Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Biocides; animal or insect repellents or attractants
Reexamination Certificate
1999-06-08
2001-07-10
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Biocides; animal or insect repellents or attractants
C424S404000
Reexamination Certificate
active
06258370
ABSTRACT:
FIELD OF INVENTION
The invention relates to compositions, containing optical brighteners, such as compositions for disinfecting the hands, skin and mucous membrane.
BACKGROUND OF THE INVENTION
Before operations, the skin or mucous membrane in the region of the operation area is treated with antiseptic disinfectants. Here, it is necessary to ensure complete wetting of the epithelium in order to guarantee complete disinfection. For this reason, intensely coloured preparations which permit visual monitoring of the application of the disinfectant are usually used for disinfecting the skin and mucous membrane.
However, the disadvantage of these compositions is that colour changes of the skin which may occur during the operation, such as, for example, pallor as a result of depletion of blood or a blue colour due to inadequate oxygen saturation of the blood, for example in cardiac insufficiency or pulmonary diseases, are masked by the dye, and any necessary measures on the part of the surgeon are thus delayed or even completely prevented. In addition, the pronounced adhesion of the dyes to the skin, in particular of patients, is found to be very troublesome. Moreover, clothing, operating tables, floors, equipment, etc. soiled by the dyes used are difficult to clean.
SUMMARY OF THE INVENTION
It is the object of the present invention to provide a process for disinfecting a surface which do not have the abovementioned disadvantages by the application of a composition on said surface or mucous membrane surface, in order to be able to ensure complete disinfection of the operating area.
This object is achieved by compositions which contain at least one optical brightener provided that the composition does not contain any fluoro-aliphatic surfactant nor reducing agent selected from the class of hydrazine and hydroxylamine and alkali metal salts of oxygen acids of divalent sulfur and tetravalent sulfur.
Optical brighteners are compounds which are caused to fluoresce in the visible wavelength range by ultraviolet radiation, i.e. substances which absorb ultraviolet radiation and emit longer-wavelength, visible radiation.
Preferably used optical brighteners are the same substances which are also used in detergents for brightening the laundry or in various personal hygiene preparations for increasing the brilliance of, for example, soaps and cosmetic formulations. Particularly preferred optical brighteners are stilbene compounds, such as, for example, diaminostilbenedisulphonic acid, coumarin derivatives, such as, for example, 4-methyl-7-diethylaminocoumarin, 1,3-diaryldipyrazoline derivatives, such as, for example, 1,3-diphenyl-4-methyl-5-alkylpyrazoline, naphthalimide derivatives, such as, for example, N-methyl-4-methoxynaphthalimide, and benzoxazole derivatives, such as, for example, 1,2-bis(5-methylbenzoxazol-2-yl)ethylene. Pyrazoline derivatives (e.g. Hostalux® PN, from Hoechst), cationic benzimidazole derivatives (e.g. Blankophor® ACR, from Bayer) and anionic distearylbiphenyl derivatives (e.g. Blankophor® VPSP 20006, from Bayer) are very particularly preferred.
Particularly suitable are of course those optical brighteners which are used for brightening wool, such as, for example, Blankophor® ACR and Blankophor® VPSP, since this natural fibre has considerable similarity with human skin. However, brighteners for other fibres, such as, for example, polyamide, paper, polyester, polyacrylonitrile and cotton, are also suitable.
The use of optical brighteners permits the preparation of disinfectants which contain a substantially lower dye concentration and preferably no customary dyes at all. In contrast to the conventional, intensely coloured disinfectants, they are therefore also suitable for disinfecting the hands as well as equipment and work surfaces, providing for the first time a possibility for monitoring the completeness of wetting in these areas too.
The excitation wavelength for the disinfectants according to the invention depends on the optical brightener used and is preferably in the range of customary UV lamps, i.e. preferably in the range from about 300 to 400 nm.
