DK2471518T3 - Sammensætning, der omfatter oliedråber - Google Patents

Sammensætning, der omfatter oliedråber Download PDF

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Publication number
DK2471518T3
DK2471518T3 DK12162237.7T DK12162237T DK2471518T3 DK 2471518 T3 DK2471518 T3 DK 2471518T3 DK 12162237 T DK12162237 T DK 12162237T DK 2471518 T3 DK2471518 T3 DK 2471518T3
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composition
mini
oil
beads
water
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DK12162237.7T
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Ivan Coulter
Bernard Francis Mcdonald
Vincenzo Aversa
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Sigmoid Pharma Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13—Cyclosporins
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
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    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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    • A61K9/1629—Organic macromolecular compounds
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1658—Proteins, e.g. albumin, gelatin
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
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    • 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
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A—HUMAN NECESSITIES
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    • 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
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dispersion Chemistry (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Fats And Perfumes (AREA)

Claims (15)

1. Vaccine eller immunmodulerende sammensætning til oral administration, der omfatter et vandopløseligt polymermatrixmateriale, hvori der er dispergeret oliedråber, hvor sammensætningen omfatter et aktivt stof, hvor det aktive stof omfatter en adjuvans, der er a-galactosylceramid.
2. Sammensætning ifølge krav 1, hvor det aktive stof omfatter adjuvansen og en immunmodulator, for eksempel en vaccine, et antigen eller et immunterapeutisk middel.
3. Sammensætning ifølge krav 1 eller krav 2, hvor olien omfatter fra 10 % til 85 %, fortrinsvis 15 % til 50 %, mere fortrinsvis 20 % til 30 % eller fra 35 % til 45 % i forhold til sammensætningens tørvægt.
4. Sammensætningen ifølge et hvilket som helst af kravene 1 til 3, hvor det aktive stof er indbefattet i mindst nogle af oliedråbeme, for eksempel i oliedråber, der omfatter dråber af vand-i-olie-emulsion.
5. Sammensætning ifølge det foregående krav, hvor olien omfatter et overfladeaktivt middel.
6. Sammensætning ifølge det foregående krav, hvor matrixen endvidere omfatter et overfladeaktivt middel.
7. Sammensætning ifølge et hvilket som helst af kravene 1 til 6, hvor det vandopløselige polymermatrixmateriale er udvalgt fra: én eller flere af gelatine, agar, et polyethylenglycol, stivelse, casein, chitosan, sojabønneprotein, saflorprotein, alginater, gellangummi, carrageenan, xanthangummi, phthalateret gelatine, succineret gelatine, cellulosephthalatacetat, oleoresin, polyvinylacetat, hydroxypropylmethylcellulose, polymerisater af acryl- eller methacrylestere og polyvinylacetatphthalat; og pektin, og fortrinsvis er gelatine, eventuelt omfattende et plastificeringsmiddel, for eksempel et polyol med lav molekylvægt.
8. Sammensætning ifølge et hvilket som helst foregående krav, hvor sammensætningen er i form af en minikugle.
9. Sammensætning ifølge krav 8, hvor minikuglen har en diameter på ffa 0,5 mm til 10 mm.
10. Sammensætning ifølge et hvilket som helst foregående krav, der er coatet eller har mindst ét lag eller én coating, der omfatter ét eller flere stoffer af en polymerart.
11. Sammensætning ifølge krav 10, hvor coatingen omfatter ethylcellulose eventuelt i forbindelse med et emulgeringsmiddel, såsom, for eksempel, ammoniumoleat.
12. Sammensætning ifølge krav 11, hvor ethylcellulosen også er i forbindelse med et plastificeringsmiddel, f.eks. dibutylsebacat eller mediumkæde-triglycerider.
13. Sammensætning ifølge et hvilket som helst af kravene 1 til 12, der er en tørret olie-i-vand-emulsion.
14. Sammensætning ifølge et hvilket som helst af kravene 1 til 13 i form af en flerhed af minikugler i et enkelt format, for eksempel en flerhed af minikugler indeholdt i en hård gelkapsel, et brev eller en beholder, eller en flerhed af minikugler i en tablet.
15. Anvendelse af en emulsion til fremstilling af en vaccine eller immunmodulerende sammensætning ifølge et hvilket som helst af kravene 1 til 14, hvilken anvendelse omfatter: i) blanding af en oliefase med en vandig fase, der omfatter et vandopløseligt polymermatrixmateriale for at danne en emulsion, mindst én af oliefasen og den vandige fase, der omfatter et aktivt stof, hvor det aktive stof omfatter et adjuvans, der er a-galactosylceramid; og derefter ii) at bevirke, at emulsionen størkner ved eksponering af dråber af emulsionen for et størkningsmedium for at danne minikugler; og iii) eventuel coating af minikugleme; hvor minikugleme eventuelt har den eller de specifikke karakteristika, der er anført i ét af, eller i en kombination tilladt ud fra afhængighed af, kravene 2 til 14.
DK12162237.7T 2009-05-18 2010-05-18 Sammensætning, der omfatter oliedråber DK2471518T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US17912109P 2009-05-18 2009-05-18
IE20090381 2009-05-18
EP10720773.0A EP2432455B1 (en) 2009-05-18 2010-05-18 Composition comprising oil drops

