HRP20200512T1 - Formulacije koje sadrže linaklotid za oralnu primjenu - Google Patents

Formulacije koje sadrže linaklotid za oralnu primjenu Download PDF

Info

Publication number
HRP20200512T1
HRP20200512T1 HRP20200512TT HRP20200512T HRP20200512T1 HR P20200512 T1 HRP20200512 T1 HR P20200512T1 HR P20200512T T HRP20200512T T HR P20200512TT HR P20200512 T HRP20200512 T HR P20200512T HR P20200512 T1 HRP20200512 T1 HR P20200512T1
Authority
HR
Croatia
Prior art keywords
pharmaceutical preparation
linaclotide
constipation
leucine
preparation according
Prior art date
Application number
HRP20200512TT
Other languages
English (en)
Inventor
Angelika Fretzen
Steven Witowski
Alfredo Grossi
Hong Zhao
Mahendra Dedhiya
Yun Mo
Original Assignee
Ironwood Pharmaceuticals, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41666602&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20200512(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ironwood Pharmaceuticals, Inc. filed Critical Ironwood Pharmaceuticals, Inc.
Publication of HRP20200512T1 publication Critical patent/HRP20200512T1/hr
Publication of HRP20200512T2 publication Critical patent/HRP20200512T2/hr

Links

Classifications

    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 amino acids
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/14—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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—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
    • A61K9/14—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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives
    • 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
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N2030/022—Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027—Liquid chromatography

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Nutrition Science (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Analytical Chemistry (AREA)
  • Mechanical Engineering (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (41)

