HUE033117T2 - Gyógyászati vagy gyógyhatású élelmiszer dózisforma bevonására alkalmas bevonat kompozíció - Google Patents

Gyógyászati vagy gyógyhatású élelmiszer dózisforma bevonására alkalmas bevonat kompozíció Download PDF

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HUE033117T2
HUE033117T2 HUE11725757A HUE11725757A HUE033117T2 HU E033117 T2 HUE033117 T2 HU E033117T2 HU E11725757 A HUE11725757 A HU E11725757A HU E11725757 A HUE11725757 A HU E11725757A HU E033117 T2 HUE033117 T2 HU E033117T2
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core
weight
ahol ahol
pharmaceutical
polymer
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HUE11725757A
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Jan Hendrik Schattka
Christian Meier
Florian Hermes
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Evonik Roehm Gmbh
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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
    • 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
    • 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
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/5089—Processes
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
    • C08F2/00—Processes of polymerisation
    • C08F2/12—Polymerisation in non-solvents
    • C08F2/16—Aqueous medium
    • C08F2/22—Emulsion polymerisation
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
    • C08F220/00—Copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and only one being terminated by only one carboxyl radical or a salt, anhydride ester, amide, imide or nitrile thereof
    • C08F220/02—Monocarboxylic acids having less than ten carbon atoms; Derivatives thereof
    • C08F220/10—Esters
    • C08F220/12—Esters of monohydric alcohols or phenols
    • C08F220/16—Esters of monohydric alcohols or phenols of phenols or of alcohols containing two or more carbon atoms
    • C08F220/18—Esters of monohydric alcohols or phenols of phenols or of alcohols containing two or more carbon atoms with acrylic or methacrylic acids
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
    • C08F265/00—Macromolecular compounds obtained by polymerising monomers on to polymers of unsaturated monocarboxylic acids or derivatives thereof as defined in group C08F20/00
    • C08F265/04—Macromolecular compounds obtained by polymerising monomers on to polymers of unsaturated monocarboxylic acids or derivatives thereof as defined in group C08F20/00 on to polymers of esters
    • C08F265/06—Polymerisation of acrylate or methacrylate esters on to polymers thereof
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2207/00—Properties characterising the ingredient of the composition
    • C08L2207/53—Core-shell polymer

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (3)

