AR119418A1 - Composiciones de pretomanid - Google Patents

Composiciones de pretomanid

Info

Publication number
AR119418A1
AR119418A1 ARP200101995A ARP200101995A AR119418A1 AR 119418 A1 AR119418 A1 AR 119418A1 AR P200101995 A ARP200101995 A AR P200101995A AR P200101995 A ARP200101995 A AR P200101995A AR 119418 A1 AR119418 A1 AR 119418A1
Authority
AR
Argentina
Prior art keywords
pretomanid
granulate
weight
compositions
composition
Prior art date
Application number
ARP200101995A
Other languages
English (en)
Inventor
Thomas Brad Gold
Graham Stanley Leonard
Rajneesh Taneja
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 AR119418A1 publication Critical patent/AR119418A1/es

Links

Classifications

    • 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
    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4709Non-condensed quinolines and containing further heterocyclic rings
    • 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
    • A61K31/5365Heterocyclic 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
    • 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
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • A61P31/06Antibacterial agents for tuberculosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Abstract

Se describe una composición farmacéutica oral que incluye un granulado que incluye una cantidad farmacéuticamente efectiva de pretomanid o un solvato farmacéuticamente aceptable del mismo. Dicho granulado puede tener una densidad aparente en un rango de aproximadamente 0,3 a 0,8 g/mL y/o una distribución de tamaño de partícula de modo tal que no más de aproximadamente 30% en peso del granulado es retenido en un tamiz ASTM #60 (250 mm). En particular, se provee una composición en donde al menos el 40% en peso del pretomanid (por ejemplo, al menos el 60% en peso) es disuelto dentro de 20 minutos según se mide en un Aparato USP-II a 37 ± 2ºC en bromuro de hexadeciltrimetilamonio (HDTMA) al 0,5% en HCl 0,1N.
ARP200101995A 2019-07-19 2020-07-16 Composiciones de pretomanid AR119418A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201962876257P 2019-07-19 2019-07-19

Publications (1)

Publication Number Publication Date
AR119418A1 true AR119418A1 (es) 2021-12-15

Family

ID=74192882

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP200101995A AR119418A1 (es) 2019-07-19 2020-07-16 Composiciones de pretomanid

Country Status (9)

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

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
EP4271679A1 (en) * 2021-02-01 2023-11-08 The Global Alliance for TB Drug Development, Inc. Pretomanid amorphous form
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
DK1590144T3 (en) 2002-12-10 2015-11-09 Nortec Dev Ass Process for preparing biologically active formulations
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
WO2008057267A2 (en) * 2006-10-27 2008-05-15 Fmc Corporation Co-processed microcrystalline cellulose and sugar alcohol as an excipient for tablet formulations
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
BR112018007625A2 (pt) 2015-10-14 2018-10-30 The Global Alliance For Tb Drug Dev Inc composição antibacteriana combinada e regime antibacteriano de curto prazo
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
EP3999039A4 (en) 2023-06-07
JP2022541583A (ja) 2022-09-26
KR20210152506A (ko) 2021-12-15
AU2020316989A1 (en) 2022-03-03
WO2021016012A1 (en) 2021-01-28
WO2021016012A8 (en) 2021-02-25
CA3143829A1 (en) 2021-01-28
JP7455189B2 (ja) 2024-03-25
MX2022000816A (es) 2022-05-13
EP3999039A1 (en) 2022-05-25
AU2020316989B2 (en) 2024-02-15
BR112022000899A2 (pt) 2022-03-29
JP2024042090A (ja) 2024-03-27

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