1. Farmaceutski pripravak, naznačen time, da obuhvaća farmaceutski prihvatljiv nosač, linaklotid, kation koji je odabran od Mg2+, Ca2+, Zn2+, Mn2+, K+, Na+ ili Al3+, i jedan sterično zapriječen primarni amin, pri čemu je farmaceutski pripravak jedan čvrsti sastav za oralno primjenjivanje.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da se navedeni Mg2+, Ca2+, Zn2+, Mn2+, K+, Na+ ili Al3+, dobivaju kao magnezijev klorid, kalcijev klorid, kalcijev fosfat, kalcijev sulfat, cinkov acetat, manganov klorid, kalijev klorid, natrijev klorid ili aluminijev klorid.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, da navedeni kation je Ca2+.
4. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da navedeni kation je Ca2+, i on je dobiven kao kalcijev klorid.
5. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da je sterično zapriječeni primarni amin jedna aminokiselina, polimerni amin, ili spoj sljedeće formule: [image] pri čemu su R1, R2 i R3 neovisno odabrani od sljedećih: H; -C(O)OH; C1-C6-alkil, opcionalno supstituiran s -CO2H, -CONH2, ili s 5-10-članim arilom ili heteroarilom; C1-C6-alkoksialkil; ili C1-C6-tioalkoksialkil, gdje bilo koja od alkilne ili arilne gornje skupine, može biti jednostruko ili višestruko supstituirana s halogenom ili -NH2, te uz uvjet da samo do dva od R1, R2 i R3, predstavljaju H.
6. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da sterično zapriječeni primarni amin je histidin, fenilalanin, alanin, glutaminska kiselina, aspartna kiselina, glutamin, leukin, metionin, asparagin, tirozin, treonin, izoleukin, triptofan ili valin.
7. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da sterično zapriječeni primarni amin je leukin.
8. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak nadalje sadrži farmaceutski prihvatljivo klizno sredstvo, mazivo ili aditiv koji djeluje i kao klizno sredstvo i kao mazivo.
9. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak nadalje sadrži jedan ili više antioksidanata, farmaceutski prihvatljivo vezivo, ili farmaceutski prihvaljivo punilo.
10. Farmaceutski pripravak prema patentnom zahtjevu 9, naznačen time, da pripravak sadrži farmaceutski prihvatljivo vezno sredstvo koje je odabrano od sljedećih: polivinilni alkohol, polivinilpirolidon (povidon), škrob, maltodekstrin ili celulozni eter.
11. Farmaceutski pripravak prema patentnom zahtjevu 10, naznačen time, da farmaceutski prihvatljivo vezno sredstvo je celulozni eter koji je odabran od metilceluloze, etilceluloze, karboksimetilceluloze, hidroksietilceluloze, hidroksietilmetilceluloze, hidroksipropilceluloze i hidroksipropilmetilceluloze.
12. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 9 do 11, naznačen time, da pripravak sadrži farmaceutski prihvatljivo punilo i farmaceutski prihvatljivo punilo je celuloza, izomalt, manitol ili dibazični kalcijev fosfat.
13. Farmaceutski pripravak prema patentnom zahtjevu 12, naznačen time, da je celuloza odabrana od mikrofine celuloze i mikrokristalne celuloze.
14. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da sterično zapriječen primarni amin je leukin i molarni omjer od leukina prema linaklotidu je najmanje 10:1.
15. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da kation je Ca2+, sterično zapriječen primarni amin je leukin i molarni omjer od Ca2+ prema leukinu je najmanje 1:1.
16. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da sljedeći molarni omjer za kation: sterično zapriječen primarni amin: linaklotid, iznosi 40-100:20-50:1.
17. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da kation je Ca2+, sterično zapriječen primarni amin je leukin, a sljedeći molarni omjer za Ca2+: leukin: linaklotid, iznosi 60:30:1.
18. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da: (i) produkt hidrolize ima sljedeću strukturu [image] koja sadrži manje od 2% po masi, kada se usporedbi s masom linaklotida; ili (ii) produkt oksidacije linaklotida koji ima molekularnu masu od 1542,8, sadrži manje od 2% po masi, kada se usporedbi s masom linaklotida.
19. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak obuhvaća sljedeće: linaklotid; Ca2+; leukin; i hidroksipropilmetilcelulozu, pri čemu je linaklotid prisutan u farmaceutskom sastavu s količinom između 100 μg i 600 μg, te sljedeći molarni omjer za Ca2+: leukin: linaklotid, iznosi između 5-100:5-50:1.
20. Farmaceutski pripravak prema patentnom zahtjevu 19, naznačen time, da je Ca2+ dobiven kao CaCl2.
21. Farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da pripravak obuhvaća obložena zrnca, a zrnca su obložena otopinom za oblaganje koja sadrži linaklotid.
22. Farmaceutski pripravak prema patentnom zahtjevu 21, naznačen time, da otopina za oblaganje obuhvaća sljedeće: linaklotid; Ca2+; leukin; i hidroksipropilmetilcelulozu, pri čemu je linaklotid prisutan u farmaceutskom sastavu s količinom između 100 μg i 600 μg, te sljedeći molarni omjer za Ca2+: leukin: linaklotid, iznosi 5-100:5-50:1.
