DK2211876T3 - Fremgangsmåde til silkefibroin-gelering under anvendelse af sonikering - Google Patents

Fremgangsmåde til silkefibroin-gelering under anvendelse af sonikering Download PDF

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DK2211876T3
DK2211876T3 DK08756432.4T DK08756432T DK2211876T3 DK 2211876 T3 DK2211876 T3 DK 2211876T3 DK 08756432 T DK08756432 T DK 08756432T DK 2211876 T3 DK2211876 T3 DK 2211876T3
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silk fibroin
gelation
solution
silk
concentration
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DK08756432.4T
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Jon Kluge
Gary G Leisk
David L Kaplan
Xiaoqin Wang
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Tufts College
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/24—Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid
    • 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
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/28—Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/25—Growth hormone-releasing factor [GH-RF] (Somatoliberin)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/43504—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from invertebrates
    • C07K14/43563—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from invertebrates from insects
    • C07K14/43586—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from invertebrates from insects from silkworms
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N11/00—Carrier-bound or immobilised enzymes; Carrier-bound or immobilised microbial cells; Preparation thereof
    • C12N11/02—Enzymes or microbial cells immobilised on or in an organic carrier
    • C12N11/10—Enzymes or microbial cells immobilised on or in an organic carrier the carrier being a carbohydrate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K2035/124—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells the cells being hematopoietic, bone marrow derived or blood cells
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5052—Proteins, e.g. albumin
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5063—Compounds of unknown constitution, e.g. material from plants or animals

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  • Health & Medical Sciences (AREA)
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  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Immunology (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
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  • Biotechnology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
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  • Wood Science & Technology (AREA)
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  • Tropical Medicine & Parasitology (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
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Claims (15)

