BR112022000899A2 - Composições de pretomanida - Google Patents

Composições de pretomanida

Info

Publication number
BR112022000899A2
BR112022000899A2 BR112022000899A BR112022000899A BR112022000899A2 BR 112022000899 A2 BR112022000899 A2 BR 112022000899A2 BR 112022000899 A BR112022000899 A BR 112022000899A BR 112022000899 A BR112022000899 A BR 112022000899A BR 112022000899 A2 BR112022000899 A2 BR 112022000899A2
Authority
BR
Brazil
Prior art keywords
weight
pretomanida
compositions
pretomanid
granulate
Prior art date
Application number
BR112022000899A
Other languages
English (en)
Inventor
Stanley Leonard Graham
Rajneesh Taneja
Brad Gold Thomas
Original Assignee
The Global Alliance For Tb Drug Dev 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 The Global Alliance For Tb Drug Dev Inc filed Critical The Global Alliance For Tb Drug Dev Inc
Publication of BR112022000899A2 publication Critical patent/BR112022000899A2/pt

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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • 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
    • A61K31/535—Heterocyclic 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
    • A61K31/5365—Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/535—Heterocyclic 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
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1635—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
    • A61K9/14—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
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/2022—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61P31/04—Antibacterial agents
    • A61P31/06—Antibacterial agents for tuberculosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

composições de pretomanida. é descrita uma composição farmacêutica oral que inclui um granulado que inclui uma quantidade farmaceuticamente eficaz de pretomanida ou solvato farmaceuticamente aceitável da mesma. esse granulado pode ter uma densidade aparente na faixa de cerca de 0,3 a 0,8 g/ml e/ou uma distribuição de tamanho de partícula tal que não mais do que cerca de 30% em peso do granulado seja retido em uma peneira astm #60 (250 µm). em particular, a composição pode fornecer que pelo menos 40% em peso da pretomanida (por exemplo, pelo menos 60% em peso) seja dissolvida em 20 minutos, conforme medido em um aparelho usp-ii a 37 ± 2°c em 0,5% de hexadeciltrimetilamônio brometo (hdtma) em hcl a 0,1n.
BR112022000899A 2019-07-19 2020-07-15 Composições de pretomanida BR112022000899A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962876257P 2019-07-19 2019-07-19
PCT/US2020/042082 WO2021016012A1 (en) 2019-07-19 2020-07-15 Pretomanid compositions

Publications (1)

Publication Number Publication Date
BR112022000899A2 true BR112022000899A2 (pt) 2022-03-29

Family

ID=74192882

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112022000899A BR112022000899A2 (pt) 2019-07-19 2020-07-15 Composições de pretomanida

Country Status (9)

Country Link
EP (1) EP3999039A4 (pt)
JP (2) JP7455189B2 (pt)
KR (1) KR20210152506A (pt)
AR (1) AR119418A1 (pt)
AU (1) AU2020316989B2 (pt)
BR (1) BR112022000899A2 (pt)
CA (1) CA3143829A1 (pt)
MX (1) MX2022000816A (pt)
WO (1) WO2021016012A1 (pt)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4164626A1 (en) * 2020-06-15 2023-04-19 Mylan Laboratories Ltd. Combination antibacterial composition and method for antibacterial therapy
JP2024505070A (ja) * 2021-02-01 2024-02-02 ザ グローバル アライアンス フォー ティービー ドラッグ デベロップメント， インコーポレイテッド プレトマニド非晶質形態
EP4316463A1 (en) * 2022-08-02 2024-02-07 GlaxoSmithKline Intellectual Property Development Limited Novel formulation

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2545454T3 (es) * 2002-12-10 2015-09-11 Nortec Development Associates, Inc. Método de preparación de formulaciones biológicamente activas
JP5258224B2 (ja) * 2006-08-08 2013-08-07 信越化学工業株式会社 固体分散体の固形製剤及びその製造方法
JP5410290B2 (ja) * 2006-10-27 2014-02-05 エフ エム シー コーポレーション 共処理組成物とその製造方法、打錠可能な錠剤処方物、錠剤の製造方法及び錠剤
PE20081891A1 (es) * 2007-03-22 2008-12-27 Opko Health Inc Formulaciones de comprimidos que contienen sales de 8-[{1-(3,5-bis-(trifluorometil)fenil)-etoxi}-metil]-8-fenil-1,7-diaza-spiro[4.5]decan-2-ona y comprimidos elaborados a partir de estas
WO2008149894A1 (ja) * 2007-06-06 2008-12-11 Asahi Kasei Chemicals Corporation セルロース系微小核粒子及びその製造方法
US20170010272A1 (en) * 2014-02-18 2017-01-12 Stc, Unm Rapid phenotype tests for antitubercular drug sensitivity and resistance
HRP20240309T1 (hr) * 2015-10-14 2024-05-10 The Global Alliance For Tb Drug Development, Inc. Kombinirani antibakterijski pripravak i kratkotrajni antibakterijski režim, koji uključuje linezolid, bedakvilin i pretomanid
CN108472261B (zh) * 2016-01-12 2021-12-03 广东东阳光药业有限公司 阿哌沙班固体组合物及其制备方法

Also Published As

Publication number Publication date
AR119418A1 (es) 2021-12-15
EP3999039A1 (en) 2022-05-25
EP3999039A4 (en) 2023-06-07
AU2020316989A1 (en) 2022-03-03
WO2021016012A8 (en) 2021-02-25
JP2024042090A (ja) 2024-03-27
MX2022000816A (es) 2022-05-13
JP7455189B2 (ja) 2024-03-25
KR20210152506A (ko) 2021-12-15
CA3143829A1 (en) 2021-01-28
WO2021016012A1 (en) 2021-01-28
AU2020316989B2 (en) 2024-02-15
JP2022541583A (ja) 2022-09-26

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