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HRP20140981T4 - Viskoelastični gelovi kao nova punila - Google Patents

Viskoelastični gelovi kao nova punila Download PDF

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Publication number
HRP20140981T4
HRP20140981T4 HRP20140981TT HRP20140981T HRP20140981T4 HR P20140981 T4 HRP20140981 T4 HR P20140981T4 HR P20140981T T HRP20140981T T HR P20140981TT HR P20140981 T HRP20140981 T HR P20140981T HR P20140981 T4 HRP20140981 T4 HR P20140981T4
Authority
HR
Croatia
Prior art keywords
hbc
acp
mixing
temperature
solution
Prior art date
Application number
HRP20140981TT
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English (en)
Inventor
Matteo D'este
Renier Davide
Original Assignee
Fidia Farmaceutici S.P.A.
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.)
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42046298&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20140981(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Fidia Farmaceutici S.P.A. filed Critical Fidia Farmaceutici S.P.A.
Publication of HRP20140981T1 publication Critical patent/HRP20140981T1/hr
Publication of HRP20140981T8 publication Critical patent/HRP20140981T8/hr
Publication of HRP20140981T2 publication Critical patent/HRP20140981T2/hr
Publication of HRP20140981T4 publication Critical patent/HRP20140981T4/hr

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Classifications

    • 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/26Mixtures of macromolecular compounds
    • 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/52Hydrogels or hydrocolloids
    • 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/10Anti-acne agents
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0003General processes for their isolation or fractionation, e.g. purification or extraction from biomass
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/006Heteroglycans, i.e. polysaccharides having more than one sugar residue in the main chain in either alternating or less regular sequence; Gellans; Succinoglycans; Arabinogalactans; Tragacanth or gum tragacanth or traganth from Astragalus; Gum Karaya from Sterculia urens; Gum Ghatti from Anogeissus latifolia; Derivatives thereof
    • C08B37/0063Glycosaminoglycans or mucopolysaccharides, e.g. keratan sulfate; Derivatives thereof, e.g. fucoidan
    • C08B37/0072Hyaluronic acid, i.e. HA or hyaluronan; Derivatives thereof, e.g. crosslinked hyaluronic acid (hylan) or hyaluronates
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00Processes of treating or compounding macromolecular substances
    • C08J3/005Processes for mixing polymers
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00Processes of treating or compounding macromolecular substances
    • C08J3/02Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques
    • C08J3/03Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques in aqueous media
    • C08J3/075Macromolecular gels
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00Processes of treating or compounding macromolecular substances
    • C08J3/12Powdering or granulating
    • C08J3/14Powdering or granulating by precipitation from solutions
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00Processes of treating or compounding macromolecular substances
    • C08J3/24Crosslinking, e.g. vulcanising, of macromolecules
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L5/00Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
    • C08L5/08Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives 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
    • 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
    • A61L2300/402Anaestetics, analgesics, e.g. lidocaine
    • 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
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602Type of release, e.g. controlled, sustained, slow
    • 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/34Materials or treatment for tissue regeneration for soft tissue reconstruction
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2305/00Characterised by the use of polysaccharides or of their derivatives not provided for in groups C08J2301/00 or C08J2303/00
    • C08J2305/08Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2205/00Polymer mixtures characterised by other features
    • C08L2205/02Polymer mixtures characterised by other features containing two or more polymers of the same C08L -group

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Health & Medical Sciences (AREA)
  • Polymers & Plastics (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Biochemistry (AREA)
  • Materials Engineering (AREA)
  • Biomedical Technology (AREA)
  • Sustainable Development (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Materials For Medical Uses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Addition Polymer Or Copolymer, Post-Treatments, Or Chemical Modifications (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Claims (4)

