ES2727454T5 - Formulación inyectable - Google Patents

Formulación inyectable Download PDF

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Publication number
ES2727454T5
ES2727454T5 ES13781458T ES13781458T ES2727454T5 ES 2727454 T5 ES2727454 T5 ES 2727454T5 ES 13781458 T ES13781458 T ES 13781458T ES 13781458 T ES13781458 T ES 13781458T ES 2727454 T5 ES2727454 T5 ES 2727454T5
Authority
ES
Spain
Prior art keywords
compound
injectable preparation
salt
dihydrate
weight
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
ES13781458T
Other languages
English (en)
Spanish (es)
Other versions
ES2727454T3 (es
Inventor
Tetsuya Sato
Takuya Minowa
Yusuke Hoshika
Hidekazu Toyofuku
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Otsuka Pharmaceutical Co Ltd
Original Assignee
Otsuka Pharmaceutical 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=ES2727454(T5) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Otsuka Pharmaceutical Co Ltd filed Critical Otsuka Pharmaceutical Co Ltd
Publication of ES2727454T3 publication Critical patent/ES2727454T3/es
Application granted granted Critical
Publication of ES2727454T5 publication Critical patent/ES2727454T5/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Neurology (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)
ES13781458T 2012-04-23 2013-04-23 Formulación inyectable Active ES2727454T5 (es)

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
ES2727454T3 ES2727454T3 (es) 2019-10-16
ES2727454T5 true ES2727454T5 (es) 2022-05-13

Family

ID=49483139

Family Applications (1)

Application Number Title Priority Date Filing Date
ES13781458T Active ES2727454T5 (es) 2012-04-23 2013-04-23 Formulación inyectable

Country Status (31)

Country Link
US (6) US20150086632A1 (enExample)
EP (1) EP2868318B2 (enExample)
JP (1) JP6249944B2 (enExample)
KR (1) KR102168263B1 (enExample)
CN (4) CN107536802A (enExample)
AR (1) AR090775A1 (enExample)
AU (1) AU2013253518B2 (enExample)
BR (1) BR112014026398B1 (enExample)
CA (1) CA2871398C (enExample)
CO (1) CO7151499A2 (enExample)
CY (1) CY1123195T1 (enExample)
DK (1) DK2868318T4 (enExample)
EA (1) EA026124B1 (enExample)
ES (1) ES2727454T5 (enExample)
HR (1) HRP20190841T4 (enExample)
HU (1) HUE043686T2 (enExample)
IL (1) IL235211A0 (enExample)
IN (1) IN2014DN08870A (enExample)
JO (1) JO3524B1 (enExample)
LT (1) LT2868318T (enExample)
MX (1) MX361722B (enExample)
MY (1) MY169099A (enExample)
NZ (1) NZ630255A (enExample)
PH (1) PH12014502366A1 (enExample)
PL (1) PL2868318T5 (enExample)
PT (1) PT2868318T (enExample)
SG (2) SG11201406775UA (enExample)
SI (1) SI2868318T2 (enExample)
TW (1) TWI641395B (enExample)
UA (1) UA118084C2 (enExample)
WO (1) WO2013161830A1 (enExample)

