HRP20110444T1 - Formulacije paratiroidnih hormona i njihove uporabe - Google Patents

Formulacije paratiroidnih hormona i njihove uporabe Download PDF

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Publication number
HRP20110444T1
HRP20110444T1 HR20110444T HRP20110444T HRP20110444T1 HR P20110444 T1 HRP20110444 T1 HR P20110444T1 HR 20110444 T HR20110444 T HR 20110444T HR P20110444 T HRP20110444 T HR P20110444T HR P20110444 T1 HRP20110444 T1 HR P20110444T1
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HR
Croatia
Prior art keywords
composition according
poloxamer
composition
pth
hpth
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HR20110444T
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English (en)
Inventor
Loer Linderoth Dorte
Lindegaard Hansen Lars
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Nycomed Danmark Aps
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Publication of HRP20110444T1 publication Critical patent/HRP20110444T1/hr

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    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Farmaceutski sastav, naznačen time, da sadrži, kada je otopljen u pogodnom nosaču, PTH u koncentraciji od 1 mg/ml do 10 mg/ml, metionin dobavljen u koncentraciji od 1 mg/ml do 10 mg/ml, najmanje jedan poloksamerski surfaktant dobavljen u koncentraciji od 0,02 mg/ml do 1 mg/ml, i fiziološki prihvatljivo pufersko sredstvo koje održava pH formulacije na vrijednosti od pH 5 do 6,5. Patent sadrži još 18 patentnih zahtjeva.

Claims (19)

1. Farmaceutski sastav, naznačen time, da sadrži, kada je otopljen u pogodnom nosaču, PTH u koncentraciji od 1 mg/ml do 10 mg/ml, metionin dobavljen u koncentraciji od 1 mg/ml do 10 mg/ml, najmanje jedan poloksamerski surfaktant dobavljen u koncentraciji od 0,02 mg/ml do 1 mg/ml, i fiziološki prihvatljivo pufersko sredstvo koje održava pH formulacije na vrijednosti od pH 5 do 6,5.
2. Sastav prema zahtjevu 1, naznačen time, da je sastav u obliku stabilne formulacijske otopine.
3. Sastav prema zahtjevu 1 ili 2, naznačen time, da je najmanje jedan poloksamerski surfaktant odabran od Poloksamera 188, Poloksamera 407, Poloksamera 237, Poloksamera 338 i Poloksamera 124.
4. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da je PTH odabran od hPTH(1-84) i nehumane, PTH molekule sisavca, kao i biološki aktivne varijante i homologa od hPTH(1-84) i nehumanih, PTH molekula sisavca.
5. Sastav prema zahtjevu 4, naznačen time, da sastav uključuje biološki aktivni homolog od hPTH(1-84) koji dijeli identitet sekvence sa hPTH(1-84) najmanje 85%, poželjno kada biološki aktivan homolog dijeli identitet sekvence sa hPTH(1-85) najmanje 95%, a najbolje kada biološki aktivan homolog dijeli identitet sekvence sa hPTH(1-85) najmanje 98%.
6. Sastav prema bilo kojem zahtjevu 1 do 5, naznačen time, da sadrži PTH u koncentraciji od 1,4 mg/ml, metionin u koncentraciji od 2 mg/ml, poloksamer u koncentraciji od 0,3 mg/ml, i fiziološki prihvatljivo pufersko sredstvo koje održava pH formulacije na pH 5,5.
7. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da spomenuti sastav nadalje obuhvaća farmaceutski prihvatljivo otapalo.
8. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da je fiziološki prihvatljivo pufersko sredstvo odabrano od citrata, acetata, fosfata, TRIS (trometamina), arginina i karbonatnih pufera.
9. Sastav prema zahtjevu 8, naznačen time, da fiziološki prikladno pufersko sredstvo je ne-isparljivi puferski agens.
10. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da nadalje sadrži najmanje jedan tonični modifikator, posebno gdje je najmanje jedan tonični modifikator odabran od natrijevog klorida, sukroze i poliolskog ekscipijenta.
11. Sastav prema zahtjevu 10, naznačen time, da je poliolski ekscipijent odabran od sorbitola, glicerola i manitola.
12. Sastav prema bilo kojem zahtjevu 10 do 11, naznačen time, da najmanje jedan tonični modifikator ko-liofilizira sa ne-isparljivim puferskim sredstvom.
13. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da nadalje sadrži najmanje jedan farmaceutski prihvatljivi konzervans, a najbolje kada je najmanje jedan farmaceutski prihvatljivi konzervans odabran od kresola, benzilnog alkohola i EDTA.
14. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da nadalje sadrži najmanje jedan farmaceutski prihvatljivi stabilizator, a najbolje kada je najmanje jedan farmaceutski prihvatljivi stabilizator odabran od ksilitola, lizina, histidina i mikrokristalinične celuloze.
15. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da je spomenuti sastav prikladan za davanje pomoću injekcije.
16. Sastav prema bilo kojem od prethodnih zahtjeva, naznačen time, da je spomenuti sastav liofiliziran.
17. Postupak za pripremanje farmaceutskog sastava, naznačen time, da sadrži korake ponovnog dobivanja sastava prema zahtjevu 16 u otopini sa farmaceutski prihvatljivim nosačem.
18. Sastav prema bilo kojem zahtjevu 1 do 16, naznačen time, da se koristi kao lijek.
19. Sastav prema bilo kojem zahtjevu 1 do 16, naznačen time, da se koristi kao lijek za liječenje ili prevenciju osteoporoze.
HR20110444T 2007-10-26 2011-06-14 Formulacije paratiroidnih hormona i njihove uporabe HRP20110444T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US99606107P 2007-10-26 2007-10-26
EP07021017A EP2052736A1 (en) 2007-10-26 2007-10-26 Parathyroid hormone formulations und uses thereof
PCT/EP2008/009069 WO2009053106A1 (en) 2007-10-26 2008-10-27 Parathyroid hormone formulations and uses thereof

