CN101932308B - 改良的配制剂和用于冻干的方法及由此提供的冻干物 - Google Patents

改良的配制剂和用于冻干的方法及由此提供的冻干物 Download PDF

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CN101932308B
CN101932308B CN200880126038.6A CN200880126038A CN101932308B CN 101932308 B CN101932308 B CN 101932308B CN 200880126038 A CN200880126038 A CN 200880126038A CN 101932308 B CN101932308 B CN 101932308B
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glibenclamide
compound
solution
lyophilizing
lyophilized
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CN101932308A (zh
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斯文·M·雅各布森
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Remedy Pharmaceuticals Inc
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    • 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
    • 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
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    • 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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
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    • A61K9/0012—Galenical forms characterised by the site of application
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    • A—HUMAN NECESSITIES
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • 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
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    • 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
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    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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    • A61P7/10—Antioedematous agents; Diuretics
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
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    • 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
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  • Urology & Nephrology (AREA)
  • Endocrinology (AREA)
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  • 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)
CN200880126038.6A 2007-12-04 2008-12-03 改良的配制剂和用于冻干的方法及由此提供的冻干物 Active CN101932308B (zh)

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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

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CN101932308B true CN101932308B (zh) 2014-11-05

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US (6) US8277845B2 (enExample)
EP (2) EP2868315B1 (enExample)
JP (5) JP5812318B2 (enExample)
CN (1) CN101932308B (enExample)
CA (3) CA3123813C (enExample)
CY (1) CY1119256T1 (enExample)
DK (1) DK2868315T3 (enExample)
ES (1) ES2638977T3 (enExample)
HR (1) HRP20171223T1 (enExample)
LT (1) LT2868315T (enExample)
PL (1) PL2868315T3 (enExample)
PT (1) PT2868315T (enExample)
SI (1) SI2868315T1 (enExample)
WO (1) WO2009073711A1 (enExample)

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CN117320727A (zh) * 2021-03-04 2023-12-29 生物切萨皮克有限责任公司 低吸附格列本脲制剂及方法
WO2025087311A1 (zh) 2023-10-24 2025-05-01 江苏恒瑞医药股份有限公司 一种磺酰脲类衍生物的药物组合物

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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 Priority date Publication date Assignee Title
CN117320727A (zh) * 2021-03-04 2023-12-29 生物切萨皮克有限责任公司 低吸附格列本脲制剂及方法
WO2025087311A1 (zh) 2023-10-24 2025-05-01 江苏恒瑞医药股份有限公司 一种磺酰脲类衍生物的药物组合物

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EP2224913A1 (en) 2010-09-08
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US20130245069A1 (en) 2013-09-19
US10869835B2 (en) 2020-12-22
US20210244669A1 (en) 2021-08-12
JP2020007334A (ja) 2020-01-16
US10426729B2 (en) 2019-10-01
US20190099372A1 (en) 2019-04-04
US20100273886A1 (en) 2010-10-28
US8858997B2 (en) 2014-10-14
US10117834B2 (en) 2018-11-06
EP2868315B1 (en) 2017-05-31
EP2868315A1 (en) 2015-05-06
CA3123813C (en) 2024-10-08
DK2868315T3 (en) 2017-09-04
EP2224913A4 (en) 2013-04-24
JP6377189B2 (ja) 2018-08-22
ES2638977T3 (es) 2017-10-24
JP6866438B2 (ja) 2021-04-28
JP5812318B2 (ja) 2015-11-11
US20200093747A1 (en) 2020-03-26
WO2009073711A1 (en) 2009-06-11
CA2707484C (en) 2021-08-10
US8277845B2 (en) 2012-10-02
CY1119256T1 (el) 2018-02-14
JP2011505424A (ja) 2011-02-24
EP2224913B1 (en) 2014-10-15
JP2017128569A (ja) 2017-07-27
PT2868315T (pt) 2017-09-04
SI2868315T1 (sl) 2017-10-30
JP6084639B2 (ja) 2017-02-22
JP6603762B2 (ja) 2019-11-06
CA3123813A1 (en) 2009-06-11
CA2707484A1 (en) 2009-06-11
CN101932308A (zh) 2010-12-29
LT2868315T (lt) 2017-09-25
JP2018197244A (ja) 2018-12-13
CA3240562A1 (en) 2009-06-11
US20150141516A1 (en) 2015-05-21
PL2868315T3 (pl) 2018-06-29

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