BR112013028453A2 - composição de revestimento adequada para formas de dosagem farmacêuticas ou nutracêuticas - Google Patents

composição de revestimento adequada para formas de dosagem farmacêuticas ou nutracêuticas

Info

Publication number
BR112013028453A2
BR112013028453A2 BR112013028453A BR112013028453A BR112013028453A2 BR 112013028453 A2 BR112013028453 A2 BR 112013028453A2 BR 112013028453 A BR112013028453 A BR 112013028453A BR 112013028453 A BR112013028453 A BR 112013028453A BR 112013028453 A2 BR112013028453 A2 BR 112013028453A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical
coating composition
core
composition suitable
dosage forms
Prior art date
Application number
BR112013028453A
Other languages
English (en)
Other versions
BR112013028453B8 (pt
BR112013028453B1 (pt
Inventor
Christian Meier
Florian Hermes
Jan Hendrik Schattka
Original Assignee
Evonik Roehm Gmbh
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
Application filed by Evonik Roehm Gmbh filed Critical Evonik Roehm Gmbh
Publication of BR112013028453A2 publication Critical patent/BR112013028453A2/pt
Publication of BR112013028453B1 publication Critical patent/BR112013028453B1/pt
Publication of BR112013028453B8 publication Critical patent/BR112013028453B8/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5089Processes
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08FMACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
    • C08F2/00Processes of polymerisation
    • C08F2/12Polymerisation in non-solvents
    • C08F2/16Aqueous medium
    • C08F2/22Emulsion polymerisation
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08FMACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
    • C08F220/00Copolymers 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
    • C08F220/02Monocarboxylic acids having less than ten carbon atoms; Derivatives thereof
    • C08F220/10Esters
    • C08F220/12Esters of monohydric alcohols or phenols
    • C08F220/16Esters of monohydric alcohols or phenols of phenols or of alcohols containing two or more carbon atoms
    • C08F220/18Esters of monohydric alcohols or phenols of phenols or of alcohols containing two or more carbon atoms with acrylic or methacrylic acids
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08FMACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
    • C08F265/00Macromolecular compounds obtained by polymerising monomers on to polymers of unsaturated monocarboxylic acids or derivatives thereof as defined in group C08F20/00
    • C08F265/04Macromolecular 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
    • C08F265/06Polymerisation of acrylate or methacrylate esters on to polymers thereof
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2207/00Properties characterising the ingredient of the composition
    • C08L2207/53Core-shell polymer

Landscapes

  • 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)

Abstract

resumo patente de invenção: "composição de revestimento adequada para formas de dosagem farmacêuticas ou nutracêuticas". a presente invenção refere-se a uma composição de revestimento adequada para o revestimento da forma de dosagem farmacêutica ou nutracêutica, que compreende um núcleo que compreende um ou mais ingredientes ativos farmacêuticos ou nutracêuticos, em que a composição de revestimento é composta por, pelo menos, 20% em peso de uma composição do polímero do núcleo/invólucro entérico derivada a partir de um processo de polimerização em emulsão, em que o núcleo da composição do polímero do núcleo/invólucro é formado por um copolímero ou um polímero reticulado, insolúvel em água e o invólucro da composição do polímero do núcleo/invólucro é formado por meio de um polímero ou copolímero aniônico.
BR112013028453A 2011-06-17 2011-06-17 Uso de uma composição de revestimento, formas de dosagem farmacêuticas ou nutracêuticas gastrorresistentes, e composição do polímero do núcleo/invólucro BR112013028453B8 (pt)

Applications Claiming Priority (1)

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

Publications (3)

Publication Number Publication Date
BR112013028453A2 true BR112013028453A2 (pt) 2017-01-24
BR112013028453B1 BR112013028453B1 (pt) 2021-10-19
BR112013028453B8 BR112013028453B8 (pt) 2022-07-05

Family

ID=44627081

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013028453A BR112013028453B8 (pt) 2011-06-17 2011-06-17 Uso de uma composição de revestimento, formas de dosagem farmacêuticas ou nutracêuticas gastrorresistentes, e composição do polímero do núcleo/invólucro

Country Status (16)

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

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US9775815B2 (en) * 2011-06-17 2017-10-03 Evonik Roehm Gmbh Gastric resistant pharmaceutical or nutraceutical composition with resistance against the influence of ethanol
CN105943519A (zh) * 2016-06-22 2016-09-21 福建省微生物研究所 一种苯磺贝他斯汀掩味颗粒
KR102408027B1 (ko) * 2016-08-15 2022-06-15 에보니크 오퍼레이션즈 게엠베하 증진된 탈유화성 성능을 갖는 관능성 폴리알킬 (메트)아크릴레이트
EP3709979A1 (en) 2017-11-17 2020-09-23 Evonik Operations GmbH Process for preparing a coated hard shell capsule
JP2021524840A (ja) 2018-05-24 2021-09-16 セラニーズ・イーブイエイ・パフォーマンス・ポリマーズ・エルエルシー 高分子薬剤化合物の持続放出用の埋め込み型デバイス
SG11202005947RA (en) 2018-05-24 2020-07-29 Celanese Eva Performance Polymers Corp Implantable device for sustained release of a macromolecular drug compound
CN109232795A (zh) * 2018-09-21 2019-01-18 佛山市森昂生物科技有限公司 一种防水型高韧性包衣材料的制备方法
WO2020221522A1 (en) 2019-04-30 2020-11-05 Evonik Operations Gmbh Pellet and multi-unit pellet system (mups)
US20220241155A1 (en) * 2019-05-15 2022-08-04 Evonik Operations Gmbh Process for preparing filled hard-shell capsules with cellulose or starch-based coatings with a capsule-filling machine
IL308701A (en) 2021-05-25 2024-01-01 Evonik Operations Gmbh Hard shell capsules with modified release coating
IL308707A (en) 2021-05-25 2024-01-01 Evonik Operations Gmbh Capsule with a hard shell with prevention of the flow of gastric fluids
EP4176874A1 (en) 2021-11-09 2023-05-10 Evonik Operations GmbH Pharmaceutical or nutraceutical composition with an alcohol resistant single layer coating system
WO2023174722A1 (en) 2022-03-15 2023-09-21 Evonik Operations Gmbh Pre-functionalized hard shell capsule with accelerated drug release at ph value 5 to 5.5
WO2023214016A1 (en) 2022-05-06 2023-11-09 Evonik Operations Gmbh Dosage form with drug release at ph 3 to 6 using double coating system with at least one release acceleration agent

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Also Published As

Publication number Publication date
JP2014517018A (ja) 2014-07-17
RU2014101228A (ru) 2015-07-27
ES2617402T3 (es) 2017-06-19
MX353426B (es) 2018-01-12
KR101799625B1 (ko) 2017-11-20
JP5832645B2 (ja) 2015-12-16
CA2839494C (en) 2018-11-06
PL2720681T3 (pl) 2017-05-31
HUE033117T2 (en) 2017-11-28
SI2720681T1 (sl) 2017-03-31
US20140079792A1 (en) 2014-03-20
BR112013028453B8 (pt) 2022-07-05
KR20140041545A (ko) 2014-04-04
IL228397A (en) 2017-07-31
EP2720681A1 (en) 2014-04-23
RU2599023C2 (ru) 2016-10-10
US9668977B2 (en) 2017-06-06
IL228397A0 (en) 2013-12-31
AU2011370763A1 (en) 2013-10-03
EP2720681B1 (en) 2016-11-23
CN103501767A (zh) 2014-01-08
CA2839494A1 (en) 2012-12-20
MX2013014143A (es) 2014-01-23
WO2012171576A1 (en) 2012-12-20
BR112013028453B1 (pt) 2021-10-19

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Legal Events

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 17/06/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO.

B25D Requested change of name of applicant approved

Owner name: ROEHM GMBH (DE)

B25G Requested change of headquarter approved

Owner name: ROEHM GMBH (DE)

B25A Requested transfer of rights approved

Owner name: EVONIK DEGUSSA GMBH (DE)

B25D Requested change of name of applicant approved

Owner name: EVONIK OPERATIONS GMBH (DE)

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

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B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2779 DE 09-04-2024 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.