JPWO2020065064A5 - - Google Patents
Download PDFInfo
- Publication number
- JPWO2020065064A5 JPWO2020065064A5 JP2021517294A JP2021517294A JPWO2020065064A5 JP WO2020065064 A5 JPWO2020065064 A5 JP WO2020065064A5 JP 2021517294 A JP2021517294 A JP 2021517294A JP 2021517294 A JP2021517294 A JP 2021517294A JP WO2020065064 A5 JPWO2020065064 A5 JP WO2020065064A5
- Authority
- JP
- Japan
- Prior art keywords
- formulation
- glp
- concentration
- analogue
- buffer
- 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.)
- Pending
Links
- 238000009472 formulation Methods 0.000 claims 46
- 239000000203 mixture Substances 0.000 claims 46
- TWSALRJGPBVBQU-PKQQPRCHSA-N Glucagon-like peptide 2 Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CC(N)=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]([C@@H](C)CC)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(O)=O)C(O)=O)[C@@H](C)CC)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@H](CO)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](C)NC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)CC)C1=CC=CC=C1 TWSALRJGPBVBQU-PKQQPRCHSA-N 0.000 claims 28
- UIIMBOGNXHQVGW-UHFFFAOYSA-M buffer Substances [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 24
- QTBSBXVTEAMEQO-UHFFFAOYSA-N acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 12
- PEDCQBHIVMGVHV-UHFFFAOYSA-N glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 12
- FBPFZTCFMRRESA-KAZBKCHUSA-N D-Mannitol Natural products OC[C@@H](O)[C@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KAZBKCHUSA-N 0.000 claims 10
- 229960002885 Histidine Drugs 0.000 claims 10
- FBPFZTCFMRRESA-KVTDHHQDSA-N Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 10
- 229940121355 glucagon like peptide 2 (GLP-2) analogues Drugs 0.000 claims 10
- 235000010355 mannitol Nutrition 0.000 claims 10
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 9
- 239000000594 mannitol Substances 0.000 claims 9
- 239000004475 Arginine Substances 0.000 claims 8
- 235000009697 arginine Nutrition 0.000 claims 8
- 206010049416 Short-bowel syndrome Diseases 0.000 claims 7
- 239000008194 pharmaceutical composition Substances 0.000 claims 7
- 239000008247 solid mixture Substances 0.000 claims 7
- 239000007983 Tris buffer Substances 0.000 claims 6
- DHMQDGOQFOQNFH-UHFFFAOYSA-N glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 6
- 239000008181 tonicity modifier Substances 0.000 claims 6
- 201000010099 disease Diseases 0.000 claims 5
- 239000007788 liquid Substances 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 5
- 239000011780 sodium chloride Substances 0.000 claims 5
- 206010009839 Coeliac disease Diseases 0.000 claims 4
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 4
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N D-sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 4
- CZMRCDWAGMRECN-GDQSFJPYSA-N Sucrose Natural products O([C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](CO)O1)[C@@]1(CO)[C@H](O)[C@@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-GDQSFJPYSA-N 0.000 claims 4
- 230000002496 gastric Effects 0.000 claims 4
- AFVFQIVMOAPDHO-UHFFFAOYSA-N methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 claims 4
- 239000000600 sorbitol Substances 0.000 claims 4
- 239000005720 sucrose Substances 0.000 claims 4
- BVQVLAIMHVDZEL-UHFFFAOYSA-N 1-phenyl-1,2-propanedione Chemical group CC(=O)C(=O)C1=CC=CC=C1 BVQVLAIMHVDZEL-UHFFFAOYSA-N 0.000 claims 3
- OWMVSZAMULFTJU-UHFFFAOYSA-N Bis-tris methane Chemical compound OCCN(CCO)C(CO)(CO)CO OWMVSZAMULFTJU-UHFFFAOYSA-N 0.000 claims 3
- 208000004232 Enteritis Diseases 0.000 claims 3
- 239000004471 Glycine Substances 0.000 claims 3
- 125000001176 L-lysyl group Chemical group [H]N([H])[C@]([H])(C(=O)[*])C([H])([H])C([H])([H])C([H])([H])C(N([H])[H])([H])[H] 0.000 claims 3
