KR20240066197A - 레보티록신의 지속성 방출 주사 가능한 제약학적 제형 및 그것의 제조 방법 - Google Patents

레보티록신의 지속성 방출 주사 가능한 제약학적 제형 및 그것의 제조 방법 Download PDF

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Publication number
KR20240066197A
KR20240066197A KR1020247015048A KR20247015048A KR20240066197A KR 20240066197 A KR20240066197 A KR 20240066197A KR 1020247015048 A KR1020247015048 A KR 1020247015048A KR 20247015048 A KR20247015048 A KR 20247015048A KR 20240066197 A KR20240066197 A KR 20240066197A
Authority
KR
South Korea
Prior art keywords
levothyroxine
pharmaceutical formulation
polymer
lactide
formulation according
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
KR1020247015048A
Other languages
English (en)
Korean (ko)
Inventor
에반겔로스 카라바스
에프티미오스 코우트리스
리다 칼란치
소티리아 차이티두
니코스 레모나키스
안나 파파다키
빈센트 브리유데즈
아르테미스 칼레지
아타나시오스 카세니스
카테리나 코티
Original Assignee
파마덴 에스.에이.
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 파마덴 에스.에이. filed Critical 파마덴 에스.에이.
Publication of KR20240066197A publication Critical patent/KR20240066197A/ko
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)
KR1020247015048A 2021-10-06 2022-10-06 레보티록신의 지속성 방출 주사 가능한 제약학적 제형 및 그것의 제조 방법 Pending KR20240066197A (ko)

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
KR20240066197A true KR20240066197A (ko) 2024-05-14

Family

ID=83996642

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020247015048A Pending KR20240066197A (ko) 2021-10-06 2022-10-06 레보티록신의 지속성 방출 주사 가능한 제약학적 제형 및 그것의 제조 방법

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
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

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