BRPI0721990B8 - composição farmacêutica de liberação controlada dependente de ph, e seu processo de preparação - Google Patents

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

Info

Publication number
BRPI0721990B8
BRPI0721990B8 BRPI0721990A BRPI0721990A BRPI0721990B8 BR PI0721990 B8 BRPI0721990 B8 BR PI0721990B8 BR PI0721990 A BRPI0721990 A BR PI0721990A BR PI0721990 A BRPI0721990 A BR PI0721990A BR PI0721990 B8 BRPI0721990 B8 BR PI0721990B8
Authority
BR
Brazil
Prior art keywords
weight
pharmaceutical composition
coating layer
controlled release
polymer blend
Prior art date
Application number
BRPI0721990A
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 BRPI0721990A2 publication Critical patent/BRPI0721990A2/pt
Publication of BRPI0721990B1 publication Critical patent/BRPI0721990B1/pt
Publication of BRPI0721990B8 publication Critical patent/BRPI0721990B8/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

Landscapes

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

Abstract

COMPOSIÇÃO OPIOIDE FARMACÊUTICA DE LIBERAÇÃO CONTROLADA DEPENDENTE DE PH COM RESISTÊNCIA CONTRA A INFLUÊNCIA DE ETANOL. A presente invenção refere-se a uma composição farmacêutica de liberação controlada dependente de pH, compreendendo um núcleo compreendendo pelo menos um ingrediente ativo farmacêutico, que é um opioide, em que o núcleo está revestido pelo menos por uma camada de revestimento, controlando a liberação da composição farmacêutica, em que a camada de revestimento compreende uma mistura de polímeros de i) 40-95% em peso, baseado no peso seco da mistura de polímero, de pelo menos um polímero vinila essencialmente neutro insolúvel em água, e ii)5-60% em peso, baseado em peso seco da mistura de polímeros, de pelo menos um polímero ou copolímero aniônico, que 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 ainda contém 110 a 250% em peso, calculado em peso seco da mistura de polímeros, de um lubrificante inerte não-poroso e a camada de revstimento está presente em uma quantidade de pelo menos 6% em peso calculada sobre o peso do núcleo.
BRPI0721990A 2007-09-21 2007-09-25 composição farmacêutica de liberação controlada dependente de ph, e seu processo de preparação BRPI0721990B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN2130CH2007 2007-09-21
IN2130/CHE/2007 2007-09-21
PCT/EP2007/060131 WO2009036812A1 (en) 2007-09-21 2007-09-25 Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol

Publications (3)

Publication Number Publication Date
BRPI0721990A2 BRPI0721990A2 (pt) 2014-03-18
BRPI0721990B1 BRPI0721990B1 (pt) 2019-12-10
BRPI0721990B8 true BRPI0721990B8 (pt) 2022-07-05

Family

ID=39232916

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0721990A BRPI0721990B8 (pt) 2007-09-21 2007-09-25 composição farmacêutica de liberação controlada dependente de ph, e seu processo de preparação

Country Status (13)

Country Link
US (1) US9700520B2 (pt)
EP (1) EP2187876B1 (pt)
JP (1) JP5204847B2 (pt)
KR (1) KR101424653B1 (pt)
CN (1) CN101801357B (pt)
BR (1) BRPI0721990B8 (pt)
CA (1) CA2699227C (pt)
ES (1) ES2393934T3 (pt)
IL (1) IL203901A (pt)
MX (1) MX2010003032A (pt)
PL (1) PL2187876T3 (pt)
SI (1) SI2187876T1 (pt)
WO (1) WO2009036812A1 (pt)

