HRP20231060T1 - Pripravci peptida glp-1 i njihova priprava - Google Patents
Pripravci peptida glp-1 i njihova priprava Download PDFInfo
- Publication number
- HRP20231060T1 HRP20231060T1 HRP20231060TT HRP20231060T HRP20231060T1 HR P20231060 T1 HRP20231060 T1 HR P20231060T1 HR P20231060T T HRP20231060T T HR P20231060TT HR P20231060 T HRP20231060 T HR P20231060T HR P20231060 T1 HRP20231060 T1 HR P20231060T1
- Authority
- HR
- Croatia
- Prior art keywords
- hydroxybenzoyl
- amino
- caprylic acid
- lubricant
- filler
- Prior art date
Links
- 238000002360 preparation method Methods 0.000 title claims 4
- 108090000765 processed proteins & peptides Proteins 0.000 title claims 4
- 239000000203 mixture Substances 0.000 title claims 3
- 101100337060 Caenorhabditis elegans glp-1 gene Proteins 0.000 title 1
- 102000004196 processed proteins & peptides Human genes 0.000 title 1
- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical class CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 claims 10
- 238000000034 method Methods 0.000 claims 9
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 claims 7
- 239000000314 lubricant Substances 0.000 claims 6
- 239000000945 filler Substances 0.000 claims 5
- 239000008187 granular material Substances 0.000 claims 5
- 238000007908 dry granulation Methods 0.000 claims 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 4
- 239000005635 Caprylic acid (CAS 124-07-2) Substances 0.000 claims 3
- 102100025101 GATA-type zinc finger protein 1 Human genes 0.000 claims 3
- 101710198884 GATA-type zinc finger protein 1 Proteins 0.000 claims 3
- 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 3
- 229960002446 octanoic acid Drugs 0.000 claims 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 235000019359 magnesium stearate Nutrition 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 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 2
- 229920000168 Microcrystalline cellulose Polymers 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
- 238000005056 compaction Methods 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- 239000003814 drug Substances 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
- 235000020824 obesity Nutrition 0.000 claims 1
- 229950011186 semaglutide Drugs 0.000 claims 1
- 108010060325 semaglutide Proteins 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
-
- 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
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
-
- 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)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Emergency Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12160743 | 2012-03-22 | ||
| US201361748840P | 2013-01-04 | 2013-01-04 | |
| EP13153459 | 2013-01-31 | ||
| EP18188815.7A EP3488857B9 (en) | 2012-03-22 | 2013-03-15 | Compositions of glp-1 peptides and preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20231060T1 true HRP20231060T1 (hr) | 2023-12-22 |
Family
ID=49221868
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20231060TT HRP20231060T1 (hr) | 2012-03-22 | 2013-03-15 | Pripravci peptida glp-1 i njihova priprava |
| HRP20181447TT HRP20181447T1 (hr) | 2012-03-22 | 2013-03-15 | Pripravci glp-1 peptida i njihova priprava |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20181447TT HRP20181447T1 (hr) | 2012-03-22 | 2013-03-15 | Pripravci glp-1 peptida i njihova priprava |
Country Status (22)
| Country | Link |
|---|---|
| US (6) | US10933120B2 (enExample) |
| EP (3) | EP4324475A1 (enExample) |
| JP (1) | JP6001158B2 (enExample) |
| KR (1) | KR102072202B1 (enExample) |
| CN (2) | CN107812181B (enExample) |
| AU (2) | AU2013234496B2 (enExample) |
| BR (1) | BR112014023374B1 (enExample) |
| CA (1) | CA2868188A1 (enExample) |
| DK (1) | DK2827885T3 (enExample) |
| ES (2) | ES2690553T3 (enExample) |
| HR (2) | HRP20231060T1 (enExample) |
| HU (2) | HUE062740T2 (enExample) |
| LT (1) | LT2827885T (enExample) |
| MX (1) | MX353067B (enExample) |
| MY (1) | MY171146A (enExample) |
| PL (2) | PL2827885T3 (enExample) |
| RS (2) | RS57727B1 (enExample) |
| RU (1) | RU2641198C3 (enExample) |
