KR102438395B1 - 발프로산을 포함하는 지연 방출 약제학적 제제, 및 그의 용도 - Google Patents

발프로산을 포함하는 지연 방출 약제학적 제제, 및 그의 용도 Download PDF

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KR102438395B1
KR102438395B1 KR1020187031904A KR20187031904A KR102438395B1 KR 102438395 B1 KR102438395 B1 KR 102438395B1 KR 1020187031904 A KR1020187031904 A KR 1020187031904A KR 20187031904 A KR20187031904 A KR 20187031904A KR 102438395 B1 KR102438395 B1 KR 102438395B1
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acid
vpa
pharmaceutically acceptable
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coating
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KR20180127480A (ko
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닐스 오베 구스타프손
한스 로저 마커스 마르텐손
니클라스 베르그
요나스 파예르손 살조
스베르커 예른
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세레노 사이언티픽 에이비
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/194Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/20Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
KR1020187031904A 2016-04-08 2017-04-10 발프로산을 포함하는 지연 방출 약제학적 제제, 및 그의 용도 Active KR102438395B1 (ko)

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Application Number Priority Date Filing Date Title
GB201606197 2016-04-08
GB1606197.0 2016-04-08
PCT/GB2017/051002 WO2017175013A1 (en) 2016-04-08 2017-04-10 Delayed release pharmaceutical formulations comprising valproic acid, and uses thereof

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KR20180127480A KR20180127480A (ko) 2018-11-28
KR102438395B1 true KR102438395B1 (ko) 2022-08-30

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US (2) US11395808B2 (https=)
EP (1) EP3439649B1 (https=)
JP (1) JP6985368B2 (https=)
KR (1) KR102438395B1 (https=)
CN (2) CN109414423A (https=)
AU (1) AU2017246697B2 (https=)
CA (1) CA3018043A1 (https=)
ES (1) ES2969021T3 (https=)
HU (1) HUE064701T2 (https=)
IL (1) IL262163B2 (https=)
MX (1) MX395521B (https=)
PL (1) PL3439649T3 (https=)
RU (1) RU2760304C2 (https=)
WO (1) WO2017175013A1 (https=)
ZA (1) ZA201806766B (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201417828D0 (en) 2014-10-08 2014-11-19 Cereno Scient Ab New methods and compositions
CA3018043A1 (en) 2016-04-08 2017-10-12 Cereno Scientific Ab Delayed release pharmaceutical formulations comprising valproic acid, and uses thereof
US20240285636A1 (en) * 2021-06-14 2024-08-29 Libbs Farmacêutica Ltda Pharmaceutical composition and use of the pharmaceutical composition
CN113995742B (zh) * 2021-10-22 2023-12-29 中国医学科学院皮肤病医院(中国医学科学院皮肤病研究所) 包含丙戊酸的美白组合物及其用途
GB2613900B (en) * 2021-12-20 2024-01-17 Cereno Scient Ab Novel compounds and methods of use thereof
WO2026068561A1 (en) 2024-09-24 2026-04-02 Cereno Scientific Ab Valproic acid for use in treating pulmonary arterial hypertension

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001039747A2 (de) 1999-12-02 2001-06-07 Gerot Pharmazeutika Gesellschaft M.B.H. Natriumvalproat-granulat mit verringerter hygroskopizität
US20050276848A1 (en) 2004-06-15 2005-12-15 Nilobon Podhipleux Sustained release neutralized divalproex sodium
WO2012120262A1 (en) 2011-03-09 2012-09-13 Larsson Pia Compounds and methods for improving impaired endogenous fibrinolysis using histone deacetylase inhibitors

