BR112018007159A2 - formulações de análogos de pthrp, emplastros transdérmicos dos mesmos e usos dos mesmos - Google Patents

formulações de análogos de pthrp, emplastros transdérmicos dos mesmos e usos dos mesmos

Info

Publication number
BR112018007159A2
BR112018007159A2 BR112018007159A BR112018007159A BR112018007159A2 BR 112018007159 A2 BR112018007159 A2 BR 112018007159A2 BR 112018007159 A BR112018007159 A BR 112018007159A BR 112018007159 A BR112018007159 A BR 112018007159A BR 112018007159 A2 BR112018007159 A2 BR 112018007159A2
Authority
BR
Brazil
Prior art keywords
formulations
bone
transdermal patches
pthrp
pthrp analog
Prior art date
Application number
BR112018007159A
Other languages
English (en)
Inventor
Harris Alan
Hamed Ehab
Hattersley Gary
Saeh Jamal
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
Application filed by 3M Innovative Properties Co, Radius Health Inc filed Critical 3M Innovative Properties Co
Publication of BR112018007159A2 publication Critical patent/BR112018007159A2/pt

Links

Classifications

    • 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, needleless injectors
    • 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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/635Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Toxicology (AREA)
  • Pain & Pain Management (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Medical Informatics (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

a presente invenção refere-se a formulações análogas pthrp para a administração transdérmica de uma quantidade terapeuticamente eficaz de um análogo pthrp bem como emplastros transdérmicos preparados usando estas formulações, métodos para preparar as formulações de acordo com a invenção e emplastros e métodos para usar estas formulações e emplastros para tratar osteoporose, osteopenia, osteoartrite e/ou fratura óssea , melhorar a densidade mineral óssea (dmo), para melhorar a pontuação do osso trabecular (tbs) e tratar, prevenir e/ou reduzir fraturas ósseas.
BR112018007159A 2015-10-09 2016-10-08 formulações de análogos de pthrp, emplastros transdérmicos dos mesmos e usos dos mesmos BR112018007159A2 (pt)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201562239773P 2015-10-09 2015-10-09
US201562239774P 2015-10-09 2015-10-09
US201562239801P 2015-10-09 2015-10-09
US201662324336P 2016-04-18 2016-04-18
US201662353249P 2016-06-22 2016-06-22
US201662396196P 2016-09-18 2016-09-18
PCT/US2016/056196 WO2017062922A1 (en) 2015-10-09 2016-10-08 Formulations of pthrp analogues, transdermal patches thereof, and uses thereof

Publications (1)

Publication Number Publication Date
BR112018007159A2 true BR112018007159A2 (pt) 2018-11-06

Family

ID=58488710

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018007159A BR112018007159A2 (pt) 2015-10-09 2016-10-08 formulações de análogos de pthrp, emplastros transdérmicos dos mesmos e usos dos mesmos

Country Status (22)

Country Link
US (1) US20190091138A1 (pt)
EP (2) EP3909566A1 (pt)
JP (3) JP6867379B2 (pt)
KR (1) KR20180067573A (pt)
CN (2) CN108697881A (pt)
AU (2) AU2016334378B2 (pt)
BR (1) BR112018007159A2 (pt)
CA (1) CA3000533C (pt)
CY (1) CY1124657T1 (pt)
DK (1) DK3359241T3 (pt)
ES (1) ES2881461T3 (pt)
HR (1) HRP20211127T1 (pt)
HU (1) HUE055658T2 (pt)
IL (2) IL287604B2 (pt)
LT (1) LT3359241T (pt)
MX (1) MX2018004192A (pt)
PL (1) PL3359241T3 (pt)
PT (1) PT3359241T (pt)
RS (1) RS62394B1 (pt)
SG (1) SG11201802871UA (pt)
SI (1) SI3359241T1 (pt)
WO (1) WO2017062922A1 (pt)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2927067T3 (es) * 2015-03-03 2022-11-02 Radius Health Inc Abaloparatida combinada con alendronato para la reducción de las fracturas óseas no vertebrales
WO2017184355A1 (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
CA3167644A1 (en) * 2017-09-22 2019-03-28 Asahi Kasei Pharma Corporation Teriparatide-containing liquid pharmaceutical composition having excellent pharmacokinetics and/or safety
CN107674113A (zh) * 2017-10-20 2018-02-09 广东医科大学 一种小分子活性肽及其制备方法、及采用该活性肽的透皮贴剂的制备方法与其用途
CN110054679B (zh) * 2018-01-18 2021-05-04 成都圣诺生物制药有限公司 一种合成Abaloparatide的方法
CN109602911B (zh) * 2019-01-09 2020-11-10 厦门大学 硫酸钙晶须或其组合物在制备皮肤促渗剂中的用途
WO2020174443A1 (en) 2019-02-28 2020-09-03 Radius Health, Inc. Transdermal system for the delivery of abaloparatide and method of use
WO2021051082A1 (en) * 2019-09-12 2021-03-18 Radius Health, Inc. Methods of improving spinal fusion with abaloparatide
WO2021149012A1 (en) 2020-01-24 2021-07-29 Radius Health, Inc. Methods of stimulating bone growth with abalopartide and denosumab
US20220378881A1 (en) * 2021-05-25 2022-12-01 Radius Health, Inc. Treatment and prevention of osteoporosis in high body mass index individuals
WO2023281447A1 (en) 2021-07-07 2023-01-12 Radius Health, Inc. Methods of treating a cardiovascular ischemic event
US11877848B2 (en) 2021-11-08 2024-01-23 Satio, Inc. Dermal patch for collecting a physiological sample
US11964121B2 (en) 2021-10-13 2024-04-23 Satio, Inc. Mono dose dermal patch for pharmaceutical delivery

