AR108955A2 - Suspensión oftálmica acuosa de rebamipida cristalina - Google Patents

Suspensión oftálmica acuosa de rebamipida cristalina

Info

Publication number
AR108955A2
AR108955A2 ARP170101857A ARP170101857A AR108955A2 AR 108955 A2 AR108955 A2 AR 108955A2 AR P170101857 A ARP170101857 A AR P170101857A AR P170101857 A ARP170101857 A AR P170101857A AR 108955 A2 AR108955 A2 AR 108955A2
Authority
AR
Argentina
Prior art keywords
aqueous solution
rebamipide
surfactants
compounds selected
soluble polymers
Prior art date
Application number
ARP170101857A
Other languages
English (en)
Inventor
Shinichi Ishikawa
Yuso Tomohira
Shogo Hiraoka
Takakuni Matsuda
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 AR108955A2 publication Critical patent/AR108955A2/es

Links

Classifications

    • 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
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4704—2-Quinolinones, e.g. carbostyril
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K9/08—Solutions
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Ophthalmology & Optometry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Un producto oftálmico que contiene rebamipida, el cual posee la suficiente transparencia como para tener una buena sensación en el uso y posee un pH neutro a débilmente ácido para no lesionar la queratoconjuntiva de un paciente que sufre de ojo seco. Se provee una suspensión acuosa de rebamipida cristalina que posee una transparencia mejorada por agregado de una solución acuosa de rebamipida disuelta por una base tal como hidróxido de sodio o una solución acuosa de una sal de rebamipida a una solución acuosa ácida tal como ácido clorhídrico que contiene por lo menos uno de los compuestos seleccionados de los polímeros solubles en agua y agentes tensioactivos, y mezclar los mismos. Reivindicación 1: Una suspensión acuosa de rebamipida cristalina caracterizada porque comprende una mezcla de (1) por lo menos uno de los compuestos seleccionados de polímeros solubles en agua y agentes tensioactivos, (2) una solución acuosa ácida, y (3) una solución acuosa que contiene una sal de rebamipida soluble en agua, donde la forma de la rebamipida cristalina es un cristal de aguja regular que tiene una longitud de calibre largo menor de 1000 nm y una longitud de calibre corto menor de 60 nm con la provisión que la relación entre la distancia larga de calibre y la distancia corta de calibre no sea menor que 4, la cual es preparada por (i) mezclar una solución acuosa ácida conteniendo al menos uno de los compuestos seleccionados de polímeros solubles en agua y agentes tensioactivos, y una solución acuosa conteniendo una sal de rebamipida soluble en agua, o (ii) mezclar una solución acuosa ácida y una solución acuosa conteniendo una sal de rebamipida soluble en agua y al menos uno de los compuestos seleccionados de polímeros solubles en agua y agentes tensioactivos, o (iii) mezclar una solución acuosa ácida conteniendo al menos uno de los compuestos seleccionados de polímeros solubles en agua y agentes tensioactivos, y una solución acuosa conteniendo una sal de rebamipida soluble en agua y al menos uno de los compuestos seleccionados de polímeros solubles en agua y agentes tensioactivos, y entonces ajustar el pH de la suspensión acuosa a 5 - 7 con una base.
ARP170101857A 2004-11-15 2017-07-05 Suspensión oftálmica acuosa de rebamipida cristalina AR108955A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2004330140 2004-11-15

Publications (1)

Publication Number Publication Date
AR108955A2 true AR108955A2 (es) 2018-10-10

Family

ID=36336674

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP050104503A AR052779A1 (es) 2004-11-15 2005-10-27 Suspension oftalmica acuosa de rebamipida cristalina
ARP170101857A AR108955A2 (es) 2004-11-15 2017-07-05 Suspensión oftálmica acuosa de rebamipida cristalina

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP050104503A AR052779A1 (es) 2004-11-15 2005-10-27 Suspension oftalmica acuosa de rebamipida cristalina

Country Status (16)

