DK2560616T3 - Kunstig tåreemulsion - Google Patents

Kunstig tåreemulsion Download PDF

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Publication number
DK2560616T3
DK2560616T3 DK11715556.4T DK11715556T DK2560616T3 DK 2560616 T3 DK2560616 T3 DK 2560616T3 DK 11715556 T DK11715556 T DK 11715556T DK 2560616 T3 DK2560616 T3 DK 2560616T3
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DK
Denmark
Prior art keywords
emulsion
use according
phospholipid
notably
lipid
Prior art date
Application number
DK11715556.4T
Other languages
English (en)
Inventor
Claude Claret
Martine Claret
Nicola Lamprecht-Weissenborn
Carole Gard
Original Assignee
Horus Pharma
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.)
Filing date
Publication date
Application filed by Horus Pharma filed Critical Horus Pharma
Application granted granted Critical
Publication of DK2560616T3 publication Critical patent/DK2560616T3/da

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    • 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
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/34—Macromolecular 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
    • 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
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/04—Artificial tears; Irrigation solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/14—Decongestants or antiallergics

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Ophthalmology & Optometry (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Compositions Of Macromolecular Compounds (AREA)

Claims (12)

1. Olie-i-vand-emulsion uden konserveringsmidler, hvis partikler har en maksimal størrelse på 220 nm eller mindre, med en osmolaritet fra 110 til 180 mOsm/L, omfattende: - mindst en mucomimetisk polymer valgt blandt hyaluronsyrerne, dextransulfat og chondroitinsulfat, - mindst et lipid af phospholipidtypen valgt blandt lecithinerne, - mindst et lipid forskeligt fra phospholipidet, - mindst en stabiliserende polymer valgt blandt cellulosepolymererne, - citratbuffermedium, - vand, til anvendelse ved behandling eller forebyggelse af øjensygdomme.
2. Olie-i-vand-emulsion til anvendelse ifølge krav 1 endvidere omfattende et terapeutisk middel til brug i øjet.
3. Emulsion til anvendelse ifølge krav 1 eller 2 til anvendelse ved behandling eller forebyggelse af okulær tørhed, allergier og/eller inflammationer i øjet.
4. Emulsion til anvendelse ifølge et hvilket som helst af de foregående krav hvor indholdet af mucomimetisk polymer varierer fra 0,01 til 5 vægtprocent i forhold til emulsionens samlede vægt.
5. Emulsion til anvendelse ifølge et hvilket som helst af kravene 1 til 4, hvor phospholipidindholdet varierer fra 0,01 til 3 vægtprocent i forhold til emulsionens samlede vægt.
6. Emulsion til anvendelse ifølge et hvilket som helst af kravene 1 til 5, hvor indholdet af lipid forskelligt fra phospholipidet varierer fra 0,01 til 5 vægtprocent i forhold til emulsionens samlede vægt.
7. Emulsion til anvendelse ifølge et af kravene 1 til 6, hvor cellulosepolymeren er valgt blandt methylcellulose, ethylcellulose, hydroxypropylcellulose og carboxymethylcellulose.
8. Emulsion til anvendelse ifølge et hvilket som helst af kravene 2 til 7, hvor indholdet af stabiliserende polymer varierer fra 0,01 til 5 vægtprocent i forhold til emulsionens samlede vægt.
9. Emulsion til anvendelse ifølge et hvilket som helst af kravene 1 til 8, kendetegnet ved at emulsionen har en viskositet på mindre end eller lig med 10'1 Pa.s.
10. Emulsion til anvendelse ifølge et hvilket som helst af kravene 1 til 9, kendetegnet ved at emulsionen har en klarhed på 0 til 5000 NTU.
11. Emulsion til anvendelse ifølge et hvilket som helst af kravene 2 til 8 med en pH fra 5,5 til 8.
12. Fremgangsmåde til fremstilling af en olie-i-vand-emulsion som defineret ifølge et hvilket som helst af kravene 1 til 11, omfattende følgende trin: a) at blande et lipid af phospholipidtypen valgt blandt lecithinerne og et lipid forskelligt fra phospholipidet, b) at opløse en mucomimetisk polymer valgt blandt hyaluronsyrerne, dextransulfat og chondroitinsulfat i en citratbuffer, c) at opløse en stabiliserende polymer valgt blandt cellulosepolymererne i den vandige fase fra trin b), d) at dispergere den olieholdige fase fra trin a) i den vandige fase fra trin c) under omrøring, e) at styre og tilpasse pH-værdien, især ved tilsætning af henholdsvis en base eller en syre og/eller at styre og tilpasse osmolariteten, og f) at sterilisere emulsionen, fortrinsvis ved filtrering under anvendelse af et 0,22 pm filter.
DK11715556.4T 2010-04-21 2011-04-21 Kunstig tåreemulsion DK2560616T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1053030A FR2962044B1 (fr) 2010-04-21 2010-04-21 Emulsion lacrymimetique
PCT/EP2011/056447 WO2011131765A2 (fr) 2010-04-21 2011-04-21 Emulsion lacrymimetique

