JP2020525436A - 胃耐性制御放出経口剤形 - Google Patents

胃耐性制御放出経口剤形 Download PDF

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JP2020525436A
JP2020525436A JP2019570906A JP2019570906A JP2020525436A JP 2020525436 A JP2020525436 A JP 2020525436A JP 2019570906 A JP2019570906 A JP 2019570906A JP 2019570906 A JP2019570906 A JP 2019570906A JP 2020525436 A JP2020525436 A JP 2020525436A
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dosage form
controlled release
compound
release dosage
subject
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JP2020525436A5 (enExample
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ジェイ・サウード
レミ・リュトランジェ
サンドラ・ウェルネ
ナディネ・ノエル
エマニュエル・ジョルジ
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ミネルバ・ニューロサイエンシズ・インコーポレイテッド
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=62904624&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP2020525436(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by ミネルバ・ニューロサイエンシズ・インコーポレイテッド filed Critical ミネルバ・ニューロサイエンシズ・インコーポレイテッド
Publication of JP2020525436A publication Critical patent/JP2020525436A/ja
Publication of JP2020525436A5 publication Critical patent/JP2020525436A5/ja
Priority to JP2023147484A priority Critical patent/JP2023175778A/ja
Priority to JP2025101290A priority patent/JP2025134828A/ja
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    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • 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
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2846Poly(meth)acrylates

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)
JP2019570906A 2017-06-21 2018-06-21 胃耐性制御放出経口剤形 Pending JP2020525436A (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2023147484A JP2023175778A (ja) 2017-06-21 2023-09-12 胃耐性制御放出経口剤形
JP2025101290A JP2025134828A (ja) 2017-06-21 2025-06-17 胃耐性制御放出経口剤形

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762523204P 2017-06-21 2017-06-21
US62/523,204 2017-06-21
PCT/US2018/038853 WO2018237207A1 (en) 2017-06-21 2018-06-21 Gastro-resistant controlled release oral dosage forms

Related Child Applications (1)

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JP2023147484A Division JP2023175778A (ja) 2017-06-21 2023-09-12 胃耐性制御放出経口剤形

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JP2020525436A true JP2020525436A (ja) 2020-08-27
JP2020525436A5 JP2020525436A5 (enExample) 2021-07-29

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JP2019570906A Pending JP2020525436A (ja) 2017-06-21 2018-06-21 胃耐性制御放出経口剤形
JP2023147484A Pending JP2023175778A (ja) 2017-06-21 2023-09-12 胃耐性制御放出経口剤形
JP2025101290A Pending JP2025134828A (ja) 2017-06-21 2025-06-17 胃耐性制御放出経口剤形

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JP2023147484A Pending JP2023175778A (ja) 2017-06-21 2023-09-12 胃耐性制御放出経口剤形
JP2025101290A Pending JP2025134828A (ja) 2017-06-21 2025-06-17 胃耐性制御放出経口剤形

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US (3) US11464744B2 (enExample)
EP (1) EP3641732A1 (enExample)
JP (3) JP2020525436A (enExample)
CN (1) CN111511353A (enExample)
AU (2) AU2018290287B2 (enExample)
BR (1) BR112019027398A2 (enExample)
CA (1) CA3067031A1 (enExample)
CL (1) CL2019003743A1 (enExample)
CO (1) CO2019014496A2 (enExample)
IL (3) IL319156A (enExample)
MX (1) MX2023002994A (enExample)
PE (1) PE20200732A1 (enExample)
UA (1) UA127349C2 (enExample)
WO (1) WO2018237207A1 (enExample)
ZA (1) ZA202409847B (enExample)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2968977A1 (en) 2014-12-02 2016-06-09 Minerva Neurosciences, Inc. Compositions comprising 2-((1-(2(4-fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)isoindolin-1-one for treating schizophrenia
EP3641732A1 (en) 2017-06-21 2020-04-29 Minerva Neurosciences, Inc. Gastro-resistant controlled release oral dosage forms
WO2020041504A1 (en) 2018-08-21 2020-02-27 Minerva Neurosciences, Inc. Use of roluperidone to treat negative symptoms and disorders, increase neuroplasticity, and promote neuroprotection
IT201800011125A1 (it) * 2018-12-14 2020-06-14 Dpl Pharma S P A Composizioni farmaceutiche orali solide comprendenti matrici monolitiche complesse per la somministrazione cronotropica di medicamenti nel tratto gastroenterico
CA3243767A1 (en) 2022-02-14 2023-08-17 Minerva Neurosciences, Inc. USE OF ROLUPERIDONE IN THE PREVENTION OF RELAPSE IN PATIENTS WITH SCHIZOPHRENIA
WO2025090588A1 (en) 2023-10-24 2025-05-01 Minerva Neurosciences, Inc. Roluperidone for the treatment of lysosomal storage disorders and their symptoms

