BRPI0606883A2 - composição farmacêutica para administração oral, método para preparar um tablete, e, forma de dosagem sólida única - Google Patents

composição farmacêutica para administração oral, método para preparar um tablete, e, forma de dosagem sólida única

Info

Publication number
BRPI0606883A2
BRPI0606883A2 BRPI0606883-9A BRPI0606883A BRPI0606883A2 BR PI0606883 A2 BRPI0606883 A2 BR PI0606883A2 BR PI0606883 A BRPI0606883 A BR PI0606883A BR PI0606883 A2 BRPI0606883 A2 BR PI0606883A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
tablet
dosage form
oral administration
solid dosage
Prior art date
Application number
BRPI0606883-9A
Other languages
English (en)
Inventor
Per Holm
Tomas Norling
Original Assignee
Lifecycle Pharma As
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36719296&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0606883(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Lifecycle Pharma As filed Critical Lifecycle Pharma As
Publication of BRPI0606883A2 publication Critical patent/BRPI0606883A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/366Lactones having six-membered rings, e.g. delta-lactones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

COMPOSIçãO FARMACêUTICA PARA ADMINISTRAçãO ORAL, MéTODO PARA PREPARAR UM TABLETE, E, FORMA DE DOSAGEM SóLIDA úNICA. Uma composição farmacêutica para administração oral, compreendendo uma combinação de dose fixa de uma primeira composição farmacêutica sólida, contendo fenofibrato como a substância ativa e segunda composição farmacêutica sólida, contendo um inibidor da HMG-CoA redutase, tal como uma estatina, como a substância ativa, em que as primeira e segunda composições farmacêuticas estão presentes em entidades separadas, em uma única forma de dosagem sólida. Por exemplo, um tablete de multicamadas, um tablete de duas camadas ou cápsulas ou sachês contendo os ingredientes ativos em granulados ou contas separados, granulados ou contas opcionalmente sendo revestidos com um revestimento protetor ou um entero- revestimento.
BRPI0606883-9A 2005-02-10 2006-02-10 composição farmacêutica para administração oral, método para preparar um tablete, e, forma de dosagem sólida única BRPI0606883A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DKPA200500200 2005-02-10
DKPA200500576 2005-04-20
PCT/DK2006/050004 WO2006084474A2 (en) 2005-02-10 2006-02-10 A stable pharmaceutical composition comprising a fixed dose combination of fenofibrate and an hmg-coa reductase inhibitor

Publications (1)

Publication Number Publication Date
BRPI0606883A2 true BRPI0606883A2 (pt) 2009-12-01

Family

ID=36719296

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0606883-9A BRPI0606883A2 (pt) 2005-02-10 2006-02-10 composição farmacêutica para administração oral, método para preparar um tablete, e, forma de dosagem sólida única

Country Status (9)

Country Link
US (1) US20080131503A1 (pt)
EP (1) EP1853249A2 (pt)
KR (1) KR20070104447A (pt)
AU (2) AU2006212609A1 (pt)
BR (1) BRPI0606883A2 (pt)
CA (1) CA2597492A1 (pt)
MX (1) MX2007009281A (pt)
RU (1) RU2007133601A (pt)
WO (1) WO2006084474A2 (pt)

