BR112013003581B8 - Composição farmacêutica ou nutracêutica gastro resistente, que compreende um ou mais sais do ácido algínico, e seu processo de produção - Google Patents
Composição farmacêutica ou nutracêutica gastro resistente, que compreende um ou mais sais do ácido algínico, e seu processo de produçãoInfo
- Publication number
- BR112013003581B8 BR112013003581B8 BR112013003581A BR112013003581A BR112013003581B8 BR 112013003581 B8 BR112013003581 B8 BR 112013003581B8 BR 112013003581 A BR112013003581 A BR 112013003581A BR 112013003581 A BR112013003581 A BR 112013003581A BR 112013003581 B8 BR112013003581 B8 BR 112013003581B8
- Authority
- BR
- Brazil
- Prior art keywords
- gastro
- salts
- alginic acid
- nutraceutical
- production process
- Prior art date
Links
- 239000002417 nutraceutical Substances 0.000 title abstract 5
- 235000021436 nutraceutical agent Nutrition 0.000 title abstract 5
- 229960001126 alginic acid Drugs 0.000 title abstract 3
- 235000010443 alginic acid Nutrition 0.000 title abstract 3
- 229920000615 alginic acid Polymers 0.000 title abstract 3
- 239000000783 alginic acid Substances 0.000 title abstract 3
- 150000004781 alginic acids Chemical class 0.000 title abstract 3
- 239000000203 mixture Substances 0.000 title abstract 3
- 238000004519 manufacturing process Methods 0.000 title 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract 2
- 239000011247 coating layer Substances 0.000 abstract 2
- 239000004615 ingredient Substances 0.000 abstract 2
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 238000000338 in vitro Methods 0.000 abstract 1
- 150000003839 salts Chemical class 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (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)
Abstract
FORMULAÇÃO FARMACÊUTICA OU NUTRACÊUTICA GASTRO RESISTENTE QUE COMPREENDE UM OU MAIS SAIS DO ÁCIDO ALGÍNICO. A presente invenção refere-se a uma composição farmacêutica ou nutracêutica gastro resistente, que compreende um núcleo, que compreende um ingrediente ativo farmacêutico ou nutracêutico e uma camada de revestimento gastro resistente sobre o núcleo, em que a liberação do ingrediente ativo farmacêutico ou nutracêutico não é maior que 15% sob condições in vitro em pH 1,2 durante 2 horas em meio de acordo com a USP e sem a adição de 40% (v/v) de etanol, em que a camada de revestimento gastro resistente compreende 10 até 100% em peso de um ou mais sais de ácido algínico com uma viscosidade de 30 até 720 cP de uma solução aquosa a 1%.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN2378CH2010 | 2010-08-18 | ||
| IN2378/CHE/2010 | 2010-08-18 | ||
| PCT/EP2011/055809 WO2012022498A1 (en) | 2010-08-18 | 2011-04-13 | Gastric resistant pharmaceutical or nutraceutical formulation comprising one or more salts of alginic acid |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BR112013003581A2 BR112013003581A2 (pt) | 2016-06-07 |
| BR112013003581B1 BR112013003581B1 (pt) | 2021-07-13 |
| BR112013003581B8 true BR112013003581B8 (pt) | 2022-07-05 |
Family
ID=44168760
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112013003581A BR112013003581B8 (pt) | 2010-08-18 | 2011-04-13 | Composição farmacêutica ou nutracêutica gastro resistente, que compreende um ou mais sais do ácido algínico, e seu processo de produção |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US9492394B2 (pt) |
| EP (1) | EP2605759B1 (pt) |
| JP (1) | JP5705319B2 (pt) |
| KR (1) | KR101873075B1 (pt) |
| CN (1) | CN103068376B (pt) |
| AU (1) | AU2011290958B2 (pt) |
| BR (1) | BR112013003581B8 (pt) |
| CA (1) | CA2808546C (pt) |
| ES (1) | ES2716550T3 (pt) |
| HK (1) | HK1182003A1 (pt) |
| MX (1) | MX360389B (pt) |
| RU (1) | RU2013111605A (pt) |
| WO (1) | WO2012022498A1 (pt) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2625017T3 (es) * | 2012-08-27 | 2017-07-18 | Evonik Röhm Gmbh | Composición farmacéutica o nutracéutica gastrorresistente con resistencia contra la influencia de etanol |
