DK3370697T3 - Fysisk og kemisk stabile orale suspensioner af givinostat - Google Patents
Fysisk og kemisk stabile orale suspensioner af givinostat Download PDFInfo
- 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
- Authority
- DK
- Denmark
- Prior art keywords
- givinostat
- physical
- oral suspensions
- stable oral
- chemical stable
- Prior art date
Links
Classifications
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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)
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)
Families Citing this family (8)
| 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 |
Family Cites Families (30)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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) |
| 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 |
| WO2006018814A2 (en) * | 2004-08-16 | 2006-02-23 | Ranbaxy Laboratories Limited | Oral liquid suspensions of metaxalone |
| EP2034958B1 (en) * | 2006-05-19 | 2009-10-28 | Norbrook Laboratories Limited | Stable aqueous suspension having palatable taste |
| SG174772A1 (en) | 2006-09-11 | 2011-10-28 | Curis Inc | Multi-functional small molecules as anti-proliferative agents |
| US8263652B2 (en) * | 2007-10-31 | 2012-09-11 | Sk Biopharmaceuticals Co., Ltd. | Stabilized pediatric suspension of carisbamate |
| EP2228054A1 (en) * | 2009-03-13 | 2010-09-15 | ITALFARMACO S.p.A. | Riluzole aqueous suspensions |
| AU2010313290A1 (en) * | 2009-10-30 | 2012-05-17 | Janssen Pharmaceutica Nv | Dosing regimen associated with long-acting injectable paliperidone esters |
| IT1397912B1 (it) * | 2010-01-28 | 2013-02-04 | Chemi Spa | Nuovo polimorfo dell'estere 6-dietilamminometil-2-naftilico dell'acido 4-idrossicarbamoil-fenil-carbammico cloridrato. |
| US20110245154A1 (en) * | 2010-03-11 | 2011-10-06 | Hemaquest Pharmaceuticals, Inc. | Methods and Compositions for Treating Viral or Virally-Induced Conditions |
| 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 |
| WO2014159224A1 (en) * | 2013-03-14 | 2014-10-02 | Chdi Foundation, Inc. | Histone deacetylase inhibitors and compositions and methods of use thereof |
| WO2015086738A2 (en) | 2013-12-11 | 2015-06-18 | Bionor Immuno As | Hiv vaccine |
-
2015
- 2015-11-03 IT ITUB2015A005193A patent/ITUB20155193A1/it unknown
-
2016
- 2016-10-20 TW TW105133874A patent/TWI727983B/zh active
- 2016-10-28 SM SM20210161T patent/SMT202100161T1/it unknown
- 2016-10-28 WO PCT/IB2016/056496 patent/WO2017077436A1/en not_active Ceased
- 2016-10-28 AU AU2016349169A patent/AU2016349169B2/en active Active
- 2016-10-28 EP EP16805507.7A patent/EP3370697B1/en active Active
- 2016-10-28 CA CA3002755A patent/CA3002755C/en active Active
- 2016-10-28 CN CN201680062179.0A patent/CN108366956B/zh active Active
- 2016-10-28 BR BR122024001653-2A patent/BR122024001653A2/pt not_active Application Discontinuation
- 2016-10-28 PT PT168055077T patent/PT3370697T/pt unknown
- 2016-10-28 HR HRP20210747TT patent/HRP20210747T1/hr unknown
- 2016-10-28 RU RU2018120170A patent/RU2721396C2/ru active
- 2016-10-28 US US15/770,443 patent/US10688047B2/en active Active
- 2016-10-28 RS RS20210421A patent/RS61694B1/sr unknown
- 2016-10-28 JP JP2018522990A patent/JP6800970B2/ja active Active
- 2016-10-28 ES ES16805507T patent/ES2870201T3/es active Active
- 2016-10-28 NZ NZ741467A patent/NZ741467A/en unknown
- 2016-10-28 HU HUE16805507A patent/HUE054123T2/hu unknown
- 2016-10-28 PE PE2018000576A patent/PE20181369A1/es unknown
- 2016-10-28 PL PL16805507T patent/PL3370697T3/pl unknown
- 2016-10-28 MX MX2018004505A patent/MX380361B/es unknown
- 2016-10-28 CN CN202110722868.2A patent/CN113368044B/zh active Active
- 2016-10-28 KR KR1020187014706A patent/KR102603894B1/ko active Active
- 2016-10-28 LT LTEP16805507.7T patent/LT3370697T/lt unknown
- 2016-10-28 DK DK16805507.7T patent/DK3370697T3/da active
- 2016-10-28 SI SI201631132T patent/SI3370697T1/sl unknown
- 2016-11-02 AR ARP160103344A patent/AR106559A1/es not_active Application Discontinuation
-
2018
- 2018-04-10 IL IL258608A patent/IL258608B/en unknown
- 2018-04-13 CO CONC2018/0003971A patent/CO2018003971A2/es unknown
- 2018-04-30 CL CL2018001151A patent/CL2018001151A1/es unknown
-
2021
- 2021-05-07 CY CY20211100388T patent/CY1124092T1/el unknown
-
2025
- 2025-12-02 LT LTPA2025540C patent/LTPA2025540I1/lt unknown
- 2025-12-04 FR FR25C1051C patent/FR25C1051I1/fr active Active
- 2025-12-05 NO NO2025053C patent/NO2025053I1/no unknown
- 2025-12-05 HU HUS2500049C patent/HUS2500049I1/hu unknown
- 2025-12-05 FI FIC20250035C patent/FIC20250035I1/fi unknown
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