BRPI0307995B8 - grânulos ou pós contendo ingrediente ativo, seu uso e processo de produção por meio de fusão de sais de ingredientes ativos - Google Patents
grânulos ou pós contendo ingrediente ativo, seu uso e processo de produção por meio de fusão de sais de ingredientes ativosInfo
- Publication number
- BRPI0307995B8 BRPI0307995B8 BRPI0307995A BR0307995A BRPI0307995B8 BR PI0307995 B8 BRPI0307995 B8 BR PI0307995B8 BR PI0307995 A BRPI0307995 A BR PI0307995A BR 0307995 A BR0307995 A BR 0307995A BR PI0307995 B8 BRPI0307995 B8 BR PI0307995B8
- Authority
- BR
- Brazil
- Prior art keywords
- active ingredient
- granules
- fusion
- production process
- powders containing
- Prior art date
Links
- 239000004480 active ingredient Substances 0.000 title abstract 5
- 239000008187 granular material Substances 0.000 title abstract 4
- 239000000843 powder Substances 0.000 title abstract 4
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 150000003839 salts Chemical class 0.000 title abstract 2
- 230000004927 fusion Effects 0.000 title 1
- 238000000034 method Methods 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 abstract 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 abstract 1
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 abstract 1
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 abstract 1
- 125000005907 alkyl ester group Chemical group 0.000 abstract 1
- 125000000217 alkyl group Chemical group 0.000 abstract 1
- 125000000129 anionic group Chemical group 0.000 abstract 1
- 229920001577 copolymer Polymers 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 238000002844 melting Methods 0.000 abstract 1
- 230000008018 melting Effects 0.000 abstract 1
- 239000000178 monomer Substances 0.000 abstract 1
- 239000002243 precursor Substances 0.000 abstract 1
- 239000000126 substance Substances 0.000 abstract 1
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
- A61K9/14—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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—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
- 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
-
- 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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
Landscapes
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- General Preparation And Processing Of Foods (AREA)
- Seasonings (AREA)
- Compositions Of Macromolecular Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Detergent Compositions (AREA)
Abstract
extrusão por fusão de sais de ingredientes ativos. a invenção se refere a um processo para produção de grânulos ou pós contendo ingrediente ativo envolvendo as etapas que se seguem: a) fusão de uma mistura consistindo em um ingrediente farmaceuticamente ativo e um copolímero de (met)acrilato que compreende em 40 a 75% em peso de ésteres c1-c4 alquila radicalmente polimerizados de ácido acrílico ou de ácido metacrílico e podem ser compreendidos de 25 a 60% em peso de monômeros de (met)acrilato possuindo um grupo aniônico no radical alquila; b) extrusão da mistura e; c) trituração do extrusado para fornecer grânulos ou pós. o processo da invenção e caracterizado pelo fato de que o ingrediente ativo é o sal de uma substância alcalina e o valor do ph, que pode ser medido no pó ou grânulo obtido, é igual a ou inferior a ph 7,0. a invenção também se refere as formas de dosagem farmacêutica ou precursores das mesmas, que podem ser produzidas usando o processo da invenção.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE10208344.4 | 2002-02-27 | ||
| DE10208344A DE10208344A1 (de) | 2002-02-27 | 2002-02-27 | Schmelzextrusion von Wirkstoffsalzen |
| PCT/EP2003/000935 WO2003072083A2 (de) | 2002-02-27 | 2003-01-30 | Schmelzextrusion von wirkstoffsalzen |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BR0307995A BR0307995A (pt) | 2004-12-07 |
| BRPI0307995B1 BRPI0307995B1 (pt) | 2019-02-26 |
| BRPI0307995B8 true BRPI0307995B8 (pt) | 2021-05-25 |
Family
ID=27675020
