BR112012008626A2 - forma farmacêutica oral sólida com liberação modificada de pelo menos um ingrediente ativo - Google Patents

forma farmacêutica oral sólida com liberação modificada de pelo menos um ingrediente ativo

Info

Publication number
BR112012008626A2
BR112012008626A2 BR112012008626A BR112012008626A BR112012008626A2 BR 112012008626 A2 BR112012008626 A2 BR 112012008626A2 BR 112012008626 A BR112012008626 A BR 112012008626A BR 112012008626 A BR112012008626 A BR 112012008626A BR 112012008626 A2 BR112012008626 A2 BR 112012008626A2
Authority
BR
Brazil
Prior art keywords
active ingredient
weight
coating
dosage form
oral dosage
Prior art date
Application number
BR112012008626A
Other languages
English (en)
Inventor
Anne-Sophie Daviaud-Venet
Catherine Castan
Original Assignee
Flamel Tech Sa
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 Flamel Tech Sa filed Critical Flamel Tech Sa
Publication of BR112012008626A2 publication Critical patent/BR112012008626A2/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine

Landscapes

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

Abstract

forma farmacêutica oral sólida com liberação modifica de pelo menos um ingrediente ativo a presente invenção refere-se a um forma farmacêutica oral sólida, com liberação modificada de pelo menos um ingrediente ativo, contendo pelo menos micropartículas contendo o dito ingrediente ativo e pelo menos um agente viscosificante em uma forma isolada a partir das ditas micropartículas do ingrediente ativo, caracterizada pelo de que as ditas micropartículas possuem um diâmetro médio na faixa de 100 a 600pm, e são formadas por um núcleo contendo pelo menos o dito ingrediente ativo e são revestidas com pelo menos uma camada de revestimento, - sendo o dito núcleo formado por uma partícula de suporte revestida por uma camada compreendendo pelo menos o dito ingrediente ativo, - sendo a dita camada de revestimento formada por um material composto de pelo menos 25 a 70% em peso em relação ao peso total do dito revestimento, de pelo menos um polímero a, que é insolúvel em água, 30 a 75% em peso em relação ao peso total do dito revestimento, de pelo menos um polímero b insolúvel em água abaixo do ph 5 e solúvel em água acima do ph 7, e 0 a 25% em peso ao peso total do dito revestimento, de pelo menos um plastificante, - estando os ditos polímeros a e b em uma proporção de peso polímero (s) b/polímero (s) a compreendida entre 0.25 e 4, e - a dita camada de revestimento representando pelo menos 35% em peso, em relação ao peso total da dita micropartícula.
BR112012008626A 2009-10-16 2010-10-15 forma farmacêutica oral sólida com liberação modificada de pelo menos um ingrediente ativo BR112012008626A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US25231709P 2009-10-16 2009-10-16
FR0957270A FR2951378B1 (fr) 2009-10-16 2009-10-16 Forme pharmaceutique orale solide anti-mesusage et dotee d'un profil specifique de liberation modifiee
PCT/IB2010/054674 WO2011045769A2 (fr) 2009-10-16 2010-10-15 Forme pharmaceutique orale solide anti-mésusage et dotée d'un profil spécifique de libération modifiée

Publications (1)

Publication Number Publication Date
BR112012008626A2 true BR112012008626A2 (pt) 2016-04-19

Family

ID=42111016

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012008626A BR112012008626A2 (pt) 2009-10-16 2010-10-15 forma farmacêutica oral sólida com liberação modificada de pelo menos um ingrediente ativo

Country Status (14)

