RU2016139409A - METHOD FOR STABILIZING DIBUTYL HYDROXYTOLUENE - Google Patents

METHOD FOR STABILIZING DIBUTYL HYDROXYTOLUENE Download PDF

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RU2016139409A
RU2016139409A RU2016139409A RU2016139409A RU2016139409A RU 2016139409 A RU2016139409 A RU 2016139409A RU 2016139409 A RU2016139409 A RU 2016139409A RU 2016139409 A RU2016139409 A RU 2016139409A RU 2016139409 A RU2016139409 A RU 2016139409A
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liquid preparation
dibutylhydroxytoluene
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outlet
container body
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RU2016139409A
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RU2016139409A3 (en
RU2690490C2 (en
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Фукико НЕМОТО
Сунсуке НАКАСЕ
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Сэндзю Фармасьютикал Ко., Лтд.
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1412Containers with closing means, e.g. caps
    • A61J1/1418Threaded type
    • 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
    • A61K31/4353Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Ophthalmology & Optometry (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)

Claims (22)

1. Продукт, содержащий дибутилгидрокситолуол, включающий жидкий препарат, помещенный в контейнер, где жидкий препарат содержит:1. A product containing dibutylhydroxytoluene, including a liquid preparation, placed in a container, where the liquid preparation contains: (A) дибутилгидрокситолуол,(A) dibutylhydroxytoluene, (B) пранопрофен и/или его фармацевтически пригодную соль, и(B) pranoprofen and / or a pharmaceutically acceptable salt thereof, and (C) по меньшей мере одно соединение, выбранное из группы, состоящей из кромоглициевой кислоты, аллантоина, глицирризиновой кислоты, хлорфенирамина, и их фармацевтически пригодных солей,(C) at least one compound selected from the group consisting of cromoglycelic acid, allantoin, glycyrrhizic acid, chlorpheniramine, and pharmaceutically acceptable salts thereof, где контейнер содержит корпус контейнера для жидкого препарата; носик, имеющий выпускное отверстие, через которое может выливаться жидкий препарат, содержащийся в корпусе контейнера; и колпачок для закрытия выпускного отверстия; иwhere the container contains a container body for a liquid preparation; a nozzle having an outlet through which a liquid preparation contained in the container body can pour out; and a cap for closing the outlet; and по меньшей мере одна поверхность стенок внутреннего пространства носика и поверхность стенок колпачка, обращенная к выпускному отверстию, содержит смолу, включающую полибутилентерефталат.at least one surface of the walls of the inner space of the spout and the surface of the walls of the cap facing the outlet contains a resin comprising polybutylene terephthalate. 2. Продукт, содержащий дибутилгидрокситолуол, по п. 1, где носик является наконечником, через который должен выливаться жидкий препарат в форме капель; а поверхность стенок внутреннего пространства наконечника изготовлена из смолы, содержащей полибутилентерефталат.2. A product containing dibutylhydroxytoluene according to claim 1, wherein the spout is a tip through which a liquid preparation in the form of drops must be poured; and the surface wall of the inner space of the tip is made of resin containing polybutylene terephthalate. 3. Продукт, содержащий дибутилгидрокситолуол, по п. 1 или 2, где корпус контейнера изготовлен из смолы, содержащей полиэтилентерефталат.3. A product containing dibutylhydroxytoluene according to claim 1 or 2, wherein the container body is made of resin containing polyethylene terephthalate. 4. Продукт, содержащий дибутилгидрокситолуол, по любому из пп. 1-3, где жидкий препарат дополнительно включает боратный буфер.4. The product containing dibutylhydroxytoluene according to any one of paragraphs. 1-3, where the liquid preparation further includes a borate buffer. 5. Продукт, содержащий дибутилгидрокситолуол, по любому из пп. 1-4, где жидкий препарат содержит компонент (А) в количестве от 0,00001 до 0,005 вес./об. %, компонент (В) в количестве от 0,005 до 0,5 вес./об. %, и компонент (С) в количестве от 0,0005 до 5 вес./об. %.5. The product containing dibutylhydroxytoluene according to any one of paragraphs. 1-4, where the liquid preparation contains component (A) in an amount of from 0.00001 to 0.005 wt./about. %, component (B) in an amount of from 0.005 to 0.5 wt./about. %, and component (C) in an amount of from 0.0005 to 5 wt./about. % 6. Продукт, содержащий дибутилгидрокситолуол, по любому из пп. 1-5, где жидкий препарат является глазными каплями.6. The product containing dibutylhydroxytoluene according to any one of paragraphs. 1-5, where the liquid preparation is eye drops. 7. Способ стабилизации дибутилгидрокситолуола в жидком препарате, содержащем:7. A method for stabilizing dibutylhydroxytoluene in a liquid preparation containing: (A) дибутилгидрокситолуол, и(A) dibutylhydroxytoluene, and (B) пранопрофен и/или его фармацевтически пригодную соль,(B) pranoprofen and / or its pharmaceutically acceptable salt, где способ включает:where the method includes: - смешивание в жидком препарате (С) по меньшей мере одного соединения, выбранного из группы, состоящей из кромоглициевой кислоты, аллантоина, глицирризиновой кислоты, хлорфенирамина, и их фармацевтически пригодных солей; и- mixing in a liquid preparation (C) at least one compound selected from the group consisting of cromoglycelic acid, allantoin, glycyrrhizic acid, chlorpheniramine, and their pharmaceutically acceptable salts; and - помещение жидкого препарата в контейнер, содержащий: корпус контейнера для вмещения жидкого препарата; носик, имеющий выпускное отверстие, через которое может выливаться жидкий препарат, содержащийся в корпусе контейнера; и колпачок для закрытия выпускного отверстия; и где по меньшей мере одна из поверхности стенок внутреннего пространства носика и поверхности стенок колпачка, обращенной к выпускному отверстию, содержит смолу, включающую полибутилентерефталат.- placing a liquid preparation in a container, comprising: a container body for containing a liquid preparation; a nozzle having an outlet through which a liquid preparation contained in the container body can pour out; and a cap for closing the outlet; and where at least one of the surface wall of the inner space of the nozzle and the wall surface of the cap facing the outlet contains a resin comprising polybutylene terephthalate. 8. Способ по п. 7, где носик является наконечником, через который выливается жидкий препарат в форме капель; а поверхность стенок внутреннего пространства наконечника изготовлена из смолы, содержащей полибутилентерефталат.8. The method according to claim 7, where the spout is a tip through which a liquid preparation is poured in the form of drops; and the surface wall of the inner space of the tip is made of resin containing polybutylene terephthalate. 9. Способ по п. 7 или 8, где корпус контейнера изготовлен из смолы, содержащей полиэтилена терефталат.9. The method according to p. 7 or 8, where the container body is made of resin containing polyethylene terephthalate. 10. Способ по любому из пп. 7-9, где жидкий препарат дополнительно включает боратный буфер.10. The method according to any one of paragraphs. 7-9, where the liquid preparation further includes a borate buffer. 11. Способ по любому из пп. 7-10, где жидкий препарат содержит компонент (А) в количестве от 0,00001 до 0,005 вес./об. %, компонент (В) в количестве от 0,005 до 0,5 вес./об. %, и компонент (С) в количестве от 0,0005 до 5 вес./об. %.11. The method according to any one of paragraphs. 7-10, where the liquid preparation contains component (A) in an amount of from 0.00001 to 0.005 wt./about. %, component (B) in an amount of from 0.005 to 0.5 wt./about. %, and component (C) in an amount of from 0.0005 to 5 wt./about. % 12. Способ по любому из пп. 7-11, где жидкий препарат является глазными каплями.12. The method according to any one of paragraphs. 7-11, where the liquid preparation is eye drops.
RU2016139409A 2014-03-10 2015-03-10 Method for stabilizing dibutylhydroxytoluene RU2690490C2 (en)

