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DK2868318T4 - Injicerbar formulering - Google Patents

Injicerbar formulering Download PDF

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Publication number
DK2868318T4
DK2868318T4 DK13781458.8T DK13781458T DK2868318T4 DK 2868318 T4 DK2868318 T4 DK 2868318T4 DK 13781458 T DK13781458 T DK 13781458T DK 2868318 T4 DK2868318 T4 DK 2868318T4
Authority
DK
Denmark
Prior art keywords
injectible formulation
injectible
formulation
Prior art date
Application number
DK13781458.8T
Other languages
English (en)
Other versions
DK2868318T3 (da
Inventor
Tetsuya Sato
Takuya Minowa
Yusuke Hoshika
Hidekazu Toyofuku
Original Assignee
Otsuka Pharma Co Ltd
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49483139&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2868318(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Otsuka Pharma Co Ltd filed Critical Otsuka Pharma Co Ltd
Publication of DK2868318T3 publication Critical patent/DK2868318T3/da
Application granted granted Critical
Publication of DK2868318T4 publication Critical patent/DK2868318T4/da

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
DK13781458.8T 2012-04-23 2013-04-23 Injicerbar formulering DK2868318T4 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261636932P 2012-04-23 2012-04-23
US201361791896P 2013-03-15 2013-03-15
PCT/JP2013/061950 WO2013161830A1 (ja) 2012-04-23 2013-04-23 注射製剤

Publications (2)

Publication Number Publication Date
DK2868318T3 DK2868318T3 (da) 2019-06-03
DK2868318T4 true DK2868318T4 (da) 2022-03-28

Family

ID=49483139

Family Applications (1)

Application Number Title Priority Date Filing Date
DK13781458.8T DK2868318T4 (da) 2012-04-23 2013-04-23 Injicerbar formulering

Country Status (31)

Country Link
US (6) US20150086632A1 (da)
EP (1) EP2868318B2 (da)
JP (1) JP6249944B2 (da)
KR (1) KR102168263B1 (da)
CN (4) CN110638752A (da)
AR (1) AR090775A1 (da)
AU (1) AU2013253518B2 (da)
BR (1) BR112014026398B1 (da)
CA (1) CA2871398C (da)
CO (1) CO7151499A2 (da)
CY (1) CY1123195T1 (da)
DK (1) DK2868318T4 (da)
EA (1) EA026124B1 (da)
ES (1) ES2727454T5 (da)
HR (1) HRP20190841T4 (da)
HU (1) HUE043686T2 (da)
IL (1) IL235211A0 (da)
IN (1) IN2014DN08870A (da)
JO (1) JO3524B1 (da)
LT (1) LT2868318T (da)
MX (1) MX361722B (da)
MY (1) MY169099A (da)
NZ (1) NZ630255A (da)
PH (1) PH12014502366B1 (da)
PL (1) PL2868318T5 (da)
PT (1) PT2868318T (da)
SG (2) SG10201608684QA (da)
SI (1) SI2868318T2 (da)
TW (1) TWI641395B (da)
UA (1) UA118084C2 (da)
WO (1) WO2013161830A1 (da)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20200109A1 (ar) 2012-04-23 2017-06-16 Otsuka Pharma Co Ltd مستحضر قابل للحقن
TWI562991B (en) * 2012-04-23 2016-12-21 Otsuka Pharma Co Ltd Dihydrate of benzothiophene compound or of a salt thereof, and process for producing the same
JOP20210047A1 (ar) * 2012-10-25 2017-06-16 Otsuka Pharma Co Ltd عامل وقائي و/أو علاجي للأعراض السلوكية والنفسية المصحوبة بمرض تنكسي عصبي أو الأعراض الإندفاعية المصحوبة بمرض ذهني، يحتوي على بريكسبيرازول أو ملحه
WO2017106641A1 (en) * 2015-12-17 2017-06-22 Assia Chemical Industries Ltd. Solid state forms of brexpiprazole
WO2017134038A1 (en) * 2016-02-01 2017-08-10 Hexal Ag Anhydrate-free polymorphically pure micronized crystalline brexpiprazole dihydrate for use in intramuscular injectable sustained release formulations
WO2017208251A1 (en) * 2016-05-31 2017-12-07 Cipla Limited A new stable polymorph of brexpiprazole and process for preparation thereof
EP3500249A1 (en) * 2016-08-16 2019-06-26 Hexal Aktiengesellschaft Pharmaceutical compositions of a benzothiophene compound
US11072605B2 (en) 2017-02-02 2021-07-27 Hexal Ag Crystalline brexpiprazole
JP7043156B2 (ja) * 2019-03-28 2022-03-29 大塚製薬株式会社 ベンゾアゼピン化合物含有凍結乾燥組成物
WO2021029020A1 (ja) * 2019-08-13 2021-02-18 大塚製薬株式会社 経口医薬組成物
CA3225183A1 (en) * 2021-09-07 2023-03-16 Ming Li Long-acting brexpiprazole preparation for injection and preparation method therefor
CN117214053A (zh) * 2023-10-17 2023-12-12 海南卫康制药(潜山)有限公司 一种注射用头孢呋辛钠肌注混悬液的粒度测定方法

