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
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- 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)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (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)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
- Biophysics (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)
Claims (10)
1. Postupak proizvodnje granule koja se sastoji od soli N-(8-(2-hidroksibenzoil)amino)kaprilne kiseline, maziva i/ili punila, naznačen time što se postupak sastoji u koracima:
a) miješanja soli N-(8-(2-hidroksibenzoil)amino)kaprilne kiseline (primjerice SNAC) s mazivom i/ili punilom; i
b) suhog granuliranja smjese iz koraka a.
2. Granula, naznačena time što je se dobiva postupkom u skladu s patentnim zahtjevom 1.
3. Farmaceutski pripravak, naznačen time što sadrži granulu proizvedenu u skladu s patentnim zahtjevom 1.
4. Postupak proizvodnje farmaceutskog pripravka koji sadrži sol N-(8-(2-hidroksibenzoil)amino)kaprilne kiseline i peptid GLP-1, naznačen time što se postupak sastoji u koracima:
i. proizvodnje granule koja se sastoji od soli N-(8-(2-hidroksibenzoil)amino)kaprilne kiseline, maziva i/ili punila:
a) miješanjem soli N-(8-(2-hidroksibenzoil)amino)kaprilne kiseline s mazivom, primjerice magnezijevim stearatom i/ili punilom, primjerice mikrokristalnom celulozom;
b) suhim granuliranjem smjese iz koraka a;
ii. miješanja granula dobivenih u koraku b) s pripravkom koji sadrži peptid GLP-1; i
iii. izbornog dodavanja dodatnog maziva, primjerice magnezijevog stearata.
5. Postupak u skladu s patentnim zahtjevom 1 ili 4, naznačen time što je navedeno suho granuliranje zbijanje valjcima.
6. Postupak u skladu s patentnim zahtjevom 4 ili 5, naznačen time što je navedena sol N-(8-(2-hidroksibenzoil)amino)kaprilne kiseline SNAC.
7. Postupak u skladu s bilo kojim od patentnih zahtjeva 4-6, naznačen time što je navedeni peptid GLP-1 semaglutid.
8. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 i 4-7, naznačen time što navedeni korak miješanja koji se sastoji u miješanju soli N-(8-(2-hidroksibenzoil)amino)kaprilne kiseline s mazivom i/ili punilom prije suhog granuliranja traje najmanje 20 minuta, primjerice najmanje 30 minuta ili najmanje 40 minuta, primjerice 50 minuta.
9. Farmaceutski pripravak, naznačen time što ga se proizvodi u skladu s bilo kojim od patentnih zahtjeva 4-8.
10. Pripravak u skladu s bilo kojim od patentnih zahtjeva 3 i 9, namijenjen upotrebi u medicini, primjerice u liječenju dijabetesa ili pretilosti, naznačen time što se navedeni pripravak primjenjuje oralno.
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 | 2018-09-11 | Pripravci glp-1 peptida i njihova priprava |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20181447TT HRP20181447T1 (hr) | 2012-03-22 | 2018-09-11 | Pripravci glp-1 peptida i njihova priprava |
Country Status (21)
Country | Link |
---|---|
US (5) | US10933120B2 (hr) |
EP (3) | EP2827885B1 (hr) |
JP (1) | JP6001158B2 (hr) |
KR (1) | KR102072202B1 (hr) |
CN (2) | CN107812181B (hr) |
AU (2) | AU2013234496B2 (hr) |
BR (1) | BR112014023374B1 (hr) |
CA (1) | CA2868188A1 (hr) |
DK (1) | DK2827885T3 (hr) |
ES (2) | ES2690553T3 (hr) |
HR (2) | HRP20231060T1 (hr) |
HU (2) | HUE039406T2 (hr) |
LT (1) | LT2827885T (hr) |
MX (1) | MX353067B (hr) |
MY (1) | MY171146A (hr) |
PL (2) | PL3488857T3 (hr) |
RS (2) | RS64460B1 (hr) |
RU (1) | RU2641198C3 (hr) |
SI (1) | SI2827885T1 (hr) |
WO (1) | WO2013139694A1 (hr) |
ZA (1) | ZA201406250B (hr) |
Families Citing this family (38)
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RS56998B1 (sr) | 2010-12-16 | 2018-05-31 | Novo Nordisk As | Čvrste kompozicije koje sadrže agonist glp-1 i so n-(8-(2-hidroksibenzoil)amino)kaprilne kiseline |
WO2012140117A1 (en) | 2011-04-12 | 2012-10-18 | Novo Nordisk A/S | Double-acylated glp-1 derivatives |
