BRPI0722042B8 - composição farmacêutica de liberação controlada dependente do ph, e seu processo de preparação - Google Patents

composição farmacêutica de liberação controlada dependente do ph, e seu processo de preparação

Info

Publication number
BRPI0722042B8
BRPI0722042B8 BRPI0722042A BRPI0722042A BRPI0722042B8 BR PI0722042 B8 BRPI0722042 B8 BR PI0722042B8 BR PI0722042 A BRPI0722042 A BR PI0722042A BR PI0722042 A BRPI0722042 A BR PI0722042A BR PI0722042 B8 BRPI0722042 B8 BR PI0722042B8
Authority
BR
Brazil
Prior art keywords
weight
controlled release
pharmaceutical composition
dependent controlled
release pharmaceutical
Prior art date
Application number
BRPI0722042A
Other languages
English (en)
Inventor
Petereit Hans-Ulrich
Ravishankar Hema
Samel Ashwini
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 BRPI0722042A2 publication Critical patent/BRPI0722042A2/pt
Publication of BRPI0722042B1 publication Critical patent/BRPI0722042B1/pt
Publication of BRPI0722042B8 publication Critical patent/BRPI0722042B8/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
    • A61K9/48—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
    • A61K9/501—Inorganic compounds
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/06—Antiarrhythmics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

COMPOSIÇÃO FARMACÊUTICA DE LIBERAÇÃO CONTROLADA DEPENDENTE DO PH PARA NÃO-OPIOIDES COM RESISTÊNCIA CONTRA A INFLUÊNCIA DO ETANOL. A presente invenção refere-se a uma composição farmacêutica de liberação controlada dependente do pH, compreendendo pelo menos um ingrediente ativo farmacêutico, com a exceção dos opioides, em que o núcleo é revestido ao menos por uma camada de revestimento, controlando a liberação da composição farmacêutica, em que a camada de revestimento compreende uma mistura polimérica de i) 40 a 95% em peso, com base no peso seco da mistura polimérica, de pelo menos um polímero ou copolímero de vinila essencialmente neutro, isolúvel em água, e ii) 5 a 60% em peso, com base no peso da mistura polimérica, de pelo menos um polímeroou copolímero aniônico, o qual é insolúvel em um meio tamponado abaixo de pH 4,0 e solúvel pelo menos na faixa de pH 7,0 a pH 8,0, caracterizada pelo fato de que a camada de revestimento adicionalmente contém 110 a 250% em peso, calculados sobre o peso seco da mistura polimérica, de um lubrificante inerte não-poroso e está presente em uma quantidade de pelo menos 60% em que calculada sobre o peso do núcleo.
BRPI0722042A 2007-09-21 2007-09-25 composição farmacêutica de liberação controlada dependente do ph, e seu processo de preparação BRPI0722042B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN2136/CHE/2007 2007-09-21
IN2136CH2007 2007-09-21
PCT/EP2007/060130 WO2009036811A1 (en) 2007-09-21 2007-09-25 Ph-dependent controlled release pharmaceutical composition for non-opioids with resistance against the influence of ethanol

Publications (3)

Publication Number Publication Date
BRPI0722042A2 BRPI0722042A2 (pt) 2014-03-25
BRPI0722042B1 BRPI0722042B1 (pt) 2019-12-10
BRPI0722042B8 true BRPI0722042B8 (pt) 2022-07-05

Family

ID=39278276

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0722042A BRPI0722042B8 (pt) 2007-09-21 2007-09-25 composição farmacêutica de liberação controlada dependente do ph, e seu processo de preparação

Country Status (13)

Country Link
US (1) US9555006B2 (pt)
EP (1) EP2187875B1 (pt)
JP (1) JP5204846B2 (pt)
KR (1) KR101454056B1 (pt)
CN (1) CN101801356B (pt)
BR (1) BRPI0722042B8 (pt)
CA (1) CA2699224C (pt)
ES (1) ES2393805T3 (pt)
IL (1) IL203870A (pt)
MX (1) MX2010003036A (pt)
PL (1) PL2187875T3 (pt)
SI (1) SI2187875T1 (pt)
WO (1) WO2009036811A1 (pt)

Families Citing this family (26)

