HRP20230929T1 - Stabilni pripravci semaglutida i njihova upotreba - Google Patents
Stabilni pripravci semaglutida i njihova upotreba Download PDFInfo
- Publication number
- HRP20230929T1 HRP20230929T1 HRP20230929TT HRP20230929T HRP20230929T1 HR P20230929 T1 HRP20230929 T1 HR P20230929T1 HR P20230929T T HRP20230929T T HR P20230929TT HR P20230929 T HRP20230929 T HR P20230929T HR P20230929 T1 HRP20230929 T1 HR P20230929T1
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- HR
- Croatia
- Prior art keywords
- preparation
- preparation according
- kit
- preceding patent
- concentration
- Prior art date
Links
- DLSWIYLPEUIQAV-UHFFFAOYSA-N Semaglutide Chemical compound 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 title claims 4
- 229950011186 semaglutide Drugs 0.000 title claims 4
- 108010060325 semaglutide Proteins 0.000 title claims 4
- 239000000203 mixture Substances 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 6
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical group CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 3
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 3
- 239000000872 buffer Substances 0.000 claims 2
- 208000008589 Obesity Diseases 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- KDQPSPMLNJTZAL-UHFFFAOYSA-L disodium hydrogenphosphate dihydrate Chemical compound O.O.[Na+].[Na+].OP([O-])([O-])=O KDQPSPMLNJTZAL-UHFFFAOYSA-L 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000007951 isotonicity adjuster Substances 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 235000020824 obesity Nutrition 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/26—Glucagons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
Claims (15)
1. Tekući farmaceutski pripravak, naznačen time što sadrži semaglutid, sredstvo za izotoničnost i histidin, što je koncentracija histidina 0,5-100 mM, te što je pH pripravka u rasponu od 6,0-10,0.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što je koncentracija histidina 0,5-15 mM.
3. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je pripravak vodena otopina, koja sadrži najmanje 60% (tež./tež.) vode, primjerice najmanje 70% (tež./tež.) vode ili najmanje 80% (tež./tež.) vode.
4. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je koncentracija semaglutida 0,1-15 mg/ml pripravka.
5. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je koncentracija semaglutida 0,1-10 mg/ml pripravka.
6. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što pripravak dodatno sadrži jedno ili više farmaceutski prihvatljivih pomoćnih sredstava, poput pufera.
7. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što pripravak sadrži fosfatni pufer.
8. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što pripravak sadrži dinatrijev hidrogenfosfat dihidrat kao pufer.
9. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je sredstvo za izotoničnost propilen-glikol.
10. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je pripravak u napunjenoj štrcaljki ili ulošku.
11. Komplet, naznačen time što sadrži farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva i upute o upotrebi.
12. Komplet u skladu s patentnim zahtjevom 11, naznačen time što komplet sadrži napunjenu štrcaljku namijenjenu primjeni farmaceutskog pripravka na subjektu.
13. Komplet u skladu s patentnim zahtjevom 11, naznačen time što komplet sadrži trajnu brizgalicu ili napunjenu brizgalicu namijenjenu primjeni farmaceutskog pripravka na subjektu.
14. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1-10, naznačen time što je namijenjen upotrebi kao medikament.
