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  • E-Articles - Protect Your Skin from Summer Sun with the Right Supplements

    Summer approaches...Plan Ahead
    Ultraviolet (UV) rays on unprotected skin can cause first and second degree burns to the skin, commonly referred to as sunburn. Long-term damage from overexposure can include premature aging and even skin cancer. The use of commercially available sunscreens with an SPF of 15 or higher is effective protection. However, a variety of natural remedies may be even more helpful t
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    han chemical-laden oils.

    Protective nutritional supplements
    Research has identified the benefits of antioxidants to prevent or minimize injury caused by UV radiation. Damage begins when UV radiation stimulates the production of free radicals and lipid peroxidases within the skin. Antioxidants such as vitamin E and vitamin C neutralize these particles and curtail cellular damage. These common nutrients ar
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    e also effective for sunburn prevention.

    In a study at the University of Munich, 10 subjects were given Vitamin C (2000 mg) and Vitamin E (1000 IU) daily or a placebo. The sunburn reaction before and after 8 days of supplement use was determined by measuring the minimal erythema (redness) dose, or MED. This is the amount of UV radiation necessary to create a uniform pink color on exposed skin.

    The results showed th
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    at subjects taking the vitamins required 20% more UV radiation to experience the same level of reaction as compared to those taking a placebo(1) . A similar result came from a separate study at the University of Frankfurt, concluding that vitamin C and vitamin E act synergistically to suppress a sunburn reaction.(2)

    Another supplement, beta-carotene, has been studied for effects as a sun protectant. Data published f
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    rom study at the University of Arizona suggests that supplementation with natural carotenoids 90 mg daily for 24 weeks conveys modest protection from both UVA- and UVB-induced erythema.(3)

    Taking these three supplements daily for a week before a going on a beach vacation, or taking them throughout the summer, could be a wonderful, safe way to protect yourself from sunburn.

    Healing Topical Therapies
    Na
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    tural topical therapies have been shown to be helpful for sunburn. A study from the University of Western Ontario showed that application of 5% Vitamin E cream immediately after a sunburn significantly decreased necrosis of the skin’s keratinocytes, commonly referred to as “peeling.” This positive effect was noted even when the application was delayed up to 8 hours after exposure.(4) This is very good news for those
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    that discover in the evening that their over-exposure occurred earlier in the day.

    A variety of herbs been reported to have soothing effects. Applying the oil from sea buckthorn (hippophae rhamnoides) 3 to 4 times per day has been useful as both a natural a sunscreen or as a sunburn therapy. Sea buckthorn oil is a natural product that contains vitamin C, malic acid, flavaniods, carotenoids, and essential fatty acids
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    . These constituents protect cells from lipid peroxidation injury.(5) Interestingly, the oil concentrate has been used to treat radiation burns caused by radiation therapy and on bedsores. Sea buckthorn increased the rate of new skin formation and hasten the formation of granulation tissue in wounds.(6) Other herbs useful for the topical treatment of sunburn include 5-10% jojoba extract,(7) jujube oil,(8) and a se
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    mi-solid preparation of 20-30% dried poplar buds.

    Beware of Herbal Photosensitizers
    Consumers need to be aware of potential complications, such as photosensitivity, associated with both natural and pharmaceutical products from only moderate sun exposure. St. Johns Wort (hypericum perforatum) can cause photosensitization when taken orally at 1800 mg/day for 15 days (9) and can cause phototoxicity at a dos
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    e of 0.5 mg/kg per day, albeit that is a rather large dose.(10) Photosensitization has been observed from both topical and large consumption of herbs that originate from plants that belong to the Apiaceae family.(11) The extensive list of common spices and vegetables from that plant family includes parsley, wild carrot, parsnip, anise, coriander, fennel, lovage, bishop’s weed, angelica root, pimpinella root, guta ko
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    la and dong quai. Interestingly, eating common figs (Ficus carica) may also cause photodematitis in sun-sensitive persons.(12) Patients should be reminded that the use of certain medications are also known to cause photosensitivity, such as sulfa and tetracycline.

