HK76092A - Salts of amlodipine - Google Patents

Salts of amlodipine Download PDF

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Publication number
HK76092A
HK76092A HK760/92A HK76092A HK76092A HK 76092 A HK76092 A HK 76092A HK 760/92 A HK760/92 A HK 760/92A HK 76092 A HK76092 A HK 76092A HK 76092 A HK76092 A HK 76092A
Authority
HK
Hong Kong
Prior art keywords
amlodipine
besylate salt
salt
excipients
besylate
Prior art date
Application number
HK760/92A
Other languages
German (de)
English (en)
Inventor
Edward Davison
James Ingram Dr. Wells
Original Assignee
Pfizer Limited
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=10595731&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HK76092(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pfizer Limited filed Critical Pfizer Limited
Publication of HK76092A publication Critical patent/HK76092A/en

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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • 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
    • A61P9/08—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
    • 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
    • A61P9/12—Antihypertensives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D211/00—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings
    • C07D211/04—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D211/80—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
    • C07D211/84—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms, with at the most one bond to halogen directly attached to ring carbon atoms
    • C07D211/90—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Hydrogenated Pyridines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Heterocyclic Compounds Containing Sulfur Atoms (AREA)
  • Pyridine Compounds (AREA)

Claims (12)

1. Procédé de préparation du bésylate d'amlodipine, caractérisé en ce qu'il comprend les étapes consistant à faire réagir l'amlodipine-base avec une solution d'acide benzènesulfonqiue ou de son sel d'ammonium dans un solvant inerte et à recueillir le bésylate d'amlodipine.
2. Procédé suivant la revendication 1, dans lequel le solvant inerte est l'alcool dénaturé.
3. Procédé de préparation d'une composition pharmaceutique, caractérisé en ce qu'il comprend l'étape consistant à mélanger le bésylate d'amlodipine à un diluant ou support pharmaceutiquement acceptable.
4. Procédé suivant la revendication 3 destiné à la préparation d'une formulation pour comprimés, caractérisé en ce qu'il comprend les étapes consistant à mélanger le bésylate d'amlodipine à des excipients et à effectuer la mise sous forme de comprimés.
5. Procédé suivant la revendication 4, caractérisé en ce qu'il comprend le étapes consistant
(a) à mélanger le bésylate d'amlodipine à du glycolate d'amidon sodique et à du phosphate monocalcique anhydre;
(b) à tamiser, à mélanger à nouveau et à tamiser;
(c) à effectuer un mélange avec de la cellulose microcristalline;
(d) à tamiser et à mélanger à nouveau;
(e) à effectuer un mélange avec du stéarate de magnésium; et
(f) à effectuer la mise sous forme de comprimés.
6. Procédé suivant la revendication 3, destiné à la préparation d'une formulation pour capsules, caractérisé en ce qu'il comprend les étapes consistant à mélanger le bésylate d'amlodipine à des excipients et à effectuer le remplissage de capsules.
7. Procédé suivant la revendication 6, caractérisé en ce qu'il comprend les étapes consistant
(a) à mélanger préalablement de la cellulose microcristalline et de l'amidon de maïs déshydraté;
(b) à mélanger le bésylate d'amlodipine à une partie du prémélange et à effectuer un tamisage;
(c) à effectuer le mélange au reste du prémélange, à tamiser et à mélanger à nouveau; et
(d) à remplir des capsules avec le mélange.
8. Procédé suivant la revendication 3, destiné à la préparation d'une solution aqueuse stérile du bésylate d'amlodipine pour l'administration parentérale, caractérisé en ce qu'il comprend les étapes consistant à former une solution du bésylate d'amlodipine dans un véhicule aqueux stérile.
9. Procédé suivant la revendication 8, caractérisé en ce qu'il comprend les étapes consistant
(a) à dissoudre le bésylate d'amlodipine, dans une solution stérile de chlorure de sodium, dans un mélange d'eau pour préparations injectables et de propylèneglycol;
(b) à ajuster le volume de la solution avec une quantité supplémentaire d'eau pour préparations injectables;
(c) à filtrer la solution à travers un filtre stérilisant; et
(d) à remplir des récipients stériles avec la solution.
10. Procédé suivant la revendication 8 ou la revendication 9, dans lequel la solution contient 20 à 40% en poids/volume de propylèneglycol et environ 1% en poids/volume de chlorure de sodium.
HK760/92A 1986-04-04 1992-10-01 Salts of amlodipine HK76092A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB868608335A GB8608335D0 (en) 1986-04-04 1986-04-04 Pharmaceutically acceptable salts

Publications (1)

Publication Number Publication Date
HK76092A true HK76092A (en) 1992-10-09

Family

ID=10595731

Family Applications (1)

Application Number Title Priority Date Filing Date
HK760/92A HK76092A (en) 1986-04-04 1992-10-01 Salts of amlodipine

Country Status (47)

Country Link
US (1) US4879303A (fr)
EP (1) EP0244944B1 (fr)
JP (1) JPS62240660A (fr)
KR (1) KR950006710B1 (fr)
CN (1) CN1023800C (fr)
AP (1) AP50A (fr)
AR (1) AR242562A1 (fr)
AT (1) ATE49752T1 (fr)
BE (1) BE1000130A4 (fr)
BG (1) BG60698B2 (fr)
CA (1) CA1321393C (fr)
CS (1) CS265237B2 (fr)
CY (1) CY1669A (fr)
CZ (1) CZ289095B6 (fr)
DD (1) DD265142A5 (fr)
DE (2) DE3710457A1 (fr)
DK (1) DK171708B1 (fr)
EC (1) ECSP941129A (fr)
EG (1) EG18266A (fr)
ES (2) ES2012803B3 (fr)
FI (1) FI85017C (fr)
FR (1) FR2596758B1 (fr)
GB (2) GB8608335D0 (fr)
GR (2) GR870525B (fr)
HK (1) HK76092A (fr)
HU (1) HU196962B (fr)
IE (1) IE59457B1 (fr)
IL (1) IL82101A (fr)
IN (1) IN168414B (fr)
IT (1) IT1203853B (fr)
LU (1) LU86812A1 (fr)
MA (1) MA20938A1 (fr)
MX (1) MX5847A (fr)
MY (1) MY101177A (fr)
NL (1) NL8700791A (fr)
NO (1) NO172181C (fr)
NZ (1) NZ219868A (fr)
PH (1) PH24348A (fr)
PL (1) PL149532B1 (fr)
PT (1) PT84611B (fr)
SE (1) SE463457B (fr)
SG (1) SG59692G (fr)
SK (1) SK278435B6 (fr)
SU (1) SU1498388A3 (fr)
UA (1) UA6344A1 (fr)
YU (1) YU44801B (fr)
ZA (1) ZA872439B (fr)

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