | EP3485900A1 (ja) |
| JP (2) | JP6672140B2 (ja) |
| KR (3) | KR20210086717A (ja) |
| AU (1) | AU2014261336B2 (ja) |
| BR (1) | BR112015026325A2 (ja) |
| CA (1) | CA2910903A1 (ja) |
| CY (1) | CY1120730T1 (ja) |
| DK (1) | DK2991671T3 (ja) |
| ES (1) | ES2688462T3 (ja) |
| HR (1) | HRP20181393T1 (ja) |
| HU (1) | HUE040609T2 (ja) |
| IL (1) | IL241813A (ja) |
| LT (1) | LT2991671T (ja) |
| MX (3) | MX369259B (ja) |
| MY (1) | MY172578A (ja) |
| PL (1) | PL2991671T3 (ja) |
| PT (1) | PT2991671T (ja) |
| RS (1) | RS58039B1 (ja) |
| RU (1) | RU2671406C2 (ja) |
| SA (1) | SA515370075B1 (ja) |
| SI (1) | SI2991671T1 (ja) |
| WO (1) | WO2014177683A1 (ja) |
| ZA (2) | ZA201507096B (ja) |
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| CN102149411A (zh) | 2008-09-12 | 2011-08-10 | 诺沃—诺迪斯克有限公司 | 酰化肽或蛋白的方法 |
| DK2513140T3 (en) * | 2009-12-16 | 2016-01-18 | Novo Nordisk As | Double-acylated GLP-1 derivatives |
| KR20130093470A (ko) * | 2010-04-30 | 2013-08-22 | 가부시키가이샤산와카가쿠켄큐쇼 | 생리활성 물질 등의 생체 내 안정성 향상을 위한 펩티드 및 생체 내 안정성이 향상된 생리활성 물질 |
| DK3326620T3 (da) * | 2010-12-16 | 2020-05-25 | Novo Nordisk As | Faste sammensætninger omfattende en glp-1-agonist og et salt af n-(8-(2- hydroxybenzoyl)amino)caprylsyre |
| MX355361B (es) | 2011-04-12 | 2018-04-17 | Novo Nordisk As | Derivados de peptido 1 tipo glucagon (glp-1) doblemente acilados. |
| WO2013009545A1 (en) | 2011-07-08 | 2013-01-17 | Amylin Pharmaceuticals, Inc. | Engineered polypeptides having enhanced duration of action with reduced immunogenicity |
| AU2013234496B2 (en) | 2012-03-22 | 2017-07-27 | Novo Nordisk A/S | Compositions of GLP-1 peptides and preparation thereof |
| EP4331667A2 (en) | 2012-03-22 | 2024-03-06 | Novo Nordisk A/S | Compositions comprising a delivery agent and preparation thereof |
| ES2871328T3 (es) * | 2012-06-20 | 2021-10-28 | Novo Nordisk As | Formulación de comprimido que comprende un péptido y un agente de suministro |
| RU2671406C2 (ru) * | 2013-05-02 | 2018-10-31 | Ново Нордиск А/С | Пероральная дозированная форма соединений глюкагоноподобного пептида-1 |
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