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
US10501450B2 (en) 2016-02-01 2019-12-10 Hexal Ag Anhydrate-free polymorphically pure micronized crystalline brexpiprazole di-hydrate 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
WO2018033484A1 (en) 2016-08-16 2018-02-22 Hexal Aktiengesellschaft Pharmaceutical compositions of a benzothiophene compound
WO2018141886A1 (en) 2017-02-02 2018-08-09 Hexal Aktiengesellschaft Crystalline brexpiprazole
WO2020196814A1 (en) * 2019-03-28 2020-10-01 Otsuka Pharmaceutical Co., Ltd. Benzoazepine compound-containing freeze-dried composition
WO2021029020A1 (ja) * 2019-08-13 2021-02-18 大塚製薬株式会社 経口医薬組成物
US20240315967A1 (en) 2021-09-07 2024-09-26 Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. 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
ES2284202T3 (es) 1997-05-14 2007-11-01 Senju Pharmaceutical Co., Ltd. Preparaciones acuosas en suspension con excelente redispersabilidad.
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
US6656505B2 (en) * 2000-07-21 2003-12-02 Alpharma Uspd Inc. Method for forming an aqueous flocculated suspension
JP5000835B2 (ja) * 2000-08-25 2012-08-15 千寿製薬株式会社 水性懸濁液剤
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
CA2543242C (en) * 2003-10-23 2015-04-14 Otsuka Pharmaceutical Co., Ltd. Controlled release sterile freeze-dried aripiprazole formulation and injectable formulation thereof
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
US20070148100A1 (en) 2005-09-15 2007-06-28 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
MX2010001311A (es) * 2007-07-31 2010-04-21 Otsuka Pharma Co Ltd Metodo para producir una suspensi?n de aripiprazol y formulacion liofilizada.
CA2717605C (en) * 2008-03-11 2012-05-15 Alcon Research Ltd. Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection
MX2011005217A (es) * 2008-11-19 2011-06-01 Merial Ltd Formulaciones que comprenden ceftiofur y cetoprofeno o ceftiofur y alcohol bencilico.
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
EP2629775A4 (en) * 2010-10-18 2014-06-11 Dainippon Sumitomo Pharma Co INJECTABLE FORMULATION WITH DELAYED RELEASE
PL2685979T3 (pl) * 2011-03-18 2017-02-28 Alkermes Pharma Ireland Limited Kompozycje farmaceutyczne do wstrzykiwania zawierające środek nierozpuszczalny w wodzie, środek przeciwpsychotyczny, laurynian sorbitanu i polisorbat 20
JP2012232958A (ja) 2011-05-09 2012-11-29 Otsuka Pharmaceut Co Ltd 注射製剤
CA2867137C (en) * 2012-03-19 2020-12-08 Alkermes Pharma Ireland Limited Pharmaceutical compositions comprising aripiprazole prodrugs and benzyl alcohol
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
JOP20200109A1 (ar) * 2012-04-23 2017-06-16 Otsuka Pharma Co Ltd مستحضر قابل للحقن

Also Published As

Publication number Publication date
MX2014012734A (es) 2015-04-10
JPWO2013161830A1 (ja) 2015-12-24
US20240277702A1 (en) 2024-08-22
TWI641395B (zh) 2018-11-21
SI2868318T2 (sl) 2022-04-29
AU2013253518A1 (en) 2014-11-06
HK1205678A1 (en) 2015-12-24
HRP20190841T1 (hr) 2019-07-26
HRP20190841T4 (hr) 2022-03-04
CN104363912A (zh) 2015-02-18
AR090775A1 (es) 2014-12-03
WO2013161830A1 (ja) 2013-10-31
TW201406401A (zh) 2014-02-16
MY169099A (en) 2019-02-18
ES2727454T3 (es) 2019-10-16
KR102168263B1 (ko) 2020-10-21
EP2868318A1 (en) 2015-05-06
EA201491937A1 (ru) 2015-03-31
PH12014502366B1 (en) 2015-01-12
LT2868318T (lt) 2019-07-25
BR112014026398B1 (pt) 2022-11-29
IL235211A0 (en) 2014-12-31
CO7151499A2 (es) 2014-12-29
EA026124B1 (ru) 2017-03-31
CN110638752A (zh) 2020-01-03
DK2868318T4 (da) 2022-03-28
PL2868318T3 (pl) 2019-09-30
NZ630255A (en) 2016-05-27
EP2868318B1 (en) 2019-03-06
IN2014DN08870A (enExample) 2015-05-22
US20250241909A1 (en) 2025-07-31
US20150086632A1 (en) 2015-03-26
PH12014502366A1 (en) 2015-01-12
EP2868318B2 (en) 2022-01-26
CN107536802A (zh) 2018-01-05
US20220305007A1 (en) 2022-09-29
JO3524B1 (ar) 2020-07-05
US20180092910A1 (en) 2018-04-05
DK2868318T3 (da) 2019-06-03
HUE043686T2 (hu) 2019-09-30
CA2871398C (en) 2021-04-27
SI2868318T1 (sl) 2019-06-28
US10624889B2 (en) 2020-04-21
KR20150003336A (ko) 2015-01-08
SG11201406775UA (en) 2014-12-30
US20200163960A1 (en) 2020-05-28
EP2868318A4 (en) 2015-12-09
SG10201608684QA (en) 2016-12-29
BR112014026398A2 (pt) 2017-06-27
PL2868318T5 (pl) 2022-06-20
AU2013253518B2 (en) 2017-10-05
PT2868318T (pt) 2019-06-07
UA118084C2 (uk) 2018-11-26
CY1123195T1 (el) 2021-10-29
CN111888329A (zh) 2020-11-06
MX361722B (es) 2018-12-14
CA2871398A1 (en) 2013-10-31
JP6249944B2 (ja) 2017-12-20

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