PL3370697T3 - Stabilne fizycznie i chemicznie doustne zawiesiny giwinostatu - Google Patents

Stabilne fizycznie i chemicznie doustne zawiesiny giwinostatu

Info

Publication number
PL3370697T3
PL3370697T3 PL16805507T PL16805507T PL3370697T3 PL 3370697 T3 PL3370697 T3 PL 3370697T3 PL 16805507 T PL16805507 T PL 16805507T PL 16805507 T PL16805507 T PL 16805507T PL 3370697 T3 PL3370697 T3 PL 3370697T3
Authority
PL
Poland
Prior art keywords
givinostat
physically
chemically stable
oral suspensions
suspensions
Prior art date
Application number
PL16805507T
Other languages
English (en)
Polish (pl)
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 PL3370697T3 publication Critical patent/PL3370697T3/pl

Links

Classifications

    • 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)
  • 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)
PL16805507T 2015-11-03 2016-10-28 Stabilne fizycznie i chemicznie doustne zawiesiny giwinostatu PL3370697T3 (pl)

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
PCT/IB2016/056496 WO2017077436A1 (en) 2015-11-03 2016-10-28 Physically and chemically stable oral suspensions of givinostat
EP16805507.7A EP3370697B1 (en) 2015-11-03 2016-10-28 Physically and chemically stable oral suspensions of givinostat

Publications (1)

Publication Number Publication Date
PL3370697T3 true PL3370697T3 (pl) 2021-07-12

Family

ID=55410062

Family Applications (1)

Application Number Title Priority Date Filing Date
PL16805507T PL3370697T3 (pl) 2015-11-03 2016-10-28 Stabilne fizycznie i chemicznie doustne zawiesiny giwinostatu

Country Status (33)

Country Link
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=)
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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GB2567093A (en) 2016-07-15 2019-04-03 Viracta Therapeutics 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
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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US4169150A (en) * 1975-11-12 1979-09-25 Teijin Limited Benzodiazepine derivatives and pharmaceutical compositions containing said derivatives
DE3902079A1 (de) * 1988-04-15 1989-10-26 Bayer Ag I.m. injektionsformen von gyrase-inhibitoren
US5369108A (en) 1991-10-04 1994-11-29 Sloan-Kettering Institute For Cancer Research Potent inducers of terminal differentiation and methods of use thereof
DE4200821A1 (de) * 1992-01-15 1993-07-22 Bayer Ag Geschmacksmaskierte pharmazeutische mittel
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)
CA2423744C (en) 2000-09-29 2012-04-03 Prolifix Limited Hydroxamic acid compounds comprising a sulfonamide linkage as hdac inhibitors
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AU2002364146A1 (en) * 2001-12-20 2003-07-09 Pharmacia Corporation 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
SI1611088T1 (sl) 2003-04-07 2009-12-31 Pharmacyclics Inc Hidroksamati kot terapevtska sredstva
DE602004004665T2 (de) 2003-08-20 2008-01-03 Pharmacyclics, Inc., Sunnyvale Acetylenderivate als inhibitoren von histondeacetylase
ITMI20041347A1 (it) 2004-07-05 2004-10-05 Italfarmaco Spa Derivati di alfa-amminoacidi ad attivita'antiinfiammatoria
US8193205B2 (en) 2004-07-28 2012-06-05 Janssen Pharmaceutica N.V. Substituted indolyl alkyl amino derivatives as novel inhibitors of histone deacetylase
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Also Published As

Publication number Publication date
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
CN108366956B (zh) 2021-09-10
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
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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