JP2014503526A5 - - Google Patents
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- JP2014503526A5 JP2014503526A5 JP2013543814A JP2013543814A JP2014503526A5 JP 2014503526 A5 JP2014503526 A5 JP 2014503526A5 JP 2013543814 A JP2013543814 A JP 2013543814A JP 2013543814 A JP2013543814 A JP 2013543814A JP 2014503526 A5 JP2014503526 A5 JP 2014503526A5
- Authority
- JP
- Japan
- Prior art keywords
- composition according
- amino
- salt
- hydroxybenzoyl
- glp
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- 239000000203 mixture Substances 0.000 claims description 34
- 125000001424 substituent group Chemical group 0.000 claims description 16
- 239000003877 glucagon like peptide 1 receptor agonist Substances 0.000 claims description 12
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 7
- 229930195729 fatty acid Natural products 0.000 claims description 7
- 239000000194 fatty acid Substances 0.000 claims description 7
- -1 (2-hydroxybenzoyl) amino Chemical group 0.000 claims description 5
- DTHNMHAUYICORS-KTKZVXAJSA-N Glucagon-like peptide 1 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 description 3
- 102100025101 GATA-type zinc finger protein 1 Human genes 0.000 claims description 2
- 101710198884 GATA-type zinc finger protein 1 Proteins 0.000 claims description 2
- 125000005313 fatty acid group Chemical group 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims 12
- 150000001768 cations Chemical class 0.000 claims 3
- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 claims 2
- 239000008247 solid mixture Substances 0.000 claims 2
- RUVRGYVESPRHSZ-UHFFFAOYSA-N 2-[2-(2-azaniumylethoxy)ethoxy]acetate Chemical class NCCOCCOCC(O)=O RUVRGYVESPRHSZ-UHFFFAOYSA-N 0.000 claims 1
- 239000005635 Caprylic acid (CAS 124-07-2) Substances 0.000 claims 1
- 108010011459 Exenatide Proteins 0.000 claims 1
- 101800004266 Glucagon-like peptide 1(7-37) Proteins 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- 208000008589 Obesity Diseases 0.000 claims 1
- DLSWIYLPEUIQAV-UHFFFAOYSA-N Semaglutide Chemical group CCC(C)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CCC(O)=O)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCC(O)=O)C(O)=O)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(O)=O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(O)=O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(O)=O)NC(=O)C(C)(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CCCNC(N)=N)C(=O)NCC(O)=O DLSWIYLPEUIQAV-UHFFFAOYSA-N 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 238000007792 addition Methods 0.000 claims 1
- 159000000007 calcium salts Chemical class 0.000 claims 1
- JUFFVKRROAPVBI-PVOYSMBESA-N chembl1210015 Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(=O)N[C@H]1[C@@H]([C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO[C@]3(O[C@@H](C[C@H](O)[C@H](O)CO)[C@H](NC(C)=O)[C@@H](O)C3)C(O)=O)O2)O)[C@@H](CO)O1)NC(C)=O)C(=O)NCC(=O)NCC(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)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)CNC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 JUFFVKRROAPVBI-PVOYSMBESA-N 0.000 claims 1
