ES3037252T3 - 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
ES3037252T3
ES3037252T3 ES17826092T ES17826092T ES3037252T3 ES 3037252 T3 ES3037252 T3 ES 3037252T3 ES 17826092 T ES17826092 T ES 17826092T ES 17826092 T ES17826092 T ES 17826092T ES 3037252 T3 ES3037252 T3 ES 3037252T3
Authority
ES
Spain
Prior art keywords
dosage form
tebipenem pivoxil
release
tablet
core
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES17826092T
Other languages
English (en)
Spanish (es)
Inventor
Akash Jain
Enxian Lu
Shaoqiong Lyu
Shoufeng Li
Timothy Keutzer
Luke Utley
Grazyna Fraczkiewicz
Joyce Macwan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Spero Therapeutics Inc
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
Application granted granted Critical
Publication of ES3037252T3 publication Critical patent/ES3037252T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic 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)
    • 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
    • A61K31/41—Heterocyclic 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
    • A61K31/425—Thiazoles
    • A61K31/427—Thiazoles not condensed and containing further heterocyclic rings
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • 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

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)
ES17826092T 2016-12-15 2017-12-15 Novel tebipenem pivoxil immediate and modified release oral dosage forms Active ES3037252T3 (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
ES3037252T3 true ES3037252T3 (en) 2025-09-30

Family

ID=60937949

Family Applications (1)

Application Number Title Priority Date Filing Date
ES17826092T Active ES3037252T3 (en) 2016-12-15 2017-12-15 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) 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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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
CN109432044B (zh) * 2018-11-27 2021-05-11 山东省药学科学院 一种替比培南酯细粒剂及其制备方法
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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CN102885811B (zh) * 2012-08-27 2014-05-28 南京华威医药科技开发有限公司 含有泰比培南酯的口服制剂
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CN103655483A (zh) * 2012-09-26 2014-03-26 扬州市星斗药业有限公司 一种含有替比培南的颗粒及其制备方法
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CN104224725A (zh) 2013-06-14 2014-12-24 北京济美堂医药研究有限公司 一种替比培南酯颗粒剂及其制备方法
CN104027310B (zh) 2013-12-26 2016-02-03 青岛大学 一种法罗培南钠颗粒剂及其制备方法
CN104013583B (zh) * 2014-06-27 2019-02-26 国药集团致君（深圳）制药有限公司 一种泰比培南酯组合物的药物制剂及其制备方法
CN105193742A (zh) 2015-10-30 2015-12-30 海口市制药厂有限公司 替比培南酯颗粒剂组合物、其制备方法及应用
CN105997891A (zh) * 2016-05-20 2016-10-12 郑州明泽医药科技有限公司 一种替比培南酯制剂及其制备方法
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
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
CO2019006183A2 (es) 2019-08-30
WO2018112372A1 (en) 2018-06-21

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