PH12019501234A1 - Novel tebipenem pivoxil immediate and modified release oral dosage forms - Google Patents

Novel tebipenem pivoxil immediate and modified release oral dosage forms

Info

Publication number
PH12019501234A1
PH12019501234A1 PH12019501234A PH12019501234A PH12019501234A1 PH 12019501234 A1 PH12019501234 A1 PH 12019501234A1 PH 12019501234 A PH12019501234 A PH 12019501234A PH 12019501234 A PH12019501234 A PH 12019501234A PH 12019501234 A1 PH12019501234 A1 PH 12019501234A1
Authority
PH
Philippines
Prior art keywords
tebipenem pivoxil
immediate
modified release
dosage forms
release oral
Prior art date
Application number
PH12019501234A
Other languages
English (en)
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 PH12019501234A1 publication Critical patent/PH12019501234A1/en

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
    • A61K9/28Dragees; 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
    • 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
    • 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)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Urology & Nephrology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
PH12019501234A 2016-12-15 2019-06-03 Novel tebipenem pivoxil immediate and modified release oral dosage forms PH12019501234A1 (en)

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
PH12019501234A1 true PH12019501234A1 (en) 2019-10-07

Family

ID=60937949

Family Applications (1)

Application Number Title Priority Date Filing Date
PH12019501234A PH12019501234A1 (en) 2016-12-15 2019-06-03 Novel tebipenem pivoxil immediate and modified release oral dosage forms

Country Status (15)

Country Link
US (2) US12226403B2 (enExample)
EP (2) EP3554484B1 (enExample)
JP (2) JP7083828B2 (enExample)
KR (1) KR102640532B1 (enExample)
CN (2) CN110072520A (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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ES3037252T3 (en) 2016-12-15 2025-09-30 Spero Therapeutics Inc Novel tebipenem pivoxil immediate and modified release oral dosage forms
KR102608037B1 (ko) 2017-02-06 2023-11-30 스페로 테라퓨틱스, 인코퍼레이티드 테비페넴 피복실 결정질 형태, 이를 포함하는 조성물, 제조 방법, 및 사용 방법
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EP4243783A1 (en) 2020-11-11 2023-09-20 Spero Therapeutics, Inc. High dosage tebipenem pivoxil tablet formulation
CN115969815A (zh) * 2023-02-10 2023-04-18 鲁南贝特制药有限公司 一种替比培南酯口服制剂及其制备方法
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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CN105963261A (zh) * 2016-07-08 2016-09-28 河南全宇制药股份有限公司 一种替比培南酯颗粒剂及其制备方法
ES3037252T3 (en) 2016-12-15 2025-09-30 Spero Therapeutics Inc Novel tebipenem pivoxil immediate and modified release oral dosage forms
KR102608037B1 (ko) 2017-02-06 2023-11-30 스페로 테라퓨틱스, 인코퍼레이티드 테비페넴 피복실 결정질 형태, 이를 포함하는 조성물, 제조 방법, 및 사용 방법
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
US12226403B2 (en) 2025-02-18
MX2019007136A (es) 2019-09-27
CO2019006183A2 (es) 2019-08-30
NZ753713A (en) 2021-09-24
EP4032531A1 (en) 2022-07-27
ZA201903309B (en) 2020-09-30
EP3554484B1 (en) 2025-05-14
IL267219A (en) 2019-08-29
MX2022006971A (es) 2022-07-13
CN110072520A (zh) 2019-07-30
CA3045566C (en) 2024-04-09
KR20190097109A (ko) 2019-08-20
EP3554484A1 (en) 2019-10-23
US20250009718A1 (en) 2025-01-09
BR112019012171B1 (pt) 2021-02-09
JP7083828B2 (ja) 2022-06-13
AU2017377062B2 (en) 2020-09-03
IL267219B1 (en) 2024-09-01
JP2020511419A (ja) 2020-04-16
AU2017377062A1 (en) 2019-06-06
IL267219B2 (en) 2025-01-01
JP2022116261A (ja) 2022-08-09
BR112019012171A2 (pt) 2019-12-17
ES3037252T3 (en) 2025-09-30
US20200016126A1 (en) 2020-01-16
CN115192533A (zh) 2022-10-18
MX2022014095A (es) 2022-12-08
KR102640532B1 (ko) 2024-02-26
CA3045566A1 (en) 2018-06-21
AU2020281095B2 (en) 2022-10-06
WO2018112372A1 (en) 2018-06-21
JP7431886B2 (ja) 2024-02-15
AU2020281095A1 (en) 2021-01-07

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