MX2019004938A - Cápsula compleja que contiene esomeprazol y método de preparación de esta. - Google Patents
Cápsula compleja que contiene esomeprazol y método de preparación de esta.Info
- Publication number
- MX2019004938A MX2019004938A MX2019004938A MX2019004938A MX2019004938A MX 2019004938 A MX2019004938 A MX 2019004938A MX 2019004938 A MX2019004938 A MX 2019004938A MX 2019004938 A MX2019004938 A MX 2019004938A MX 2019004938 A MX2019004938 A MX 2019004938A
- Authority
- MX
- Mexico
- Prior art keywords
- coating layer
- core
- esomeprazole
- methacrylic acid
- preparation
- Prior art date
Links
- 239000002775 capsule Substances 0.000 title abstract 3
- SUBDBMMJDZJVOS-DEOSSOPVSA-N esomeprazole Chemical compound C([S@](=O)C1=NC2=CC=C(C=C2N1)OC)C1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-DEOSSOPVSA-N 0.000 title abstract 3
- 229960004770 esomeprazole Drugs 0.000 title abstract 3
- 238000002360 preparation method Methods 0.000 title 1
- 239000011247 coating layer Substances 0.000 abstract 5
- 239000010410 layer Substances 0.000 abstract 5
- 239000002702 enteric coating Substances 0.000 abstract 4
- 238000009505 enteric coating Methods 0.000 abstract 4
- 239000004480 active ingredient Substances 0.000 abstract 2
- 239000011248 coating agent Substances 0.000 abstract 2
- 238000000576 coating method Methods 0.000 abstract 2
- 239000002131 composite material Substances 0.000 abstract 2
- 239000000463 material Substances 0.000 abstract 2
- 229920003145 methacrylic acid copolymer Polymers 0.000 abstract 2
- 229940117841 methacrylic acid copolymer Drugs 0.000 abstract 2
- 150000003839 salts Chemical class 0.000 abstract 2
- LRDIEHDJWYRVPT-UHFFFAOYSA-N 4-amino-5-hydroxynaphthalene-1-sulfonic acid Chemical compound C1=CC(O)=C2C(N)=CC=C(S(O)(=O)=O)C2=C1 LRDIEHDJWYRVPT-UHFFFAOYSA-N 0.000 abstract 1
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 abstract 1
- 229920001222 biopolymer Polymers 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
Classifications
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- 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
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
-
- 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
- A61K9/4833—Encapsulating processes; Filling of capsules
-
- 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
- A61K9/4891—Coated capsules; Multilayered drug free capsule shells
-
- 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
-
- 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
- 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)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (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
Se proporciona una cápsula compuesta y un método de preparación de esta, comprendiendo la cápsula compuesta: una primera parte que se disuelve que comprende un núcleo que comprende, como principio activo, esomeprazol o una sal farmacéuticamente aceptable de este, una capa de recubrimiento interno sobre el núcleo y una primera capa de recubrimiento entérico sobre la capa de recubrimiento interno; y una segunda parte que se disuelve que comprende un núcleo que comprende, como principio activo, esomeprazol o una sal farmacéuticamente aceptable de este, una capa de recubrimiento interno sobre el núcleo y una segunda capa de recubrimiento entérico sobre la capa de recubrimiento interno, donde la primera capa de recubrimiento entérico comprende, como material base de recubrimiento, copolímero de ácido metacrílico LD en una cantidad de aproximadamente un 5% (p/p) a aproximadamente un 50% (p/p) del núcleo sobre el cual se forma la capa de recubrimiento interno, y la segunda capa de recubrimiento entérico comprende, como material base de recubrimiento, una mezcla que contiene copolimero de ácido metacrílieo S y biopolímero de ácido metacrílico L en una relación de aproximadamente l.5:1 (p/p) a aproximadamente 3.5:1 (p/p) en una cantidad de aproximadamente un 15% (p/p) a aproximadamente un 40% (p/p) del núcleo sobre el cual la capa de recubrimiento interno.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020160142156A KR101877350B1 (ko) | 2016-10-28 | 2016-10-28 | 에스오메프라졸 함유 복합 캡슐제 및 그 제조방법 |
| PCT/KR2017/011571 WO2018080104A1 (ko) | 2016-10-28 | 2017-10-19 | 에스오메프라졸 함유 복합 캡슐제 및 그 제조방법 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2019004938A true MX2019004938A (es) | 2019-10-09 |
| MX385644B MX385644B (es) | 2025-03-18 |
Family
ID=62023771
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2019004938A MX385644B (es) | 2016-10-28 | 2017-10-19 | Cápsula compleja que contiene esomeprazol y método de preparación de esta. |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US11052048B2 (es) |
