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CO2017013317A2 - Formulación sólida oral que contiene irinotecán y método de preparación de la misma - Google Patents

Formulación sólida oral que contiene irinotecán y método de preparación de la misma

Info

Publication number
CO2017013317A2
CO2017013317A2 CONC2017/0013317A CO2017013317A CO2017013317A2 CO 2017013317 A2 CO2017013317 A2 CO 2017013317A2 CO 2017013317 A CO2017013317 A CO 2017013317A CO 2017013317 A2 CO2017013317 A2 CO 2017013317A2
Authority
CO
Colombia
Prior art keywords
preparation
formulation containing
solid oral
oral formulation
containing irinotecan
Prior art date
Application number
CONC2017/0013317A
Other languages
English (en)
Inventor
Jae Hyun Park
Jong Soo Woo
Caleb Hyung Min Park
Myeong Ki Jung
Jin Cheul Kim
Yong Il Kim
Original Assignee
Hanmi Pharm Ind 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 Hanmi Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of CO2017013317A2 publication Critical patent/CO2017013317A2/es

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
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4738Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • 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
    • A61K47/20Organic 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

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

Abstract

Una formulación sólida oral incluye irinotecán o una sal aceptable farmacéuticamente del mismo como un ingrediente activo y un agente acidificante.
CONC2017/0013317A 2015-06-30 2017-12-22 Formulación sólida oral que contiene irinotecán y método de preparación de la misma CO2017013317A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020150093413A KR102293907B1 (ko) 2015-06-30 2015-06-30 이리노테칸 함유 경구용 고형제제 및 그 제조방법
PCT/KR2016/006513 WO2017003120A1 (en) 2015-06-30 2016-06-20 Oral solid formulation containing irinotecan and method of preparing the same

Publications (1)

Publication Number Publication Date
CO2017013317A2 true CO2017013317A2 (es) 2018-03-28

Family

ID=57608859

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2017/0013317A CO2017013317A2 (es) 2015-06-30 2017-12-22 Formulación sólida oral que contiene irinotecán y método de preparación de la misma

Country Status (30)

Country Link
US (2) US11090299B2 (es)
EP (1) EP3300483B1 (es)
JP (2) JP6835746B2 (es)
KR (2) KR102293907B1 (es)
CN (1) CN107949375B (es)
AR (1) AR105203A1 (es)
AU (2) AU2016286804B2 (es)
BR (1) BR112017028468B1 (es)
CA (1) CA2988079C (es)
CL (1) CL2017003437A1 (es)
CO (1) CO2017013317A2 (es)
CR (1) CR20170604A (es)
DO (1) DOP2017000307A (es)
EC (1) ECSP17085443A (es)
ES (1) ES2930663T3 (es)
GT (1) GT201700280A (es)
IL (1) IL256278B (es)
JO (1) JO3683B1 (es)
MX (2) MX381735B (es)
MY (1) MY191297A (es)
PE (1) PE20181040A1 (es)
PH (1) PH12017502376A1 (es)
RU (1) RU2716595C2 (es)
SA (1) SA517390602B1 (es)
SG (1) SG10201913274VA (es)
SV (1) SV2017005603A (es)
TW (2) TW202137985A (es)
UY (1) UY36761A (es)
WO (1) WO2017003120A1 (es)
ZA (1) ZA201708429B (es)

