Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2001-02-14
2003-02-04
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S078020, C424S078030, C424S094100, C424S400000
Reexamination Certificate
active
06514506
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to whitening compositions. More specifically, the invention relates to a whitening composition comprising an Ascomycete based enzymatic extract which degrades epidermal melanin when topically applied to the skin.
BACKGROUND OF THE INVENTION
Beauty is in the eye of the beholder. The desire to whiten the skin can be just as appealing to some as achieving a tan is to others. Thus, while a mole, beauty mark or freckled skin might be attractive to some, others may consider these dark spots on the skin to be unattractive. Dark spots are visible on the skin in areas where the production of melanin is increased. Melanin is responsible for the “color” of skin and functions to protect the skin from the harmful effects of UV light. In the skin, the production of melanin, in response to the stimulus of UV light, produces the well known tanning effect of the skin, and the natural increased production of melanin in the skin of certain ethnic groups of people produces a darker skin tone. For those who dislike the presence of dark spots on the skin or simply desire a lighter skin tone, whitening compositions are useful.
To achieve a whitening effect on the skin, various types of whitening agents are known. Hydroquinone, 4-isopropylcatechol, and hydroquinone monobenzyl ether are examples of bleaching agents. However, bleaching agents require repeat applications to the skin as the top dead cell layer of the skin sheds. When the new dead cell layer surfaces, spots darken again or reappear. In addition, bleaching agents can be irritating because of their strength, and in some instances, may cause skin conditions such as leucoderma (vitiligo), and rashing. Another method of whitening the skin is the use of whitening agents such as ascorbic acid, salicylic acid and lactic acid, which cause the top layer of dead skin cells to shed or peel off, and along with it the spots caused by increased melanin production which have migrated up to the skin surface, are also shed. This method, however, requires a long period of time, about 2 to 4 weeks, to produce a whitening effect, and also requires frequent applications.
Other known whitening agents are tyrosinase inhibitors such as, for example, kojic acid, which interfere with the production of melanin in the skin. Melanin is synthesized in melanocytes, cells that are present in the epidermal basal layer of the skin. A number of precursors lead to the production of melanin, such as tyrosine, dopa, dopa-quinone via the action of tyrosinase, and the precursor indole-5,6-dihydroquinone which is polymerized into melanin. Inhibition of any one of the precursors involved in the production of melanin in the skin thereby prevents melanin from being produced, and can achieve a depigmenting or “whitening” effect on the skin.
While the production of melanin can be inhibited, another method of whitening the skin involves the decomposition of melanin. This is described in, for example, U.S. Pat. No. 5,578,296, by using a cultured product or processed product of a species of Basidiomycetes fungus or any wood-rotting fungi having melanin decomposing potency. This method, because it breaks down melanin, allows melanin to be produced in the skin as protection against harmful UV light. However, decomposing melanin does not prevent new spots from being developed in the skin, and therefore, this method still requires repeat application like other whitening methods. Further, the Basidiomycete fungus is pre-cultured in nitrogen limited defined media. The selection of Basidiomycete fungus came after unsuccessful intensive screenings of microorganisms. In addition JP 8119843 describes a suppressant for melanin containing an extract of
Armeniacae Semen
or
Pseudocydonia sinensis Schneid
. as an active ingredient, and JP 6269278 describes a microbial strain, MEL-1 (FERM P-12991), for decoloring melanin developed on the skin.
It is also described by authors Luther and Lipke, in “Degradation of Melanin by
Aspergillus fumigatus
”, Applied and Environmental Microbiology, vol. 40, no. 1, pp. 145-155 (July 1980), that a strain of
Aspergillus fumigatus
, NRRL 6463, isolated from a compost heap in Watertown, Mass., utilized synthetic tyrosine and dopa, and deproteinized hair melanins as sole sources of carbon. The
Aspergillus fumigatus
described in the study develops a black color over the course of melanin degradation. Thus, the use of
Aspergillus fumigatus
on the skin as a whitening agent is not described. Further, the structural diversity of melanin may have an effect on the identity of microorganisms which are capable of contributing to stages of melanin degradation. The composition of melanin, although it occurs widely in both marine and terrestrial animals, varies in the ratio of inolic and phenolic substituents. The chemical composition and physical properties of a certain class of melanin are highly dependent on the milieu from which it is formed. Epidermal melanin is known to have two classes of melanins, eumelanins and phaeomelanins. Eumelanin in particular includes a peptide coating. Conclusions regarding a specific melanin polymer are not a priori applicable to an entire class of melanin. “Melanin: Its Role in Human Photoprotection”, Zeise, L., et al. Eds., p. 11 to 12 (Valdenmar Publishing Company 1995). The study described by Luther and Lipke used deproteinized hair melanin and synthetic precursors, and the ability of
Aspergillus fumigatus
enzyme extract for degrading melanin when topically applied to the skin has not been described. It is also not known in the prior art that a fungus derived enzyme extract can surprisingly be twice as effective in whitening the skin as a commonly used tyrosinase inhibitor.
In addition, the effect of divalent metal cations on the hydrolytic activity on melanin was found using an isolation of a melanolytic fungus of the Acrostaphylus species, a filamentous fungus belonging to the Fungi Imperfecti and reclassified as Nodulisporium. The particular strain NDMC-101 was used as disclosed by Liu, Yu-tien, in “Isolation of a Melanolytic Fungus and its Hydrolytic Activity on Melanin”, Mycologia, vol. 87, no. 5, pp. 651 to 654 (1995). The Acrostaphylus species is saprophytic on wood and decaying plant materials, such as logs and stumps, dead twigs and branches of trees, and dead leaves and stems of herbacious plants. The fungal strain can utilize melanin as a nitrogen source for supporting its growth in medium containing an appropriate amount of divalent metallic ion, and therefore can degrade melanin in polluted water.
It has now been surprisingly discovered that an Ascomycete-derived enzyme extract in a cosmetic or pharmaceutical composition can be useful as a whitening agent for the skin. Accordingly, a topical whitening composition is provided by the present invention that can produce a whitening effect upon application to the skin without negative side effects and without the necessity of being combined with other types of whitening treatment.
SUMMARY OF THE INVENTION
The present invention relates to a topical cosmetic or pharmaceutical composition for application to the skin that comprises a whitening effective amount of a melanase enzyme extract derived from the Ascomycete phylum. The Ascomycete can be derived from the group of Aspergillus or Saccharomyces. In particular, the extract contains a melanin-degrading enzyme derived from a species of fungus,
Aspergillus fumigatus
, or yeast,
Saccharomyces cerevisiae
, effective in whitening the skin. Preparation of the compositions of the present invention also includes purifying the crude enzyme extract before it is added to the cosmetic or pharmaceutical composition.
In addition, the present invention includes the method of whitening the skin by topically applying the compositions containing these Ascomycete derived enzymes. The method includes extracting enzymes from
Aspergillus fumigatus
or
Saccharomyces cerevisiae
. The melanase enzyme extract is added to a cosmetic or pharmaceutical composition, and topically applied to the skin. The met
Maes Daniel H.
Mammone Thomas
Marenus Kenneth D.
Schnittger Steven F.
Color Access Inc.
Dees Jose′ G.
Gollamudi Sharmila S.
Price, Esq. Dorene M.
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