Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-10-30
2003-10-07
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S400000, C424S464000, C424S600000, C424S617000, C424S630000, C424S639000, C424S641000, C424S474000
Reexamination Certificate
active
06630158
ABSTRACT:
TECHNICAL FIELD
This invention relates to dietary supplement compositions useful for improving or maintaining the skin.
BACKGROUND OF THE INVENTION
This invention relates to new and improved dietary supplement compositions for and methods of promoting healthy skin in humans and other animals. More particularly it relates to a composition comprised of lycopene, biotin, selenium, chromium and carotenoids and the administration of such a composition to human or animal subjects.
More particularly, the invention relates to various compositions of dietary supplements designed to promote optimal levels of such nutrients in the body and methods of using such compositions.
The skin is the body's outer covering and the body's largest organ. Skin protects the body against heat, light, injury, and infection. It regulates body temperature and stores water, fat, and vitamin D. The skin is comprised of two layers, the outer epidermis and the inner dermis. The epidermis consists of primarily flat, scale-like cells called squamous cells. Beneath the squamous cells is a round layer of cells called basal cells. As basal cells mature they become squamous cells. The deepest part of the epidermis also contains melanocytes that produce the skin pigment melanin. The dermis contains blood and lymph vessels, hair follicles, and sweat and sebum producing glands that reach the surface through pores. Sweat helps regulate body temperature, and sebum, an oily substance, helps keep the skin from drying out.
The epidermis is continuously renewed by cell division of the keratinocytes in the basal cell layer. The basal layer is composed of columnar shaped cells that are anchored to a basement membrane separating the epidermis and dermis. Interspersed amongst the basal cells are the melanocytes responsible for melanin pigment production. Basal cells divide and form an intermediate prickle cell layer. As these cells ascend toward the surface they undergo keratinization in which the cells are filled with fibrous protein keratin. The skin surface is called the stratum corneum and is comprised of fully flattened, keratinized cells devoid of nuclei and other cellular organelles. Adjacent cells overlap at their margins and this locking together of cells, together with intercellular lipid, forms a very effective barrier. The stratum corneum is of variable thickness depending on the region of the body. It is thickest over the hands and feet. Daily wear and tear abrade away the stratum corneum. The renewal cycle runs approximately 52-75 days.
The prickle cell layer acquires its name from the spiky appearance produced by desmosomes (intercellular bridges) that connect adjacent cells. Scattered throughout the prickle cell layer are numbers of dendritic cells called Langerhans cells. Like macrophages, Langerhans cells originate in the bone marrow and have an antigen-presenting capacity. Between the prickle cell layer and the stratum corneum is the granular layer that is composed of rather flattened cells. Cells in the granular layer also contain organelles known as lamellar granules. Lamellar granules contain lipids and enzymes that are discharged into the intercellular spaces between the granular layer and stratum corneum, serving to join the two layers.
The rate of cell production in the germinative compartment of the epidermis must be balanced by the rate of cell loss at the surface of the stratum corneum. The control mechanism of epidermopoiesis consists of a balance of stimulatory and inhibitory signals. Wound healing provides a model to examine the changes in growth control that occur in establishing a new epidermis. Wounding of the skin is followed by a wave of epidermal mitotic activity, which represents the effects of diffusible factors spreading from the wound into the surrounding tissue. These factors include cytokines and growth factors that are produced by keratinocytes in vitro and can be found in physiological amounts in normal human skin.
Damage to the skin from normal environmental exposures has been well documented. U.S. Pat. No. 5,804,168 discloses that the skin is considered a highly stressed organ. It is subject to chemical attack and also to constant exposure to ultraviolet radiation. Prolonged exposure to ultraviolet light is linked to skin damage characterized by sunburn, aging and cancer. The production of free radicals from oxygen in the presence of ultraviolet light is linked to degradation of collagen and other structural components of the skin in addition to DNA mutation and structural changes which impair the skins ability to heal itself or worse causes normal cells to turn cancerous.