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US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE102004032049A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
ES2304911T3 (es) * 2005-05-03 2011-05-30 Ranbaxy Laboratories Limited Sales magnésicas de inhibidores de la reductasa hmg-coa.
DK1957452T3 (da) 2005-11-21 2010-07-26 Warner Lambert Co Nye former af [R-(R*,R*)]-2-(4-fluorphenyl)-B,B-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-heptansyre- magnesium
US7772273B2 (en) * 2006-02-10 2010-08-10 Lifecycle Pharma A/S Stabilized atorvastatin
SI22255A (sl) * 2006-04-14 2007-10-31 Krka, Tovarna Zdravil, D.D., Novo Mesto Novi polimorfi statinovih soli in njihova uporabav farmacevtskih formulacijah
DE102006033723A1 (de) * 2006-07-21 2008-01-24 Bayer Technology Services Gmbh Formulierungen von Multikompartimenten-Granulaten für Wirkstoffe
HU227610B1 (en) * 2006-09-18 2011-09-28 Richter Gedeon Nyrt Pharmaceutical compositions containing rosuvastatin potassium
WO2008117154A2 (en) * 2007-03-26 2008-10-02 Torrent Pharmaceuticals Limited Stable pharmaceutical compositions of hmg-coa reductase inhibitor and process for preparation thereof
US20110165239A1 (en) * 2008-09-24 2011-07-07 Laman Alani Pharmaceutical compositions of atorvastatin
WO2010078429A1 (en) * 2008-12-30 2010-07-08 Impax Laboratories, Inc. Pharmaceutical dosage forms and methods of manufacturing same
ES2428938T3 (es) 2009-07-22 2013-11-12 Grünenthal GmbH Forma de dosificación resistente a la manipulación y estabilizada frente a la oxidación
BR112012001547A2 (pt) 2009-07-22 2016-03-08 Gruenenthal Gmbh forma de dosagem farmacêutica extrusada por fusão a quente
KR101248804B1 (ko) * 2010-05-14 2013-03-29 한미사이언스 주식회사 HMG-CoA 환원효소 억제제 및 이베살탄을 포함하는 이층정 약제학적 복합제제
SI2585051T2 (sl) 2010-06-23 2020-07-31 Krka, D.D., Novo Mesto Farmacevtske oralne odmerne oblike,ki obsegajo lerkanidipin in enalapril in njune farmacevtsko sprejemljive soli
TR201005326A2 (tr) 2010-06-30 2012-01-23 B�Lg�� Mahmut Çoklu dozaj formları.
KR101302243B1 (ko) * 2010-07-28 2013-09-02 씨제이제일제당 (주) 로수바스타틴 또는 이의 약학적 허용염을 포함하는 약학 조성물
CA2808219C (en) 2010-09-02 2019-05-14 Gruenenthal Gmbh Tamper resistant dosage form comprising inorganic salt
CA2839123A1 (en) 2011-07-29 2013-02-07 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
PL2736497T3 (pl) 2011-07-29 2018-01-31 Gruenenthal Gmbh Tabletka odporna na ingerencję, zapewniająca natychmiastowe uwalnianie leku
PL2838512T3 (pl) 2012-04-18 2018-12-31 Grünenthal GmbH Farmaceutyczna postać dawkowania odporna na niewłaściwe użycie i odporna na uderzeniowe uwalnianie dawki
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
WO2014003706A1 (en) * 2012-06-25 2014-01-03 Mylan, Inc. Fenofibrate formulation
US8722083B2 (en) 2012-06-25 2014-05-13 Mylan, Inc. Fenofibrate formulation
MX371432B (es) 2013-05-29 2020-01-30 Gruenenthal Gmbh Forma de dosificacion resistente al uso indebido que contiene una o mas particulas.
US10624862B2 (en) 2013-07-12 2020-04-21 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
WO2015055234A1 (en) * 2013-10-15 2015-04-23 Ecolab Inc. Use of an active solid for cleaning and inactivating unconventional infectious agents on surfaces
BR102013028912A2 (pt) * 2013-11-08 2017-02-14 Hypermarcas S A composição farmacêutica, forma farmacêutica oral, cápsula, comprimido de dupla camada, usos, método de tratamento de hipercolesterolemia, hipertrigliceridemia e/ou dislipidemia mista e método de prevenção de aterosclerose, diabetes ou prevenção secundária de outras doenças cardiovasculares
WO2015078891A1 (en) 2013-11-26 2015-06-04 Farmaceutici Formenti S.P.A. Preparation of a powdery pharmaceutical composition by means of cryo-milling
US20150320690A1 (en) 2014-05-12 2015-11-12 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
EP3148512A1 (en) 2014-05-26 2017-04-05 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
CN107072997A (zh) * 2014-11-11 2017-08-18 盐野义制药株式会社 含有对光不稳定的药物的多层片剂
BR112017021475A2 (pt) 2015-04-24 2018-07-10 Gruenenthal Gmbh forma de dosagem resistente à adulteração (tamper) com liberação imediata e resistência contra extração de solvente
AU2016319203A1 (en) 2015-09-10 2018-02-22 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations
HUE069392T2 (hu) 2017-04-04 2025-03-28 Synthon Bv Lenvatinib-mezilátot tartalmazó gyógyszerkészítmény
HRP20251674T1 (hr) 2019-07-31 2026-02-13 Intas Pharmaceuticals Ltd. Farmaceutski pripravak koji sadrži inhibitore hmg coa reduktaze i fenofibrat
EP4180036A4 (en) * 2020-09-29 2024-01-31 Laboratorios Silanes, S.A. de C.V. PHARMACEUTICAL COMBINATIONS OF STATINS AND FIBRATES FOR THE TREATMENT AND PREVENTION OF HYPERLIPIDEMIA AND CARDIOVASCULAR DISEASES
WO2023146320A1 (ko) * 2022-01-28 2023-08-03 동광제약 주식회사 로수바스타틴 또는 이의 약학적으로 허용되는 염 및 페노피브레이트를 함유하는 캡슐 제제

