• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
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    • 专利摘要:
    Ophthalmological product, method of obtaining and method of cleaning and disinfecting contact lenses. The present invention relates to an ophthalmological product comprising a silver ion concentration very low but effective in cleaning and disinfecting, as well as the method of obtaining it. The present invention also relates to a method of cleaning and disinfecting contact lenses with the product of the invention. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2593473A1
    申请号:ES201631361
    申请日:2016-10-24
    公开日:2016-12-09
    发明作者:Raquel HERRERO COLMENERO；Paula CIAURRIZ GORTARI；Aaron CABRERA ASENSIO
    申请人:DISOP SA；
    IPC主号:
    专利说明:

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    performed under aseptic conditions, that is, by sterilizing filtration. The packaging materials (container, cap and insert were previously sterilized by the beta irradiation technique above 25 kGy. Finally the packaged product was subjected to a sterility test according to the European Pharmacopoeia.
    In the present example, the solution has the following composition shown in Table 1.
    Table 1. Composition of the contact lens cleaning and disinfectant solution.
    Ingredient % (p / V)
    Sodium chloride 0.63
    2H2O disodium phosphate 0.30
    2H2O sodium phosphate 0.05
    Sodium citrate 0.10
    Poloxamer 0.10
    Hioaluronic acid 0.0175
    Ag + 0.000034
    Purified water c.s.p.
    10 To determine the disinfectant capacity of the composition, the tests were carried out according to ISO14729.
    Table 2. Test results according to ISO14729. fifteen
    twenty
    Microorganism t = 3ht = 8ht = 24h
    P.auroginosa 3.554.695.89
    S.aureus 3.054.555.83
    S. marcescens 3.545.575.57
    C. albicans 0.891.461.64
    F. solani 1.632.935.23
    Except for C. albicans at 3 o'clock the rest meets the test requirements for bacteria
    25 reduction of 3 logarithms in the number of cells and in fungi reduction of 1 logarithm. The tests are in triplicate. It was found that with more money the objectives are not improved. Table 3 shows the results for the containers where two were introduced.
    7
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    Escherichia coli 9.4 105<10<103.0 103<103.7 103<101.1 103<10
    Pseudomonas aeruginosa 8.9 105<10<103.4 103<101.1 103<101.1 103<10
    Staphylococcus aureus 1.0 106<10<102.3 103<101.7 103<101.6 103<10
    The results demonstrate that the formulation of the example contains an amount of Ag + sufficient to reduce the microbial load of the 5 microorganisms for 92 days and after successive realmization.
    5 These results demonstrate that the formulation can be used as the basis for ophthalmic solutions (wetting drops, lens maintenance products, eye baths, ...)
    10 The biological safety tests were also carried out where it was verified that the ophthalmological product of the invention complies with the ISO 10993-1 (2009) biological safety standards for invasive medical devices and permanent contact in the mucous membrane.
    essays Results
    Systemic Subchronic Toxicity Test The product after intraperitoneal administration in repeated dose rodents for 90 days has no toxicity.
    Ames test The product is not carcinogenic because it does not have mutagenic capacity at the concentrations tested.
    Cytotoxicity There are no significant differences between the product test and the negative control, which indicates that the product is not cytotoxic.
    Eye irritation The primary irritation index has a value of 0, which means that it is classified as non-irritating.
    Sensitization test The product is not sensitizing.
    9
    权利要求:
    Claims (1)
    [1]
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    类似技术:
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    同族专利:
    公开号 | 公开日
    ES2593473B1|2017-09-13|
    EP3311852A1|2018-04-25|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    GB1167285A|1967-03-15|1969-10-15|Ceskoslovenska Akademie Ved|Method of Preserving Hydrophilic Gels|
    US5320843A|1992-12-10|1994-06-14|Polymer Technology Corporation|Method for improving antibacterial properties of ophthalmic solutions|
    WO2005088351A2|2004-03-17|2005-09-22|Thorkild Andersen|Contact lens, container and insert for avoiding infection of the eye|
    JP2008006801A|2006-06-27|2008-01-17|Hanssem Co Ltd|Method of manufacturing nano-silver coated surface material|
    IT1304957B1|1997-02-11|2001-04-05|Glisente Landrini|SILVER ION DISPENSER FOR THE STERILIZATION OF LIQUIDS, SPECIAL WATER AND OBJECTS|
    DE10054248A1|2000-11-02|2002-05-08|Inst Neue Mat Gemein Gmbh|Microbicide-coated article, process for its production and its use|
    US8691287B2|2011-05-09|2014-04-08|Abbott Medical Optics Inc.|Ophthalmic system with synergistic properties|
    法律状态:
    2017-09-13| FG2A| Definitive protection|Ref document number: 2593473 Country of ref document: ES Kind code of ref document: B1 Effective date: 20170913 |
    优先权:
    申请号 | 申请日 | 专利标题
    ES201631361A|ES2593473B1|2016-10-24|2016-10-24|Ophthalmic product, method of obtaining and method of cleaning and disinfection of contact lenses|ES201631361A| ES2593473B1|2016-10-24|2016-10-24|Ophthalmic product, method of obtaining and method of cleaning and disinfection of contact lenses|
    EP17382706.4A| EP3311852A1|2016-10-24|2017-10-24|Ophthalmological product, production method and contact lens cleaning and disinfection method|
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