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1. WO2007090721 - PHARMACEUTICAL COMPOSITIONS CONTAINING MIXTURES OF POLYMERS AND ACTIVE AGENTS POORLY SOLUBLE IN WATER

Publication Number WO/2007/090721
Publication Date 16.08.2007
International Application No. PCT/EP2007/050465
International Filing Date 17.01.2007
IPC
A61K 9/16 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
16Agglomerates; Granulates; Microbeadlets
A61K 9/20 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, lozenges or tablets
A61K 9/50 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
50Microcapsules
CPC
A61K 9/1635
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605Excipients; Inactive ingredients
1629Organic macromolecular compounds
1635obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
A61K 9/1652
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605Excipients; Inactive ingredients
1629Organic macromolecular compounds
1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
A61K 9/2027
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2004Excipients; Inactive ingredients
2022Organic macromolecular compounds
2027obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
A61K 9/2054
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2004Excipients; Inactive ingredients
2022Organic macromolecular compounds
205Polysaccharides, e.g. alginate, gums; Cyclodextrin
2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
A61K 9/2077
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2072characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
A61K 9/5084
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
50Microcapsules ; 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
5084Mixtures 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
Applicants
  • EVONIK RÖHM GMBH [DE]/[DE] (AllExceptUS)
  • MEIER, Christian [DE]/[DE] (UsOnly)
  • NOLLENBERGER, Kathrin [DE]/[DE] (UsOnly)
  • GRYCZKE, Andreas [DE]/[DE] (UsOnly)
  • PETEREIT, Hans-Ulrich [DE]/[DE] (UsOnly)
  • DRESSMAN, Jennifer [AU]/[DE] (UsOnly)
Inventors
  • MEIER, Christian
  • NOLLENBERGER, Kathrin
  • GRYCZKE, Andreas
  • PETEREIT, Hans-Ulrich
  • DRESSMAN, Jennifer
Priority Data
10 2006 005 485.703.02.2006DE
Publication Language German (DE)
Filing Language German (DE)
Designated States
Title
(DE) PHARMAZEUTISCHE ZUSAMMENSETZUNGEN, ENTHALTEND MISCHUNGEN AUS POLYMEREN UND IN WASSER SCHLECHT LÖSLICHEN WIRKSTOFFEN
(EN) PHARMACEUTICAL COMPOSITIONS CONTAINING MIXTURES OF POLYMERS AND ACTIVE AGENTS POORLY SOLUBLE IN WATER
(FR) COMPOSITIONS PHARMACEUTIQUES CONTENANT DES MÉLANGES DE POLYMÈRES ET D'AGENTS ACTIFS PEU SOLUBLES DANS L'EAU
Abstract
(DE)
Die Erfindung betrifft eine pharmazeutische Zusammensetzung, enthaltend eine Mischung aus zumindest einem kationischen, wasserlöslichen (Meth)acrylatcopolymer, zumindest einem wasserunlöslichen Polymer und zumindest einem Wirkstoff mit einer Löslichkeit in entmineralisiertem Wasser von 3,3 g/l oder weniger, dadurch gekennzeichnet, dass das wasserunlösliche Polymer und der Wirkstoff in einem Verhältnis von höchstens 3,5 zu 1 Gewichtsteilen vorliegen, und die pharmazeutische Zusammensetzung die Eigenschaft aufweist, den enthaltenen Wirkstoff in einem auf pH 1,2 gepufferten Medium in gelöster Form in einer Konzentration freizusetzen, die nach 2 Stunden bei pH 1,2 mindestens dem sechzehnfachen Löslichkeitswert des Wirkstoffs allein bei pH 1,2 entspricht.
(EN)
The invention relates to a pharmaceutical composition, containing a mixture of at least one cationic water-soluble (meth)acrylate copolymer, at least one water-insoluble polymer and at least one active agent with a solubility in demineralised water of 3,3 g/l or less, characterised in that the water-insoluble polymer and the active agent are present in a ratio of at most 3.5 to 1 parts by weight and the pharmaceutical composition has the following properties: the contained active agent is released in dissolved form in a medium buffered at pH 1.2, which, after 2 hours at pH 1.2, corresponds to at least 16 times the solubility value of the active agent alone at pH 1.2.
(FR)
L'invention concerne une composition pharmaceutique contenant un mélange d'au moins un copolymère de (méth)acrylate cationique, soluble dans l'eau, d'au moins un polymère insoluble dans l'eau, et d'au moins un agent actif présentant une solubilité dans l'eau déminéralisée de 3,3 g/l ou moins. La composition selon l'invention est caractérisée en ce que le polymère insoluble dans l'eau et l'agent actif sont présents dans un rapport de max. 3,5 sur 1 parts en poids, et en ce que ladite composition présente la propriété de libérer l'agent actif qu'elle contient dans un milieu tamponné à un pH de 1,2 sous forme dissoute, dans une concentration correspondant au moins à 16 fois l'indice de solubilité de l'agent actif seul à un pH de 1,2, après 2 heures à un pH de 1,2.
Latest bibliographic data on file with the International Bureau