HRP20200072T1 - Načini doziranja za spojeve klase ehinokandina - Google Patents

Načini doziranja za spojeve klase ehinokandina Download PDF

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Publication number
HRP20200072T1
HRP20200072T1 HRP20200072TT HRP20200072T HRP20200072T1 HR P20200072 T1 HRP20200072 T1 HR P20200072T1 HR P20200072T T HRP20200072T T HR P20200072TT HR P20200072 T HRP20200072 T HR P20200072T HR P20200072 T1 HRP20200072 T1 HR P20200072T1
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Croatia
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aqueous solution
pharmaceutically acceptable
acceptable salt
compound
subject
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HRP20200072TT
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English (en)
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Balasingam Radhakrishnan
Kenneth Duke James
Anuradha VAIDYA
Karen Polowy
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Cidara Therapeutics, Inc.
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Publication of HRP20200072T1 publication Critical patent/HRP20200072T1/hr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • 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
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • 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
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics

Claims (11)

1. Vodena otopina koja sadrži spoj 22 koji ima formulu ili njenu farmaceutski prihvatljivu sol za upotrebu u postupku liječenja gljivične infekcije kod subjekta, gdje se spomenuta vodena otopina daje subjektu u obliku intravenozne infuzije, intravenoznog bolusa ili gdje se spomenuta vodena otopina daje potkožno, u količini koja je dovoljna za liječenje spomenute gljivične infekcije, i gdje se spomenuta vodena otopina daje u intervalu od jedne doze tjedno.
2. Vodena otopina koja sadrži spoj 22 ili njenu farmaceutski prihvatljivu sol za upotrebu kao što je zahtijevano u zahtjevu 1, gdje spomenuta vodena otopina sadrži od 25 mg/mL do 500 mg/mL spoja 22, ili njegove farmaceutski prihvatljive soli.
3. Vodena otopina koja sadrži spoj 22 ili njegovu farmaceutski prihvatljivu sol za upotrebu kao što je zahtijevano u zahtjevu 1, gdje se spomenuta vodena otopina daje subjektu u obliku intravenozne infuzije.
4. Vodena otopina koja sadrži spoj 22 ili njegovu farmaceutski prihvatljivu sol za upotrebu kao što je zahtijevano u zahtjevu 1, gdje se spomenuta vodena otopina daje subjektu u obliku intravenoznog bolusa.
5. Vodena otopina koja sadrži spoj 22 ili njegovu farmaceutski prihvatljivu sol za upotrebu kao što je zahtijevano u zahtjevu 1, gdje se spomenuta vodena otopina daje potkožno.
6. Vodena otopina koja sadrži spoj 22 ili njegovu farmaceutski prihvatljivu sol za upotrebu kao što je zahtijevano u bilo kojem od zahtjeva 1-5, gdje spomenuti postupak dalje uključuje pripremanje vodene otopine rekonstituiranjem liofiliziranog praha koji uključuje spoj 22 ili njegovu farmaceutski prihvatljivu sol.
7. Vodena otopina koja sadrži spoj 22 ili njegovu farmaceutski prihvatljivu sol za upotrebu kao što je zahtijevano u bilo kojem od zahtjeva 1-6, gdje se spoj 22 ili njegova farmaceutski prihvatljiva sol daje u farmaceutskom sastavu.
8. Vodena otopina koja sadrži spoj 22 ili njegovu farmaceutski prihvatljivu sol za upotrebu kao što je zahtijevano u bilo kojem od zahtjeva 1-5, gdje je farmaceutski prihvatljiva sol spoja 22 acetatna sol.
9. Komplet koji sadrži (i) jedinični dozni oblik koji sadrži liofilizirani prah koji sadrži spoj 22 koji ima formulu kao što je definirano u zahtjevu 1, ili njegovu farmaceutski prihvatljivu sol, i (ii) uputstva za rekonstituiranje liofiliziranog praha s vodenom otopinom da se formira farmaceutski sastav pogodan za ubrizgavanje u subjekt.
10. Farmaceutski sastav u jediničnom doznom obliku ili (A) koji sadrži od 1 mL do 10 mL vodene otopine koja sadrži od 25 mg/mL do 500 mg/mL spoja 22, ili njegovu farmaceutski prihvatljivu sol, gdje je navedeni jedinični dozni oblik pogodan za intravenozno bolus ubrizgavanje u subjekt, i gdje se spomenuta vodena otopina priprema rekonstituiranjem injektabilnog sastava od liofiliziranog praha koji sadrži spoj 22, ili njegovu farmaceutski prihvatljivu sol, ili (B) koji sadrži od 0,05 mL do 1,0 mL vodene otopine koja sadrži od 100 mg/mL do 250 mg/mL spoja 22, ili njegovu farmaceutski prihvatljivu sol, gdje je spomenuti jedinični dozni oblik pogodan za subkutano ubrizgavanje u subjekt, i gdje se spomenuta vodena otopina priprema rekonstituiranjem injektabilnog sastava od liofiliziranog praha koji sadrži spoj 22, ili njegovu farmaceutski prihvatljivu sol, gdje spoj 22 ima formulu
11. Farmaceutski sastav prema zahtjevu 10, gdje spomenuta vodena otopina sadrži pufer.
HRP20200072TT 2012-03-19 2020-01-17 Načini doziranja za spojeve klase ehinokandina HRP20200072T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201261612676P 2012-03-19 2012-03-19
US201261707142P 2012-09-28 2012-09-28
PCT/US2013/031678 WO2013142279A1 (en) 2012-03-19 2013-03-14 Dosing regimens for echinocandin class compounds
EP13764974.5A EP2827710B1 (en) 2012-03-19 2013-03-14 Dosing regimens for echinocandin class compounds

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HRP20200072T1 true HRP20200072T1 (hr) 2020-04-03

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HRP20231151TT HRP20231151T1 (hr) 2012-03-19 2013-03-14 Režimi za doziranje spojeva iz klase ehinokandina
HRP20200072TT HRP20200072T1 (hr) 2012-03-19 2020-01-17 Načini doziranja za spojeve klase ehinokandina

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US (4) US9526835B2 (hr)
EP (2) EP3677252B1 (hr)
JP (3) JP6117907B2 (hr)
KR (2) KR102236462B1 (hr)
CN (2) CN104507309B (hr)
AU (4) AU2013235512B2 (hr)
CA (1) CA2867132A1 (hr)
CY (1) CY1122786T1 (hr)
DK (2) DK3677252T3 (hr)
ES (2) ES2957620T3 (hr)
FI (1) FI3677252T3 (hr)
HK (2) HK1206202A1 (hr)
HR (2) HRP20231151T1 (hr)
HU (2) HUE063336T2 (hr)
IL (3) IL234505A (hr)
LT (2) LT3677252T (hr)
MX (1) MX2014011299A (hr)
PL (2) PL2827710T3 (hr)
PT (2) PT2827710T (hr)
RS (2) RS59960B1 (hr)
RU (1) RU2639483C2 (hr)
SI (2) SI2827710T1 (hr)
WO (1) WO2013142279A1 (hr)

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