HUE054123T2 - Fizikailag és kémiailag stabil orális givinostat szuszpenziók - Google Patents

Fizikailag és kémiailag stabil orális givinostat szuszpenziók

Info

Publication number
HUE054123T2
HUE054123T2 HUE16805507A HUE16805507A HUE054123T2 HU E054123 T2 HUE054123 T2 HU E054123T2 HU E16805507 A HUE16805507 A HU E16805507A HU E16805507 A HUE16805507 A HU E16805507A HU E054123 T2 HUE054123 T2 HU E054123T2
Authority
HU
Hungary
Prior art keywords
givinostat
suspensions
physically
chemically stable
stable oral
Prior art date
Application number
HUE16805507A
Other languages
English (en)
Hungarian (hu)
Inventor
Giuseppe Colombo
Roberta Artico
Paolo Mascagni
Maria Valmen Monzani
Silvia Puccianti
Original Assignee
Italfarmaco Spa
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
Application filed by Italfarmaco Spa filed Critical Italfarmaco Spa
Publication of HUE054123T2 publication Critical patent/HUE054123T2/hu

Links

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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • 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
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, 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
    • 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
    • A61K31/325—Carbamic acids; Thiocarbamic acids; Anhydrides or salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular 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
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • A61P7/02—Antithrombotic 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)
HUE16805507A 2015-11-03 2016-10-28 Fizikailag és kémiailag stabil orális givinostat szuszpenziók HUE054123T2 (hu)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ITUB2015A005193A ITUB20155193A1 (it) 2015-11-03 2015-11-03 Sospensioni orali di Givinostat fisicamente e chimicamente stabili

Publications (1)

Publication Number Publication Date
HUE054123T2 true HUE054123T2 (hu) 2021-08-30

Family

ID=55410062

Family Applications (2)

Application Number Title Priority Date Filing Date
HUE16805507A HUE054123T2 (hu) 2015-11-03 2016-10-28 Fizikailag és kémiailag stabil orális givinostat szuszpenziók
HUS2500049C HUS2500049I1 (hu) 2015-11-03 2025-12-05 Fizikailag és kémiailag stabil orális givinostat szuszpenziók

Family Applications After (1)

Application Number Title Priority Date Filing Date
HUS2500049C HUS2500049I1 (hu) 2015-11-03 2025-12-05 Fizikailag és kémiailag stabil orális givinostat szuszpenziók

Country Status (33)

Country Link
US (1) US10688047B2 (enExample)
EP (1) EP3370697B1 (enExample)
JP (1) JP6800970B2 (enExample)
KR (1) KR102603894B1 (enExample)
CN (2) CN108366956B (enExample)
AR (1) AR106559A1 (enExample)
AU (1) AU2016349169B2 (enExample)
BR (1) BR122024001653A2 (enExample)
CA (1) CA3002755C (enExample)
CL (1) CL2018001151A1 (enExample)
CO (1) CO2018003971A2 (enExample)
CY (1) CY1124092T1 (enExample)
DK (1) DK3370697T3 (enExample)
ES (1) ES2870201T3 (enExample)
FI (1) FIC20250035I1 (enExample)
FR (1) FR25C1051I1 (enExample)
HR (1) HRP20210747T1 (enExample)
HU (2) HUE054123T2 (enExample)
IL (1) IL258608B (enExample)
IT (1) ITUB20155193A1 (enExample)
LT (2) LT3370697T (enExample)
MX (1) MX380361B (enExample)
NO (1) NO2025053I1 (enExample)
NZ (1) NZ741467A (enExample)
PE (1) PE20181369A1 (enExample)
PL (1) PL3370697T3 (enExample)
PT (1) PT3370697T (enExample)
RS (1) RS61694B1 (enExample)
RU (1) RU2721396C2 (enExample)
SI (1) SI3370697T1 (enExample)
SM (1) SMT202100161T1 (enExample)
TW (1) TWI727983B (enExample)
WO (1) WO2017077436A1 (enExample)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4650005A3 (en) 2016-07-15 2026-01-28 Viracta Subsidiary, Inc. Histone deacetylase inhibitors for use in immunotherapy
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
TWI853940B (zh) 2019-05-31 2024-09-01 美商維拉克塔股份有限公司 以組蛋白去乙醯酶抑制劑治療病毒相關癌症之方法
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
WO2026109535A1 (en) 2024-11-20 2026-05-28 Italfarmaco S.P.A. Givinostat hydrochloride monohydrate for use in treating arrhythmogenic cardiomyopathy

