BR112014023374B1 - Composições de peptídeos de glp-1, seu processo de preparação e seu uso para o tratamento de diabetes e obesidade - Google Patents
Composições de peptídeos de glp-1, seu processo de preparação e seu uso para o tratamento de diabetes e obesidade Download PDFInfo
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- BR112014023374B1 BR112014023374B1 BR112014023374-8A BR112014023374A BR112014023374B1 BR 112014023374 B1 BR112014023374 B1 BR 112014023374B1 BR 112014023374 A BR112014023374 A BR 112014023374A BR 112014023374 B1 BR112014023374 B1 BR 112014023374B1
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- Prior art keywords
- ethoxy
- glp
- amino
- peptide
- hydroxybenzoyl
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- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
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- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
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- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
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- 239000004408 titanium dioxide Substances 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- 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
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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)
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- Animal Behavior & Ethology (AREA)
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- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Obesity (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Child & Adolescent Psychology (AREA)
- Emergency Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
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| US201361748840P | 2013-01-04 | 2013-01-04 | |
| US61/748,840 | 2013-01-04 | ||
| EP13153459.6 | 2013-01-31 | ||
| EP13153459 | 2013-01-31 | ||
| PCT/EP2013/055362 WO2013139694A1 (en) | 2012-03-22 | 2013-03-15 | Compositions of glp-1 peptides and preparation thereof |
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| RS60321B1 (sr) | 2010-12-16 | 2020-07-31 | Novo Nordisk As | Čvrste kompozicije koje sadrže glp-1 agonist i so n-(8-(2- hidroksibenzoil)amino)kaprilne kiseline |
| DK2696687T3 (en) | 2011-04-12 | 2017-02-06 | Novo Nordisk As | Double-acylated GLP-1 derivatives |
| HUE042757T2 (hu) * | 2012-03-22 | 2019-07-29 | Novo Nordisk As | Szállító szert tartalmazó készítmények és elõállításuk |
| PL2827885T3 (pl) | 2012-03-22 | 2019-01-31 | Novo Nordisk A/S | Kompozycje peptydów GLP-1 i ich otrzymywanie |
| KR102266299B1 (ko) * | 2012-03-22 | 2021-06-18 | 노보 노르디스크 에이/에스 | Glp-1 펩티드의 조성물 및 그것의 제조 |
| RS58636B1 (sr) | 2012-03-22 | 2019-05-31 | Novo Nordisk As | Kompozicije koje sadrže sredstvo za isporuku i njihova priprema |
| WO2013189988A1 (en) | 2012-06-20 | 2013-12-27 | Novo Nordisk A/S | Tablet formulation comprising a peptide and a delivery agent |
| KR20210086717A (ko) * | 2013-05-02 | 2021-07-08 | 노보 노르디스크 에이/에스 | Glp-1 화합물의 경구 투여 |
| DK3006045T3 (en) | 2014-10-07 | 2017-07-17 | Cyprumed Gmbh | Pharmaceutical formulations for oral administration of peptide or protein drugs |
| AU2016335287A1 (en) | 2015-10-07 | 2018-04-12 | Cyprumed Gmbh | Pharmaceutical formulations for the oral delivery of peptide drugs |
| JP7053480B2 (ja) | 2016-03-03 | 2022-04-12 | ノヴォ ノルディスク アー/エス | Glp-1誘導体及びその使用 |
| 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 |
| MX2020001525A (es) | 2017-08-24 | 2020-03-20 | Novo Nordisk As | Composiciones de peptido similar al glucagon tipo 1 (glp-1) y sus usos. |
| CN111683676B (zh) | 2018-02-02 | 2024-06-18 | 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 |