23. Farmaceutski pripravak prema patentnom zahtjevu 22, naznačen time, da zrnca sadrže mikrokristalnu celulozu.
24. Postupak proizvodnje farmaceutskog pripravka koji sadrži linaklotid ili njegovu sol, naznačen time, da postupak obuhvaća sljedeće: (a) pripravljanje vodene otopine koja sadrži: (i) linaklotid ili njegovu farmaceutski prihvatljivu sol; (ii) kation koji je odabran od Mg2+, Ca2+, Zn2+, Mn2+, K+, Na+ ili Al3+, i jedan sterično zapriječen primarni amin; i (iii) prema potrebi, farmaceutski prihvatljivo vezivo; te (b) nanošenje vodene otopine na farmaceutski prihvatljivo punilo u svrhu generiranja punila koje je obloženo linaklotidom.
25. Postupak prema patentnom zahtjevu 24, naznačen time, da se vodena otopina nanosi na punilo putem raspršivanja.
26. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 23, naznačen time, da se upotrebljava u postupku liječenja pacijenta koji boluje od oštećenja crijevne peristaltike, sindroma iritabilnih crijeva, konstipacije, dispepsije, gastropareze, kronične crijevne pseudo-opstrukcije, Crohnove bolesti, ulcerativnog kolitisa, upalne bolesti crijeva, ili od bolova koji su povezani s konstipacijom.
27. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 26, naznačen time, da se kod sindroma iritabilnih crijeva radi o sindromu iritabilnih crijeva s prevladavajućom konstipacijom ili se radi o periodično promjenjivom sindromu iritabilnih crijeva.
28. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 27, naznačen time, da se kod navedenog sindroma iritabilnih crijeva radi o sindromu iritabilnih crijeva s prevladavajućom konstipacijom.
29. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 26, naznačen time, da navedena konstipacija je kronična konstipacija, idiopatska konstipacija, post-operativni ileus ili konstipacija uzrokovana uporabom opijata.
30. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 29, naznačen time, da navedena konstipacija je kronična konstipacija.
31. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži od 50 μg do 1 mg linaklotida.
32. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži 67,5 μg, 133 μg, 150 μg, 266 μg ili 300 μg linaklotida.
33. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži 266 μg linaklotida.
34. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, da farmaceutski pripravak sadrži 133 μg linaklotida.
35. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 34, naznačen time, da se farmaceutski pripravak primjenjuje jednom dnevno ili dva puta dnevno.
36. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 35, naznačen time, da se farmaceutski pripravak primjenjuje jednom dnevno kao jedna ili dvije tablete ili kapsule.
37. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 36, naznačen time, da se farmaceutski pripravak primjenjuje na pacijentu u vremenskom periodu od najmanje četiri tjedna.
38. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 37, naznačen time, da liječenje s ovim pripravkom poboljšava barem jedan simptom koji je odabran od sljedećih: smanjenje abdominalnih bolova, povećanje broja potpuno spontanih crijevnih pokreta (CSBM – engl. complete spontaneous bowel movements) za vrijeme jednog tjedna, povećanje broja spontanih crijevnih pokreta (SBM – engl. spontaneous bowel movements) za vrijeme jednog tjedna, poboljšanje konzistencije stolice, smanjenje naprezanja, smanjenje abdominalne neugode, smanjenje nadimanja, ili smanjenje ozbiljnog simptomatskog stanja kod sindroma iritabilnih crijeva s konstipacijom (IBS-c – engl. irritable bowel syndrom with constipation).
39. Oblik jediničnog doziranja, naznačen time, da on obuhvaća farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 23.
40. Zabrtvljeni spremnik, naznačen time, da on obuhvaća veći broj oblika jediničnog doziranja u skladu s patentnim zahtjevom 39.
41. Uporaba farmaceutskog pripravka prema bilo kojem od patentnih zahtjeva 1 do 23, naznačena time, da služi za proizvodnju lijeka za liječenje pacijenta koji boluje od oštećenja crijevne peristaltike, sindroma iritabilnih crijeva, konstipacije, dispepsije, gastropareze, kronične crijevne pseudo-opstrukcije, Crohnove bolesti, ulcerativnog kolitisa, upalne bolesti crijeva ili od bolova koji su povezani s konstipacijom.
HRP20200512TT 2008-08-15 2009-08-14 Formulacije koje sadrže linaklotid za oralnu primjenu HRP20200512T2 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US8942208P 2008-08-15 2008-08-15
US27333209P 2009-08-03 2009-08-03
US23172509P 2009-08-06 2009-08-06
PCT/US2009/004675 WO2010019266A2 (en) 2008-08-15 2009-08-14 Stable solid formulation of a gc-c receptor agonist polypeptide suitable for oral administration
EP09789142.8A EP2328601B1 (en) 2008-08-15 2009-08-14 Linaclotide-containing formulations for oral administration

