HRP20211880T1 - Sastavi i metode za liječenje i profilaksu infekcija kirurškog mjesta - Google Patents

Sastavi i metode za liječenje i profilaksu infekcija kirurškog mjesta Download PDF

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HRP20211880T1
HRP20211880T1 HRP20211880TT HRP20211880T HRP20211880T1 HR P20211880 T1 HRP20211880 T1 HR P20211880T1 HR P20211880T T HRP20211880T T HR P20211880TT HR P20211880 T HRP20211880 T HR P20211880T HR P20211880 T1 HRP20211880 T1 HR P20211880T1
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substrate
biodegradable
use according
matrix composition
surgery
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HRP20211880TT
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Noam Emanuel
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Polypid Ltd.
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/65Tetracyclines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/683Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/685Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00Preparations for dentistry
    • A61K6/80Preparations for artificial teeth, for filling teeth or for capping teeth
    • A61K6/849Preparations for artificial teeth, for filling teeth or for capping teeth comprising inorganic cements
    • 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
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/148Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/02Local antiseptics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution

Claims (17)

1. Biorazgradivi impregnirani supstrat ili čija je površina potpuno ili djelomično obložena matričnim sastavom koji sadrži (a) biorazgradivi poliestar, (b) prvu lipidnu komponentu koja sadrži najmanje jedan sterol koji je nekovalentno povezan s biorazgradivim poliestrom, (c) drugu lipidnu komponentu koja sadrži najmanje jedan fosfolipid koji ima dijelove masnih kiselina od najmanje 12 ugljika; i (d) antibiotsko sredstvo odabrano između doksiciklina i doksiciklin hiklata, za uporabu u liječenju ili profilaksi infekcije na mjestu incizije povezane s kirurškom operacijom kod subjekta kojem je to potrebno, pri čemu je supstrat mineralni supstrat oblikovan u obliku čestica.
2. Biorazgradivi supstrat za upotrebu sukladno patentnom zahtjevu 1, naznačen time, da infekcija uključuje površinsku incizijsku infekciju, infekciju dubokih incizija i infekciju organa/prostora.
3. Biorazgradivi supstrat za upotrebu sukladno patentnom zahtjevu 1, koristan za barem jedno smanjenja ukupne stope infekcije nakon operacije, iskorjenjivanja infekcija mekog tkiva koje mogu postojati prije operacije, inhibicije stvaranja biofilma na mjestu incizije i iskorjenjivanje postojećeg biofilma na mjestu incizije.
4. Biorazgradivi supstrat za upotrebu sukladno patentnim zahtjevima 1 do 3, gdje infekcija uključuje bolnički stečene rezistentne bakterije.
5. Biorazgradivi supstrat za upotrebu sukladno patentnim zahtjevima 1-4, naznačen time što je kirurška operacija odabrana između ortopedskih kirurških operacija, kirurških operacija na kralježnici, kirurških operacija na organu probavnog sustava, kardioloških zahvata, popravke kile, vaskularni zahvati, carskog reza, prostatektomije, opstetričke i ginekoloških kirurških operacija, kirurgije karcinoma glave i vrata, operacija transplantacije, neurokirurgije i plastičnih operacija.
6. Biorazgradivi mineralni supstrat za upotrebu sukladno patentnom zahtjevu 5, naznačen time da su kirurške operacije na organu probavnog sustava odabrane između jednjaka, želuca, tankog crijeva, debelog crijeva, rektuma, kolona, slijepog crijeva, jetre, gušterača, žučni mjehur, čira na želucu, zahvati protiv karcinoma želuca, otvorenog želučanog baypasa, apendektomije, kolektomije, holecistektomije, vagotomije, zahvati na otvorenom bilijarnom traktu, zahvati na tankom crijevu i kolorektalni zahvati.
7. Biorazgradivi supstrat za upotrebu sukladno patentnom zahtjevu 5, naznačen time da je kirurška operacija kardiološki kirurški zahvat, i pri čemu liječenje obuhvaća korak nanošenja obloženog supstrata na površinu sternalnih polovica i okolnog mekog tkiva.
8. Biorazgradivi supstrat za upotrebu sukladno bilo kojem od patentnih zahtjeva 1-7, za upotrebu u liječenju ili profilaksi infekcije mjesta incizije povezano s kirurškom operacijom kod subjekta kojem je to potrebno kao dodatak standardnim procedurama njege radi smanjenja bakterijskog inokuluma, odabranih iz skupine koju čine odgovarajuća priprema kirurškog mjesta, sustavni preventivni antibiotici, terapija zasnovana na stanicama i poboljšanje domaćina perioperativnom dodatnom oksigenacijom, održavanjem normotermije i kontrolom glikemije.
9. Biorazgradivi supstrat za upotrebu sukladno patentnim zahtjevima 1-8, naznačen time da je biorazgradivi supstrat odabranih iz skupine koju čine hidroksiapatit, fluorapatit, oksiapatit, volastonit, apatit/volastonit staklo keramika, anortit, kalcijev fluorid, kalcijev sulfat, kalcijev karbonat, tetrakalcijev fosfat, α-trikalcijev fosfat (α-TCP), β-trikalcijev fosfat (β-TCP), amorfni kalcijev fosfat, dikalcijev fosfat, agrelit, devitrit, kanazit, flogopit, monetit, brušit, oktokalcijev fosfat, vitlokit, kordierit, berlinit, kombeit, kristali fosforne kiseline, dinatrijev hidrogen fosfat i druga biokeramika na bazi fosfatne soli.
10. Biorazgradivi mineralni supstrat za upotrebu sukladno patentnom zahtjevu 9, naznačen time, da je supstrat trikalcijev fosfat odabran između α-trikalcijevog fosfata (α-TCP) i β-trikalcijevog fosfata (β-TCP).
11. Biorazgradivi supstrat za upotrebu sukladno bilo kojem od patentnih zahtjeva 1 do 9, naznačen time da sastav matriksa sadrži fosfolipid odabran od fosfatidilholina ili kombinacije fosfatidilkolina koji imaju ostatke masnih kiselina koje imaju najmanje 12 ugljika; poželjno gdje je navedeni fosfolipid fosfatidilkolin ili kombinacija fosfatidilkolina koji imaju ostatke masnih kiselina sa 14 - 18 ugljika.
12. Biorazgradivi supstrat za upotrebu sukladno bilo kojem od patentnih zahtjeva 1 do 11, naznačen time što je biorazgradivi poliester odabran iz skupine koju čine PLA (polimliječna kiselina), PGA (poliglikolna kiselina) i PLGA (poli (mliječna ko-glikolna kiselina).
13. Biorazgradivi supstrat za upotrebu sukladno bilo kojem od patentnih zahtjeva 1 do 12, naznačen time da matrični sastav nadalje sadrži farmaceutski aktivno sredstvo odabrano iz skupine sastavljene od antiseptičkog sredstva, antiupalnog sredstva, i antifungalnog sredstva; ili gdje matrični sastav sadrži mnoštvo antibiotskih sredstava; ili gdje matrični sastav nadalje sadrži najmanje jedno antiupalno sredstvo.
14. Biorazgradivi supstrat za upotrebu sukladno bilo kojem od patentnih zahtjeva 1-13, naznačen time da je sterol u matričnom sastavu kolesterol; poželjno gdje je težinski odnos ukupnih lipida prema navedenom biorazgradivom poliestru između 1:1 i 9:1 uključujući.
15. Biorazgradivi supstrat za upotrebu sukladno bilo kojem od patentnih zahtjeva, naznačen time da obloženi biorazgradivi supstrat sadrži između 60-90% (m/m) biorazgradivog supstrata i 10-40% (m/m) matričnog sastava, poželjno, gdje obloženi biorazgradivi supstrat sadrži između 70-90% (m/m) biorazgradivog supstrata i 10-30% (m/m) matričnog sastava.
16. Biorazgradivi supstrat za upotrebu sukladno bilo kojem od patentnih zahtjeva 1-15, naznačen time, da je navedeni matrični sastav u osnovi bez vode; poželjno pri čemu kada se obloženi biorazgradivi supstrat održava u vodenom okruženju, matrični sastav osigurava produženo oslobađanje navedenog antibiotskog sredstva, pri čemu se najmanje 30% navedenog antibiotskog sredstva oslobađa iz sastava kinetikom nultog reda.
17. Biorazgradivi supstrat za upotrebu sukladno patentnom zahtjevu 1, naznačen time, da matrični sastav sadrži: (a) 15-25% (m/m) poli (mliječne-ko-glikolne kiseline) (PLGA) (b) 5-15% (m/m) kolesterola; (c) 50-70% (m/m) smjese 1,2-dipalmitoil-sn-glicero-3-fosfoholina (DPPC) i l,2-distearoil-sn-glicero-3-fosfoholina (DSPC), pri čemu je odnos DPPC prema DSPC između 5:1 i 2:1 i (d) 7-12% (m/m) doksiciklina ili doksiciklin hiklata, pri čemu supstrat čini između 80-90% (m/m) i matrični sastav čini 10-20% (m/m) ukupne težine obloženog supstrata.
HRP20211880TT 2014-10-02 2015-09-27 Sastavi i metode za liječenje i profilaksu infekcija kirurškog mjesta HRP20211880T1 (hr)