Country Link
US (2) US9211254B2 (es)
EP (1) EP1812000A4 (es)
JP (3) JP4934587B2 (es)
KR (1) KR101271959B1 (es)
CN (1) CN100594901C (es)
AR (2) AR052779A1 (es)
AU (1) AU2005302908B2 (es)
BR (1) BRPI0518928A2 (es)
CA (1) CA2584017C (es)
HK (1) HK1112718A1 (es)
MX (1) MX2007005782A (es)
MY (1) MY152867A (es)
RU (1) RU2398585C2 (es)
SG (1) SG156692A1 (es)
TW (1) TWI363626B (es)
WO (1) WO2006052018A1 (es)

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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
WO2008074853A1 (en) * 2006-12-21 2008-06-26 Novartis Ag Ophthalmic rebamipide solution
KR20110027786A (ko) * 2008-06-19 2011-03-16 오츠카 세이야쿠 가부시키가이샤 레바미피드를 함유하는 의약 조성물
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AU2012232062B2 (en) * 2011-03-24 2017-04-20 Otsuka Pharmaceutical Co., Ltd. A pharmaceutical composition for treating a disease in the oral cavity comprising rebamipide
TW201322982A (zh) * 2011-11-01 2013-06-16 Otsuka Pharma Co Ltd 用於治療前眼疾病之藥劑，該藥劑包含瑞巴派特及眼淚保持劑
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EP2996673A1 (en) * 2013-05-16 2016-03-23 Universiteit Antwerpen Thermolabile drug release formulation
TWI697337B (zh) * 2013-08-07 2020-07-01 學校法人近畿大學 奈米粒子或奈米粒子組成物之製造方法，及支架或球囊導管之製造方法
CN104586762A (zh) * 2014-04-11 2015-05-06 广州仁恒医药科技有限公司 含有瑞巴派特的药物组合物及其制备方法
JP6854587B2 (ja) * 2015-04-17 2021-04-07 ロート製薬株式会社 医薬製剤
KR101718733B1 (ko) * 2015-08-21 2017-03-22 국제약품 주식회사 레바미피드의 가용화 방법 및 이에 의해 제조된 안구건조증 치료용 액제
KR20170039347A (ko) * 2015-10-01 2017-04-11 삼진제약주식회사 레바미피드를 함유하는 신규한 점안 조성물 및 이의 제조방법
KR102307958B1 (ko) 2015-10-01 2021-10-05 삼진제약주식회사 레바미피드를 함유하는 신규한 점안 조성물 및 이의 제조방법
JP6732441B2 (ja) * 2015-12-11 2020-07-29 ロート製薬株式会社 局所粘膜適用水性組成物
KR101840256B1 (ko) * 2017-09-21 2018-03-21 대우제약 주식회사 레바미피드를 함유하는 새로운 안구건조증 치료용 점안 조성물 및 이의 가용화 및 안정화 방법
KR101923519B1 (ko) 2018-06-26 2019-02-27 대우제약 주식회사 레바미피드를 함유하는 안구 건조증 치료용 수용성 다회용 점안제 조성물 및 이의 가용화 및 안정화 방법
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Also Published As

Publication number Publication date
EP1812000A1 (en) 2007-08-01
TW200621252A (en) 2006-07-01
US9533052B2 (en) 2017-01-03
CA2584017A1 (en) 2006-05-18
JP2012092139A (ja) 2012-05-17
RU2007122392A (ru) 2008-12-20
HK1112718A1 (en) 2008-09-12
TWI363626B (en) 2012-05-11
AU2005302908A1 (en) 2006-05-18
US20070287729A1 (en) 2007-12-13
KR101271959B1 (ko) 2013-06-10
WO2006052018A1 (en) 2006-05-18
CN100594901C (zh) 2010-03-24
SG156692A1 (en) 2009-11-26
EP1812000A4 (en) 2012-08-08
KR20070092965A (ko) 2007-09-14
JP2014077012A (ja) 2014-05-01
US9211254B2 (en) 2015-12-15
JP4934587B2 (ja) 2012-05-16
JP2008519759A (ja) 2008-06-12
CA2584017C (en) 2013-08-27
CN101056636A (zh) 2007-10-17
AU2005302908B2 (en) 2011-03-31
MY152867A (en) 2014-11-28
AR052779A1 (es) 2007-04-04
MX2007005782A (es) 2007-07-19
RU2398585C2 (ru) 2010-09-10
BRPI0518928A2 (pt) 2008-12-16
US20160101183A1 (en) 2016-04-14

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