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CA2923102C (en) 2007-08-13 2019-10-15 Omeho Life Sciences Inc. Abuse resistant drugs, method of use and method of making
JP5453434B2 (ja) 2008-09-24 2014-03-26 エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング エタノールの影響に対する耐性を有するオピオイドではないｐＨ依存の制御放出の医薬組成物
US9757343B2 (en) * 2008-09-24 2017-09-12 Evonik Röhm Gmbh PH-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol
WO2010057870A1 (en) * 2008-11-18 2010-05-27 Ucb Pharma, S.A. Prolonged release formulations comprising an 2 -oxo- 1 -pyrrolidine derivative
AU2009317279B2 (en) * 2008-11-18 2013-10-24 Ucb Pharma, S.A. Prolonged release formulations comprising an 2-oxo-1-pyrrolidine derivate
US9730899B2 (en) 2009-03-18 2017-08-15 Evonik Roehm Gmbh Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising neutral vinyl polymers and excipients
AU2010325960C1 (en) 2009-12-02 2015-08-06 Adamas Pharma, Llc Amantadine compositions and methods of use
US9877925B2 (en) 2010-05-14 2018-01-30 Ethypharm Alcohol-resistant oral pharmaceutical form
US20130059010A1 (en) * 2010-05-14 2013-03-07 Ethypharm Alcohol-resistant oral pharmaceutical form
CN103501768B (zh) * 2011-06-17 2016-11-09 赢创罗姆有限公司 具有抗乙醇影响抗性的抗胃酸的药物或营养组合物
MX353427B (es) 2011-06-17 2018-01-12 Evonik Roehm Gmbh Composicion de recubrimiento adecuada para formas de dosis farmaceuticas o nutraceuticas.
JP5832645B2 (ja) * 2011-06-17 2015-12-16 エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツングＥｖｏｎｉｋ Ｒｏｅｈｍ ＧｍｂＨ 医薬剤形又は栄養補助剤形に適したコーティング組成物
BR112015018895A2 (pt) * 2013-02-13 2017-07-18 Evonik Roehm Gmbh composição farmacêutica multiparticulada compreendendo uma multiplicidade de dois tipos de pelotas
WO2014146093A2 (en) 2013-03-15 2014-09-18 Inspirion Delivery Technologies, Llc Abuse deterrent compositions and methods of use
US10154971B2 (en) 2013-06-17 2018-12-18 Adamas Pharma, Llc Methods of administering amantadine
US20150352140A1 (en) * 2014-06-07 2015-12-10 Api Intellectual Property Holdings, Llc Biomass-based dietary supplement
US10729685B2 (en) 2014-09-15 2020-08-04 Ohemo Life Sciences Inc. Orally administrable compositions and methods of deterring abuse by intranasal administration
CN105769823A (zh) * 2014-12-24 2016-07-20 上海星泰医药科技有限公司 一种左旋盐酸米那普仑缓释胶囊及其制备方法
US20170042806A1 (en) 2015-04-29 2017-02-16 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
KR20200057019A (ko) 2017-09-14 2020-05-25 에보닉 오퍼레이션스 게엠베하 서방성 및 에탄올의 영향에 대한 내성을 갖는 중합체 및 투여 형태
EP3485879A1 (en) * 2017-11-17 2019-05-22 Maat Pharma Pharmaceutical oral formulation comrpsing bacteria
JP2021515778A (ja) 2018-03-09 2021-06-24 エボニック オペレーションズ ゲーエムベーハー エタノールの影響に対する耐性を有するポリマー混合物
WO2021252951A1 (en) 2020-06-12 2021-12-16 Vanderbilt University Methods of treatment for gastrointestinal motility disorders
US20260027062A1 (en) * 2022-03-03 2026-01-29 Cyprumed Gmbh Improved oral pharmaceutical formulations of therapeutic peptides and proteins
JP2025536556A (ja) 2022-10-25 2025-11-07 ヴェラダーミクス インコーポレイテッド 放出調節ミノキシジル用組成物および使用方法

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JPH08143476A (ja) * 1994-11-18 1996-06-04 Japan Tobacco Inc 薬物放出制御膜及び固形製剤
FR2759293B1 (fr) * 1997-02-11 1999-04-30 Ethypharm Lab Prod Ethiques Microgranules contenant du cisplatine, procede de fabrication, preparation pharmaceutique et utilisation en polychimiotherapie ou en association avec une radiotherapie
US7374779B2 (en) * 1999-02-26 2008-05-20 Lipocine, Inc. Pharmaceutical formulations and systems for improved absorption and multistage release of active agents
CA2459976A1 (en) * 2001-09-26 2003-04-03 Penwest Pharmaceuticals Company Opioid formulations having reduced potential for abuse
DE10211289A1 (de) * 2002-03-14 2003-09-25 Basf Ag Kombination von Polyvinylacetat von wasserunlöslichen, säureunlöslichen oder alkaliunlöslichen Polymeren zur Hestellung von Filmüberzügen mit sehr kontrollierter Freisetzung und hoher Stabilität
CA2481091A1 (en) * 2002-04-05 2003-10-23 Penwest Pharmaceuticals Co. Sustained release metoprolol formulations
CA2543689A1 (en) * 2003-10-31 2005-05-12 Hexal Ag Pharmaceutical actve-ingredient-containing formulation with coating
WO2006079550A2 (en) * 2005-01-28 2006-08-03 Euro-Celtique S.A. Alcohol resistant dosage forms
DE102005024614A1 (de) * 2005-05-25 2006-11-30 Röhm Gmbh Verwendung von Polymermischungen zur Herstellung von überzogenen Arzneiformen sowie Arzneiform mit polymerem Mischüberzug

Also Published As

Publication number Publication date
CA2699224C (en) 2014-12-16
PL2187875T3 (pl) 2013-01-31
CN101801356A (zh) 2010-08-11
KR101454056B1 (ko) 2014-10-27
ES2393805T3 (es) 2012-12-28
WO2009036811A1 (en) 2009-03-26
SI2187875T1 (sl) 2012-12-31
IL203870A (en) 2015-02-26
CN101801356B (zh) 2016-10-19
CA2699224A1 (en) 2009-03-26
MX2010003036A (es) 2010-04-09
US9555006B2 (en) 2017-01-31
KR20100063067A (ko) 2010-06-10
EP2187875B1 (en) 2012-09-05
US20100221324A1 (en) 2010-09-02
EP2187875A1 (en) 2010-05-26
JP2010539196A (ja) 2010-12-16
BRPI0722042B1 (pt) 2019-12-10
BRPI0722042A2 (pt) 2014-03-25
JP5204846B2 (ja) 2013-06-05

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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]

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

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 10/12/2019, OBSERVADAS AS CONDICOES LEGAIS. (CO) 10 (DEZ) ANOS CONTADOS A PARTIR DE 10/12/2019, 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 25/09/2007 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

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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 2741 DE 18-07-2023 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.