HRP20240485T1 - Pripravci glp-1 i njihova upotreba - Google Patents
Pripravci glp-1 i njihova upotreba Download PDFInfo
- Publication number
- HRP20240485T1 HRP20240485T1 HRP20240485TT HRP20240485T HRP20240485T1 HR P20240485 T1 HRP20240485 T1 HR P20240485T1 HR P20240485T T HRP20240485T T HR P20240485TT HR P20240485 T HRP20240485 T HR P20240485T HR P20240485 T1 HRP20240485 T1 HR P20240485T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation
- semaglutide
- preparation according
- intended
- buffer
- Prior art date
Links
- 101100337060 Caenorhabditis elegans glp-1 gene Proteins 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 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 claims 8
- 229950011186 semaglutide Drugs 0.000 claims 8
- 108010060325 semaglutide Proteins 0.000 claims 8
- 239000000825 pharmaceutical preparation Substances 0.000 claims 6
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 4
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical group CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 3
- 239000000872 buffer Substances 0.000 claims 3
- 239000007788 liquid Substances 0.000 claims 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- 239000008363 phosphate buffer Substances 0.000 claims 2
- 230000001105 regulatory effect Effects 0.000 claims 2
- 208000008589 Obesity Diseases 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims 1
- 235000019799 monosodium phosphate Nutrition 0.000 claims 1
- 235000020824 obesity Nutrition 0.000 claims 1
- 238000007911 parenteral administration Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000002335 preservative effect Effects 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical group [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims 1
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- 235000011008 sodium phosphates Nutrition 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Classifications
-
- 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
- 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
- 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
- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Zoology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Emergency Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Adhesives Or Adhesive Processes (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (18)
1. Tekući farmaceutski pripravak namijenjen parenteralnoj primjeni, koji sadrži semaglutid i najviše 0,01% (tež./tež.) fenola, naznačen time što navedeni pripravak:
a. je vodena otopina, koja sadrži najmanje 60% (tež./tež.) vode; i/ili
b. dodatno sadrži jedno ili više farmaceutski prihvatljivih pomoćnih sredstava, koja se bira iz skupine koju čine pufer ili sredstvo za reguliranje izotoničnosti.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što navedeni pripravak ne sadrži fenol.
3. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je koncentracija semaglutida 0,5-10 mg/ml ili 0,01-5 mg/ml u navedenom pripravku.
4. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je koncentracija semaglutida 0,5-5 mg/ml u navedenom pripravku.
5. Pripravak u skladu s patentnim zahtjevom 1 ili patentnim zahtjevom 2, naznačen time što je koncentracija semaglutida najmanje 0,01 mg/ml semaglutida, a najviše 4 mg/ml semaglutida.
6. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni pufer prisutan u koncentraciji od 0,01-50 mM u navedenom pripravku.
7. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni pufer fosfatni pufer.
8. Pripravak u skladu s patentnim zahtjevom 6, naznačen time što se navedeni fosfatni pufer bira iz skupine koju čine natrijev dihidrogenfosfat, dinatrijev hidrogenfosfat, te natrijev fosfat.
9. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeno sredstvo za reguliranje izotoničnosti propilen-glikol ili natrijev klorid.
10. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeni pripravak ne sadrži konzervans.
11. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeni pripravak ima pH u rasponu od 6,0-10,0.
12. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeni pripravak ima pH u rasponu od pH 7,0-7,8.
13. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni pripravak namijenjen supkutanoj primjeni.
14. Komplet, naznačen time što sadrži tekući farmaceutski pripravak, koji sadrži semaglutid i najviše 0,01% (tež./tež.) fenola, te upute o upotrebi.
15. Komplet, naznačen time što sadrži tekući farmaceutski pripravak, koji sadrži semaglutid i najviše 0,01% (tež./tež.) fenola, te uređaj za injiciranje, namijenjen primjeni navedenog pripravka na subjektu, gdje se navedeni uređaj za injiciranje bira iz skupine koju čine višekratna brizgalica i napunjena brizgalica.
16. Komplet u skladu s patentnim zahtjevom 14 ili 15, naznačen time što je navedeni farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1-13.
17. Farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je namijenjen upotrebi u medicini.
18. Farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je namijenjen upotrebi u liječenju dijabetesa ili pretilosti.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17187676 | 2017-08-24 | ||
| EP18756449.7A EP3474820B1 (en) | 2017-08-24 | 2018-08-24 | Glp-1 compositions and uses thereof |
| PCT/EP2018/072835 WO2019038412A1 (en) | 2017-08-24 | 2018-08-24 | GLP-1 COMPOSITIONS AND USES THEREOF |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20240485T1 true HRP20240485T1 (hr) | 2024-07-05 |
Family
ID=59713860
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20240485TT HRP20240485T1 (hr) | 2017-08-24 | 2018-08-24 | Pripravci glp-1 i njihova upotreba |
Country Status (25)
| Country | Link |
|---|---|
| US (4) | US10888605B2 (hr) |
| EP (2) | EP4360651A3 (hr) |
| JP (1) | JP6633777B2 (hr) |
| KR (1) | KR102665710B1 (hr) |
| CN (3) | CN118903385A (hr) |
| AR (1) | AR112480A1 (hr) |
| AU (2) | AU2018321157B2 (hr) |
| BR (1) | BR112020002804A2 (hr) |
| CA (1) | CA3082033A1 (hr) |
| CL (2) | CL2020000422A1 (hr) |
| CO (1) | CO2020002647A2 (hr) |
| ES (1) | ES2976496T3 (hr) |
| HR (1) | HRP20240485T1 (hr) |
| HU (1) | HUE066356T2 (hr) |
| IL (1) | IL272232B1 (hr) |
| MA (1) | MA46990B1 (hr) |
| MX (1) | MX2020001525A (hr) |
| MY (1) | MY198425A (hr) |
| PE (1) | PE20211202A1 (hr) |
| PH (1) | PH12020550051B1 (hr) |
| PL (1) | PL3474820T3 (hr) |
| RS (1) | RS65380B1 (hr) |
| SG (1) | SG11202000940XA (hr) |
| TW (3) | TWI783890B (hr) |
| WO (1) | WO2019038412A1 (hr) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MA46990B1 (fr) | 2017-08-24 | 2024-03-29 | Novo Nordisk As | Compositions glp-1 et ses utilisations |
| CN118873634A (zh) | 2018-02-02 | 2024-11-01 | 诺和诺德股份有限公司 | 包含glp-1激动剂、n-(8-(2-羟基苯甲酰基)氨基)辛酸的盐和润滑剂的固体组合物 |
| WO2020127476A1 (en) * | 2018-12-19 | 2020-06-25 | Krka, D.D., Novo Mesto | Pharmaceutical composition comprising glp-1 analogue |
| WO2020190757A1 (en) * | 2019-03-15 | 2020-09-24 | Novetide Ltd. | Improved processes for the preparation of semaglutide |
| MA55278A (fr) * | 2019-03-15 | 2022-01-19 | Novo Nordisk As | Procédé de séchage à pulvérisation d'un peptide glp-1 |
| US11208477B2 (en) | 2019-04-01 | 2021-12-28 | Novo Nordisk A/S | Antibodies and use thereof |
| WO2020208541A1 (en) * | 2019-04-08 | 2020-10-15 | Enzene Biosciences Limited | Composition comprising glp-1 analogue |
| WO2021105393A1 (en) * | 2019-11-29 | 2021-06-03 | Novo Nordisk A/S | Processes for obtaining stable glp-1 compositions |
| WO2021123228A1 (en) * | 2019-12-18 | 2021-06-24 | Krka, D.D., Novo Mesto | Pharmaceutical composition comprising glp-1 analogue |
| JP2023512910A (ja) | 2020-02-18 | 2023-03-30 | ノヴォ ノルディスク アー／エス | 医薬製剤 |
| US11478533B2 (en) * | 2020-04-27 | 2022-10-25 | Novo Nordisk A/S | Semaglutide for use in medicine |
| JP2024544920A (ja) | 2021-11-10 | 2024-12-05 | アイ２オー セラピューティクス，インク． | イオン液体組成物 |
| CN114146163B (zh) * | 2021-12-07 | 2023-09-26 | 苏州天马医药集团天吉生物制药有限公司 | 司美格鲁肽制剂的制备方法 |
| 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 |
| CN116159027A (zh) * | 2022-12-29 | 2023-05-26 | 江苏诺泰澳赛诺生物制药股份有限公司 | 一种司美格鲁肽冻干药物组合物及其制备方法 |
| WO2024148155A1 (en) | 2023-01-06 | 2024-07-11 | Nano Precision Medical, Inc. | Formulations, devices and methods for a glp-1 agonist |
| KR20240149356A (ko) | 2023-04-05 | 2024-10-14 | 주식회사 아울바이오 | Glp-1 수용체 작용제, gip/glp-1 수용체 이중작용제, 및 glp-1/gip/gcg 수용체 삼중작용제로 이루어진 군으로부터 선택되는 1종 이상을 포함하는 액상 제형 및 미립구 제형을 포함하는 약학 조성물 |
| KR20240173155A (ko) | 2023-06-02 | 2024-12-10 | 주식회사 아울바이오 | Glp-1 수용체 작용제, gip/glp-1 수용체 작용제 및/또는 glp-1/gip/gcg 수용체 삼중작용제를 포함하는 약학적 조성물 |
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