1. Postupak miješanja ACP s HBC koji je proveden u postupku koji obuhvaća sljedeće korake: a. otapanje u alkalnoj otopini diepoksida BDDE u stehiometrijskom omjeru od 2.5 do 25% u molovima prema ponavljajućim jedinicama hialuronske kiseline, nakon čega slijedi b. disperzija hialuronske kiseline (HA) u otopini navedenoj u paragrafu a), pri sobnoj temperaturi, c. poticanje reakcije aktivacijom toplinom, zagrijavanjem otopine navedene u paragrafu b) pri temperaturi između 35 i 55 °C kroz između 2 i 36 sati, d. ekstruzija dobivene mase preko metalnog sita da se čestice smanje na veličinu od približno 600 µm. e. hidratacija dobivenog gela razrijeđivanjem vodom 3 do 20 puta, f. podešavanje pH vodenom otopinom HCl do neutralnog, g. taloženje organskim otapalom topljivim u vodi do dobivanja produkta u obliku praška, h. pranje organskim otapalima koji sadrže vodu, i. sušenje u vakuumu da se otapalo eliminira i njegov sadržaj bude ispod 400 ppm te nastane praškasti HBC, pri čemu postupak miješanja obuhvaća sljedeće korake: j. miješanje praškastog ACP s praškastim HBC u ACP: HBC omjer je između 90:10 i 10:90, k. hidratacija otopinom soli ili fosfatnim puferom, tako da ukupna koncentracija HA bude između 12 i 27 mg/mL, l. ekstruzija pri temperaturi između 25 i 65 °C kroz sito veličine otvora između 50 i 500 µm, m. punjenje injekcije, n. sterilizacija toplinom sa zasićenom vodenom parom pri temperaturi između 120 i 124 °C najmanje 10 minuta.
2. Postupak miješanja ACP s HBC koji je proveden u postupku koji obuhvaća sljedeće korake: a. otapanje u alkalnoj otopini diepoksida BDDE u stehiometrijskom omjeru od 2.5 do 25% u molovima prema ponavljajućim jedinicama hialuronske kiseline, nakon čega slijedi b. disperzija hialuronske kiseline (HA) u otopini navedenoj u paragrafu a), pri sobnoj temperaturi, c. poticanje reakcije aktivacije toplinom, zagrijavanjem otopine navedene u paragrafu b) pri temperaturi između 35 i 55 °C kroz između 2 i 36 sati, d. podešavanje pH vodenom otopinom HCl do neutralnog, e. hidratacija dobivenog gela razrijeđivanjem vodom 3 do 20 puta, pri čemu postupak miješanja obuhvaća sljedeće korake: f. miješanje ACP u obliku praška ili gela i HBC u obliku gela u omjeru između 90:10 i 10:90, g. usitnjavanje i homogenizajcija prolaskom kroz filter s koeficijentom retencije usitnjene tvari između 25 i 150 µm, h. punjenje injekcije, i. sterilizacija toplinom sa zasićenom vodenom parom pri temperaturi između 120 i 124 °C najmanje 10 minuta.
3. Postupak kako je prijavljen u patentnom zahtjevu 1 ili 2, naznačen time da HA koja se koristi za prirpavu HBC i ACP derivata ima prosječnu molekularnu masu između 400 i 3x106 Da, preferiranije između 1x105 Da i 1x106 Da, još preferiranije između 200000 i 1x106 Da.
4. Postupak kako je prijavljen u patentnom zahtjevu 2, naznačen time da maseni omjer ACP:HBC iznosi 25:75.
HRP20140981TT 2009-08-27 2010-08-25 Viskoelastični gelovi kao nova punila HRP20140981T4 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ITPD2009A000246A IT1395392B1 (it) 2009-08-27 2009-08-27 Geli viscoelastici come nuovi filler
EP10750046.4A EP2470230B2 (en) 2009-08-27 2010-08-25 Viscoelastic gels as novel fillers
PCT/EP2010/005161 WO2011023355A2 (en) 2009-08-27 2010-08-25 Viscoelastic gels as novel fillers

Publications (4)

Publication Number Publication Date
HRP20140981T1 HRP20140981T1 (en) 2014-11-21
HRP20140981T8 HRP20140981T8 (en) 2015-01-16
HRP20140981T2 HRP20140981T2 (hr) 2016-05-06
HRP20140981T4 true HRP20140981T4 (hr) 2022-08-19

Family

ID=42046298

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20140981TT HRP20140981T4 (hr) 2009-08-27 2010-08-25 Viskoelastični gelovi kao nova punila
HRP20160196T HRP20160196T1 (hr) 2009-08-27 2016-02-25 Viskoelastični gelovi kao nova punila

Family Applications After (1)

Application Number Title Priority Date Filing Date
HRP20160196T HRP20160196T1 (hr) 2009-08-27 2016-02-25 Viskoelastični gelovi kao nova punila

Country Status (22)

Country Link
US (1) US8846640B2 (hr)
EP (2) EP2470230B2 (hr)
JP (1) JP5976537B2 (hr)
KR (1) KR101749660B1 (hr)
CN (2) CN104623730B (hr)
AU (1) AU2010288937B2 (hr)
BR (1) BR112012004157B8 (hr)
CA (2) CA2995957C (hr)
CY (2) CY1115628T1 (hr)
DK (2) DK2470230T4 (hr)
ES (2) ES2563160T3 (hr)
HK (2) HK1172850A1 (hr)
HR (2) HRP20140981T4 (hr)
HU (1) HUE026830T2 (hr)
IT (1) IT1395392B1 (hr)
MX (1) MX2012002364A (hr)
PL (2) PL2772273T3 (hr)
PT (1) PT2470230E (hr)
RU (2) RU2543329C2 (hr)
SI (2) SI2470230T2 (hr)
SM (1) SMT201600062B (hr)
WO (1) WO2011023355A2 (hr)

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