HK65493A - Method for production of stable nicorandil preparation - Google Patents

Method for production of stable nicorandil preparation Download PDF

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Publication number
HK65493A
HK65493A HK654/93A HK65493A HK65493A HK 65493 A HK65493 A HK 65493A HK 654/93 A HK654/93 A HK 654/93A HK 65493 A HK65493 A HK 65493A HK 65493 A HK65493 A HK 65493A
Authority
HK
Hong Kong
Prior art keywords
nicorandil
acid
preparation
stable
tablets
Prior art date
Application number
HK654/93A
Other languages
English (en)
French (fr)
Inventor
Yoshimitsu Iida
Takashi Terazono
Shuji Sumida
Original Assignee
Chugai Seiyaku Kabushiki Kaisha
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 Seiyaku Kabushiki Kaisha filed Critical Chugai Seiyaku Kabushiki Kaisha
Publication of HK65493A publication Critical patent/HK65493A/en

Links

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
    • 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
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
    • 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
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • 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
    • 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
    • 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
    • A61K9/2072—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (6)

1. Stabiles, Nicorandil enthaltendes pharmazeutisches Präparat, enthaltend Nicorandil und als pharmazeutisch verträgliche(n) Träger einen Zucker mit einer durchschnittlichen Teilchengröße von nicht mehr als 10 um und/oder eine pulverförmige organische Säure.
2. Präparat nach Anspruch 1, wobei es sich bei dem Zucker um Mannit, Lactose, Saccharose, Glucose, Galactose, Maltose und/oder Fructose handelt.
3. Präparat nach Anspruch 1, wobei es sich bei der organischen Säure um Fumarsäure, Oxsalsäure, Salicylsäure, Weinsäure und/oder Glutarsäure handelt.
4. Präparat nach Anspruch 1, wobei die organische Säure einen Anteil von mindestens 0,1 Gew.-%, bezogen auf das Gesamtgewicht des Präparats, ausmacht.
5. Verfahren zur Herstellung eines stabilen, Nicorandil enthaltenden pharmazeutischen Präparats nach Anspruch 1, bei dem man Nicorandil mit einem Zucker mit einer Teilchengröße von nicht mehr als 10 um und/oder einer pulverförmigen organischen Säure vermischt.
6. Verfahren nach Anspruch 5, wobei die organische Säure in einer Menge von mindestens 0,1 Gew.- %, bezogen auf das Gesamtgewicht des Präparats, zugesetzt wird.
HK654/93A 1984-12-17 1993-07-08 Method for production of stable nicorandil preparation HK65493A (en)

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
HK65493A true HK65493A (en) 1993-07-16

Family

ID=27319808

Family Applications (1)

Application Number Title Priority Date Filing Date
HK654/93A HK65493A (en) 1984-12-17 1993-07-08 Method for production of stable nicorandil preparation

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)

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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
AU718658B2 (en) 1996-04-16 2000-04-20 Bayer Aktiengesellschaft D-mannitol and its preparation
US6235947B1 (en) * 1997-04-14 2001-05-22 Takeda Chemical Industries, Ltd. D-mannitol and its preparation
US8071128B2 (en) 1996-06-14 2011-12-06 Kyowa Hakko Kirin Co., Ltd. Intrabuccally rapidly disintegrating tablet and a production method of the tablets
KR100481583B1 (ko) * 1996-06-14 2005-07-12 교와 핫꼬 고교 가부시끼가이샤 구강내에서빠르게붕괴하는정제
JP3797387B2 (ja) * 1996-06-14 2006-07-19 協和醗酵工業株式会社 口腔内速崩壊錠
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
CN102958515A (zh) 2009-12-02 2013-03-06 阿普塔利斯制药有限公司 非索非那定微胶囊及含有非索非那定微胶囊的组合物
US20110212171A1 (en) * 2010-01-08 2011-09-01 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

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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
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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
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
JPS61143316A (ja) 1986-07-01
DK583385D0 (da) 1985-12-16
AU579431B2 (en) 1988-11-24
ATE54050T1 (de) 1990-07-15
HUT40567A (en) 1987-01-28
CN1007209B (zh) 1990-03-21
FI855032L (fi) 1986-06-18
FI84781C (fi) 1992-01-27
RU1811401C (ru) 1993-04-23
US4803213A (en) 1989-02-07
YU45292B (en) 1992-05-28
PT81680B (pt) 1988-11-30
IE853176L (en) 1986-06-17
HU195731B (en) 1988-07-28
DK583385A (da) 1986-06-18
AU5076285A (en) 1986-06-26
AR241515A1 (es) 1992-08-31
YU197385A (en) 1988-04-30
KR860004633A (ko) 1986-07-11
NO855048L (no) 1986-06-18
DK167171B1 (da) 1993-09-13
FI84781B (fi) 1991-10-15
EP0185347A3 (en) 1987-04-22
NO171826C (no) 1993-05-12
EP0185347B1 (de) 1990-06-27
IE59158B1 (en) 1994-01-12
NO171826B (no) 1993-02-01
FI855032A0 (fi) 1985-12-17
DE3578373D1 (de) 1990-08-02
SG52493G (en) 1993-08-06
MX166095B (es) 1992-12-18
KR930007251B1 (ko) 1993-08-04
BA98214B1 (bs) 1999-08-02
CN85109190A (zh) 1986-07-16
JPH0653658B2 (ja) 1994-07-20
CA1255227A (en) 1989-06-06
ZA859390B (en) 1986-08-27
PT81680A (en) 1986-01-01
EP0185347A2 (de) 1986-06-25

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Effective date: 20051215