CN108366956B - 物理和化学稳定的吉维诺司他口服混悬液 - Google Patents

物理和化学稳定的吉维诺司他口服混悬液 Download PDF

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Publication number
CN108366956B
CN108366956B CN201680062179.0A CN201680062179A CN108366956B CN 108366956 B CN108366956 B CN 108366956B CN 201680062179 A CN201680062179 A CN 201680062179A CN 108366956 B CN108366956 B CN 108366956B
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suspension
present
agent
buffer
givenostat
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Chinese (zh)
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CN108366956A (zh
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G·哥伦布
R·阿尔蒂科
P·马斯卡尼
M·V·莫扎尼
S·普钱蒂
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Italfarmaco SpA
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/325Carbamic acids; Thiocarbamic acids; Anhydrides or salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/18Antivirals for RNA viruses for HIV
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hematology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Biochemistry (AREA)
  • Oncology (AREA)
  • Rheumatology (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Neurosurgery (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Virology (AREA)
  • Psychiatry (AREA)
  • AIDS & HIV (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
CN201680062179.0A 2015-11-03 2016-10-28 物理和化学稳定的吉维诺司他口服混悬液 Active CN108366956B (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202110722868.2A CN113368044B (zh) 2015-11-03 2016-10-28 物理和化学稳定的吉维诺司他口服混悬液

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ITUB2015A005193A ITUB20155193A1 (it) 2015-11-03 2015-11-03 Sospensioni orali di Givinostat fisicamente e chimicamente stabili
IT102015000068150 2015-11-03
PCT/IB2016/056496 WO2017077436A1 (en) 2015-11-03 2016-10-28 Physically and chemically stable oral suspensions of givinostat

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CN202110722868.2A Division CN113368044B (zh) 2015-11-03 2016-10-28 物理和化学稳定的吉维诺司他口服混悬液

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CN108366956A CN108366956A (zh) 2018-08-03
CN108366956B true CN108366956B (zh) 2021-09-10

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US (1) US10688047B2 (https=)
EP (1) EP3370697B1 (https=)
JP (1) JP6800970B2 (https=)
KR (1) KR102603894B1 (https=)
CN (2) CN108366956B (https=)
AR (1) AR106559A1 (https=)
AU (1) AU2016349169B2 (https=)
BR (1) BR122024001653A2 (https=)
CA (1) CA3002755C (https=)
CL (1) CL2018001151A1 (https=)
CO (1) CO2018003971A2 (https=)
CY (1) CY1124092T1 (https=)
DK (1) DK3370697T3 (https=)
ES (1) ES2870201T3 (https=)
FI (1) FIC20250035I1 (https=)
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HR (1) HRP20210747T1 (https=)
HU (2) HUE054123T2 (https=)
IL (1) IL258608B (https=)
IT (1) ITUB20155193A1 (https=)
LT (2) LT3370697T (https=)
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NO (1) NO2025053I1 (https=)
NZ (1) NZ741467A (https=)
PE (1) PE20181369A1 (https=)
PL (1) PL3370697T3 (https=)
PT (1) PT3370697T (https=)
RS (1) RS61694B1 (https=)
RU (1) RU2721396C2 (https=)
SI (1) SI3370697T1 (https=)
SM (1) SMT202100161T1 (https=)
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CA3142142A1 (en) 2019-05-31 2020-12-03 Viracta Subsidiary, Inc. Methods of treating virally associated cancers with histone deacetylase inhibitors
WO2022088037A1 (zh) * 2020-10-30 2022-05-05 中国科学院深圳先进技术研究院 Sirtinol在制备预防和治疗冠状病毒的药物中的应用
CN114306311A (zh) * 2022-01-14 2022-04-12 同济大学 组蛋白去乙酰化酶抑制剂在制备治疗心脏病的药物中的应用
CN116173003A (zh) * 2023-02-24 2023-05-30 山西医科大学 药物吉维司他在治疗阿尔茨海默病中的用途
WO2026052723A1 (en) 2024-09-05 2026-03-12 Italfarmaco S.P.A. Givinostat hydrochloride monohydrate for use in treating muscular dystrophy

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CN104093403A (zh) * 2012-02-03 2014-10-08 意大发马克股份公司 用于治疗肌肉萎缩症的二乙基-[6-(4-羟基氨基甲酰基-苯基-氨基甲酰氧基-甲基)-萘-2-基-甲基]-氯化铵

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SMT202100161T1 (it) 2021-05-07
BR122024001653A2 (pt) 2024-03-05
HK1254811A1 (en) 2019-07-26
CL2018001151A1 (es) 2018-12-07
DK3370697T3 (da) 2021-04-26
HRP20210747T1 (hr) 2021-06-25
MX380361B (es) 2025-03-12
JP6800970B2 (ja) 2020-12-16
KR102603894B1 (ko) 2023-11-20
CN113368044B (zh) 2023-06-02
RU2721396C2 (ru) 2020-05-19
SI3370697T1 (sl) 2021-04-30
HUE054123T2 (hu) 2021-08-30
EP3370697B1 (en) 2021-02-17
IL258608A (en) 2018-06-28
LTPA2025540I1 (https=) 2025-12-29
AR106559A1 (es) 2018-01-24
CN113368044A (zh) 2021-09-10
ITUB20155193A1 (it) 2017-05-03
NO2025053I1 (no) 2025-12-05
PE20181369A1 (es) 2018-08-27
PT3370697T (pt) 2021-04-06
IL258608B (en) 2022-06-01
BR112018008870A2 (pt) 2018-11-06
NZ741467A (en) 2021-07-30
KR20180082468A (ko) 2018-07-18
TWI727983B (zh) 2021-05-21
LT3370697T (lt) 2021-06-10
CO2018003971A2 (es) 2018-07-19
US20180311160A1 (en) 2018-11-01
CA3002755C (en) 2022-10-18
JP2019501116A (ja) 2019-01-17
CN108366956A (zh) 2018-08-03
US10688047B2 (en) 2020-06-23
BR112018008870A8 (pt) 2019-02-26
RU2018120170A3 (https=) 2019-12-05
PL3370697T3 (pl) 2021-07-12
CA3002755A1 (en) 2017-05-11
CY1124092T1 (el) 2022-05-27
AU2016349169A1 (en) 2018-05-17
TW201722401A (zh) 2017-07-01
FIC20250035I1 (fi) 2025-12-05
EP3370697A1 (en) 2018-09-12
MX2018004505A (es) 2018-09-12
WO2017077436A1 (en) 2017-05-11
RS61694B1 (sr) 2021-05-31
RU2018120170A (ru) 2019-12-05
FR25C1051I1 (fr) 2026-01-16
ES2870201T3 (es) 2021-10-26
AU2016349169B2 (en) 2021-11-11
HUS2500049I1 (hu) 2025-12-28

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