Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Wearing apparel – fabric – or cloth
Reexamination Certificate
1998-04-22
2003-08-19
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Wearing apparel, fabric, or cloth
C424S400000, C424S405000, C514S844000, C514S938000
Reexamination Certificate
active
06607738
ABSTRACT:
The present composition relates to a chemical composition comprising a preservative system and to a method of making and a use of such a chemical composition. Particularly although not exclusively the present invention relates to a chemical composition comprising a personal care product including a preservative system.
Personal care products come in many different forms. They include creams, lotions, pastes, liquids, aerosols, shampoos, gels, wipes, bars, sticks, powders and granules any or all of which are intended for topical application to the skin including the scalp and the mucosa including the lips.
The products are generally designed to have a substantial shelf life. The products need to be manufactured at one site, transported possibly over considerable distance to a depot or other storage facility prior to further transport to a point of sale. The product may then spend considerable time on a retailer's shelf prior to purchase and further storage by the user whether for individual use or use in for example a hotel, workplace, institution or the like. All of such storage will take place under uncontrolled conditions including considerable variation in temperature.
In order to keep microbiological and fungal growth in such products at an acceptable level it is conventional practice for the products to contain a preservative. Many preservatives are available. The appropriate preservative has to be selected with regard to its efficacy and its acceptability to contact with human or animal skin. With regard to its acceptability there are in many countries laws and regulations governing the maximum permitted content of preservative in products intended for human use due to their possible toxic or otherwise harmful effect.
The need to control microbiological growth in personal care products is known to be particularly acute in water based products such as non-ionic oil-in-water emulsions and in pre-impregnated wipes such as baby wipes.
It is an object of the present invention to provide an effective preservative system permitting its use at low levels.
It is a further object of the present invention to provide a personal care product containing an effective preservative system at a low level.
It is yet a further object of the present invention to provide a wipe intended for personal use pre-impregnated with a non-ionic oil-in-water emulsion and containing an effective preservative system at a low level.
According to a first aspect of the present invention there is provided a chemical composition comprising a preservative system comprising iodopropynyl butyl carbamate and phenoxyethanol at a weight ratio of iodopropynyl butyl carbamate to phenoxyethanol within the range of about 1:90 to about 1:400.
Such a preservative system can show a synergistic preservative action greater than would be expected from the two components acting independently. This synergistic action can produce a broad anti-microbial effect and can permit use of the preservative system at a low level in end use products such as personal care products. Use of the preservative at a low level can lead to cost savings and can reduce the chance of any untoward reactions between the preservative system and the skin of a user of a personal care product containing the preservative system.
The efficacy of the present preservative system containing a maximum of one part of iodopropynyl butyl carbamate to 90 parts phenoxyethanol is surprising. A known preservative system ex Lonza advocates the use of iodopropynyl butyl carbamate as a 10 wt % solution in PEG-4 laurate in combination with phenoxyethanol at a minimum ratio of one part iodopropynyl butyl carbamate per se to 70 parts phenoxyethanol at a total level of the preservative system in for example a shampoo of at least 1 wt %. The present invention requires a lower ratio of iodopropynyl butyl carbamate to phenoxyethanol, avoids the need for PEG-4 laurate or EDTA and yet can provide effective anti-microbial action at a comparatively lower level of use in a personal care product.
The present chemical composition can moreover provide a broad anti-microbial effect without the use of formaldehyde donors or paraben derived products. These traditional preservatives have been widely used in the past but are now no longer permitted in a number of countries for products intended for human use.
Preferably the present chemical composition comprises a preservative system wherein the weight ratio of iodopropynyl butyl carbamate to phenoxyethanol lies within the range of about 1:90 to about 1:200. Preferably the iodopropynyl butyl carbamate is dissolved in the phenoxyethanol. More suitably the preservative system comprises a 0.7% wt solution of iodopropynyl butyl carbamate in phenoxyethanol.
The present preservative system can conveniently be supplied to a manufacturer as a ready dissolved solution of iodopropynyl butyl carbamate in phenoxyethanol. Even more conveniently the preservative system can be supplied in premeasured dosed quantities.
Preferably the present chemical composition comprises additionally a personal care product. Suitably the chemical composition comprises the preservative system present in the personal care product at a level between 0.15 and 1.00 wt % with respect to the total weight of the chemical composition. More suitably the chemical composition comprises the preservative system present in the personal care product at a level between 0.25 and 0.60 wt % with respect to the total weight of the chemical composition.
According to another aspect of the present invention there is provided a personal care product containing with respect to the final composition weight between 0.15 and 1.00 wt % of a preservative system comprising a solution of iodopropynyl butyl carbamate in phenoxyethanol at a weight ratio of iodopropynyl butyl carbamate to phenoxyethanol within the range of about 1:90 to about 1:400. Preferably the preservative system is present at between 0.25 and 0.60 wt % with respect to the final composition weight.
Personal care products suitable for use in the present invention can be in any form and can include creams, lotions, pastes, liquids, aerosols, shampoos, gels, wipes, bars, sticks, powders and granules any or all of which are intended for topical application to the skin including the scalp and the mucosa including the lies.
It is understood that the present invention extends to a wipe or wipes impregnated with the present chemical composition. In such an embodiment of the present invention the level of preservative system present is measured with respect to the chemical composition impregnated on to the wipe, not with respect to the total weight of the personal care product including the wipe or wipes.
The personal care product can be aqueous based such as an oil-in-water emulsion. The present invention is deemed particularly suitable for a wipe, such as contained in a tub or sachet of baby wipes, impregnated with a non-ionic oil-in-water emulsion.
According to another aspect of the present invention there is provided use of a chemical composition comprising a preservative system comprising iodopropynyl butyl carbamate and phenoxyethanol at a weight ratio of iodopropynyl butyl carbamate to phenoxyethanol within the range of about 1:90 to about 1:400 in preserving a personal care product.
According to another aspect of the present invention there is provided a method for making a chemical composition comprising a preservative system comprising admixing iodopropynyl butyl carbamate and phenoxyethanol at a weight ratio of iodopropynyl butyl carbamate to phenoxyethanol within the range of about 1:90 to about 1:400, preferably within the range of about 1:90 to 1:200.
The present preservative system can be prepared by dissolving the iodopropynyl butyl carbamate in phenoxyethanol at the required ratio. Gentle heating up to 40° C. can be employed if desired. Suitably the present method comprises a preservative system comprising a 0.7 wt % solution of iodopropynyl butyl carbamate in phenoxyethanol.
The preservative system can be incorporated in a
Godfrey Dene Clifford
Salmon Michael
Sidney Sandra
Dees Jose′ G.
DeWitty Robert M
Mangini Michele G.
Nipa Laboratories, LTD.
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