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(12) Patent Application Publication (10) Pub. No.: US 2002/0035087 A1 Barclay (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2002/0035087 A1 Barclay (43) Pub US 20020035087A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2002/0035087 A1 Barclay (43) Pub. Date: Mar. 21, 2002 (54) B COMPLEX VITAMIN COMPOSITIONS (57) ABSTRACT THAT PROTECT AGAINST CELLULAR The present invention relates generally to the use of Vitamin DAMAGE CAUSED BY ULTRAVIOLET B12 (cobalamin or cyanocobalamin) alone or in combina LIGHT tion with other photoprotective agents, including Specifically other vitamins such as vitamin B9 (folic acid or folate) and Vitamin B3 (niacin or niacinamide), or any chemical deriva (76) Inventor: Barry J. Barclay, St. Albert (CA) tive of these Vitamins and their Salts, as a filter to protect cells against the damaging effects of ultraviolet (UV) light. The invention is, in one aspect, a method of reducing the rate Correspondence Address: of UV damage to cells exposed to a UV light source, by Kevin S. Lemack treating the celis with the Vitamin composition, either alone Nields & Lemack or in combination with other photoprotective agents. Other 176 E. Main Street - Suite 8 aspects of the invention are compositions comprising effec Westboro, MA 01581 (US) tive amounts of vitamin B12 alone or in combination with other photoprotective agents including Vitamin B9 and Vita min B3 and a pharmaceutically-acceptable carrier, that are (21) Appl. No.: 09/900,064 useful in protecting cells, particularly Skin cells, against the burning, genotoxic (mutagenic and carcinogenic), immuno (22) Filed: Jul. 6, 2001 Suppressive and photoaging effects of UV light, especially Sunlight. The invention has application as a UV light filter in (30) Foreign Application Priority Data oral preparations including tablets and drinks, topical creams, lotions, sprays, wipes and cosmetics. The invention Jul. 6, 2000 (CA).......................................... 2,313,659 also has application as a medicinal treatment for dermato logical conditions caused by exposure to Sunlight, Such as Publication Classification actinic keratoses, photodermatitis, photo-induced (discoid) lupus erythematosus and the photoSensitizing effects of a (51) Int. Cl. .................................................. A61K 31/714 variety of drugs used commonly in clinical practice (e.g. certain antihistamines, ACE inhibitors, and antibiotics Such (52) U.S. Cl. ................................................................ 514/52 as tetracycline). Patent Application Publication Mar. 21, 2002. Sheet 1 of 3 US 2002/0035087 A1 Figure 1 HO Patent Application Publication Mar. 21, 2002. Sheet 2 of 3 US 2002/0035087 A1 Figure 2 COO Patent Application Publication Mar. 21, 2002. Sheet 3 of 3 US 2002/0035087 A1 Figure 3 H-C SC1O-H H-C N C-HNicotinic Acid US 2002/0035087 A1 Mar. 21, 2002 B COMPLEXVITAMIN COMPOSITIONS THAT 0005) Many of the effects of solar light on the human PROTECT AGAINST CELLULAR DAMAGE body are interrelated. For example, children who experience CAUSED BY ULTRAVIOLET LIGHT only a single episode of blistering Sunburn in childhood (before the age of 18) double their risk of developing skin FIELD OF THE INVENTION cancer later in life. Tanning of the skin was long thought to 0001. The invention relates generally to sunscreens and be an important component of a healthy lifestyle. It is now Sunfilters, and to methods and compositions for protecting considered by most experts to be quite the opposite and cells against the damaging effects of Sunlight and artificial should be more properly considered as the unhealthy appear Sources of UV light Such as lamps and arc welding equip ance of Sundamaged skin. In addition, contrary to another ment. In particular, the invention is directed to the use of widely held belief, it is now well documented that tanning vitamin B12, alone or in combination with folate (used here confers no protection whatsoever against the most Serious to refer to all of the folic acid derivatives found commonly effect of chronic Sun exposure, the increased risk of skin in nature), and niacin (specifically niacinamide) in methods CCC. and compositions for protecting cells and organisms includ ing humans against the burning, genotoxic, immunosuppres 0006 The skin cancers induced by Sunlight can be Sive and photoaging effects of exposure to UV light. broadly categorized into two types: melanomas and non melanomas (basal cell and Squamous). It was generally BACKGROUND OF THE INVENTION accepted for some time that exposure to UVB (the burning 0002. Over the past several decades, the worldwide inci rays of the Sun with the wavelengths ranging from 280 to dence of skin cancer has been increasing at an alarming rate. 315 nm) was responsible for the induction of melanomas, The reason for the dramatic increase in Skin cancers that has the most Serious form of skin cancer and the tumor type occurred over this period and the human Suffering associated responsible for most deaths. This was held to be especially with these