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US5369108A (en) 1991-10-04 1994-11-29 Sloan-Kettering Institute For Cancer Research Potent inducers of terminal differentiation and methods of use thereof
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IT1283637B1 (it) 1996-05-14 1998-04-23 Italfarmaco Spa Composti ad attivita' antinfiammatoria ed immunosoppressiva
US6174905B1 (en) 1996-09-30 2001-01-16 Mitsui Chemicals, Inc. Cell differentiation inducer
PE20020354A1 (es) 2000-09-01 2002-06-12 Novartis Ag Compuestos de hidroxamato como inhibidores de histona-desacetilasa (hda)
EP2292593A3 (en) 2000-09-29 2011-05-25 TopoTarget UK Limited Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors
US6897220B2 (en) 2001-09-14 2005-05-24 Methylgene, Inc. Inhibitors of histone deacetylase
US20030157172A1 (en) * 2001-12-20 2003-08-21 Lu Guang Wei Pharmaceutical suspension for oral administration
ES2306859T3 (es) 2002-03-13 2008-11-16 Janssen Pharmaceutica Nv Derivados de sulfonil como nuevos inhibidores de histona deacetilasa.
ITMI20030063A1 (it) 2003-01-17 2004-07-18 Italfarmaco Spa Cloridrato monoidrato dell'estere (6-dietilamminometil-naftalen-2-il)metilico dell'acido (4-idrossicarbammoil-fenil)carbammico.
US7244751B2 (en) 2003-02-14 2007-07-17 Shenzhen Chipscreen Biosciences Ltd. Histone deacetylase inhibitors of novel benzamide derivatives with potent differentiation and anti-proliferation activity
PT1611088E (pt) 2003-04-07 2009-09-24 Pharmacyclics Inc Hidroxamatos como agentes terapêuticos
MXPA05011286A (es) 2003-08-20 2006-01-24 Axys Pharm Inc Derivados de acetileno como inhibidores de histona deacetilasa.
ITMI20041347A1 (it) 2004-07-05 2004-10-05 Italfarmaco Spa Derivati di alfa-amminoacidi ad attivita'antiinfiammatoria
HRP20120327T1 (hr) 2004-07-28 2012-05-31 Janssen Pharmaceutica Nv Supstituirani indolil alkil amino derivati kao novi inhibitori histonske deacetilaze
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TW201245115A (en) * 2011-01-24 2012-11-16 Chdi Foundation Inc Histone deacetylase inhibitors and compositions and methods of use thereof
PL3858340T3 (pl) * 2012-02-03 2026-07-06 Italfarmaco Spa Chlorek dietylo-[6-(4-hydroksykarbamoilofenylokarbamoiloksymetylo)naftaleno-2-ylometylo]amoniowy w połączeniu z co najmniej jednym kortykosteroidem glukokortykoidowym do zastosowania w leczeniu dystrofii mięśniowej
CA2905404C (en) * 2013-03-12 2021-07-20 Synedgen, Inc. Oral formulations of polyglucosamine derivatives in combination with a non-fermentable sugar
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WO2015086738A2 (en) 2013-12-11 2015-06-18 Bionor Immuno As Hiv vaccine

Also Published As

Publication number Publication date
RU2018120170A3 (enExample) 2019-12-05
NZ741467A (en) 2021-07-30
ES2870201T3 (es) 2021-10-26
HUS2500049I1 (hu) 2025-12-28
KR20180082468A (ko) 2018-07-18
AU2016349169A1 (en) 2018-05-17
AU2016349169B2 (en) 2021-11-11
SI3370697T1 (sl) 2021-04-30
BR112018008870A2 (pt) 2018-11-06
LTPA2025540I1 (enExample) 2025-12-29
PE20181369A1 (es) 2018-08-27
MX2018004505A (es) 2018-09-12
TWI727983B (zh) 2021-05-21
FR25C1051I1 (fr) 2026-01-16
PL3370697T3 (pl) 2021-07-12
LT3370697T (lt) 2021-06-10
EP3370697B1 (en) 2021-02-17
DK3370697T3 (da) 2021-04-26
CL2018001151A1 (es) 2018-12-07
CN108366956B (zh) 2021-09-10
ITUB20155193A1 (it) 2017-05-03
IL258608B (en) 2022-06-01
US10688047B2 (en) 2020-06-23
FIC20250035I1 (fi) 2025-12-05
MX380361B (es) 2025-03-12
KR102603894B1 (ko) 2023-11-20
RS61694B1 (sr) 2021-05-31
WO2017077436A1 (en) 2017-05-11
RU2018120170A (ru) 2019-12-05
CO2018003971A2 (es) 2018-07-19
HRP20210747T1 (hr) 2021-06-25
CA3002755A1 (en) 2017-05-11
CN113368044A (zh) 2021-09-10
TW201722401A (zh) 2017-07-01
JP6800970B2 (ja) 2020-12-16
BR112018008870A8 (pt) 2019-02-26
CN108366956A (zh) 2018-08-03
SMT202100161T1 (it) 2021-05-07
US20180311160A1 (en) 2018-11-01
RU2721396C2 (ru) 2020-05-19
BR122024001653A2 (pt) 2024-03-05
EP3370697A1 (en) 2018-09-12
NO2025053I1 (no) 2025-12-05
CA3002755C (en) 2022-10-18
JP2019501116A (ja) 2019-01-17
IL258608A (en) 2018-06-28
CY1124092T1 (el) 2022-05-27
HK1254811A1 (en) 2019-07-26
CN113368044B (zh) 2023-06-02
AR106559A1 (es) 2018-01-24
PT3370697T (pt) 2021-04-06

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