HRP20210747T1 - Fizički i kemijski stabilne oralne suspenzije givinostata - Google Patents

Fizički i kemijski stabilne oralne suspenzije givinostata Download PDF

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Publication number
HRP20210747T1
HRP20210747T1 HRP20210747TT HRP20210747T HRP20210747T1 HR P20210747 T1 HRP20210747 T1 HR P20210747T1 HR P20210747T T HRP20210747T T HR P20210747TT HR P20210747 T HRP20210747 T HR P20210747T HR P20210747 T1 HRP20210747 T1 HR P20210747T1
Authority
HR
Croatia
Prior art keywords
vol
suspension
suspension according
agent
givinostat
Prior art date
Application number
HRP20210747TT
Other languages
English (en)
Croatian (hr)
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 HRP20210747T1 publication Critical patent/HRP20210747T1/hr

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    • 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)
HRP20210747TT 2015-11-03 2016-10-28 Fizički i kemijski stabilne oralne suspenzije givinostata HRP20210747T1 (hr)

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
HRP20210747T1 true HRP20210747T1 (hr) 2021-06-25

Family

ID=55410062

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20210747TT HRP20210747T1 (hr) 2015-11-03 2016-10-28 Fizički i kemijski stabilne oralne suspenzije givinostata

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)

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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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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
HUE054123T2 (hu) 2021-08-30
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
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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