- 125000002842 L-seryl group Chemical group O=C([*])[C@](N([H])[H])([H])C([H])([H])O[H] 0.000 claims 3
- 239000004472 Lysine Substances 0.000 claims 3
- 239000007993 MOPS buffer Substances 0.000 claims 3
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 3
- HDTRYLNUVZCQOY-LIZSDCNHSA-N Trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 3
- 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 claims 3
- 125000003295 alanine group Chemical group N[C@@H](C)C(=O)* 0.000 claims 3
- 125000000217 alkyl group Chemical group 0.000 claims 3
- 150000001413 amino acids Chemical group 0.000 claims 3
- 238000002512 chemotherapy Methods 0.000 claims 3
- 125000002485 formyl group Chemical group [H]C(*)=O 0.000 claims 3
- 229910052739 hydrogen Inorganic materials 0.000 claims 3
- 239000001257 hydrogen Substances 0.000 claims 3
- 125000004435 hydrogen atoms Chemical class [H]* 0.000 claims 3
- 230000000968 intestinal Effects 0.000 claims 3
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims 3
- 238000002560 therapeutic procedure Methods 0.000 claims 3
- 125000004044 trifluoroacetyl group Chemical group FC(C(=O)*)(F)F 0.000 claims 3
- 229940090047 Auto-Injector Drugs 0.000 claims 2
- 206010011401 Crohn's disease Diseases 0.000 claims 2
- 102100003818 GCG Human genes 0.000 claims 2
- 101710042131 GCG Proteins 0.000 claims 2
- 206010022114 Injury Diseases 0.000 claims 2
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-Arginine Natural products OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 claims 2
- 235000014852 L-arginine Nutrition 0.000 claims 2
- 125000002059 L-arginyl group Chemical group O=C([*])[C@](N([H])[H])([H])C([H])([H])C([H])([H])C([H])([H])N([H])C(=N[H])N([H])[H] 0.000 claims 2
- 206010025476 Malabsorption Diseases 0.000 claims 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 2
- 239000008351 acetate buffer Substances 0.000 claims 2
- 159000000021 acetate salts Chemical class 0.000 claims 2
- 230000001093 anti-cancer Effects 0.000 claims 2
- 239000002246 antineoplastic agent Substances 0.000 claims 2
- 230000015572 biosynthetic process Effects 0.000 claims 2
- 230000000694 effects Effects 0.000 claims 2
- 238000005755 formation reaction Methods 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- 230000002265 prevention Effects 0.000 claims 2
- 238000001959 radiotherapy Methods 0.000 claims 2
- 231100000486 side effect Toxicity 0.000 claims 2
- 208000004998 Abdominal Pain Diseases 0.000 claims 1
- 210000004534 Cecum Anatomy 0.000 claims 1
- 206010009900 Colitis ulcerative Diseases 0.000 claims 1
- 206010012735 Diarrhoea Diseases 0.000 claims 1
- 206010021972 Inflammatory bowel disease Diseases 0.000 claims 1
- 210000004347 Intestinal Mucosa Anatomy 0.000 claims 1
- 125000002066 L-histidyl group Chemical group [H]N1C([H])=NC(C([H])([H])[C@](C(=O)[*])([H])N([H])[H])=C1[H] 0.000 claims 1
- 208000004155 Malabsorption Syndromes Diseases 0.000 claims 1
- 229940071643 Prefilled Syringe Drugs 0.000 claims 1
- 206010044697 Tropical sprue Diseases 0.000 claims 1
- 206010068760 Ulcers Diseases 0.000 claims 1
- 206010047700 Vomiting Diseases 0.000 claims 1
- 230000001419 dependent Effects 0.000 claims 1
- 201000008286 diarrhea Diseases 0.000 claims 1
- 230000001079 digestive Effects 0.000 claims 1
- 230000004064 dysfunction Effects 0.000 claims 1
- 108010074605 gamma-Globulins Proteins 0.000 claims 1
- 101710038873 glc-1 Proteins 0.000 claims 1
- 125000003372 histidine group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims 1
- 230000002458 infectious Effects 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 230000000051 modifying Effects 0.000 claims 1
- 125000000896 monocarboxylic acid group Chemical group 0.000 claims 1
