HRP20161376T1 - Emulzije ili mikroemulzije za uporabu u endoskopskoj mukoznoj resekciji i/ili endoskopskoj submukoznoj disekciji - Google Patents

Emulzije ili mikroemulzije za uporabu u endoskopskoj mukoznoj resekciji i/ili endoskopskoj submukoznoj disekciji Download PDF

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HRP20161376T1
HRP20161376T1 HRP20161376TT HRP20161376T HRP20161376T1 HR P20161376 T1 HRP20161376 T1 HR P20161376T1 HR P20161376T T HRP20161376T T HR P20161376TT HR P20161376 T HRP20161376 T HR P20161376T HR P20161376 T1 HRP20161376 T1 HR P20161376T1
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emulsion
pharmaceutical preparation
poloxamer
oil
microemulsion according
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HRP20161376TT
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English (en)
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Luigi Maria Longo
Luigi Moro
Enrico Frimonti
Alessandro Repici
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Cosmo Technologies Ltd
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Publication of HRP20161376T1 publication Critical patent/HRP20161376T1/hr

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    • 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
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/06Organic 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
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/001Preparation for luminescence or biological staining
    • A61K49/006Biological staining of tissues in vivo, e.g. methylene blue or toluidine blue O administered in the buccal area to detect epithelial cancer cells, dyes used for delineating tissues during surgery
    • 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
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/0005Ingredients of undetermined constitution or reaction products thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001Use of materials characterised by their function or physical properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/046Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/442Colorants, dyes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/06Flowable or injectable implant compositions

Claims (15)

1. Farmaceutski pripravak u obliku emulzije ili mikroemulzije, koji je u tekućoj fazi na temperaturi do oko 40°C in vitro, a koji sadrži: a) vodenu fazu; b) uljnu fazu; c) barem jednu ne-ionsku površinski aktivnu tvar (surfaktant); d) barem jedan poloksamer u količini između 5% i 12% težine, s obzirom na težinu pripravka; e) po izboru barem jednu fiziološki prikladnu pomoćnu tvar; f) barem jednu boju odabranu između Lugolove otopine, metilenskog modrila, toluidin plave, kristal violet, indigo karmin, kongo crvene i fenol crvene.
2. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 1, gdje je taj pripravak emulzija ili mikroemulzija ulje-u-vodi.
3. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 1, gdje taj pripravak ima viskoznost nižu od oko 0,15 Pa·s (150 cP), poželjno nižu od oko 0,1 Pa·s (100 cP), poželjnije nižu od oko 0,05 Pa·s (50 cP), još poželjnije nižu od oko 0,02 Pa·s (20 cP).
4. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 3, gdje se ta viskoznost mjeri na oko 25°C, oko 30°C i/ili oko 37°C.
5. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 1, gdje je taj barem jedan poloksamer u količini između oko 5% i oko 11 % težine, s obzirom na težinu pripravka.
6. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 1, gdje je taj barem jedan poloksamer u količini od oko 7%, oko 8%, oko 9% ili oko 10% težine, s obzirom na težinu pripravka.
7. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 1, gdje se taj barem jedan poloksamer odabire između poloksamer 124, poloksamer 188, poloksamer 237, poloksamer 338, i poloksamer 407.
8. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 7, gdje taj barem jedan poloksamer jest poloksamer 188.
9. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 8, gdje je poloksamer 188 u količini od oko 10% težine, s obzirom na težinu pripravka.
10. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 1, gdje ta uljna faza sadrži barem jedan lipofilni spoj.
11. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 10, gdje se taj barem jedan lipofilni spoj odabire između prirodnih ulja, kao što su bademovo ulje, kanola ulje, ricinusovo ulje, kukuruzno ulje, pamučno ulje, maslinovo ulje, ulje šafranike, sezamovo ulje, sojino ulje; estera masnih kiselina, kao što su izopropil palmitat, izopropil miristat, etil oleat; masnih alkohola, kao što su miristinski alkohol, oleinski alkohol; masnih kiselina, kao što su miristinska kiselina, oleinska kiselina, palmitinska kiselina; triglicerida, kao što su dugolančani i/ili srednjelančani trigliceridi; diglicerida i monoglicerida.
12. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 10, gdje je taj barem jedan lipofilni spoj srednjelančani triglicerid.
13. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 1, gdje se taj ne-ionski surfaktant odabire između polisorbata 80 i PEG-15 hidroksistearata.
14. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema bilo kojem od prethodnih zahtjeva, koji dalje sadrži barem jedan ko-surfaktant.
15. Farmaceutski pripravak u obliku emulzije ili mikroemulzije prema zahtjevu 14, gdje se taj barem jedan ko-surfaktant odabire između propilen glikola, glicerola i natrijevog oleata.
HRP20161376TT 2013-11-20 2016-10-21 Emulzije ili mikroemulzije za uporabu u endoskopskoj mukoznoj resekciji i/ili endoskopskoj submukoznoj disekciji HRP20161376T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT001924A ITMI20131924A1 (it) 2013-11-20 2013-11-20 Emulsions or microemulsions for use in endoscopic mucosal resectioning and/or endoscopic submucosal dissection emulsioni o microemulsioni per uso nella resezione mucosale endoscopica e/o dissezione submucosale endoscopica
EP14799474.3A EP2911707B1 (en) 2013-11-20 2014-11-18 Emulsions or microemulsions for use in endoscopic mucosal resectioning and/or endoscopic submucosal dissection
PCT/EP2014/074886 WO2015075024A1 (en) 2013-11-20 2014-11-18 Emulsions or microemulsions for use in endoscopic mucosal resectioning and/or endoscopic submucosal dissection.

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HRP20161376T1 true HRP20161376T1 (hr) 2016-12-02

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HRP20161376TT HRP20161376T1 (hr) 2013-11-20 2016-10-21 Emulzije ili mikroemulzije za uporabu u endoskopskoj mukoznoj resekciji i/ili endoskopskoj submukoznoj disekciji
HRP20210048TT HRP20210048T1 (hr) 2013-11-20 2021-01-12 Emulzije ili mikroemulzije namijenjene upotrebi u endoskopskoj resekciji sluznice i/ili endoskopskoj sekciji podsluznice

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US (7) US9226996B2 (hr)
EP (2) EP2911707B1 (hr)
JP (2) JP6675981B2 (hr)
KR (1) KR102398802B1 (hr)
CN (2) CN110665047B (hr)
AU (1) AU2014352009B2 (hr)
BR (1) BR112016011345B1 (hr)
CA (1) CA2929911C (hr)
DK (2) DK2911707T3 (hr)
ES (2) ES2602964T3 (hr)
HK (1) HK1210972A1 (hr)
HR (2) HRP20161376T1 (hr)
HU (2) HUE052870T2 (hr)
IL (1) IL245118B (hr)
IT (1) ITMI20131924A1 (hr)
LT (2) LT2911707T (hr)
MX (2) MX2016006581A (hr)
NZ (1) NZ720148A (hr)
PL (2) PL3106182T3 (hr)
PT (2) PT2911707T (hr)
RS (2) RS61290B1 (hr)
RU (1) RU2696263C1 (hr)
WO (1) WO2015075024A1 (hr)
ZA (1) ZA201603313B (hr)

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