Publications (2)

Publication Number Publication Date
HRP20200512T1 true HRP20200512T1 (hr) 2020-06-26
HRP20200512T2 HRP20200512T2 (hr) 2024-05-24

Family

ID=41666602

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20200512TT HRP20200512T2 (hr) 2008-08-15 2009-08-14 Formulacije koje sadrže linaklotid za oralnu primjenu

Country Status (31)

Country Link
US (7) US8802628B2 (hr)
EP (2) EP3701962A1 (hr)
JP (9) JP5770629B2 (hr)
KR (11) KR20170138580A (hr)
CN (5) CN109010254A (hr)
AU (1) AU2009282446B2 (hr)
BR (1) BRPI0917807A2 (hr)
CA (1) CA2732892C (hr)
CL (1) CL2011000314A1 (hr)
CO (1) CO6351746A2 (hr)
CY (1) CY1122801T1 (hr)
DK (1) DK2328601T3 (hr)
EA (1) EA201170337A1 (hr)
ES (1) ES2785980T3 (hr)
GE (1) GEP20156209B (hr)
HK (2) HK1161978A1 (hr)
HR (1) HRP20200512T2 (hr)
HU (1) HUE049023T2 (hr)
IL (1) IL211028A (hr)
LT (1) LT2328601T (hr)
MX (3) MX2020005326A (hr)
NZ (1) NZ591713A (hr)
PE (2) PE20110543A1 (hr)
PH (1) PH12015501579B1 (hr)
PL (1) PL2328601T3 (hr)
PT (1) PT2328601T (hr)
RS (1) RS60101B1 (hr)
SG (1) SG193801A1 (hr)
SI (1) SI2328601T1 (hr)
WO (1) WO2010019266A2 (hr)
ZA (1) ZA201101523B (hr)

