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

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

Info

Publication number
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
Authority
KR
South Korea
Prior art keywords
acid
vpa
pharmaceutically acceptable
hours
coating
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
KR1020187031904A
Other languages
English (en)
Korean (ko)
Other versions
KR20180127480A (ko
Inventor
닐스 오베 구스타프손
한스 로저 마커스 마르텐손
니클라스 베르그
요나스 파예르손 살조
스베르커 예른
Original Assignee
세레노 사이언티픽 에이비
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 세레노 사이언티픽 에이비 filed Critical 세레노 사이언티픽 에이비
Publication of KR20180127480A publication Critical patent/KR20180127480A/ko
Application granted granted Critical
Publication of KR102438395B1 publication Critical patent/KR102438395B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (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)

Applications Claiming Priority (3)

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

Publications (2)

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

Family

ID=58709491

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020187031904A Active KR102438395B1 (ko) 2016-04-08 2017-04-10 발프로산을 포함하는 지연 방출 약제학적 제제, 및 그의 용도

Country Status (14)

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

Families Citing this family (5)

* 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
US11395808B2 (en) 2016-04-08 2022-07-26 Cereno Scientific Ab Delayed release pharmaceutical formulations comprising valproic acid, and uses thereof
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
DE3773926D1 (de) 1987-07-22 1991-11-21 Farvalsa Ag Feuchtigkeitsstabile feste valproinsaeure-zubereitung und verfahren zu ihrer herstellung.
HK1042427A1 (zh) * 1999-09-30 2002-08-16 Penwest Pharmaceuticals Co. 用於高溶度药物的持续释放基质方法
WO2002055017A2 (en) 2000-11-21 2002-07-18 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
CA2621560A1 (en) 2005-09-07 2007-03-15 Braincells, Inc. Modulation of neurogenesis by hdac inhibition
EP1937650B1 (en) 2005-09-08 2011-06-15 S*BIO Pte Ltd Heterocyclic compounds
US20070082046A1 (en) * 2005-10-11 2007-04-12 Banner Pharmacaps, Inc. Enteric valproic acid
ES2317450T3 (es) * 2006-01-11 2009-04-16 Teva Pharmaceutical Industries Ltd. Formulacion de liberacion controlada de acido valproico y sus derivados.
US20100061984A1 (en) 2006-01-20 2010-03-11 The Trustees Of The University Of Pennsylvania Compositions and methods for modulation of suppressor t cell activation
EP2004234A2 (en) 2006-04-06 2008-12-24 Novartis AG Combination of organic compounds
NZ575171A (en) 2006-08-31 2012-04-27 Aptalis Pharmatech Inc 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
US20110245154A1 (en) 2010-03-11 2011-10-06 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
UA110853C2 (uk) 2011-09-13 2016-02-25 Фармасайклікс, Інк. Лікарські форми інгібітора гістондеацетилази у комбінації з бендамустином та їхнє застосування
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
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
US11395808B2 (en) 2016-04-08 2022-07-26 Cereno Scientific Ab Delayed release pharmaceutical formulations comprising valproic acid, and uses thereof

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.)

Also Published As

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

Similar Documents

Publication Publication Date Title
US12245999B2 (en) Valproic acid for the treatment or prevention of pathological conditions associated with excess fibrin deposition and/or thrombus formation
US12023311B2 (en) Delayed release pharmaceutical formulations comprising valproic acid, and uses thereof
US20230364089A1 (en) Compounds and compositions for the treatment or prevention of pathological conditions associated with excess fibrin deposition and/or thrombus formation
HK40089307A (en) Medical application of valproic acid
HK40086166A (en) Medical application of valproic acid
BR112018070626B1 (pt) Formulação farmacêutica e uso da mesma
HK40004470B (en) Delayed release pharmaceutical formulations comprising valproic acid, and uses thereof
HK40004470A (en) Delayed release pharmaceutical formulations comprising valproic acid, and uses thereof

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

R17-X000 Change to representative recorded

St.27 status event code: A-3-3-R10-R17-oth-X000

A201 Request for examination
E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

E701 Decision to grant or registration of patent right
PE0701 Decision of registration

St.27 status event code: A-1-2-D10-D22-exm-PE0701

GRNT Written decision to grant
PR0701 Registration of establishment

St.27 status event code: A-2-4-F10-F11-exm-PR0701

PR1002 Payment of registration fee

St.27 status event code: A-2-2-U10-U12-oth-PR1002

Fee payment year number: 1

PG1601 Publication of registration

St.27 status event code: A-4-4-Q10-Q13-nap-PG1601

R18-X000 Changes to party contact information recorded

St.27 status event code: A-5-5-R10-R18-oth-X000

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 4

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-OTH-PR1001 (AS PROVIDED BY THE NATIONAL OFFICE)

Year of fee payment: 4

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 5

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-OTH-PR1001 (AS PROVIDED BY THE NATIONAL OFFICE)

Year of fee payment: 5