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE68346T1 (de) 1987-07-22 1991-11-15 Farvalsa Ag Feuchtigkeitsstabile feste valproinsaeurezubereitung und verfahren zu ihrer herstellung.
CN1228043C (zh) * 1999-09-30 2005-11-23 爱德华·孟岱尔股份有限公司 用于高溶解度药物的缓释基质
AU2002243231A1 (en) 2000-11-21 2002-07-24 Wake Forest University Method of treating autoimmune diseases
US6610326B2 (en) * 2001-02-16 2003-08-26 Andrx Corporation Divalproex sodium tablets
ITMI20011733A1 (it) 2001-08-07 2003-02-07 Italfarmaco Spa Derivati dell'acido idrossamico inibitori degli enzimi istone deacetilasi, quali nuovi farmaci antiinfiammatori inibenti la sintesi di citoc
JP2006507297A (ja) 2002-05-13 2006-03-02 チルドレンズ・ホスピタル・ロサンジェルス ケロイドおよび他の皮膚または内部創傷または病変における異常瘢痕形成の処置および予防
US8034831B2 (en) 2002-11-06 2011-10-11 Celgene Corporation Methods for the treatment and management of myeloproliferative diseases using 4-(amino)-2-(2,6-Dioxo(3-piperidyl)-isoindoline-1,3-dione in combination with other therapies
US20040224006A1 (en) 2003-04-21 2004-11-11 Samn Raffaniello Ancrod irradiated, impregnated or coated sutures and other first aid or wound management bandaging materials for minimizing scarring and/or preventing excessive scar formation
ITMI20040876A1 (it) 2004-04-30 2004-07-30 Univ Degli Studi Milano Inibitori delle istone deacetilasi-hdac-quali agenti ipolipidemizzati per la terapia e la prevenzione dell'arteriosclerosi e malattie cardiovascolari
US7713550B2 (en) * 2004-06-15 2010-05-11 Andrx Corporation Controlled release sodium valproate formulation
WO2006117165A2 (en) 2005-05-02 2006-11-09 Friedrich-Alexander-Universität Erlangen-Nürnberg Means and methods for the treatment of head injuries and stroke
EP1743654A1 (en) 2005-07-15 2007-01-17 TopoTarget Germany AG Use of inhibitors of histone deacetylases in combination with NSAID for the therapy of cancer and/or inflammatory diseases
EP1937236A2 (en) 2005-09-07 2008-07-02 Braincells, Inc. Modulation of neurogenesis by hdac inhibition
TWI393708B (zh) 2005-09-08 2013-04-21 Mei Pharma Inc 異羥肟酸脂化合物,其用途及其之合成方法
US20070082046A1 (en) * 2005-10-11 2007-04-12 Banner Pharmacaps, Inc. Enteric valproic acid
DE602006003848D1 (de) * 2006-01-11 2009-01-08 Teva Pharma Formulierung zur verzögerten Freisetzung von Valproinsäure und deren Derivate
WO2007084775A2 (en) 2006-01-20 2007-07-26 The Trustees Of The University Of Pennsylvania Compositions and methods for modulation of suppressor t cell activation
US20090312311A1 (en) 2006-04-06 2009-12-17 Gary Michael Ksander Combination of organic compounds
US20080069878A1 (en) 2006-08-31 2008-03-20 Gopi Venkatesh Drug Delivery Systems Comprising Solid Solutions of Weakly Basic Drugs
GB2454118B (en) 2007-06-06 2010-06-02 Univ Maryland Hdac inhibitors and hormone targeted drugs for the treatment of cancer
WO2009009737A1 (en) * 2007-07-12 2009-01-15 Neurosci, Inc. Sustained release formulation of active pharmaceuticals in a lipid based sustained release
US20090270497A1 (en) 2008-04-24 2009-10-29 Pharmacyclics, Inc. Treatment of Non-Localized Inflammation with pan-HDAC Inhibitors
GB201003766D0 (en) 2010-03-05 2010-04-21 Univ Strathclyde Pulsatile drug release
WO2011113013A2 (en) 2010-03-11 2011-09-15 Hemaquest Pharmaceuticals, Inc. Methods and compositions for treating viral or virally-induced conditions
CN101947209B (zh) * 2010-07-21 2012-07-25 河南中帅医药科技发展有限公司 双丙戊酸钠小丸及其制备方法
JP6330118B2 (ja) 2011-09-13 2018-05-30 ファーマサイクリックス エルエルシー ベンダムスチンと組み合わせたヒストンデアセチラーゼ阻害剤の製剤とその使用
CN104248627A (zh) * 2013-06-25 2014-12-31 北大方正集团有限公司 丙戊酸半钠泡腾干混悬剂及其制备方法
GB201417828D0 (en) 2014-10-08 2014-11-19 Cereno Scient Ab New methods and compositions
CA3018043A1 (en) 2016-04-08 2017-10-12 Cereno Scientific Ab Delayed release pharmaceutical formulations comprising valproic acid, and uses thereof
WO2017175010A1 (en) 2016-04-08 2017-10-12 Cereno Scientific Ab Compounds and compositions for the treatment or prevention of pathological conditions associated with excess fibrin deposition and/or thrombus formation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001039747A2 (de) 1999-12-02 2001-06-07 Gerot Pharmazeutika Gesellschaft M.B.H. Natriumvalproat-granulat mit verringerter hygroskopizität
US20050276848A1 (en) 2004-06-15 2005-12-15 Nilobon Podhipleux Sustained release neutralized divalproex sodium
WO2012120262A1 (en) 2011-03-09 2012-09-13 Larsson Pia Compounds and methods for improving impaired endogenous fibrinolysis using histone deacetylase inhibitors

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
437/MUM/2003
International Journal of Pharmaceutics vol.264, no.1/02, pp.85-96 (2003.10.02.)

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Publication number Publication date
AU2017246697A1 (en) 2018-10-04
AU2017246697B2 (en) 2022-06-02
JP6985368B2 (ja) 2021-12-22
IL262163B1 (en) 2023-03-01
IL262163A (en) 2018-11-29
BR112018070626A2 (pt) 2019-02-05
EP3439649C0 (en) 2023-11-15
NZ746269A (en) 2024-10-25
RU2018137399A (ru) 2020-05-12
MX395521B (es) 2025-03-25
RU2018137399A3 (https=) 2020-06-18
US20190111011A1 (en) 2019-04-18
US20230120670A1 (en) 2023-04-20
RU2760304C2 (ru) 2021-11-23
EP3439649A1 (en) 2019-02-13
CN114209667A (zh) 2022-03-22
HUE064701T2 (hu) 2024-04-28
KR20180127480A (ko) 2018-11-28
IL262163B2 (en) 2023-07-01
EP3439649B1 (en) 2023-11-15
JP2019510834A (ja) 2019-04-18
ES2969021T3 (es) 2024-05-16
PL3439649T3 (pl) 2024-03-18
US12023311B2 (en) 2024-07-02
US11395808B2 (en) 2022-07-26
CN109414423A (zh) 2019-03-01
ZA201806766B (en) 2024-03-27
WO2017175013A1 (en) 2017-10-12
CA3018043A1 (en) 2017-10-12
MX2018012224A (es) 2019-05-16

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