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050032698A1 (en) * 2003-07-14 2005-02-10 Nps Allelix Corp. Stabilized formulation of parathyroid hormone
WO2007106597A2 (en) * 2006-03-15 2007-09-20 Alza Corporation Method for the transdermal delivery of parathyroid hormone agents for treating osteopenia
BRPI0719821B8 (pt) * 2006-10-03 2021-05-25 Ipsen Pharma Sas composição estável na armazenagem apropriada para administração a pacientes
WO2009054988A1 (en) * 2007-10-23 2009-04-30 Alza Corporation Transdermal sustained release drug delivery
CN102448482A (zh) * 2009-03-27 2012-05-09 范安德尔研究所 甲状旁腺素肽和甲状旁腺素相关蛋白肽及使用方法
KR101728194B1 (ko) * 2010-02-24 2017-05-02 히사미쓰 세이야꾸 가부시키가이샤 마이크로 니들 디바이스 및 그 제조 방법
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US20130006217A1 (en) * 2011-04-22 2013-01-03 Gary Hattersley METHOD OF DRUG DELIVERY FOR PTH, PTHrP AND RELATED PEPTIDES
CA2857502C (en) * 2011-11-30 2019-08-13 3M Innovative Properties Company Microneedle device including a peptide therapeutic agent and an amino acid and methods of making and using the same
CN102526220A (zh) * 2012-01-10 2012-07-04 上海市中医医院 一种治疗期前收缩的中药贴剂及其制备方法和应用
US9581438B2 (en) * 2012-12-31 2017-02-28 General Electric Company Systems and methods for control of a non-destructive testing system
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US10905744B2 (en) * 2015-10-07 2021-02-02 Cyprumed Gmbh Pharmaceutical formulations for the oral delivery of peptide drugs

Also Published As

Publication number Publication date
JP6867379B2 (ja) 2021-04-28
SG11201802871UA (en) 2018-05-30
DK3359241T3 (da) 2021-07-19
CN115025068A (zh) 2022-09-09
JP7146011B2 (ja) 2022-10-03
CY1124657T1 (el) 2022-07-22
CA3000533C (en) 2023-10-17
HUE055658T2 (hu) 2021-12-28
JP2021119141A (ja) 2021-08-12
WO2017062922A1 (en) 2017-04-13
JP2018536631A (ja) 2018-12-13
IL258441B (en) 2021-12-01
IL258441A (en) 2018-05-31
IL287604B2 (en) 2024-04-01
HRP20211127T1 (hr) 2021-10-15
EP3359241A1 (en) 2018-08-15
AU2016334378A1 (en) 2018-04-19
AU2016334378B2 (en) 2021-12-02
EP3359241B1 (en) 2021-04-14
EP3359241A4 (en) 2019-06-26
EP3909566A1 (en) 2021-11-17
PT3359241T (pt) 2021-07-21
IL287604B1 (en) 2023-12-01
SI3359241T1 (sl) 2021-11-30
KR20180067573A (ko) 2018-06-20
CN108697881A (zh) 2018-10-23
CA3000533A1 (en) 2017-04-13
US20190091138A1 (en) 2019-03-28
JP2022174274A (ja) 2022-11-22
PL3359241T3 (pl) 2021-12-20
RS62394B1 (sr) 2021-10-29
ES2881461T3 (es) 2021-11-29
AU2021269361A1 (en) 2021-12-16
IL287604A (en) 2021-12-01
LT3359241T (lt) 2021-10-11
MX2018004192A (es) 2018-09-26

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Legal Events

Date Code Title Description
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B25A Requested transfer of rights approved

Owner name: RADIUS HEALTH, INC. (US) ; KINDEVA DRUG DELIVERY L.P. (US)

B25L Entry of change of name and/or headquarter and transfer of application, patent and certificate of addition of invention: publication cancelled

Owner name: RADIUS HEALTH, INC. (US) ; 3M INNOVATIVE PROPERTIES COMPANY (US)

Free format text: ANULADA A PUBLICACAO CODIGO 25.1 NA RPI NO 2660 DE 28/12/2021 POR TER SIDO INDEVIDA.

B25G Requested change of headquarter approved

Owner name: RADIUS HEALTH, INC. (US) ; 3M INNOVATIVE PROPERTIES COMPANY (US)

B25A Requested transfer of rights approved

Owner name: RADIUS HEALTH, INC. (US) ; KINDEVA DRUG DELIVERY L.P. (US)