15. Farmaceutski pripravak u skladu s patentnim zahtjevom 14, naznačen time što je namijenjen upotrebi u liječenju dijabetesa ili pretilosti.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP18202801 | 2018-10-26 | ||
| EP19158226 | 2019-02-20 | ||
| PCT/EP2019/079214 WO2020084126A1 (en) | 2018-10-26 | 2019-10-25 | Stable semaglutide compositions and uses thereof |
| EP19801228.8A EP3870213B1 (en) | 2018-10-26 | 2019-10-25 | Stable semaglutide compositions and uses thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230929T1 true HRP20230929T1 (hr) | 2023-11-24 |
Family
ID=68503076
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230929TT HRP20230929T1 (hr) | 2018-10-26 | 2019-10-25 | Stabilni pripravci semaglutida i njihova upotreba |
Country Status (21)
| Country | Link |
|---|---|
| US (1) | US20210379159A1 (hr) |
| EP (1) | EP3870213B1 (hr) |
| JP (1) | JP7422754B2 (hr) |
| KR (1) | KR20210087465A (hr) |
| CN (1) | CN112912100A (hr) |
| AU (1) | AU2019363725A1 (hr) |
| BR (1) | BR112021006598A2 (hr) |
| CA (1) | CA3116271A1 (hr) |
| CL (1) | CL2021000938A1 (hr) |
| CO (1) | CO2021005915A2 (hr) |
| ES (1) | ES2954584T3 (hr) |
| HR (1) | HRP20230929T1 (hr) |
| HU (1) | HUE062893T2 (hr) |
| IL (1) | IL281938B2 (hr) |
| MX (1) | MX2021004331A (hr) |
| PE (1) | PE20211492A1 (hr) |
| PH (1) | PH12021550705A1 (hr) |
| PL (1) | PL3870213T3 (hr) |
| RS (1) | RS64438B1 (hr) |
| SG (1) | SG11202103137WA (hr) |
| WO (1) | WO2020084126A1 (hr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021105393A1 (en) * | 2019-11-29 | 2021-06-03 | Novo Nordisk A/S | Processes for obtaining stable glp-1 compositions |
| KR20220143037A (ko) | 2020-02-18 | 2022-10-24 | 노보 노르디스크 에이/에스 | Glp-1 조성물 및 이의 용도 |
| US11478533B2 (en) | 2020-04-27 | 2022-10-25 | Novo Nordisk A/S | Semaglutide for use in medicine |
| WO2023083301A1 (zh) * | 2021-11-12 | 2023-05-19 | 福建盛迪医药有限公司 | Glp-1受体和gip受体双重激动剂的药物组合物及其用途 |
| CN114660214B (zh) * | 2022-02-18 | 2024-04-05 | 兰州积石药业有限公司 | 一种司美格鲁肽的液相色谱检测方法及其应用 |
Family Cites Families (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9930882D0 (en) | 1999-12-30 | 2000-02-23 | Nps Allelix Corp | GLP-2 formulations |
| WO2003002136A2 (en) * | 2001-06-28 | 2003-01-09 | Novo Nordisk A/S | Stable formulation of modified glp-1 |
| US20060287221A1 (en) * | 2003-11-13 | 2006-12-21 | Novo Nordisk A/S | Soluble pharmaceutical compositions for parenteral administration comprising a GLP-1 peptide and an insulin peptide of short time action for treatment of diabetes and bulimia |
| MXPA06005581A (es) | 2003-11-20 | 2006-08-11 | Novo Nordisk As | Formulaciones de peptidos que contienen propilenglicol que son optimas para la produccion y uso en dispositivos de inyeccion. |
| JP2008513384A (ja) * | 2004-09-17 | 2008-05-01 | ノボ ノルディスク アクティーゼルスカブ | インスリンおよびインスリン分泌性ペプチドを含有する医薬組成物 |
| TWI362392B (en) | 2005-03-18 | 2012-04-21 | Novo Nordisk As | Acylated glp-1 compounds |
| EP2036539A1 (en) * | 2007-09-11 | 2009-03-18 | Novo Nordisk A/S | Stable formulations of amylin and its analogues |
| WO2011109787A1 (en) * | 2010-03-05 | 2011-09-09 | Conjuchem, Llc | Methods of administering insulinotropic peptides |
| US20120208755A1 (en) * | 2011-02-16 | 2012-08-16 | Intarcia Therapeutics, Inc. | Compositions, Devices and Methods of Use Thereof for the Treatment of Cancers |
| CN103566354B (zh) * | 2012-07-25 | 2017-12-05 | 江苏豪森药业集团有限公司 | 含有glp‑1类似物的衍生物或其可药用盐的药物组合物 |
