DE3578373D1 - Herstellungverfahren fuer stabile nicorandilpraeparate. - Google Patents

Herstellungverfahren fuer stabile nicorandilpraeparate.

Info

Publication number
DE3578373D1
DE3578373D1 DE8585116032T DE3578373T DE3578373D1 DE 3578373 D1 DE3578373 D1 DE 3578373D1 DE 8585116032 T DE8585116032 T DE 8585116032T DE 3578373 T DE3578373 T DE 3578373T DE 3578373 D1 DE3578373 D1 DE 3578373D1
Authority
DE
Germany
Prior art keywords
manufacturing process
preparations
stable nicorandil
stable
nicorandil preparations
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
DE8585116032T
Other languages
English (en)
Inventor
Yoshimitsu Iida
Takashi Terazono
Shuji Sumida
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chugai Pharmaceutical Co Ltd
Original Assignee
Chugai Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Chugai Pharmaceutical Co Ltd filed Critical Chugai Pharmaceutical Co Ltd
Application granted granted Critical
Publication of DE3578373D1 publication Critical patent/DE3578373D1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/02Suppositories; Bougies; Bases therefor; Ovules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
DE8585116032T 1984-12-17 1985-12-16 Herstellungverfahren fuer stabile nicorandilpraeparate. Expired - Lifetime DE3578373D1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP59265888A JPH0653658B2 (ja) 1984-12-17 1984-12-17 安定な錠剤の製造法
JP14968885 1985-07-08
JP21327785 1985-09-26

Publications (1)

Publication Number Publication Date
DE3578373D1 true DE3578373D1 (de) 1990-08-02

Family

ID=27319808

Family Applications (1)

Application Number Title Priority Date Filing Date
DE8585116032T Expired - Lifetime DE3578373D1 (de) 1984-12-17 1985-12-16 Herstellungverfahren fuer stabile nicorandilpraeparate.

Country Status (23)

Country Link
US (1) US4803213A (de)
EP (1) EP0185347B1 (de)
JP (1) JPH0653658B2 (de)
KR (1) KR930007251B1 (de)
CN (1) CN1007209B (de)
AR (1) AR241515A1 (de)
AT (1) ATE54050T1 (de)
AU (1) AU579431B2 (de)
BA (1) BA98214B1 (de)
CA (1) CA1255227A (de)
DE (1) DE3578373D1 (de)
DK (1) DK167171B1 (de)
FI (1) FI84781C (de)
HK (1) HK65493A (de)
HU (1) HU195731B (de)
IE (1) IE59158B1 (de)
MX (1) MX166095B (de)
NO (1) NO171826C (de)
PT (1) PT81680B (de)
RU (1) RU1811401C (de)
SG (1) SG52493G (de)
YU (1) YU45292B (de)
ZA (1) ZA859390B (de)

