RU2016138577A - Жидкая фармцевтическая композиция - Google Patents

Жидкая фармцевтическая композиция Download PDF

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Publication number
RU2016138577A
RU2016138577A RU2016138577A RU2016138577A RU2016138577A RU 2016138577 A RU2016138577 A RU 2016138577A RU 2016138577 A RU2016138577 A RU 2016138577A RU 2016138577 A RU2016138577 A RU 2016138577A RU 2016138577 A RU2016138577 A RU 2016138577A
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Russia
Prior art keywords
pharmaceutical composition
liquid pharmaceutical
composition according
sodium
magnesium oxide
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RU2016138577A
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English (en)
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RU2668882C2 (ru
Inventor
Бон Гиль НАМ
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Ферринг Интернэшнл Сентер СА
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    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4402Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/194Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4425Pyridinium derivatives, e.g. pralidoxime, pyridostigmine
    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/08Oxides; Hydroxides
    • 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
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10Laxatives

Landscapes

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

Claims (10)

1. Жидкая фармацевтическая композиция, которая является физически и химически стабильной, содержащая пикосульфат натрия, оксид магния, лимонную кислоту и яблочную кислоту.
2. Жидкая фармацевтическая композиция по п. 1, которую используют для очищения толстого кишечника.
3. Жидкая фармацевтическая композиция по п. 1, где однократная доза жидкой фармацевтической композиции находится в диапазоне от 50 мл до 500 мл.
4. Жидкая фармацевтическая композиция по п. 1, где рН жидкой фармацевтической композиции находится в диапазоне от 4,1 до 5,4.
5. Жидкая фармацевтическая композиция по п. 1, содержащая эксципиент и очищенную воду.
6. Жидкая фармацевтическая композиция по п. 5, где эксципиент представляет собой по меньшей мере один эксципиент, выбранный из группы, состоящей из регулирующего рН агента, стабилизатора, консерванта, подсластителя и ароматизирующего ингредиента.
7. Жидкая фармацевтическая композиция по п. 6, где регулирующий рН агент представляет собой подщелачивающий агент.
8. Жидкая фармацевтическая композиция по п. 7, где подщелачивающий агент представляет собой по меньшей мере один подщелачивающий агент, выбранный из группы, состоящей из гидроксида натрия, гидроксида калия, бикарбоната натрия, раствора аммиака, цитрата калия, триэтаноламина и цитрата натрия.
9. Жидкая фармацевтическая композиция по п. 1, где пикосульфат натрия, оксид магния, лимонная кислота и яблочная кислота имеют массовое соотношение 0,003~0,009:1~3:3,5~10,5:0,01~13 (пикосульфат натрия : оксид магния : лимонная кислота : яблочная кислота).
10. Жидкая фармацевтическая композиция по п. 1, где физическая и химическая стабильность означает, что в течение 24 месяцев образуются примеси в количестве 2,0 мас.%, или меньше, и не происходит образования осадка, или образуется осадок в количестве 5,0 об.% или меньше.
RU2016138577A 2014-03-19 2014-06-23 Жидкая фармацевтическая композиция RU2668882C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR1020140032242A KR101420315B1 (ko) 2014-03-19 2014-03-19 약학적 액제 조성물
KR10-2014-0032242 2014-03-19
PCT/KR2014/005512 WO2015141897A1 (ko) 2014-03-19 2014-06-23 약학적 액제 조성물

Publications (2)

Publication Number Publication Date
RU2016138577A true RU2016138577A (ru) 2018-04-20
RU2668882C2 RU2668882C2 (ru) 2018-10-04

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RU2016138577A RU2668882C2 (ru) 2014-03-19 2014-06-23 Жидкая фармацевтическая композиция

Country Status (11)

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US (4) US9827231B2 (ru)
EP (1) EP3120835B1 (ru)
JP (1) JP6347891B2 (ru)
KR (1) KR101420315B1 (ru)
CN (1) CN106456534B (ru)
AU (1) AU2014386903B2 (ru)
CA (1) CA2942878C (ru)
ES (1) ES2907324T3 (ru)
MX (1) MX366499B (ru)
RU (1) RU2668882C2 (ru)
WO (1) WO2015141897A1 (ru)

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US11471447B2 (en) 2019-06-20 2022-10-18 Hetero Labs Limited Stable pharmaceutical product and vessel comprising sodium picosulfate, magnesium oxide and citric acid

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Publication number Publication date
US20200345708A1 (en) 2020-11-05
CA2942878C (en) 2021-08-24
US10624879B2 (en) 2020-04-21
WO2015141897A1 (ko) 2015-09-24
JP2017508815A (ja) 2017-03-30
US20180235947A1 (en) 2018-08-23
EP3120835A4 (en) 2017-10-18
MX2016011938A (es) 2017-05-30
US11191753B2 (en) 2021-12-07
JP6347891B2 (ja) 2018-06-27
AU2014386903A1 (en) 2016-11-03
KR101420315B1 (ko) 2014-07-17
MX366499B (es) 2019-07-11
EP3120835A1 (en) 2017-01-25
US20220193052A1 (en) 2022-06-23
CN106456534A (zh) 2017-02-22
CN106456534B (zh) 2019-05-14
EP3120835B1 (en) 2021-12-08
AU2014386903B2 (en) 2020-01-30
US20160324837A1 (en) 2016-11-10
RU2668882C2 (ru) 2018-10-04
US9827231B2 (en) 2017-11-28
CA2942878A1 (en) 2015-09-24
ES2907324T3 (es) 2022-04-22

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