ECSP15039103A - Formulación de liberación sostenida de mosapride que proporciona efectos farmacológicos y clínicos con administración una vez al día - Google Patents
Formulación de liberación sostenida de mosapride que proporciona efectos farmacológicos y clínicos con administración una vez al díaInfo
- Publication number
- ECSP15039103A ECSP15039103A ECIEPI201539103A ECPI201539103A ECSP15039103A EC SP15039103 A ECSP15039103 A EC SP15039103A EC IEPI201539103 A ECIEPI201539103 A EC IEPI201539103A EC PI201539103 A ECPI201539103 A EC PI201539103A EC SP15039103 A ECSP15039103 A EC SP15039103A
- Authority
- EC
- Ecuador
- Prior art keywords
- sustained release
- formulation
- once daily
- release formulation
- daily administration
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 5
- 238000009472 formulation Methods 0.000 title abstract 4
- 230000000144 pharmacologic effect Effects 0.000 title abstract 3
- 238000013268 sustained release Methods 0.000 title abstract 3
- 239000012730 sustained-release form Substances 0.000 title abstract 3
- YPELFRMCRYSPKZ-UHFFFAOYSA-N 4-amino-5-chloro-2-ethoxy-N-({4-[(4-fluorophenyl)methyl]morpholin-2-yl}methyl)benzamide Chemical compound CCOC1=CC(N)=C(Cl)C=C1C(=O)NCC1OCCN(CC=2C=CC(F)=CC=2)C1 YPELFRMCRYSPKZ-UHFFFAOYSA-N 0.000 title abstract 2
- 229960004085 mosapride Drugs 0.000 title abstract 2
- 230000000694 effects Effects 0.000 title 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 4
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 abstract 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 4
- 239000010410 layer Substances 0.000 abstract 3
- 239000003814 drug Substances 0.000 abstract 2
- 229940079593 drug Drugs 0.000 abstract 2
- 210000001035 gastrointestinal tract Anatomy 0.000 abstract 2
- 238000013270 controlled release Methods 0.000 abstract 1
- 238000004090 dissolution Methods 0.000 abstract 1
- 239000002355 dual-layer Substances 0.000 abstract 1
- 238000012423 maintenance Methods 0.000 abstract 1
- 230000014759 maintenance of location Effects 0.000 abstract 1
- 239000011159 matrix material Substances 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 230000002459 sustained effect Effects 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
-
- 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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- 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
-
- 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
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Nutrition Science (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Diabetes (AREA)
- Physiology (AREA)
- Obesity (AREA)
- Emergency Medicine (AREA)
- Endocrinology (AREA)
- Hematology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
La formulación para administración oral de la presente invención que contiene Mosapride o su sal es una formulación de capa doble que consiste en una capa de liberación rápida para liberación rápida de un fármaco y una capa de liberación sostenida para liberación lenta a fin de satisfacer simultáneamente la presentación rápida de actividades farmacológicas y el mantenimiento sostenido de las actividades farmacológicas durante 24 horas, en la que la hidroxipropil metilcelulosa (HPMC) de viscosidad alta y la HPMC de viscosidad baja se usan en una mezcla tal que el contenido de HPMC de viscosidad alta como una matriz de liberación controlada dentro de la capa de liberación sostenida tiene un contenido más alto, de este modo es capaz de controlar la velocidad de disolución en las regiones que tienen diferentes valores de pH dentro del tracto gastrointestinal y/o el tiempo de retención en el tracto gastrointestinal. De forma adicional, la formulación de la presente invención es una preparación de tamaño pequeño con un peso total de 200 mg o menos, preferentemente de 150 mg a 160 mg, de este modo es capaz de mejorar la conformidad con los fármacos de los pacientes.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR20130027945 | 2013-03-15 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ECSP15039103A true ECSP15039103A (es) | 2015-11-30 |
