ES2952874T3 - Composiciones de péptidos GLP-1 y preparación de estas - Google Patents
Composiciones de péptidos GLP-1 y preparación de estas Download PDFInfo
- Publication number
- ES2952874T3 ES2952874T3 ES18188815T ES18188815T ES2952874T3 ES 2952874 T3 ES2952874 T3 ES 2952874T3 ES 18188815 T ES18188815 T ES 18188815T ES 18188815 T ES18188815 T ES 18188815T ES 2952874 T3 ES2952874 T3 ES 2952874T3
- Authority
- ES
- Spain
- Prior art keywords
- ethoxy
- glp
- amino
- peptide
- hydroxybenzoyl
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 125000005931 tert-butyloxycarbonyl group Chemical group [H]C([H])([H])C(OC(*)=O)(C([H])([H])[H])C([H])([H])[H] 0.000 description 1
- 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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- 230000001960 triggered effect Effects 0.000 description 1
- 150000004684 trihydrates Chemical class 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
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- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 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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- 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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- 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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- 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
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- 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
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- 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
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- A61P3/00—Drugs for disorders of the metabolism
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- 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
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- Chemical & Material Sciences (AREA)
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- Animal Behavior & Ethology (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Obesity (AREA)
- Organic Chemistry (AREA)
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- Proteomics, Peptides & Aminoacids (AREA)
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- Zoology (AREA)
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- 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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| RU2600440C3 (ru) | 2010-12-16 | 2021-12-10 | Ново Нордиск А/С | Твердые композиции, содержащие агонист glp-1 и соль n-(8-(2-гидроксибензоил)амино)каприловой кислоты |
| CA2832811A1 (en) | 2011-04-12 | 2012-10-18 | Novo Nordisk A/S | Double-acylated glp-1 derivatives |
| KR102266299B1 (ko) * | 2012-03-22 | 2021-06-18 | 노보 노르디스크 에이/에스 | Ｇｌｐ-1 펩티드의 조성물 및 그것의 제조 |
| ES2715308T3 (es) * | 2012-03-22 | 2019-06-03 | Novo Nordisk As | Composiciones que comprenden un agente de suministro y su preparación |
| US10933120B2 (en) | 2012-03-22 | 2021-03-02 | Novo Nordisk A/S | Compositions of GLP-1 peptides and preparation thereof |
| HUE064694T2 (hu) | 2012-03-22 | 2024-04-28 | Novo Nordisk As | Továbbítószert tartalmazó készítmények és elõállításuk |
| ES2871328T3 (es) | 2012-06-20 | 2021-10-28 | Novo Nordisk As | Formulación de comprimido que comprende un péptido y un agente de suministro |
| AU2014261336B2 (en) * | 2013-05-02 | 2019-02-28 | 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 |
| JP2018529749A (ja) | 2015-10-07 | 2018-10-11 | シプルメット・ゲーエムベーハー | ペプチド薬物を経口送達するための医薬製剤 |
| 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 |
| 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 |
| EP3474820B1 (en) | 2017-08-24 | 2024-02-07 | Novo Nordisk A/S | Glp-1 compositions and uses thereof |
| BR112020014624A2 (pt) | 2018-02-02 | 2020-12-08 | Novo Nordisk A/S | Composições sólidas compreendendo agonista de glp-1, sal de ácido n-(8-(2-hidroxibenzoil) amino)caprílico e lubrificante |
| US11666637B2 (en) * | 2018-03-09 | 2023-06-06 | Northwestern University | Insulin-loaded metal-organic frameworks |
| WO2019193204A1 (en) | 2018-04-06 | 2019-10-10 | 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 |
| JP7422754B2 (ja) | 2018-10-26 | 2024-01-26 | ノヴォ ノルディスク アー／エス | 安定性セマグルチド組成物およびその使用 |
| 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 |
| WO2020127950A1 (en) * | 2018-12-21 | 2020-06-25 | Novo Nordisk A/S | Process of spray drying of glp-1 peptide |
| CN113329810A (zh) * | 2019-01-24 | 2021-08-31 | 诺和诺德股份有限公司 | 辊压机和使用辊压机的干法制粒方法 |
| MY210034A (en) * | 2019-03-15 | 2025-08-22 | 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 |
| 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 |
| CN114641276A (zh) | 2019-11-07 | 2022-06-17 | 诺和诺德股份有限公司 | 包含glp-1激动剂、sglt2抑制剂和n-(8-(2-羟基苯甲酰基)氨基)辛酸的盐的固体组合物 |
| 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 |
| 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 |
| JP2024518058A (ja) * | 2021-05-07 | 2024-04-24 | イーライ リリー アンド カンパニー | 浸食性錠剤 |
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| MX2024000768A (es) * | 2021-07-15 | 2024-02-12 | Novo Nordisk As | Comprimido que comprende una sal del acido n-(8-(2-hidroxibenzoil) amino)caprilico. |
| US20240294466A1 (en) | 2021-07-16 | 2024-09-05 | Novo Nordisk A/S | Sodium n-(8-(2- hydroxybenzoyl)amino)caprylate polymorphic form a |
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| JP2024543196A (ja) * | 2021-12-01 | 2024-11-19 | 江▲蘇▼恒瑞医▲薬▼股▲フン▼有限公司 | Ｇｌｐ－１及びｇｉｐ受容体二重アゴニストの医薬組成物並びにその使用 |
| 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 |
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| 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 |
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