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DK2471518T3 true DK2471518T3 (da) 2017-12-04

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DK12162237.7T DK2471518T3 (da) 2009-05-18 2010-05-18 Sammensætning, der omfatter oliedråber
DK10720773.0T DK2432455T3 (da) 2009-05-18 2010-05-18 Sammensætning omfattende oliedråber

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US (5) US9278070B2 (da)
EP (3) EP2432455B1 (da)
JP (1) JP5640079B2 (da)
CN (2) CN102470106B (da)
BR (1) BRPI1012196B1 (da)
CA (1) CA2762179A1 (da)
DK (2) DK2471518T3 (da)
ES (2) ES2530049T3 (da)
GB (1) GB2483815B (da)
HR (1) HRP20150110T1 (da)
PL (1) PL2471518T3 (da)
SG (1) SG176145A1 (da)
SI (1) SI2432455T1 (da)
SM (1) SMT201700555T1 (da)
WO (1) WO2010133609A2 (da)

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CN102573802A (zh) * 2009-08-12 2012-07-11 希格默伊德药业有限公司 包含聚合物基质和油相的免疫调节组合物
GB201020032D0 (en) 2010-11-25 2011-01-12 Sigmoid Pharma Ltd Composition
EP2661307A4 (en) 2011-01-03 2014-08-06 Univ California HIGH-DENSITY EPIDURAL STIMULATION TO FACILITATE MOVEMENTS, ATTACHMENTS, ARBITRARY MOVEMENTS AND RECOVERY OF AUTONOMIC, SEXUAL, VASOMOTORIC AND COGNITIVE FUNCTIONS AFTER NEUROLOGICAL INJURIES
US20130338121A1 (en) * 2011-03-01 2013-12-19 Le Tien Canh Two speed monolithic system for controlled release of drugs
ITMI20111050A1 (it) * 2011-06-10 2012-12-11 Sevecom Spa Uso di emulsionanti in associazione con oleine vegetali in un alimento per animali.
JP2014533183A (ja) 2011-11-11 2014-12-11 ニューロイネイブリング テクノロジーズ インコーポレイテッド 運動神経、感覚、自律、性的、血管運動および認知機能の回復を可能にするための非侵襲性神経調節装置
US9724304B2 (en) 2012-06-14 2017-08-08 Temple University—Of the Commonwealth System of Higher Education Nanospheres for therapeutic agent delivery
GB201212010D0 (en) 2012-07-05 2012-08-22 Sigmoid Pharma Ltd Formulations
MX356551B (es) 2012-08-23 2018-06-04 Grupo Medifarma S A De C V Star Composición antiséptica, antiseborreica y exfoliante para eliminar o prevenir el acné.
CN103054796B (zh) * 2012-12-11 2014-07-16 山东省眼科研究所 一种环孢素a胶束滴眼液及其制备方法
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