KR950016748A - 니세르골린을 함유하는 방출-조절성 약제학적 조성물 - Google Patents

니세르골린을 함유하는 방출-조절성 약제학적 조성물 Download PDF

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KR950016748A
KR950016748A KR1019930028487A KR930028487A KR950016748A KR 950016748 A KR950016748 A KR 950016748A KR 1019930028487 A KR1019930028487 A KR 1019930028487A KR 930028487 A KR930028487 A KR 930028487A KR 950016748 A KR950016748 A KR 950016748A
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composition
microgranules
nisergoline
salt
film
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KR1019930028487A
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English (en)
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세기찌 로베르토
비탈리 로마노
지니 루이기
피페리 죠르지오
Original Assignee
쥬세페 팔리안티
인베르니렐라 베파파르마슈티시 에스. 알. 엘
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Publication of KR950016748A publication Critical patent/KR950016748A/ko

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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
    • A61K9/48—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
    • 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
    • A61K31/48—Ergoline derivatives, e.g. lysergic acid, ergotamine
    • 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
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

본 발명은 활성성분으로서 니세르골린을 함유하는 경구용 방출-조절성의 약제학적 제형에 관한 것이다. 즉 니세르골린 또는 그의 염이 충전되고 다음과 같이 구성되는 필름으로 코팅된 미세과립의 혼합물을 포함하는 것을 특징으로 하는, 활성성분으로서 니세르골린 또는 그의 약제학적으로 허용되는 염을 함유하는 경구용 방출 조절된 약제학적 조성물은 환자의 순응도가 높고 부작용의 발현을 감소시킬 수 있다:
-에틸 아크릴레이트 및 메틸 메타크릴레이트로 구성되는 평균 분자 800,000을 갖는 중성의 공중합체 100-97%: -수용성 물질 0-3%

Description

니세르골린을 함유하는 방출-조절성 약제학적 조성물
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (12)

  1. 니세르골린 또는 그의 염이 충전되고 다음과 같이 구성되는 필름으로 코팅된 미세과립의 혼합물을 포함하는 것을 특징으로 하는, 활성성분으로서 니세르골린 또는 그의 약제학적으로 허용되는 염을 함유하는 경구용 방출 조절된 약제학적 조성물: -에틸 아클리레이트 및 메틸 메타크릴리에트로 구성되는 평균 분자량 800,000을 갖는 중성의 공중합체 100-97%; -수용성 물질0-3%.
  2. 제1항에 있어서, 니세르골린 또는 그의 염이 충전된 불활성 미세과립이 0.4내지 1.4mm크기를 갖는 전분 및 설탕의 미세과립인 것을 특징으로 하는 조성물.
  3. 제2항에 있어서, 미세과립이 0.6내지 0.9mm 범위의 크기를 갖는 것을 특징으로 하는 조성물.
  4. 제1항에 있어서, 크기 및 코팅이 다른 미세과립을 포함하여 활성 성분의 조절된 방출 속도를 제공하도록 된 조성물.
  5. 제1항에 있어서, 필름이 분자량 800,000을 갖는 중성의 100% 에틸 아크릴레이트/메틸 메타크릴레이트 공중합체로 구성되는 것을 특징으로 하는 조성물.
  6. 제5항에 있어서, 필름이 조성물의 4내지 20%w/w의 양인 것을 특징으로 하는 조성물.
  7. 제1항에 있어서, 필름이 중성의 에틸 아크릴레이트/메틸메타크릴레이트 공중합체 97-99% 및 수용성 물질 1--3%로 구성되는 것을 특징으로 하는 조성물.
  8. 제7항에 있어서, 수용성 물질이 폴리비닐피롤리돈, 폴리에킬렌 글리콜, 히드록시프로필메틸 셀룰로오스, 유당, 설탕 또는 이들의 혼합물로부터 선택되는 것을 특징으로 하는 조성물.
  9. 제7항에 있어서, 필름이 조성물의 10내지 30% w/w의 양인 것을 특징으로 하는 조성물.
  10. 제1항에 있어서, 니세르골린 또는 그의 염으로 충전된 비코팅된 미세과립과 함게 코팅된 미세과립의 적절한 혼합물을 포함하는 조성물.
  11. 제1항 내지 제10항의 어느 한 항에 있어서, 니세르골린 20내지 l00mg을 함유하는 조성물.
  12. 제1항에 따른 미세과립을 포함하는 캅셀 또는 정제.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019930028487A 1992-12-18 1993-12-18 니세르골린을 함유하는 방출-조절성 약제학적 조성물 KR950016748A (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI92A002885 1992-12-18
ITMI922885A IT1256743B (it) 1992-12-18 1992-12-18 Composizioni farmaceutiche a rilascio controllato contenenti nicergolina

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KR950016748A true KR950016748A (ko) 1995-07-20

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KR1019930028487A KR950016748A (ko) 1992-12-18 1993-12-18 니세르골린을 함유하는 방출-조절성 약제학적 조성물

Country Status (8)

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EP (1) EP0602619A1 (ko)
JP (1) JPH0748256A (ko)
KR (1) KR950016748A (ko)
CN (1) CN1093254A (ko)
CZ (1) CZ277593A3 (ko)
HU (1) HUT66371A (ko)
IT (1) IT1256743B (ko)
PL (1) PL301513A1 (ko)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2786100B1 (fr) 1998-11-24 2002-03-01 Aventis Laboratoire Nouvelle application therapeutique de la nicergoline
FR2786101B1 (fr) 1998-11-24 2002-07-05 Aventis Laboratoire Utilisation de la nicergoline dans le traitement de la spasticite
JP3718398B2 (ja) * 2000-01-11 2005-11-24 信越化学工業株式会社 フィルムコーティング剤及び経口固形製剤
JP5228359B2 (ja) * 2007-04-12 2013-07-03 ニプロ株式会社 主薬粒子及びその製造方法ならびに口腔内崩壊錠
CN102228450B (zh) * 2011-06-28 2012-10-31 重庆市庆余堂制药有限公司 尼麦角林胶囊及其生产方法
CN106333927A (zh) 2015-07-08 2017-01-18 昆山龙灯瑞迪制药有限公司 修饰释放的尼麦角林组合物
CN111904938A (zh) * 2020-05-15 2020-11-10 山东方明药业集团股份有限公司 一种尼麦角林片剂的制备方法
CN113081993A (zh) * 2021-04-15 2021-07-09 海南通用三洋药业有限公司 一种尼麦角林片剂的制备方法
CN113398089A (zh) * 2021-06-29 2021-09-17 海南通用三洋药业有限公司 一种尼麦角林胶囊的制备方法和尼麦角林胶囊

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5015480A (en) * 1987-11-25 1991-05-14 Eli Lilly And Company Film coating formulations

Also Published As

Publication number Publication date
ITMI922885A1 (it) 1994-06-18
HU9303633D0 (en) 1994-04-28
HUT66371A (en) 1994-11-28
ITMI922885A0 (it) 1992-12-18
PL301513A1 (en) 1994-06-27
IT1256743B (it) 1995-12-15
EP0602619A1 (en) 1994-06-22
CN1093254A (zh) 1994-10-12
JPH0748256A (ja) 1995-02-21
CZ277593A3 (en) 1994-07-13

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