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
IN2136CH2007 2007-09-21
IN2136/CHE/2007 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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2008286914B2 (en) 2007-08-13 2014-10-02 Ohemo Life Sciences Inc. Abuse resistant drugs, method of use and method of making
CA2738197C (en) 2008-09-24 2016-01-05 Evonik Operations Gmbh Ph-dependent controlled release pharmaceutical composition for non-opioids with resistance against the influence of ethanol
WO2010034342A1 (en) * 2008-09-24 2010-04-01 Evonik Röhm Gmbh Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol
EP2358360B1 (en) 2008-11-18 2016-09-14 UCB Biopharma SPRL Prolonged release formulations comprising an 2-oxo-1-pyrrolidine derivative
CA2741038C (en) * 2008-11-18 2015-01-13 Ucb Pharma S.A. Prolonged release formulations comprising an 2-oxo-1-pyrrolidine derivate
CA2755808C (en) 2009-03-18 2016-01-19 Evonik Operations Gmbh Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising neutral vinyl polymers and excipients
CA2994873A1 (en) 2009-12-02 2011-06-09 Adamas Pharma, Llc Amantadine compositions and methods of use
US9877925B2 (en) 2010-05-14 2018-01-30 Ethypharm Alcohol-resistant oral pharmaceutical form
FR2959935B1 (fr) * 2010-05-14 2013-02-08 Ethypharm Sa Forme pharmaceutique orale alcoolo-resistante
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
RU2606588C2 (ru) * 2011-06-17 2017-01-10 Эвоник Рем ГмбХ Композиция покрытия, подходящая для фармацевтических или нутрицевтических дозированных форм
BR112013027484A8 (pt) * 2011-06-17 2022-07-05 Evonik Roehm Gmbh Composição farmacêutica ou nutracêutica com resistência gástrica, e uso de um polímero de (met)acrilato
CN105007902A (zh) * 2013-02-13 2015-10-28 赢创罗姆有限公司 包含大量的两种丸粒的多颗粒药物组合物
US20140275149A1 (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
BR112020004997A2 (pt) 2017-09-14 2020-09-24 Evonik Operations Gmbh polímero e forma de dosagem com propriedades de liberação sustentada e resistência contra a influência de etanol
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
US12569481B2 (en) 2020-06-12 2026-03-10 Vanderbilt University Methods of treatment for gastrointestinal motility disorders
JP2025508982A (ja) * 2022-03-03 2025-04-10 サイプルメド ゲーエムベーハー 治療用ペプチドおよびタンパク質の改善された経口医薬製剤
AU2023366929A1 (en) 2022-10-25 2025-05-08 Veradermics, Incorporated Compositions and methods of use for modified release minoxidil

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
AU2002337686B2 (en) * 2001-09-26 2008-05-15 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
EP1499295A4 (en) * 2002-04-05 2006-04-05 Penwest Pharmaceuticals Co EXTENDED RELEASE METOPROLOL FORMULATIONS
ATE549015T1 (de) * 2003-10-31 2012-03-15 Hexal Ag Pharmazeutische wirkstoffhaltige formulierung mit überzug
CA2594373A1 (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
MX2010003036A (es) 2010-04-09
KR101454056B1 (ko) 2014-10-27
BRPI0722042B1 (pt) 2019-12-10
CA2699224A1 (en) 2009-03-26
CN101801356A (zh) 2010-08-11
EP2187875A1 (en) 2010-05-26
KR20100063067A (ko) 2010-06-10
US20100221324A1 (en) 2010-09-02
WO2009036811A1 (en) 2009-03-26
ES2393805T3 (es) 2012-12-28
BRPI0722042A2 (pt) 2014-03-25
US9555006B2 (en) 2017-01-31
JP5204846B2 (ja) 2013-06-05
CN101801356B (zh) 2016-10-19
SI2187875T1 (sl) 2012-12-31
JP2010539196A (ja) 2010-12-16
EP2187875B1 (en) 2012-09-05
PL2187875T3 (pl) 2013-01-31
IL203870A (en) 2015-02-26

Similar Documents

Publication Publication Date Title
BRPI0722042B8 (pt) composição farmacêutica de liberação controlada dependente do ph, e seu processo de preparação
BRPI0823096B8 (pt) composição farmacêutica de opióide de liberação controlada, dependente do ph, com resistência contra a influência do etanol, processo para sua preparação, e seu uso
BRPI0823128B8 (pt) composição farmacêutica de liberação controlada dependente do ph para não opioides com resistência contra a influência de etanol, e processo para sua preparação
BRPI0721990B8 (pt) composição farmacêutica de liberação controlada dependente de ph, e seu processo de preparação
BRPI0924543B8 (pt) composição farmacêutica de liberação controlada, e seu processo de preparação
BRPI0707465B8 (pt) composições farmacêuticas compreendendo misturas de polímeros e ingredientes ativos dificilmente solúveis em água, seu uso e seus processos de preparação, forma farmacêutica e seu processo de produção
BRPI0807569A8 (pt) Péletes compreendendo uma matriz de substância ativa resistentes ao suco gástrico
BRPI0807771A8 (pt) Filme ou revestimento polimérico compreendendo hemicelulose.
MX2011009669A (es) Composición farmacéutica de liberación controlada con resistencia a la influencia de etanol mediante un revestimiento compuesto de una mezcla polimérica y excipientes.
KR101041512B1 (ko) 로티고틴 투여를 위한 핫 멜트형 경피제제
MX339671B (es) Forma oral solida con perfil de liberacion dual que contiene particulas multiples.
BR112012008626A2 (pt) forma farmacêutica oral sólida com liberação modificada de pelo menos um ingrediente ativo
BRPI0716156A8 (pt) Composição compreendendo nanopartículas tipo núcleo-casca, método para a preparação da referida composição e revestimento
BRPI0810306A2 (pt) "composição de revestimento, processo para o revestimento de chapas de aço elétrico, para a preparação de um núcleo da chapa de aço elétrica, chapa de aço elétrico e núcleo de chapa de aço elétrico"
BR0112725A (pt) Composição de verniz antimicótico para unha
BRPI0815424A2 (pt) particulando polimérico revestido e processo para revestir um particulado polimérico
BRPI0515390A (pt) composição farmacêutica, compreendendo uma dispersão sólida com matriz polìmero, compreendendo uma fase contìnua de polidextrose e uma fase contìnua de um polìmero além da polidextrose
BRPI0515328A (pt) composições hidráulicas flexìveis
BRPI0703508A (pt) copolìmero em emulsão aquosa, anfifìlico, e, método para produzir copolìmero em emulsão, anfifìlico
BR112013003934A2 (pt) depot de fosfolipídeos
BRPI0810944A2 (pt) "composição de revestimento aquoso para a formação de um revestimento temporário descascável sobre um substrato, processo de formação de um revestimento temporário sobre um substrato, substrato revestido com um revestimento temporário descascável e uso de partículas sólidas de um polímero com base em resina amino como aditivo em uma composição de revestimento com base em água"
BR0208081A (pt) Dispersões de matéria sintética aquosas, processo para produção das mesmas e uso das mesmas
NZ602010A (en) Improved glucocorticoid therapy
BR112022015751A2 (pt) Revestimento
BRPI0508997A (pt) microcamada com siloxanas

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

Free format text: REFERENTE A 16A 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 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.