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KR102293907B1 (ko) * 2015-06-30 2021-08-26 한미약품 주식회사 이리노테칸 함유 경구용 고형제제 및 그 제조방법
KR102066402B1 (ko) * 2017-12-22 2020-01-15 대화제약 주식회사 이리노테칸 또는 그의 약제학적으로 허용가능한 염을 포함하는 경구투여용 약제학적 조성물
KR102185475B1 (ko) * 2019-06-20 2020-12-02 대화제약 주식회사 이리노테칸 자유 염기를 포함하는 경구투여용 약학 조성물
KR102444073B1 (ko) * 2020-01-06 2022-09-16 (주)휴온스 안정성이 향상된 메틸에르고메트린말레산염 함유 약제학적 제제 및 이의 제조방법
MX2022013343A (es) * 2020-04-24 2022-11-30 Dr Falk Pharma Gmbh Formulacion sistemica de un derivado de la piridinona para la enfermedad celiaca.
KR20220006776A (ko) * 2020-07-09 2022-01-18 주식회사유한양행 다이아미노피리미딘 유도체 또는 이의 약학적으로 허용가능한 염을 포함하는 약학 조성물 및 이의 제조방법
BR112023002056A2 (pt) * 2020-08-06 2023-03-07 Sk Biopharmaceuticals Co Ltd Forma de dosagem oral sólida, e, método para preparar uma forma de dosagem oral sólida
MX2023003933A (es) 2020-10-07 2023-07-05 Athenex Inc Derivados de acetamido-feniltetrazol y métodos para utilizar los mismos.
CR20230266A (es) * 2020-12-18 2023-07-19 Daewoong Pharmaceutical Co Ltd Nueva formulación para administración oral, que comprende 1-(5-(2,4-difluorofenil)-1-((3-fluorofenil)sulfonil)-4-metoxi-1h-pirrol-3-il)-n-metilmetanamina
JP2022174508A (ja) * 2021-05-11 2022-11-24 花王株式会社 顆粒の製造方法
WO2025064381A1 (en) * 2023-09-18 2025-03-27 Phathom Pharmaceuticals Inc. Method for preparing vonoprazan with reduced nitrosamine

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KR102293907B1 (ko) * 2015-06-30 2021-08-26 한미약품 주식회사 이리노테칸 함유 경구용 고형제제 및 그 제조방법

Also Published As

Publication number Publication date
SV2017005603A (es) 2018-03-12
CN107949375B (zh) 2023-04-21
ES2930663T3 (es) 2022-12-20
PH12017502376B1 (en) 2018-06-25
KR102293907B1 (ko) 2021-08-26
AR105203A1 (es) 2017-09-13
TW201713339A (zh) 2017-04-16
AU2016286804A1 (en) 2017-11-30
ECSP17085443A (es) 2018-01-31
KR20210106946A (ko) 2021-08-31
JP6835746B2 (ja) 2021-02-24
KR102317664B1 (ko) 2021-10-26
AU2016286804B2 (en) 2021-03-25
PH12017502376A1 (en) 2018-06-25
JO3683B1 (ar) 2020-08-27
NZ737238A (en) 2024-03-22
UY36761A (es) 2016-12-30
AU2021204259A1 (en) 2021-07-22
HK1246656A1 (zh) 2018-09-14
US20180153878A1 (en) 2018-06-07
WO2017003120A1 (en) 2017-01-05
RU2017143849A (ru) 2019-08-01
US20210330666A1 (en) 2021-10-28
MX2021004439A (es) 2021-05-27
US11090299B2 (en) 2021-08-17
BR112017028468B1 (pt) 2023-03-28
TW202137985A (zh) 2021-10-16
ZA201708429B (en) 2019-06-26
EP3300483A1 (en) 2018-04-04
CN107949375A (zh) 2018-04-20
JP2018519279A (ja) 2018-07-19
TWI750125B (zh) 2021-12-21
SG10201913274VA (en) 2020-03-30
PE20181040A1 (es) 2018-07-03
RU2017143849A3 (es) 2019-09-25
MX2017014994A (es) 2018-08-15
KR20170003143A (ko) 2017-01-09
BR112017028468A2 (pt) 2018-08-28
CA2988079A1 (en) 2017-01-05
IL256278B (en) 2020-11-30
CL2017003437A1 (es) 2018-06-22
JP2021070705A (ja) 2021-05-06
CA2988079C (en) 2023-09-26
EP3300483B1 (en) 2022-11-09
MY191297A (en) 2022-06-14
DOP2017000307A (es) 2018-03-15
RU2716595C2 (ru) 2020-03-13
CR20170604A (es) 2018-04-27
SA517390602B1 (ar) 2022-11-09
GT201700280A (es) 2019-10-10
MX381735B (es) 2025-03-13
IL256278A (en) 2018-02-28
EP3300483A4 (en) 2018-12-12

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