diseases is not entirely clear. Many experts true in those individuals who had at least one episode of believe that it is due, at least in part, to depletion of the severe Sunburn early in childhood. It seems likely from more earth's protective OZone layer. The widespread use of Sun recent Studies, (especially an elegant Series of experiments Screens that protect against Some but not all of the Sun's by Dr Richard Setlow reported recently to the annual harmful UV radiation (UVB but not UVA) has also played meeting of the American Academy of Dermatology) that this a role. According to the National Cancer Institute (NCI), is simply not the case. Based on Spectral and mutational there will be over one million new cases of skin cancer fingerprint analysis (each type of UV light causes a charac reported in the United States in the year 2001 and approxi teristic mutational pattern in target genes) Dr Setlow has mately 7000 deaths. This nears the total of all other cancers Suggested that melanomas are due mainly to chronic expo combined. NCI also reports that if present trends continue sure to UVA. Wrongly considered by many people to be the 40-50% of fair skinned Americans now living are expected harmless tanning rays of the Sun, UVA has wavelengths to develop at least one type of skin cancer by age Sixty-five. between 320 and 400 nm. UVA has less energy than UVB These numbers are alarming, but in regions of the World but is more penetrating and passes through window glass closer to the equator, the rates of skin cancer are even higher. and into deeper layers of the skin more easily. 0003. In some regions of Australia for example, the 0007. There are several implications of this more detailed probability of non-indigenous people (most of whom are of understanding of the carcinogenic potential of UVA and European descent) developing skin cancer at Some point UVB. First, UVA light passes easily through the atmosphere during their lifetime approaches 100%. Skin cancers are now and is not absorbed by the OZone layer. It is the main type the main cause of death in Australia of all perSons between of Solar UV irradiation (about 95%) that reaches the surface the ages of 25 and 40. Worldwide, skin cancer is expected to of the earth. In the past, it was generally believed that UVA become the leading cause of death due to malignant disease had only beneficial effects to humans Such as Stimulation of in the next decade. Vitamin D formation and tanning. However, this is clearly 0004. How did this alarming situation come about'? The not the case. Wavelengths in the UVA range are damaging to Worldwide pandemic of skin cancers is probably not due to the Skin, cause photoaging and are causally related to the a single cause but more likely is due to a number of causal induction of melanomas. factors. These include lifestyle choices (Suntanning, 0008 Second, depletion of the ozone layer and the con increased outdoor leisure activities), an aging population comitant increase in the amount of UVB light reaching the (accumulated skin damage due to chronic Sun exposure and Surface of the earth cannot be the explanation for the decreased DNA repair capacity with age) dietary factors dramatic increase in melanomas Seen Worldwide in recent (folic acid is the most common nutritional deficiency in the years. More likely it is due to the widespread use of world and other micro-nutrient deficiencies) and environ Sunscreen products that Slow burning of the skin by filtering mental factors (workplace hazards and depletion of the UVB and giving a false impression to the user that Sun ozone layer). In addition to increased risk of skin cancer, damage is not occurring. These individuals are not only at exposure to Sunlight has a variety of adverse effects on the greater risk of melanoma formation but also increased risk human body, including erythema (burning of the skin), of photoaging of the skin and Suppression of their immune photoaging (wrinkling) and Suppression of the immune System. System. Recently, it has also been Suggested that Sunlight exposure in Women might also increase the risk of neural 0009 Last, chronic exposure to UVA over the lifetime of tube defects in the developing fetus and risk of developing an individual and not acute Sunburn in childhood is now endometriosis (a condition characterized by invasion of the considered to be the main causative factor in the induction inner lining (endometrium) tissue into the outer layers of the of melanomas, the most Serious form of skin cancer and the uterus.) type causing most deaths (six out of seven deaths due to skin US 2002/0035087 A1 Mar. 21, 2002 cancer in the United States are caused by melanomas). The combine Sunfiltering agents that absorb UV light in different general implication of these findings is that tanning is portions of the spectrum. However, most of these agents are unhealthy whether done in Sunlight or by exposure to Synthetic chemicals not found in commonly in nature and it artificial Sources of UVA Such as those used in Salons.
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