BR112023025552A2 - Composições estabilizadas de apilimod e usos das mesmas - Google Patents

Composições estabilizadas de apilimod e usos das mesmas

Info

Publication number
BR112023025552A2
BR112023025552A2 BR112023025552A BR112023025552A BR112023025552A2 BR 112023025552 A2 BR112023025552 A2 BR 112023025552A2 BR 112023025552 A BR112023025552 A BR 112023025552A BR 112023025552 A BR112023025552 A BR 112023025552A BR 112023025552 A2 BR112023025552 A2 BR 112023025552A2
Authority
BR
Brazil
Prior art keywords
apilimod
stabilized
salt
compositions
pharmaceutically acceptable
Prior art date
Application number
BR112023025552A
Other languages
English (en)
Inventor
Joan Edwards
Keith Fandrick
S Melvin Lawrence Jr
Paul Beckett
Ronald Young Peter
Original Assignee
Orphai Therapeutics Inc
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 Orphai Therapeutics Inc filed Critical Orphai Therapeutics Inc
Publication of BR112023025552A2 publication Critical patent/BR112023025552A2/pt

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
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • A61K31/53771,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/2063Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurosurgery (AREA)
  • Virology (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

composições estabilizadas de apilimod e usos das mesmas. a presente invenção se refere a uma composição farmacêutica compreendendo um sal farmaceuticamente aceitável estabilizado de apilimod, e um ou mais excipientes farmaceuticamente aceitáveis. uma forma de dosagem oral sólida de apilimod compreendendo um sal de apilimod e um ou mais excipientes farmaceuticamente aceitáveis, em que o sal de apilimod é um hidrocloreto, malonato, ou sal de l-tartrato de apilimod. as referidas composições para uso no tratamento de doenças neurodegenerativas, câncer, e infecções virais.
BR112023025552A 2021-06-11 2022-06-10 Composições estabilizadas de apilimod e usos das mesmas BR112023025552A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163202438P 2021-06-11 2021-06-11
PCT/US2022/033107 WO2022261499A1 (en) 2021-06-11 2022-06-10 Stabilized apilimod compositions and uses thereof

Publications (1)

Publication Number Publication Date
BR112023025552A2 true BR112023025552A2 (pt) 2024-02-27

Family

ID=82404185

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112023025552A BR112023025552A2 (pt) 2021-06-11 2022-06-10 Composições estabilizadas de apilimod e usos das mesmas

Country Status (10)

Country Link
US (1) US20240277720A1 (pt)
EP (1) EP4351585A1 (pt)
JP (1) JP2024521449A (pt)
KR (1) KR20240075774A (pt)
CN (1) CN117529324A (pt)
AU (1) AU2022289498A1 (pt)
BR (1) BR112023025552A2 (pt)
CA (1) CA3220152A1 (pt)
IL (1) IL309143A (pt)
WO (1) WO2022261499A1 (pt)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024118515A1 (en) * 2022-11-28 2024-06-06 Orphai Therapeutics Inc. Pikfyve inhibitor combination therapy

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9908014D0 (en) 1999-04-08 1999-06-02 Scherer Corp R P Pharmaceutical compositions
CN100372536C (zh) * 2001-02-15 2008-03-05 田边三菱制药株式会社 在口腔中迅速崩解的片剂
US6693097B2 (en) 2001-11-30 2004-02-17 Synta Pharmaceuticals Corp. Pyrimidine compounds
EP1737845A4 (en) 2004-04-13 2010-07-21 Synta Pharmaceuticals Corp DISPLAY HEMMER OF IL-12 PRODUCTION
US7972621B2 (en) 2004-06-03 2011-07-05 R.P. Scherer Technologies, Llc Process for formulating fast dispersing dosage forms comprising at least one fish gelatin selected on the basis of molecular weight
TW200630363A (en) 2004-11-10 2006-09-01 Synta Pharmaceuticals Corp Process for preparing trisubstituted pyrimidine compounds
TW200720256A (en) 2005-05-13 2007-06-01 Synta Pharmaceuticals Corp IL-12 modulatory compounds
WO2006128129A2 (en) 2005-05-26 2006-11-30 Synta Pharmaceuticals Corp. Method for treating cancer
US10548839B2 (en) 2010-03-16 2020-02-04 Wei Tian Process of manufacturing a lyophilized fast dissolving, multi-phasic dosage form
CA2937655C (en) * 2014-01-24 2022-06-28 Lam Therapeutics, Inc. Apilimod compositions for cancer treatment
KR20170098813A (ko) * 2014-11-07 2017-08-30 램 테라퓨틱스, 인코포레이티드 대장암 치료에 사용하기 위한 아필리모드
WO2016112072A1 (en) * 2015-01-07 2016-07-14 President And Fellows Of Harvard College Methods for treating or preventing ebolavirus or marburgvirus infections
US20180078561A1 (en) * 2015-03-31 2018-03-22 Lam Therapeutics, Inc. Active metabolites of apilimod and uses thereof
TWI746449B (zh) * 2015-07-20 2021-11-21 美商Ai治療公司 使用阿吡莫德治療癌症之方法
US10517834B2 (en) 2017-05-16 2019-12-31 Owen Murray Fast dissolving tablet formulations and methods of making thereof
RU2020130837A (ru) * 2018-02-21 2022-03-21 ЭйАй ТЕРАПЬЮТИКС, ИНК. Комбинационная терапия апилимодом и глутаматергическими агентами
TW202140028A (zh) * 2020-02-07 2021-11-01 美商Ai治療公司 抗病毒組成物及使用方法

Also Published As

Publication number Publication date
CA3220152A1 (en) 2022-12-15
WO2022261499A1 (en) 2022-12-15
JP2024521449A (ja) 2024-05-31
IL309143A (en) 2024-02-01
CN117529324A (zh) 2024-02-06
US20240277720A1 (en) 2024-08-22
KR20240075774A (ko) 2024-05-29
EP4351585A1 (en) 2024-04-17
AU2022289498A1 (en) 2024-01-04

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