BRPI0513904A - forma farmacêutica de multipartìcula para substáncias ativas de baixa solubilidade e um processo para preparar a forma farmacêutica - Google Patents
forma farmacêutica de multipartìcula para substáncias ativas de baixa solubilidade e um processo para preparar a forma farmacêuticaInfo
- Publication number
- BRPI0513904A BRPI0513904A BRPI0513904-0A BRPI0513904A BRPI0513904A BR PI0513904 A BRPI0513904 A BR PI0513904A BR PI0513904 A BRPI0513904 A BR PI0513904A BR PI0513904 A BRPI0513904 A BR PI0513904A
- Authority
- BR
- Brazil
- Prior art keywords
- active agent
- pharmaceutical form
- polymer
- matrix
- substentially
- 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
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/427—Thiazoles not condensed and containing further heterocyclic rings
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
- 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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—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
- A61K9/48—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
- A61K9/14—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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
FORMA FARMACêUTICA DE MULTIPARTìCULA PARA SUBSTáNCIAS ATIVAS DE BAIXA SOLUBILIDADE E UM PROCESSO PARA PREPARAR A FORMA FARMACêUTICA. A presente invenção refere-se a uma forma de dosagem farmacêutica de multipartícula na forma de receptáculo reduzindo os valores de pH do estómago, contendo uma pluralidade de péletes, partículas, grânulos ou aglomerados cujo diâmetro médio varia de 50 a 2500 <109>m substancialmente consistindo em a) uma camada de matriz interna contendo um agente ativo não é peptídeo ou proteína, nem os derivados ou conjugados destes, uma matriz lipofílica cujo ponto de fusão é maior do que 37<198>C e um polímero com efeito mucoadesivo, b) um revestimento de película externa substancialmente consistindo em um polímero ou um copolímero aniónico que é opcionalmente formulado com aditivos farmacêuticos convencionais, em que o agente ativo tem uma solubilidade de água de acordo com DAB 10, de pelo menos 30 partes em volume de água para uma parte em peso do agente ativo e é revestido com a matriz lipofílica e o referido agente ativo contendo matriz lipofílica é revestido com uma matriz feita a partir de um polímero com efeito mucoadesivo. Um método para produzir a dosagem farmacêutica de multipartícula inventiva é da mesma forma descrito.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102004036437A DE102004036437A1 (de) | 2004-07-27 | 2004-07-27 | Multipartikuläre Arzneiform für wenig lösliche Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform |
| PCT/EP2005/007427 WO2006010453A1 (de) | 2004-07-27 | 2005-07-08 | Multipartikuläre arzneiform für wenig lösliche wirkstoffe sowie ein verfahren zur herstellung der arzneiform |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BRPI0513904A true BRPI0513904A (pt) | 2008-05-20 |
| BRPI0513904B1 BRPI0513904B1 (pt) | 2019-02-05 |
| BRPI0513904B8 BRPI0513904B8 (pt) | 2021-05-25 |
Family
ID=35169905
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0513904A BRPI0513904B8 (pt) | 2004-07-27 | 2005-07-08 | forma farmacêutica de multipartícula para substâncias ativas de baixa solubilidade e um processo para preparar a forma farmacêutica |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US8273375B2 (pt) |
| EP (1) | EP1771157B1 (pt) |
| JP (1) | JP5455305B2 (pt) |
| KR (1) | KR101216750B1 (pt) |
| AT (1) | ATE388692T1 (pt) |
| BR (1) | BRPI0513904B8 (pt) |
| CA (1) | CA2570608C (pt) |
| DE (2) | DE102004036437A1 (pt) |
| ES (1) | ES2302209T3 (pt) |
| IL (1) | IL180943A (pt) |
| MX (1) | MX2007000955A (pt) |
| PL (1) | PL1771157T3 (pt) |
| SI (1) | SI1771157T1 (pt) |
| WO (1) | WO2006010453A1 (pt) |
Families Citing this family (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10332160A1 (de) * | 2003-07-15 | 2005-02-03 | Röhm GmbH & Co. KG | Multipartikuläre Arzneiform, enthaltend mucoadhaesiv formulierte Peptid- oder Protein-Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform |
| DE102004059792A1 (de) * | 2004-12-10 | 2006-06-14 | Röhm GmbH & Co. KG | Multipartikuläre Arzneiform, enthaltend mucoadhaesiv formulierte Nukleinsäure-Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform |
| DE102005007059A1 (de) | 2005-02-15 | 2006-08-24 | Röhm GmbH & Co. KG | Teilneutralisiertes anionisches (Meth)acrylat-Copolymer |
| US8048413B2 (en) | 2006-05-17 | 2011-11-01 | Helene Huguet | Site-specific intestinal delivery of adsorbents, alone or in combination with degrading molecules |
| DE102006035549A1 (de) * | 2006-07-27 | 2008-01-31 | Evonik Röhm Gmbh | Arzneiform mit mindestens zweischichtiger Trennschicht |
| DE102007031697A1 (de) | 2007-07-06 | 2009-01-08 | Walter Rau Neusser Öl und Fett AG | Kosmetische oder pharmazeutische Zubereitung |
| RU2604861C2 (ru) | 2010-02-25 | 2016-12-10 | Эвоник Рем ГмбХ | Фармацевтический или нутрицевтический состав |
| US9211263B2 (en) | 2012-01-06 | 2015-12-15 | Elcelyx Therapeutics, Inc. | Compositions and methods of treating metabolic disorders |
| US11974971B2 (en) | 2011-01-07 | 2024-05-07 | Anji Pharmaceuticals Inc. | Compositions and methods for treating metabolic disorders |
| US9572784B2 (en) | 2011-01-07 | 2017-02-21 | Elcelyx Therapeutics, Inc. | Compositions comprising statins, biguanides and further agents for reducing cardiometabolic risk |
| US11759441B2 (en) | 2011-01-07 | 2023-09-19 | Anji Pharmaceuticals Inc. | Biguanide compositions and methods of treating metabolic disorders |
| US8796338B2 (en) | 2011-01-07 | 2014-08-05 | Elcelyx Therapeutics, Inc | Biguanide compositions and methods of treating metabolic disorders |
| RS61153B1 (sr) | 2011-01-07 | 2020-12-31 | Anji Pharma Us Llc | Ligand hemosenzornog receptora-osnovne terapije |
| WO2012103411A2 (en) | 2011-01-28 | 2012-08-02 | Zx Pharma, Llc | Controlled-release melatonin composition and related methods |
| US9532952B2 (en) | 2011-01-28 | 2017-01-03 | Physician's Seal, LLC | Controlled-release compositions of melatonin combined with sedative and/or analgesic ingredients |
| US8911780B2 (en) | 2011-02-11 | 2014-12-16 | Zx Pharma, Llc | Multiparticulate L-menthol formulations and related methods |
| US8808736B2 (en) | 2011-02-11 | 2014-08-19 | Zx Pharma, Llc | Enteric coated multiparticulate controlled release peppermint oil composition and related methods |
| US8568776B2 (en) | 2011-02-11 | 2013-10-29 | Zx Pharma, Llc | Multiparticulate L-menthol formulations and related methods |
| SI2720681T1 (sl) * | 2011-06-17 | 2017-03-31 | Evonik Roehm Gmbh | Sestavek za oplaščenje primeren za farmacevtske ali nutracevtske dozirne oblike |
| KR102231554B1 (ko) * | 2012-01-06 | 2021-03-23 | 앤지 파마 유에스 엘엘씨 | 대사 장애를 치료하는 조성물 및 방법 |
| CN110693868A (zh) | 2012-01-06 | 2020-01-17 | 埃尔舍利克斯治疗公司 | 双胍组合物和治疗代谢性病症的方法 |
| MX2015014915A (es) | 2013-04-23 | 2016-03-07 | Zx Pharma Llc | Composicion multiparticulada con recubrimiento enterico que tiene un subrecubrimiento proteinico. |
| CN105188415A (zh) * | 2013-05-06 | 2015-12-23 | 帝斯曼知识产权资产管理有限公司 | 粉末状维生素e制剂 |
| US20160022644A1 (en) * | 2014-07-22 | 2016-01-28 | Tsu-I Catherine Wang | Oral Transmucosal Compositions Including Aromatase Inhibitors for Treating Female Infertility |
| WO2016077454A1 (en) * | 2014-11-11 | 2016-05-19 | Verdure Sciences | Stable solid lipid particle composition for improved bioavailability of lipophilic compounds for age-related diseases |
| JP2018525340A (ja) * | 2015-06-26 | 2018-09-06 | アドバンスド バイオニュートリション コープ． | 動物に活性剤を送達するための組成物 |
| EP3801462A4 (en) | 2018-05-24 | 2022-03-16 | Celanese EVA Performance Polymers LLC | IMPLANTABLE DEVICE FOR EXTENDED RELEASE OF A MACROMOLECULAR DRUG COMPOUND |
| CN111989068A (zh) | 2018-05-24 | 2020-11-24 | 塞拉尼斯伊娃高性能聚合物公司 | 用于持续释放大分子药物化合物的可植入器件 |
| CN115154661A (zh) * | 2022-07-29 | 2022-10-11 | 广州莱度品牌管理有限公司 | 一种仿生角质膜的制备方法 |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW209174B (pt) * | 1991-04-19 | 1993-07-11 | Takeda Pharm Industry Co Ltd | |
| US5938990A (en) * | 1994-07-01 | 1999-08-17 | Roche Vitamins Inc. | Encapsulation of oleophilic substances and compositions produced thereby |
| US20030017195A1 (en) | 2001-07-20 | 2003-01-23 | Samir Mitragotri | Method for oral drug delivery |
| US7670627B2 (en) * | 2002-12-09 | 2010-03-02 | Salvona Ip Llc | pH triggered targeted controlled release systems for the delivery of pharmaceutical active ingredients |
