Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2000-02-10
2003-10-07
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S401000, C424S725000, C424S735000, C424S736000, C424S744000, C424S765000, C424S768000, C424S059000
Reexamination Certificate
active
06630163
ABSTRACT:
TECHNICAL FIELD
The invention relates to dermatological agents containing fruit extracts and methods of using the same to treat dermatological disorders. In particular, the fruit extracts include extracts from apricots, apples, peaches, pears, pineapples, papayas, pomegranates, cherries, kiwis, tangerines, grapes, and oranges.
BACKGROUND OF THE INVENTION
The skin is the most environmentally-stressed organ in mammals, particularly in humans. Not only is the skin subjected to toxic chemicals and hostile environments, but it is also the only organ directly exposed to ultraviolet (“UV”) light in the presence of oxygen. [See, e.g., P. Mayer, et al.,
Cosmetic & Toiletries
, 108:99-109 (February 1993)]. Lengthy exposure of the skin to UV light typically damages the skin, resulting in sunburn, photoaging and carcinogenesis.
UV light exposure in the presence of oxygen results in the creation of free radicals. In the skin, these radicals frequently trigger the release of inflammatory mediators, commonly manifested as sun burn; cytoskeletal alterations, breaking down the collagen in the skin; and may also result in structural DNA changes, such as DNA strand breaks and dimer formation. [K. Werninghaus, et al.,
Arch Dernatol
., 130:1257-1261 (October 1994)]. The body attempts to neutralize the free radicals generated by UV light through the use of antioxidants. Antioxidants are commonly found in two forms: enzymatic and non-enzymatic. Superoxide dismutase (SOD), catalase, and glutathione peroxidase are some of the natural enzymatic antioxidants used by the body. SOD accelerates the spontaneous reduction of superoxide free radicals into peroxides and oxygen. Catalase then further decomposes hydrogen peroxide into water and oxygen. Finally, the glutathione peroxidase reduces both hydrogen peroxide and free organic hydroperoxides. Some non-enzymatic antioxidants, such as Vitamin E (tocopherol), Vitamin A (beta-carotene), and Vitamin C (ascorbic acid) have each been individually applied to assist the skin in scavenging free radicals and neutralizing the harmful effects of UV light. [P. Pugliese, “A Brief Introduction to Free Radicals and Oxygen Stress,” Paper presented at International Conference of Aesthetics and Dermatology, Los Angeles, (February 1991)]. Conventional skin protection efforts typically attempt to either shield the skin from UV light to prevent the production of free radicals or provide additional agents capable of neutralizing the free radicals.
Topical applications are one such effort known in the art to help shield the skin from the sun's harmful UV effects. These sun-screens often are water- or oil-based lotions or ointments that incorporate photo-protectant materials such as titanium and zinc oxide. [J. Weiss,
Skin
, 16-23 (March/April 1996)]. Although the most widely used form of protection against exposure to sunlight, these topical applications tend to suffer from several drawbacks. First, large amounts of photo-protective materials are usually incorporated into the topical applications, some of which have recently become suspected of having toxicity or otherwise being harmful under these conditions. Furthermore, the effectiveness of such topical applications is dependent upon a constant and uniform coverage of the skin, which is often difficult to obtain. Many individuals fail to use these topical sunscreens on a regular or continuing basis, as is required under prolonged UV exposure. Finally, sunscreens and other topical applications do not consistently provide good protection for all types of UV light. [Id.].
It is also known that certain fruit extracts may be added to preparations, such as lotions, creams and gels, which are topically applied to the skin, usually for fragrance or conditioning, i.e., softening the skin.
F-D-C Accession No. 02150070012, The Rose Sheet, Feb. 14, 1994, Vol. 15, Issue 7 discloses a skin lotion and cream that combines the benefits of alpha hydroxy acid, antioxidants and sunscreen in one product. The composition is formulated with green tea extract and a triple fruit acid complex to allegedly smooth skin texture, reduce the appearance of fine wrinkles and lines and even out skin tone. The composition also contains a combination of melanin and vitamin E that allegedly neutralizes free radicals before they can damage the skin and an SPF 8 broad spectrum sunscreen.
