AU2021390901B9 - Stable oral formulation containing 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid - Google Patents

Stable oral formulation containing 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid Download PDF

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Publication number
AU2021390901B9
AU2021390901B9 AU2021390901A AU2021390901A AU2021390901B9 AU 2021390901 B9 AU2021390901 B9 AU 2021390901B9 AU 2021390901 A AU2021390901 A AU 2021390901A AU 2021390901 A AU2021390901 A AU 2021390901A AU 2021390901 B9 AU2021390901 B9 AU 2021390901B9
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Australia
Prior art keywords
api
weight
oral formulation
maintained
relative humidity
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AU2021390901A
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English (en)
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AU2021390901A1 (en
AU2021390901B2 (en
AU2021390901A9 (en
Inventor
Sun Lee
Junghong PARK
Hyun Ji SUN
Seok Cheol YOO
Duck Il Yun
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LG Chem Ltd
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LG Chem Ltd
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Publication of AU2021390901A1 publication Critical patent/AU2021390901A1/en
Publication of AU2021390901A9 publication Critical patent/AU2021390901A9/en
Priority to AU2024227367A priority Critical patent/AU2024227367A1/en
Application granted granted Critical
Publication of AU2021390901B2 publication Critical patent/AU2021390901B2/en
Publication of AU2021390901B9 publication Critical patent/AU2021390901B9/en
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Classifications

    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • A61K31/4155—1,2-Diazoles non condensed and containing further heterocyclic rings
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents

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  • 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)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
AU2021390901A 2020-12-01 2021-11-30 Stable oral formulation containing 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid Active AU2021390901B9 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024227367A AU2024227367A1 (en) 2020-12-01 2024-10-16 Stable oral formulation containing 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR20200166051 2020-12-01
KR10-2020-0166051 2020-12-01
PCT/KR2021/017842 WO2022119269A1 (ko) 2020-12-01 2021-11-30 1-(3-시아노-1-아이소프로필-인돌-5-일)피라졸-4-카르복실산을 포함하는 안정한 경구용 제제

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2024227367A Division AU2024227367A1 (en) 2020-12-01 2024-10-16 Stable oral formulation containing 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid

Publications (4)

Publication Number Publication Date
AU2021390901A1 AU2021390901A1 (en) 2023-06-08
AU2021390901A9 AU2021390901A9 (en) 2024-05-23
AU2021390901B2 AU2021390901B2 (en) 2024-11-07
AU2021390901B9 true AU2021390901B9 (en) 2024-11-21

Family

ID=81854222

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2021390901A Active AU2021390901B9 (en) 2020-12-01 2021-11-30 Stable oral formulation containing 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid
AU2024227367A Withdrawn AU2024227367A1 (en) 2020-12-01 2024-10-16 Stable oral formulation containing 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2024227367A Withdrawn AU2024227367A1 (en) 2020-12-01 2024-10-16 Stable oral formulation containing 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid

Country Status (15)

Country Link
US (1) US20240000751A1 (https=)
EP (1) EP4257123A4 (https=)
JP (1) JP7678106B2 (https=)
KR (1) KR20220077091A (https=)
CN (1) CN116528852A (https=)
AR (1) AR124178A1 (https=)
AU (2) AU2021390901B9 (https=)
CA (1) CA3197405A1 (https=)
CL (1) CL2023001215A1 (https=)
CO (1) CO2023008265A2 (https=)
MX (1) MX2023005459A (https=)
PE (1) PE20240222A1 (https=)
TW (3) TWI896975B (https=)
WO (1) WO2022119269A1 (https=)
ZA (1) ZA202305156B (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20240242A1 (es) * 2021-06-15 2024-02-16 Lg Chemical Ltd Una composicion farmaceutica que comprende acido 1-(3-ciano-1-isopropil-indol-5-il)pirazol-4-carboxilico
AR126164A1 (es) * 2021-06-17 2023-09-27 Lg Chemical Ltd Formulación compuesta para dosificación oral que comprende ácido 1-(3-ciano-1-isopropil-indol-5-il)pirazol-4-carboxílico

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012138147A2 (en) * 2011-04-06 2012-10-11 Lg Life Sciences Ltd. 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid crystalline form and the producing method thereof

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MXPA05000862A (es) * 2002-07-31 2005-04-19 Pharmacia Corp Forma de dosificacion farmaceutica capaz de mantener un perfil de disolucion estable tras el almacenamiento.
DE602006014607D1 (de) * 2005-01-21 2010-07-15 Teva Pharma Stabile pharmazeutische Zusammensetzungen von Zonisamide und Verfahren zur deren Herstellung
JP5330989B2 (ja) * 2007-04-11 2013-10-30 キッセイ薬品工業株式会社 （アザ）インドール誘導体及びその医薬用途
TWI423962B (zh) * 2009-10-07 2014-01-21 Lg Life Sciences Ltd 有效作為黃嘌呤氧化酶抑制劑之新穎化合物、其製備方法及含該化合物之醫藥組成物
WO2020109319A1 (en) * 2018-11-27 2020-06-04 Zaklady Farmaceutyczne Polpharma S.A Pharmaceutical composition comprising ramipril and indapamide
US20240000750A1 (en) * 2020-11-04 2024-01-04 Lg Chem, Ltd. Method for preparing crystalline particles of 1-(3-cyano-1-isopropyl-indole-5-yl)pyrazole-4-carboxylic acid, and pharmaceutical composition comprising same
PE20230850A1 (es) * 2020-12-01 2023-05-23 Lg Chemical Ltd Formulacion compuesta para administracion oral que comprende acido 1-(3-ciano-1-isopropil-indol-5-il)pirazol-4-carboxilico y un proceso para su preparacion
TWI903066B (zh) * 2021-04-16 2025-11-01 南韓商Ｌｇ化學股份有限公司 包含１－（３－氰基－１－異丙基－吲哚－５－基）吡唑－４－羧酸之口服用複合調配物

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012138147A2 (en) * 2011-04-06 2012-10-11 Lg Life Sciences Ltd. 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid crystalline form and the producing method thereof

Also Published As

Publication number Publication date
TWI896975B (zh) 2025-09-11
CL2023001215A1 (es) 2023-12-15
CA3197405A1 (en) 2022-06-09
WO2022119269A1 (ko) 2022-06-09
JP7678106B2 (ja) 2025-05-15
EP4257123A1 (en) 2023-10-11
KR20220077091A (ko) 2022-06-08
AU2024227367A1 (en) 2024-10-31
JP2023551712A (ja) 2023-12-12
ZA202305156B (en) 2024-09-25
AU2021390901A1 (en) 2023-06-08
TW202600130A (zh) 2026-01-01
AU2021390901B2 (en) 2024-11-07
TW202408496A (zh) 2024-03-01
TWI840721B (zh) 2024-05-01
PE20240222A1 (es) 2024-02-16
AU2021390901A9 (en) 2024-05-23
US20240000751A1 (en) 2024-01-04
CN116528852A (zh) 2023-08-01
EP4257123A4 (en) 2024-05-08
AR124178A1 (es) 2023-02-22
CO2023008265A2 (es) 2023-06-30
TW202228679A (zh) 2022-08-01
MX2023005459A (es) 2023-05-23

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