Family
ID=51537143
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ECIEPI201539103A ECSP15039103A (es) | 2013-03-15 | 2015-09-10 | Formulación de liberación sostenida de mosapride que proporciona efectos farmacológicos y clínicos con administración una vez al día |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US9962390B2 (es) |
| EP (1) | EP2974720B1 (es) |
| JP (1) | JP6273302B2 (es) |
| KR (1) | KR101612931B1 (es) |
| CN (2) | CN105142618A (es) |
| EC (1) | ECSP15039103A (es) |
| HK (1) | HK1212910A1 (es) |
| MX (1) | MX2015011896A (es) |
| PE (1) | PE20151592A1 (es) |
| PH (1) | PH12015502134B1 (es) |
| WO (1) | WO2014142616A1 (es) |
Families Citing this family (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101990951B1 (ko) * | 2015-04-27 | 2019-06-20 | 주식회사 네비팜 | 리바스티그민 함유 서방출 의약조성물 |
| RU2697836C2 (ru) * | 2015-06-26 | 2019-08-21 | Кореа Юнайтед Фарм. Инк. | Комбинированный препарат мозаприда и рабепразола |
| KR102393596B1 (ko) | 2016-04-22 | 2022-05-04 | 리셉터 홀딩스, 인크. | 속효성 식물-계 의약 화합물 및 영양 보충제 |
| EA201892396A1 (ru) | 2016-12-02 | 2019-04-30 | Ресептор Лайф Сайенсиз, Инк. | Быстродействующие растительные лекарственные соединения и биологически активные добавки |
| KR101984892B1 (ko) | 2017-06-23 | 2019-06-03 | 한국유나이티드제약 주식회사 | 신규한 용출 파라미터를 사용한 모사프리드 함유 서방제제 |
| KR102467265B1 (ko) * | 2017-06-23 | 2022-11-16 | 한국유나이티드제약 주식회사 | 분자량분포 특성을 조절한 모사프리드 함유 서방제제 |
| KR102465629B1 (ko) * | 2017-06-23 | 2022-11-11 | 한국유나이티드제약 주식회사 | 1일 1회 경구투여하는 모사프리드 함유 서방제제 |
| KR102294186B1 (ko) * | 2017-06-23 | 2021-08-27 | 한국유나이티드제약 주식회사 | 1일 1회 경구투여하는 모사프리드 함유 서방제제 |
| KR101962654B1 (ko) * | 2017-06-23 | 2019-03-27 | 한국유나이티드제약 주식회사 | 용출 특성을 조절한 모사프리드 함유 경구 투여 서방제제 |
| KR102294190B1 (ko) * | 2017-06-23 | 2021-08-27 | 한국유나이티드제약 주식회사 | 신규한 용출 파라미터를 이용한 모사프리드 함유 서방제제 |
| CN107456444B (zh) * | 2017-08-14 | 2021-07-02 | 南京百思福医药科技有限公司 | 一种莫沙必利的缓释干混悬剂及其制备方法 |
| KR102189191B1 (ko) * | 2017-09-12 | 2020-12-09 | 한국유나이티드제약 주식회사 | 1일 1회 경구투여하는 이토프라이드 염산염 함유 서방제제 |
| KR102210422B1 (ko) * | 2017-09-13 | 2021-02-02 | 한국유나이티드제약 주식회사 | 신규한 용출 파라미터를 이용한 이토프라이드 함유 서방제제 |
| KR102189200B1 (ko) * | 2017-09-13 | 2020-12-09 | 한국유나이티드제약 주식회사 | 용출 특성을 조절한 이토프라이드 염산염 함유 경구 투여 서방제제 |
| KR102034694B1 (ko) * | 2017-12-14 | 2019-10-22 | 한국유나이티드제약 주식회사 | 모사프리드와 라베프라졸을 함유하는 유핵정 복합제제 |
| AR117118A1 (es) | 2018-11-19 | 2021-07-14 | Receptor Holdings Inc | Aminoácidos grasos n-acilados para reducir la variabilidad de absorción en composiciones a base de cannabinoides |
| IT201800011125A1 (it) * | 2018-12-14 | 2020-06-14 | Dpl Pharma S P A | Composizioni farmaceutiche orali solide comprendenti matrici monolitiche complesse per la somministrazione cronotropica di medicamenti nel tratto gastroenterico |
| KR102244108B1 (ko) * | 2018-12-21 | 2021-04-23 | (주)휴온스 | 티카그렐러 또는 이의 염을 함유하는 서방형 약제학적 조성물 |
| KR102275045B1 (ko) | 2019-02-13 | 2021-07-08 | 한국바이오켐제약 주식회사 | 모사프리드시트르산염수화물의 제조방법 및 이를 포함하는 약학제제 |
| CN110354093B (zh) * | 2019-07-31 | 2021-09-17 | 常州恒邦药业有限公司 | 一种枸橼酸莫沙必利药物组合物 |
| KR102087415B1 (ko) | 2019-10-21 | 2020-03-10 | 김용성 | 모사프리드 또는 이의 약제학적으로 허용되는 염을 유효성분으로 포함하는 대장투여용 조성물 |
| KR102334699B1 (ko) * | 2019-12-10 | 2021-12-06 | 한국유나이티드제약 주식회사 | 프로톤펌프억제제 및 모사프리드를 포함하는 유핵정 제제 |
| CN114845704A (zh) * | 2019-12-19 | 2022-08-02 | 赛特瑞恩股份有限公司 | 包含西苯唑啉或其盐的药物制剂 |
| CN110934853B (zh) * | 2019-12-30 | 2023-06-23 | 鲁南制药集团股份有限公司 | 一种枸橼酸莫沙必利缓释微丸胶囊及其制备方法 |
| CN111110645B (zh) * | 2020-02-14 | 2022-02-22 | 齐齐哈尔医学院 | 一种枸橼酸莫沙必利缓释片及其制备方法 |
