DK3370697T3 - Fysisk og kemisk stabile orale suspensioner af givinostat - Google Patents

Fysisk og kemisk stabile orale suspensioner af givinostat Download PDF

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Publication number
DK3370697T3
DK3370697T3 DK16805507.7T DK16805507T DK3370697T3 DK 3370697 T3 DK3370697 T3 DK 3370697T3 DK 16805507 T DK16805507 T DK 16805507T DK 3370697 T3 DK3370697 T3 DK 3370697T3
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DK
Denmark
Prior art keywords
givinostat
physical
oral suspensions
stable oral
chemical stable
Prior art date
Application number
DK16805507.7T
Other languages
Danish (da)
English (en)
Inventor
Giuseppe Colombo
Roberta Artico
Paolo Mascagni
Maria Valmen Monzani
Silvia Puccianti
Original Assignee
Italfarmaco Spa
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Application filed by Italfarmaco Spa filed Critical Italfarmaco Spa
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Publication of DK3370697T3 publication Critical patent/DK3370697T3/da

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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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hematology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Neurology (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Rheumatology (AREA)
  • Diabetes (AREA)
  • Oncology (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Neurosurgery (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
DK16805507.7T 2015-11-03 2016-10-28 Fysisk og kemisk stabile orale suspensioner af givinostat DK3370697T3 (da)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
DK3370697T3 true DK3370697T3 (da) 2021-04-26

Family

ID=55410062

Family Applications (1)

Application Number Title Priority Date Filing Date
DK16805507.7T DK3370697T3 (da) 2015-11-03 2016-10-28 Fysisk og kemisk stabile orale suspensioner af givinostat

Country Status (33)

Country Link
US (1) US10688047B2 (https=)
EP (1) EP3370697B1 (https=)
JP (1) JP6800970B2 (https=)
KR (1) KR102603894B1 (https=)
CN (2) CN113368044B (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=)
FR (1) FR25C1051I1 (https=)
HR (1) HRP20210747T1 (https=)
HU (2) HUE054123T2 (https=)
IL (1) IL258608B (https=)
IT (1) ITUB20155193A1 (https=)
LT (2) LT3370697T (https=)
MX (1) MX380361B (https=)
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=)
TW (1) TWI727983B (https=)
WO (1) WO2017077436A1 (https=)

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JP7158104B2 (ja) 2016-07-15 2022-10-21 ビラクタ セラピューティクス,インク. Nk細胞ベースの療法で使用するためのhdac阻害剤
IT201900003281A1 (it) * 2019-03-06 2020-09-06 Chemi Spa Processo per preparare {6-[(dietilammino)metil]naftalen-2-il}metil [4-(idrossicarbamoil)fenil]carbammato ad elevata purezza
AU2020283590A1 (en) 2019-05-31 2022-01-20 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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Also Published As

Publication number Publication date
CN113368044B (zh) 2023-06-02
RU2018120170A3 (https=) 2019-12-05
IL258608B (en) 2022-06-01
HRP20210747T1 (hr) 2021-06-25
JP2019501116A (ja) 2019-01-17
SMT202100161T1 (it) 2021-05-07
CY1124092T1 (el) 2022-05-27
RS61694B1 (sr) 2021-05-31
NO2025053I1 (no) 2025-12-05
FR25C1051I1 (fr) 2026-01-16
PT3370697T (pt) 2021-04-06
ES2870201T3 (es) 2021-10-26
PL3370697T3 (pl) 2021-07-12
TW201722401A (zh) 2017-07-01
MX2018004505A (es) 2018-09-12
EP3370697B1 (en) 2021-02-17
JP6800970B2 (ja) 2020-12-16
AU2016349169B2 (en) 2021-11-11
BR122024001653A2 (pt) 2024-03-05
MX380361B (es) 2025-03-12
US20180311160A1 (en) 2018-11-01
CN113368044A (zh) 2021-09-10
EP3370697A1 (en) 2018-09-12
KR102603894B1 (ko) 2023-11-20
CA3002755C (en) 2022-10-18
BR112018008870A2 (pt) 2018-11-06
CL2018001151A1 (es) 2018-12-07
KR20180082468A (ko) 2018-07-18
HUS2500049I1 (hu) 2025-12-28
IL258608A (en) 2018-06-28
RU2721396C2 (ru) 2020-05-19
CN108366956A (zh) 2018-08-03
US10688047B2 (en) 2020-06-23
TWI727983B (zh) 2021-05-21
PE20181369A1 (es) 2018-08-27
ITUB20155193A1 (it) 2017-05-03
WO2017077436A1 (en) 2017-05-11
AR106559A1 (es) 2018-01-24
BR112018008870A8 (pt) 2019-02-26
CN108366956B (zh) 2021-09-10
CO2018003971A2 (es) 2018-07-19
RU2018120170A (ru) 2019-12-05
LTPA2025540I1 (https=) 2025-12-29
FIC20250035I1 (fi) 2025-12-05
LT3370697T (lt) 2021-06-10
HK1254811A1 (en) 2019-07-26
SI3370697T1 (sl) 2021-04-30
AU2016349169A1 (en) 2018-05-17
HUE054123T2 (hu) 2021-08-30
CA3002755A1 (en) 2017-05-11
NZ741467A (en) 2021-07-30

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