DK2007362T3 - Orale doseringsformer, herunder et antitrombocytmiddel og en syrehæmmer - Google Patents

Orale doseringsformer, herunder et antitrombocytmiddel og en syrehæmmer Download PDF

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Publication number
DK2007362T3
DK2007362T3 DK07760105.2T DK07760105T DK2007362T3 DK 2007362 T3 DK2007362 T3 DK 2007362T3 DK 07760105 T DK07760105 T DK 07760105T DK 2007362 T3 DK2007362 T3 DK 2007362T3
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Prior art keywords
dosage form
oral dosage
clopidogrel
omeprazole
effective amount
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DK07760105.2T
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English (en)
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Mark A Goldsmith
Elizabeth Vadas
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Kg Acquisition Llc
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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4743—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having sulfur as a ring hetero atom
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; 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
    • 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
    • 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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/48—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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of 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
    • A61K9/50—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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Claims (12)

1. Anvendelse af en adenosindiphosphat (ADP)-antagonist eller P2Yi2-anta-gonist og en protonpumpehæmmer (PPI) til fremstilling af en farmaceutisk sammensætning til behandling af en patient med en gastrointestinal (GI) sygdom forbundet med en ADP- eller P2Yi2-antagonist hos en patient, hvor patienten ikke vides at have en GI sygdom, hvor den farmaceutiske sammensætning er en oral enkeltenhedsdoseringsform, der omfatter: (a) en terapeutisk virksom mængde af en adenosindiphosphat (ADP)-antago-nist eller P2Yi2-antagonist til hæmning af trombocytaggregation, hvor ADP- eller P2Yi2-antagonisten er clopidogrel eller et farmaceutisk acceptabelt salt, solvat, hydrat, enantiomer eller polymorf deraf; og (b) en terapeutisk virksom mængde af en PPI til forebyggelse af en GI sygdom forbundet med ADP- eller P2Yi2-antagonisten, hvor PPI'en er omeprazol eller et farmaceutisk acceptabelt salt, enantiomer eller polymorf deraf; hvor PPI'en er enterisk coatet; og hvor den orale enkeltenhedsdoseringsform ikke indbefatter et ikke-aspirin ikke-steroidt anti-inflammatorisk lægemiddel (NSAID).
2. Anvendelse ifølge krav 1, hvor enhedsdoseringsformen omfatter ca. 20-200 mg clopidogrel eller et farmaceutisk acceptabelt salt, solvat, polymorf, hydrat eller enantiomer deraf.
3. Anvendelse ifølge krav 1 eller 2, hvor enhedsdoseringsformen omfatter ca. 10-100 mg omeprazol eller et farmaceutisk acceptabelt salt, enantiomer eller polymorf deraf.
4. Anvendelse ifølge et hvilket som helst af kravene 1 til 3, hvor enhedsdoseringsformen omfatter: (a) 50-100 mg clopidogrel eller et farmaceutisk acceptabelt salt, solvat, polymorf, hydrat eller enantiomer deraf; og/eller (b) 10-40 mg omeprazol eller et farmaceutisk acceptabelt salt, enantiomer eller polymorf deraf.
5. Anvendelse ifølge krav 1, hvor enhedsdoseringsformen omfatter ca. 75 mg clopidogrel eller et farmaceutisk acceptabelt salt, solvat, polymorf, hydrat eller enantiomer deraf.
6. Anvendelse ifølge krav 1,2,4 eller 5, hvor enhedsdoseringsformen omfatter ca. 20 mg omeprazol eller et farmaceutisk acceptabelt salt, enantiomer eller polymorf deraf.
7. Oral enkeltenhedsdoseringsform, der omfatter en terapeutisk virksom mængde af en adenosindiphosphat (ADP)-antagonist eller P2Yi2-antagonist og en terapeutisk virksom mængde af en protonpumpehæmmer (PPI), hvor ADP- eller P2Yi2-antagonisten er clopidogrel eller et farmaceutisk acceptabelt salt, solvat, polymorf, hydrat eller enantiomer deraf, og PPI'en er omeprazol eller et farmaceutisk acceptabelt salt, ester, solvat, polymorf, hydrat eller enantiomer deraf, hvor PPI'en er enterisk coatet; og hvor doseringsformen er uden et ikke-steroidt anti-inflammatorisk lægemiddel (NSAID).
8. Doseringsform ifølge krav 7, hvor enhedsdoseringsformen omfatter ca. 20-200 mg clopidogrel eller et farmaceutisk acceptabelt salt, solvat, polymorf, hydrat eller enantiomer deraf.
9. Doseringsform ifølge 7 eller 8, hvor enhedsdoseringsformen omfatter ca. 10-100 mg omeprazol eller et farmaceutisk acceptabelt salt, enantiomer eller polymorf deraf.
10. Doseringsform ifølge et hvilket som helst af kravene 7 til 9, hvor enhedsdoseringsformen omfatter: (a) 50-100 mg clopidogrel eller et farmaceutisk acceptabelt salt, solvat, polymorf, hydrat eller enantiomer deraf; og/eller (b) 10-40 mg omeprazol eller et farmaceutisk acceptabelt salt, enantiomer eller polymorf deraf.
11. Doseringsform ifølge krav 7, hvor enhedsdoseringsformen omfatter ca. 75 mg clopidogrel eller et farmaceutisk acceptabelt salt, solvat, polymorf, hydrat eller enantiomer deraf.
12. Doseringsform ifølge krav 7, 8, 10 eller 11, hvor enhedsdoseringsformen omfatter ca. 20 mg omeprazol eller et farmaceutisk acceptabelt salt, enantiomer eller polymorf deraf.
DK07760105.2T 2006-04-04 2007-04-04 Orale doseringsformer, herunder et antitrombocytmiddel og en syrehæmmer DK2007362T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US78954306P 2006-04-04 2006-04-04
US81232606P 2006-06-09 2006-06-09
PCT/US2007/065967 WO2007115305A2 (en) 2006-04-04 2007-04-04 Oral dosage forms including an antiplatelet agent and an acid inhibitor

Publications (1)

Publication Number Publication Date
DK2007362T3 true DK2007362T3 (da) 2018-11-26

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DK07760105.2T DK2007362T3 (da) 2006-04-04 2007-04-04 Orale doseringsformer, herunder et antitrombocytmiddel og en syrehæmmer

Country Status (24)

Country Link
US (1) US9504678B2 (da)
EP (1) EP2007362B1 (da)
JP (3) JP5844028B2 (da)
KR (2) KR20150105419A (da)
CN (1) CN101460154B (da)
AU (1) AU2007234398B9 (da)
BR (1) BRPI0709745A2 (da)
CA (1) CA2647497C (da)
CY (1) CY1120961T1 (da)
DK (1) DK2007362T3 (da)
ES (1) ES2699444T3 (da)
HK (1) HK1131566A1 (da)
HR (1) HRP20181971T1 (da)
HU (1) HUE040311T2 (da)
IL (1) IL194472A (da)
LT (1) LT2007362T (da)
MX (2) MX349787B (da)
PL (1) PL2007362T3 (da)
PT (1) PT2007362T (da)
RS (1) RS58162B1 (da)
SG (1) SG170826A1 (da)
SI (1) SI2007362T1 (da)
TR (1) TR201816133T4 (da)
WO (1) WO2007115305A2 (da)

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LT2007362T (lt) 2018-11-26
AU2007234398A1 (en) 2007-10-11
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