- 230000037430 deletion Effects 0.000 claims 1
- 238000012217 deletion Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229960001519 exenatide Drugs 0.000 claims 1
- 108010063245 glucagon-like peptide 1 (7-36)amide Proteins 0.000 claims 1
- 238000003780 insertion Methods 0.000 claims 1
- 230000037431 insertion Effects 0.000 claims 1
- 235000020824 obesity Nutrition 0.000 claims 1
- WWZKQHOCKIZLMA-UHFFFAOYSA-M octanoate Chemical compound CCCCCCCC([O-])=O WWZKQHOCKIZLMA-UHFFFAOYSA-M 0.000 claims 1
- 229960002446 octanoic acid Drugs 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims 1
- GCYXWQUSHADNBF-AAEALURTSA-N preproglucagon 78-108 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](CCCCN)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](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 GCYXWQUSHADNBF-AAEALURTSA-N 0.000 claims 1
- 229950011186 semaglutide Drugs 0.000 claims 1
- 108010060325 semaglutide Proteins 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 159000000000 sodium salts Chemical class 0.000 claims 1
- 238000006467 substitution reaction Methods 0.000 claims 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 1
- 150000004665 fatty acids Chemical class 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10195285.1 | 2010-12-16 | ||
| EP10195285 | 2010-12-16 | ||
| US201061425087P | 2010-12-20 | 2010-12-20 | |
| US61/425,087 | 2010-12-20 | ||
| PCT/EP2011/073060 WO2012080471A1 (en) | 2010-12-16 | 2011-12-16 | Solid compositions comprising a glp-1 agonist and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016045452A Division JP2016117759A (ja) | 2010-12-16 | 2016-03-09 | Ｇｌｐ−１アゴニストとｎ−（８−（２−ヒドロキシベンゾイル）アミノ）カプリル酸の塩とを含む固形組成物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2014503526A JP2014503526A (ja) | 2014-02-13 |
| JP2014503526A5 true JP2014503526A5 (https=) | 2015-02-12 |
| JP5902194B2 JP5902194B2 (ja) | 2016-04-13 |
Family
ID=43903993
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013543814A Active JP5902194B2 (ja) | 2010-12-16 | 2011-12-16 | Ｇｌｐ−１アゴニストとｎ−（８−（２−ヒドロキシベンゾイル）アミノ）カプリル酸の塩とを含む固形組成物 |
| JP2016045452A Withdrawn JP2016117759A (ja) | 2010-12-16 | 2016-03-09 | Ｇｌｐ−１アゴニストとｎ−（８−（２−ヒドロキシベンゾイル）アミノ）カプリル酸の塩とを含む固形組成物 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016045452A Withdrawn JP2016117759A (ja) | 2010-12-16 | 2016-03-09 | Ｇｌｐ−１アゴニストとｎ−（８−（２−ヒドロキシベンゾイル）アミノ）カプリル酸の塩とを含む固形組成物 |
Country Status (21)
| Country | Link |
|---|---|
| US (7) | US9278123B2 (https=) |
| EP (3) | EP3730127A1 (https=) |
| JP (2) | JP5902194B2 (https=) |
| KR (1) | KR101925620B1 (https=) |
| CN (2) | CN105963685B (https=) |
| AU (1) | AU2011343190B2 (https=) |
| BR (1) | BR112013014942B1 (https=) |
| CA (1) | CA2821886A1 (https=) |
| DK (2) | DK2651398T3 (https=) |
| ES (1) | ES2661676T3 (https=) |
| HR (1) | HRP20180425T1 (https=) |
| HU (1) | HUE036066T2 (https=) |
| LT (1) | LT2651398T (https=) |
| MX (2) | MX377589B (https=) |
| PL (2) | PL3326620T3 (https=) |
| PT (1) | PT2651398T (https=) |
| RS (2) | RS56998B1 (https=) |
| RU (1) | RU2600440C3 (https=) |
| SI (2) | SI2651398T1 (https=) |
| SM (1) | SMT201800117T1 (https=) |
| WO (1) | WO2012080471A1 (https=) |
