AU2022360328A1 - Sustained release injectable pharmaceutical formulation of levothyroxine and process for preparation thereof - Google Patents

Sustained release injectable pharmaceutical formulation of levothyroxine and process for preparation thereof Download PDF

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Publication number
AU2022360328A1
AU2022360328A1 AU2022360328A AU2022360328A AU2022360328A1 AU 2022360328 A1 AU2022360328 A1 AU 2022360328A1 AU 2022360328 A AU2022360328 A AU 2022360328A AU 2022360328 A AU2022360328 A AU 2022360328A AU 2022360328 A1 AU2022360328 A1 AU 2022360328A1
Authority
AU
Australia
Prior art keywords
pharmaceutical formulation
levothyroxine
polymer
lactide
glycolide
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.)
Pending
Application number
AU2022360328A
Other languages
English (en)
Inventor
Vincent Brieudes
Sotiria Chaitidou
Lida Kalantzi
Artemis Kalezi
Evangelos Karavas
Athanasios Katsenis
Katerina KOTTI
Efthymios Koutris
Nikos Lemonakis
Anna Papadaki
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.)
Pharmathen SA
Original Assignee
Pharmathen SA
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
Priority claimed from GR20210100683A external-priority patent/GR1010327B/el
Priority claimed from GB2119164.8A external-priority patent/GB2613656A/en
Application filed by Pharmathen SA filed Critical Pharmathen SA
Publication of AU2022360328A1 publication Critical patent/AU2022360328A1/en
Pending legal-status Critical Current

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2022360328A 2021-10-06 2022-10-06 Sustained release injectable pharmaceutical formulation of levothyroxine and process for preparation thereof Pending AU2022360328A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
GR20210100683A GR1010327B (el) 2021-10-06 2021-10-06 Παρατεταμενης αποδεσμευσης ενεσιμο φαρμακευτικο σκευασμα λεβοθυροξινης και μεθοδος παρασκευης αυτου
GR20210100683 2021-10-06
GB2119164.8A GB2613656A (en) 2021-12-13 2021-12-13 Sustained release injectable pharmaceutical formulation of levothyroxine and process for preparation thereof
GB2119164.8 2021-12-13
PCT/EP2022/025463 WO2023057088A1 (en) 2021-10-06 2022-10-06 Sustained release injectable pharmaceutical formulation of levothyroxine and process for preparation thereof

Publications (1)

Publication Number Publication Date
AU2022360328A1 true AU2022360328A1 (en) 2024-05-16

Family

ID=83996642

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2022360328A Pending AU2022360328A1 (en) 2021-10-06 2022-10-06 Sustained release injectable pharmaceutical formulation of levothyroxine and process for preparation thereof

Country Status (10)

Country Link
US (1) US20250268830A1 (https=)
EP (1) EP4412594A1 (https=)
JP (1) JP2024536419A (https=)
KR (1) KR20240066197A (https=)
AU (1) AU2022360328A1 (https=)
CA (1) CA3234073A1 (https=)
CO (1) CO2024005798A2 (https=)
MX (1) MX2024004141A (https=)
WO (1) WO2023057088A1 (https=)
ZA (1) ZA202403411B (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4701631A1 (en) * 2023-04-28 2026-03-04 Maia Pharmaceuticals, Inc. Levothyroxine dispersions
CN116831994B (zh) * 2023-06-25 2026-03-27 湖南赛隆药业(长沙)有限公司 一种注射用左甲状腺素钠缓释微球冻干制剂及其制备方法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1127634A (zh) 1995-04-06 1996-07-31 中国科学院成都有机化学研究所 一种激素缓释微球注射剂及其制备方法
CN113384537A (zh) * 2021-04-25 2021-09-14 苏州大学 一种左旋千金藤啶碱缓释微球及其制备方法

Also Published As

Publication number Publication date
US20250268830A1 (en) 2025-08-28
CA3234073A1 (en) 2023-04-13
JP2024536419A (ja) 2024-10-04
CO2024005798A2 (es) 2024-05-10
MX2024004141A (es) 2024-07-10
WO2023057088A1 (en) 2023-04-13
ZA202403411B (en) 2025-01-29
EP4412594A1 (en) 2024-08-14
KR20240066197A (ko) 2024-05-14

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