PE20212107A1 - SOLID FORMULATION OF CAPSIDE ASSEMBLY MODULATOR - Google Patents

SOLID FORMULATION OF CAPSIDE ASSEMBLY MODULATOR

Info

Publication number
PE20212107A1
PE20212107A1 PE2021001464A PE2021001464A PE20212107A1 PE 20212107 A1 PE20212107 A1 PE 20212107A1 PE 2021001464 A PE2021001464 A PE 2021001464A PE 2021001464 A PE2021001464 A PE 2021001464A PE 20212107 A1 PE20212107 A1 PE 20212107A1
Authority
PE
Peru
Prior art keywords
solid formulation
solid
assembly modulator
hpmc
ratio
Prior art date
Application number
PE2021001464A
Other languages
Spanish (es)
Inventor
Michael Bertil S Anne
Claire Elisabeth Balmain
Maria Jansens
Oliver Lenz
Abhishek Singh
Jan Snoeys
Joris Jozef Vandenbossche
Dycke Frederic Anne R Van
Dominique Josiane W Verstraete
Original Assignee
Janssen Sciences Ireland Unlimited Co
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
Priority claimed from PCT/IB2019/000231 external-priority patent/WO2019175657A1/en
Application filed by Janssen Sciences Ireland Unlimited Co filed Critical Janssen Sciences Ireland Unlimited Co
Publication of PE20212107A1 publication Critical patent/PE20212107A1/en

Links

Classifications

    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
    • A61K9/2022—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses

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)
  • General Chemical & Material Sciences (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Virology (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Referido a una dispersion solida que comprende el compuesto A, o un solvato o sal farmaceuticamente aceptable del mismo, y un estabilizador seleccionado de al menos uno de Hipromelosa (HPMC) y Acetato-succinato de hipromelosa (HPMC-AS) a una razon de 1:1 a menos de 1:3 en peso, con la condicion de que la razon no sea 1:2 en peso. Esta formulacion solida tiene actividad inhibidora de ensamblaje de la capside para el tratamiento de la infeccion por el virus de la hepatitis B (VHB). Tambien se refiere a una forma farmaceutica oral solida, que comprende dicha dispersion solida, y un procedimiento para preparar dicha forma farmaceutica.Referred to a solid dispersion comprising compound A, or a pharmaceutically acceptable salt or solvate thereof, and a stabilizer selected from at least one of Hypromellose (HPMC) and Hypromellose Acetate-succinate (HPMC-AS) at a ratio of 1 :1 to less than 1:3 by weight, provided that the ratio is not 1:2 by weight. This solid formulation has capsid assembly inhibitory activity for the treatment of hepatitis B virus (HBV) infection. It also relates to a solid oral dosage form, comprising said solid dispersion, and a process for preparing said dosage form.

PE2021001464A 2019-03-13 2020-03-13 SOLID FORMULATION OF CAPSIDE ASSEMBLY MODULATOR PE20212107A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
PCT/IB2019/000231 WO2019175657A1 (en) 2018-03-14 2019-03-13 Capsid assembly modulator dosing regimen
EP2019056348 2019-03-13
US16/352,754 US10973801B2 (en) 2018-03-14 2019-03-13 Capsid assembly modulator dosing regimen
EP19197566 2019-09-16
PCT/EP2020/056991 WO2020183020A1 (en) 2019-03-13 2020-03-13 Capsid assembly modulator solid formulation

Publications (1)

Publication Number Publication Date
PE20212107A1 true PE20212107A1 (en) 2021-11-04

Family

ID=72427202

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2021001464A PE20212107A1 (en) 2019-03-13 2020-03-13 SOLID FORMULATION OF CAPSIDE ASSEMBLY MODULATOR

Country Status (16)

Country Link
EP (1) EP3937928A1 (en)
JP (1) JP2022524819A (en)
KR (1) KR20210137484A (en)
CN (1) CN113557016A (en)
AU (1) AU2020235442A1 (en)
BR (1) BR112021017525A2 (en)
CA (1) CA3132095A1 (en)
CR (1) CR20210481A (en)
EC (1) ECSP21067052A (en)
IL (1) IL286209A (en)
JO (1) JOP20210250A1 (en)
MA (1) MA55280A (en)
MX (1) MX2021011030A (en)
PE (1) PE20212107A1 (en)
SG (1) SG11202109710QA (en)
WO (1) WO2020183020A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2017248828A1 (en) 2016-04-15 2018-11-01 Janssen Sciences Ireland Uc Combinations and methods comprising a capsid assembly inhibitor
JP2021515769A (en) * 2018-03-14 2021-06-24 ヤンセン・サイエンシズ・アイルランド・アンリミテッド・カンパニー Capsid aggregation regulator dosing regimen

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3603B1 (en) 2013-05-17 2020-07-05 Janssen Sciences Ireland Uc Sulphamoylpyrrolamide derivatives and the use thereof as medicaments for the treatment of hepatitis b
JP2021515769A (en) * 2018-03-14 2021-06-24 ヤンセン・サイエンシズ・アイルランド・アンリミテッド・カンパニー Capsid aggregation regulator dosing regimen

Also Published As

Publication number Publication date
KR20210137484A (en) 2021-11-17
CN113557016A (en) 2021-10-26
SG11202109710QA (en) 2021-10-28
WO2020183020A1 (en) 2020-09-17
AU2020235442A1 (en) 2021-08-12
MX2021011030A (en) 2021-10-13
IL286209A (en) 2021-10-31
JP2022524819A (en) 2022-05-10
EP3937928A1 (en) 2022-01-19
JOP20210250A1 (en) 2023-01-30
ECSP21067052A (en) 2021-11-18
CR20210481A (en) 2021-10-25
CA3132095A1 (en) 2020-09-17
MA55280A (en) 2022-01-19
BR112021017525A2 (en) 2021-11-23

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