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HK1111609A1 - Solid dosage form comprising proton pump inhibitor and suspension made thereof - Google Patents

Solid dosage form comprising proton pump inhibitor and suspension made thereof Download PDF

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Publication number
HK1111609A1
HK1111609A1 HK08102573.3A HK08102573A HK1111609A1 HK 1111609 A1 HK1111609 A1 HK 1111609A1 HK 08102573 A HK08102573 A HK 08102573A HK 1111609 A1 HK1111609 A1 HK 1111609A1
Authority
HK
Hong Kong
Prior art keywords
dosage form
granulate
suspension
gelling agent
form according
Prior art date
Application number
HK08102573.3A
Other languages
German (de)
English (en)
Chinese (zh)
Other versions
HK1111609B (en
Inventor
Eva Persson
Eva Trofast
Original Assignee
Astrazeneca Ab
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Application filed by Astrazeneca Ab filed Critical Astrazeneca Ab
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Publication of HK1111609B publication Critical patent/HK1111609B/en

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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
    • A61K31/33—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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/009—Sachets, pouches characterised by the material or function of the envelope
    • A—HUMAN NECESSITIES
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    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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    • A61K9/10—Dispersions; Emulsions
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    • 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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    • 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
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    • 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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
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    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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    • 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
    • A61K9/1682—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K9/5026—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
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    • 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
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • A61P11/16—Central respiratory analeptics
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    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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    • A—HUMAN NECESSITIES
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    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
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  • Biophysics (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physiology (AREA)
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  • Biochemistry (AREA)
  • Otolaryngology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Anesthesiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (20)

  1. Forme galénique pharmaceutique orale qui est un mélange granulé solide à gélification rapide adapté à la fabrication d'une suspension, et qui comprend I) un inhibiteur de la pompe à protons sensible acide qui est l'ésoméprazole, l'un de ses sels alcalins ou une forme hydratée du composé ou de l'un quelconque de ses sels au titre de principe actif, répartis en une multitude de granules à enrobage entérique et II) un granulat, caractérisé en ce que le granulat est un granulat modificateur de suspension qui comprend un diluant à dissolution rapide choisi parmi le glucose et le sucrose ainsi que leurs hydrates, un agent gélifiant choisi parmi les gommes xanthane, un agent de régulation du pH acide, un agent liant et un agent délitant optionnel, en ce que le granulat ne contient pas de sels de bicarbonate et/ou de sels de carbonate, et en ce que le rapport massique entre l'agent liant et l'agent gélifiant dans le granulat (II) est compris entre 1:2 et 1:3.
  2. Forme galénique conforme à la revendication 1, et ne comprenant pas de lactose.
  3. Forme galénique conforme à l'une quelconque des revendications 1 à 2, où le diluant à dissolution rapide et l'agent gélifiant sont mélangés et granulés ensemble de sorte que le diluant à dissolution rapide soit distribué de façon aléatoire à l'intérieur et à la surface des particules granulées obtenues.
  4. Forme galénique conforme à l'une quelconque des revendications 1 à 3, où la concentration de l'agent gélifiant est comprise entre 0,6 % et 12 % en masse du granulat modificateur de suspension (II).
  5. Forme galénique conforme à l'une quelconque des revendications 1 à 3, où la concentration de l'agent gélifiant est comprise entre 1,8 % et 4,8 % en masse du granulat modificateur de suspension (II).
  6. Forme galénique conforme à l'une quelconque des revendications 1 à 5, où le granulat modificateur de suspension (II), lorsqu'il est dispersé dans l'eau, forme une suspension dont le pH est compris dans l'intervalle 3,0 à 6,0.
  7. Forme galénique conforme à l'une quelconque des revendications 1 à 5, où le granulat modificateur de suspension (II), lorsqu'il est dispersé dans l'eau, forme une suspension dont le pH est compris dans l'intervalle 3,0 à 5,0.
  8. Forme galénique conforme à l'une quelconque des revendications 1 à 7, où les granules à enrobage entérique sont constitués des composants structurels suivants : une matière de noyau comprenant le principe actif, une couche de sous-enrobage, une couche d'enrobage entérique et aucune couche d'enrobage supplémentaire par-dessus l'enrobage entérique.
  9. Forme galénique conforme à l'une quelconque des revendications 1 à 8, où les granules à enrobage entérique présentent un diamètre moyen compris entre 0,2 et 1,8 mm.
  10. Forme galénique conforme à l'une quelconque des revendications 1 à 8, où les granules à enrobage entérique présentent un diamètre moyen compris entre 0,4 et 1,0 mm.
  11. Sachet comprenant la forme galénique conforme à l'une quelconque des revendications 1 à 10.
  12. Sachet conforme à la revendication 11, où la quantité de principe actif est comprise entre 1 mg et 100 mg.
  13. Sachet conforme à la revendication 11, où la quantité de principe actif est comprise entre 1 mg et 40 mg.
  14. Formule liquide prête à l'emploi, comprenant un liquide aqueux et la forme galénique conforme à l'une quelconque des revendications 1 à 13.
  15. Formule liquide conforme à la revendication 14, où la quantité de liquide aqueux est entre 2,5 et 7,5 fois supérieure à la quantité du granulat modificateur de suspension (II).
  16. Formule liquide conforme à l'une quelconque des revendications 14 à 15, où le liquide aqueux est l'eau.
  17. Procédé d'élaboration du granulat modificateur de suspension (II) employé dans la forme galénique conforme à l'une quelconque des revendications 1 à 10, le procédé comprenant l'étape de mélangeage et de granulation simultanés du diluant à dissolution rapide et de l'agent gélifiant, qui sont ensuite séchés, ladite étape résultant en la distribution aléatoire du diluant à dissolution rapide à l'intérieur et en surface de chacune des particules granulées obtenues.
  18. Procédé de fabrication du granulat modificateur de suspension (II) employé dans la forme galénique conforme à l'une quelconque des revendications 1 à 10, le procédé incluant les étapes suivantes dans l'ordre suivant :
    I) mélangeage de l'agent gélifiant à l'agent régulateur de pH, au diluant à dissolution rapide et à l'agent délitant optionnel
    II) dissolution de l'agent liant dans l'éthanol
    III) mouillage du mélange obtenu dans l'étape I par la solution obtenue dans l'étape II
    IV) agitation du mélange humide obtenu dans l'étape III pour obtenir un contact proche/intime de la quasi-totalité des particules d'agent gélifiant avec le diluant à dissolution rapide susmentionné
    V) séchage du mélange humide agité de l'étape IV jusqu'à ce que la teneur finale en humidité dans le granulat modificateur de suspension (II), mesurée par perte au séchage, soit inférieure à 3 % en masse,
    VI) broyage ou fraisage des granules secs obtenus dans l'étape V jusqu'à ce que plus de 95 % en masse des granules passent à travers un tamis de maillage 1,0 mm.
  19. Procédé de fabrication du granulat modificateur de suspension (II) employé dans la forme galénique conforme à l'une quelconque des revendications 1 à 10, le procédé incluant les étapes suivantes dans l'ordre suivant :
    I) dissolution de l'agent liant dans l'éthanol
    II) mélangeage de l'agent gélifiant à l'agent régulateur de pH, au diluant à dissolution rapide et à l'agent délitant optionnel
    III) mouillage du mélange obtenu dans l'étape II par la solution obtenue dans l'étape I
    IV) agitation du mélange humide obtenu dans l'étape III pour obtenir un contact proche/intime de la quasi-totalité des particules d'agent gélifiant avec le diluant à dissolution rapide susmentionné
    V) séchage du mélange humide agité de l'étape IV jusqu'à ce que la teneur finale en humidité dans le granulat modificateur de suspension (II), mesurée par perte au séchage, soit inférieure à 3 % en masse,
    VI) broyage ou fraisage des granules secs obtenus dans l'étape V jusqu'à ce que plus de 95 % en masse des granules passent à travers un tamis de maillage 1,0 mm.
  20. Forme galénique pharmaceutique conforme à l'une quelconque des revendications 1 à 13, destinée au traitement des maladies gastro-intestinales.
HK08102573.3A 2004-12-22 2005-12-20 Solid dosage form comprising proton pump inhibitor and suspension made thereof HK1111609B (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US63843504P 2004-12-22 2004-12-22
US638435P 2004-12-22
PCT/SE2005/001972 WO2006068596A1 (fr) 2004-12-22 2005-12-20 Forme galénique solide comprenant un inhibiteur de la pompe à protons et suspension réalisée à partir de ladite forme galénique