- 230000000069 prophylaxis Effects 0.000 claims 1
- 239000003638 reducing agent Substances 0.000 claims 1
- 238000010254 subcutaneous injection Methods 0.000 claims 1
- 239000007929 subcutaneous injection Substances 0.000 claims 1
- 201000010874 syndrome Diseases 0.000 claims 1
- 230000002588 toxic Effects 0.000 claims 1
- 231100000331 toxic Toxicity 0.000 claims 1
- 231100000397 ulcer Toxicity 0.000 claims 1
- 201000006704 ulcerative colitis Diseases 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP18197755.4 | 2018-09-28 | ||
| EP18197755.4A EP3628683A1 (en) | 2018-09-28 | 2018-09-28 | Formulations of glucagon-like-peptide-2 (glp-2) analogues |
| PCT/EP2019/076305 WO2020065064A1 (en) | 2018-09-28 | 2019-09-27 | Formulations of glucagon-like-peptide-2 (glp-2) analogues |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2022502432A JP2022502432A (ja) | 2022-01-11 |
| JPWO2020065064A5 true JPWO2020065064A5 (ko) | 2022-09-13 |
Family
ID=63794308
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021517294A Pending JP2022502432A (ja) | 2018-09-28 | 2019-09-27 | グルカゴン様ペプチド−２（ｇｌｐ−２）類似体の製剤 |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US20220265551A1 (ko) |
| EP (2) | EP3628683A1 (ko) |
| JP (1) | JP2022502432A (ko) |
| KR (1) | KR20210069056A (ko) |
| CN (1) | CN112771073A (ko) |
| AU (1) | AU2019348538A1 (ko) |
| BR (1) | BR112021005858A2 (ko) |
| CA (1) | CA3114330A1 (ko) |
| CL (1) | CL2021000678A1 (ko) |
| IL (1) | IL281362A (ko) |
| MX (1) | MX2021003271A (ko) |
| SG (1) | SG11202102383VA (ko) |
| WO (1) | WO2020065064A1 (ko) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4154869A1 (en) * | 2020-05-22 | 2023-03-29 | Hanmi Pharm. Co., Ltd. | Liquid formulation of long-acting conjugate of glp-2 |
| MX2023006901A (es) * | 2020-12-16 | 2023-06-26 | Zealand Pharma As | Uso de analogos de glp-2 en pacientes con insuficiencia renal. |
| AU2022341538A1 (en) * | 2021-09-10 | 2024-04-11 | Zealand Pharma A/S | Process for formulating compositions comprising glucagon-like-peptide-2 (glp-2) analogues |
| TW202325855A (zh) | 2021-12-23 | 2023-07-01 | 丹麥商西蘭製藥公司 | 用於合成似升糖素胜肽2(glp-2)類似物的方法 |
| WO2024068933A1 (en) | 2022-09-30 | 2024-04-04 | Zealand Pharma A/S | Glucagon-like-peptide-2 (glp-2) analogues and their medical uses for the treatment of short bowel syndrome (sbs) |
| WO2024075135A1 (en) * | 2022-10-03 | 2024-04-11 | Orbicular Pharmaceutical Technologies Private Limited | "stable injectable compositions of glp-2 peptide" |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ250844A (en) * | 1993-04-07 | 1996-03-26 | Pfizer | Treatment of non-insulin dependant diabetes with peptides; composition |
| US6184201B1 (en) | 1995-04-14 | 2001-02-06 | Nps Allelix Corp. | Intestinotrophic glucagon-like peptide-2 analogs |
| US5789379A (en) | 1995-04-14 | 1998-08-04 | Allelix Biopharmaceutical Inc. | Glucagon-like peptide-2 analogs |
| CA2251576C (en) | 1996-04-12 | 2012-08-21 | 1149336 Ontario Inc. | Glucagon-like peptide-2 analogs |
| EP1076066A1 (en) | 1999-07-12 | 2001-02-14 | Zealand Pharmaceuticals A/S | Peptides for lowering blood glucose levels |
| WO2001041779A2 (en) | 1999-12-08 | 2001-06-14 | 1149336 Ontario Inc. | Combined use of glp-2 receptor agonist and chemotherapeutic agent in treatment |
| GB9930882D0 (en) | 1999-12-30 | 2000-02-23 | Nps Allelix Corp | GLP-2 formulations |
| AU2002233089B2 (en) | 2001-02-16 | 2005-12-22 | Conjuchem Biotechnologies Inc. | Long lasting glucagon-like peptide 2 (GLP-2) for the treatment of gastrointestinal diseases and disorders |
| KR101200227B1 (ko) * | 2005-05-04 | 2012-11-13 | 질랜드 파마 에이/에스 | 글루카곤 유사 펩티드-2(ｇｌｐ-2) 유사체 |
| WO2007074010A1 (en) * | 2005-12-24 | 2007-07-05 | Teagasc Dairy Products Research Centre | Process for the production of trans-10, cis 12 octadecadienoic acid |