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3402195B2 (ja) * 1997-05-14 2003-04-28 千寿製薬株式会社 再分散性の良い水性懸濁液剤
EP0995435B1 (en) 1997-05-14 2007-04-25 Senju Pharmaceutical Co., Ltd. Aqueous suspension preparations with excellent redispersibility
US6656505B2 (en) * 2000-07-21 2003-12-02 Alpharma Uspd Inc. Method for forming an aqueous flocculated suspension
US20030195179A1 (en) 2000-08-25 2003-10-16 Shirou Sawa Aqueous suspension preparations
AR033485A1 (es) * 2001-09-25 2003-12-26 Otsuka Pharma Co Ltd Sustancia medicinal de aripiprazol de baja higroscopicidad y proceso para la preparacion de la misma
US20050032811A1 (en) * 2003-08-06 2005-02-10 Josiah Brown Methods for administering aripiprazole
AU2004285448C1 (en) * 2003-10-23 2021-08-19 Otsuka Pharmaceutical Co., Ltd. Controlled release sterile injectable aripiprazole formulation and method
TWI320783B (en) * 2005-04-14 2010-02-21 Otsuka Pharma Co Ltd Heterocyclic compound
JP4315393B2 (ja) * 2005-04-14 2009-08-19 大塚製薬株式会社 複素環化合物
EP1933814A2 (en) * 2005-09-15 2008-06-25 Elan Pharma International Limited Nanoparticulate aripiprazole formulations
TW200808375A (en) 2006-05-12 2008-02-16 Otsuka Pharma Co Ltd Hydrogel suspension and manufacturing process thereof
TWI415629B (zh) * 2006-10-26 2013-11-21 Otsuka Pharma Co Ltd 含有瑞巴匹特之水性醫藥懸浮物及其製造方法
JP4879349B2 (ja) 2007-07-31 2012-02-22 大塚製薬株式会社 アリピプラゾール懸濁液及び凍結乾燥製剤の製造方法
DK2262506T3 (da) * 2008-03-11 2014-06-10 Alcon Res Ltd Meget flokkulerede triamcinolonacetonid-suspensioner med lav viskositet til intravitreal injektion
JP5685193B2 (ja) * 2008-11-19 2015-03-18 メリアル リミテッド セフチオフルおよびケトプロフェンとまたはセフチオフルとベンジルアルコールとを含む製剤
NZ603076A (en) * 2010-08-24 2014-12-24 Otsuka Pharma Co Ltd Suspension and cake composition containing carbostyril derivative and silicone oil and/or silicone oil derivative
WO2012053654A1 (en) * 2010-10-18 2012-04-26 Dainippon Sumitomo Pharma Co., Ltd. Sustained-release formulation for injection
FI3156056T3 (fi) * 2011-03-18 2024-03-01 Alkermes Pharma Ireland Ltd Sorbitaaniestereitä käsittäviä farmaseuttisia koostumuksia
JP2012232958A (ja) 2011-05-09 2012-11-29 Otsuka Pharmaceut Co Ltd 注射製剤
ES2950418T3 (es) * 2012-03-19 2023-10-09 Alkermes Pharma Ireland Ltd Composiciones farmacéuticas que comprenden alcohol bencílico
JOP20200109A1 (ar) * 2012-04-23 2017-06-16 Otsuka Pharma Co Ltd مستحضر قابل للحقن
TWI562991B (en) * 2012-04-23 2016-12-21 Otsuka Pharma Co Ltd Dihydrate of benzothiophene compound or of a salt thereof, and process for producing the same

Also Published As

Publication number Publication date
CA2871398A1 (en) 2013-10-31
SG11201406775UA (en) 2014-12-30
US20150086632A1 (en) 2015-03-26
BR112014026398B1 (pt) 2022-11-29
CN111888329A (zh) 2020-11-06
JP6249944B2 (ja) 2017-12-20
US20240277702A1 (en) 2024-08-22
EP2868318B2 (en) 2022-01-26
TW201406401A (zh) 2014-02-16
IN2014DN08870A (da) 2015-05-22
JPWO2013161830A1 (ja) 2015-12-24
JO3524B1 (ar) 2020-07-05
LT2868318T (lt) 2019-07-25
DK2868318T3 (da) 2019-06-03
US20200163960A1 (en) 2020-05-28
UA118084C2 (uk) 2018-11-26
WO2013161830A1 (ja) 2013-10-31
SI2868318T1 (sl) 2019-06-28
US20180092910A1 (en) 2018-04-05
TWI641395B (zh) 2018-11-21
EP2868318B1 (en) 2019-03-06
EP2868318A1 (en) 2015-05-06
CN107536802A (zh) 2018-01-05
CN104363912A (zh) 2015-02-18
ES2727454T5 (es) 2022-05-13
PH12014502366A1 (en) 2015-01-12
BR112014026398A2 (pt) 2017-06-27
EA201491937A1 (ru) 2015-03-31
SG10201608684QA (en) 2016-12-29
NZ630255A (en) 2016-05-27
US20250241909A1 (en) 2025-07-31
AR090775A1 (es) 2014-12-03
IL235211A0 (en) 2014-12-31
HK1205678A1 (en) 2015-12-24
CN110638752A (zh) 2020-01-03
ES2727454T3 (es) 2019-10-16
SI2868318T2 (sl) 2022-04-29
PT2868318T (pt) 2019-06-07
US10624889B2 (en) 2020-04-21
CY1123195T1 (el) 2021-10-29
PL2868318T3 (pl) 2019-09-30
MY169099A (en) 2019-02-18
AU2013253518A1 (en) 2014-11-06
HUE043686T2 (hu) 2019-09-30
MX2014012734A (es) 2015-04-10
HRP20190841T4 (hr) 2022-03-04
US20220305007A1 (en) 2022-09-29
AU2013253518B2 (en) 2017-10-05
KR102168263B1 (ko) 2020-10-21
PH12014502366B1 (en) 2015-01-12
CA2871398C (en) 2021-04-27
HRP20190841T1 (hr) 2019-07-26
EA026124B1 (ru) 2017-03-31
CO7151499A2 (es) 2014-12-29
EP2868318A4 (en) 2015-12-09
PL2868318T5 (pl) 2022-06-20
KR20150003336A (ko) 2015-01-08
MX361722B (es) 2018-12-14

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