HK12295A - Process for the preparation of stabilized isosorbide-5-mononitrate tablets, being also of sustained release, and formulations thus obtained - Google Patents

Process for the preparation of stabilized isosorbide-5-mononitrate tablets, being also of sustained release, and formulations thus obtained Download PDF

Info

Publication number
HK12295A
HK12295A HK12295A HK12295A HK12295A HK 12295 A HK12295 A HK 12295A HK 12295 A HK12295 A HK 12295A HK 12295 A HK12295 A HK 12295A HK 12295 A HK12295 A HK 12295A
Authority
HK
Hong Kong
Prior art keywords
tablets
isosorbide
mononitrate
mixture
pvp
Prior art date
Application number
HK12295A
Other languages
German (de)
English (en)
Inventor
Massimo Calanchi
Piergiorgio Rossi
Original Assignee
Eurand International S.P.A.
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 Eurand International S.P.A. filed Critical Eurand International S.P.A.
Publication of HK12295A publication Critical patent/HK12295A/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
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • 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
    • A61K9/2027—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/08—Vasodilators for multiple indications
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (7)

  1. Procédé pour préparer une formulation pharmaceutique convenable pour la fabrication de comprimés normaux ou à effet retard contenant, en plus des excipients généralement utilisés dans la préparation des comprimés, de l'isosorbide-5-mononitrate en doses efficaces du point de vue thérapeutique et une polyvinylpyrrolidone (PVP) selon un rapport compris entre 1/5 et 5/1 et de préférence entre 1/2 et 2/1, caractérisé en ce que le composant actif, l'isosorbide-5-mononitrate, est mélangé à une polyvinylpyrrolidone (PVP) en tant que liant pour former une solution solide, et que ce mélange est ensuite empastillé en comprimés.
  2. Procédé suivant la revendication 1, caractérisé en ce que le rapport entre la polyvinylpyrrolidone et l'isosorbide-5-mononitrate est compris entre 1/5 et 5/1 et de préférence entre 1/2 et 2/1.
  3. Procédé suivant la revendication 1, caractérisé en ce que pour obtenir des comprimés à libération continue, des substances qui confèrent un effet retard sont ajoutées au mélange en des quantités variant entre 20 et 80% du poids du comprimé et de préférence mélangées au préalable.
  4. Procédé suivant la revendication 3, caractérisé en ce que les substances qui confèrent l'effet retard sont une hydropropylméthylcellulose, seule ou avec d'autres dérivés cellulosiques, comme une hydroxypropylcellulose, une éthyl cellulose et une carboxyméthylcellulose.
  5. Procédé suivant la revendication 1, caractérisé en ce qu'avant d'être mélangé aux autres composants de la formulation, l'isosorbide-5-mononitrate est mélangé au préalable avec un agent qui augmente la fluidité du composant actif, comme une silice colloïdale, la lévilite et le lactose.
  6. Procédé suivant l'une quelconque des revendications 1 à 5, caractérisé en ce que d'autres excipients inertes et/ou lubrifiants qui améliorent les qualités physiques à la fois du mélange à empastiller et des comprimés finis, sont ajoutés au mélange à comprimer.
  7. Procédé suivant la revendication 6, caractérisé en ce que du stéarate de magnésium, de l'acide stéarique et des poluéthylène glycols sont utilisés de préférence, mais non exclusivement, en tant que lubrifiants.
HK12295A 1985-10-15 1995-01-26 Process for the preparation of stabilized isosorbide-5-mononitrate tablets, being also of sustained release, and formulations thus obtained HK12295A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT22493/85A IT1187750B (it) 1985-10-15 1985-10-15 Procedimento per la preparazione di compresse,anche a rilascio prolungato,di iscsorbide-5-mononitrato stabilizzato e formulazioni cosi' ottenute

Publications (1)

Publication Number Publication Date
HK12295A true HK12295A (en) 1995-02-03

Family

ID=11197007

Family Applications (1)

Application Number Title Priority Date Filing Date
HK12295A HK12295A (en) 1985-10-15 1995-01-26 Process for the preparation of stabilized isosorbide-5-mononitrate tablets, being also of sustained release, and formulations thus obtained

Country Status (12)

Country Link
US (1) US4812316A (fr)
EP (1) EP0219161B1 (fr)
JP (1) JPS62123114A (fr)
AT (1) ATE71290T1 (fr)
AU (1) AU591185B2 (fr)
CA (1) CA1285489C (fr)
DE (1) DE3683342D1 (fr)
ES (1) ES2035819T3 (fr)
GR (1) GR3004285T3 (fr)
HK (1) HK12295A (fr)
IT (1) IT1187750B (fr)
ZA (1) ZA867768B (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111068644A (zh) * 2019-12-20 2020-04-28 中海油天津化工研究设计院有限公司 一种均四甲苯氧化制均酐催化剂及其制备方法

