CA3020333A1 - 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
CA3020333A1
CA3020333A1 CA3020333A CA3020333A CA3020333A1 CA 3020333 A1 CA3020333 A1 CA 3020333A1 CA 3020333 A CA3020333 A CA 3020333A CA 3020333 A CA3020333 A CA 3020333A CA 3020333 A1 CA3020333 A1 CA 3020333A1
Authority
CA
Canada
Prior art keywords
abaloparatide
transdermal patch
transdermal
administration
excipient
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
CA3020333A
Other languages
English (en)
French (fr)
Inventor
Gary Hattersley
Alan Harris
Jamal SAEH
Ehab Hamed
Kenneth Brown
Daniel Dohmeier
Joan Moseman
Ying Zhang
Lisa Dick
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.)
Kindeva Drug Delivery LP
Original Assignee
3M Innovative Properties Co
Radius Health Inc
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 3M Innovative Properties Co, Radius Health Inc filed Critical 3M Innovative Properties Co
Publication of CA3020333A1 publication Critical patent/CA3020333A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/29Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/30Zinc; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs 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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (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)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (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)
CA3020333A 2016-04-18 2017-04-06 Formulations of abaloparatide, transdermal patches thereof, and uses thereof Pending CA3020333A1 (en)

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
PCT/US2016/056196 WO2017062922A1 (en) 2015-10-09 2016-10-08 Formulations of pthrp analogues, transdermal patches thereof, and uses thereof
USPCT/US2016/056196 2016-10-08
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

Publications (1)

Publication Number Publication Date
CA3020333A1 true CA3020333A1 (en) 2017-10-26

Family

ID=60116311

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3020333A Pending CA3020333A1 (en) 2016-04-18 2017-04-06 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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CA3020333A1 (en) 2016-04-18 2017-10-26 Radius Health, Inc. Formulations of abaloparatide, transdermal patches thereof, and uses thereof
US10996208B2 (en) * 2017-04-28 2021-05-04 Radius Health, Inc. Abaloparatide formulations and methods of testing, storing, modifying, and using same
KR20210134324A (ko) * 2019-02-28 2021-11-09 라디우스 헬쓰, 인코포레이티드 아발로파라티드의 전달을 위한 경피 시스템 및 사용 방법
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
WO2022149066A1 (en) * 2021-01-05 2022-07-14 Radius Health, Inc. Treatment of long bone fractures with abaloparatide
US12023156B2 (en) 2021-10-13 2024-07-02 Satio, Inc. Dermal patch for collecting a physiological sample
US11452474B1 (en) 2021-04-14 2022-09-27 Satio, Inc. Dual lever dermal patch system
US12178979B2 (en) 2021-10-13 2024-12-31 Satio, Inc. Dermal patch for delivering a pharmaceutical
US12053284B2 (en) 2021-11-08 2024-08-06 Satio, Inc. Dermal patch for collecting a physiological sample
US12214346B2 (en) 2021-10-13 2025-02-04 Satio, Inc. Dermal patch with a diagnostic test strip
US11964121B2 (en) 2021-10-13 2024-04-23 Satio, Inc. Mono dose dermal patch for pharmaceutical delivery
US11877848B2 (en) 2021-11-08 2024-01-23 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
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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Also Published As

Publication number Publication date
JP6919087B2 (ja) 2021-08-11
JP2021113209A (ja) 2021-08-05
EP3481414B1 (en) 2021-11-03
AU2021204233A1 (en) 2021-07-15
AU2017253674B2 (en) 2021-07-29
US10568937B2 (en) 2020-02-25
JP2022171769A (ja) 2022-11-11
JP2021175744A (ja) 2021-11-04
AU2021204233B2 (en) 2023-07-13
JP2019511558A (ja) 2019-04-25
AU2017253674A1 (en) 2018-10-25
WO2017184355A1 (en) 2017-10-26
US10980862B2 (en) 2021-04-20
US20190117739A1 (en) 2019-04-25
EP3998061A1 (en) 2022-05-18
US20200164045A1 (en) 2020-05-28
EP3481414A1 (en) 2019-05-15
ES2904891T3 (es) 2022-04-06
JP6920341B2 (ja) 2021-08-18
EP3481414A4 (en) 2020-05-13
US20210369816A1 (en) 2021-12-02
JP7139498B2 (ja) 2022-09-20

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Effective date: 20220310