Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Phosphorus containing other than solely as part of an...
Reexamination Certificate
1999-08-26
2001-11-13
Dodson, Shelley A. (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Phosphorus containing other than solely as part of an...
C514S159000, C514S552000, C514S847000, C514S861000, C514S936000, C514S937000, C514S944000
Reexamination Certificate
active
06316428
ABSTRACT:
TECHNICAL FIELD
The present invention is related to a process and composition for moisturizing and rejuvenating keratinous tissues including skin, hair, fingernails, and toenails of humans and animals, and also hooves and horns of animals. More particularly, the present invention relates to topically applying the composition disclosed herein in order to treat the affected keratinous tissue.
BACKGROUND OF THE INVENTION
The skin is the largest organ in the body and serves several important functions that are essential to life. The skin retards dehydration and also acts as a barrier to the invasion of various pathogens and noxious substances. Skin is composed of the epidermis, or upper layer, and the subjacent dermis. The epidermis is the superficial layer and gives rise to the nails, hair, sebaceous glands, sweat glands, and the parenchyma of mammary glands. The epidermis is composed of several layers. As cells from the deeper layer, the stratum germinativum, move toward the surface, they begin to synthesize the intracellular protein keratin. During subsequent movement, these cells lose their distinct nuclei and form the outermost layer of the epidermis known as the stratum corneum which is comprised of several layers of cornified epidermal cells that are embedded in an intercellular matrix of semi-polar and polar lipids. This layer acts as a transport route for various drugs, such as hydrocortisone, and also acts as a barrier to the transport of other drugs and cosmetics (Elias et al.,
Journal of Investigative Dermatology
73: 339-348, 1979). In addition, this lipid layer of the stratum corneum assists in the retention of water. The water content of the stratum corneum has a profound influence on the appearance, flexibility, texture, and dryness of the skin, and also on the absorption of drugs and other molecules into and through the skin.
With increasing age, the skin gradually loses ceramides and water and becomes drier, less flexible and supple, more wrinkled, and scaly in appearance. One of the major objectives of the cosmetic industry is to retard the drying and wrinkling of the skin that occurs with normal aging or as the result of exposure to wind, sun, cold and chemicals. As the mean age of the population increases, more people are seeking products that will retard the effects of aging on the skin and will essentially rejuvenate the skin. Increasing the moisture content of the skin is one mechanism for achieving this objective. Furthermore, enhanced skin hydration facilitates the transport of pharmaceuticals across the epidermis to reach the underlying dermis and subjacent capillaries of the lymphatic and circulatory systems.
Another objective of the cosmetic industry is to retard the drying of the hair, fingernails and toenails, which all arise from the epidermis. In addition to enhancing the youthful appearance of an individual, increased hydration of these structures prevents the painful effects of cracked nails and itchy, scaly scalp. In animals, similar problems can occur with fingernails and toenails and also with horns and hooves which are all epidermal derivatives. For example, cracked hooves can result in lameness or in injury to the coronary band, the primary growth and nutritional source for the hoof wall. Injuries to the coronary band can cause serious permanent defects in the growth of the hoof wall.
The formation of organogels containing lecithin dissolved with isopropyl palmitate or other solvents, and water, has been described by Luisi et al.,
Colloid and Polymer Science
268: 356-374 (1990) and Scartazzini et al.,
The Journal of Physical Chemistry
92: 829-833 (1988), which are incorporated herein by reference in their entirety. Williman et al.,
Journal of Pharmaceutical Sciences
81:871-874 (1992), which is incorporated herein by reference in its entirety, examined the efficacy of lecithin organogels for use in the transdermal delivery of drugs such as scopolamine and broxaterol. Williman et al., also observed that lecithin organogels had no detrimental effect on skin when compared to control samples treated with physiological saline (see page 872, column. 2, paragraph 3,
Journal of Pharmaceutical Sciences
81:871-874 (1992)).
Catz et al., in U.S. Pat. No. 5,238,933, discloses skin permeation enhancer systems which increase the permeability of the skin to transdermally administered, pharmacologically active agents.
Smith, in U.S. Pat. No. 3,952,099, discloses dermatological compositions for enhancing the penetration of pharmacologically active agents, such compositions comprising a sugar ester in combination with a sulfoxide or phosphine oxide.
Loucks, in U.S. Pat. No. 4,701,471, discloses a cosmetic and pharmaceutical composition comprising bovine bone marrow acids mixed with lecithin for prevention of the fatty acid oxidation and odor putrefacation.
In U.S. Pat. No. 3,957,971, Oleniacz discloses moisturizing units for treating keratinous tissue comprising liposomes having a ternary lipid mixture of lecithin, dicetyl phosphate, and a sterol
Sakai et al., in U.S. Pat. No. 4,760,096, discloses a skin moisturizing method and preparation containing a combination of a phosphatide such as soy lecithin, and one or more C
10
-C
30
carboxylic acid sterol esters.
U.S. Pat. No. 4,783,450 to Fawzi et al. discloses the use of lecithin as a skin penetration enhancer for transdermal delivery of the drug procaterol through skin.
A method and composition for increasing the moisture of epidermal structures are needed. The composition should be easy to apply topically, enhance moisture retention, and also have the capacity to deliver compounds that will assist in moisturizing and rejuvenating keratinous structures such as the skin hair, fingernails, toenails, hooves and horns.
SUMMARY OF THE INVENTION
The present invention is a method of moisturizing keratinous tissue of a human or animal comprising the step of topically applying to the keratinous tissue of the human or animal, a composition comprising lecithin, in an organic solvent and water whereby the composition is delivered into the stratum corneum, epidermis and dermis. Another embodiment of the present invention comprises a method of treating keratinous tissue of a human or animal comprising the step of topically applying to the keratinous tissue of the human or animal, a composition comprising water dispersible lecithin.
In one embodiment, the present invention provides an easy to use therapeutic and cosmetic process for treating dry skin and for alleviating the associated irritation and cracking of the skin by topically applying the composition disclosed herein. Use of this process and composition increases the moisture content of the skin, reduces wrinkling, and provides a rejuvenated appearance to the skin. In addition, this invention has great utility for the treatment of dry and brittle fingernails and toenails, and the adjacent skin that often is dry and cracked. In another embodiment, this invention is a therapeutic and cosmetic process for application to animals with cracked and damaged horns and/or hooves. A horn or hoof dressing in show horses and cattle would produce a more vibrant and healthy appearance. In addition, rapid closure of cracks in hooves would prevent invasion by foreign material and reduce the incidence of infection.
An additional embodiment of the invention is a therapeutic and cosmetic process for the treatment of dry and thinning hair to provide increased hair growth and thickness. It is understood that the present invention also encompasses a method and composition for delivery of molecules including, but not limited, to elastin, collagen and collagen fragments, glucosamine, glucosamine sulfate, glycerol, urea, ceramides, dimethicone, N-decylmethyl sulfoxide, salicylic acid, lanolin, chondroitin sulfate, hyaluronic acid, squalene, and various alpha hydroxy compounds such as lactic acid, citric acid, and glycolic acid, into the epidermis, dermis and other keratinous tissue.
The present invention can include other pharmaceutically acceptable components such as gelling agents,
Dodson Shelley A.
Kilpatrick & Stockton LLP
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