AU2020284587B2 - Leuprolide acetate compositions and methods of using the same to treat breast cancer - Google Patents

Leuprolide acetate compositions and methods of using the same to treat breast cancer

Info

Publication number
AU2020284587B2
AU2020284587B2 AU2020284587A AU2020284587A AU2020284587B2 AU 2020284587 B2 AU2020284587 B2 AU 2020284587B2 AU 2020284587 A AU2020284587 A AU 2020284587A AU 2020284587 A AU2020284587 A AU 2020284587A AU 2020284587 B2 AU2020284587 B2 AU 2020284587B2
Authority
AU
Australia
Prior art keywords
leuprolide
subject
extended release
release composition
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.)
Active
Application number
AU2020284587A
Other languages
English (en)
Other versions
AU2020284587A1 (en
Inventor
John Arthur Mclane
John Middleton
Terri L. MORTON
Avinash Nangia
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.)
Tolmar International Ltd
Original Assignee
Tolmar International Ltd
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 Tolmar International Ltd filed Critical Tolmar International Ltd
Publication of AU2020284587A1 publication Critical patent/AU2020284587A1/en
Application granted granted Critical
Publication of AU2020284587B2 publication Critical patent/AU2020284587B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K31/4196—1,2,4-Triazoles
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/566—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol having an oxo group in position 17, e.g. estrone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • 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
    • A61K47/12—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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Saccharide Compounds (AREA)
  • Peptides Or Proteins (AREA)
AU2020284587A 2019-05-27 2020-05-26 Leuprolide acetate compositions and methods of using the same to treat breast cancer Active AU2020284587B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962853153P 2019-05-27 2019-05-27
US62/853,153 2019-05-27
PCT/IB2020/054984 WO2020240417A1 (en) 2019-05-27 2020-05-26 Leuprolide acetate compositions and methods of using the same to treat breast cancer

Publications (2)

Publication Number Publication Date
AU2020284587A1 AU2020284587A1 (en) 2022-01-06
AU2020284587B2 true AU2020284587B2 (en) 2025-09-18

Family

ID=70922081

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020284587A Active AU2020284587B2 (en) 2019-05-27 2020-05-26 Leuprolide acetate compositions and methods of using the same to treat breast cancer

Country Status (17)

Country Link
US (2) US12453754B2 (enExample)
EP (1) EP3975990A1 (enExample)
JP (1) JP7664855B2 (enExample)
KR (1) KR20220041782A (enExample)
CN (1) CN114144169A (enExample)
AR (1) AR119021A1 (enExample)
AU (1) AU2020284587B2 (enExample)
BR (1) BR112021023904A2 (enExample)
CA (1) CA3141456A1 (enExample)
EA (1) EA202193257A1 (enExample)
IL (1) IL288503A (enExample)
MX (1) MX2021014540A (enExample)
PH (1) PH12021552976A1 (enExample)
SG (1) SG11202112888RA (enExample)
TW (1) TWI757753B (enExample)
UY (1) UY38717A (enExample)
WO (1) WO2020240417A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114144169A (zh) 2019-05-27 2022-03-04 托尔玛国际有限公司 醋酸亮丙瑞林组合物和使用其治疗乳腺癌的方法
DK4135830T3 (da) 2020-12-23 2024-10-28 Tolmar International Ltd Systemer og fremgangsmåder til blanding af sprøjteventilanordninger
CN115518144A (zh) * 2021-06-26 2022-12-27 王婧宜 一种含有亮丙瑞林或其衍生物的口服药物组合物
USD1029245S1 (en) 2022-06-22 2024-05-28 Tolmar International Limited Syringe connector

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160331802A1 (en) * 2006-01-18 2016-11-17 Yuhua Li Pharmaceutical Compositions with Enhanced Stability

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US5702716A (en) 1988-10-03 1997-12-30 Atrix Laboratories, Inc. Polymeric compositions useful as controlled release implants
US4938763B1 (en) 1988-10-03 1995-07-04 Atrix Lab Inc Biodegradable in-situ forming implants and method of producing the same
US5324519A (en) 1989-07-24 1994-06-28 Atrix Laboratories, Inc. Biodegradable polymer composition
JP4259610B2 (ja) 1994-04-08 2009-04-30 キューエルティー・ユーエスエイ・インコーポレーテッド 液体デリバリー組成物
US6565874B1 (en) 1998-10-28 2003-05-20 Atrix Laboratories Polymeric delivery formulations of leuprolide with improved efficacy
US8470359B2 (en) 2000-11-13 2013-06-25 Qlt Usa, Inc. Sustained release polymer
DK3660073T3 (da) * 2007-02-15 2023-09-18 Tolmar International Ltd Poly(lactid-co-glycolid) med lav sprængning
DE202009010095U1 (de) 2009-07-24 2009-10-22 Chang, Ti-Li, Houli Verbindungsvorrichtung für einen auswechselbaren, abgeschlossenen Sekret-Absaugkatheter
IL301603A (en) * 2011-10-14 2023-05-01 Genentech Inc Pertuzumab, trastuzumab, docetaxel and carboplatin for use in the preoperative treatment of a patient
CN114144169A (zh) 2019-05-27 2022-03-04 托尔玛国际有限公司 醋酸亮丙瑞林组合物和使用其治疗乳腺癌的方法
KR102162217B1 (ko) 2020-05-07 2020-10-06 주식회사 파인비엠 스태틱믹서를 갖는 연결장치를 구비한 시린지 결합 키트
DK4135830T3 (da) 2020-12-23 2024-10-28 Tolmar International Ltd Systemer og fremgangsmåder til blanding af sprøjteventilanordninger
AU2022331238A1 (en) 2021-08-19 2024-02-01 Carefusion 303, Inc. Pivc-integrated hemolysis-reduction accessories with anti-spillage component for direct blood draw
FR3131618A1 (fr) 2021-12-30 2023-07-07 Parker Hannifin Emea Sarl Dispositif de raccordement aseptique d’un tube

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160331802A1 (en) * 2006-01-18 2016-11-17 Yuhua Li Pharmaceutical Compositions with Enhanced Stability

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
HARISH B. RAVIVARAPU ET AL: "Sustained suppression of pituitary-gonadal axis with an injectable,in situ forming implant of leuprolide acetate", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 89, no. 6, 1 June 2000, pages 732 - 741 *
HB RAVIVARAPU ET AL: "Sustained Activity and Release of Leuprolide Acetate from an In Situ Forming Polymeric Implant", AAPS PHARMSCITECH, vol. 01, no. 01, 1 January 2000 (2000-01-01), pages e1, XP055143271, DOI: 10.1208/pt010101 *

Also Published As

Publication number Publication date
WO2020240417A1 (en) 2020-12-03
KR20220041782A (ko) 2022-04-01
MX2021014540A (es) 2022-04-12
AR119021A1 (es) 2021-11-17
TW202110472A (zh) 2021-03-16
IL288503A (en) 2022-01-01
TWI757753B (zh) 2022-03-11
SG11202112888RA (en) 2021-12-30
AU2020284587A1 (en) 2022-01-06
UY38717A (es) 2020-11-30
US12453754B2 (en) 2025-10-28
EA202193257A1 (ru) 2022-03-10
PH12021552976A1 (en) 2022-07-04
BR112021023904A2 (pt) 2022-02-01
US20220265760A1 (en) 2022-08-25
US20260027176A1 (en) 2026-01-29
JP2022535694A (ja) 2022-08-10
JP7664855B2 (ja) 2025-04-18
EP3975990A1 (en) 2022-04-06
CA3141456A1 (en) 2020-12-03
CN114144169A (zh) 2022-03-04

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