| US20090028832A1 (en) * | 2006-08-10 | 2009-01-29 | Chung Leland F | Compositions and methods for targeted tumor therapy |
| JP5819586B2 (ja) * | 2006-11-08 | 2015-11-24 | ジーランド ファーマ アクティーゼルスカブ | 選択的グルカゴン様ペプチド−２（ｇｌｐ−２）類似体 |
| MX2012013375A (es) * | 2010-05-17 | 2013-04-11 | Cebix Inc | Peptido c pegilado. |
| FR2994390B1 (fr) * | 2012-08-10 | 2014-08-15 | Adocia | Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee |
| AU2015335743B2 (en) * | 2014-10-23 | 2020-12-24 | Amgen Inc. | Reducing viscosity of pharmaceutical formulations |
| US11020484B2 (en) * | 2016-11-21 | 2021-06-01 | Eiger Biopharmaceuticals, Inc. | Buffered formulations of exendin (9-39) |
-
2018
- 2018-09-28 EP EP18197755.4A patent/EP3628683A1/en not_active Withdrawn
-
2019
- 2019-09-27 EP EP19773860.2A patent/EP3856766A1/en active Pending
- 2019-09-27 JP JP2021517294A patent/JP2022502432A/ja active Pending
- 2019-09-27 BR BR112021005858-3A patent/BR112021005858A2/pt unknown
- 2019-09-27 WO PCT/EP2019/076305 patent/WO2020065064A1/en active Application Filing
- 2019-09-27 CA CA3114330A patent/CA3114330A1/en active Pending
- 2019-09-27 KR KR1020217010775A patent/KR20210069056A/ko active Search and Examination
- 2019-09-27 US US17/276,252 patent/US20220265551A1/en active Pending
- 2019-09-27 MX MX2021003271A patent/MX2021003271A/es unknown
- 2019-09-27 SG SG11202102383VA patent/SG11202102383VA/en unknown
- 2019-09-27 AU AU2019348538A patent/AU2019348538A1/en active Pending
- 2019-09-27 CN CN201980063594.1A patent/CN112771073A/zh active Pending
-
2021
- 2021-03-09 IL IL281362A patent/IL281362A/en unknown
- 2021-03-19 CL CL2021000678A patent/CL2021000678A1/es unknown
-
2023
- 2023-10-16 US US18/487,666 patent/US20240065978A1/en active Pending
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| AU2013365945B2 (en) | A stable aqueous composition comprising human insulin or an analogue or derivative thereof | |
| ES2365410T3 (es) | Formulaciones farmacéuticas que comprenden péptido de incretina y un disolvente polar aprótico. | |
| ES2249933T3 (es) | Formulacion autoestable de peptido 1 tipo glucagon. | |
| EP3295952B1 (en) | Pharmaceutical formulation comprising glp-1 analogue and preparation method thereof | |
| AU2017277590A1 (en) | Compositions in the form of an injectable aqueous solution, comprising human glucagon and an end-grafted copolyamino acid | |
| US20090202494A1 (en) | Combined use of glp-1 agonists and gastrin for regulating blood glucose levels | |
| CN113730555A (zh) | Ph为7且至少含pi为5.8至8.5之基础胰岛素和取代共聚(氨基酸)的可注射溶液 | |
| JP2014524480A5 (ko) | ||
| ES2896971T3 (es) | Formas de administración de hormona del crecimiento de acción prolongada | |
| AU2017345720B2 (en) | Terlipressin compositions and their methods of use | |
| US20220265551A1 (en) | Formulations of glucagon-like-peptide-2 (glp-2) analogues | |
| CN101095942A (zh) | 一种包含稳定剂的Exendin注射剂药物配方 | |
| KR20220143037A (ko) | Glp-1 조성물 및 이의 용도 | |
| JPWO2020065064A5 (ko) | ||
| JP2022522833A (ja) | １日ごとのソマトロピンよりも優れた効力を有する長時間作用性成長ホルモン剤形 | |
| US20220249424A1 (en) | Parenteral esmolol formulation | |
| JP2017517561A (ja) | 最適化ハムスターｒｅｇ３ガンマペプチドを利用する糖尿病を有する患者の間でのインスリン非依存性 | |
| TW201815410A (zh) | 藥物之經黏膜吸收促進劑 | |
| US20150110885A1 (en) | Parenteral pharmaceutical composition containing cosyntropin | |
| JP2004513069A (ja) | ペプチド医薬処方 | |
| RU2021106892A (ru) | Составы аналогов глюкагоноподобного пептида-2 (glp-2) | |
| WO2014102623A1 (en) | Pharmaceutical composition | |
| EP3628682A1 (en) | Formulations of glucagon-like-peptide-2 (glp-2) analogues | |
| WO2021129779A1 (zh) | 一种新型两亲性蛋白、其制备方法及用途 | |
| WO2023036862A1 (en) | Process for formulating compositions comprising glucagon-like-peptide-2 (glp-2) analogues |