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IE64726B1 (en) * 1987-11-20 1995-08-23 Elan Corp Plc Pharmaceutical formulations for preventing drug tolerance
IT1237638B (it) * 1989-10-25 1993-06-12 Ghirardi Paolo E. Impiego dell'isosorbide 2-mononitrato per la preparazione di composi- zioni farmaceutiche atte al trattamento dell'angina pectoris
FR2666506A1 (fr) * 1990-09-07 1992-03-13 Pf Medicament Comprime a liberation prolongee a base de 5-mononitrate d'isosorbide et son procede de preparation.
FR2677886B1 (fr) * 1991-06-18 1995-03-31 Adir Comprime matriciel permettant la liberation prolongee d'indapamide apres administration par voie orale.
IT1251114B (it) * 1991-07-26 1995-05-04 Farcon Ag Forme farmaceutiche antivirali per applicazione vaginale
DE4313726A1 (de) * 1993-04-27 1994-11-03 Byk Nederland Bv Feste Darreichungsform
US6080428A (en) 1993-09-20 2000-06-27 Bova; David J. Nicotinic acid compositions for treating hyperlipidemia and related methods therefor
US6129930A (en) 1993-09-20 2000-10-10 Bova; David J. Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night
US6818229B1 (en) 1993-09-20 2004-11-16 Kos Pharmaceuticals, Inc. Intermediate release nicotinic acid compositions for treating hyperlipidemia
US6676967B1 (en) * 1993-09-20 2004-01-13 Kos Pharmaceuticals, Inc. Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia
US20060263428A1 (en) * 1993-09-20 2006-11-23 Eugenio Cefali Methods for treating hyperlipidemia with intermediate release nicotinic acid compositions having unique biopharmaceutical characteristics
US6746691B2 (en) 1993-09-20 2004-06-08 Kos Pharmaceuticals, Inc. Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics
US5900425A (en) * 1995-05-02 1999-05-04 Bayer Aktiengesellschaft Pharmaceutical preparations having controlled release of active compound and processes for their preparation
DE19515972A1 (de) * 1995-05-02 1996-11-07 Bayer Ag Arzneizubereitungen mit kontrollierter Freisetzung und Verfahren zu ihrer Herstellung
WO1998005306A1 (fr) * 1996-08-02 1998-02-12 Cal International Limited Composition de comprime a liberation controlee d'isosorbide-5-mononitrate
US5851555A (en) * 1997-08-15 1998-12-22 Fuisz Technologies Ltd. Controlled release dosage forms containing water soluble drugs
PE20011065A1 (es) 2000-02-01 2001-11-21 Procter & Gamble Proceso para fabricar bisfosfonatos geminales
US6410520B2 (en) 2000-02-01 2002-06-25 The Procter & Gamble Company Selective crystallization of 3-pyridyl-1-hydroxyethylidene-1, 1-bisphosphonic acid sodium as the hemipentahydrate or monohydrate
JP4696210B2 (ja) * 2000-06-07 2011-06-08 トーアエイヨー株式会社 イソソルビド‐５‐モノニトレートを有効成分とする徐放性錠剤及びその製造方法
JP4840549B2 (ja) * 2000-11-20 2011-12-21 トーアエイヨー株式会社 安定な血管拡張剤及びその製造方法
US7008979B2 (en) * 2002-04-30 2006-03-07 Hydromer, Inc. Coating composition for multiple hydrophilic applications
US20040109889A1 (en) * 2002-12-04 2004-06-10 Bunick Frank J. Surface treatment composition for soft substrates
AU2006340298B2 (en) * 2006-03-16 2012-10-04 Glycologic Limited Gastric raft composition comprising preferably processed starches for inducing satiety
CN115487162B (zh) * 2022-10-13 2023-10-13 山东力诺制药有限公司 一种单硝酸异山梨酯缓释片的制备方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2301664C3 (de) * 1973-01-13 1979-07-12 Byk Gulden Lomberg Chemische Fabrik Gmbh, 7750 Konstanz Oral verabreichbares, Nitroglycerin enthaltendes Arzneimittel
US3972995A (en) * 1975-04-14 1976-08-03 American Home Products Corporation Dosage form
US4291015A (en) * 1979-08-14 1981-09-22 Key Pharmaceuticals, Inc. Polymeric diffusion matrix containing a vasodilator
IL61721A (en) * 1980-12-16 1984-03-30 Blank Izhak Nitroglycerin preparations
US4369172A (en) * 1981-12-18 1983-01-18 Forest Laboratories Inc. Prolonged release therapeutic compositions based on hydroxypropylmethylcellulose
DE3325652A1 (de) * 1983-07-15 1985-01-24 Dr. Rentschler Arzneimittel Gmbh & Co, 7958 Laupheim Feste, stabile isosorbid-5-mononitrat enthaltende arzneimittelzubereitungen und verfahren zu ihrer herstellung
JPS60181052A (ja) * 1984-02-29 1985-09-14 Tooa Eiyoo Kk 安定なイソソルビド硝酸エステル組成物及びその製造法

