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

    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
    • 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
    • A61K31/40—Heterocyclic 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
    • 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
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (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
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
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte 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.
WO2007057755A1 (en) * 2005-11-21 2007-05-24 Warner-Lambert Company Llc Novel forms of [r-(r*,r*)]-2-(4-fluorophenyl)-b,b-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-hept anoic acid 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
CN102573805A (zh) 2009-07-22 2012-07-11 格吕伦塔尔有限公司 热熔挤出的控制释放剂型
RU2015138422A (ru) 2009-07-22 2018-12-25 Грюненталь Гмбх Стабильная при окислении, прочная на излом лекарственная форма
KR101248804B1 (ko) * 2010-05-14 2013-03-29 한미사이언스 주식회사 ＨＭＧ-ＣｏＡ 환원효소 억제제 및 이베살탄을 포함하는 이층정 약제학적 복합제제
EP2585051B2 (en) 2010-06-23 2020-04-08 KRKA, tovarna zdravil, d.d., Novo mesto Pharmaceutical oral dosage forms comprising lercanidipine and enalapril and their pharmaceutically acceptable salts
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
NZ607392A (en) 2010-09-02 2015-03-27 Gruenenthal Chemie Tamper resistant dosage form comprising inorganic salt
RS56527B1 (sr) 2011-07-29 2018-02-28 Gruenenthal Gmbh Tableta za trenutno oslobađanje leka rezistentna na zloupotrebu
PE20141638A1 (es) 2011-07-29 2014-11-22 Gruenenthal Chemie Tableta a prueba de manipulacion que proporciona liberacion de farmaco inmediato
DK2838512T3 (en) 2012-04-18 2018-11-19 Gruenenthal Gmbh MANIPULATED AND DOSAGE DUMPED PHARMACEUTICAL DOSAGE FORM
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
US8722083B2 (en) 2012-06-25 2014-05-13 Mylan, Inc. Fenofibrate formulation
WO2014003706A1 (en) * 2012-06-25 2014-01-03 Mylan, Inc. Fenofibrate formulation
JP6445537B2 (ja) 2013-05-29 2018-12-26 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング １個または複数の粒子を含有する改変防止（ｔａｍｐｅｒ−ｒｅｓｉｓｔａｎｔ）剤形
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
AU2014356581C1 (en) 2013-11-26 2020-05-28 Grunenthal Gmbh Preparation of a powdery pharmaceutical composition by means of cryo-milling
MX2016014738A (es) 2014-05-12 2017-03-06 Gruenenthal Gmbh Formulacion en capsula de liberacion inmediata resistente a alteraciones que comprende tapentadol.
MX2016015417A (es) 2014-05-26 2017-02-22 Gruenenthal Gmbh Multiparticulas protegidas contra vertido de dosis etanolico.
KR20170083071A (ko) * 2014-11-11 2017-07-17 시오노기 앤드 컴파니, 리미티드 광에 대해서 불안정한 약물을 함유하는 다층 정제
JP2018517676A (ja) 2015-04-24 2018-07-05 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング 即時放出および溶媒抽出に対する耐性を有する改変防止製剤
AU2016319203A1 (en) 2015-09-10 2018-02-22 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations
PL3384901T3 (pl) * 2017-04-04 2025-01-13 Synthon B.V. Kompozycja farmaceutyczna zawierająca mesylan lenwatynibu
RS63740B1 (sr) 2019-07-31 2022-12-30 Intas Pharmaceuticals Ltd Farmaceutski sastav koji se sastoji od inhibitora hmg-coa reduktaze i fenofibrata
MX2022015336A (es) * 2020-09-29 2023-01-11 Laboratorios Silanes S A De C V Combinaciones farmaceuticas de estatinas y fibratos para el tratamiento y prevencion de hiperlipidemias y enfermedades cardiovasculares.
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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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
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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
EP1804769A1 (en) * 2004-10-01 2007-07-11 LifeCycle Pharma A/S Pharmaceutical compositions comprising fenofibrate and atorvastatin

Also Published As

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

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Legal Events

Date Code Title Description
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.