| IT202000011050A1 (it) * | 2020-05-14 | 2021-11-14 | Mogon Pharmaceuticals Sagl | Composizioni orali solide comprendenti matrici monolitiche composite per la somministrazione cronotropica nel tratto gastroenterico di ingredienti attivi |
| KR20240114885A (ko) * | 2023-01-18 | 2024-07-25 | 한국유나이티드제약 주식회사 | 모사프리드 서방성 제제 |
| CN119055596A (zh) * | 2024-08-27 | 2024-12-03 | 吉林修正药业新药开发有限公司 | 一种枸橼酸莫沙必利胃漂浮制剂、其制备方法及其应用 |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5009895A (en) * | 1990-02-02 | 1991-04-23 | Merck & Co., Inc. | Sustained release with high and low viscosity HPMC |
| SE9600072D0 (sv) * | 1996-01-08 | 1996-01-08 | Astra Ab | New oral formulation of two active ingredients II |
| WO2003011256A1 (en) * | 2001-07-30 | 2003-02-13 | Sun Pharmaceutical Industries Limited | Oral controlled release pharmaceutical composition of a prokinetic agent |
| WO2005055989A1 (ja) * | 2003-12-09 | 2005-06-23 | Dainippon Sumitomo Pharma Co., Ltd. | 薬物含有粒子および該粒子を含む固形製剤 |
| KR20120046766A (ko) * | 2009-08-11 | 2012-05-10 | 다이닛본 스미토모 세이야꾸 가부시끼가이샤 | 2종 이상의 입자들을 함유하는 구강 속붕해성 정제 |
| CN102548544B (zh) | 2009-10-09 | 2015-01-21 | 永进药品工业株式会社 | 同时具有速效特性和长效特性的药物组合物 |
| CN101785774A (zh) * | 2009-10-20 | 2010-07-28 | 中国药科大学 | 复方烟酸辛伐他汀的双层缓释片 |
| KR101288001B1 (ko) * | 2009-11-17 | 2013-07-23 | 풍림무약주식회사 | 모사프라이드를 유효성분으로 함유하는 서방성 제제 |
| JP2010155854A (ja) | 2010-02-25 | 2010-07-15 | Otsuka Pharmaceut Co Ltd | 持続性医薬製剤 |
| GB201003766D0 (en) * | 2010-03-05 | 2010-04-21 | Univ Strathclyde | Pulsatile drug release |
| GB201003734D0 (en) * | 2010-03-05 | 2010-04-21 | Univ Strathclyde | Delayed prolonged drug delivery |
| KR101190708B1 (ko) * | 2010-03-12 | 2012-10-12 | 주식회사 대웅제약 | 모사프리드 또는 이의 염을 포함하는 서방형 약학 조성물 |
| WO2011126327A2 (en) * | 2010-04-09 | 2011-10-13 | Hyundai Pharm Co., Ltd. | Pharmaceutical composition with controlled-release properties comprising mosapride or levodropropizine, and preparing method thereof |
| KR101246553B1 (ko) * | 2010-04-09 | 2013-03-26 | 현대약품 주식회사 | 서방성 약제학적 조성물 및 이의 제조방법 |
| KR101465622B1 (ko) * | 2010-12-21 | 2014-11-27 | 현대중공업 주식회사 | 총조블록 운반 및 탑재공법 |
| KR20120094882A (ko) * | 2012-06-29 | 2012-08-27 | 주식회사 대웅제약 | 모사프리드 또는 이의 염을 포함하는 서방형 약학 조성물 |
-
2014
- 2014-03-14 KR KR1020140030361A patent/KR101612931B1/ko active Active
- 2014-03-14 JP JP2015562936A patent/JP6273302B2/ja active Active
- 2014-03-14 PE PE2015001899A patent/PE20151592A1/es not_active Application Discontinuation
- 2014-03-14 US US14/776,386 patent/US9962390B2/en active Active
- 2014-03-14 MX MX2015011896A patent/MX2015011896A/es unknown
- 2014-03-14 CN CN201480016211.2A patent/CN105142618A/zh active Pending
- 2014-03-14 EP EP14764801.8A patent/EP2974720B1/en active Active
- 2014-03-14 HK HK16100936.9A patent/HK1212910A1/zh unknown
- 2014-03-14 WO PCT/KR2014/002189 patent/WO2014142616A1/ko not_active Ceased
- 2014-03-14 CN CN201810516438.3A patent/CN108653226A/zh active Pending
-
2015
- 2015-09-10 EC ECIEPI201539103A patent/ECSP15039103A/es unknown
- 2015-09-15 PH PH12015502134A patent/PH12015502134B1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US9962390B2 (en) | 2018-05-08 |
| EP2974720A4 (en) | 2016-08-31 |
| PH12015502134A1 (en) | 2016-01-25 |
| PE20151592A1 (es) | 2015-11-04 |
| HK1212910A1 (zh) | 2016-06-24 |
| EP2974720A1 (en) | 2016-01-20 |
| MX2015011896A (es) | 2016-07-19 |
| US20160030436A1 (en) | 2016-02-04 |
| CN105142618A (zh) | 2015-12-09 |
| KR20140113542A (ko) | 2014-09-24 |
| JP6273302B2 (ja) | 2018-01-31 |
| EP2974720B1 (en) | 2024-02-21 |
| WO2014142616A1 (ko) | 2014-09-18 |
| PH12015502134B1 (en) | 2019-04-12 |
| CN108653226A (zh) | 2018-10-16 |
| KR101612931B1 (ko) | 2016-04-18 |
| JP2016512235A (ja) | 2016-04-25 |
Similar Documents
| Publication | Publication Date | Title |
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