| US11666637B2 (en) * | 2018-03-09 | 2023-06-06 | 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 |
| CN120617158A (zh) | 2018-10-26 | 2025-09-12 | 诺和诺德股份有限公司 | 稳定的司美鲁肽组合物及其用途 |
| 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 |
| EP3897582B1 (en) * | 2018-12-21 | 2024-09-11 | 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 |
| SG11202108530VA (en) | 2019-03-15 | 2021-09-29 | Novo Nordisk As | Process for spray drying a glp-1 peptide |
| EP4009958A1 (en) | 2019-08-07 | 2022-06-15 | Novo Nordisk A/S | Solid compositions comprising an egf(a) derivative and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid |
| JP2022543826A (ja) * | 2019-08-07 | 2022-10-14 | ノヴォ ノルディスク アー/エス | Pyy化合物とn-(8-(2-ヒドロキシベンゾイル)アミノ)カプリル酸の塩とを含む固形組成物 |
| CN114340655A (zh) * | 2019-09-02 | 2022-04-12 | 诺和诺德股份有限公司 | 生产包含glp-1肽的片剂的方法 |
| 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 |
| WO2021089761A1 (en) | 2019-11-07 | 2021-05-14 | Novo Nordisk A/S | Solid compositions comprising a pcsk9 inhibitor and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid |
| JP7777085B2 (ja) * | 2020-04-29 | 2025-11-27 | ノヴォ ノルディスク アー/エス | Glp-1作動薬およびヒスチジンを含む固形組成物 |
| TW202440619A (zh) | 2020-12-18 | 2024-10-16 | 丹麥商諾佛 儂迪克股份有限公司 | Glp-1及澱粉素受體之共促效劑 |
| WO2022235991A1 (en) * | 2021-05-07 | 2022-11-10 | Eli Lilly And Company | Erodible tablet |
| US20230000764A1 (en) * | 2021-06-11 | 2023-01-05 | 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 |
| CA3223236A1 (en) * | 2021-07-15 | 2023-01-19 | Thomas Kvistgaard Vilhelmsen | Tablet comprising a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid |
| CA3223247A1 (en) | 2021-07-16 | 2023-01-19 | Thomas Kvistgaard Vilhelmsen | Sodium n-(8-(2- hydroxybenzoyl)amino)caprylate polymorphic form a |
| WO2023012263A1 (en) | 2021-08-04 | 2023-02-09 | Novo Nordisk A/S | Solid oral peptide formulations |
| WO2023065231A1 (en) * | 2021-10-21 | 2023-04-27 | Guangzhou Dazhou Biomedicine Ltd. | Oral delivery of therapeutic agents |
| IL312672A (en) | 2021-11-10 | 2024-07-01 | I2O Therapeutics Inc | Ionic liquid compositions |
| MX2024006492A (es) * | 2021-12-01 | 2024-06-19 | Jiangsu Hengrui Pharmaceuticals Co Ltd | Composicion farmaceutica de doble agonista de los receptores glp-1 y gip y uso de la misma. |
| 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 |
| CN114984191B (zh) * | 2022-07-04 | 2022-10-25 | 北京惠之衡生物科技有限公司 | 一种多肽类药物口服递送组合物 |
| CA3265745A1 (en) * | 2022-08-25 | 2024-02-29 | The University Of British Columbia | Mucoadhesive pharmaceutical form for the unidirectional release of therapeutic peptidic particles |
| WO2024110614A1 (en) | 2022-11-25 | 2024-05-30 | Novo Nordisk A/S | Oral administration of peptide therapeutics, such as glp-1 |
| CN116785412B (zh) * | 2023-07-27 | 2025-02-28 | 重庆宸安生物制药有限公司 | 一种glp-1类似物口服递送组合物 |
| WO2025037595A1 (ja) * | 2023-08-14 | 2025-02-20 | 三生医薬株式会社 | 吸収促進造粒物およびその製造方法、医薬組成物、並びに組み合わせ剤 |
| WO2025077751A1 (zh) * | 2023-10-09 | 2025-04-17 | 甘李药业股份有限公司 | Glp-1肽组合物及其用途 |
| KR20250083391A (ko) | 2023-11-30 | 2025-06-10 | 노보 노르디스크 에이/에스 | Glp-1, gip, 및 아밀린 수용체의 삼중작용제 |
| WO2025146144A1 (zh) * | 2024-01-05 | 2025-07-10 | 成都国为生物医药有限公司 | 一种地非法林的口服药物组合物 |
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| CN118370728B (zh) * | 2024-06-24 | 2024-11-08 | 山东则正医药技术有限公司 | 一种glp-1ra载药纳米颗粒和制剂及其制备方法 |
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| NZ219575A (en) | 1986-03-12 | 1990-04-26 | Glaxo Group Ltd | Phosphate, substituted alkoxy, or amino-carbonyloxy derivatives of milbemycin, and pesticidal compositions |
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| CA2073856C (en) | 1990-01-24 | 2002-12-03 | Douglas I. Buckley | Glp-1 analogs useful for diabetes treatment |
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