The scientific and patent literature contains numerous examples of attempts to prevent or repair skin damage using nutritional supplements. Such efforts have included topical and oral use of vitamins, minerals, essential fatty acids and various plant extracts in an effort to assist the skin in responding to environmental stresses. Many of these nutritional supplements contain active ingredients that are not part of the United States Recommended Daily Allowance (RDA) of essential nutrients.
Table 1 sets forth the United States Recommended Daily Allowance (US RDA) as established by the Department of Health and Human Services and the Department of Agriculture. The US RDA is a list of vitamins and minerals for which minimum or maximum daily nutritional requirements have been established.
TABLE 1
United States Recommended Daily Allowance (US RDA)
List of nutritionally essential macronutrients and micronutrients
(13 vitamins and 14 minerals), as described in the Code of Federal
Regulation (21 CFR 101.9, 2000).
Essential Nutrient
100% (D.V.)
Total Fat
65 g
Saturated Fat
20 g
Cholesterol
300 mg
Sodium
2,400 mg
Potassium
3,500 mg
Total Carbohydrate
300 g
Dietary Fiber
25 g
Protein
50 g
Vitamin A
5,000 IU*
(Beta Carotene)
(as % of vitamin A)
Vitamin C
60 mg
Calcium
1,000 mg
Iron
18 mg
Vitamin D
400 IU
Vitamin E
30 IU
Vitamin K
80 mcg
Thiamine (Vitamin B1)
1.5 mg
Riboflavin (Vitamin B2)
1.7 mg
Niacin
20 mg
Vitamin B6
2.0 mg
Folate
400 mcg
Vitamin B12
6.0 mcg
Biotin
300 mcg
Pantothenic Acid
10 mg
Phosphorus
1,000 mg
Iodine
150 mcg
Magnesium
400 mg
Zinc
15 mg
Selenium
70 mcg
Copper
2.0 mg
Manganese
2.0 mg
Chromium
120 mcg
Molybdenum
75 mcg
Chloride
3,400 mg
U.S. Pat. No. 5,804,168 discloses a nutritional composition to protect skin from the damaging effects of sunlight comprising an antioxidant, such as vitamin A, an anti-inflammatory component, such as vitamin E or zinc, and an immunity-boosting compound such as echinacea or golden seal.
U.S. Pat. Nos. 6,099,854 and 6,086,910 disclose and claim a dietary supplement flavonoid and polyphenol composition optionally including one or more of the following: Lutein, 2 to 50, mg, Beta carotene, 2 to 20 mg, Vitamin A, 400 to 600, Vitamin C, 75 to 250 mg, Folic Acid, 0.1 to 1.0 mg, Selenium, 80 to 120 mug, Copper, 2 to 4 mg, Zinc, 10 to 20 mg, Coenzyme Q10, 10 to 200, mg, Aspirin, 10 to 150
U.S. Pat. No. 6,121,243 discloses the topical dermatological use of alpha-glucosyl rutin in combination with one or more cinnamic acids and optionally carotenoids (alpha-carotene, beta-carotene and lycopene), alpha-hydroxy acids, folic acid, vitamin C and derivatives, tocopherols, vitamin A and zinc and selenium.
U.S. Pat. No. 6,103,756 discloses oral compounds and methods for treating diseases of the eye comprising: vitamin A, vitamin E, vitamin C, magnesium, selenium, bilberry extract, L-taurine, lutein extract, lycopene extract, alpha lipoic acid, quercetin, rutin and citrus bioflavonoids. The formulation optionally contains at least one of the following: vitamin D3, thiamine, riboflavin, niacin, vitamin B6, folic acid, vitamin B12, biotin, pantothenic acid, calcium, iodine, zinc, copper, manganese, chromium, molybdenum, n-acetyl-cysteine, plant enzymes, biopene, malic acid, L-glycine, L-glutathionine or boron.
U.S. Pat. No. 6,048,846 discloses a dietary supplement comprising dehydroepiandrosterone (DHEA) or melatonin; an amino acid selected from the group consisting of taurine, argini
Alioto Samuel J.
Popp Karl F.
Evans Charesse
Lott & Friedland, P.A.
Stiefel Laboratories, Inc.
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