BR112022021511A2 - Composição de pó seco para administração peroral - Google Patents

Composição de pó seco para administração peroral

Info

Publication number
BR112022021511A2
BR112022021511A2 BR112022021511A BR112022021511A BR112022021511A2 BR 112022021511 A2 BR112022021511 A2 BR 112022021511A2 BR 112022021511 A BR112022021511 A BR 112022021511A BR 112022021511 A BR112022021511 A BR 112022021511A BR 112022021511 A2 BR112022021511 A2 BR 112022021511A2
Authority
BR
Brazil
Prior art keywords
average diameter
weight
volume
dry powder
composition
Prior art date
Application number
BR112022021511A
Other languages
English (en)
Inventor
Camber Ola
Everaert Arnout
Grudén Stefan
Original Assignee
Vicore Pharma Ab
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 Vicore Pharma Ab filed Critical Vicore Pharma Ab
Publication of BR112022021511A2 publication Critical patent/BR112022021511A2/pt

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Classifications

    • 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
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K31/41Heterocyclic 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
    • A61K31/41641,3-Diazoles
    • A61K31/41781,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K9/14Particulate 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
    • A61K9/1611Inorganic compounds
    • 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
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • 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
    • A61K9/485Inorganic compounds
    • 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
    • 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
    • A61K9/4866Organic macromolecular compounds
    • 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
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • 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
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/16Antivirals for RNA viruses for influenza or rhinoviruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D403/00Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00
    • C07D403/02Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings
    • C07D403/08Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings linked by a carbon chain containing alicyclic rings

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)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Virology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

COMPOSIÇÃO DE PÓ SECO PARA ADMINISTRAÇÃO PERORAL. De acordo com a invenção é fornecida uma forma de dosagem farmacêutica adequada para administração oral no trato gastrointestinal, em que a forma de dosagem compreende uma composição farmacêutica na forma de uma mistura particulada que compreende partículas sólidas de N butiloxicarbonil 3 (4 imidazol 1 ilmetilfenil) 5 iso butiltiofeno 2 sulfonamida (C21), ou um sal farmaceuticamente aceitável do mesmo, misturado por adição com uma mescla de partículas carreadoras com um diâmetro médio baseado em peso e/ou volume, e/ou uma densidade estrutural/de partículas, que é/são semelhantes ao diâmetro médio baseado em peso e/ou volume, e/ou a densidade estrutural/de partículas, das partículas sólidas de C21 e um deslizante, em que a composição está contida dentro de uma cápsula que é adequada para tal administração oral. As partículas carreadoras preferidas têm um diâmetro médio baseado em peso e/ou volume que é inferior a cerca de 100 pm. Os materiais de partículas carreadoras preferidos incluem manitol. Os deslizantes preferidos compreendem sílica coloidal. Tais formas de dosagem encontram utilidade no tratamento de doenças pulmonares, tais como fibrose pulmonar idiopática, sarcoidose e danos nos tecidos induzidos por vírus respiratórios.
BR112022021511A 2020-04-24 2021-04-23 Composição de pó seco para administração peroral BR112022021511A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB2006079.4A GB202006079D0 (en) 2020-04-24 2020-04-24 New composition
PCT/GB2021/050994 WO2021214488A1 (en) 2020-04-24 2021-04-23 New dry powder composition for peroral administration

Publications (1)

Publication Number Publication Date
BR112022021511A2 true BR112022021511A2 (pt) 2023-01-24

Family

ID=71080269

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112022021511A BR112022021511A2 (pt) 2020-04-24 2021-04-23 Composição de pó seco para administração peroral

Country Status (17)

Country Link
US (1) US11844868B2 (pt)
EP (2) EP4389212A2 (pt)
JP (2) JP7387903B2 (pt)
KR (1) KR20230005220A (pt)
CN (1) CN115697309A (pt)
AU (1) AU2021260923A1 (pt)
BR (1) BR112022021511A2 (pt)
CA (1) CA3180646A1 (pt)
DK (1) DK4138790T3 (pt)
GB (1) GB202006079D0 (pt)
IL (1) IL297373A (pt)
LT (1) LT4138790T (pt)
MX (1) MX2022013070A (pt)
PL (1) PL4138790T3 (pt)
PT (1) PT4138790T (pt)
SI (1) SI4138790T1 (pt)
WO (1) WO2021214488A1 (pt)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB202201723D0 (en) 2022-02-10 2022-03-30 Vicore Pharma Ab New use

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9800550D0 (sv) 1998-02-24 1998-02-24 A & Science Invest Ab A pharmaceutical preparation comprising an angiotensin II type 2 receptor agonist, and use thereof
AU2002257970B2 (en) 2001-05-31 2007-08-02 Vicore Pharma Ab Tricyclic compounds useful as angiotensin II agonists
JP2008502699A (ja) 2004-06-14 2008-01-31 セプラコール・インコーポレイテッド 肺疾患治療方法、及びそのための組成物
PE20060777A1 (es) 2004-12-24 2006-10-06 Boehringer Ingelheim Int Derivados de indolinona para el tratamiento o la prevencion de enfermedades fibroticas
WO2008073927A1 (en) * 2006-12-12 2008-06-19 Gilead Colorado, Inc. Ambrisentan combined with a renin inhibitor for hypertensive disorder
AU2012206945B2 (en) * 2011-01-11 2015-02-19 Dimerix Bioscience Pty Ltd Combination therapy
MX2017010993A (es) * 2015-03-02 2018-04-11 Vicore Pharma Ab Agonista del receptor de angiotensina ii para tratar la fibrosis pulmonar.
WO2017221012A1 (en) 2016-06-21 2017-12-28 Vicore Pharma Ab Methods and compositions for preventing or reducing the risk of cancer treatment-related cardiotoxicity
GB201710906D0 (en) 2017-07-06 2017-08-23 Vicore Pharma Ab Compounds and methods for treating peripheral neuropathy
US11931341B2 (en) * 2018-03-22 2024-03-19 University Of Lowa Research Foundation Compositions and methods for the treatment and prevention of muscular dystrophy
GB201818164D0 (en) 2018-11-07 2018-12-19 Vicore Pharma Ab New composition

Also Published As

Publication number Publication date
PT4138790T (pt) 2024-04-01
AU2021260923A1 (en) 2022-12-08
US11844868B2 (en) 2023-12-19
SI4138790T1 (sl) 2024-05-31
IL297373A (en) 2022-12-01
EP4138790A1 (en) 2023-03-01
JP7387903B2 (ja) 2023-11-28
US20220202726A1 (en) 2022-06-30
KR20230005220A (ko) 2023-01-09
JP2023503178A (ja) 2023-01-26
WO2021214488A1 (en) 2021-10-28
CA3180646A1 (en) 2021-10-28
DK4138790T3 (en) 2024-03-11
LT4138790T (lt) 2024-04-10
GB202006079D0 (en) 2020-06-10
CN115697309A (zh) 2023-02-03
JP2024020417A (ja) 2024-02-14
EP4138790B1 (en) 2024-01-31
MX2022013070A (es) 2022-11-30
PL4138790T3 (pl) 2024-06-10
EP4389212A2 (en) 2024-06-26

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