Families Citing this family (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2020005326A (es) 2008-08-15 2022-03-03 Ironwood Pharmaceuticals Inc Formulaciones que contienen linaclotida para administracion oral.
US20100221329A1 (en) 2008-12-03 2010-09-02 Synergy Pharmaceuticals, Inc. Formulations of guanylate cyclase c agonists and methods of use
US8748573B2 (en) 2009-08-06 2014-06-10 Ironwood Pharmaceuticals, Inc. Formulations comprising linaclotide
EP2464373A1 (en) * 2009-08-13 2012-06-20 Ironwood Pharmaceuticals, Inc. Method for modulating the pharmacodynamic effect of orally administered guanylate cyclase receptor agonists
DK2521561T3 (en) * 2009-11-03 2017-09-11 Ironwood Pharmaceuticals Inc LINACLOTID FOR TREATMENT OF CHRONIC CONSTIPATION
NZ599751A (en) 2009-11-09 2014-08-29 Ironwood Pharmaceuticals Inc Treatments for gastrointestinal disorders
EP2509992B1 (en) 2009-12-07 2015-10-14 Ironwood Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
US8933030B2 (en) 2010-02-17 2015-01-13 Ironwwod Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
ES2919136T3 (es) * 2010-08-11 2022-07-22 Ironwood Pharmaceuticals Inc Formulaciones estables de linaclotida
WO2012034068A1 (en) * 2010-09-11 2012-03-15 Ironwood Pharmaceuticals, Inc. Treatment of constipation-predominant irritable bowel syndrome
AU2011302006A1 (en) 2010-09-15 2013-03-07 Synergy Pharmaceuticals Inc. Formulations of guanylate cyclase C agonists and methods of use
US9616097B2 (en) * 2010-09-15 2017-04-11 Synergy Pharmaceuticals, Inc. Formulations of guanylate cyclase C agonists and methods of use
US9650417B2 (en) 2011-05-11 2017-05-16 Ironwood Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
WO2012155114A1 (en) 2011-05-11 2012-11-15 Ironwood Pharmaceuticals, Inc. Peptides derived from uroguanylin and their use in gastrointestinal disorders
WO2012170766A1 (en) 2011-06-08 2012-12-13 Ironwood Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
US9617305B2 (en) 2011-06-08 2017-04-11 Ironwood Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
US9708371B2 (en) * 2011-08-17 2017-07-18 Ironwood Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
US20140242158A1 (en) * 2011-09-30 2014-08-28 Astellas Pharma, Inc. Granular Pharmaceutical Composition
JP2016521249A (ja) * 2012-07-12 2016-07-21 フォレスト ラボラトリーズ ホールディングス リミテッド リナクロチド組成物
EP2950803A1 (en) * 2013-01-30 2015-12-09 Sandoz AG Crystalline form of linaclotide
AU2014305843B2 (en) 2013-08-09 2019-08-29 Ardelyx, Inc. Compounds and methods for inhibiting phosphate transport
UA119335C2 (uk) * 2013-12-11 2019-06-10 Айронвуд Фармасьютикалз, Інк. Композиції лінаклотиду з затриманим вивільненням
WO2016024291A1 (en) * 2014-08-11 2016-02-18 Sun Pharmaceutical Industries Ltd. Linaclotide stable composition
EP3006045B3 (en) * 2014-10-07 2021-03-17 Cyprumed GmbH Pharmaceutical formulations for the oral delivery of peptide or protein drugs
CN104569245A (zh) * 2014-12-08 2015-04-29 江苏泰洁检测技术有限公司 一种工作场所脂肪族胺类中环己胺浓度测定方法
WO2016125064A1 (en) * 2015-02-02 2016-08-11 Aurobindo Pharma Ltd Stable compositions comprising linaclotide
WO2016197042A1 (en) * 2015-06-05 2016-12-08 Ironwood Pharmaceuticals, Inc. Modified or targeted release formulations of linaclotide
CA2997343A1 (en) 2015-10-07 2017-04-13 Cyprumed Gmbh Pharmaceutical formulations for the oral delivery of peptide drugs
BR112019012689A2 (pt) 2016-12-21 2019-11-19 Ironwood Pharmaceuticals Inc métodos de tratamento da síndrome do intestino irritável com formulações de linaclotide modificada ou de liberação prolongada
CN107669700A (zh) * 2017-09-14 2018-02-09 湖南晓林生物科技发展有限公司 一种治疗溃疡性结肠炎的药物及其制备方法
WO2020012243A2 (en) 2018-07-09 2020-01-16 Abbott Laboratories Gmbh Pharmaceutical composition containing a peptide
US20200368223A1 (en) 2019-05-21 2020-11-26 Ardelyx, Inc. Methods for inhibiting phosphate transport
CN112121021B (zh) * 2019-06-24 2022-03-25 深圳翰宇药业股份有限公司 一种含利那洛肽的药物组合物及其制备方法
JP2023539385A (ja) * 2020-06-30 2023-09-13 オクヴィルク，ゼレン グアニル酸シクラーゼｃ（ｇｕｃｙ２ｃ）アゴニストおよび短鎖脂肪酸またはそのプロドラッグの組み合わせを含む医薬組成物
CN113616616A (zh) * 2021-09-07 2021-11-09 四川国为制药有限公司 一种利那洛肽胶囊制剂及其制备方法
US20230106943A1 (en) * 2021-09-17 2023-04-06 Peptilogics, Inc. Engineered antimicrobial peptides and usage thereof
CN114632141B (zh) * 2022-04-19 2023-08-01 苏州中化药品工业有限公司 一种含利那洛肽的药物组合物、胶囊制剂及其制备方法
CN116672309A (zh) * 2023-07-26 2023-09-01 北京普诺旺康医药科技有限公司 干混悬药物组合物

