AU2017253674B2 - Formulations of abaloparatide, transdermal patches thereof, and uses thereof - Google Patents

Formulations of abaloparatide, transdermal patches thereof, and uses thereof Download PDF

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Publication number
AU2017253674B2
AU2017253674B2 AU2017253674A AU2017253674A AU2017253674B2 AU 2017253674 B2 AU2017253674 B2 AU 2017253674B2 AU 2017253674 A AU2017253674 A AU 2017253674A AU 2017253674 A AU2017253674 A AU 2017253674A AU 2017253674 B2 AU2017253674 B2 AU 2017253674B2
Authority
AU
Australia
Prior art keywords
abaloparatide
patch
transdermal
formulation
administration
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.)
Ceased
Application number
AU2017253674A
Other languages
English (en)
Other versions
AU2017253674A1 (en
Inventor
Kenneth Brown
Lisa Dick
Daniel Dohmeier
Ehab Hamed
Alan Harris
Gary Hattersley
Joan Moseman
Jamal SAEH
Ying Zhang
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.)
Radius Health Inc
Kindeva Drug Delivery LP
Original Assignee
Radius Health Inc
Kindeva Drug Delivery LP
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 PCT/US2016/056196 external-priority patent/WO2017062922A1/en
Application filed by Radius Health Inc, Kindeva Drug Delivery LP filed Critical Radius Health Inc
Publication of AU2017253674A1 publication Critical patent/AU2017253674A1/en
Assigned to 3M INNOVATIVE PROPERTIES COMPANY, RADIUS HEALTH, INC. reassignment 3M INNOVATIVE PROPERTIES COMPANY Request for Assignment Assignors: RADIUS HEALTH, INC.
Assigned to RADIUS HEALTH, INC., KINDEVA DRUG DELIVERY L.P. reassignment RADIUS HEALTH, INC. Request for Assignment Assignors: 3M INNOVATIVE PROPERTIES COMPANY, RADIUS HEALTH, INC.
Priority to AU2021204233A priority Critical patent/AU2021204233B2/en
Application granted granted Critical
Publication of AU2017253674B2 publication Critical patent/AU2017253674B2/en
Ceased 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
    • 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
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/30—Zinc; Compounds 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
    • A61K47/08—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • 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
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2017253674A 2016-04-18 2017-04-06 Formulations of abaloparatide, transdermal patches thereof, and uses thereof Ceased AU2017253674B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2021204233A AU2021204233B2 (en) 2016-04-18 2021-06-23 Formulations of abaloparatide, transdermal patches thereof, and uses thereof

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US201662324336P 2016-04-18 2016-04-18
US62/324,336 2016-04-18
US201662353249P 2016-06-22 2016-06-22
US62/353,249 2016-06-22
US201662396196P 2016-09-18 2016-09-18
US62/396,196 2016-09-18
AUPCT/US2016/056196 2016-10-08
PCT/US2016/056196 WO2017062922A1 (en) 2015-10-09 2016-10-08 Formulations of pthrp analogues, transdermal patches thereof, and uses thereof
US201762479250P 2017-03-30 2017-03-30
US62/479,250 2017-03-30
PCT/US2017/026462 WO2017184355A1 (en) 2016-04-18 2017-04-06 Formulations of abaloparatide, transdermal patches thereof, and uses thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2021204233A Division AU2021204233B2 (en) 2016-04-18 2021-06-23 Formulations of abaloparatide, transdermal patches thereof, and uses thereof

Publications (2)

Publication Number Publication Date
AU2017253674A1 AU2017253674A1 (en) 2018-10-25
AU2017253674B2 true AU2017253674B2 (en) 2021-07-29

Family

ID=60116311

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2017253674A Ceased AU2017253674B2 (en) 2016-04-18 2017-04-06 Formulations of abaloparatide, transdermal patches thereof, and uses thereof
AU2021204233A Ceased AU2021204233B2 (en) 2016-04-18 2021-06-23 Formulations of abaloparatide, transdermal patches thereof, and uses thereof

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2021204233A Ceased AU2021204233B2 (en) 2016-04-18 2021-06-23 Formulations of abaloparatide, transdermal patches thereof, and uses thereof

Country Status (7)

Country Link
US (3) US10568937B2 (enExample)
EP (2) EP3481414B1 (enExample)
JP (4) JP6920341B2 (enExample)
AU (2) AU2017253674B2 (enExample)
CA (1) CA3020333A1 (enExample)
ES (1) ES2904891T3 (enExample)
WO (1) WO2017184355A1 (enExample)