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JP2014046903 2014-03-10
JP2014-046903 2014-03-10
PCT/JP2015/056985 WO2015137326A1 (en) 2014-03-10 2015-03-10 Method for stabilizing dibutylhydroxytoluene

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TWI644663B (en) * 2014-03-10 2018-12-21 日商千壽製藥股份有限公司 Method for stabilizing dibutylhydroxytoluene, and products containing dibutylhydroxytoluene (1)
CN106456791B (en) * 2014-06-10 2021-08-10 日本乐敦制药株式会社 Ophthalmic aqueous composition
JP2017105752A (en) * 2015-08-31 2017-06-15 ロート製薬株式会社 Ophthalmic composition
JPWO2017043488A1 (en) * 2015-09-08 2018-06-28 ロート製薬株式会社 Ophthalmic composition
JPWO2019230971A1 (en) * 2018-05-31 2021-07-08 千寿製薬株式会社 Ophthalmic solution with suppressed decrease in the content of dibutylhydroxytoluene

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PL179534B1 (en) * 1994-03-15 2000-09-29 Senju Pharma Co Method of stabilising pranoprophene and stable liquid pranoprophene preparation
JP4831944B2 (en) * 2004-04-28 2011-12-07 ロート製薬株式会社 Planoprofen-containing composition
JP4989898B2 (en) * 2005-01-26 2012-08-01 ロート製薬株式会社 Planoprofen-containing composition
JP2007099697A (en) * 2005-10-05 2007-04-19 Rohto Pharmaceut Co Ltd Ophthalmic solution containing pranoprofen and cromoglicic acid salt
JP6009141B2 (en) * 2009-10-09 2016-10-19 ロート製薬株式会社 Aqueous composition
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WO2013009961A1 (en) * 2011-07-12 2013-01-17 University Of Houston Design of ultra-fast suspended graphene nano-sensors suitable for large scale production
CN104010661B (en) * 2011-12-27 2017-06-06 千寿制药株式会社 The stabilization method of preparation and dibutyl hydroxy toluene containing dibutyl hydroxy toluene
TWI644663B (en) * 2014-03-10 2018-12-21 日商千壽製藥股份有限公司 Method for stabilizing dibutylhydroxytoluene, and products containing dibutylhydroxytoluene (1)

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RU2016139409A3 (en) 2018-09-26
JP6800264B2 (en) 2020-12-16
CN106068122B (en) 2019-04-19
JP2019147802A (en) 2019-09-05
TWI644663B (en) 2018-12-21
JPWO2015137326A1 (en) 2017-04-06
RU2690490C2 (en) 2019-06-04
JP6509811B2 (en) 2019-05-08
TW201617056A (en) 2016-05-16
CN106068122A (en) 2016-11-02
WO2015137326A1 (en) 2015-09-17

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