AU2020354534B2 - Pediatric trazodone compositions and method of treatment thereof - Google Patents

Pediatric trazodone compositions and method of treatment thereof

Info

Publication number
AU2020354534B2
AU2020354534B2 AU2020354534A AU2020354534A AU2020354534B2 AU 2020354534 B2 AU2020354534 B2 AU 2020354534B2 AU 2020354534 A AU2020354534 A AU 2020354534A AU 2020354534 A AU2020354534 A AU 2020354534A AU 2020354534 B2 AU2020354534 B2 AU 2020354534B2
Authority
AU
Australia
Prior art keywords
trazodone
pediatric
administered
ndd
compositions
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
AU2020354534A
Other languages
English (en)
Other versions
AU2020354534A1 (en
Inventor
Fabrizio CALISTI
Laura OGGIANU
Rossella PICOLLO
Lorella Ragni
Serena Tongiani
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.)
Angelini SpA
Original Assignee
Angelini SpA
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 Angelini SpA filed Critical Angelini SpA
Publication of AU2020354534A1 publication Critical patent/AU2020354534A1/en
Application granted granted Critical
Publication of AU2020354534B2 publication Critical patent/AU2020354534B2/en
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
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4965—Non-condensed pyrazines
    • A61K31/497—Non-condensed pyrazines 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Anesthesiology (AREA)
  • Psychology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2020354534A 2019-09-26 2020-09-25 Pediatric trazodone compositions and method of treatment thereof Active AU2020354534B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962906166P 2019-09-26 2019-09-26
US62/906,166 2019-09-26
PCT/EP2020/077017 WO2021058810A1 (en) 2019-09-26 2020-09-25 Pediatric trazodone compositions and method of treatment thereof

Publications (2)

Publication Number Publication Date
AU2020354534A1 AU2020354534A1 (en) 2022-04-14
AU2020354534B2 true AU2020354534B2 (en) 2025-10-02

Family

ID=72665264

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020354534A Active AU2020354534B2 (en) 2019-09-26 2020-09-25 Pediatric trazodone compositions and method of treatment thereof

Country Status (13)

Country Link
US (1) US12514856B2 (enExample)
EP (1) EP4034117A1 (enExample)
JP (1) JP7629453B2 (enExample)
KR (1) KR102936358B1 (enExample)
CN (1) CN114615983A (enExample)
AU (1) AU2020354534B2 (enExample)
BR (1) BR112022005343A2 (enExample)
CA (1) CA3153639A1 (enExample)
GE (2) GEP20257739B (enExample)
IL (1) IL291548A (enExample)
MX (1) MX2022003442A (enExample)
UA (1) UA129270C2 (enExample)
WO (1) WO2021058810A1 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240173315A1 (en) * 2022-11-14 2024-05-30 OWP Pharmaceuticals, Inc. Trazodone oral solution
US20240390277A1 (en) * 2023-04-15 2024-11-28 Rubicon Research Private Limited Liquid formulations of trazodone
CN119280155B (zh) * 2024-12-11 2025-02-25 新基元(北京)医药科技有限公司 一种改善稳定性的盐酸曲唑酮液体药物组合物及其制备方法

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009016069A2 (en) * 2007-07-31 2009-02-05 Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.P.A. Stable liquid pharmaceutical composition based on trazodone

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI1931346T1 (sl) 2005-09-09 2012-10-30 Angelini Labopharm Llc Trazodonski sestavek za dajanje enkrat dnevno
ITMI20071603A1 (it) 2007-08-03 2009-02-04 Acraf Trazodone e trazodone cloridrato in forma purificata

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009016069A2 (en) * 2007-07-31 2009-02-05 Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.P.A. Stable liquid pharmaceutical composition based on trazodone
US20100256159A1 (en) * 2007-07-31 2010-10-07 Aziende Chim. Riun. Ang. Franc. A.C.R.A.F. S.P.A. Stable liquid pharmaceutical composition based on trazodone

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ANGRIMAN MCARAVALE BNOVELLI LFERRI RBRUNI O: "Sleep in children with neurodevelopmental disabilities", NEUROPEDIATRICS, vol. 46, no. 3, June 2015 (2015-06-01), pages 199 - 210 *

Also Published As

Publication number Publication date
JP2022549473A (ja) 2022-11-25
IL291548A (en) 2022-05-01
JP7629453B2 (ja) 2025-02-13
CA3153639A1 (en) 2021-04-01
GEAP202415936A (en) 2024-10-28
WO2021058810A1 (en) 2021-04-01
MX2022003442A (es) 2022-07-11
BR112022005343A2 (pt) 2022-06-14
GEP20257739B (en) 2025-02-25
US12514856B2 (en) 2026-01-06
KR102936358B1 (ko) 2026-03-10
EP4034117A1 (en) 2022-08-03
KR20220080096A (ko) 2022-06-14
US20220331312A1 (en) 2022-10-20
UA129270C2 (uk) 2025-03-05
CN114615983A (zh) 2022-06-10
AU2020354534A1 (en) 2022-04-14

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