Family Cites Families (71)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CH658973A5 (fr) 1983-12-29 1986-12-31 Nestle Sa Produit aromatisant.
JPS6197229A (ja) * 1984-10-18 1986-05-15 Chugai Pharmaceut Co Ltd 安定なエリトロポエチン製剤
DE3729863A1 (de) * 1987-09-05 1989-03-16 Boehringer Mannheim Gmbh Stabilisierte erythropoietin-lyophilisate
JPS649938A (en) 1987-06-30 1989-01-13 Agency Ind Science Techn Oral ingestive composition
JPH03505334A (ja) 1989-04-11 1991-11-21 イミユノバイオロジー・リサーチ・インスチチユート・インコーポレーテツド 凍結乾燥されたペプチド製剤
IT1240314B (it) 1989-09-28 1993-12-07 Immunobiology Research Institutes, Inc. Formulazioni acquose stabilizzate di piccoli peptidi.
US5221495A (en) 1990-04-13 1993-06-22 Colgate-Palmolive Company Enzyme stabilizing composition and stabilized enzyme containing built detergent compositions
US5451410A (en) * 1993-04-22 1995-09-19 Emisphere Technologies, Inc. Modified amino acids for encapsulating active agents
US6284727B1 (en) 1993-04-07 2001-09-04 Scios, Inc. Prolonged delivery of peptides
US5681811A (en) 1993-05-10 1997-10-28 Protein Delivery, Inc. Conjugation-stabilized therapeutic agent compositions, delivery and diagnostic formulations comprising same, and method of making and using the same
IL115592A (en) * 1994-10-13 2000-07-26 Novo Nordisk As Stabilized pharmaceutical formulation comprising a growth hormone and leucine
US5654278A (en) * 1994-10-13 1997-08-05 Novo Nordisk A/S Composition and method comprising growth hormone and leucine
US5593696A (en) * 1994-11-21 1997-01-14 Mcneil-Ppc, Inc. Stabilized composition of famotidine and sucralfate for treatment of gastrointestinal disorders
US5904935A (en) 1995-06-07 1999-05-18 Alza Corporation Peptide/protein suspending formulations
ZA965368B (en) 1995-07-14 1997-01-14 Novo Nordisk As A pharmaceutical formulation
US5932547A (en) 1996-07-03 1999-08-03 Alza Corporation Non-aqueous polar aprotic peptide formulations
US5916582A (en) 1996-07-03 1999-06-29 Alza Corporation Aqueous formulations of peptides
CZ433898A3 (cs) 1996-07-03 1999-04-14 Alza Corporation Nevodné protické peptidové formulace
US20020151502A1 (en) * 1997-10-09 2002-10-17 Albert Sattin Tri-peptides for neurological and neurobehavior applications
US6541606B2 (en) 1997-12-31 2003-04-01 Altus Biologics Inc. Stabilized protein crystals formulations containing them and methods of making them
US6087478A (en) 1998-01-23 2000-07-11 The Rockefeller University Crystal of the N-terminal domain of a STAT protein and methods of use thereof
JP2002521322A (ja) 1998-07-23 2002-07-16 ノボ ノルディスク アクティーゼルスカブ 安定な医薬製剤の製造のための湿式顆粒化方法
BR9913302A (pt) * 1998-09-04 2002-09-24 Gaplast Gmbh Recipiente
JP4497725B2 (ja) 1998-11-27 2010-07-07 ▲高▼田 ▲寛▼治 消化管用薬物送達経口製剤
US6734162B2 (en) 2000-01-24 2004-05-11 Minimed Inc. Mixed buffer system for stabilizing polypeptide formulations
JP4711520B2 (ja) * 2000-03-21 2011-06-29 日本ケミカルリサーチ株式会社 生理活性ペプチド含有粉末
CN1245974C (zh) 2000-06-28 2006-03-22 特瓦制药工业有限公司 卡维地洛
FR2811884B1 (fr) 2000-07-21 2003-01-31 Oreal Utilisation en cosmetique de betainates d'amidon et composition les comprenant associes a au moins un agent benefique pour les matieres keratiniques
US6613308B2 (en) 2000-09-19 2003-09-02 Advanced Inhalation Research, Inc. Pulmonary delivery in treating disorders of the central nervous system
AU2001296389A1 (en) 2000-09-29 2002-04-08 Cognetix, Inc. Stable peptide formulations
US6896906B2 (en) 2000-12-21 2005-05-24 Nektar Therapeutics Storage stable powder compositions of interleukin-4 receptor
JP2004521123A (ja) 2001-02-02 2004-07-15 ファルマシア・コーポレーション 腸癌阻害のためのウログアニリンおよびシクロオキシゲナーゼ−２阻害薬の組合わせ
GB0104371D0 (en) 2001-02-22 2001-04-11 Clariant Int Ltd Color improving stabilizing compositions comprising leucine
US6573237B2 (en) 2001-03-16 2003-06-03 Eli Lilly And Company Protein formulations
JP4206272B2 (ja) 2001-03-29 2009-01-07 サイナージィ ファーマスーティカルズ、インコーポレイテッド 組織炎症及び発癌を治療するためのグアニル酸シクラーゼ受容体アゴニスト
AU2002355542A1 (en) 2001-08-09 2003-02-24 Doctor's Signature Sales And Marketing International Corp. ((Dba)) Life Force International Protonic formulation
US20030104996A1 (en) 2001-08-30 2003-06-05 Tiansheng Li L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
US20040161776A1 (en) 2001-10-23 2004-08-19 Maddon Paul J. PSMA formulations and uses thereof
EP1458407A1 (en) * 2001-12-21 2004-09-22 Novo Nordisk A/S Liquid composition of modified factor vii polypeptides
JP2003201256A (ja) 2001-12-28 2003-07-18 Hisamitsu Pharmaceut Co Inc 大腸送達性経口医薬製剤、大腸癌治療用経口医薬製剤および大腸炎治療用経口医薬製剤
DE10261126A1 (de) * 2002-08-13 2004-03-04 Aventis Behring Gmbh Lagerungsstabile, flüssige Fibrinogen-Formulierung
PL377479A1 (pl) 2002-12-11 2006-02-06 Pfizer Products Inc. Kontrolowane uwalnianie substancji czynnej do środowiska o wysokiej zawartości tłuszczu
US7304036B2 (en) * 2003-01-28 2007-12-04 Microbia, Inc. Methods and compositions for the treatment of gastrointestinal disorders
SI1594517T1 (sl) * 2003-01-28 2007-10-31 Microbia Inc Sestavki za zdravljenje gastrointestinalnih motenj
US7371727B2 (en) 2003-01-28 2008-05-13 Microbia, Inc. Methods and compositions for the treatment of gastrointestinal disorders
US7772188B2 (en) 2003-01-28 2010-08-10 Ironwood Pharmaceuticals, Inc. Methods and compositions for the treatment of gastrointestinal disorders
ATE390142T1 (de) 2003-05-14 2008-04-15 Indus Biotech Pvt Ltd Synergistische zusammensetzung zur behandlung von diabetes mellitus
KR100610003B1 (ko) * 2003-06-10 2006-08-08 주식회사 엘지생명과학 혈청 알부민을 함유하지 않는 안정한 인 에리쓰로포이에틴용액 제형
EP1644021B1 (en) 2003-06-13 2012-08-22 Ironwood Pharmaceuticals, Inc. Methods and compositions for the treatment of gastrointestinal disorders
US7494979B2 (en) 2003-06-13 2009-02-24 Ironwood Pharmaceuticals, Inc. Method for treating congestive heart failure and other disorders
KR100560697B1 (ko) 2003-08-06 2006-03-16 씨제이 주식회사 알부민을 함유하지 않는 에리스로포이에틴 제제
DE102004011663B4 (de) 2004-03-10 2006-04-27 Bioceuticals Arzneimittel Ag Erythropoietin-Flüssigformulierung
WO2006071102A1 (en) 2004-12-30 2006-07-06 Dobeel Co., Ltd. Spray-dried composition containing collectin family proteins or variants therof and process for preparing the same
US20090253634A1 (en) 2005-08-19 2009-10-08 Microbia, Inc. Methods and Compositions for the Treatment of Gastrointestinal Disorders
WO2007044375A2 (en) 2005-10-06 2007-04-19 Nastech Pharmaceutical Company Inc. Pth formulations and methods of use
JP2009527504A (ja) * 2006-02-23 2009-07-30 イオメディックス スリープ インターナショナル エスアールエル 良質な睡眠の誘導および維持のための組成物および方法
EP1996218A4 (en) 2006-02-24 2012-07-11 Ironwood Pharmaceuticals Inc METHODS AND COMPOSITIONS FOR THE TREATMENT OF GASTROINTESTINAL DISORDERS
ITMI20060629A1 (it) 2006-03-31 2007-10-01 Daniele Giovannone Composizioni solide orali a base di s-adenosilmetionina e processo per il loro ottenimento
AU2007272272B2 (en) 2006-07-10 2012-04-12 Pba3 Biomed Gmbh Antimicrobial peptides
AU2007284759B2 (en) 2006-08-09 2010-10-28 Intarcia Therapeutics, Inc. Osmotic delivery systems and piston assemblies
AU2007289344B2 (en) 2006-08-31 2011-04-14 Novartis Ag Pharmaceutical compositions comprising hGH for oral delivery
CA2673260A1 (en) * 2006-12-20 2008-07-03 Bayer Healthcare Llc Factor vii and viia compositions
WO2008106429A2 (en) 2007-02-26 2008-09-04 Ironwood Pharmaceuticals, Inc. Methods and compositions for the treatment of heart failure and other disorders
EP2170930B3 (en) 2007-06-04 2013-10-02 Synergy Pharmaceuticals Inc. Agonists of guanylate cyclase useful for the treatment of gastrointestinal disorders, inflammation, cancer and other disorders
MX2020005326A (es) 2008-08-15 2022-03-03 Ironwood Pharmaceuticals Inc Formulaciones que contienen linaclotida para administracion oral.
EP2341898A2 (en) * 2008-09-04 2011-07-13 Ironwood Pharmaceuticals, Inc. Stable solid formulations of gc-c receptor agonist polypeptides suitable for oral administration
WO2010027404A2 (en) 2008-09-04 2010-03-11 Ironwood Pharmaceuticals, Inc. Stable solid formulation of therapeutic polypeptides suitable for oral administration
US20100221329A1 (en) * 2008-12-03 2010-09-02 Synergy Pharmaceuticals, Inc. Formulations of guanylate cyclase c agonists and methods of use
US20130012454A1 (en) * 2009-07-06 2013-01-10 Ironwood Pharmaceuticals, Inc. Orally Disintegrating Compositions of Linaclotide
WO2011019819A1 (en) 2009-08-12 2011-02-17 Forest Laboratories Holdings Limited Orally disintegrating compositions of linaclotide
US8748573B2 (en) 2009-08-06 2014-06-10 Ironwood Pharmaceuticals, Inc. Formulations comprising linaclotide