| SI (1) | SI2827885T1 (enExample) |
| SM (1) | SMT201800491T1 (enExample) |
| WO (1) | WO2013139694A1 (enExample) |
| ZA (1) | ZA201406250B (enExample) |
Families Citing this family (56)
| 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. |
| AU2012241894B2 (en) | 2011-04-12 | 2015-12-03 | Novo Nordisk A/S | Double-acylated GLP-1 derivatives |
| ES2715308T3 (es) | 2012-03-22 | 2019-06-03 | Novo Nordisk As | Composiciones que comprenden un agente de suministro y su preparación |
| KR102072202B1 (ko) | 2012-03-22 | 2020-01-31 | 노보 노르디스크 에이/에스 | Ｇｌｐ-1 펩티드의 조성물 및 그것의 제조 |
| KR102266299B1 (ko) * | 2012-03-22 | 2021-06-18 | 노보 노르디스크 에이/에스 | Ｇｌｐ-1 펩티드의 조성물 및 그것의 제조 |
| HUE064694T2 (hu) | 2012-03-22 | 2024-04-28 | Novo Nordisk As | Továbbítószert tartalmazó készítmények és elõállításuk |
| WO2013189988A1 (en) | 2012-06-20 | 2013-12-27 | Novo Nordisk A/S | Tablet formulation comprising a peptide and a delivery agent |
| RS58039B1 (sr) | 2013-05-02 | 2019-02-28 | Novo Nordisk As | Oralno doziranje glp-1 jedinjenja |
| DK3006045T3 (en) | 2014-10-07 | 2017-07-17 | Cyprumed Gmbh | Pharmaceutical formulations for oral administration of peptide or protein drugs |
| EP3359181A1 (en) | 2015-10-07 | 2018-08-15 | Cyprumed GmbH | Pharmaceutical formulations for the oral delivery of peptide drugs |
| WO2017149070A1 (en) | 2016-03-03 | 2017-09-08 | Novo Nordisk A/S | Glp-1 derivatives and uses thereof |
| CN108606957A (zh) * | 2016-12-13 | 2018-10-02 | 南京星银药业集团有限公司 | 一种含索马鲁肽的口服缓释制剂及其制备方法 |
| AR112015A1 (es) | 2017-06-09 | 2019-09-11 | Novo Nordisk As | Composiciones sólidas para administración oral |
| BR112020002804A2 (pt) | 2017-08-24 | 2020-07-28 | Novo Nordisk A/S | composição farmacêutica líquida, e, kit |
| AR114353A1 (es) | 2018-02-02 | 2020-08-26 | Novo Nordisk As | Composiciones sólidas que comprenden un agonista del glp-1 y una sal del ácido n-(8-(2-hidroxibenzoil)amino)caprílico |
| US11666637B2 (en) * | 2018-03-09 | 2023-06-06 | Northwestern University | Insulin-loaded metal-organic frameworks |
| US20210087250A1 (en) | 2018-04-06 | 2021-03-25 | Cyprumed Gmbh | Pharmaceutical compositions for the transmucosal delivery of therapeutic peptides and proteins |
| 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 |
| MY206306A (en) | 2018-10-26 | 2024-12-07 | Novo Nordisk As | Stable semaglutide compositions and uses thereof |
| CN111265654B (zh) * | 2018-12-05 | 2023-05-16 | 江苏恒瑞医药股份有限公司 | Glp-1类似物的药物组合物及其制备方法 |
| CN113194929B (zh) * | 2018-12-21 | 2022-12-09 | 诺和诺德股份有限公司 | Glp-1肽的喷雾干燥工艺 |
| EP3914383B1 (en) * | 2019-01-24 | 2026-07-15 | Novo Nordisk A/S | Method of dry granulation using a roller compactor |
| WO2020180534A1 (en) | 2019-03-01 | 2020-09-10 | President And Fellows Of Harvard College | Methods and compositions for protein delivery |
| MY210034A (en) | 2019-03-15 | 2025-08-22 | Novo Nordisk As | Process for spray drying a glp-1 peptide |
| CN114222581A (zh) | 2019-08-07 | 2022-03-22 | 诺和诺德股份有限公司 | 包含egf(a)衍生物和n-(8-(2-羟基苯甲酰基)氨基)辛酸的盐的固体组合物 |
| EP4009957B1 (en) * | 2019-08-07 | 2023-10-11 | Novo Nordisk A/S | Solid composition comprising a pyy compound and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid |
| JP7767264B2 (ja) * | 2019-09-02 | 2025-11-11 | ノヴォ ノルディスク アー／エス | Ｇｌｐ－１ペプチドを含む錠剤を生成するためのプロセス |
| JP2023502004A (ja) | 2019-11-07 | 2023-01-20 | ノヴォ ノルディスク アー／エス | Ｇｌｐ－１作動薬、ｓｇｌｔ２阻害剤、およびｎ－（８－（２－ヒドロキシベンゾイル）アミノ）カプリル酸の塩を含む固形組成物 |
| JP2023500031A (ja) | 2019-11-07 | 2023-01-04 | ノヴォ ノルディスク アー／エス | Ｐｃｓｋ９阻害剤およびｎ－（８－（２－ヒドロキシベンゾイル）アミノ）カプリル酸の塩を含む固形組成物 |
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| US12605426B2 (en) | 2020-02-14 | 2026-04-21 | G2Gbio, Inc. | Pharmaceutical comprising sustained-release microspheres including GLP-1 analogue or pharmaceutically acceptable salt thereof |
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| JP2024529250A (ja) | 2021-07-16 | 2024-08-06 | ノヴォ ノルディスク アー／エス | Ｎ－（８－（２－ヒドロキシベンゾイル）アミノ）カプリル酸ナトリウム多形形態ａ |
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- 2013-03-15 WO PCT/EP2013/055362 patent/WO2013139694A1/en not_active Ceased
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