CA2307547A1 - Chronotherapeutic diltiazem formulations and the administration thereof - Google Patents

Chronotherapeutic diltiazem formulations and the administration thereof Download PDF

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Publication number
CA2307547A1
CA2307547A1 CA002307547A CA2307547A CA2307547A1 CA 2307547 A1 CA2307547 A1 CA 2307547A1 CA 002307547 A CA002307547 A CA 002307547A CA 2307547 A CA2307547 A CA 2307547A CA 2307547 A1 CA2307547 A1 CA 2307547A1
Authority
CA
Canada
Prior art keywords
diltiazem
given
administration
hours
release
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.)
Granted
Application number
CA002307547A
Other languages
French (fr)
Other versions
CA2307547C (en
Inventor
Kenneth Stephen Albert
Paul Jose Maes
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.)
Valeant International Bermuda
Original Assignee
Biovail Laboratories Inc
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=25681399&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2307547(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from CA002292247A external-priority patent/CA2292247A1/en
Application filed by Biovail Laboratories Inc filed Critical Biovail Laboratories Inc
Priority to CA002566590A priority Critical patent/CA2566590C/en
Priority to CA002307547A priority patent/CA2307547C/en
Priority to US09/567,451 priority patent/US7108866B1/en
Priority to EP00930909A priority patent/EP1235562B1/en
Priority to DE60042168T priority patent/DE60042168D1/en
Priority to AT00930909T priority patent/ATE430561T1/en
Priority to ES00930909T priority patent/ES2325826T3/en
Priority to AU49037/00A priority patent/AU4903700A/en
Priority to JP2001543089A priority patent/JP2003516347A/en
Priority to PCT/CA2000/000593 priority patent/WO2001041744A1/en
Publication of CA2307547A1 publication Critical patent/CA2307547A1/en
Publication of CA2307547C publication Critical patent/CA2307547C/en
Application granted granted Critical
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A61K9/50—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
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of 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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K9/14—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
    • 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
    • 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
    • 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
    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

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

Abstract

A controlled-release Galenical preparation of pharmaceutically acceptable Diltiazem including the pharmaceutically acceptable salts thereof, suitable for evening dosing every 24 hours containing from about 120 mg to about 540 mg or more (as desired) of the form of Diltiazem associated with excipients to provide controlled (sustained) release of the form of Diltiazem for providing a C max of Diltiazem in the blood at between about 10 hours and about 15 hours after administration, the preparation comprising the form of Diltiazem in oral sustained--release dosage form in which the Diltiazem is adapted to be released after administration over a prolonged period of time and exhibits when given to humans (i) a higher bioavailability when given at night compared to when given in the morning without food according to FDA guidelines or criteria and (ii) bioequivalence when given in the morning with and without food according to the same FDA guidelines or criteria.
CA002307547A 1999-12-10 2000-05-04 Chronotherapeutic diltiazem formulations and the administration thereof Expired - Lifetime CA2307547C (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
CA002566590A CA2566590C (en) 1999-12-10 2000-05-04 Cronotherapeutic diltiazem formulation and the administration thereof
CA002307547A CA2307547C (en) 1999-12-10 2000-05-04 Chronotherapeutic diltiazem formulations and the administration thereof
US09/567,451 US7108866B1 (en) 1999-12-10 2000-05-08 Chronotherapeutic diltiazem formulations and the administration thereof
PCT/CA2000/000593 WO2001041744A1 (en) 1999-12-10 2000-05-23 Chronotherapeutic diltiazem formulations and the administration thereof
AT00930909T ATE430561T1 (en) 1999-12-10 2000-05-23 CHRONOTHERAPEUTIC DILTIAZEM FORMULATIONS AND THEIR ADMINISTRATION
DE60042168T DE60042168D1 (en) 1999-12-10 2000-05-23 CHRONOTHERAPEUTIC DILTIAZEM FORMULATIONS AND THEIR ADMINISTRATION
EP00930909A EP1235562B1 (en) 1999-12-10 2000-05-23 Chronotherapeutic diltiazem formulations and the administration thereof
ES00930909T ES2325826T3 (en) 1999-12-10 2000-05-23 FORMULATIONS OF DILTIAZEM CHRONOTHERAPEUTICS AND ITS ADMINISTRATION.
AU49037/00A AU4903700A (en) 1999-12-10 2000-05-23 Chronotherapeutic diltiazem formulations and the administration thereof
JP2001543089A JP2003516347A (en) 1999-12-10 2000-05-23 Diltiazem preparation for chronotherapy and its administration method

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CA002292247A CA2292247A1 (en) 1999-12-10 1999-12-10 Chronotherapeutic formulations of diltiazem and the administration thereof
CA2,292,247 1999-12-10
CA002307547A CA2307547C (en) 1999-12-10 2000-05-04 Chronotherapeutic diltiazem formulations and the administration thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA002566590A Division CA2566590C (en) 1999-12-10 2000-05-04 Cronotherapeutic diltiazem formulation and the administration thereof

Publications (2)

Publication Number Publication Date
CA2307547A1 true CA2307547A1 (en) 2001-06-10
CA2307547C CA2307547C (en) 2007-08-14

Family

ID=25681399

Family Applications (2)

Application Number Title Priority Date Filing Date
CA002307547A Expired - Lifetime CA2307547C (en) 1999-12-10 2000-05-04 Chronotherapeutic diltiazem formulations and the administration thereof
CA002566590A Expired - Lifetime CA2566590C (en) 1999-12-10 2000-05-04 Cronotherapeutic diltiazem formulation and the administration thereof

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA002566590A Expired - Lifetime CA2566590C (en) 1999-12-10 2000-05-04 Cronotherapeutic diltiazem formulation and the administration thereof

Country Status (1)

Country Link
CA (2) CA2307547C (en)

Also Published As

Publication number Publication date
CA2307547C (en) 2007-08-14
CA2566590C (en) 2008-04-15
CA2566590A1 (en) 2001-06-10

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MKEX Expiry

Effective date: 20200504