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012527425A (ja) * 2009-05-18 2012-11-08 シグモイド・ファーマ・リミテッド 油滴含有組成物
JP2013536186A (ja) * 2010-08-11 2013-09-19 エフ.ホフマン−ラ ロシュ アーゲー 代謝型グルタミン酸5受容体(mGlu5)アンタゴニストの医薬組成物
CN104586771A (zh) * 2013-10-30 2015-05-06 广州朗圣药业有限公司 一种盐酸坦洛新缓释微丸制剂
WO2016025762A1 (en) * 2014-08-13 2016-02-18 Cedars-Sinai Medical Center Anti-methanogenic compositions and uses thereof
WO2016089766A1 (en) * 2014-12-02 2016-06-09 Minerva Neurosciences, Inc. Compositions comprising 2-((1-(2(4-fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)isoindolin-1-one for treating schizophrenia
JP2017514832A (ja) * 2014-04-30 2017-06-08 インサイト・コーポレイションIncyte Corporation Jak1抑制剤を調製する方法及びその新しい形態

Family Cites Families (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0325063B1 (en) 1988-01-21 1994-03-09 Merrell Dow Pharmaceuticals Inc. Use of 1,4-disubstituted-piperidinyl compounds in the manufacture of a medicament for the treatment of insomnia
ZA908641B (en) 1989-10-27 1992-06-24 Du Pont (n-phthalimidoalkyl)piperidines
NZ251610A (en) 1992-04-23 1996-02-27 Merrell Dow Pharma 4-imidomethyl-1-(2-phenyl-2-oxoethyl)piperidine derivatives and pharmaceutical compositions
PT1260512E (pt) 2000-02-29 2007-10-10 Mitsubishi Pharma Corp ''novos derivados de amida cíclicos''
WO2002026214A1 (en) 2000-09-29 2002-04-04 Solvay Pharmaceuticals B.V. Ion-strength independent sustained release pharmaceutical formulation
US20050095292A1 (en) 2003-10-29 2005-05-05 Wyeth Sustained release pharmaceutical compositions
MY147202A (en) * 2003-11-26 2012-11-14 Novartis Ag Compositions comprising organic compounds
TW200616608A (en) 2004-07-09 2006-06-01 Forest Laboratories Memantine as adjunctive treatment to atypical antipsychotics in schizophrenia patients
DOP2006000125A (es) 2005-06-06 2006-12-31 Merck Sharp & Dohme Derivados de ciclohexanosulfonilo como inhibidores de glyt1 para tratar esquizofrenia
JP2009525979A (ja) 2006-02-07 2009-07-16 田辺三菱製薬株式会社 4−アシルアミノピリジン誘導体を介した神経新生
CA2569776A1 (en) 2006-02-17 2007-08-17 Kos Life Sciences, Inc. Low flush niacin formulation
TW200817400A (en) 2006-05-30 2008-04-16 Elbion Ag Pyrido [3,2-e] pyrazines, their use as inhibitors of phosphodiesterase 10, and processes for preparing them
JP2008273954A (ja) 2007-03-30 2008-11-13 Mitsubishi Tanabe Pharma Corp うつ病の予防及び/又は治療剤
GB2462611A (en) 2008-08-12 2010-02-17 Cambridge Lab Pharmaceutical composition comprising tetrabenazine
EP2246331A1 (en) 2009-04-24 2010-11-03 Westfälische Wilhelms-Universität Münster NR2B-selective NMDA-receptor antagonists
UY33455A (es) 2010-06-16 2012-01-31 Teijin Pharma Ltd Tableta con núcleo recubierto de liberación controlada
US8937900B2 (en) 2010-07-20 2015-01-20 Qualcomm Incorporated Enhancing pilot channel transmission in TD-SCDMA multicarrier systems using secondary carrier frequencies
EP3335731B1 (en) 2010-07-20 2024-09-04 Minerva Neurosciences, Inc. Use of cyclic amide derivatives to treat sleep disorders
EP4070794A3 (en) 2010-07-20 2023-01-18 Minerva Neurosciences, Inc. Methods of use cyclic amide derivatives to treat sigma receptor-mediated disorders
EP2468264A1 (en) * 2010-12-27 2012-06-27 Laboratorios Liconsa, S.A. Oral pharmaceutical tablet for controled release of mesalazine and process for obtaining it
US9737531B2 (en) 2012-07-12 2017-08-22 Glytech, Llc Composition and method for treatment of depression and psychosis in humans
EP2685966A1 (en) 2011-03-17 2014-01-22 Lupin Limited Controlled release pharmaceutical compositions of selective serotonin reuptake inhibitor
CA2845228C (en) * 2011-08-16 2021-08-10 Baker Idi Heart & Diabetes Institute Holdings Limited Oral controlled-release formulation of 5-(pyridinyl)-2(1h)-pyridinone compounds
BR112015023124A2 (pt) * 2013-03-14 2017-07-18 Therabiome Llc liberação de organismos probióticos e/ou agentes terapêuticos almejada para o trato gastrintestinal
EP3144308B1 (en) 2014-05-16 2020-06-24 Takeda Pharmaceutical Company Limited Nitrogen-containing heterocyclic compound
WO2015191554A1 (en) 2014-06-09 2015-12-17 Intra-Cellular Therapies, Inc. Compounds and methods of use to treat schizophrenia
WO2017066134A1 (en) * 2015-10-16 2017-04-20 Merck Sharp & Dohme Corp. Processes for preparing formulations for gastrointestinal-targeted therapies
SG11201810358YA (en) 2016-05-25 2018-12-28 Mitsubishi Tanabe Pharma Corp Compositions and methods for treating negative symptoms in non-schizophrenic patients
EP3641732A1 (en) 2017-06-21 2020-04-29 Minerva Neurosciences, Inc. Gastro-resistant controlled release oral dosage forms
WO2020041504A1 (en) 2018-08-21 2020-02-27 Minerva Neurosciences, Inc. Use of roluperidone to treat negative symptoms and disorders, increase neuroplasticity, and promote neuroprotection
US12441701B2 (en) 2019-06-28 2025-10-14 Tapi Czech Industries S.R.O. Solid state forms of roluperidone and salts thereof
CA3243767A1 (en) 2022-02-14 2023-08-17 Minerva Neurosciences, Inc. USE OF ROLUPERIDONE IN THE PREVENTION OF RELAPSE IN PATIENTS WITH SCHIZOPHRENIA

