CA2707484C - Improved formulations and methods for lyophilization and lyophilates provided thereby - Google Patents

Improved formulations and methods for lyophilization and lyophilates provided thereby Download PDF

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Publication number
CA2707484C
CA2707484C CA2707484A CA2707484A CA2707484C CA 2707484 C CA2707484 C CA 2707484C CA 2707484 A CA2707484 A CA 2707484A CA 2707484 A CA2707484 A CA 2707484A CA 2707484 C CA2707484 C CA 2707484C
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Prior art keywords
glibenclamide
pharmaceutical composition
composition
solution
pharmaceutically acceptable
Prior art date
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Active
Application number
CA2707484A
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English (en)
French (fr)
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CA2707484A1 (en
Inventor
Sven Martin Jacobson
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.)
Remedy Pharmaceuticals Inc
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Biogen Chesapeake LLC
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Filing date
Publication date
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Priority to CA3123813A priority Critical patent/CA3123813C/en
Publication of CA2707484A1 publication Critical patent/CA2707484A1/en
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Publication of CA2707484C publication Critical patent/CA2707484C/en
Active legal-status Critical Current
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    • 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
    • A61K9/1682—Processes
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/17—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
    • A61K31/175—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine having the group, >N—C(O)—N=N— or, e.g. carbonohydrazides, carbazones, semicarbazides, semicarbazones; Thioanalogues thereof
    • 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
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/451—Non condensed piperidines, e.g. piperocaine having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
    • 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
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • 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
    • A61K9/1611—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
    • A61K9/14—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
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10—Antioedematous agents; Diuretics
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Psychology (AREA)
  • Emergency Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Obesity (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
CA2707484A 2007-12-04 2008-12-03 Improved formulations and methods for lyophilization and lyophilates provided thereby Active CA2707484C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3123813A CA3123813C (en) 2007-12-04 2008-12-03 IMPROVED GLIBENCLAMIDE FORMULATIONS AND RELATED FREEZE-DRYING METHODS, AND FREEZE-DRY SATE PRODUCED THUS

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US99224107P 2007-12-04 2007-12-04
US60/992,241 2007-12-04
PCT/US2008/085384 WO2009073711A1 (en) 2007-12-04 2008-12-03 Improved formulations and methods for lyophilization and lyophilates provided thereby

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3123813A Division CA3123813C (en) 2007-12-04 2008-12-03 IMPROVED GLIBENCLAMIDE FORMULATIONS AND RELATED FREEZE-DRYING METHODS, AND FREEZE-DRY SATE PRODUCED THUS

Publications (2)

Publication Number Publication Date
CA2707484A1 CA2707484A1 (en) 2009-06-11
CA2707484C true CA2707484C (en) 2021-08-10

Family

ID=40718143

Family Applications (3)

Application Number Title Priority Date Filing Date
CA2707484A Active CA2707484C (en) 2007-12-04 2008-12-03 Improved formulations and methods for lyophilization and lyophilates provided thereby
CA3123813A Active CA3123813C (en) 2007-12-04 2008-12-03 IMPROVED GLIBENCLAMIDE FORMULATIONS AND RELATED FREEZE-DRYING METHODS, AND FREEZE-DRY SATE PRODUCED THUS
CA3240562A Pending CA3240562A1 (en) 2007-12-04 2008-12-03 Improved formulations and methods for lyophilization and lyophilates provided thereby

Family Applications After (2)

Application Number Title Priority Date Filing Date
CA3123813A Active CA3123813C (en) 2007-12-04 2008-12-03 IMPROVED GLIBENCLAMIDE FORMULATIONS AND RELATED FREEZE-DRYING METHODS, AND FREEZE-DRY SATE PRODUCED THUS
CA3240562A Pending CA3240562A1 (en) 2007-12-04 2008-12-03 Improved formulations and methods for lyophilization and lyophilates provided thereby

Country Status (14)

Country Link
US (6) US8277845B2 (show.php)
EP (2) EP2224913B1 (show.php)
JP (5) JP5812318B2 (show.php)
CN (1) CN101932308B (show.php)
CA (3) CA2707484C (show.php)
CY (1) CY1119256T1 (show.php)
DK (1) DK2868315T3 (show.php)
ES (1) ES2638977T3 (show.php)
HR (1) HRP20171223T1 (show.php)
LT (1) LT2868315T (show.php)
PL (1) PL2868315T3 (show.php)
PT (1) PT2868315T (show.php)
SI (1) SI2868315T1 (show.php)
WO (1) WO2009073711A1 (show.php)

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CN113274361B (zh) * 2021-06-08 2022-05-06 吉林津升制药有限公司 一种烟酰胺冻干粉针剂及其制备方法
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Publication number Publication date
US10426729B2 (en) 2019-10-01
WO2009073711A1 (en) 2009-06-11
US20190099372A1 (en) 2019-04-04
EP2224913A1 (en) 2010-09-08
US10117834B2 (en) 2018-11-06
EP2868315B1 (en) 2017-05-31
CA3123813A1 (en) 2009-06-11
JP6377189B2 (ja) 2018-08-22
CY1119256T1 (el) 2018-02-14
US20210244669A1 (en) 2021-08-12
JP6866438B2 (ja) 2021-04-28
CA2707484A1 (en) 2009-06-11
US20200093747A1 (en) 2020-03-26
JP2015134763A (ja) 2015-07-27
US20150141516A1 (en) 2015-05-21
LT2868315T (lt) 2017-09-25
JP2011505424A (ja) 2011-02-24
JP6603762B2 (ja) 2019-11-06
CA3240562A1 (en) 2009-06-11
JP6084639B2 (ja) 2017-02-22
US20130245069A1 (en) 2013-09-19
CN101932308A (zh) 2010-12-29
CA3123813C (en) 2024-10-08
EP2224913A4 (en) 2013-04-24
SI2868315T1 (sl) 2017-10-30
US8858997B2 (en) 2014-10-14
US20100273886A1 (en) 2010-10-28
DK2868315T3 (en) 2017-09-04
CN101932308B (zh) 2014-11-05
JP2017128569A (ja) 2017-07-27
EP2868315A1 (en) 2015-05-06
HRP20171223T1 (hr) 2017-11-03
US8277845B2 (en) 2012-10-02
PL2868315T3 (pl) 2018-06-29
US10869835B2 (en) 2020-12-22
EP2224913B1 (en) 2014-10-15
ES2638977T3 (es) 2017-10-24
JP2018197244A (ja) 2018-12-13
JP5812318B2 (ja) 2015-11-11
PT2868315T (pt) 2017-09-04
JP2020007334A (ja) 2020-01-16

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