Families Citing this family (87)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX377589B (es) | 2010-12-16 | 2025-03-10 | Novo Nordisk As | Composiciones sólidas que comprenden agonista de glp-1 y sal del ácido n-(8-(2-hidroxibenzoil)amino)caprílico. |
| RU2602601C2 (ru) | 2011-04-12 | 2016-11-20 | Ново Нордиск А/С | Дважды ацилированные производные glp-1 |
| DK2827845T3 (en) | 2012-03-22 | 2019-04-01 | Novo Nordisk As | COMPOSITIONS INCLUDING A PROCEDURE AND PREPARING THEREOF |
| EP3542790B1 (en) | 2012-03-22 | 2023-09-13 | Novo Nordisk A/S | Compositions comprising a delivery agent and preparation thereof |
| CN104203266B (zh) | 2012-03-22 | 2017-12-26 | 诺和诺德股份有限公司 | Glp‑1肽组合物及其制备 |
| JP6517690B2 (ja) * | 2012-06-20 | 2019-05-22 | ノヴォ ノルディスク アー／エス | ペプチド及び送達剤を含む錠剤製剤 |
| HRP20251088T1 (hr) | 2012-07-01 | 2025-11-07 | Novo Nordisk A/S | Upotreba dugodjelujućih peptida glp‑1 |
| UA116217C2 (uk) | 2012-10-09 | 2018-02-26 | Санофі | Пептидна сполука як подвійний агоніст рецепторів glp1-1 та глюкагону |
| HK1211232A1 (en) | 2012-12-21 | 2016-05-20 | Sanofi | Exendin-4 derivatives as dual glp1/gip or trigonal glp1/gip/glucagon agonists |
| WO2014138241A1 (en) | 2013-03-05 | 2014-09-12 | Enteris Biopharma, Inc. | Pharmaceuticals for oral delivery |
| CN104055735B (zh) * | 2013-03-22 | 2016-08-03 | 深圳翰宇药业股份有限公司 | 一种萨摩鲁泰的脂质体及其制备方法 |
| JP6672140B2 (ja) | 2013-05-02 | 2020-03-25 | ノヴォ ノルディスク アー／エス | Ｇｌｐ−１化合物の経口投薬 |
| EP3080152A1 (en) | 2013-12-13 | 2016-10-19 | Sanofi | Non-acylated exendin-4 peptide analogues |
| TW201609799A (zh) | 2013-12-13 | 2016-03-16 | 賽諾菲公司 | 雙重ｇｌｐ－１／ｇｉｐ受體促效劑 |
| WO2015086728A1 (en) | 2013-12-13 | 2015-06-18 | Sanofi | Exendin-4 peptide analogues as dual glp-1/gip receptor agonists |
| WO2015086733A1 (en) | 2013-12-13 | 2015-06-18 | Sanofi | Dual glp-1/glucagon receptor agonists |
| TW201625670A (zh) | 2014-04-07 | 2016-07-16 | 賽諾菲公司 | 衍生自ｅｘｅｎｄｉｎ－４之雙重ｇｌｐ－１／升糖素受體促效劑 |
| TW201625668A (zh) | 2014-04-07 | 2016-07-16 | 賽諾菲公司 | 作為胜肽性雙重ｇｌｐ－１／昇糖素受體激動劑之艾塞那肽－４衍生物 |
| TW201625669A (zh) | 2014-04-07 | 2016-07-16 | 賽諾菲公司 | 衍生自艾塞那肽－４（Ｅｘｅｎｄｉｎ－４）之肽類雙重ＧＬＰ－１／升糖素受體促效劑 |
| US9932381B2 (en) | 2014-06-18 | 2018-04-03 | Sanofi | Exendin-4 derivatives as selective glucagon receptor agonists |
| DK3006045T3 (en) * | 2014-10-07 | 2017-07-17 | Cyprumed Gmbh | Pharmaceutical formulations for oral administration of peptide or protein drugs |
| CN105777872B (zh) * | 2014-12-16 | 2019-06-07 | 深圳翰宇药业股份有限公司 | 一种萨摩鲁肽的纯化方法 |
| US9833411B2 (en) | 2015-01-12 | 2017-12-05 | Enteris Biopharma, Inc. | Solid oral dosage forms |
| US10265384B2 (en) * | 2015-01-29 | 2019-04-23 | Novo Nordisk A/S | Tablets comprising GLP-1 agonist and enteric coating |
| CN113713090B (zh) | 2015-02-09 | 2023-06-02 | 安特拉贝欧有限公司 | 骨质疏松症的治疗 |
| WO2016168388A2 (en) | 2015-04-14 | 2016-10-20 | Palatin Technologies, Inc. | Therapies for obesity, diabetes and related indications |
| AR105319A1 (es) | 2015-06-05 | 2017-09-27 | Sanofi Sa | Profármacos que comprenden un conjugado agonista dual de glp-1 / glucagón conector ácido hialurónico |
| AR105284A1 (es) | 2015-07-10 | 2017-09-20 | Sanofi Sa | Derivados de exendina-4 como agonistas peptídicos duales específicos de los receptores de glp-1 / glucagón |
