DK2651398T3 - Faste sammensætninger omfattende en GLP-1-agonist og et salt af N-(8-(2-hydroxybenzyl)amino)caprylsyre - Google Patents
Faste sammensætninger omfattende en GLP-1-agonist og et salt af N-(8-(2-hydroxybenzyl)amino)caprylsyre Download PDFInfo
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- DK2651398T3 DK2651398T3 DK11805824.7T DK11805824T DK2651398T3 DK 2651398 T3 DK2651398 T3 DK 2651398T3 DK 11805824 T DK11805824 T DK 11805824T DK 2651398 T3 DK2651398 T3 DK 2651398T3
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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
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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
-
- 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
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- 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
- A61P3/06—Antihyperlipidemics
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
Claims (13)
1, En fast sammensætning til oral administration omfattende en GLP-l-agonist og et sait af N-(8-(2-hydiOxybenzoyl)amino)caprylsyre, hvor mængden af nævnte sait af N-(8-(2-hydroxybenzoyl)amino)caprylsyre er mindst 0,6 mmol; og hvor nævnte GLP-l-agonist er semaglutid.
2, Sammensætning ifplge det foregâende krav, hvor nævnte sammensætning er i form af en tablet,
3, Sammensætning if pige et hviiket som helst af de foregâende krav, hvor nævnte sait af N-(8-(2-hydroxybenzoyl)amino)caprylsyre er natrium N-(8-(2-hydiOxybenzoyl)amino)caprylat (SNAC).
4, Sammensætning ifdlge et hviiket som helst af de foregâende krav, hvor molforhol-det mellem GLP-l-agonist og sait af N-(8-(2-hydroxybenzoyl)amino)cap.rylsyre i naîvnte sammensætning er mindre end 10, sâsom mindre end 5 eller mindre end 1.
5, Sammensætning ifplge et hviiket som helst af de foregâende krav, hvor mængden af nævnte sait af N-(8-(2-hydroxybenzoyl)amino)caprylsyre er i omrâdet fra 0,6-2,1 mmol, sâsom 0,6-1,9 mmol, 0,7-1,7 mmol eller 0,8-1,3 mmol.
6, Sammensætning ifplge et hviiket som helst af de foregâende krav, hvor mængden af nævnte sait af N-(8-(2-hydroxybenzoyl)amino)caprylsyre er mindst 0,6 mmol, sâsom udvalgt blandt gruppen bestâende af mindst 0,65 mmol, mindst 0,7 mmol, mindst 0,75 mmol, mindst 0,8 mmol, mindst 0,8 mmol, mindst 0,9 mmol, mindst 0,95 mmol og mindst 1 mmol.
7, Sammensætning ifdlge et hviiket som helst af de foregâende krav, hvor mængden af nævnte sait af N-(8-(2-hydroxybenzoyl)amino)caprylsyre er op til 2,1 mmol, sâsom udvalgt blandt gruppen bestâende af op til 2,1 mmol, op til 2 mmol, op til 1,9 mmol, op til 1,8 mmol, op til 1,7 mmol, op til 1,6 mmol, op til 1,5 mmol, op til 1,4 mmol, op til 1,3 mmol, op til 1,2 mmol og op til 1,1 mmol.
8. Sammensætning i folge et hvilket som helst af de foregâende krav, hvor mængden af GLP-l-agonisten er i omrädet fra 0,01 mg til 100 mg.
9. Sammensætning ifplge et hvilket som helst af de foregâende krav, hvor mængden af GLP-l-agonisten er i omrädet fra 0,05 til 25 pmol, sâsom i omradet tra 0,5 til 2,5 μ mol.
10. Sammensætning ifplge et hvilket som helst af de foregâende krav, hvor nævnte sammensætning er i form af en tablet, hvor tablettens vægt er i omrädet fra 175 mg til 1000 mg.
11. Sammensætning ifplge et hvilket som helst af de foregâende krav, hvor nævnte sammensætning omfatter mindst en yderligere farmaceutisk acceptabel excipiens.
12. Sammensætning som defineret i et hviiket som helst af de foregâende krav til an-vendelse i medicin.
13. Sammensætning ifolge krav 12 til anvendelse til behandling af type II diabetes el 1er fedme.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10195285 | 2010-12-16 | ||
| US201061425087P | 2010-12-20 | 2010-12-20 | |
| PCT/EP2011/073060 WO2012080471A1 (en) | 2010-12-16 | 2011-12-16 | Solid compositions comprising a glp-1 agonist and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2651398T3 true DK2651398T3 (da) | 2018-03-12 |
Family
ID=43903993
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17204363.0T DK3326620T3 (da) | 2010-12-16 | 2011-12-16 | Faste sammensætninger omfattende en glp-1-agonist og et salt af n-(8-(2- hydroxybenzoyl)amino)caprylsyre |
| DK11805824.7T DK2651398T3 (da) | 2010-12-16 | 2011-12-16 | Faste sammensætninger omfattende en GLP-1-agonist og et salt af N-(8-(2-hydroxybenzyl)amino)caprylsyre |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17204363.0T DK3326620T3 (da) | 2010-12-16 | 2011-12-16 | Faste sammensætninger omfattende en glp-1-agonist og et salt af n-(8-(2- hydroxybenzoyl)amino)caprylsyre |
Country Status (20)
| Country | Link |
|---|---|
| US (6) | US9278123B2 (da) |
| EP (3) | EP3326620B1 (da) |
| JP (2) | JP5902194B2 (da) |
| KR (1) | KR101925620B1 (da) |
| CN (2) | CN103260608A (da) |
| AU (1) | AU2011343190B2 (da) |
| BR (1) | BR112013014942B1 (da) |
| CA (1) | CA2821886A1 (da) |
| DK (2) | DK3326620T3 (da) |
| ES (1) | ES2661676T3 (da) |
| HR (1) | HRP20180425T1 (da) |
| HU (1) | HUE036066T2 (da) |
| LT (1) | LT2651398T (da) |
| MX (1) | MX345501B (da) |
| PL (2) | PL2651398T3 (da) |
| PT (1) | PT2651398T (da) |
| RS (2) | RS56998B1 (da) |
| RU (1) | RU2600440C3 (da) |
| SI (2) | SI3326620T1 (da) |
| WO (1) | WO2012080471A1 (da) |
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