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ES2904891T3 (es) 2016-04-18 2022-04-06 Radius Health Inc Formulaciones de abaloparatida, parche transdérmico de la misma y usos de la misma
US10996208B2 (en) 2017-04-28 2021-05-04 Radius Health, Inc. Abaloparatide formulations and methods of testing, storing, modifying, and using same
EP3930743A1 (en) * 2019-02-28 2022-01-05 Radius Health, Inc. Transdermal system for the delivery of abaloparatide and method of use
CN110917243B (zh) * 2019-12-30 2021-06-04 南京晓庄学院 一种含植物提取物的凝胶膏剂及其制备方法
WO2021149012A1 (en) 2020-01-24 2021-07-29 Radius Health, Inc. Methods of stimulating bone growth with abalopartide and denosumab
JP2024502334A (ja) * 2021-01-05 2024-01-18 ラジウス ヘルス，インコーポレイテッド アバロパラチドを用いた長骨骨折の治療
US12029562B2 (en) 2021-04-14 2024-07-09 Satio, Inc. Dermal patch system
US11877848B2 (en) 2021-11-08 2024-01-23 Satio, Inc. Dermal patch for collecting a physiological sample
US12053284B2 (en) 2021-11-08 2024-08-06 Satio, Inc. Dermal patch for collecting a physiological sample
US12023156B2 (en) 2021-10-13 2024-07-02 Satio, Inc. Dermal patch for collecting a physiological sample
US12048543B2 (en) 2021-11-08 2024-07-30 Satio, Inc. Dermal patch for collecting a physiological sample with removable vial
US12178979B2 (en) 2021-10-13 2024-12-31 Satio, Inc. Dermal patch for delivering a pharmaceutical
US11964121B2 (en) 2021-10-13 2024-04-23 Satio, Inc. Mono dose dermal patch for pharmaceutical delivery
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WO2023281447A1 (en) 2021-07-07 2023-01-12 Radius Health, Inc. Methods of treating a cardiovascular ischemic event
WO2024246840A1 (en) * 2023-06-01 2024-12-05 Radius Health, Inc. Methods for identification and quantitation of abaloparatide and related peptide impurities
CN119113134B (zh) * 2024-09-13 2025-05-16 南京羚诺生物医药技术研究院有限公司 一种提升阿巴帕肽半衰期的制备方法及其在治疗骨质疏松症中的用途

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US20090016935A1 (en) * 2007-07-09 2009-01-15 Andrianov Alexander K Coating formulations including polyphosphazene polyelectrolytes and biologically active agents and asperities coated with such formulations
WO2016055550A1 (en) * 2014-10-07 2016-04-14 Cyprumed Gmbh Pharmaceutical formulations for the oral delivery of peptide or protein drugs

Also Published As

Publication number Publication date
EP3481414A4 (en) 2020-05-13
JP2022171769A (ja) 2022-11-11
JP2021113209A (ja) 2021-08-05
US10980862B2 (en) 2021-04-20
JP6920341B2 (ja) 2021-08-18
US20200164045A1 (en) 2020-05-28
WO2017184355A1 (en) 2017-10-26
AU2021204233B2 (en) 2023-07-13
JP2021175744A (ja) 2021-11-04
JP6919087B2 (ja) 2021-08-11
ES2904891T3 (es) 2022-04-06
JP2019511558A (ja) 2019-04-25
EP3481414B1 (en) 2021-11-03
JP7139498B2 (ja) 2022-09-20
EP3481414A1 (en) 2019-05-15
US10568937B2 (en) 2020-02-25
US20210369816A1 (en) 2021-12-02
US20190117739A1 (en) 2019-04-25
AU2021204233A1 (en) 2021-07-15
AU2017253674A1 (en) 2018-10-25
CA3020333A1 (en) 2017-10-26
EP3998061A1 (en) 2022-05-18

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Legal Events

Date Code Title Description
PC1 Assignment before grant (sect. 113)

Owner name: RADIUS HEALTH, INC.

Free format text: FORMER APPLICANT(S): RADIUS HEALTH, INC.

Owner name: 3M INNOVATIVE PROPERTIES COMPANY

Free format text: FORMER APPLICANT(S): RADIUS HEALTH, INC.

DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO READ HATTERSLEY, GARY; HARRIS, ALAN; SAEH, JAMAL; HAMED, EHAB; BROWN, KENNETH; DOHMEIER, DANIEL; MOSEMAN, JOAN; ZHANG, YANG AND DICK, LISA

DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO READ HATTERSLEY, GARY; HARRIS, ALAN; SAEH, JAMAL; HAMED, EHAB; BROWN, KENNETH; DOHMEIER, DANIEL; MOSEMAN, JOAN; ZHANG, YING AND DICK, LISA

PC1 Assignment before grant (sect. 113)

Owner name: RADIUS HEALTH, INC.

Free format text: FORMER APPLICANT(S): RADIUS HEALTH, INC.; 3M INNOVATIVE PROPERTIES COMPANY

Owner name: KINDEVA DRUG DELIVERY L.P.

Free format text: FORMER APPLICANT(S): RADIUS HEALTH, INC.; 3M INNOVATIVE PROPERTIES COMPANY

FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired