BRPI0621996B8 - preparação farmacêutica compreendendo um núcleo com um ingrediente ativo e com um ácido orgânico e/ou com o sal de um ácido orgânico, e um revestimento que envolve o núcleo e que compreende um ou mais copolímeros de (met)acrilato, e seu uso. - Google Patents

preparação farmacêutica compreendendo um núcleo com um ingrediente ativo e com um ácido orgânico e/ou com o sal de um ácido orgânico, e um revestimento que envolve o núcleo e que compreende um ou mais copolímeros de (met)acrilato, e seu uso.

Info

Publication number
BRPI0621996B8
BRPI0621996B8 BRPI0621996A BRPI0621996A BRPI0621996B8 BR PI0621996 B8 BRPI0621996 B8 BR PI0621996B8 BR PI0621996 A BRPI0621996 A BR PI0621996A BR PI0621996 A BRPI0621996 A BR PI0621996A BR PI0621996 B8 BRPI0621996 B8 BR PI0621996B8
Authority
BR
Brazil
Prior art keywords
core
organic acid
meth
active ingredient
acrylate
Prior art date
Application number
BRPI0621996A
Other languages
English (en)
Inventor
Petereit Hans-Ulrich
Ravishankar Hema
Bodinge Shraddha
Original Assignee
Evonik Roehm Gmbh
Roehm Gmbh
Evonik Degussa Gmbh
Evonik Operations 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, Roehm Gmbh, Evonik Degussa Gmbh, Evonik Operations Gmbh filed Critical Evonik Roehm Gmbh
Publication of BRPI0621996A2 publication Critical patent/BRPI0621996A2/pt
Publication of BRPI0621996B1 publication Critical patent/BRPI0621996B1/pt
Publication of BRPI0621996B8 publication Critical patent/BRPI0621996B8/pt

Links

Classifications

    • 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
    • A61K9/5073—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
    • 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
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/48—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

PREPARAÇÃO FARMACÊUTICA COM LIBERAÇÃO DE INGREDIENTE ATIVO CONTROLADA PARA INGREDIENTES ATIVOS COM BOA SOLUBILIDADE EM ÁGUA E USO DA MESMA. A presente invenção refere-se a uma preparação farmacêutica compreendendo a) um núcleo com um ingrediente ativo e com um ácido orgânico e/ou com o sal de um ácido orgânico; b) um revestimento que circunda o núcleo e que compreende teor de polímero composto de copolímeros de (met)acrilato tendo não mais do que 15% em peso de grupos catiônicos ou aniônicos, e que compreende pelo menos 60% em peso de um copolímero de (met)acrilato que é composto de unidades polimerizadas por radical livre a partir de 93 a 98% em peso de ésteres C1-C4-alquílicos de ácido acrilico ou metacrílico e a partir de 7 a 2% em peso de monômeros de (met)acrilato tendo um grupo amônio quaternário no radical alquila, caracterizada pelo fato de que a solubilidade em água do ingrediente ativo é pelo menos 10 g/l a 20ºC e o revestimento compreende partículas de diáxido de silício cujo tamanho de partícula médio está na faixa de 1 a 50 mm.
BRPI0621996A 2006-08-18 2006-09-21 preparação farmacêutica compreendendo um núcleo com um ingrediente ativo e com um ácido orgânico e/ou com o sal de um ácido orgânico, e um revestimento que envolve o núcleo e que compreende um ou mais copolímeros de (met)acrilato, e seu uso. BRPI0621996B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN1465/CHE/2006 2006-08-18
IN1465CH2006 2006-08-18
PCT/EP2006/066583 WO2008019712A1 (de) 2006-08-18 2006-09-21 Pharmazeutische zusammensetzung mit kontrollierter wirkstoffabgabe für wirkstoffe mit guter löslichkeit in wasser

Publications (3)

Publication Number Publication Date
BRPI0621996A2 BRPI0621996A2 (pt) 2011-12-27
BRPI0621996B1 BRPI0621996B1 (pt) 2020-07-14
BRPI0621996B8 true BRPI0621996B8 (pt) 2022-07-05

Family

ID=37872157

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0621996A BRPI0621996B8 (pt) 2006-08-18 2006-09-21 preparação farmacêutica compreendendo um núcleo com um ingrediente ativo e com um ácido orgânico e/ou com o sal de um ácido orgânico, e um revestimento que envolve o núcleo e que compreende um ou mais copolímeros de (met)acrilato, e seu uso.

Country Status (14)

Country Link
US (1) US8465769B2 (pt)
EP (1) EP2051704B1 (pt)
JP (1) JP5661281B2 (pt)
KR (2) KR101556797B1 (pt)
CN (1) CN101484147B (pt)
AT (1) ATE553754T1 (pt)
BR (1) BRPI0621996B8 (pt)
CA (1) CA2661561C (pt)
ES (1) ES2385498T3 (pt)
IL (1) IL195407A (pt)
MX (1) MX2009001597A (pt)
PL (1) PL2051704T3 (pt)
SI (1) SI2051704T1 (pt)
WO (1) WO2008019712A1 (pt)

Families Citing this family (28)

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DE102005007059A1 (de) * 2005-02-15 2006-08-24 Röhm GmbH & Co. KG Teilneutralisiertes anionisches (Meth)acrylat-Copolymer
DE102005032806A1 (de) * 2005-07-12 2007-01-18 Röhm Gmbh Verwendung eines teilneutralisierten, anionischen (Meth)acrylat-Copolymers als Überzug für die Herstellung einer Arzneiform mit einer Wirkstofffreisetzung bei erniedrigten pH-Werten
DE102006035549A1 (de) 2006-07-27 2008-01-31 Evonik Röhm Gmbh Arzneiform mit mindestens zweischichtiger Trennschicht
DE102007009243A1 (de) * 2007-02-22 2008-09-18 Evonik Röhm Gmbh Pellets mit einer Wirkstoff-Matrix und einem Polymerüberzug, sowie ein Verfahren zur Herstellung der Pellets
PT2152250T (pt) 2007-05-07 2019-12-12 Evonik Operations Gmbh Formas farmacêuticas sólidas que compreendem um revestimento entérico com libertação acelerada do fármaco
CA2711475A1 (en) * 2008-01-10 2009-07-16 Evonik Roehm Gmbh Coated pharmaceutical or nutraceutical preparation with accelerated controlled active substance release
ES2626078T3 (es) * 2008-01-10 2017-07-21 Evonik Röhm Gmbh Preparación farmacéutica o nutracéutica revestida con liberación de sustancia activa mejorada en el colon
US9011907B2 (en) * 2008-01-10 2015-04-21 Evonik Röhm Gmbh Coated pharmaceutical or nutraceutical preparation with enhanced pulsed active substance release
JP2011524353A (ja) * 2008-06-10 2011-09-01 テバ ファーマシューティカル インダストリーズ リミティド ラサギリン軟ゼラチンカプセル
EP2133072A1 (en) 2008-06-13 2009-12-16 KRKA, D.D., Novo Mesto Gastro-resistant pharmaceutical oral compositions comprising duloxetine or its pharmaceutically acceptable derivatives
CA2729015A1 (en) * 2008-06-26 2009-12-30 Mcneil-Ppc, Inc. Coated particles containing pharmaceutically active agents
EP2359814A1 (en) * 2010-02-11 2011-08-24 Laboratorios Liconsa, S.A. Pharmaceutical mini-tablets for sustained release of flecainide acetate
WO2012162492A1 (en) * 2011-05-24 2012-11-29 Teva Pharmaceutical Industries Ltd. Compressed core comprising organic acids for a pharmaceutical composition
HUE051406T2 (hu) 2012-11-14 2021-03-01 Grace W R & Co Biológiailag aktív anyagot és rendezetlen szervetlen oxidot tartalmazó kompozíciók
US9636305B2 (en) * 2013-03-14 2017-05-02 Redhill Biopharma Ltd. Antiemetic extended release solid dosage forms
CA2941829C (en) * 2014-03-11 2021-11-02 Redhill Biopharma Ltd Ondansetron extended release solid dosage forms for treating either nausea, vomiting or diarrhea symptoms
US9580896B2 (en) 2014-07-05 2017-02-28 John David Hopkins Apparatus and method for prolonged active agent in aqueous systems
US10799138B2 (en) 2018-04-05 2020-10-13 University Of Maryland, Baltimore Method of administering sotalol IV/switch
KR20210013088A (ko) 2018-05-24 2021-02-03 셀라니즈 이브이에이 퍼포먼스 폴리머스 엘엘씨 거대 분자 약물 화합물의 지속적인 방출을 위한 이식가능 장치
EP3803866A4 (en) 2018-05-24 2022-03-16 Nureva Inc. METHOD, APPARATUS, AND COMPUTER READABLE MATERIALS FOR MANAGING SEMI-CONSTANT (PERSISTENT) SOUND SOURCES IN MICROPHONE CATCH/HOME AREAS
KR20210013089A (ko) 2018-05-24 2021-02-03 셀라니즈 이브이에이 퍼포먼스 폴리머스 엘엘씨 거대 분자 약물 화합물의 지속적인 방출을 위한 이식가능 장치
US11696902B2 (en) 2018-08-14 2023-07-11 AltaThera Pharmaceuticals, LLC Method of initiating and escalating sotalol hydrochloride dosing
US12396970B2 (en) 2021-08-20 2025-08-26 AltaThera Pharmaceuticals LLC Anti-arrhythmic compositions and methods
US11344518B2 (en) 2018-08-14 2022-05-31 AltaThera Pharmaceuticals LLC Method of converting atrial fibrillation to normal sinus rhythm and loading oral sotalol in a shortened time frame
US10512620B1 (en) 2018-08-14 2019-12-24 AltaThera Pharmaceuticals, LLC Method of initiating and escalating sotalol hydrochloride dosing
US11610660B1 (en) 2021-08-20 2023-03-21 AltaThera Pharmaceuticals LLC Antiarrhythmic drug dosing methods, medical devices, and systems
EP3866962A4 (en) 2018-10-16 2021-11-24 Silicycle Inc. ADJUSTABLE PROCESS FOR MANUFACTURING SILICON DIOXIDE CAPSULES / BALLS AND THEIR USE
BR112023022439A2 (pt) 2021-04-26 2023-12-26 Celanese Eva Performance Polymers Llc Dispositivo implantável para liberação sustentada de um composto de fármaco macromolecular

