KR20230090184A - Pharmaceutical composite formulation comprising esomeprazole and rebamipide - Google Patents
Pharmaceutical composite formulation comprising esomeprazole and rebamipide Download PDFInfo
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- KR20230090184A KR20230090184A KR1020210179212A KR20210179212A KR20230090184A KR 20230090184 A KR20230090184 A KR 20230090184A KR 1020210179212 A KR1020210179212 A KR 1020210179212A KR 20210179212 A KR20210179212 A KR 20210179212A KR 20230090184 A KR20230090184 A KR 20230090184A
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- rebamipide
- zollinger
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- 238000009472 formulation Methods 0.000 title claims abstract description 16
- 239000000203 mixture Substances 0.000 title claims abstract description 16
- ALLWOAVDORUJLA-UHFFFAOYSA-N Rebamipida Chemical compound C=1C(=O)NC2=CC=CC=C2C=1CC(C(=O)O)NC(=O)C1=CC=C(Cl)C=C1 ALLWOAVDORUJLA-UHFFFAOYSA-N 0.000 title claims abstract description 14
- 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 claims abstract description 14
- 229960004770 esomeprazole Drugs 0.000 title claims abstract description 14
- 229950004535 rebamipide Drugs 0.000 title claims abstract description 14
- 239000002131 composite material Substances 0.000 title abstract 2
- 208000021302 gastroesophageal reflux disease Diseases 0.000 claims abstract description 29
- 238000011282 treatment Methods 0.000 claims abstract description 17
- 201000008629 Zollinger-Ellison syndrome Diseases 0.000 claims abstract description 15
- 201000000052 gastrinoma Diseases 0.000 claims abstract description 15
- 206010061164 Gastric mucosal lesion Diseases 0.000 claims abstract description 14
- 208000007107 Stomach Ulcer Diseases 0.000 claims abstract description 14
- 230000000740 bleeding effect Effects 0.000 claims abstract description 14
- 230000003628 erosive effect Effects 0.000 claims abstract description 14
- 206010030113 Oedema Diseases 0.000 claims abstract description 13
- 239000003814 drug Substances 0.000 claims abstract description 8
- 229940079593 drug Drugs 0.000 claims abstract description 3
- 238000013265 extended release Methods 0.000 claims description 8
- 201000005917 gastric ulcer Diseases 0.000 claims description 8
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims description 6
- 238000011221 initial treatment Methods 0.000 claims description 5
- 229940124597 therapeutic agent Drugs 0.000 claims description 5
- 238000002360 preparation method Methods 0.000 claims description 4
- 239000003795 chemical substances by application Substances 0.000 claims description 3
- 230000008961 swelling Effects 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract description 4
- 239000004615 ingredient Substances 0.000 abstract description 2
- 230000000630 rising effect Effects 0.000 abstract description 2
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- 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
- 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
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- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4704—2-Quinolinones, e.g. carbostyril
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Animal Behavior & Ethology (AREA)
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- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
Description
본 발명은 위식도 역류질환(GERD) 및 졸링거-엘리슨 증후군을 동반한 위궤양 및 위점막병변(미란,출혈,발적,부종)을 치료하는 에스오메프라졸(esomeprazole) 및 레바미피드(rebamipide) 성분을 포함하는 약제학적 복합제제에 관한 것이다.The present invention provides esomeprazole and rebamipide components for treating gastric ulcers and gastric mucosal lesions (erosion, bleeding, redness, edema) associated with gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome. It relates to a pharmaceutical combination preparation comprising
일반적으로 위식도 역류질환(GERD) 및 졸링거-엘리슨 증후군은 에스오메프라졸(esomeprazole) 단독 성분의 제제로 치료하고, In general, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome are treated with esomeprazole alone.
위궤양 및 위점막병변(미란,출혈,발적,부종)의 치료는 레바미피드(rebamipide) 단독 성분의 제제로 치료한다.Treatment of gastric ulcer and gastric mucosal lesions (erosion, bleeding, redness, edema) is treated with preparations containing only rebamipide.