Publications (1)

Publication Number Publication Date
HRP20110444T1 true HRP20110444T1 (hr) 2011-08-31

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Family Applications (1)

Application Number Title Priority Date Filing Date
HR20110444T HRP20110444T1 (hr) 2007-10-26 2011-06-14 Formulacije paratiroidnih hormona i njihove uporabe

Country Status (15)

Country Link
EP (2) EP2052736A1 (hr)
AT (1) ATE501725T1 (hr)
CY (1) CY1112106T1 (hr)
DE (1) DE602008005643D1 (hr)
DK (1) DK2219665T3 (hr)
ES (1) ES2363272T3 (hr)
HK (1) HK1146465A1 (hr)
HR (1) HRP20110444T1 (hr)
MX (1) MX2010004388A (hr)
PL (1) PL2219665T3 (hr)
PT (1) PT2219665E (hr)
RU (1) RU2467762C2 (hr)
SI (1) SI2219665T1 (hr)
WO (1) WO2009053106A1 (hr)
ZA (1) ZA201002812B (hr)

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EP2709645B1 (en) * 2011-05-18 2023-08-09 Eumederis Pharmaceuticals, Inc. Improved peptide pharmaceuticals
EP2785327B1 (en) 2011-11-30 2023-11-22 Kindeva Drug Delivery L.P. Microneedle device having a peptide therapeutic agent and an amino acid, methods of making and using the same
US10591472B2 (en) 2012-08-13 2020-03-17 Minicare B.V. Use of antioxidants in methods and means for detection of target molecules in a blood sample
RU2737496C2 (ru) 2015-04-29 2020-12-01 Радиус Фармасьютикалз, Инк. Способы лечения рака
GB201602880D0 (en) 2016-02-18 2016-04-06 Ge Healthcare Uk Ltd Method and composition for biomolecule stabilization
CN115025239A (zh) 2016-03-01 2022-09-09 阿森迪斯药物骨疾病股份有限公司 Pth前药
AU2017336251B2 (en) 2016-09-29 2024-02-22 Ascendis Pharma Bone Diseases A/S PTH compounds with low peak-to-trough ratios
AU2017336249B2 (en) 2016-09-29 2024-08-01 Ascendis Pharma Bone Diseases A/S Dosage regimen for a controlled-release PTH compound
FI3565542T3 (fi) 2017-01-05 2024-06-24 Radius Pharmaceuticals Inc Rad1901-2hcl:n polymorfisia muotoja
EP3685849A4 (en) * 2017-09-22 2021-12-22 Asahi Kasei Pharma Corporation LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TRIPARATIDE WITH EXCELLENT STABILITY
US11643385B2 (en) 2018-07-04 2023-05-09 Radius Pharmaceuticals, Inc. Polymorphic forms of RAD1901-2HCl
WO2020028011A1 (en) * 2018-07-30 2020-02-06 Shire-Nps Pharmaceuticals Inc. Formulations for improved stability of recombinant human parathyroid hormone
WO2020165087A1 (en) * 2019-02-11 2020-08-20 Ascendis Pharma Bone Diseases A/S Liquid pharmaceutical formulations of pth conjugates
CN112439054B (zh) * 2019-08-28 2023-05-16 深圳翰宇药业股份有限公司 一种特立帕肽缓释凝胶注射液及其制备方法
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
CN113101275A (zh) * 2021-05-27 2021-07-13 海南通用康力制药有限公司 注射用棓丙酯冻干粉针剂及其制备方法

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ZA966075B (en) * 1995-07-27 1998-01-19 Genentech Inc Protein formulation.
WO2004075913A1 (ja) * 2003-02-28 2004-09-10 Chugai Seiyaku Kabushiki Kaisha タンパク質含有安定化製剤
WO2005051456A2 (en) * 2003-11-13 2005-06-09 Alza Corporation Composition and apparatus for transdermal delivery
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US8093207B2 (en) * 2005-12-09 2012-01-10 Unigene Laboratories, Inc. Fast-acting oral peptide pharmaceutical products

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Publication number Publication date
RU2467762C2 (ru) 2012-11-27
HK1146465A1 (en) 2011-06-10
ES2363272T3 (es) 2011-07-28
DE602008005643D1 (de) 2011-04-28
EP2219665A1 (en) 2010-08-25
SI2219665T1 (sl) 2011-09-30
ATE501725T1 (de) 2011-04-15
EP2219665B1 (en) 2011-03-16
CY1112106T1 (el) 2015-11-04
RU2010121165A (ru) 2011-12-10
ZA201002812B (en) 2011-12-28
EP2052736A1 (en) 2009-04-29
DK2219665T3 (da) 2011-06-27
WO2009053106A1 (en) 2009-04-30
PT2219665E (pt) 2011-06-29
PL2219665T3 (pl) 2011-11-30
MX2010004388A (es) 2010-08-10

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