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012527425A (ja) * 2009-05-18 2012-11-08 シグモイド・ファーマ・リミテッド 油滴含有組成物
JP2013536186A (ja) * 2010-08-11 2013-09-19 エフ.ホフマン−ラ ロシュ アーゲー 代謝型グルタミン酸5受容体(mGlu5)アンタゴニストの医薬組成物
CN104586771A (zh) * 2013-10-30 2015-05-06 广州朗圣药业有限公司 一种盐酸坦洛新缓释微丸制剂
JP2017514832A (ja) * 2014-04-30 2017-06-08 インサイト・コーポレイションIncyte Corporation Jak1抑制剤を調製する方法及びその新しい形態
WO2016025762A1 (en) * 2014-08-13 2016-02-18 Cedars-Sinai Medical Center Anti-methanogenic compositions and uses thereof
WO2016089766A1 (en) * 2014-12-02 2016-06-09 Minerva Neurosciences, Inc. Compositions comprising 2-((1-(2(4-fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)isoindolin-1-one for treating schizophrenia

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
EVONIK INDUSTRIESのカタログ(PLASACRYLTM HTP20 AND PLASACRYLTM T20)[オンライン], JPN7022006038, 2012, pages 7, ISSN: 0005081996 *
編集者:橋田 充, 経口投与製剤の設計と評価, JPN6022031525, 1995, pages 337 - 339, ISSN: 0005081995 *

Also Published As

Publication number Publication date
JP2025134828A (ja) 2025-09-17
IL271606B1 (en) 2024-01-01
WO2018237207A1 (en) 2018-12-27
IL271606B2 (en) 2024-05-01
UA127349C2 (uk) 2023-07-26
CL2019003743A1 (es) 2020-07-03
AU2018290287A1 (en) 2020-01-16
CO2019014496A2 (es) 2020-04-01
JP2023175778A (ja) 2023-12-12
IL319156A (en) 2025-04-01
EP3641732A1 (en) 2020-04-29
IL308650B1 (en) 2025-04-01
US12048768B2 (en) 2024-07-30
RU2020102015A (ru) 2021-07-21
US20250009665A1 (en) 2025-01-09
BR112019027398A2 (pt) 2020-07-07
AU2018290287B2 (en) 2024-06-13
CN111511353A (zh) 2020-08-07
US11464744B2 (en) 2022-10-11
US20220401368A1 (en) 2022-12-22
MX2023002994A (es) 2023-09-15
RU2020102015A3 (enExample) 2021-10-04
AU2024219717A1 (en) 2024-10-03
IL308650A (en) 2024-01-01
ZA202409847B (en) 2025-09-25
IL308650B2 (en) 2025-08-01
CA3067031A1 (en) 2018-12-27
PE20200732A1 (es) 2020-07-23
IL271606A (en) 2020-02-27
US20190038561A1 (en) 2019-02-07

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