CO2019006183A2 - Nuevas formas de dosificación oral de liberación inmediata y modificada de tebipenem pivoxil - Google Patents

Nuevas formas de dosificación oral de liberación inmediata y modificada de tebipenem pivoxil

Info

Publication number
CO2019006183A2
CO2019006183A2 CONC2019/0006183A CO2019006183A CO2019006183A2 CO 2019006183 A2 CO2019006183 A2 CO 2019006183A2 CO 2019006183 A CO2019006183 A CO 2019006183A CO 2019006183 A2 CO2019006183 A2 CO 2019006183A2
Authority
CO
Colombia
Prior art keywords
tebipenem pivoxil
immediate
dosage forms
oral dosage
modified release
Prior art date
Application number
CONC2019/0006183A
Other languages
English (en)
Spanish (es)
Inventor
Akash Jain
Enxian Lu
Shaoqiong Lyu
Shoufeng Li
Timothy Keutzer
Luke Utley
Grazyna Fraczkiewicz
Joyce Macwan
Original Assignee
Spero 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 Spero Therapeutics Inc filed Critical Spero Therapeutics Inc
Publication of CO2019006183A2 publication Critical patent/CO2019006183A2/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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K31/425Thiazoles
    • A61K31/427Thiazoles not condensed and containing further heterocyclic rings
    • 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
    • A61K9/1617Organic 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
    • A61K9/14Particulate 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic 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
    • A61K9/20Pills, 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
    • A61K9/2027Organic 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
    • A61K9/20Pills, 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Urology & Nephrology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CONC2019/0006183A 2016-12-15 2019-06-13 Nuevas formas de dosificación oral de liberación inmediata y modificada de tebipenem pivoxil CO2019006183A2 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662434643P 2016-12-15 2016-12-15
US201662438071P 2016-12-22 2016-12-22
PCT/US2017/066729 WO2018112372A1 (en) 2016-12-15 2017-12-15 Novel tebipenem pivoxil immediate and modified release oral dosage forms

Publications (1)

Publication Number Publication Date
CO2019006183A2 true CO2019006183A2 (es) 2019-08-30

Family

ID=60937949

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2019/0006183A CO2019006183A2 (es) 2016-12-15 2019-06-13 Nuevas formas de dosificación oral de liberación inmediata y modificada de tebipenem pivoxil

Country Status (15)

Country Link
US (2) US12226403B2 (enExample)
EP (2) EP3554484B1 (enExample)
JP (2) JP7083828B2 (enExample)
KR (1) KR102640532B1 (enExample)
CN (2) CN115192533A (enExample)
AU (2) AU2017377062B2 (enExample)
BR (1) BR112019012171B1 (enExample)
CA (1) CA3045566C (enExample)
CO (1) CO2019006183A2 (enExample)
ES (1) ES3037252T3 (enExample)
IL (1) IL267219B2 (enExample)
MX (3) MX2019007136A (enExample)
PH (1) PH12019501234A1 (enExample)
WO (1) WO2018112372A1 (enExample)
ZA (1) ZA201903309B (enExample)

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EP4243783A1 (en) * 2020-11-11 2023-09-20 Spero Therapeutics, Inc. High dosage tebipenem pivoxil tablet formulation
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CN118526466B (zh) * 2024-07-22 2024-11-05 山东则正医药技术有限公司 一种替比培南匹伏酯颗粒制剂及其制备方法

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CN115192533A (zh) 2016-12-15 2022-10-18 斯派尔治疗有限公司 新型替比培南匹伏酯速释和调释口服剂型
JP7309607B2 (ja) 2017-02-06 2023-07-18 スペロ セラピューティックス,インコーポレイテッド テビペネムピボキシル臭化水素酸塩の結晶形、および医薬組成物
CN107737107B (zh) 2017-12-02 2020-05-29 北京达因高科儿童药物研究院有限公司 一种含替比培南酯组合物的口服制剂及其制备方法
EP4243783A1 (en) 2020-11-11 2023-09-20 Spero Therapeutics, Inc. High dosage tebipenem pivoxil tablet formulation

Also Published As

Publication number Publication date
AU2020281095B2 (en) 2022-10-06
AU2017377062A1 (en) 2019-06-06
JP7431886B2 (ja) 2024-02-15
US12226403B2 (en) 2025-02-18
AU2017377062B2 (en) 2020-09-03
ZA201903309B (en) 2020-09-30
EP3554484A1 (en) 2019-10-23
US20250009718A1 (en) 2025-01-09
BR112019012171A2 (pt) 2019-12-17
JP7083828B2 (ja) 2022-06-13
JP2022116261A (ja) 2022-08-09
KR102640532B1 (ko) 2024-02-26
BR112019012171B1 (pt) 2021-02-09
CA3045566C (en) 2024-04-09
MX2022006971A (es) 2022-07-13
CA3045566A1 (en) 2018-06-21
AU2020281095A1 (en) 2021-01-07
EP3554484B1 (en) 2025-05-14
JP2020511419A (ja) 2020-04-16
US20200016126A1 (en) 2020-01-16
IL267219B1 (en) 2024-09-01
NZ753713A (en) 2021-09-24
MX2022014095A (es) 2022-12-08
EP4032531A1 (en) 2022-07-27
MX2019007136A (es) 2019-09-27
CN115192533A (zh) 2022-10-18
PH12019501234A1 (en) 2019-10-07
IL267219B2 (en) 2025-01-01
KR20190097109A (ko) 2019-08-20
CN110072520A (zh) 2019-07-30
IL267219A (en) 2019-08-29
WO2018112372A1 (en) 2018-06-21
ES3037252T3 (en) 2025-09-30

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