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 únicaInfo
- 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
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)
- 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.
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) |
Families Citing this family (42)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| AU2001259099B2 (en) * | 2001-02-22 | 2005-12-22 | Skyepharma Canada Inc. | Fibrate-statin combinations with reduced fed-fasted effects |
| 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 |
-
2006
- 2006-02-10 AU AU2006212609A patent/AU2006212609A1/en not_active Abandoned
- 2006-02-10 CA CA002597492A patent/CA2597492A1/en not_active Abandoned
- 2006-02-10 KR KR1020077019786A patent/KR20070104447A/ko not_active Ceased
- 2006-02-10 MX MX2007009281A patent/MX2007009281A/es unknown
- 2006-02-10 EP EP06706137A patent/EP1853249A2/en not_active Withdrawn
- 2006-02-10 RU RU2007133601/15A patent/RU2007133601A/ru not_active Application Discontinuation
- 2006-02-10 BR BRPI0606883-9A patent/BRPI0606883A2/pt not_active IP Right Cessation
- 2006-02-10 US US10/582,410 patent/US20080131503A1/en not_active Abandoned
- 2006-02-10 WO PCT/DK2006/050004 patent/WO2006084474A2/en not_active Ceased
-
2010
- 2010-04-30 AU AU2010201739A patent/AU2010201739B2/en not_active Ceased
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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| B08F | Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette] |
Free format text: REFERENTE A 6A ANUIDADE. |
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| 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. |