Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Utility Patent
1999-01-13
2001-01-02
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S070100, C424S059000, C514S035000, C514S053000, C514S054000, C514S847000
Utility Patent
active
06168799
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to topical compositions for the treatment of superficial and partial thickness burns and wounds of the skin and mucosa. More particularly, the invention pertains to formulations of topical creams and gels providing cleansing, moisturizing, soothing and anti-pruritic activity for topical therapeutic treatment of wounds and burns and other skin loss injuries and conditions.
2. State of the Art
A group of complex polysaccharides known as glucans are found in the cell walls of yeast and bacteria. Though the structures of the microbial-derived glucans have not been completely elucidated, they are known to include long-chain carbohydrate polymers composed solely of &bgr;-D-glucan residues with 1,3 linkages or a combination of 1,3- and 1,6-linkages. In the cell walls of the yeast
Saccharomyces cerevisiae,
the glucans may also be associated with mannan, another complex polysaccharide.
Studies have indicated that yeast-derived 1,3-glucan activates macrophages, including phages with immunological activity against tumor growth. The 1,6-glucans were found to be inactive relative to macrophages. Such is reported by Di Luzio et al. in THE MACROPHAGE IN NEOPLASIA, Mary A. Fink, editor, 1976, Academic Press, New York, pp 181-182.
In U.S. Pat. No. 5,158,772 of Davis, the incorporation of a microbial-derived beta-1,3-glucan-type polysaccharide in a topical composition is disclosed. The polysaccharide is produced by a bacterial microorganism known as
Cellulomonas flavigena.
The functions of the polysaccharide in the topical composition are described as three-fold, i.e. (a) its effectiveness as a water-holding agent by which it controls the fluidity, appearance and “feel” of a composition, (b) its viscosity raising effect, and (c) its ability to suspend other cosmetic and therapeutic agents such as dyes, drugs, germicides, anesthetics, etc. as a carrier.
In a U.S. patent application of Williams and Lawin, bearing Ser. No. 08/423,838 and commonly assigned with this application, a mesh matrix wound dressing is disclosed which incorporates cereal-derived &bgr;-D-glucan and collagen in a cast burn dressing.
A topical healing unguent is needed for treatment of burns and wounds of the skin and mucosa where a wound dressing is not indicated.
SUMMARY OF THE INVENTION
The invention comprises a multi-purpose topical composition for application to the skin and mucosa. It is intended for use as a topically applied cream or gel to provide cleansing and soothing relief of superficial and partial thickness burns, as a moisturizer to enhance water retention of the stratum corneum, and to relieve the itching associated with hypertrophic or keloid scarring.
The active ingredient of the topical composition of the invention is being investigated as a possible biological response modifier and macrophage stimulant.
The primary active component of the topical composition is cereal-derived &bgr;-D-Glucan, chemically comprising a large number of glucopyranosyl units determined to be linked by (1-3) and (1-4) linkages. The preferred active agent is &bgr;-D-Glucan derived from oats, although the glucans from barley, wheat and/or other cereal grains may be used for the topical composition, provided the (1-4) (1-3) &bgr;-D-Glucan can be extracted economically.
As generally formulated, the composition of the topical cream of the invention comprises the following, where the indicated concentration of each component is uniformly given as a percentage of the total of all components:
cereal-derived &bgr;-D-Glucan (active agent)
about 0.5-15 w/w %
ointment base
about 10-20 w/w %
humectant(s)
about 2-6 w/w %
suspending/viscosity increasing agent(s)
about 0.01-8.0 w/w %
stiffening agent(s)
about 0.5-6 w/w %
emulsifying/solubilizing agent(s)
about 0.1-8 w/w %
antimicrobial agent(s)
about 0.1-2 w/w %
plasticizer(s)
about 5-15 w/w %
solvent(s)
balance
Some ingredients may have several functions. For example, glycerol may serve both as a solvent and a plasticizer, and propylene glycol may serve as a solvent, humectant and plasticizer.
A general formulation for a gel composition of the invention is:
cereal derived &bgr;-D-Glucan (active agent)
about 0.5-15 w/w %
water
about 80-98 w/w %
suspending/viscosity increasing agent(s)
about 0.5-8 w/w %
emulsifying/solubilizing agent(s)
about 0-5 w/w %
antimicrobial agent(s)
about 0.05-1 w/w %
The cereal-derived &bgr;-D-Glucan in this composition is significantly different from glucans obtained from other sources, including &bgr;-D-Glucans derived from yeast such as
Saccharomyces cerevisiae
and bacteria such as
Cellulomonas flavigena.
The primary source of &bgr;-Glucan has historically been yeast and bacterial cells. However, the cereal-derived (1-4)(1-3) &bgr;-D-glucan useful in the invention is distinctive from microbial-derived glucans which have all (1-3) linkages or primarily (1-3) linkages with a few (1-6) linkages. The molecular weight of the mixed-linkage cereal-derived &bgr;-D-Glucan used in this invention is much greater than that of the microbial-derived glucans.
REFERENCES:
patent: 5573785 (1996-11-01), Murphy
patent: 5783569 (1998-07-01), Jamas et al.
Estrada et al, Immunomodulatory activities of oat beta glucan in vitro and in vivo, Biosis (AN 128:191445, 1997.
Osborne, Method and composition for cleaning wounds—comprises irrigating the wound with a surfactant, an antiseptic preservative mixed in an aqueous solution having minimal cytotoxity, WPIDS (97-489402 (45)), 1997.
Osborne, Topical bactericidal composition, eg for wound cleansing containing essential oil distilled from Schinus Molle L. tree, effective e.g. agiainstPseudomonas aeruginosa, (WPIDS AN 96-200652 )28)), 1996.
Camano, Topical bactericidal composition e.g. for wound cleandsing containing—essential oil distilled, (WPIDS AN 97-309779 (28)), 1997.*
Brennen Medical, Inc.
Criares Theodore J.
Moore & Hansen
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