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Application Number Priority Date Filing Date Title
US201462058809P 2014-10-02 2014-10-02
EP15846726.6A EP3200748B1 (en) 2014-10-02 2015-09-27 Compositions and methods for the treatment and prophylaxis of surgical site infections
PCT/IB2015/057409 WO2016051321A1 (en) 2014-10-02 2015-09-27 Compositions and methods for the treatment and prophylaxis of surgical site infections

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US (3) US20170246112A1 (hr)
EP (2) EP3200748B1 (hr)
JP (2) JP6899767B2 (hr)
KR (2) KR20230175331A (hr)
CN (2) CN106999356A (hr)
AU (1) AU2015326428B2 (hr)
BR (1) BR112017006406B1 (hr)
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EA (1) EA201790383A1 (hr)
ES (1) ES2900816T3 (hr)
HR (1) HRP20211880T1 (hr)
HU (1) HUE056523T2 (hr)
IL (1) IL251351B (hr)
LT (1) LT3200748T (hr)
MX (1) MX2017004318A (hr)
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PH (1) PH12017500569A1 (hr)
PL (1) PL3200748T3 (hr)
PT (1) PT3200748T (hr)
RS (1) RS62696B1 (hr)
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ES2900816T3 (es) 2022-03-18
PH12017500569A1 (en) 2017-08-30
EP4094783A1 (en) 2022-11-30
ZA201702884B (en) 2018-04-25
HUE056523T2 (hu) 2022-02-28
EP3200748A4 (en) 2018-05-23
SG10202012452UA (en) 2021-01-28
RS62696B1 (sr) 2022-01-31
CA2963370A1 (en) 2016-04-07
US20200268669A1 (en) 2020-08-27
JP2021063123A (ja) 2021-04-22
AU2015326428A1 (en) 2017-03-23
JP2017534585A (ja) 2017-11-24
JP6899767B2 (ja) 2021-07-07
EP3200748A1 (en) 2017-08-09
SI3200748T1 (sl) 2022-01-31
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