Families Citing this family (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5188840A (en) * 1985-09-26 1993-02-23 Chugai Seiyaku Kabushiki Kaisha Slow-release pharmaceutical agent
KR950010150B1 (ko) * 1986-01-14 1995-09-11 쥬우가이세이야꾸 가부시끼가이샤 니코란딜 함유 주사제의 안정화 방법
KR940000232B1 (ko) * 1986-01-17 1994-01-12 쥬우가이세이야꾸 가부시끼가이샤 니코란딜 제제의 안정화 방법
GR871267B (en) * 1986-08-18 1987-12-24 Chugai Pharmaceutical Co Ltd Method for the manufacture of a pharmaceutical preparation for administration by percutaneous absortion
US4940580A (en) * 1986-11-03 1990-07-10 Schering Corporation Sustained release labetalol tablets
CA1322957C (en) * 1988-03-30 1993-10-12 Hitoshi Yamauchi Cyclic amp derivative ointments
JP2535141B2 (ja) * 1995-01-17 1996-09-18 中外製薬株式会社 フマル酸含有徐放性製剤
US6235947B1 (en) * 1997-04-14 2001-05-22 Takeda Chemical Industries, Ltd. D-mannitol and its preparation
HUP9902165A3 (en) 1996-04-16 2001-01-29 Bayer Ag D-mannit and with big specific surface area process for preparing it and solid pharmaceuticals containing it
KR100481583B1 (ko) * 1996-06-14 2005-07-12 교와 핫꼬 고교 가부시끼가이샤 구강내에서빠르게붕괴하는정제
AU733032C (en) * 1996-06-14 2002-01-03 Kyowa Hakko Kirin Co., Ltd. Intraorally rapidly disintegrable tablet
US8071128B2 (en) 1996-06-14 2011-12-06 Kyowa Hakko Kirin Co., Ltd. Intrabuccally rapidly disintegrating tablet and a production method of the tablets
IT1293835B1 (it) * 1997-08-08 1999-03-10 Foscama Biomed Chim Farma Composizioni farmaceutiche orali in forma solida a cessione modulata contenenti nicorandil e procedimento per la loro preparazione
US6417207B1 (en) 1999-05-12 2002-07-09 Nitromed, Inc. Nitrosated and nitrosylated potassium channel activators, compositions and methods of use
KR100483080B1 (ko) * 2001-09-21 2005-04-14 한인규 염산·베타인(betaine·HCl), 판크레아틴, 제2인산 칼슘, 크롬 피콜리네이트, 락토바실러스속·비피도박테리아속·스트렙토코커스속·프럭토 올리고당, 비타민, 미네랄을 유효성분으로 구성된 것을 특징으로 하는 증체개선용 영양강화 사료첨가제
US9358214B2 (en) 2001-10-04 2016-06-07 Adare Pharmaceuticals, Inc. Timed, sustained release systems for propranolol
US8367111B2 (en) * 2002-12-31 2013-02-05 Aptalis Pharmatech, Inc. Extended release dosage forms of propranolol hydrochloride
JP4235149B2 (ja) 2004-07-02 2009-03-11 インターナショナル・ビジネス・マシーンズ・コーポレーション ノートブック型コンピュータ
US8747895B2 (en) * 2004-09-13 2014-06-10 Aptalis Pharmatech, Inc. Orally disintegrating tablets of atomoxetine
US9884014B2 (en) 2004-10-12 2018-02-06 Adare Pharmaceuticals, Inc. Taste-masked pharmaceutical compositions
NZ589750A (en) 2004-10-21 2012-07-27 Aptalis Pharmatech Inc Taste-masked pharmaceutical compositions with gastrosoluble pore-formers
US20060105038A1 (en) * 2004-11-12 2006-05-18 Eurand Pharmaceuticals Limited Taste-masked pharmaceutical compositions prepared by coacervation
US9161918B2 (en) 2005-05-02 2015-10-20 Adare Pharmaceuticals, Inc. Timed, pulsatile release systems
CN100417381C (zh) * 2006-02-09 2008-09-10 西安力邦医药科技有限责任公司 尼可地尔冻干粉的制备方法
US20090076095A1 (en) * 2007-09-15 2009-03-19 Protia, Llc Deuterium-enriched nicorandil
GB0720516D0 (en) * 2007-10-18 2007-11-28 Cadbury Schweppes Plc Comestible products
ES2668203T3 (es) 2009-12-02 2018-05-17 Adare Pharmaceuticals S.R.L. Microcápsulas de fexofenadina y composiciones que las contienen
WO2011085181A1 (en) * 2010-01-08 2011-07-14 Eurand, Inc. Taste masked topiramate composition and an orally disintegrating tablet comprising the same
CN111606847B (zh) * 2020-05-26 2021-12-31 中国科学院上海药物研究所 尼可地尔与1-羟基-2-萘甲酸的共晶及其制备方法和应用
CN114732792A (zh) * 2022-03-25 2022-07-12 北京诺康达医药科技股份有限公司 一种尼可地尔口腔崩解片及其制备方法
CN115317456A (zh) * 2022-08-17 2022-11-11 北京科源创欣科技有限公司 一种尼可地尔片组合物及其制备方法
CN115282123B (zh) * 2022-09-13 2023-11-03 南京比逊医药科技有限公司 一种稳定的尼可地尔制剂的制备方法