| WO2017149070A1 (en) | 2016-03-03 | 2017-09-08 | Novo Nordisk A/S | Glp-1 derivatives and uses thereof |
| JP7221694B2 (ja) * | 2016-04-28 | 2023-02-14 | ノヴォ ノルディスク アー／エス | 心血管状態におけるセマグルチド |
| IL264880B2 (en) | 2016-08-17 | 2024-09-01 | Entera Bio Ltd | Preparations for oral administration of active substances |
| JOP20190060A1 (ar) | 2016-09-26 | 2019-03-26 | Chugai Pharmaceutical Co Ltd | مشتق بيرازولو بيريدين له تأثير مساعد لمستقبل glp-1 |
| WO2018200691A2 (en) * | 2017-04-25 | 2018-11-01 | Proteus Digital Health, Inc. | Lisinopril compositions with an ingestible event marker |
| AR112015A1 (es) * | 2017-06-09 | 2019-09-11 | Novo Nordisk As | Composiciones sólidas para administración oral |
| WO2019004088A1 (ja) | 2017-06-27 | 2019-01-03 | 株式会社バイオセレンタック | 粘膜付着性経口製剤 |
| HRP20240485T1 (hr) | 2017-08-24 | 2024-07-05 | Novo Nordisk A/S | Pripravci glp-1 i njihova upotreba |
| JP7148605B2 (ja) | 2017-10-12 | 2022-10-05 | ノヴォ ノルディスク アー／エス | 医学療法におけるセマグルチド |
| PL3746111T3 (pl) | 2018-02-02 | 2024-01-15 | Novo Nordisk A/S | Stałe kompozycje zawierające agonistę glp-1 i sól kwasu n-(8-(2- hydroksybenzoilo)amino kaprylowego i substancję poślizgową |
| TWI829687B (zh) | 2018-05-07 | 2024-01-21 | 丹麥商諾佛 儂迪克股份有限公司 | 包含glp-1促效劑與n-(8-(2-羥基苯甲醯基)胺基)辛酸之鹽的固體組成物 |
| HRP20230929T1 (hr) | 2018-10-26 | 2023-11-24 | Novo Nordisk A/S | Stabilni pripravci semaglutida i njihova upotreba |
| US20220072493A1 (en) | 2019-01-24 | 2022-03-10 | Novo Nordisk A/S | Roller compactor and method of dry granulation using a roller compactor |
| EP3930757A1 (en) | 2019-03-01 | 2022-01-05 | President And Fellows Of Harvard College | Methods and compositions for protein delivery |
| CN113677336B (zh) | 2019-04-10 | 2024-04-30 | 基恩菲特公司 | 包含式(i)化合物和glp-1受体激动剂的组合疗法 |
| US20220280611A1 (en) * | 2019-08-07 | 2022-09-08 | Novo Nordisk A/S | Solid composition comprising a pyy compound and a salt of n-(8-(2- hydroxybenzoyl)amino)caprylic acid |
| KR20220046565A (ko) | 2019-08-07 | 2022-04-14 | 노보 노르디스크 에이/에스 | Egf(a) 유도체 및 n-(8-(2-하이드록시벤조일)아미노)카프릴산의 염을 포함하는 고형 조성물 |
| CN114340655A (zh) * | 2019-09-02 | 2022-04-12 | 诺和诺德股份有限公司 | 生产包含glp-1肽的片剂的方法 |
| ES3006288T3 (en) | 2019-09-06 | 2025-03-18 | Novo Nordisk As | Method and equipment for fractionation of granules for use in pharmaceutical compositions |
| CA3154744A1 (en) | 2019-11-06 | 2021-05-14 | Sarah FRIEDRICH | Glp-1 receptor agonists in dementia |
| IL291893A (en) | 2019-11-07 | 2022-06-01 | Novo Nordisk As | Solid preparations comprising a pcsk9 inhibitor and a salt of n-(8-(2-hydroxybenzoyl)amino) caprylic acid |
| CN114641276A (zh) | 2019-11-07 | 2022-06-17 | 诺和诺德股份有限公司 | 包含glp-1激动剂、sglt2抑制剂和n-(8-(2-羟基苯甲酰基)氨基)辛酸的盐的固体组合物 |
| EP4104820A4 (en) | 2020-02-14 | 2024-04-17 | G2GBIO, Inc. | Pharmaceutical composition comprising sustained-release microspheres including glp-1 analogue or pharmaceutically acceptable salt thereof |
| EP4142695B1 (en) | 2020-04-29 | 2025-11-05 | Novo Nordisk A/S | Solid compositions comprising a glp-1 agonist and histidine |
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