AU2019315807B2 - Formulations for improved stability of recombinant human parathyroid hormone - Google Patents

Formulations for improved stability of recombinant human parathyroid hormone Download PDF

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Publication number
AU2019315807B2
AU2019315807B2 AU2019315807A AU2019315807A AU2019315807B2 AU 2019315807 B2 AU2019315807 B2 AU 2019315807B2 AU 2019315807 A AU2019315807 A AU 2019315807A AU 2019315807 A AU2019315807 A AU 2019315807A AU 2019315807 B2 AU2019315807 B2 AU 2019315807B2
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Australia
Prior art keywords
rhpth
buffer
formulation
composition
present
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AU2019315807A
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AU2019315807A1 (en
Inventor
Sujit Basu
Nitin Dixit
Vinh Nguyen
Pierre SOUILLAC
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Takeda Pharmaceutical Co Ltd
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Takeda Pharmaceutical Co Ltd
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Publication of AU2019315807A1 publication Critical patent/AU2019315807A1/en
Assigned to TAKEDA PHARMACEUTICALS U.S.A., INC. reassignment TAKEDA PHARMACEUTICALS U.S.A., INC. Amend patent request/document other than specification (104) Assignors: SHIRE-NPS PHARMACEUTICALS INC.
Assigned to TAKEDA PHARMACEUTICAL COMPANY LIMITED reassignment TAKEDA PHARMACEUTICAL COMPANY LIMITED Request for Assignment Assignors: TAKEDA PHARMACEUTICALS U.S.A., INC.
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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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2019315807A 2018-07-30 2019-07-12 Formulations for improved stability of recombinant human parathyroid hormone Active AU2019315807B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862711767P 2018-07-30 2018-07-30
US62/711,767 2018-07-30
PCT/US2019/041609 WO2020028011A1 (en) 2018-07-30 2019-07-12 Formulations for improved stability of recombinant human parathyroid hormone

Publications (2)

Publication Number Publication Date
AU2019315807A1 AU2019315807A1 (en) 2021-02-18
AU2019315807B2 true AU2019315807B2 (en) 2025-07-10

Family

ID=69232628

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019315807A Active AU2019315807B2 (en) 2018-07-30 2019-07-12 Formulations for improved stability of recombinant human parathyroid hormone

Country Status (9)

Country Link
US (1) US20210315978A1 (https=)
EP (1) EP3829625A4 (https=)
JP (2) JP7399382B2 (https=)
KR (1) KR20210038618A (https=)
CN (1) CN112638407A (https=)
AU (1) AU2019315807B2 (https=)
CA (1) CA3107105A1 (https=)
TW (1) TWI831813B (https=)
WO (1) WO2020028011A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102885113B1 (ko) 2018-10-18 2025-11-13 머크 샤프 앤드 돔 엘엘씨 항-rsv 항체의 제제 및 그의 사용 방법
CN120842406A (zh) 2018-10-31 2025-10-28 默沙东有限责任公司 抗人pd-1抗体晶体及其使用方法
US20230190880A1 (en) * 2020-03-30 2023-06-22 Sichuan Luzhou Buchang Bio-Pharmaceutical Co., Ltd. Formulations of Human Parathyroid Hormone (PTH) and Methods for Producing Same
WO2025032376A1 (en) * 2023-08-04 2025-02-13 Precise Biopharma Pvt Ltd A room temperature stable solution for injection of abaloparatide

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009053106A1 (en) * 2007-10-26 2009-04-30 Nycomed Danmark Aps Parathyroid hormone formulations and uses thereof

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5496801A (en) * 1993-12-23 1996-03-05 Allelix Biopharmaceuticals Inc. Parathyroid hormone formulation
EP1030658A1 (en) 1997-10-14 2000-08-30 Eli Lilly And Company Method of building and maintaining bone
KR100700869B1 (ko) * 2005-06-03 2007-03-29 재단법인 목암생명공학연구소 Ｐｔｈ, 완충제 및 안정제를 포함하는 안정한 ｐｔｈ조성물
CN100553674C (zh) * 2007-02-02 2009-10-28 重庆科润生物医药研发有限公司 一种重组人甲状旁腺激素(1-84)药物组合物及其制备方法
WO2013108235A1 (en) * 2012-01-20 2013-07-25 Lupin Limited Stabilized pth formulation

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009053106A1 (en) * 2007-10-26 2009-04-30 Nycomed Danmark Aps Parathyroid hormone formulations and uses thereof

Also Published As

Publication number Publication date
EP3829625A1 (en) 2021-06-09
WO2020028011A1 (en) 2020-02-06
TW202019461A (zh) 2020-06-01
TWI831813B (zh) 2024-02-11
JP2024003211A (ja) 2024-01-11
KR20210038618A (ko) 2021-04-07
US20210315978A1 (en) 2021-10-14
EP3829625A4 (en) 2022-08-10
CA3107105A1 (en) 2020-02-06
JP7738046B2 (ja) 2025-09-11
AU2019315807A1 (en) 2021-02-18
JP7399382B2 (ja) 2023-12-18
CN112638407A (zh) 2021-04-09
JP2021532110A (ja) 2021-11-25

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HB Alteration of name in register

Owner name: TAKEDA PHARMACEUTICALS U.S.A., INC.

Free format text: FORMER NAME(S): SHIRE-NPS PHARMACEUTICALS INC.

PC1 Assignment before grant (sect. 113)

Owner name: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Free format text: FORMER APPLICANT(S): TAKEDA PHARMACEUTICALS U.S.A., INC.

FGA Letters patent sealed or granted (standard patent)