Also Published As

Publication number Publication date
AU2009282446A1 (en) 2010-02-18
HK1161978A1 (zh) 2012-08-17
MX2020005326A (es) 2022-03-03
PE20110543A1 (es) 2011-08-04
EA201170337A1 (ru) 2012-01-30
SI2328601T1 (sl) 2020-08-31
JP5770629B2 (ja) 2015-08-26
NZ591713A (en) 2013-07-26
JP2016190870A (ja) 2016-11-10
JP2014139246A (ja) 2014-07-31
CN117530912A (zh) 2024-02-09
MX2011001620A (es) 2011-03-25
KR20120008017A (ko) 2012-01-25
PL2328601T3 (pl) 2020-07-13
US20100048489A1 (en) 2010-02-25
CN105168114A (zh) 2015-12-23
US20210290554A1 (en) 2021-09-23
KR20200105730A (ko) 2020-09-08
CL2011000314A1 (es) 2011-10-07
EP2328601B1 (en) 2020-01-22
JP2019163340A (ja) 2019-09-26
JP2018104468A (ja) 2018-07-05
IL211028A0 (en) 2011-04-28
HRP20200512T2 (hr) 2024-05-24
WO2010019266A2 (en) 2010-02-18
CN109010254A (zh) 2018-12-18
CA2732892A1 (en) 2010-02-18
US20220125734A1 (en) 2022-04-28
JP6034327B2 (ja) 2016-11-30
JP2024015361A (ja) 2024-02-01
CN114668711A (zh) 2022-06-28
JP2021073297A (ja) 2021-05-13
US20230310329A1 (en) 2023-10-05
PT2328601T (pt) 2020-04-30
KR20220100101A (ko) 2022-07-14
PH12015501579A1 (en) 2016-02-22
DK2328601T3 (da) 2020-04-14
ZA201101523B (en) 2011-10-26
US20130273169A1 (en) 2013-10-17
JP2012500196A (ja) 2012-01-05
WO2010019266A3 (en) 2010-06-03
IL211028A (en) 2016-10-31
LT2328601T (lt) 2020-04-27
EP2328601A2 (en) 2011-06-08
JP2022132383A (ja) 2022-09-08
HK1219062A1 (zh) 2017-03-24
CO6351746A2 (es) 2011-12-20
CN102186490A (zh) 2011-09-14
PH12015501579B1 (en) 2016-02-22
KR20170138580A (ko) 2017-12-15
KR20180137043A (ko) 2018-12-26
EP3701962A1 (en) 2020-09-02
SG193801A1 (en) 2013-10-30
US8802628B2 (en) 2014-08-12
PE20151205A1 (es) 2015-08-31
KR20210145307A (ko) 2021-12-01
MX2019013628A (es) 2020-01-21
JP2018104469A (ja) 2018-07-05
JP6473532B2 (ja) 2019-02-20
KR20210043728A (ko) 2021-04-21
HUE049023T2 (hu) 2020-08-28
CN102186490B (zh) 2015-07-29
KR101704832B1 (ko) 2017-02-08
GEP20156209B (en) 2015-01-12
US20120213846A1 (en) 2012-08-23
KR20170016522A (ko) 2017-02-13
KR20230025926A (ko) 2023-02-23
US20190029967A1 (en) 2019-01-31
KR20200000462A (ko) 2020-01-02
RS60101B1 (sr) 2020-05-29
KR20240025699A (ko) 2024-02-27
AU2009282446B2 (en) 2016-03-31
CA2732892C (en) 2020-12-15
BRPI0917807A2 (pt) 2019-11-19
ES2785980T3 (es) 2020-10-08
CY1122801T1 (el) 2021-05-05

Similar Documents

Publication Publication Date Title
HRP20200512T1 (hr) Formulacije koje sadrže linaklotid za oralnu primjenu
JP2012500196A5 (hr)
HRP20170677T1 (hr) Farmaceutski sastav za kontrolirano otpuštanje koji sadrži ester fumarne kiseline
HRP20150592T1 (hr) Organoborni esterski spojevi i njihove farmaceutske kompozicije
HRP20201685T1 (hr) Sastavi gama-hidroksibutirata i njihova upotreba za liječenje poremećaja
JP2014524444A5 (hr)
HRP20171384T1 (hr) Farmaceutski pripravak
HRP20100127T1 (hr) Višečestični oblici
HRP20140780T4 (hr) Amorfni i kristalinični oblik genz 112638 hemitartrata kao inhibitor glukozilceramid sintaze
FI3067043T3 (fi) Angiotensiinireseptoriantagonistin/-salpaajan (arb) ja neutraalin endopeptidaasin (nep) estäjän superrakenteisiin perustuvia farmaseuttisia koostumuksia
JP2010090168A5 (hr)
RU2017134002A (ru) Стабильные композиции тетрагидробиоптерина
JPWO2013054872A1 (ja) ７−［４−（４−ベンゾ［ｂ］チオフェン−４−イル−ピペラジン−１−イル）ブトキシ］−１Ｈ−キノリン−２−オン又はその塩を含む錠剤
RU2012142811A (ru) Фармацевтические композиции и пероральные дозированные формы пролекарства леводопы и способы применения
JP2019116494A (ja) アカンプロサート製剤、それを用いる方法、およびそれを含む合剤
HRP20201316T1 (hr) Novi modulatori receptora sfingozin-fosfata
JP2017504590A5 (hr)
JP2011502997A5 (hr)
RU2012109415A (ru) Способ модуляции фармакодинамического эффекта перорально вводимых агонистов рецептора гуанилатциклазы
JP2018527305A5 (hr)
RU2009102443A (ru) Фармацевтический препарат для контрацепции и для предотвращения риска врожденных пороков развития
JP2019196395A (ja) 縮合アミノジヒドロチアジン誘導体の医薬組成物
WO2014059309A1 (en) Pharmaceutical formulations of pilocarpine
CZ236798A3 (cs) Farmaceutické přípravky obsahující cilansetron stabilizované proti racemizaci
HRP20100113T1 (hr) Upotreba pripravaka koji sadrže antagonist kapa-opioidnog receptora, namijenjenih liječenju disocijativnih poremećaja