CA3234073A1 - 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

Info

Publication number
CA3234073A1
CA3234073A1 CA3234073A CA3234073A CA3234073A1 CA 3234073 A1 CA3234073 A1 CA 3234073A1 CA 3234073 A CA3234073 A CA 3234073A CA 3234073 A CA3234073 A CA 3234073A CA 3234073 A1 CA3234073 A1 CA 3234073A1
Authority
CA
Canada
Prior art keywords
pharmaceutical formulation
levothyroxine
polymer
glycolide
lactide
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
CA3234073A
Other languages
English (en)
French (fr)
Inventor
Evangelos Karavas
Efthymios Koutris
Lida Kalantzi
Sotiria Chaitidou
Nikos Lemonakis
Anna Papadaki
Vincent Brieudes
Artemis Kalezi
Athanasios Katsenis
Katerina KOTTI
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
Individual
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 Individual filed Critical Individual
Publication of CA3234073A1 publication Critical patent/CA3234073A1/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)
CA3234073A 2021-10-06 2022-10-06 Sustained release injectable pharmaceutical formulation of levothyroxine and process for preparation thereof Pending CA3234073A1 (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
CA3234073A1 true CA3234073A1 (en) 2023-04-13

Family

ID=83996642

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3234073A Pending CA3234073A1 (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
AU2022360328A1 (en) 2024-05-16
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

Similar Documents

Publication Publication Date Title
EP2394663B1 (en) Compositions for injectable in-situ biodegradable implants
EP2575890B1 (en) Antipsychotic injectable depot composition
ES2798103T3 (es) Composición farmacéutica inyectable estable de antagonista del receptor de neuroquinina-1 y procedimiento para su preparación
CA3234073A1 (en) Sustained release injectable pharmaceutical formulation of levothyroxine and process for preparation thereof
US20240415765A1 (en) Continuous delivery preparation capable of being stably released and preparation method therefor
CN102133180A (zh) 一种甾体5α-还原酶抑制剂长效注射制剂及其制备方法
GB2613656A (en) Sustained release injectable pharmaceutical formulation of levothyroxine and process for preparation thereof
US20250205150A1 (en) Long-acting sustained-release preparation containing pramipexole and preparation method therefor
CN118201604A (zh) 左旋甲状腺素的缓释可注射药物制剂及其制备方法
HK40105344A (zh) 左旋甲状腺素的缓释可注射药物制剂及其制备方法
EP4294367A1 (en) Non-aqueous injectable composition for sustained release of buprenorphine and use thereof
CN101006981A (zh) 一种含紫杉烷及铂类化合物的缓释注射剂
CN101380303A (zh) 一种同载铂类化合物及其增效剂的抗癌药物缓释注射剂
EP4551298A1 (en) Stable, liquid pharmaceutical compositions comprising melphalan
EA052517B1 (ru) Препарат для непрерывной доставки, способный стабильно высвобождаться, и способ его получения
KR20240079177A (ko) 인-시튜 임플란트를 형성할 수 있는 서방형 약학 조성물 및 이의 제조방법
CN101019828A (zh) 一种含磷酸肌醇3－激酶抑制剂及激素类药物的抗癌组合物
CN120643518A (zh) 平稳释药的长效戈舍瑞林注射式原位成型植入剂及其制备方法和应用
CN118267362A (zh) 一种爱地那非长效缓释注射剂及其制备方法和用途
CN101254169A (zh) 含抗结核病药物的缓释剂
CN1969825A (zh) 一种氟尿嘧啶及其增效剂的缓释剂
CN118043036A (zh) 包含他克莫司的药物制剂、其制备方法和用途
CN101361710A (zh) 一种含拓马替尼的抗癌组合物
WO2021064580A1 (en) Controlled release injectable ondansetron formulations
CN1969824A (zh) 一种含氟尿嘧啶及其增效剂的抗癌缓释剂

Legal Events

Date Code Title Description
MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 2ND ANNIV.) - STANDARD

Year of fee payment: 2

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20240808

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20240808

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 3RD ANNIV.) - STANDARD

Year of fee payment: 3

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250922

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250922