| EP (1) | EP3513784A4 (es) |
| JP (1) | JP2019532960A (es) |
| KR (1) | KR101877350B1 (es) |
| CN (1) | CN109890372B (es) |
| AU (1) | AU2017349091A1 (es) |
| EA (1) | EA201990704A1 (es) |
| MX (1) | MX385644B (es) |
| MY (1) | MY205729A (es) |
| PH (1) | PH12019500919A1 (es) |
| WO (1) | WO2018080104A1 (es) |
| ZA (1) | ZA201902867B (es) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3648745B1 (en) * | 2017-09-28 | 2024-06-26 | Hanmi Pharm. Co., Ltd. | Pharmaceutical composition including multi-unit spheroidal tablet containing esomeprazole and spheroidal pharmaceutically acceptable salt thereof, and method of preparing the pharmaceutical composition |
| US20220202795A1 (en) * | 2019-04-02 | 2022-06-30 | Hanmi Pharm. Co., Ltd | Pharmaceutical composition comprising esomeprazole or pharmaceutically acceptable salt thereof and having double-release profile |
| KR102312604B1 (ko) * | 2020-02-04 | 2021-10-15 | 한국유나이티드제약 주식회사 | 장용성의 프로톤펌프억제제 및 서방성의 모사프리드 제제를 포함하는 경질캡슐 제제 |
| WO2022165339A1 (en) * | 2021-01-31 | 2022-08-04 | Alexion Pharmaceuticals, Inc. | Novel formulation for treating copper metabolism-associated diseases or disorders |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CZ289804B6 (cs) | 1994-07-08 | 2002-04-17 | Astrazeneca Ab | Multijednotková tabletovaná dávková forma I |
| MY148805A (en) * | 2002-10-16 | 2013-05-31 | Takeda Pharmaceutical | Controlled release preparation |
| US8802139B2 (en) * | 2003-06-26 | 2014-08-12 | Intellipharmaceutics Corp. | Proton pump-inhibitor-containing capsules which comprise subunits differently structured for a delayed release of the active ingredient |
| BRPI0412697A (pt) * | 2003-07-17 | 2006-10-03 | Reddys Lab Inc Dr | composições farmacêuticas que apresentam um revestimento expansìvel |
| WO2005051362A2 (en) * | 2003-11-28 | 2005-06-09 | Ranbaxy Laboratories Limited | Oral benzimidazole compositions comprising an active core, an optional separating layer and an enteric coating |
| US7670624B2 (en) * | 2004-01-29 | 2010-03-02 | Astella Pharma Inc. | Gastrointestinal-specific multiple drug release system |
| AR052225A1 (es) | 2004-11-04 | 2007-03-07 | Astrazeneca Ab | Formulaciones de tabletas de liberacion modificada par inhibidores de la bomba de protones |
| EP2319504A1 (en) * | 2009-11-07 | 2011-05-11 | Laboratorios Del. Dr. Esteve, S.A. | Pharmaceutical solid dosage form |
| WO2012001705A2 (en) * | 2010-06-29 | 2012-01-05 | Cadila Healthcare Limited | Pharmaceutical compositions of (r)-lansoprazole |
| CN102100671B (zh) | 2011-01-14 | 2013-04-24 | 寿光富康制药有限公司 | 一种埃索美拉唑镁肠溶微丸的制备方法 |
| CN102670521B (zh) | 2012-05-18 | 2014-05-21 | 珠海润都制药股份有限公司 | 一种埃索美拉唑镁肠溶微丸及其制备方法 |
| CN102940611B (zh) | 2012-11-26 | 2017-02-22 | 康普药业股份有限公司 | 一种含有埃索美拉唑镁的肠溶片剂 |
| CN103040774B (zh) | 2012-11-30 | 2015-03-04 | 上海信谊万象药业股份有限公司 | 埃索美拉唑镁肠溶片中埃索美拉唑镁的制粒包衣工艺 |
| CN104940170A (zh) | 2015-07-23 | 2015-09-30 | 浙江亚太药业股份有限公司 | 一种埃索美拉唑镁肠溶胶囊及其制备方法 |
-
2016
- 2016-10-28 KR KR1020160142156A patent/KR101877350B1/ko active Active
-
2017
- 2017-10-19 CN CN201780067122.4A patent/CN109890372B/zh active Active
- 2017-10-19 JP JP2019519729A patent/JP2019532960A/ja not_active Ceased
- 2017-10-19 EA EA201990704A patent/EA201990704A1/ru unknown
- 2017-10-19 MY MYPI2019002286A patent/MY205729A/en unknown
- 2017-10-19 MX MX2019004938A patent/MX385644B/es unknown
- 2017-10-19 WO PCT/KR2017/011571 patent/WO2018080104A1/ko not_active Ceased
- 2017-10-19 EP EP17866143.5A patent/EP3513784A4/en active Pending
- 2017-10-19 US US16/345,456 patent/US11052048B2/en not_active Expired - Fee Related
- 2017-10-19 AU AU2017349091A patent/AU2017349091A1/en not_active Abandoned
-
2019
- 2019-04-24 PH PH12019500919A patent/PH12019500919A1/en unknown
- 2019-05-07 ZA ZA2019/02867A patent/ZA201902867B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CN109890372A (zh) | 2019-06-14 |
| ZA201902867B (en) | 2020-08-26 |
| EP3513784A1 (en) | 2019-07-24 |
| WO2018080104A1 (ko) | 2018-05-03 |
| PH12019500919A1 (en) | 2019-08-19 |
| US20190247316A1 (en) | 2019-08-15 |
| JP2019532960A (ja) | 2019-11-14 |
| MX385644B (es) | 2025-03-18 |
| BR112019008402A2 (pt) | 2019-07-09 |
| KR101877350B1 (ko) | 2018-08-09 |
| CN109890372B (zh) | 2022-06-24 |
| EA201990704A1 (ru) | 2019-09-30 |
| MY205729A (en) | 2024-11-08 |
| EP3513784A4 (en) | 2020-06-03 |
| KR20180046682A (ko) | 2018-05-09 |
| AU2017349091A1 (en) | 2019-05-16 |
| US11052048B2 (en) | 2021-07-06 |
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