| KR101973235B1 (ko) * | 2012-08-27 | 2019-08-16 | 에보니크 룀 게엠베하 | 에탄올의 영향에 대해 지속 방출 특성 및 내성을 갖는 제약 또는 기능식품 조성물 |
| CA2888278A1 (en) * | 2012-10-15 | 2014-04-24 | Isa Odidi | Oral drug delivery formulations |
| CN104688775A (zh) * | 2013-12-04 | 2015-06-10 | 博晖(大连)实业有限公司 | 一种含海星成份的组合胃药 |
| US9895318B2 (en) | 2014-02-17 | 2018-02-20 | Evonik Roehm Gmbh | Pharmaceutical or nutraceutical composition with sustained release characteristic and with resistance against the influence of ethanol |
| CA2910865C (en) | 2014-07-15 | 2016-11-29 | Isa Odidi | Compositions and methods for reducing overdose |
| CA2902911C (en) * | 2014-10-31 | 2017-06-27 | Purdue Pharma | Methods and compositions particularly for treatment of attention deficit disorder |
| WO2016106315A1 (en) * | 2014-12-23 | 2016-06-30 | Fmc Corporation | Enteric film coating compositions, method of coating, and coated forms |
| US20170042806A1 (en) | 2015-04-29 | 2017-02-16 | Dexcel Pharma Technologies Ltd. | Orally disintegrating compositions |
| BR112017025148A2 (pt) * | 2015-06-05 | 2018-08-07 | Evonik Röhm Gmbh | composição farmacêutica ou nutracêutica com resistência contra a influência do etanol |
| EP3167879A1 (en) * | 2015-11-10 | 2017-05-17 | Evonik Technochemie GmbH | Gastric retention active delivery systems |
| JP6801203B2 (ja) * | 2016-03-18 | 2020-12-16 | 日油株式会社 | ｐＨ応答溶出性被覆造粒物および食品 |
| US10076494B2 (en) | 2016-06-16 | 2018-09-18 | Dexcel Pharma Technologies Ltd. | Stable orally disintegrating pharmaceutical compositions |
| JP7111104B2 (ja) * | 2017-08-09 | 2022-08-02 | ライオン株式会社 | コーティング組成物、コーティング膜、コーティング製剤及びその製造方法 |
| WO2019072877A1 (en) * | 2017-10-10 | 2019-04-18 | Capsugel Belgium Nv | GETTING MULTIPARTICULAR COMPOSITIONS |
| CN114126610A (zh) * | 2019-07-16 | 2022-03-01 | 阿斯利康(瑞典)有限公司 | 含维立诺雷的抗剂量倾泻药物配制品 |
| CN117794518A (zh) | 2021-07-29 | 2024-03-29 | 营养与生物科学美国1有限责任公司 | 控释包衣剂 |
| EP4176874A1 (en) | 2021-11-09 | 2023-05-10 | Evonik Operations GmbH | Pharmaceutical or nutraceutical composition with an alcohol resistant single layer coating system |
Family Cites Families (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH0725663B2 (ja) * | 1985-03-11 | 1995-03-22 | 大正製薬株式会社 | 腸溶性軟カプセルの製造方法 |
| WO1997000674A1 (en) * | 1995-06-20 | 1997-01-09 | Pharma-Vinci A/S | A method of preparing an oral preparation provided on the outer side with an enteric coating, as well as an oral preparation obtained by the method |
| US5811126A (en) * | 1995-10-02 | 1998-09-22 | Euro-Celtique, S.A. | Controlled release matrix for pharmaceuticals |
| DE10011447A1 (de) | 2000-03-10 | 2001-09-20 | Roehm Gmbh | Dispersion mit nichtionischem Emulgator |
| US6544556B1 (en) * | 2000-09-11 | 2003-04-08 | Andrx Corporation | Pharmaceutical formulations containing a non-steroidal antiinflammatory drug and a proton pump inhibitor |
| US6620426B2 (en) * | 2001-06-05 | 2003-09-16 | Isp Investments Inc. | Tablet coating composition |
| US20040253309A1 (en) * | 2003-01-27 | 2004-12-16 | Yamanouchi Pharmaceutical Co., Ltd. | Enteric sustained-release fine particles of tamsulosin and its salt and manufacturing method thereof |
| JP2004249231A (ja) * | 2003-02-21 | 2004-09-09 | Takeda Chem Ind Ltd | 粒状物の製造方法とその装置 |
| GB0320020D0 (en) * | 2003-08-27 | 2003-10-01 | Mw Encap Ltd | Improved formulation for providing an enteric coating material |
| DE102004011349A1 (de) | 2004-03-05 | 2005-09-22 | Basf Ag | Wässrige Polymerdispersion auf Basis von Alkyl(meth)-acrylaten |
| TW200533391A (en) | 2004-03-25 | 2005-10-16 | Sun Pharmaceutical Ind Ltd | Gastric retention drug delivery system |
| WO2005097082A1 (en) * | 2004-03-31 | 2005-10-20 | Bpsi Holdings, Inc. | Enteric coatings for orally ingestible substrates |
| US20050239845A1 (en) * | 2004-04-16 | 2005-10-27 | Santarus, Inc. | Combination of proton pump inhibitor, buffering agent, and prokinetic agent |
