DK2323617T3 - Hyaluronsyrebaserede geler indbefattende anæstætiske midler - Google Patents

Hyaluronsyrebaserede geler indbefattende anæstætiske midler Download PDF

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Publication number
DK2323617T3
DK2323617T3 DK09785852.6T DK09785852T DK2323617T3 DK 2323617 T3 DK2323617 T3 DK 2323617T3 DK 09785852 T DK09785852 T DK 09785852T DK 2323617 T3 DK2323617 T3 DK 2323617T3
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Prior art keywords
lidocaine
hyaluronic acid
gel
crosslinked
cohesive
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DK09785852.6T
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English (en)
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Pierre Lebreton
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Allergan Ind Sas
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • 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
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    • A61K8/0241—Containing particulates characterized by their shape and/or structure
    • A—HUMAN NECESSITIES
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    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/37—Esters of carboxylic acids
    • A61K8/375—Esters of carboxylic acids the alcohol moiety containing more than one hydroxy group
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
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    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4973—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom
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    • A61L2/08—Radiation
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L27/20—Polysaccharides
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    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/001—Preparations for care of the lips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/91—Injection
    • A—HUMAN NECESSITIES
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    • A61L—METHODS 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
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
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    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials
    • A—HUMAN NECESSITIES
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    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction

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  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
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  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Birds (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Gerontology & Geriatric Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Anesthesiology (AREA)
  • Neurosurgery (AREA)
  • Emergency Medicine (AREA)
  • Rheumatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)
  • Polymers & Plastics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (8)

1. Fremgangsmåde til fremstilling afen blødvævsfyldstofsammensætning, hvilken fremgangsmåde omfatter følgende trin: tilvejebringelse af en hyaluronsyrekomponent tværbundet med mindst ét tværbindingsmiddel udvalgt fra gruppen bestående af 1,4-butandioldiglycidylether (BDDE), l,2-bis(2,3-epoxypropoxy) ethylen og 1-(2,3-epoxypropyl)-2,3-epoxycyclohexan, eller kombinationer deraf; justering af hyaluronsyrekomponentens pH til et justeret pH over 7,2; og tilsætning af en opløsning, der indeholder mindst ét anæstetisk middel, til hyaluronsyrekomponenten med det justerede pH for at opnå blødvævsfyldstofsammensætningen, hvor det mindst ene anæstetiske middel er lidocain HCI.
2. Fremgangsmåde ifølge krav 1, hvor blødvævsfyldstofsammensætningen er kohæsiv.
3. Fremgangsmåde ifølge krav 1, hvor det justerede pH er over 7,5.
4. Fremgangsmåde ifølge krav 1, der endvidere omfatter trinnet med homogenisering af hyaluronsyrekomponenten under eller efter trinnet med tilsætning af opløsningen indeholdende det anæstetiske middel.
5. Fremgangsmåde ifølge krav 1, hvor trinnet med tilvejebringelse afen hyaluronsyrekomponent omfatter tilvejebringelse af tørt, ikke-tværbundet natriumhyaluronatmateriale og hydrering af det tørre, ikke-tværbundne natriumhyaluronatmateriale i en alkalisk opløsning for at opnå en alkalisk, ikke-tværbundet natriumhyaluronatgel.
6. Fremgangsmåde ifølge krav 5, hvor den alkaliske, ikke-tværbundne natriumhyaluronatgel har et pH over 8,0.
7. Fremgangsmåde ifølge krav 6, hvor den alkaliske, ikke-tværbundne natriumhyaluronatgel har et pH over 10.
8. Fremgangsmåde til fremstilling afen kohæsiv, hyaluronsyrebaseret fyldstofsammensætning, hvilken fremgangsmåde omfatter følgende trin: tilvejebringelse af tørt, ikke-tværbundet natriumhyaluronatmateriale og hydrering af det tørre, ikke-tværbundne natriumhyaluronatmateriale i en alkalisk opløsning for at opnå en alkalisk, ikke-tværbundet natriumhyaluronatgel; tværbinding af den ikke-tværbundne natriumhyaluronatgel med BDDE for at danne en tværbundet, alkalisk hyaluronsyresammensætning med et pH over 7,2; tilsætning afen opløsning indeholdende lidocain HCI til hyaluronsyrekomponenten med det justerede pH for at opnå den hyaluronsyrebaserede fyldstofsammensætning; homogenisering af den hyaluronsyrebaserede fyldstofsammensætning, hvorved der dannes en homogeniseret, hyaluronsyrebaseret fyldstofsammensætning; og sterilisering af den homogeniserede, hyaluronsyrebaserede fyldstofsammensætning, hvorved den kohæsive, hyaluronsyrebaserede fyldstofsammensætning dannes, hvor den kohæsive, hyaluronsyrebaserede fyldstofsammensætning haren ekstruderingskraft på mellem 10 N og 13 N ved en ekstruderingshastighed på 12,5 mm/minut og har en viskositet på mellem 5 Pa*s og 450 Pa*s ved måling ved 5 Hz.
DK09785852.6T 2008-08-04 2009-03-02 Hyaluronsyrebaserede geler indbefattende anæstætiske midler DK2323617T3 (da)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US8595608P 2008-08-04 2008-08-04
US8793408P 2008-08-11 2008-08-11
US9627808P 2008-09-11 2008-09-11
US12/393,768 US8450475B2 (en) 2008-08-04 2009-02-26 Hyaluronic acid-based gels including lidocaine
US12/393,884 US8357795B2 (en) 2008-08-04 2009-02-26 Hyaluronic acid-based gels including lidocaine
PCT/IB2009/005048 WO2010015901A1 (en) 2008-08-04 2009-03-02 Hyaluronic acid-based gels including anesthetic agents

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DK2323617T3 true DK2323617T3 (da) 2017-04-24

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DK13004017.3T DK2674147T3 (da) 2008-08-04 2009-03-02 Fremgangsmåde til fremstilling af en hyaluronsyre-baseret gel, som inkluderer lidocain HCl.
DK09785852.6T DK2323617T3 (da) 2008-08-04 2009-03-02 Hyaluronsyrebaserede geler indbefattende anæstætiske midler
DK09785850.0T DK2326302T3 (da) 2008-08-04 2009-03-02 Hyaluronsyre-baserede geler, der indbefatter lidocainhydrochlorid

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US (22) US8357795B2 (da)
EP (6) EP2326302B1 (da)
JP (5) JP5670899B2 (da)
KR (2) KR101747441B1 (da)
CN (3) CN102170856B (da)
AU (2) AU2009278884B2 (da)
BR (3) BRPI0917573B1 (da)
CA (6) CA2732928A1 (da)
CY (2) CY1118281T1 (da)
DK (3) DK2674147T3 (da)
ES (3) ES2780190T3 (da)
HU (3) HUE031483T2 (da)
MX (3) MX2011001321A (da)
PL (3) PL2323617T3 (da)
PT (2) PT2323617T (da)
RU (2) RU2496474C2 (da)
SG (2) SG10202104803SA (da)
SI (2) SI2323617T1 (da)
WO (2) WO2010015901A1 (da)

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US20050226936A1 (en) 2004-04-08 2005-10-13 Q-Med Ab Method of soft tissue augmentation
EP2152743A2 (en) * 2007-05-23 2010-02-17 Allergan, Inc. Cross-linked collagen and uses thereof
US20110077737A1 (en) * 2007-07-30 2011-03-31 Allergan, Inc. Tunably Crosslinked Polysaccharide Compositions
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