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0307995A BRPI0307995B8 (pt) | 2002-02-27 | 2003-01-30 | grânulos ou pós contendo ingrediente ativo, seu uso e processo de produção por meio de fusão de sais de ingredientes ativos |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US8642089B2 (pt) |
| EP (1) | EP1478344B1 (pt) |
| JP (1) | JP5054278B2 (pt) |
| KR (1) | KR100707712B1 (pt) |
| AT (1) | ATE362754T1 (pt) |
| AU (1) | AU2003210196A1 (pt) |
| BR (1) | BRPI0307995B8 (pt) |
| CA (1) | CA2474691C (pt) |
| DE (2) | DE10208344A1 (pt) |
| ES (1) | ES2286447T3 (pt) |
| IL (2) | IL162082A0 (pt) |
| MX (1) | MXPA04008345A (pt) |
| PL (1) | PL204465B1 (pt) |
| WO (1) | WO2003072083A2 (pt) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10239999A1 (de) * | 2002-08-27 | 2004-03-04 | Röhm GmbH & Co. KG | Granulat oder Pulver zur Herstellung von Überzugs- und Bindemitteln für Arzneiformen |
| DE10304403A1 (de) | 2003-01-28 | 2004-08-05 | Röhm GmbH & Co. KG | Verfahren zur Herstellung einer oralen Arzneiform mit unmittelbarem Zerfall und Wirkstofffreisetzung |
| US8025899B2 (en) | 2003-08-28 | 2011-09-27 | Abbott Laboratories | Solid pharmaceutical dosage form |
| US8377952B2 (en) | 2003-08-28 | 2013-02-19 | Abbott Laboratories | Solid pharmaceutical dosage formulation |
| JP2006028028A (ja) * | 2004-07-12 | 2006-02-02 | Teikoku Medix Kk | 経口医薬組成物 |
| US8481565B2 (en) | 2004-12-27 | 2013-07-09 | Eisai R&D Management Co., Ltd. | Method for stabilizing anti-dementia drug |
| ATE482690T1 (de) * | 2005-12-14 | 2010-10-15 | Hoffmann La Roche | Hcv-prodrug-formulierung |
| US20090317355A1 (en) * | 2006-01-21 | 2009-12-24 | Abbott Gmbh & Co. Kg, | Abuse resistant melt extruded formulation having reduced alcohol interaction |
| US20100172989A1 (en) * | 2006-01-21 | 2010-07-08 | Abbott Laboratories | Abuse resistant melt extruded formulation having reduced alcohol interaction |
| DE102007009242A1 (de) * | 2007-02-22 | 2008-09-18 | Evonik Röhm Gmbh | Pellets mit magensaftresistenter Wirkstoff-Matix |
| DE102007026550A1 (de) | 2007-06-08 | 2008-12-11 | Bayer Healthcare Ag | Extrudate mit verbesserter Geschmacksmaskierung |
| CA2712010A1 (en) * | 2008-01-11 | 2009-07-12 | Cipla Limited | Solid pharmaceutical dosage form |
| TW200950776A (en) * | 2008-01-24 | 2009-12-16 | Abbott Gmbh & Co Kg | Abuse resistant melt extruded formulation having reduced alcohol interaction |
| JP2011511782A (ja) | 2008-02-12 | 2011-04-14 | アボット・ラボラトリーズ | 長期放出性ヒドロコドンアセトアミノフェンならびにその関連方法および用途 |
| KR101753222B1 (ko) | 2014-12-12 | 2017-07-04 | 강원대학교산학협력단 | 용융압출하여 제조된 당귀-고체분산체 및 그 제조방법 |
| WO2018111459A1 (en) * | 2016-12-14 | 2018-06-21 | Dow Global Technologies Llc | Method for generating salts of pharmaceutical active ingredients |
| WO2019222856A1 (en) | 2018-05-24 | 2019-11-28 | Nureva Inc. | Method, apparatus and computer-readable media to manage semi-constant (persistent) sound sources in microphone pickup/focus zones |
| AU2019275406B2 (en) | 2018-05-24 | 2024-11-14 | Celanese Eva Performance Polymers Llc | Implantable device for sustained release of a macromolecular drug compound |
| WO2019226519A1 (en) | 2018-05-24 | 2019-11-28 | Celanese EVA Performance Polymers Corporation | Implantable device for sustained release of a macromolecular drug compound |
| WO2022231930A1 (en) | 2021-04-26 | 2022-11-03 | Celanese Eva Performance Polymers Llc | Implantable device for sustained release of a macromolecular drug compound |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CH668553A5 (de) * | 1987-02-02 | 1989-01-13 | Mepha Ag | Arzneimittel mit verzoegerter wirkstofffreisetzung. |
| US5084278A (en) * | 1989-06-02 | 1992-01-28 | Nortec Development Associates, Inc. | Taste-masked pharmaceutical compositions |
| WO1993007859A1 (en) * | 1991-10-23 | 1993-04-29 | Warner-Lambert Company | Novel pharmaceutical pellets and process for their production |
| US5965161A (en) * | 1994-11-04 | 1999-10-12 | Euro-Celtique, S.A. | Extruded multi-particulates |
| US5695781A (en) * | 1995-03-01 | 1997-12-09 | Hallmark Pharmaceuticals, Inc. | Sustained release formulation containing three different types of polymers |
