Drug – bio-affecting and body treating compositions – Anti-perspirants or perspiration deodorants
Reexamination Certificate
2002-02-19
2003-01-07
Dodson, Shelley A. (Department: 1616)
Drug, bio-affecting and body treating compositions
Anti-perspirants or perspiration deodorants
C424S065000, C424S066000, C424S068000, C424S400000, C424S401000
Reexamination Certificate
active
06503492
ABSTRACT:
The invention relates to antiperspirant or deodorant compositions intended for topical application to human skin. In particular, it relates to antiperspirant or deodorant compositions comprising an agent that is capable of ameliorating or controlling skin irritancy.
BACKGROUND
In many countries, civilised behaviour encourages people to take steps to prevent or control body odours or visible wet patches caused by sweating, particularly in the underarm or on clothing in the vicinity of the underarm. People in some countries prefer to control both sweat and odour, whereas in other countries control of odour alone is favoured.
The antiperspirant market is currently dominated by topically applied products based on aluminium or zirconium salts which are intended to prevent, or at least control, localised perspiration at the skin surface, particularly on the underarm. Such formulations can often simultaneously provide a perceived degree of deodorancy.
In contrast, deodorants are formulations that are designed either to mask malodour or to prevent or hinder its formation. The latter method usually comprises reducing and/or controlling the re-growth of the local micro-organism populations, or targeting preferentially those bacteria such as a sub-class of Coryne bacteria which contribute disproportionately to axillary odour generation, or interrupting the pathways by which malodours are formed from secretions.
Antiperspirant and deodorant formulations are utilised in many applicator forms e.g. roll-ons, creams or soft solids, gels, firm sticks, aerosols and pump sprays. However all forms can suffer from a number of common disadvantages.
A principal disadvantage of many deodorants and antiperspirants is that they contain one or more commonly employed ingredients which are perceptibly unfriendly to human skin in those areas of the body to which the formulations are normally applied. Such ingredients are usually employed because they demonstrate other attributes which are advantageous or otherwise render the formulation particularly effective. Such essential or otherwise highly desirable ingredients include liquid carriers such as volatile silicones and ethanol, and indeed many deodorant or antiperspirant actives as well as a host of other ingredients commonly employed in deodorant and antiperspirant formulations. Such ingredients are perceived to exhibit an adverse effect, in particular an irritant effect, on a user's skin following application. Of those ingredients, particular attention may be accorded to aluminium and zirconium salts and complexes that act as antiperspirants.
Physiologically, irritation in the underarm usually adopts either or both of two forms, which are not mutually exclusive. It can manifest itself as redness due to inflammation or as noxious somatosensory responses such as pruritus (itch), sting and/or burn.
Skin unfriendliness can be tolerated, at least to some extent, which will vary from user to user, but it would be advantageous to identify means of reducing or eliminating the effect. Manifestly, irritation can be ameliorated by lowering the amount of any offending active ingredient in the formulation, but a serious drawback of such an approach is that the efficacy of the ingredient would be impaired.
Rather than look only empirically for materials which can demonstrate skin benefits in an antiperspirant or deodorant formulation, the inventors of the present invention have investigated mechanisms within skin cells which generate irritancy and related adverse skin conditions in humans and have sought means to alleviate or control those mechanisms.
Mankind has sought therapeutic means to relieve pain and suffering ever since records have been kept. Early remedies involved the administration of natural products, commonly by ingestion, topical application or inhalation, presumably as a result of empirical observations. For example,
Cannabis sativa
, colloquially called cannabis, or extracts therefrom, has been employed therapeutically for approximately 3000 years, being first mentioned in the time of Emperor Shen Nung in the
Chinese Compendium of Medicine
. It has subsequently been suggested that its perceived efficacy can be due to the action of &Dgr;
9
-tetrahydrocannabinol. Cannabinoid agents have been asserted to have anti-inflammatory actions (A. W. Wirth et al., Life Sci. 26, 1991-1995 (1980)). More recent research has shown that the biological actions of cannabis are mediated by two similar, but distinct, types of membrane receptor which have been termed Cannabinoid Receptor 1 (CB1R) and Cannabinoid Receptor 2 (CB2R) (Matsuda et al, Nature 346, 561-564 (1990), Munro et al, Nature, 365, 61-65 (1993)).
CB1R is by far the predominant form in the central nervous system, whereas both CB1R and CB2R are located in the peripheral tissues, including the skin. Some investigations have been made to locate natural endogenous ligands that can activate one or other of these receptors. Herein a reference to a CBR activator includes either or both CB1R and CB2R activators.
Arachidonylethanolamide (anandamide) has been stated to exhibit a greater affinity for the CB1R compared with CB2R and is believed to be the endogenous CB1R agonist (Pertwee et al, Br. J. Pharmacol. 105, 980-984 (1992)). It has been suggested that palmitoylethanolamide and 2-arachidonyl-glycerol are putative CB2R agonists (Facci et al, Proc. Natl. Acad. Sci. 92, 3376-3380 (1995), Sugiura et al., J. Biol. Chem. 275, 605-612 (2000)). Ligands that activate both CB1R and CB2R have been shown to be analgesic, whether applied systemically or cutaneously (Calignano et al, Nature,394, 277-280 (1998)).
Therapeutic uses have already been contemplated involving CBRs. For example, U.S. Pat. No. 5,990,170 (Della Valle et al) teaches the therapeutic use of a range of selected mono and dicarboxylic acid amides which bind the CB2R in order to treat diseases connected with this receptor. EP-A-550006 (Della Valle et al) teaches that a range of N-acyl derivatives of amino alcohols to be used for the treatment of pathologies characterised by the degranulation of mast cells. U.S. Pat. No. 5,679,667 describes the use of amino alcohols-N-acyl derivatives as therapeutic agents against neurogenic endoneural edema of the peripheral nerve. However, none of these references disclose or contemplate in any way antiperspirant or deodorant formulations or the use of any of the actives disclosed therein in such formulations.
During the last century, many different classes of compounds have been proposed in patent or other publications for incorporation in antiperspirant or deodorant formulations. However, none of such antiperspirant or deodorant publications have disclosed the subject of the present invention, either knowingly or unwittingly, for example because the compounds that are disclosed in them for other purposes are inactive for the present purpose, even though some of them may be chemically related to an active compound. Alternatively, the selection of ingredients of the instant invention has not been disclosed.
Thus, for example, U.S. Pat. No. 4,781,917 (Luebbe et al) describes the use of different monoethanolamides such as coconut mono- or stearamide monoethanolamide in antiperspirant gel sticks that do not exhibit the advantageous properties required for the instant invention. In addition, U.S. Pat. No. 5,407,668 (Kellner) teaches of the use of a class of alkanolamides in clear deodorant stick compositions as a component of a clarity enhancing solubilizer system, but does not contemplate expressly the presence of aluminium or zirconium antiperspirant salts or complexes. Accordingly, '668 does not teach how to select materials to satisfy the instant invention.
SUMMARY OF THE INVENTION
According to the invention there is provided an antiperspirant or deodorant cosmetic composition suitable for topical application to the human skin, characterised by comprising:
i. an antiperspirant or deodorant active comprising an aluminium and/or zirconium salt or complex;
ii. a carrier for the antiperspirant or deodorant active;
McGlone Francis
Paterson Sarah
Rawlings Anthony Vincent
Rukwied Roman
Watkinson Allan
Stein Kevin J.
Unilever Home & Personal Care USA a division of Conopco, Inc.
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