Skin surfaces treated with the disinfectants according to the invention therefore fluoresce brightly on exposure to a UV lamp, permitting simple monitoring of the surfaces treated with the compositions and hence guaranteeing complete disinfection of the desired surface. In normal daylight, the disinfectants according to the invention and hence also the treated skin areas and all other articles, such as clothing, floors and equipment, which have come into contact with the compositions are not coloured.
A particular advantage of the optical brighteners used according to the invention is that, in contrast to many traditional dyes, they are not absorbed, therefore do not have systemic activity and are hence toxicologically safe. Furthermore, they have no sensitizing properties.
The optical brighteners are used in an amount such that, on exposure to UV light of a suitable wavelength, a clear distinction between treated and untreated surfaces is possible. For this purpose, the brighteners are typically used in an amount of from 0.0001 to 3% by weight, preferably in an amount of from 0.001 to 2.0% by weight, based on the total amount of disinfectant.
The concentration of the brightener furthermore depends on the intended use of the composition. While washing hand disinfectants frequently require higher concentrations, for example in the range from 0.2 to 1.0% by weight, since these compositions are for the most part rinsed off again after use, lower concentrations of from 0.005 to 0.5% by weight and in particular from 0.05 to 0.3% by weight may be entirely sufficient in the case of other compositions.
The disinfectants according to the invention contain, as further components, conventional constituents such as antimicrobial active ingredients, liquid carriers and excipients. Suitable compositions are known from the prior art.
Antimicrobial active ingredients include, quaternary compounds, guanidine derivatives, phenol derivatives iodine-eliminating compounds, aromatics alcohols, aliphatic alcohols, peroxide compounds such as hydrogene peroxide or organic peroxyacid compounds such as peracetic acid.
Excipients include anionic surfactants, cationic surfactants or non-ionic surfactants such as alkylether sulfates, alkylbenzene sulfonates, alkylsulfates, fatty acid esters, fattyacid alcohols, polyalkoxylated derivatives of fatty alcohols or of fatty acids, alkylpolyglycosides, betaines, sultaine, imidazoline and their derivatives, and fatty quaternary amonium salts.
Excipients also include thickening agents.
Compositions for disinfecting the skin and mucous membrane preferably contain one or more of the following constituents:
Antimicrobial active ingredients
Quaternary compounds
from 0.005 to 50%
by weight;
Guanidine derivatives
from 0.1 to 10%
by weight;
Phenol derivatives
from 0.02 to 5%
by weight;
Iodine-eliminating
from 0.5 to 20%
compounds
by weight;
Peroxide compounds
from 0.001 to 10%
by weight;
Aromatic alcohols
from 0.5 to 5%
by weight
and/or
from 1 to 15%
Alcohols
by weight.
Excipients
Surfactants (preferably cocamidopropylbetaine, sulphosuccinate, sodium lauryl ether sulphate) and/or
Stabilizers (preferably H
2
O
2
, buffer substances).
Compositions for disinfecting the skin preferably contain one or more of the following constituents:
Antimicrobial active ingredients
Alcohols
from 5 to 96%
by weight;
Quartenary compounds
from 0.05 to 50%
by weight;
Guanidine derivatives
from 0.1 to 10%
by weight;
Phenol derivatives
from 0.01 to 10%
by weight;
Iodine-eliminating
from 0.5 to 20%
compounds
by weight;
Peroxide compounds
from 0.001 to 10%
by weight;
Aromatic alcohols
from 0.5 to 10%
by weight;
Fatty acids
from 0.1% to 5%
by weight
and/or
from 0.1 to 5%
Hydroxy carboxylic acids
by weight.
Excipients
Stabilizers (preferably H
2
O
2
).
Compositions for disinfecting the hands preferably contain one or more of the following constituents:
Antimicrobial active ingredients
Alcohols
from 5 to 96%
by weight;
Quaternary compounds
fro
Behrends Sabine
Harke Hans-Peter
Air Liquide Sante ( International)
Page Thurman K.
Pulliam Amy E.
Young & Thompson
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