F-D-C Accession No. 02150250004, The Rose Sheet, Jun. 20, 1994, Vol. 15, Issue 25 discloses a passion flower shower and bath gel that has a fruity fragrance and contains passion flower and extracts of orange flower, mango, strawberry, grapefruit and lavender. Also disclosed is a Vitamin E flower shower and bath gel formula with a light floral fragrance that includes the antioxidant Vitamin E, as well as ginseng, elder flower and rosemary extracts, apricot oil and lavender.
F-D-C Accession No. 02160380003, The Rose Sheet, Sep. 18, 1995, Vol. 16, Issue 38 discloses a triple action complex containing apple extract that allegedly inhibits the effects of irritants and makes skin more resilient, kola nut extract that allegedly defuses the irritation potential of skin-damaging free radicals, bisabool to soothe, and an unspecified antioxidant complex.
F-D-C Accession No. 02170140007, The Rose Sheet, Apr. 1, 1996, Vol. 17, Issue 14 discloses a self tanner formulated with alpha- and beta- hydroxy acids, as well as phytoglycolipids to extend color and prevent skin peeling, an Environmental Protection Complex to neutralize free radicals, and apple extract to help firm skin. The Environmental Protection Complex contains green tea, co-enzyme Q-10 and Vitamins E and C.
F-D-C Accession No. 02170370002, The Rose Sheet, Sep. 19, 1996, Vol. 17, Issue 37 discloses bath and shower gels and body lotions available in pear, pink grapefruit, pomegranate and tangerine fragrances. Also disclosed are body lotions having kiwi fruit, orange peel, apricot, and Vitamin E and provitamins B5 to allegedly help condition skin.
F-D-C Accession No. 02170440013, The Rose Sheet, Oct. 28, 1996, Vol. 17, Issue 44 discloses a pink grapefruit facial soap with grapefruit seed, orange blossom and yarrow extracts that leaves behind a soft, smooth moisturized complexion.
F-D-C Accession No. 02170440015, The Rose Sheet, Oct. 28, 1996, Volume 17, Issue 44 discloses a body wash formulated with seaweed, orange peel extract and sage extract that leaves the skin hydrated and revitalized. Also disclosed is a hand cream containing seaweed, green tea extract, cooling eucalyptus, and shea butter.
F-D-C Accession No. 02170500003, The Rose Sheet, Dec. 9, 1996, Vol. 17, Issue 50 discloses a scent named Green Tea eau de toilette, which has notes of freesia, green pineapple, Granny Smith apple, along with Japanese green tea, pink grapefruit, bergamont, mandarin and mint accords.
F-D-C Accession No. 02180100000, The Rose Sheet, Mar. 10, 1997, Vol. 18, Issue 10 discloses a lotion for face and throat that allegedly provides the immediate perception of firm, uplifted skin using a ceramide retinyl complex, which combines the “anti-aging properties” of ceramide 6 and retinyl linoleate with the tissue respiratory factors found in Vitamin C and apple extract.
F-D-C Accession No. 05050320012, The Tan Sheet, Aug. 11, 1997, Vol. 5, Issue 32 discloses a Fruit Polyphenol Antioxidant Complex “Vegicap” with extracts from cherries, apples, apricots, prunes, pomegranates, quercetin,.and vitamin C. Also disclosed is a formulation including hawthorne berry extract.
F-D-C Accession No. 0219008005, The Rose Sheet, Feb. 23, 1998, Vol. 19, Issue 8 discloses a body lotion moisturizer that combines BHAs, AHAs, vitamins A, E and green tea extract to exfoliate skin while providing antioxidant benefits. Other antioxidants contained in the product include willow, apple and lemon extract blend.
F-D-C Accession No. 02190130012, The Rose Sheet, Mar. 30, 1998, Vol. 19, Issue 13 discloses a Daily Moisture Care cream-gel that pairs Calabria orange extract with antioxidants to allegedly strengthen the skin's natura
Di Nola-Baron Liliana
Page Thurman K.
Pennie & Edmonds LLP
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