| DE10332160A1 (de) * | 2003-07-15 | 2005-02-03 | Röhm GmbH & Co. KG | Multipartikuläre Arzneiform, enthaltend mucoadhaesiv formulierte Peptid- oder Protein-Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform |
| DE10353196A1 (de) | 2003-11-13 | 2005-06-16 | Röhm GmbH & Co. KG | Mehrschichtige Arzneiform mit einer die Abgabe einer modulatorischen Substanz beeinflussenden Matrix |
| DE10353186A1 (de) | 2003-11-13 | 2005-06-16 | Röhm GmbH & Co. KG | Mehrschichtige Arzneiform, enthaltend eine in Bezug auf die Wirkstoffabgabe modulatorisch wirkende Substanz |
| EP1732513A2 (en) * | 2003-12-31 | 2006-12-20 | Alpharma, Inc. | Rosiglitazone formulations |
| US20040224019A1 (en) * | 2004-03-03 | 2004-11-11 | Adi Shefer | Oral controlled release system for targeted drug delivery into the cell and its nucleus for gene therapy, DNA vaccination, and administration of gene based drugs |
| DE102006035549A1 (de) | 2006-07-27 | 2008-01-31 | Evonik Röhm Gmbh | Arzneiform mit mindestens zweischichtiger Trennschicht |
-
2004
- 2004-07-27 DE DE102004036437A patent/DE102004036437A1/de not_active Withdrawn
-
2005
- 2005-07-08 PL PL05758133T patent/PL1771157T3/pl unknown
- 2005-07-08 DE DE502005003223T patent/DE502005003223D1/de active Active
- 2005-07-08 BR BRPI0513904A patent/BRPI0513904B8/pt active IP Right Grant
- 2005-07-08 KR KR1020077002117A patent/KR101216750B1/ko active IP Right Grant
- 2005-07-08 AT AT05758133T patent/ATE388692T1/de active
- 2005-07-08 MX MX2007000955A patent/MX2007000955A/es active IP Right Grant
- 2005-07-08 CA CA2570608A patent/CA2570608C/en active Active
- 2005-07-08 US US11/572,720 patent/US8273375B2/en active Active
- 2005-07-08 WO PCT/EP2005/007427 patent/WO2006010453A1/de active IP Right Grant
- 2005-07-08 EP EP05758133A patent/EP1771157B1/de active Active
- 2005-07-08 SI SI200530221T patent/SI1771157T1/sl unknown
- 2005-07-08 JP JP2007522954A patent/JP5455305B2/ja active Active
- 2005-07-08 ES ES05758133T patent/ES2302209T3/es active Active
-
2007
- 2007-01-25 IL IL180943A patent/IL180943A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US8273375B2 (en) | 2012-09-25 |
| BRPI0513904B1 (pt) | 2019-02-05 |
| DE502005003223D1 (de) | 2008-04-24 |
| JP5455305B2 (ja) | 2014-03-26 |
| KR101216750B1 (ko) | 2012-12-28 |
| MX2007000955A (es) | 2007-04-16 |
| PL1771157T3 (pl) | 2008-08-29 |
| CA2570608C (en) | 2015-07-07 |
| KR20070046089A (ko) | 2007-05-02 |
| US20080166416A1 (en) | 2008-07-10 |
| DE102004036437A1 (de) | 2006-03-23 |
| ES2302209T3 (es) | 2008-07-01 |
| SI1771157T1 (sl) | 2008-06-30 |
| IL180943A0 (en) | 2007-07-04 |
| ATE388692T1 (de) | 2008-03-15 |
| EP1771157B1 (de) | 2008-03-12 |
| CA2570608A1 (en) | 2006-02-02 |
| IL180943A (en) | 2010-12-30 |
| JP2008508204A (ja) | 2008-03-21 |
| EP1771157A1 (de) | 2007-04-11 |
| BRPI0513904B8 (pt) | 2021-05-25 |
| WO2006010453A1 (de) | 2006-02-02 |
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Legal Events
| Date | Code | Title | Description |
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| B25D | Requested change of name of applicant approved |
Owner name: EVONIK ROEHM GMBH (DE) Free format text: NOME ALTERADO DE: ROEHM GMBH |
|
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| 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] | ||
| B07A | Application suspended after technical examination (opinion) [chapter 7.1 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 05/02/2019, OBSERVADAS AS CONDICOES LEGAIS. (CO) 10 (DEZ) ANOS CONTADOS A PARTIR DE 05/02/2019, OBSERVADAS AS CONDICOES LEGAIS |
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| 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 08/07/2005 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) |
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| B25G | Requested change of headquarter approved |
Owner name: ROEHM GMBH (DE) |
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| B25A | Requested transfer of rights approved |
Owner name: EVONIK DEGUSSA GMBH (DE) |
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| B25D | Requested change of name of applicant approved |
Owner name: EVONIK OPERATIONS GMBH (DE) |