Publications (2)

Publication Number Publication Date
HK1111609A1 true HK1111609A1 (en) 2008-08-15
HK1111609B HK1111609B (en) 2013-04-05

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MY149156A (en) 2013-07-15
ES2389844T3 (es) 2012-11-02
CA2592030A1 (fr) 2006-06-29
PL1830816T3 (pl) 2012-11-30
CN101087590A (zh) 2007-12-12
AU2005319732A1 (en) 2006-06-29
ME01458B (fr) 2014-04-20
WO2006068596A1 (fr) 2006-06-29
KR20070094610A (ko) 2007-09-20
DK1830816T3 (da) 2012-10-01
IL183658A (en) 2014-04-30
MX2007007423A (es) 2007-07-17
RU2007127781A (ru) 2009-01-27
AR052173A1 (es) 2007-03-07
CN101087590B (zh) 2012-06-13
EP1830816A1 (fr) 2007-09-12
UA87341C2 (uk) 2009-07-10
IL183658A0 (en) 2007-09-20
SA05260421B1 (ar) 2010-03-08
PT1830816E (pt) 2012-09-11
TW200635618A (en) 2006-10-16
AU2005319732B2 (en) 2008-12-11
JP5171259B2 (ja) 2013-03-27
US20150079186A1 (en) 2015-03-19
HK1115308A1 (en) 2008-11-28
SI1830816T1 (sl) 2012-10-30
KR101321641B1 (ko) 2013-10-22
NO20073731L (no) 2007-09-24
ZA200705113B (en) 2009-12-30
EP1830816A4 (fr) 2011-06-15
NZ555833A (en) 2009-10-30
CY1113207T1 (el) 2016-04-13
CA2592030C (fr) 2014-01-28
US20080020053A1 (en) 2008-01-24
US20060134210A1 (en) 2006-06-22
US20170165248A1 (en) 2017-06-15
RS52472B (sr) 2013-02-28
BRPI0519186A2 (pt) 2008-12-30
JP2008525433A (ja) 2008-07-17
HRP20120719T1 (hr) 2012-10-31
US20130273168A1 (en) 2013-10-17
RU2397756C2 (ru) 2010-08-27
TWI478735B (zh) 2015-04-01
EP1830816B1 (fr) 2012-08-01

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