| KR100676075B1 (ko) * | 2005-02-17 | 2007-02-01 | 한국유나이티드제약 주식회사 | 경구투여용 클래리스로마이신 함유 펠렛 제제 |
| BRPI0609598A2 (pt) * | 2005-03-29 | 2010-04-20 | Roehm Gmbh | forma farmacêutica multiparticulada compreendendo péletes com uma substáncia possuindo um efeito modular em relação à liberação de ingrediente ativo |
| US7645802B2 (en) * | 2005-06-27 | 2010-01-12 | Biovail Laboratories International Srl. | Bupropion hydrobromide and therapeutic applications |
| US9048951B2 (en) | 2005-09-02 | 2015-06-02 | Georgios Margaritis | Free space optics photodetector and transceiver |
| US20070104789A1 (en) | 2005-11-04 | 2007-05-10 | Donald Spector | Gastro-resistant and ethanol-resistant controlled-release formulations comprising hydromorphone |
| WO2007063553A1 (en) * | 2005-11-29 | 2007-06-07 | Ideal Cures Pvt. Ltd. | Aqueous film coating composition containing sodium alginate and preparation thereof |
| KR20100014629A (ko) * | 2007-03-29 | 2010-02-10 | 파나세아 바이오테크 리미티드 | 타크로리무스의 변형제형 |
| CN101888828A (zh) * | 2007-07-27 | 2010-11-17 | 蒂宝制药公司 | 脉冲胃滞留剂型 |
| BRPI0721990B8 (pt) * | 2007-09-21 | 2022-07-05 | Evonik Roehm Gmbh | composição farmacêutica de liberação controlada dependente de ph, e seu processo de preparação |
-
2011
- 2011-04-13 CN CN201180040052.6A patent/CN103068376B/zh not_active Expired - Fee Related
- 2011-04-13 EP EP11714754.6A patent/EP2605759B1/en active Active
- 2011-04-13 BR BR112013003581A patent/BR112013003581B8/pt not_active IP Right Cessation
- 2011-04-13 MX MX2013001824A patent/MX360389B/es active IP Right Grant
- 2011-04-13 CA CA2808546A patent/CA2808546C/en active Active
- 2011-04-13 WO PCT/EP2011/055809 patent/WO2012022498A1/en active Application Filing
- 2011-04-13 KR KR1020137006647A patent/KR101873075B1/ko active IP Right Grant
- 2011-04-13 RU RU2013111605/15A patent/RU2013111605A/ru not_active Application Discontinuation
- 2011-04-13 ES ES11714754T patent/ES2716550T3/es active Active
- 2011-04-13 AU AU2011290958A patent/AU2011290958B2/en not_active Ceased
- 2011-04-13 JP JP2013524383A patent/JP5705319B2/ja not_active Expired - Fee Related
- 2011-04-13 US US13/086,079 patent/US9492394B2/en active Active
-
2013
- 2013-08-08 HK HK13109297.6A patent/HK1182003A1/zh not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| HK1182003A1 (zh) | 2013-11-22 |
| BR112013003581B1 (pt) | 2021-07-13 |
| EP2605759B1 (en) | 2018-11-21 |
| AU2011290958B2 (en) | 2014-06-19 |
| RU2013111605A (ru) | 2014-09-27 |
| JP2013535509A (ja) | 2013-09-12 |
| MX2013001824A (es) | 2013-03-08 |
| US20120093926A1 (en) | 2012-04-19 |
| CA2808546C (en) | 2018-02-20 |
| KR20130099944A (ko) | 2013-09-06 |
| US9492394B2 (en) | 2016-11-15 |
| MX360389B (es) | 2018-10-31 |
| EP2605759A1 (en) | 2013-06-26 |
| WO2012022498A1 (en) | 2012-02-23 |
| CA2808546A1 (en) | 2012-02-23 |
| JP5705319B2 (ja) | 2015-04-22 |
| ES2716550T3 (es) | 2019-06-13 |
| CN103068376B (zh) | 2016-04-20 |
| KR101873075B1 (ko) | 2018-06-29 |
| BR112013003581A2 (pt) | 2016-06-07 |
| AU2011290958A1 (en) | 2013-04-04 |
| CN103068376A (zh) | 2013-04-24 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 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 |
|
| B06T | Formal requirements before examination [chapter 6.20 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: 20 (VINTE) ANOS CONTADOS A PARTIR DE 13/04/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |
|
| 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) |
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| B21F | Lapse acc. art. 78, item iv - on non-payment of the annual fees in time |
Free format text: REFERENTE A 13A ANUIDADE. |
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| B24J | Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12) |
Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2770 DE 06-02-2024 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013. |