HRP20231142T3 - Kontrolirano oslobađanje 25-hidroksivitamina d - Google Patents

Kontrolirano oslobađanje 25-hidroksivitamina d

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Publication number
HRP20231142T3
HRP20231142T3 HRP20231142TT HRP20231142T HRP20231142T3 HR P20231142 T3 HRP20231142 T3 HR P20231142T3 HR P20231142T T HRP20231142T T HR P20231142TT HR P20231142 T HRP20231142 T HR P20231142T HR P20231142 T3 HRP20231142 T3 HR P20231142T3
Authority
HR
Croatia
Prior art keywords
hydroxyvitamin
treatment process
process according
pharmaceutical preparation
patient
Prior art date
Application number
HRP20231142TT
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English (en)
Inventor
Charles W. Bishop
Samir P. Tabash
Sammy A. Agudoawu
Jay A. White
Keith H. Crawford
Eric J. Messner
P. Martin Petkovich
Original Assignee
Eirgen Pharma Ltd.
Opko Renal, Llc
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 Eirgen Pharma Ltd., Opko Renal, Llc filed Critical Eirgen Pharma Ltd.
Publication of HRP20231142T3 publication Critical patent/HRP20231142T3/hr

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
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    • 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

Claims (18)

1. Farmaceutski pripravak koji sadrži oralnu formulaciju 25-hidroksivitamina D3 za uporabu u postupku liječenja sekundarnog hiperparatireoidizma kod ljudskog pacijenata koji ima kroničnu bolest bubrega, naznačen time što postupak liječenja sadrži davanje pripravka pacijentu, pri čemu se pacijent liječi bez izazivanja suprafizioloških valova u razinama 25-hidroksivitamina D3u krvi, i pri čemu farmaceutski pripravak sadrži 25-hidroksivitamin D3 zajedno sa sredstvom za modificiranje otpuštanja koje kontrolira brzinu otpuštanja spoja vitamina D iz oblika doziranja da se smanji Cmax i/ili odgodi Tmax i/ili smanji Cmax24hr/C24hr.
2. Farmaceutski pripravak za uporabu u postupku liječenja prema zahtjevu 1 naznačen time što pacijent ima stadij 3 ili stadij 4 kronične bolesti bubrega.
3. Farmaceutski pripravak za uporabu u postupku liječenja prema zahtjevu 1 ili 2 naznačen time što pacijent ima kroničnu bolest bubrega povezanu s brzinom glomerularne filtracije ispod 60 ml/min/1.73 m2.
4. Farmaceutski pripravak za uporabu u postupku liječenja prema bilo kojem od prethodnih zahtjeva naznačen time što pacijent kojeg treba liječiti ima niske ukupne razine 25-hidroksivitamina D u serumu na početku liječenja.
5. Farmaceutski pripravak za uporabu u postupku liječenja prema zahtjevu 4, naznačen time što pacijent kojeg treba liječiti ima ukupnu razinu 25-hidroksivitamina D u serumu manju od 30 ng/mL na početku liječenja.
6. Farmaceutski pripravak za uporabu u postupku liječenja prema zahtjevu 4 ili 5, naznačen time što postupak liječenja sadrži davanje pripravka pacijentu tako da se insuficijencija i/ili nedostatak 25-hidroksivitamina D kod pacijenta liječi bez izazivanja suprafizioloških valova u razinama 25-hidroksivitamina D3 u krvi.
7. Farmaceutski pripravak za uporabu u postupku liječenja prema bilo kojem od prethodnih zahtjeva naznačen time što je pacijent odrasli čovjek.
8. Farmaceutski pripravak za uporabu u postupku liječenja prema bilo kojem od prethodnih zahtjeva naznačen time što je sredstvo za modificiranje otpuštanja crijevna ovojnica.