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CA2039763A1 (en) * 1990-04-30 1991-10-31 Henry Y. Pan Combination of pravastatin and a fibric acid derivative, and method for treating dyslipidemia using such combination
CA2048395A1 (en) * 1990-08-23 1992-02-24 Henry Y. Pan Method for preventing onset of or treating type iii hyperlipoproteinemia employing pravastatin
DE19858789A1 (de) * 1998-12-18 2000-06-21 Bayer Ag Kombination von Cerivastatin und Fibraten
US6696084B2 (en) * 2000-09-20 2004-02-24 Rtp Pharma Inc. Spray drying process and compositions of fenofibrate
US7037934B2 (en) * 2000-12-14 2006-05-02 Sankyo Company, Limited Blood lipid ameliorant composition
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CA2456732C (en) * 2001-08-07 2012-10-30 Galephar M/F Oral pharmaceutical composition containing a combination of ppar.alpha. and a hmg-coa reductase inhibitor
US7259186B2 (en) * 2002-12-17 2007-08-21 Abbott Laboratories Salts of fenofibric acid and pharmaceutical formulations thereof
WO2006037348A1 (en) * 2004-10-01 2006-04-13 Lifecycle Pharma A/S Pharmaceutical compositions comprising fenofibrate and a statin
CA2582405A1 (en) * 2004-10-01 2006-04-13 Lifecycle Pharma A/S Pharmaceutical compositions comprising fenofibrate and atorvastatin

Also Published As

Publication number Publication date
MX2007009281A (es) 2007-09-25
WO2006084474A2 (en) 2006-08-17
EP1853249A2 (en) 2007-11-14
AU2010201739A1 (en) 2010-05-20
RU2007133601A (ru) 2009-03-20
CA2597492A1 (en) 2006-08-17
WO2006084474A3 (en) 2006-11-02
US20080131503A1 (en) 2008-06-05
KR20070104447A (ko) 2007-10-25
AU2006212609A1 (en) 2006-08-17
AU2010201739B2 (en) 2012-03-29

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Legal Events

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B06G Technical and formal requirements: other requirements [chapter 6.7 patent gazette]

Free format text: SOLICITA-SE A REGULARIZACAO DA PROCURACAO, UMA VEZ QUE BASEADO NO ARTIGO 216 1O DA LPI, O DOCUMENTO DE PROCURACAO DEVE SER APRESENTADO EM SUA FORMA AUTENTICADA; OU SEGUNDO MEMO/INPI/PROC/NO 074/93, DEVE CONSTAR UMA DECLARACAO DE VERACIDADE, A QUAL DEVE SER ASSINADA POR UMA PESSOA DEVIDAMENTE AUTORIZADA A REPRESENTAR O INTERESSADO, DEVENDO A MESMA CONSTAR NO INSTRUMENTO DE PROCURACAO, OU NO SEU SUBSTABELECIMENTO.

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

Free format text: REFERENTE A 6A ANUIDADE.

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: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2161 DE 05/06/2012.