위식도 역류질환(GERD) 및 졸링거-엘리슨 증후군을 치료하기 위해 에스오메프라졸(esomeprazole) 단독 성분의 제제는 1일 2회 정도 복용하고,To treat gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome, esomeprazole alone is taken twice a day,
위궤양 및 위점막병변(미란,출혈,발적,부종)을 치료하기 위해 레바미피드(rebamipide) 단독 성분의 제제는 1일 3회 정도 복용한다.In order to treat gastric ulcer and gastric mucosal lesions (erosion, bleeding, redness, edema), rebamipide-only preparations are taken three times a day.
본 발명은 위식도 역류질환(GERD) 및 졸링거-엘리슨 증후군을 동반한 위궤양 및 위점막병변(미란,출혈,발적,부종)을 치료하는 경우,The present invention treats gastric ulcers and gastric mucosal lesions (erosion, bleeding, redness, edema) accompanied by gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome,
각 단독 성분의 제제를 개별적으로 복용해야 할 뿐만 아니라 치료 효과 지속 시간이 짧아 여러 번 복용해야 하는 번거로움과 약가 상승에 따른 경제적 비용 부담이 발생하는 문제점을 해결한다.It solves the problem of not only having to take each individual ingredient separately, but also the inconvenience of having to take multiple doses due to the short duration of treatment effect and the burden of economic costs due to rising drug prices.
본 발명은 1개의 치료제로 사중정을 복합 구성하고 있는 4종의 제제 중에서 위식도 역류질환(GERD) 및 졸링거-엘리슨 증후군을 일차로 치료하기 위해 에스오메프라졸(esomeprazole) 속효성 제제(immediately release)를 포함하는 사중정,The present invention provides an immediate release of esomeprazole to treat gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome as a primary treatment among four formulations comprising a quadruple tablet as one therapeutic agent. containing quartet,
1개의 치료제로 사중정을 복합 구성하고 있는 4종의 제제 중에서 위식도 역류질환(GERD) 및 졸링거-엘리슨 증후군을 이차로 치료하기 위해 에스오메프라졸(esomeprazole) 서방형 제제(extended release)를 포함하는 사중정,Among the 4 types of formulations that consist of a quadruple tablet as one therapeutic agent, esomeprazole extended release formulations are included for the secondary treatment of gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome. quartet,
1개의 치료제로 사중정을 복합 구성하고 있는 4종의 제제 중에서 위궤양 및 위점막병변(미란,출혈,발적,부종)을 일차로 치료하기 위해 레바미피드(rebamipide) 속효성 제제(immediately release)를 포함하는 사중정,Among the 4 types of formulations that make up the quadruple tablet as one treatment, rebamipide (immediately release) is included for the primary treatment of gastric ulcer and gastric mucosal lesions (erosion, bleeding, redness, edema). quartet to do,
1개의 치료제로 사중정을 복합 구성하고 있는 4종의 제제 중에서 위궤양 및 위점막병변(미란,출혈,발적,부종)을 이차로 치료하기 위해 레바미피드(rebamipide) 서방형 제제(extended release)를 포함하는 사중정으로 구성된다.Among the 4 types of formulations that consist of a quadruple tablet as one treatment, rebamipide (extended release) is selected for the secondary treatment of gastric ulcer and gastric mucosal lesions (erosion, bleeding, redness, edema). It consists of a quartet containing
본 발명은 위식도 역류질환(GERD) 및 졸링거-엘리슨 증후군을 동반한 위궤양 및 위점막병변(미란,출혈,발적,부종)을 4종의 제제로 복합 구성된 1개의 사중정으로 치료함으로써, The present invention treats gastric ulcers and gastric mucosal lesions (erosion, bleeding, redness, edema) accompanied by gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome with one quadruple tablet composed of four types of agents,
위식도 역류질환(GERD) 및 졸링거-엘리슨 증후군 그리고 위궤양 및 위점막병변(미란,출혈,발적,부종)의 치료 효과 지속 시간이 길어지도록 하여 복용의 편의성과 경제적 효율성이 개선된 새로운 약제학적 복합제제 제공의 효과를 가진다.A new pharmaceutical complex with improved convenience and economic efficiency by prolonging the duration of treatment effects for gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, gastric ulcer and gastric mucosal lesions (erosion, bleeding, redness, edema) It has the effect of providing an agent.