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US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
EP1337244A4 (en) 2000-10-30 2006-01-11 Euro Celtique Sa HYDROCODON FORMULATIONS WITH CONTROLLED RELEASE
US20080069891A1 (en) 2006-09-15 2008-03-20 Cima Labs, Inc. Abuse resistant drug formulation
US8445018B2 (en) 2006-09-15 2013-05-21 Cima Labs Inc. Abuse resistant drug formulation
WO2009023672A2 (en) * 2007-08-13 2009-02-19 Abuse Deterrent Pharmaceutical Llc Abuse resistant drugs, method of use and method of making
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
KR101535701B1 (ko) 2008-09-24 2015-07-09 에보니크 룀 게엠베하 에탄올의 영향에 대하여 내성을 갖는 비-오피오이드용 ｐｈ-의존성 조절 방출 제약 조성물
WO2010105673A1 (en) * 2009-03-18 2010-09-23 Evonik Röhm Gmbh Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising a polymer mixture and excipients
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
US9107451B2 (en) * 2009-07-29 2015-08-18 Evonik Röhm Gmbh Coating composition for the dip coating of capsule halves
DE102009028076A1 (de) * 2009-07-29 2011-02-03 Evonik Röhm Gmbh Beschichtungsmittel zum Tauchbeschichten von Kapselhälften
FR2951378B1 (fr) * 2009-10-16 2012-06-01 Flamel Tech Sa Forme pharmaceutique orale solide anti-mesusage et dotee d'un profil specifique de liberation modifiee
EP2371356B1 (en) 2010-03-12 2012-12-19 Phoeme GmbH Multi-particle pharmaceutical formulation for colon absorption
EP2568977A1 (en) 2010-05-11 2013-03-20 Cima Labs Inc. Alcohol-resistant metoprolol-containing extended- release oral dosage forms
US9492394B2 (en) 2010-08-18 2016-11-15 Evonik Roehm Gmbh Gastric resistant pharmaceutical or nutraceutical formulation comprising one or more salts of alginic acid
HUE030548T2 (en) * 2011-06-17 2017-05-29 Evonik Roehm Gmbh A stomach-resistant medical or nutritional preparation that is resistant to ethanol
PL2720682T3 (pl) 2011-06-17 2017-05-31 Evonik Röhm Gmbh Kompozycja powlekająca odpowiednia do farmaceutycznych lub nutraceutycznych postaci dawkowania
PL2720681T3 (pl) 2011-06-17 2017-05-31 Evonik Röhm Gmbh Kompozycja powlekająca odpowiednia do farmaceutycznych lub nutraceutycznych postaci dawkowania
HUE031251T2 (en) * 2011-06-30 2017-07-28 Develco Pharma Schweiz Ag Controlled release oral dosage form containing oxycodone
US20140323512A1 (en) * 2011-10-18 2014-10-30 Purdue Pharma L.P. Acrylic Polymer Formulations
US11571390B2 (en) 2013-03-15 2023-02-07 Othemo Life Sciences, Inc. Abuse deterrent compositions and methods of use
CA3042642A1 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US20150118300A1 (en) 2013-10-31 2015-04-30 Cima Labs Inc. Immediate Release Abuse-Deterrent Granulated Dosage Forms
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
WO2015095391A1 (en) 2013-12-17 2015-06-25 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
GB201411704D0 (en) * 2014-07-01 2014-08-13 Lucideon Ltd Coated particles
ES2809458T3 (es) 2014-07-17 2021-03-04 Pharmaceutical Manufacturing Res Services Inc Forma de dosificación llena de líquido, disuasoria del abuso y de liberación inmediata
US10729685B2 (en) 2014-09-15 2020-08-04 Ohemo Life Sciences Inc. Orally administrable compositions and methods of deterring abuse by intranasal administration
EP3209282A4 (en) 2014-10-20 2018-05-23 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
CA2936746C (en) 2014-10-31 2017-06-27 Purdue Pharma Methods and compositions particularly for treatment of attention deficit disorder
WO2018044895A1 (en) * 2016-08-29 2018-03-08 Cima Labs Inc. Immediate release dosage forms with abuse deterrence and alcohol resistance
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Also Published As

Publication number Publication date
ES2393934T3 (es) 2013-01-02
CN101801357A (zh) 2010-08-11
BRPI0721990B1 (pt) 2019-12-10
SI2187876T1 (sl) 2012-12-31
KR101424653B1 (ko) 2014-08-06
BRPI0721990A2 (pt) 2014-03-18
EP2187876A1 (en) 2010-05-26
CN101801357B (zh) 2013-08-07
MX2010003032A (es) 2010-04-09
KR20100059885A (ko) 2010-06-04
IL203901A (en) 2015-03-31
PL2187876T3 (pl) 2013-01-31
US20100226978A1 (en) 2010-09-09
CA2699227A1 (en) 2009-03-26
EP2187876B1 (en) 2012-08-22
WO2009036812A1 (en) 2009-03-26
US9700520B2 (en) 2017-07-11
JP5204847B2 (ja) 2013-06-05
JP2010539197A (ja) 2010-12-16
CA2699227C (en) 2014-12-02

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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.