Publications (1)

Publication Number Publication Date
DK2560616T3 true DK2560616T3 (da) 2017-10-16

Family

ID=43242426

Family Applications (1)

Application Number Title Priority Date Filing Date
DK11715556.4T DK2560616T3 (da) 2010-04-21 2011-04-21 Kunstig tåreemulsion

Country Status (10)

Country Link
US (1) US9801899B2 (da)
EP (1) EP2560616B1 (da)
JP (1) JP5917490B2 (da)
DK (1) DK2560616T3 (da)
ES (1) ES2638868T3 (da)
FR (1) FR2962044B1 (da)
HU (1) HUE034442T2 (da)
PL (1) PL2560616T3 (da)
PT (1) PT2560616T (da)
WO (1) WO2011131765A2 (da)

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DE102014203152A1 (de) * 2014-02-21 2015-08-27 Ursapharm Arzneimittel Gmbh Mikro- oder Nanoemulsion zur ophthalmologischen Anwendung
BR112017024804B1 (pt) * 2015-05-21 2024-02-27 Ophtalmis Monaco Composição oftálmica na forma de uma emulsão óleo-em-água, processo para preparar a emulsão óleo-em-água, e uso de ácido lipóico
EP3297733A1 (fr) 2015-05-21 2018-03-28 Ophtalmis Monaco Association d'acide lipoique et de taurine en tant qu'agent osmoprotecteur
ITUB20152542A1 (it) 2015-07-28 2017-01-28 Altergon Sa Formulati oftalmici a base di complessi cooperativi di acido ialuronico a basso e alto peso molecolare
ES2621877B1 (es) * 2016-01-04 2018-05-04 Agencia Pública Empresarial Sanitaria Hospital De Poniente Solución para resección endoscópica
EP3691654A4 (en) 2017-09-25 2021-11-24 Surface Pharmaceuticals, Inc. OPHTHALMIC PHARMACEUTICAL COMPOSITIONS AND METHODS FOR TREATMENT OF EYE SURFACE DISEASES
MX2019010618A (es) * 2019-09-06 2021-11-30 Sophia Holdings S A De C V Composicion farmacéutica oftálmica, procesos de preparación y usos de las mismas.
EP4393496A1 (en) * 2021-10-29 2024-07-03 Rohto Pharmaceutical Co., Ltd. Ophthalmic composition

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Also Published As

Publication number Publication date
ES2638868T3 (es) 2017-10-24
WO2011131765A2 (fr) 2011-10-27
EP2560616B1 (fr) 2017-07-19
US9801899B2 (en) 2017-10-31
HUE034442T2 (en) 2018-02-28
PT2560616T (pt) 2017-08-30
JP5917490B2 (ja) 2016-05-18
PL2560616T3 (pl) 2017-12-29
WO2011131765A3 (fr) 2012-02-23
EP2560616A2 (fr) 2013-02-27
FR2962044A1 (fr) 2012-01-06
FR2962044B1 (fr) 2013-02-22
US20130156867A1 (en) 2013-06-20
JP2013525335A (ja) 2013-06-20

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