도 1 : 본 발명의 상세도Figure 1 : Detailed view of the present invention
본 발명은 1개의 치료제로 사중정을 복합 구성하고 있는 4종의 제제 중에서 위식도 역류질환(GERD) 및 졸링거-엘리슨 증후군을 일차로 치료하기 위해 에스오메프라졸(esomeprazole) 속효성 제제(immediately release)를 포함하는 사중정(100),The present invention provides an immediate release of esomeprazole to treat gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome as a primary treatment among four formulations comprising a quadruple tablet as one therapeutic agent. A quartet containing (100),
1개의 치료제로 사중정을 복합 구성하고 있는 4종의 제제 중에서 위식도 역류질환(GERD) 및 졸링거-엘리슨 증후군을 이차로 치료하기 위해 에스오메프라졸(esomeprazole) 서방형 제제(extended release)를 포함하는 사중정(200),Among the 4 types of formulations that consist of a quadruple tablet as one therapeutic agent, esomeprazole extended release formulations are included for the secondary treatment of gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome. Quadruple Court (200),
1개의 치료제로 사중정을 복합 구성하고 있는 4종의 제제 중에서 위궤양 및 위점막병변(미란,출혈,발적,부종)을 일차로 치료하기 위해 레바미피드(rebamipide) 속효성 제제(immediately release)를 포함하는 사중정(300),Among the 4 types of formulations that make up the quadruple tablet as one treatment, rebamipide (immediately release) is included for the primary treatment of gastric ulcer and gastric mucosal lesions (erosion, bleeding, redness, edema). quadruple (300) to do,
1개의 치료제로 사중정을 복합 구성하고 있는 4종의 제제 중에서 위궤양 및 위점막병변(미란,출혈,발적,부종)을 이차로 치료하기 위해 레바미피드(rebamipide) 서방형 제제(extended release)를 포함하는 사중정(400)으로 구성된다.Among the 4 types of formulations that consist of a quadruple tablet as one treatment, rebamipide (extended release) is selected for the secondary treatment of gastric ulcer and gastric mucosal lesions (erosion, bleeding, redness, edema). It consists of a quartet (400) containing
100. 에스오메프라졸(esomeprazole) 속효성 제제(immediately release)를 포함하는 사중정(100),
200. 에스오메프라졸(esomeprazole) 서방형 제제(extended release)를 포함하는 사중정(200),
300. 레바미피드(rebamipide) 속효성 제제(immediately release)를 포함하는 사중정(300),
400. 레바미피드(rebamipide) 서방형 제제(extended release)를 포함하는 사중정(400)100. Quadruple tablet (100) containing esomeprazole immediate release,
200. Quadruple tablet (200) containing esomeprazole extended release,
300.
400. Quadruple tablet (400) containing rebamipide extended release
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Citations (2)
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KR20050050145A (en) | 2002-10-18 | 2005-05-27 | 아스트라제네카 아베 | Method for the synthesis of a benzimidazole compound |
KR20100051850A (en) | 2007-08-10 | 2010-05-18 | 오츠카 세이야쿠 가부시키가이샤 | Medical composition containing rebamipide |
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KR20050050145A (en) | 2002-10-18 | 2005-05-27 | 아스트라제네카 아베 | Method for the synthesis of a benzimidazole compound |
KR20100051850A (en) | 2007-08-10 | 2010-05-18 | 오츠카 세이야쿠 가부시키가이샤 | Medical composition containing rebamipide |
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