PT2827885T (pt) * | 2012-03-22 | 2018-11-05 | Novo Nordisk As | Composições de péptidos glp-1 e sua preparação |
HUE042757T2 (hu) * | 2012-03-22 | 2019-07-29 | Novo Nordisk As | Szállító szert tartalmazó készítmények és elõállításuk |
WO2013139694A1 (en) | 2012-03-22 | 2013-09-26 | Novo Nordisk A/S | Compositions of glp-1 peptides and preparation thereof |
CN104203221A (zh) | 2012-03-22 | 2014-12-10 | 诺和诺德A/S(股份有限公司) | 包含递送剂的组合物及其制备 |
WO2013189988A1 (en) | 2012-06-20 | 2013-12-27 | Novo Nordisk A/S | Tablet formulation comprising a peptide and a delivery agent |
US20160067184A1 (en) | 2013-05-02 | 2016-03-10 | Novo Nordisk A/S | Oral Dosing of GLP-1 Compounds |
ES2630106T3 (es) | 2014-10-07 | 2017-08-18 | Cyprumed Gmbh | Formulaciones farmacéuticas para la administración oral de fármacos peptídicos o proteicos |
AU2016335287A1 (en) | 2015-10-07 | 2018-04-12 | Cyprumed Gmbh | Pharmaceutical formulations for the oral delivery of peptide drugs |
EP3423481B1 (en) | 2016-03-03 | 2020-10-07 | 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 |
TWI797133B (zh) | 2017-06-09 | 2023-04-01 | 丹麥商諾佛 儂迪克股份有限公司 | 用於經口投予的固體組成物 |
KR102647171B1 (ko) | 2018-02-02 | 2024-03-15 | 노보 노르디스크 에이/에스 | Glp-1 작용제 및 n-(8-(2-하이드록시벤조일)아미노)카프릴산의 염을 포함하는 고형 조성물 |
WO2019173571A1 (en) * | 2018-03-09 | 2019-09-12 | Northwestern University | Insulin-loaded metal-organic frameworks |
JP7442823B2 (ja) | 2018-04-06 | 2024-03-05 | シプルメット・ゲーエムベーハー | 治療用ペプチド及び治療用タンパク質の経粘膜送達のための薬学的組成物 |
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 |
SG11202103137WA (en) | 2018-10-26 | 2021-04-29 | 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 |
EP3897582A1 (en) * | 2018-12-21 | 2021-10-27 | Novo Nordisk A/S | Process of spray drying of glp-1 peptide |
US20220072493A1 (en) | 2019-01-24 | 2022-03-10 | Novo Nordisk A/S | Roller compactor and method of dry granulation using a roller compactor |
CN113631251A (zh) * | 2019-03-15 | 2021-11-09 | 诺和诺德股份有限公司 | Glp-1肽的喷雾干燥工艺 |
WO2021023817A1 (en) * | 2019-08-07 | 2021-02-11 | Novo Nordisk A/S | Solid composition comprising a pyy compound and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid |
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 |
WO2021089752A1 (en) | 2019-11-07 | 2021-05-14 | Novo Nordisk A/S | Solid compositions comprising a glp-1 agonist, an sglt2 inhibitor and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid |
PE20221458A1 (es) | 2019-11-07 | 2022-09-21 | Novo Nordisk As | Composiciones solidas que comprenden un inhibidor de pcsk9 y una sal de acido n-(8-(2-hidroxibenzoil)amino)caprilico |
WO2021219710A1 (en) * | 2020-04-29 | 2021-11-04 | Novo Nordisk A/S | Solid compositions comprising a glp-1 agonist and histidine |
AU2021403851A1 (en) | 2020-12-18 | 2023-06-15 | Novo Nordisk A/S | Co-agonists of the glp-1 and amylin receptors |
WO2022235991A1 (en) * | 2021-05-07 | 2022-11-10 | Eli Lilly And Company | Erodible tablet |
WO2022261545A2 (en) * | 2021-06-11 | 2022-12-15 | Boa Nutrition, Inc. | Pressurized nutritional supplement delivery |
WO2022268213A1 (zh) | 2021-06-25 | 2022-12-29 | 甘李药业股份有限公司 | 含glp-1化合物的药物组合物 |
CN117979958A (zh) * | 2021-07-15 | 2024-05-03 | 诺和诺德股份有限公司 | 包含n-(8-(2-羟基苯甲酰基)氨基)辛酸盐的片剂 |
WO2023012263A1 (en) | 2021-08-04 | 2023-02-09 | Novo Nordisk A/S | Solid oral peptide formulations |
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WO2023174433A1 (en) * | 2022-03-18 | 2023-09-21 | Smart Pharmaceutical (Suzhou) Co., Ltd. | Solid, semisolid, or liquid compositions for augmenting the stability, permeability and bioavailability of active pharmaceutical substances |
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WO2024110614A1 (en) | 2022-11-25 | 2024-05-30 | Novo Nordisk A/S | Oral administration of peptide therapeutics, such as glp-1 |
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