  1. tó fglpÿ göptplg
    1. MM* ipoypgni aæmtti gyógyászati vagy gyôgyhab&amp;ô élefcmsæer d&amp;dsîorm* hevomisâra alkalmas bevonat óból ix hevonst kompod!#· iiplábbolS. .tömegé bllfeso o^böó> smokies pvhmarizlgiós eljárásból sgárópgó roagfoéj pofimat: totpbæfëlât tartalmibb sihöt a :««tfdiéj polimer hmmozidö magját egy vízben nem «kiható, térhálósított poísimn seg> kopokmet alkotja és a mag/héi fblmjefköptpöiföió ls^:t:égÿt®lftÂs pohosét vagy kopohmer alkotja, J; >; a/ osont« ooomot xnpv \'>p' oe\i s non uks óéi knpnkmereh vng> pont ín« pohmmk u*g> kopolí merek kövéből vftiass?.tott és ahol a.t anionom imei>akrilái kopölttiéb Ä- aÄbt psllmetfeilb egységeket tamlnvmza:: 10-40 tömegé nkni- vagy th#t»knlsay 10-50 tômeg% etil&amp;kritát 10-80 töroegH akrik vagy atsvtkniaav 4-iE szenatomsaamö aJkH-ésstere és adó« esel boa 0-20 tömeg·· o nsehbntet&amp;k.nkg mgya® alábbi psfceti-MH egységekéi' ÍPi0 timl^üétakrH^v és 00-40 tömegé etiláiilf|||^§|^eí|?t#t^|gék::^^s ÍO törne sfö metil-metakfilát és tO tőmeg% metakrifsav polimerizál} egységek vagy ó ό o t ,g* ' * «χ\>\Η t ς< "0 o«m ati ist e\ N I *> römeg% metakrüsav polimeriíáIs. egységek 2. A/. I. igénypont szemű bevonat kompozíció, amely legföljebb 80 tömeg% gyógyászati vagy gyógyhatású élelmiszer sgféáanysfot tartalmaz amíoxidápsóks tlnye^ószarékg iÂôspyàgob, ixesftôsxmk, ömlesziési segédanyagok, iíUttany&amp;gpk, esúszialőbbérák^ behmolási segítő szemig fetékaoyagpk, lágy készetek, nem térhálósított polimerek. póreskópzö saeffk vagy sínbslizálészérek bőréből választva. 1 öv : >agv 2 igmnpom verntí hmm«« konpwscm, nmek vsiáot Óvóban uts mbm em> wts ihszpemöban, l-óh mmeg** szárazanyag tartalommal •4. Az I -3. igénypontok közöl egy vagy több szerkói bevonat kompozíció, amely száraz por vagy guoasklnan tormában van jelen. I, Ait M, igény pontok közül egy vagy·' több szeri«« bevonat kompozíció, ahol a stábén oldhatatlan polimer vagy kopni nner (meí)akrilát pohnarek vagy kopollmerok vagy poilvinil polimerek vagy kopolimerek bőréből választott. :&amp;·.Λζ 14 igény pontok közül egy vagy több szerinti bevonat kompozíció, ahol a· bevonat kompeeteid <-gy vagy több gyógyászait vagy gyógyhatású élelmiszer hntó&amp;ny »got tartalmaz.
  2. 7, Ciyomomeds efewd'o xegs gxôgynaiôxy x chr v?t <k\t '> *m&amp;, x» "U> fetx* \ ya eg\ v<sc\ több g\ ög> ^szao caps k>óg>h,et*v e'efenx/m 'mayt-mapm turhúrm.Y magot ex eg> g>onmrnedv«eílenátló bevonoréteget &amp; magon, »hoi a gyomornmhMíík'mtlló feevooóréteg egy bevonó :é|#l$h«d aikalmazzhfc #|yísevuoatIófe|mzfeió dlkahne/ásávak ameh legalább 20 femeg% bélben ολ>ο ("ftibfes rt*1 ví7í\kV x'-arä'xbo ^oúv\u mm Hj μ*Φο>ογ kompozíciódattein*x? ahol , mag&amp;éj polimer kompozíció mag|át egy vigbsis ?s«m oilhsté, térfeÂÉett kogoimer alkotja ev a mag bős polimer hmrtfm ouo h&amp;M egy tmones polimer \»μ> kopoúmm alkotja gi&amp; ,7c :i§Éáypotti s2e^»Í:;.poma*^^Ífe^iÍá::gyágyászaa vagy gyógyhatású élelmiszer dózisforms* ilol a gyógyászati vagy gyógyhatásó élelmiszer hatóanyag felszabadulása legfeljebb Ki % m vHm löriihrfeoyek közöd, 1,2 pH erőkén 2 ó«a cítvítéu'l egy közegben. ez 1 »S \ G>og>»zerkon>\ alaptan, 20 %-os (v/v) etanol hozzáadásával vagy aitélkúl 9. \ ’ \ag'·· é x'Mxpxxat noüSi i.xem»me<K ellenálló gyógyászért vagx ítyogybaiáMi e\hne--,e? dózisí«rmsí, ahol a gyógyászati vagy gyógyhatású éfehmsser batoanyagdélszebadulása lfpt;í|bb lő % m ' t«‘ kor, ,íik nek között o 0 sagy '2 Ή et teke5 a ' pesc után egy puffe? eb közegben ,'Z l'$A Cs> ógy.szerhöny v alapján.. íöv Egyi Ij. yggy : S, Igénypont szerbit;: items«; iompziii#: alMmazása egy gyógyászati vagy; gyúgyhatte élelmiszer dömfoona magjának lse vonására, ahol a mag gxoes útzárt x ,m> gyógyhatású éielmts/er hatóanyagot tartalmaz, ahol a kapott bevont mag a gyógyászati vagy gyógybsl:á|n;: élelmiszer hatóanyag legfeljebb 10 %-os felszabadölá'tát mutatja «« vitro körülményei kÄÜ* 1; J ρϊϊ x'ttx'ko' 2 óm xHvlh Xxl o Nx.>ix\n ο χ te fen^s x'rfe ro\ alafh 2d '«· os yv/v) etanol hozzáadásával vagy estéik ül ÎL Egy i. vagy 6, igénypont szét inti bvvon»ltóittp#Ító^álMl.^^sá2kóí5^>-agként:t#gyógyásmÍ« vagy gyógyhatású élelmiszer hatóanyag megkötésére egy gyój^ászati vagy gyógyhatású élelmiszer dózsstóí: m|: bevoäfeÄeu yi|y mng| ában.
  3. 12, Az L és/vagy ó. tglttfpsUzetinii meg/héj polmfer kompozíció alkalmazási;böyönatkéitt vú^y Äoany ágként xm.y gyógyászstí vagy gy ógyhatású éfeimtvze? óözísíomtáhan, 13, A 12. Igénypont szerinti rnag/héj polimet kompozCeió, ahol a mag tósnege a teljes kompozíció IÖ« fel % -a.
HUE11725757A 2011-06-17 2011-06-17 Gyógyászati vagy gyógyhatású élelmiszer dózisforma bevonására alkalmas bevonat kompozíció HUE033117T2 (hu)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP11725757.6A EP2720681B1 (en) 2011-06-17 2011-06-17 Coating composition suitable for pharmaceutical or nutraceutical dosage forms
PCT/EP2011/060097 WO2012171576A1 (en) 2011-06-17 2011-06-17 Coating composition suitable for pharmaceutical or nutraceutical dosage forms

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US (1) US9668977B2 (hu)
EP (1) EP2720681B1 (hu)
JP (1) JP5832645B2 (hu)
KR (1) KR101799625B1 (hu)
CN (1) CN103501767A (hu)
AU (1) AU2011370763A1 (hu)
BR (1) BR112013028453B8 (hu)
CA (1) CA2839494C (hu)
ES (1) ES2617402T3 (hu)
HU (1) HUE033117T2 (hu)
IL (1) IL228397A (hu)
MX (1) MX353426B (hu)
PL (1) PL2720681T3 (hu)
RU (1) RU2599023C2 (hu)
SI (1) SI2720681T1 (hu)
WO (1) WO2012171576A1 (hu)

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