9. Farmaceutski pripravak za uporabu u postupku liječenja prema bilo kojem od prethodnih zahtjeva naznačen time što u postupku liječenja: (a) maksimalna koncentracija 25-hidroksivitamina D3 u serumu u intervalu doziranja (Cmax) je smanjena u usporedbi s Cmax za ekvivalentnu količinu 25-hidroksivitamina D3 primijenjenu bolus IV injekcijom i/ili oralnim oblikom doziranja, s trenutnim oslobađanjem, ili (b) omjer maksimalne koncentracije u serumu unutar 24 sata nakon primjene 25-hidroksivitamina D3 i koncentracije 24 sata nakon primjene (Cmax24h/C24h) smanjen je u usporedbi s Cmax24h /C24h, za ekvivalentnu količinu od 25-hidroksivitamina D3 primijenjenog bolus IV injekcijom i/ili oralnim oblikom doziranja, s trenutnim oslobađanjem, ili (c) vrijeme u kojem koncentracija 25-hidroksivitamina D3 u plazmi dosegne svoj maksimum u intervalu doziranja nakon primjene (Tmax) je povećano u usporedbi s Tmaxom za ekvivalentnu količinu 25-hidroksivitamina D3 primijenjenog bolus IV injekcijom i/ili oralnim oblikom doziranja, s trenutačnim oslobađanjem.
10. Farmaceutski pripravak za uporabu u postupku liječenja prema zahtjevu 9, naznačen time što je Cmax smanjen za faktor od najmanje 20%.
11. Farmaceutski pripravak za uporabu u postupku liječenja prema zahtjevu 9, naznačen time što je Tmax povećan za faktor od najmanje 25%.
12. Farmaceutski pripravak za uporabu u postupku liječenja prema zahtjevu 9, naznačen time što je Cmax24hr/C24h smanjen za faktor od najmanje 20%.
13. Farmaceutski pripravak za uporabu u postupku liječenja prema bilo kojem od prethodnih zahtjeva, naznačen time što se 25-hidroksivitamin D3 oralno primjenjuje u količinama doziranja od 1 do 100 µg, poželjno od 5 do 100 µg dnevno.
14. Farmaceutski pripravak za uporabu u postupku liječenja prema bilo kojem od prethodnih zahtjeva, naznačen time što se 25-hidroksivitamin D3 oralno primjenjuje u količinama doziranja od 200 do 400 µg.
15. Farmaceutski pripravak za uporabu u postupku liječenja prema bilo kojem od prethodnih zahtjeva, naznačen time što se 25-hidroksivitamin D3 oralno primjenjuje u količinama doziranja od 5 do 80 µg, poželjno od 30 do 80 µg, poželjnije od 30 µg do 60 µg.
16. Farmaceutski pripravak za uporabu u postupku liječenja prema zahtjevu 15, naznačen time što se 25-hidroksivitamin D3 oralno primjenjuje u količini doziranja od 10 µg.
17. Farmaceutski pripravak za uporabu u postupku liječenja prema zahtjevu 15 naznačen time što se 25-hidroksivitamin D3 oralno primjenjuje u količini doziranja od 30 ili 60 µg.
18. Farmaceutski pripravak za uporabu u postupku liječenja prema bilo kojem od zahtjeva 13 do 17, naznačen time što se 25-hidroksivitamin D3 oralno primjenjuje jednom dnevno.
HRP20231142TT 2007-04-25 2008-04-25 Kontrolirano oslobađanje 25-hidroksivitamina d HRP20231142T3 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US91385307P 2007-04-25 2007-04-25
EP19172946.6A EP3542792B1 (en) 2007-04-25 2008-04-25 Controlled release 25-hydroxyvitamin d

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HRP20231142T3 true HRP20231142T3 (hr) 2024-01-05

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US (8) US8361488B2 (hr)
EP (6) EP3542792B1 (hr)
JP (4) JP5501956B2 (hr)
KR (6) KR20190028822A (hr)
CN (2) CN104523707B (hr)
CA (2) CA2943032C (hr)
DK (3) DK3342405T3 (hr)
ES (4) ES2956794T3 (hr)
HK (4) HK1142013A1 (hr)
HR (1) HRP20231142T3 (hr)
HU (1) HUE063590T2 (hr)
NO (1) NO2020043I1 (hr)
PL (3) PL3542792T3 (hr)
PT (3) PT2481400E (hr)
SI (2) SI2481400T1 (hr)
WO (1) WO2008134512A1 (hr)

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