1. Fremgangsmåde til hurtig dannelse af silkefibroin-gelering, omfattende eksponering af silkefibroin til en behandling omfattende ultrasonikering i en periode på ca. 5 sekunder til ca. 60 sekunder til initiering af gelering, hvor væsentlig silkefibroin-gelering dannes mindre end 24 timer efter ultrasonikeringsbehandlingen.
2. Fremgangsmåden ifølge krav 1, hvor silkefibroin-gelering dannes mindre end to timer efter ultrasonikeringsbehandlingen.
3. Fremgangsmåden ifølge krav 1, hvor silkefibroinet undergår gelering i en tidsperiode der spænder fra ca. 5 minutter til ca. to timer efter ultrasonikeringsbehandlingen.
4. Fremgangsmåden ifølge krav 1, 2 eller 3, hvor behandlingen yderligere omfatter en saltopløsning, hvor saltopløsningen eventuelt omfatter ioner valgt fra gruppen bestående af kalium, calcium, natrium, magnesium, kobber, zink, og kombinationer deraf.
5. Fremgangsmåden ifølge krav 1, hvor silkefibroinet er i form af en vandig opløsning med en pH der er ca. pH 4 eller derunder eller er ca. pH 7,5 eller derover.
6. Fremgangsmåden ifølge krav 4, hvor saltet er kalium, saltkoncentrationen er mindre end lOOmM, og saltopløsningens pH er ca. pH 4 eller derunder.
7. Fremgangsmåde til at styre silkefibroiners geleringstid ved at benytte en fremgangsmåde ifølge et hvilket som helst af kravene 1 til 4, hvor silkefibroinet undergår væsentlig gelering inden for ca. to timer.
8. Fremgangsmåden ifølge krav 7, hvor geleringstiden styres gennem ultrasonikeringens amplitude og koncentrationen af silkefibroinopløsningen.
9. Fremgangsmåden ifølge krav 7 eller 8, hvor geleringstiden styres gennem koncentrationen af silkefibroinopløsningen og koncentrationen af saltopløsningen, og eventuelt, hvor koncentrationen af silkefibroinet er 4 vægtprocent eller derunder, saltopløsningen omfatter kaliumioner, og koncentrationen af kaliumsaltopløsningen spænder fra 20mM til lOOmM.
10. Fremgangsmåden ifølge krav 7, hvor geleringstiden styres gennem koncentrationen og pH af saltopløsningen, og eventuelt, hvor saltopløsningen omfatter kaliumioner, koncentrationen af kaliumsaltopløsningen spænder fra 20mM til lOOmM, og opløsningens pH er pH 4 eller derunder.
11. Fremgangsmåde til indkapsling af mindst et middel i silkefibroin, omfattende: at bringe en silkefibroinopløsning i kontakt med en ultrasonikeringsbehandling i en periode på ca. 5 sekunder til ca. 60 sekunder for at initiere gelering; og tilsætte midlet/midlerne til silkefibroinopløsningen før væsentlig gelering sker i silkefibroinopløsningen; for at danne et silkefibroin-indkapslet middel.
12. Fremgangsmåde til indkapsling af mindst et middel i silkefibroin, omfattende: tilsætte midlet/midlerne til en silkefibroinopløsning; og at bringe en silkefibroinopløsning i kontakt med en ultrasonikeringsbehandling i en periode på ca. 5 sekunder til ca. 60 sekunder for at initiere gelering; for at danne et silkefibroin-indkapslet middel.
13. Fremgangsmåden ifølge krav 11 eller 12, hvor midlet er et terapeutisk middel eller et biologisk materiale, eller begge, og/eller hvor midlet er mindst et biologisk materiale valgt fra gruppen bestående af celler, proteiner, peptider, nukleinsyrer, PNA, aptamerer, antistoffer, hormoner, vækstfaktorer, cytokiner, enzymer, antimikrobielle forbindelser, og kombinationer deraf, og/eller hvor cellen er en ikke-embryonisk stamcelle, og/eller hvor et cellevækstmedium tilsættes til silkefibroin med det biologiske materiale, og/eller hvor midlet er et terapeutisk middel valgt fra gruppen bestående af små molekyler, lægemidler, og kombinationer deraf.
14. Fremgangsmåden ifølge krav 12 eller 13, hvor væsentlig gelering sker inden for ca. 2 timer, og/eller hvor væsentlig gelering sker i tidsperioden der spænder fra ca. 5 minutter til ca. to timer, og/eller hvor behandlingen yderligere omfatter en saltopløsning, og/eller hvor silkefibroinet er i form af en vandig opløsning med en pH der er ca. pH 4 eller derunder eller er ca. pH 7,5 eller derover.
15. Silkefibroin-indkapslet biologisk materiale opnået ved en fremgangsmåde ifølge krav 12 og 13, til anvendelse som en biodelivery enhed.
DK08756432.4T 2007-05-29 2008-05-29 Fremgangsmåde til silkefibroin-gelering under anvendelse af sonikering DK2211876T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US94055407P 2007-05-29 2007-05-29
PCT/US2008/065076 WO2008150861A1 (en) 2007-05-29 2008-05-29 Method for silk fibroin gelation using sonication

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DK2211876T3 true DK2211876T3 (da) 2015-01-12

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US (4) US8187616B2 (da)
EP (1) EP2211876B1 (da)
JP (2) JP2010529230A (da)
KR (2) KR101839659B1 (da)
CN (2) CN104013598A (da)
AU (1) AU2008260156B2 (da)
BR (1) BRPI0813312A2 (da)
CA (1) CA2688431C (da)
CY (1) CY1116090T1 (da)
DK (1) DK2211876T3 (da)
EA (1) EA019118B1 (da)
ES (1) ES2527125T3 (da)
HK (1) HK1201470A1 (da)
HR (1) HRP20141265T1 (da)
IL (1) IL202354A (da)
MX (1) MX2009012978A (da)
PL (1) PL2211876T3 (da)
PT (1) PT2211876E (da)
SI (1) SI2211876T1 (da)
WO (1) WO2008150861A1 (da)

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