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IE55745B1 (en) * 1983-04-06 1991-01-02 Elan Corp Plc Sustained absorption pharmaceutical composition
JPH0674206B2 (ja) * 1989-12-28 1994-09-21 田辺製薬株式会社 放出制御型製剤およびその製法
US5945124A (en) * 1995-07-05 1999-08-31 Byk Gulden Chemische Fabrik Gmbh Oral pharmaceutical composition with delayed release of active ingredient for pantoprazole
DE19845358A1 (de) 1998-10-02 2000-04-06 Roehm Gmbh Überzogene Arzneiformen mit kontrollierter Wirkstoffabgabe
WO2000040224A1 (en) * 1999-01-07 2000-07-13 Elan Corporation, Plc Multiparticulate oral dosage forms
US6368628B1 (en) * 2000-05-26 2002-04-09 Pharma Pass Llc Sustained release pharmaceutical composition free of food effect
DE10260919A1 (de) * 2002-12-20 2004-07-01 Röhm GmbH & Co. KG Verfahren zur Herstellung von überzogenen Arzneiformen und Nahrungsergänzungsmitteln mit Konzentrationsgradienten im Überzug
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DE102004035938A1 (de) * 2004-07-23 2006-02-16 Röhm GmbH & Co. KG Verfahren zur Herstellung von überzogenen Arzneiformen mit stabilem Wirkstofffreigabeprofil
TW200626185A (en) * 2004-12-17 2006-08-01 Bpsi Holdings Inc Enteric film coating composition containing entericpolymer micronized with detackifier
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Also Published As

Publication number Publication date
KR101556797B1 (ko) 2015-10-01
BRPI0621996B1 (pt) 2020-07-14
EP2051704A1 (de) 2009-04-29
SI2051704T1 (sl) 2012-08-31
ATE553754T1 (de) 2012-05-15
CN101484147A (zh) 2009-07-15
ES2385498T3 (es) 2012-07-25
CN101484147B (zh) 2015-07-08
KR20140019038A (ko) 2014-02-13
WO2008019712A1 (de) 2008-02-21
MX2009001597A (es) 2009-02-23
IL195407A0 (en) 2009-08-03
BRPI0621996A2 (pt) 2011-12-27
CA2661561A1 (en) 2008-02-21
EP2051704B1 (de) 2012-04-18
IL195407A (en) 2013-05-30
CA2661561C (en) 2013-12-24
JP2010501015A (ja) 2010-01-14
US8465769B2 (en) 2013-06-18
US20080044470A1 (en) 2008-02-21
JP5661281B2 (ja) 2015-01-28
KR20090042922A (ko) 2009-05-04
PL2051704T3 (pl) 2012-09-28

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 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: 10 (DEZ) ANOS CONTADOS A PARTIR DE 14/07/2020, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/09/2006 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

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

Free format text: REFERENTE A 19A ANUIDADE.

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 2846 DE 22-07-2025 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.