| AU3404997A (en) * | 1996-05-31 | 1998-01-05 | Euro-Celtique S.A. | Sustained release oxycodone formulations with no fed/fast effect |
| US6673367B1 (en) | 1998-12-17 | 2004-01-06 | Euro-Celtique, S.A. | Controlled/modified release oral methylphenidate formulations |
| DE19958007A1 (de) | 1999-12-02 | 2001-06-07 | Roehm Gmbh | Spritzgußverfahren für (Meth)acrylat-Copolymere mit teritiären Ammoniumgruppen |
| HU229344B1 (en) | 2001-02-27 | 2013-11-28 | Evonik Roehm Gmbh | Coating and binding agent for pharmaceutical formulations with improved storage stability |
| DE10239999A1 (de) | 2002-08-27 | 2004-03-04 | Röhm GmbH & Co. KG | Granulat oder Pulver zur Herstellung von Überzugs- und Bindemitteln für Arzneiformen |
-
2002
- 2002-02-27 DE DE10208344A patent/DE10208344A1/de not_active Withdrawn
-
2003
- 2003-01-30 PL PL370426A patent/PL204465B1/pl unknown
- 2003-01-30 AT AT03742925T patent/ATE362754T1/de active
- 2003-01-30 WO PCT/EP2003/000935 patent/WO2003072083A2/de not_active Ceased
- 2003-01-30 JP JP2003570829A patent/JP5054278B2/ja not_active Expired - Lifetime
- 2003-01-30 KR KR1020047013278A patent/KR100707712B1/ko not_active Expired - Lifetime
- 2003-01-30 IL IL16208203A patent/IL162082A0/xx unknown
- 2003-01-30 US US10/498,829 patent/US8642089B2/en active Active
- 2003-01-30 MX MXPA04008345A patent/MXPA04008345A/es active IP Right Grant
- 2003-01-30 BR BRPI0307995A patent/BRPI0307995B8/pt not_active IP Right Cessation
- 2003-01-30 AU AU2003210196A patent/AU2003210196A1/en not_active Abandoned
- 2003-01-30 EP EP03742925A patent/EP1478344B1/de not_active Expired - Lifetime
- 2003-01-30 DE DE50307321T patent/DE50307321D1/de not_active Expired - Lifetime
- 2003-01-30 ES ES03742925T patent/ES2286447T3/es not_active Expired - Lifetime
- 2003-01-30 CA CA2474691A patent/CA2474691C/en not_active Expired - Lifetime
-
2004
- 2004-05-20 IL IL162082A patent/IL162082A/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| ATE362754T1 (de) | 2007-06-15 |
| IL162082A0 (en) | 2005-11-20 |
| CA2474691A1 (en) | 2003-09-04 |
| PL370426A1 (en) | 2005-05-30 |
| CA2474691C (en) | 2011-04-19 |
| WO2003072083A2 (de) | 2003-09-04 |
| DE50307321D1 (de) | 2007-07-05 |
| PL204465B1 (pl) | 2010-01-29 |
| EP1478344A2 (de) | 2004-11-24 |
| ES2286447T3 (es) | 2007-12-01 |
| IL162082A (en) | 2009-11-18 |
| KR100707712B1 (ko) | 2007-04-16 |
| US8642089B2 (en) | 2014-02-04 |
| BR0307995A (pt) | 2004-12-07 |
| US20040253314A1 (en) | 2004-12-16 |
| WO2003072083A3 (de) | 2004-04-08 |
| JP2005526731A (ja) | 2005-09-08 |
| DE10208344A1 (de) | 2003-09-04 |
| BRPI0307995B1 (pt) | 2019-02-26 |
| JP5054278B2 (ja) | 2012-10-24 |
| AU2003210196A1 (en) | 2003-09-09 |
| MXPA04008345A (es) | 2004-11-26 |
| KR20040084936A (ko) | 2004-10-06 |
| EP1478344B1 (de) | 2007-05-23 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B25D | Requested change of name of applicant approved |
Owner name: ROEHM GMBH (DE) Free format text: NOME ALTERADO DE: ROEEHM GMBH AND CO. KG |
|
| B25D | Requested change of name of applicant approved |
Owner name: EVONIK ROEHM GMBH (DE) Free format text: NOME ALTERADO DE: ROEHM GMBH |
|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 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 |
|
| B07A | Application suspended after technical examination (opinion) [chapter 7.1 patent gazette] | ||
| B07C | Technical examination (opinion): republication [chapter 7.3 patent gazette] |
Free format text: REFERENTE A RPI 2457, DE 06/02/2018 |
|
| B09B | Patent application refused [chapter 9.2 patent gazette] | ||
| B09T | Decision of refusal: decision cancelled [chapter 9.2.1 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 26/02/2019, 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 30/01/2003 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF |
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| 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) |
|
| B21A | Patent or certificate of addition expired [chapter 21.1 patent gazette] |
Free format text: PATENTE EXTINTA EM 30/01/2023 |