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AR094291A1 - Formulacion inyectable de liberacion prolongada que comprende tolvaptan opticamente activo, y un procedimiento para producirla - Google Patents

Formulacion inyectable de liberacion prolongada que comprende tolvaptan opticamente activo, y un procedimiento para producirla

Info

Publication number
AR094291A1
AR094291A1 ARP130105041A ARP130105041A AR094291A1 AR 094291 A1 AR094291 A1 AR 094291A1 AR P130105041 A ARP130105041 A AR P130105041A AR P130105041 A ARP130105041 A AR P130105041A AR 094291 A1 AR094291 A1 AR 094291A1
Authority
AR
Argentina
Prior art keywords
procedure
produce
optically active
prolonged release
injectable formulation
Prior art date
Application number
ARP130105041A
Other languages
English (en)
Inventor
Fujiki Hiroyuki
Kinoshita Shizuo
Suzuki Kai
Kaneko Daiki
Matsuda Takakuni
Miyata Kenichi
Ohmoto Koji
Aihara Miki
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
Application filed by Otsuka Pharma Co Ltd filed Critical Otsuka Pharma Co Ltd
Publication of AR094291A1 publication Critical patent/AR094291A1/es

Links

Classifications

    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Una formulación inyectable para administrar por vía intramuscular o subcutánea que se usa para la prevención o para el tratamiento de la enfermedad renal poliquística, y que puede mantener una concentración de tolvaptán en sangre terapéuticamente eficaz durante un largo período; y un procedimiento para producirlo. Más específicamente, una formulación inyectable de liberación prolongada que comprende (1) una partícula de tolvaptán ópticamente activo, como un ingrediente activo, y (2) un vehículo farmacéuticamente aceptable para inyección, y un procedimiento para producirlo.
ARP130105041A 2012-12-28 2013-12-27 Formulacion inyectable de liberacion prolongada que comprende tolvaptan opticamente activo, y un procedimiento para producirla AR094291A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201261747005P 2012-12-28 2012-12-28

Publications (1)

Publication Number Publication Date
AR094291A1 true AR094291A1 (es) 2015-07-22

Family

ID=50097796

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP130105041A AR094291A1 (es) 2012-12-28 2013-12-27 Formulacion inyectable de liberacion prolongada que comprende tolvaptan opticamente activo, y un procedimiento para producirla

Country Status (19)

Country Link
US (1) US9597283B2 (es)
EP (1) EP2941242B1 (es)
JP (1) JP6265999B2 (es)
KR (1) KR20150102083A (es)
CN (1) CN104902874A (es)
AR (1) AR094291A1 (es)
AU (1) AU2013366872A1 (es)
BR (1) BR112015015439A2 (es)
CA (1) CA2894516A1 (es)
EA (1) EA201591233A1 (es)
HK (1) HK1211225A1 (es)
IL (1) IL239351A0 (es)
MX (1) MX2015008220A (es)
NZ (1) NZ630346A (es)
PH (1) PH12015501373A1 (es)
SG (1) SG11201504381VA (es)
TW (1) TW201427669A (es)
WO (1) WO2014104412A1 (es)
ZA (1) ZA201504338B (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI660748B (zh) * 2013-03-01 2019-06-01 日商大塚製藥股份有限公司 用於口服投藥之包含非晶型托伐普坦（Ｔｏｌｖａｐｔａｎ）的懸浮液
TW201605488A (zh) * 2013-10-15 2016-02-16 大塚製藥股份有限公司 用以預防及／或治療多囊腎病之藥物
WO2017193066A1 (en) * 2016-05-05 2017-11-09 Liquidia Technologies, Inc. Precision controlled load and release particles for post-operative pain
WO2018096560A1 (en) * 2016-11-23 2018-05-31 Cipla Limited Long acting depot formulation for the continuous dopaminergic stimulation
GB2561355A (en) * 2017-04-10 2018-10-17 Eaststone Ltd Pharmaceutical composition and a method for manufacturing the same
CN109528636B (zh) * 2018-12-20 2022-05-03 常州市阳光药业有限公司 托伐普坦口服溶液及其制备方法
WO2020131680A1 (en) * 2018-12-21 2020-06-25 Resilio Therapeutics, LLC Compounds and methods for the treatment of polycystic kidney disease (pkd)

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR0167349B1 (ko) 1989-10-20 1999-02-18 오스카 아끼히꼬 벤조헤테로 고리 화합물
US5258510A (en) 1989-10-20 1993-11-02 Otsuka Pharma Co Ltd Benzoheterocyclic compounds
US5985869A (en) 1989-10-20 1999-11-16 Otsuka Pharmaceutical Company, Limited Benzoheterocyclic compounds
US5753677A (en) 1989-10-20 1998-05-19 Otsuka Pharmaceutical Co., Ltd. Benzoheterocyclic compounds
JPH04210355A (ja) 1990-07-24 1992-07-31 Ono Sokki Co Ltd 加工装置
JP4210355B2 (ja) * 1997-07-03 2009-01-14 大塚製薬株式会社 固形製剤組成物
ES2533007T3 (es) * 2005-12-27 2015-04-06 Otsuka Pharmaceutical Co., Ltd. Compuesto de benzoacepina soluble en agua y su composición farmacéutica
TWI459947B (zh) * 2007-06-26 2014-11-11 Otsuka Pharma Co Ltd 苯并氮呯化合物及藥學製劑
JP5590780B2 (ja) * 2007-06-26 2014-09-17 大塚製薬株式会社 医薬
TWI704919B (zh) 2012-05-31 2020-09-21 日商大塚製藥股份有限公司 用於預防及/或治療多囊性腎臟病之藥物

Also Published As

Publication number Publication date
JP6265999B2 (ja) 2018-01-24
US20150352041A1 (en) 2015-12-10
MX2015008220A (es) 2015-09-29
EP2941242A1 (en) 2015-11-11
BR112015015439A2 (pt) 2017-07-11
US9597283B2 (en) 2017-03-21
AU2013366872A1 (en) 2015-07-02
NZ630346A (en) 2016-06-24
PH12015501373A1 (en) 2015-09-07
KR20150102083A (ko) 2015-09-04
ZA201504338B (en) 2016-11-30
EP2941242B1 (en) 2017-02-01
HK1211225A1 (en) 2016-05-20
EA201591233A1 (ru) 2015-11-30
SG11201504381VA (en) 2015-07-30
CN104902874A (zh) 2015-09-09
JP2016503753A (ja) 2016-02-08
CA2894516A1 (en) 2014-07-03
WO2014104412A1 (en) 2014-07-03
TW201427669A (zh) 2014-07-16
IL239351A0 (en) 2015-07-30

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