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111068644A (zh) * 2019-12-20 2020-04-28 中海油天津化工研究设计院有限公司 一种均四甲苯氧化制均酐催化剂及其制备方法
CN111068644B (zh) * 2019-12-20 2023-01-03 中海油天津化工研究设计院有限公司 一种均四甲苯氧化制均酐催化剂及其制备方法

Also Published As

Publication number Publication date
JPS62123114A (ja) 1987-06-04
US4812316A (en) 1989-03-14
CA1285489C (fr) 1991-07-02
ES2035819T3 (es) 1993-05-01
IT1187750B (it) 1987-12-23
ZA867768B (en) 1987-06-24
ATE71290T1 (de) 1992-01-15
IT8522493A0 (it) 1985-10-15
GR3004285T3 (fr) 1993-03-31
EP0219161A2 (fr) 1987-04-22
EP0219161A3 (en) 1988-01-13
DE3683342D1 (de) 1992-02-20
JPH0524888B2 (fr) 1993-04-09
AU591185B2 (en) 1989-11-30
EP0219161B1 (fr) 1992-01-08
AU6383186A (en) 1987-04-16

Similar Documents

Publication Publication Date Title
EP0219161B1 (fr) Procédé de préparation de comprimés d'isosorbide-5-mononitrate à effet retardé et leurs formulations ainsi obtenues
US4834984A (en) Controlled release dihydrocodeine composition
CA1315202C (fr) Formule orale d'acetaminophene a liberation progressive et mode de fabrication
US5211958A (en) Pharmaceutical composition and process for its preparation
NO174795B (no) Fremgangsmåte for fremstilling av faste farmasöytiske preparater som inneholder estere og/eller etere av polyetylenglykoler som opplöseliggjörende middel
IE921952A1 (en) Matrix tablet permitting the sustained release of indapamide after oral administration
GB2196852A (en) Sustained release composition
US4822808A (en) Method for production of stable nicorandil preparation
KR920006908B1 (ko) 디히드로피리딘을 함유하는 고상 약제의 제조 방법
JP3110794B2 (ja) １，４−ジヒドロピリジン誘導体を含有する製剤
EP0284849B1 (fr) Comprimés à libération retardée à base d'hydroxypropylméthylcellulose à poids moléculaire élevé et procédé pour leur fabrication
KR20040006887A (ko) 아세트아미노펜을 함유하는 제어방출성의 경구용 제제
EP0441245B1 (fr) Procédé de préparation de comprimés médicamenteux à libération retardée
EP0449426B1 (fr) Composition pharmaceutique
US5266581A (en) Solid composition containing dihydropyridine, PVP and PVPP
WO2010018866A1 (fr) Composition pharmaceutique stabilisée
KR100267525B1 (ko) 시타라빈 옥포스페이트 경질 캡슐제
EP1713452B1 (fr) Composition pharmaceutique d'indapamide a liberation prolongee
CN114533690B (zh) 含抗凝血药物西洛他唑的新制剂及其制备方法
JPH1067657A (ja) マルチプルユニット型持続性製剤
RU2079301C1 (ru) Способ регулируемого выделения активного вещества из состава
EP2175855B1 (fr) Composition pharmaceutique stable d'un sel de vinorelbine soluble dans l'eau
JPH0474137A (ja) 徐放性製剤用基剤粉末
JPH05124966A (ja) カルシトリオール固形製剤
EP1001773A1 (fr) Compositions pharmaceutiques solides pour administration par voie orale permettant la liberation modulee de nicorandil et leur procede de preparation

Legal Events

Date Code Title Description
PC Patent ceased (i.e. patent has lapsed due to the failure to pay the renewal fee)