Country Link
US (1) US20110091537A1 (pt)
EP (1) EP2488161B1 (pt)
JP (1) JP5562428B2 (pt)
KR (1) KR101551732B1 (pt)
CN (1) CN102596181A (pt)
AU (1) AU2010308016B2 (pt)
BR (1) BR112012008626A2 (pt)
CA (1) CA2777010C (pt)
ES (1) ES2582453T3 (pt)
FR (1) FR2951378B1 (pt)
IL (1) IL218992B (pt)
MX (1) MX2012004472A (pt)
WO (1) WO2011045769A2 (pt)
ZA (1) ZA201202451B (pt)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2794171C (en) 2010-03-24 2018-07-03 Jazz Pharmaceuticals, Inc. Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances
WO2014011830A1 (en) 2012-07-12 2014-01-16 Mallinckrodt Llc Extended release, abuse deterrent pharmaceutical compositions
WO2014034929A1 (ja) * 2012-09-03 2014-03-06 第一三共株式会社 ヒドロモルフォン塩酸塩含有の経口用徐放性医薬組成物
FR2999426B1 (fr) * 2012-12-13 2015-01-02 Flamel Tech Sa Forme orale multiparticulaire a liberation immediate d'au moins un compose actif, comprenant des particules enrobees resistantes au broyage.
CA2919892C (en) 2013-08-12 2019-06-18 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
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
US9707184B2 (en) 2014-07-17 2017-07-18 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
EP3209282A4 (en) 2014-10-20 2018-05-23 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
US10398662B1 (en) 2015-02-18 2019-09-03 Jazz Pharma Ireland Limited GHB formulation and method for its manufacture
US20180185352A1 (en) * 2015-06-09 2018-07-05 KVK-Tech, Inc. Abuse deterrent pharmaceutical compositions
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
UY37341A (es) 2016-07-22 2017-11-30 Flamel Ireland Ltd Formulaciones de gamma-hidroxibutirato de liberación modificada con farmacocinética mejorada
US20180263936A1 (en) 2017-03-17 2018-09-20 Jazz Pharmaceuticals Ireland Limited Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
GB2571696B (en) 2017-10-09 2020-05-27 Compass Pathways Ltd Large scale method for the preparation of Psilocybin and formulations of Psilocybin so produced
EP3473246A1 (en) 2017-10-19 2019-04-24 Capsugel Belgium NV Immediate release abuse deterrent formulations
JP7472116B2 (ja) 2018-11-19 2024-04-22 ジャズ ファーマシューティカルズ アイルランド リミテッド 耐アルコール性製剤
CN113473980A (zh) 2019-03-01 2021-10-01 弗拉梅尔爱尔兰有限公司 在进食状态下具有改善的药代动力学的γ-羟基丁酸酯组合物
AU2020259406A1 (en) 2019-04-17 2021-11-04 Compass Pathfinder Limited Treatment of depression and other various disorders with psilocybin
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT374025B (de) * 1981-03-20 1984-03-12 Hoffelner Volkwin Vorrichtung zur erzeugung hochfrequenter schall- wellen
CA2007181C (en) * 1989-01-06 1998-11-24 Angelo Mario Morella Sustained release pharmaceutical composition
FR2830447B1 (fr) * 2001-10-09 2004-04-16 Flamel Tech Sa Forme galenique orale microparticulaire pour la liberation retardee et controlee de principes actifs pharmaceutiques
EP1545468A4 (en) * 2002-09-20 2007-06-20 Alpharma Inc SUSTAINED RELEASE OPIOID PREPARATIONS AND METHODS OF USE
FR2892937B1 (fr) * 2005-11-10 2013-04-05 Flamel Tech Sa Forme pharmaceutique orale microparticulaire anti-mesusage
US8652529B2 (en) * 2005-11-10 2014-02-18 Flamel Technologies Anti-misuse microparticulate oral pharmaceutical form
CA2661683C (en) * 2006-08-31 2015-11-24 Eurand, Inc Drug delivery systems comprising solid solutions of weakly basic drugs
DE102007030987A1 (de) * 2007-07-04 2009-01-08 Robert Bosch Gmbh Vorrichtung zur Bestimmung einer Geschwindigkeit mit einem Beschleunigungssensor
CA2699227C (en) * 2007-09-21 2014-12-02 Evonik Roehm Gmbh Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol

Also Published As

Publication number Publication date
ES2582453T3 (es) 2016-09-13
EP2488161B1 (fr) 2016-04-20
ZA201202451B (en) 2012-11-28
JP2013508268A (ja) 2013-03-07
AU2010308016B2 (en) 2014-06-05
AU2010308016A1 (en) 2012-04-26
EP2488161A2 (fr) 2012-08-22
FR2951378B1 (fr) 2012-06-01
FR2951378A1 (fr) 2011-04-22
JP5562428B2 (ja) 2014-07-30
CN102596181A (zh) 2012-07-18
KR20120110167A (ko) 2012-10-09
IL218992B (en) 2018-07-31
CA2777010A1 (fr) 2011-04-21
US20110091537A1 (en) 2011-04-21
KR101551732B1 (ko) 2015-09-10
WO2011045769A3 (fr) 2011-06-16
IL218992A0 (en) 2012-06-28
WO2011045769A2 (fr) 2011-04-21
CA2777010C (fr) 2017-01-10
MX2012004472A (es) 2012-05-08

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Legal Events

Date Code Title Description
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE AS 4A, 5A E 6A ANUIDADES.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2384 DE 13-09-2016 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.