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3168438A (en) * 1962-08-09 1965-02-02 Synergistics Inc Vasodilation by nitric acid ester derivatives of nicotinic acid
US3332848A (en) * 1963-07-10 1967-07-25 Hoffmann La Roche Microcrystalline cellulose with starch in niacinamide ascorbic acid tablet granulations
US3577491A (en) * 1968-01-02 1971-05-04 Miles Lab Tableting
DK145608C (da) * 1976-04-02 1983-07-11 Chugai Pharmaceutical Co Ltd Analogifremgangsmaade til fremstilling af salpetersyreesteren af n-(2-hydroxyethyl)nicotinamid
US4200640A (en) * 1976-04-02 1980-04-29 Chugai Seiyaku Kabushiki Kaisha Nitric ester of N-(2-hydroxyethyl)nicotinamide and pharmaceutical use
JPS599539B2 (ja) * 1979-11-13 1984-03-03 日本化薬株式会社 ニトログリセリン水溶液及びその製造法
DE3175410D1 (en) * 1980-07-29 1986-11-06 Sanofi Sa Acid stabilized compositions of thieno-pyridine derived compounds and process for preventing degradation of such compounds
US4490377A (en) * 1980-07-29 1984-12-25 Syntex (U.S.A.) Inc. Acid stabilized compositions of thieno-pyridine derived compounds
US4382091A (en) * 1981-04-30 1983-05-03 Syntex (U.S.A.) Inc. Stabilization of 1-substituted imidazole derivatives in talc
JPS5885819A (ja) * 1981-11-17 1983-05-23 Chugai Pharmaceut Co Ltd 気管支拡張剤
DK150008C (da) * 1981-11-20 1987-05-25 Benzon As Alfred Fremgangsmaade til fremstilling af et farmaceutisk oralt polydepotpraeparat
DE3244178A1 (de) * 1982-11-30 1984-05-30 Bayer Ag, 5090 Leverkusen 1,4-dihydropyridinderivate, verfahren zu ihrer herstellung sowie ihre verwendung in arzneimitteln

Also Published As

Publication number Publication date
FI84781B (fi) 1991-10-15
HU195731B (en) 1988-07-28
EP0185347B1 (de) 1990-06-27
EP0185347A3 (en) 1987-04-22
CN85109190A (zh) 1986-07-16
PT81680A (en) 1986-01-01
DK583385D0 (da) 1985-12-16
PT81680B (pt) 1988-11-30
CA1255227A (en) 1989-06-06
CN1007209B (zh) 1990-03-21
RU1811401C (ru) 1993-04-23
AU5076285A (en) 1986-06-26
NO171826C (no) 1993-05-12
ZA859390B (en) 1986-08-27
HK65493A (en) 1993-07-16
SG52493G (en) 1993-08-06
US4803213A (en) 1989-02-07
ATE54050T1 (de) 1990-07-15
FI84781C (fi) 1992-01-27
DK167171B1 (da) 1993-09-13
NO855048L (no) 1986-06-18
KR930007251B1 (ko) 1993-08-04
JPS61143316A (ja) 1986-07-01
NO171826B (no) 1993-02-01
HUT40567A (en) 1987-01-28
AR241515A1 (es) 1992-08-31
YU197385A (en) 1988-04-30
DK583385A (da) 1986-06-18
AU579431B2 (en) 1988-11-24
BA98214B1 (bs) 1999-08-02
EP0185347A2 (de) 1986-06-25
FI855032A (fi) 1986-06-18
IE853176L (en) 1986-06-17
FI855032A0 (fi) 1985-12-17
MX166095B (es) 1992-12-18
JPH0653658B2 (ja) 1994-07-20
KR860004633A (ko) 1986-07-11
YU45292B (en) 1992-05-28
IE59158B1 (en) 1994-01-12

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Legal Events

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8364 No opposition during term of opposition