    A Final Note
    Lack of exposure to sun can cause significant health problems too. Sunshine on the skin converts 7-dehydrocholesterol to pre-vit
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    amin D, which is further processed by the kidneys into 1,25-dihydroxyvitamin D, the active form of the vitamin. A New England Journal of Medicine article reports that roughly one-third of men and half of women over the age of 60 are deficient in vitamin D, the nutrient essential to maintaining health bones.(13) Spending 20 to 30 minutes in full sunlight, without sunscreen, three times a week, will allow the body to p
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    roduce the much-needed vitamin D.

    A very recent study published in the American Journal of Clinical Nutrition states that vitamin D is not toxic at intakes much higher than previously considered unsafe. "This risk assessment was needed to show that newer evidence supports the conclusion that vitamin D is much safer then previously thought, particularly because of all the emergence research that shows benefit for vit
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    amin D at higher levels than consumers were traditionally taking," lead author John Hathcock told NutraIngredients.com. In fact, the Council for Responsible nutrition scientists state that this could be raised to 10,000 IU (250 micrograms per day). (14)

    Using common sense in the sun moderate exposure and an awareness of potentially phototoxic herbal remedies will go along way to promote good health for your skin and
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    make summer fun a delightful experience instead of an eventful one.

    _______________________________________
    (1) Eberlein-Konig B, Placzek M, Pryzbilla. Protective effect against sunburn of combined systemic ascorbic acid (vitamin C) and d-alpha-tocoperhol (vitamin E). J Am Acad. Dermatol. 1998 Jan;38(1):45-8.
    (2) Fuchs J, Kern H. Modulation of UV-light-induced shin inflammation by d-alpha-tocoperhol and
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    L-ascorbic acid: a clinical study using solar simulated radiation. Free Radic Biol Med. 1998 Dec:25(9):1006-12.
    (3) Lee J; Jiang S; Levine N; Watson RR. Carotenoid supplementation reduces erythema in human skin after simulated solar radiation exposure. Proc Soc Exp Biol Med 2000 Feb;223(2):170-4.
    (4) Trevithick, JR; et.al. Reduction of sunburn damage to skin by topical application to vitamin E acetate fol
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    lowing exposure to ultraviolet B radiation: effect of delaying application or of reducing concentration of Vitamin E acetate applied. Scanning Microsc 1993 Dec;7(4):1269-81.
    (5) Wang Y, Lu y, Liu X, et. al. the protective effect of Hippophae rhamnoides L. on hyperlipidemic serum cultured smooth muscle cells in vitro [article in Chinese]. Chung Kuo chung Yao Tsa chih 1992; 17(10): 601, 624-26, inside back cover.
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

    (6) Gruenwald J, et al. PDR for Herbal Medicines. 1st Edition. Montvale, NJ: Medical Economics Company, Inc., 1998.
    (7) Leung AY, Foster S. Encyclopedia of Common Natural Ingredients Used in Food, Drugs and Cosmetics. 2nd Edition. New York, NY: Jon Wiley & Sons, 1996.
    (8) Ibid.
    (9) Upton R, ed. St. John’s Wort, Hypercium perforatum: quality control, analytical and therapeutic monograph. Santa
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    Cruz, CA: American herbal Pharmacopoeia; 1997;1-32.
    (10) Gulick RM, McAuliffe V, Holden-wiltse J, et al. Phase I studies of hypericin, the active compound in St. John’s Wort, as an antiretroviral agent in HIV-infected adults. AIDS Clinical Trials Group Protocols 150 and 258. Ann Int Med 1999;130(6): 510-4.
    (11) Blumenthal M, et al. The complete German Commission E Monographs: Therapeutic Guide to Herbal
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    Medicines. Trans. S. Klein. Boston, MA: American Botanical Council, 1998.
    (12) Brinker F. Herb Contraindications and Drug Interactions. 2nd ed Sandy, OR: Eclectic Medical Publications, 1998.
    (13)Utiger, RD. NEJM, 1998: Vol.338(12): 828-Editorial.
    (14) J.N. Hathcock, A. Shao, R. Vieth, R. Heaney. Risk assessment for vitamin D" American Journal of Clinical Nutrition. January 2007, Volume85, Pages 6-18


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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