| WO2014124096A1 (en) * | 2013-02-06 | 2014-08-14 | Perosphere Inc. | Stable glucagon formulations |
| JP2014214153A (ja) | 2013-04-30 | 2014-11-17 | ニプロ株式会社 | 水溶液製剤およびその製造方法 |
| WO2016038521A1 (en) * | 2014-09-08 | 2016-03-17 | Sun Pharmaceutical Industries Limited | Pharmaceutical compositions of liraglutide |
| WO2016077220A1 (en) * | 2014-11-10 | 2016-05-19 | Mb2 Llc | Gip/glp-1 co-agonist peptides for human administration |
| CN106999602B (zh) * | 2014-11-27 | 2022-02-01 | 诺和诺德股份有限公司 | Glp-1衍生物及其用途 |
| TWI622596B (zh) | 2015-10-26 | 2018-05-01 | 美國禮來大藥廠 | 升糖素受體促效劑 |
| 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 |
| CN107661288A (zh) * | 2016-07-29 | 2018-02-06 | 江苏泰康生物医药有限公司 | 含有glp‑1 类似物融合蛋白的稳定液体制剂及其制备 |
| CN107952064B (zh) * | 2016-10-14 | 2023-10-20 | 江苏豪森药业集团有限公司 | 含有聚乙二醇洛塞那肽的药物制剂及其制备方法 |
| CN108210890A (zh) * | 2016-12-09 | 2018-06-29 | 江苏泰康生物医药有限公司 | 重组人胰高血糖素样肽-1类似物融合蛋白的新型稳定制剂 |
| GB201621987D0 (en) * | 2016-12-22 | 2017-02-08 | Archer Virgil L See Archer Sheri A Arecor Ltd | Novel composition |
-
2019
- 2019-10-25 MX MX2021004331A patent/MX2021004331A/es unknown
- 2019-10-25 JP JP2021521260A patent/JP7422754B2/ja active Active
- 2019-10-25 BR BR112021006598A patent/BR112021006598A2/pt unknown
- 2019-10-25 CA CA3116271A patent/CA3116271A1/en active Pending
- 2019-10-25 US US17/288,128 patent/US20210379159A1/en active Pending
- 2019-10-25 IL IL281938A patent/IL281938B2/en unknown
- 2019-10-25 WO PCT/EP2019/079214 patent/WO2020084126A1/en active Application Filing
- 2019-10-25 PE PE2021000506A patent/PE20211492A1/es unknown
- 2019-10-25 PL PL19801228.8T patent/PL3870213T3/pl unknown
- 2019-10-25 AU AU2019363725A patent/AU2019363725A1/en active Pending
- 2019-10-25 RS RS20230658A patent/RS64438B1/sr unknown
- 2019-10-25 EP EP19801228.8A patent/EP3870213B1/en active Active
- 2019-10-25 KR KR1020217014336A patent/KR20210087465A/ko not_active Application Discontinuation
- 2019-10-25 SG SG11202103137WA patent/SG11202103137WA/en unknown
- 2019-10-25 ES ES19801228T patent/ES2954584T3/es active Active
- 2019-10-25 HU HUE19801228A patent/HUE062893T2/hu unknown
- 2019-10-25 HR HRP20230929TT patent/HRP20230929T1/hr unknown
- 2019-10-25 CN CN201980070660.8A patent/CN112912100A/zh active Pending
-
2021
- 2021-03-29 PH PH12021550705A patent/PH12021550705A1/en unknown
- 2021-04-15 CL CL2021000938A patent/CL2021000938A1/es unknown
- 2021-05-05 CO CONC2021/0005915A patent/CO2021005915A2/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO2020084126A1 (en) | 2020-04-30 |
| JP2022505290A (ja) | 2022-01-14 |
| CL2021000938A1 (es) | 2021-09-10 |
| IL281938B2 (en) | 2024-04-01 |
| IL281938B1 (en) | 2023-12-01 |
| CA3116271A1 (en) | 2020-04-30 |
| HUE062893T2 (hu) | 2023-12-28 |
| CO2021005915A2 (es) | 2021-08-09 |
| JP7422754B2 (ja) | 2024-01-26 |
| PE20211492A1 (es) | 2021-08-11 |
| RS64438B1 (sr) | 2023-09-29 |
| CN112912100A (zh) | 2021-06-04 |
| AU2019363725A1 (en) | 2021-05-20 |
| MX2021004331A (es) | 2021-05-27 |
| EP3870213C0 (en) | 2023-06-07 |
| PL3870213T3 (pl) | 2023-11-20 |
| IL281938A (en) | 2021-05-31 |
| BR112021006598A2 (pt) | 2021-07-06 |
| EP3870213A1 (en) | 2021-09-01 |
| EP3870213B1 (en) | 2023-06-07 |
| SG11202103137WA (en) | 2021-04-29 |
| ES2954584T3 (es) | 2023-11-23 |
| KR20210087465A (ko) | 2021-07-12 |
| US20210379159A1 (en) | 2021-12-09 |
| PH12021550705A1 (en) | 2021-11-03 |
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