Description

1. Field of Invention

The present invention relates to a topical composition used to treat AK (Actinic Keratosis) , Basal Cell carcinoma, solar keratosis, squamous cell carcinoma and abnormal skin conditions.

BACKGROUND OF THE INVENTION

There is a strong association between exposure of the skin to the ultraviolet light component of sunlight and the development of skin cancers, such as malignant melanoma and the non-melanoma skin cancers, mainly basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs). The incidence of these cancers has been rapidly increasing world wide. In Britain, there were 4000 newly-diagnosed cases of malignant melanoma in 1994, an 80% increase over the past 10 years (Wessex Cancer Trust, 1996). In the United States, approximately 34,100 new cases were expected, an increase of 4% per year. Queensland, Australia, has the highest incidence of melanoma in the world, but early detection and widespread public health campaigns and the promotion of the use of sunscreens and reduction of ultraviolet exposure have helped to reduce the number of deaths. BCCs currently affect one in 1,000 in the U.K. population, and the incidence has more than doubled in the last 20 years (Imperial Cancer Research Fund, U.K., 1997). One million new cases of BCCs and SCCs are expected to be diagnosed in the USA in 1997, compared to 600,000 in 1990 and 400,000 in 1980 (National Oceanic and Atmospheric Administration U.S.A., 1997). In Australia, there is no reason to suspect that a similarly increasing incidence would not also apply, despite extensive publicising of the dangers of solar and UV radiation, with the Queensland population being at the greatest risk.

Over 90% of all skin cancers occur on areas of the skin that have been regularly exposed to sunlight or other ultraviolet radiation, with U.V.B. responsible for burning the skin and associated with malignant melanomas, and U.V.A. associated with premature skin aging and the development of BCCs and SCCs (Wessex Cancer Trust, 1996). Childhood sun exposure has been linked to the development of malignant melanoma in younger adults. Other risk factors include a genetic predisposition (fair complexion, many skin moles), chemical pollution, over-exposure to X-rays, and exposure to some drugs ^' and pesticides. Depletion of the ozone layer of the stratosphere is considered to contribute to long-term increases in skin cancer.

Surgical removal is by far the most common treatment for malignant melanomas, BCCs and SCCs. This can take the form of electrodesiccation and curettage, cryosurgery, simple wide excision, micrographic surgery or laser therapy. Other treatments, used when the cancers are detected at a later stage of development, are external radiation therapy, chemotherapy or to a lesser extent bio-immunotherapy or photodynamic therapy. The choice of treatment is dependent on the type and stage of the disease and the age and health of the patient (National Cancer Institute, U.S.A., 1997).

All of the present treatments suffer from severe limitations. The major concern is the poor recognition of cancerous cells at the site of excision and the high likelihood of recurrence, necessitating follow-up surgery and treatment, with the risk of further disfigurement and scarring. In one publication, the reported rates for incompletely-excised BCCs was 30-67% (Sussman and Liggins, 1996). Immune suppression associated with surgery may cause any remaining cells to proliferate, and increase the risk of metastases. In melanoma patients there is a high risk that the cancer has already metastasized at the time of initial surgery, and late recurrence leading to death is common. Present alternatives to surgery, such as radiation therapy and chemotherapy, also carry risks of immune suppression and poor specificity. Immunotherapy l and gene therapy hold the greatest promise, but the rational application of these is likely to be still decades away.

When the tumour is past the stage amenable to surgery, the most common treatment for melanoma or metastatic skin cancer of all types is chemotherapy, which has been largely unsuccessful (Beljanski and Crochet, 1996)

In theory, an ideal drug would be one that when applied topically to an exposed melanoma, BCC or SCC, selectively necrotises the tumour cells or induces them to undergo apoptosis, without causing damage to the surrounding healthy skin cells. In practice, this has yet to be achieved. The drugs currently available are neither selective nor penetrative.

The lay public is also enamoured of the concept of topical chemotherapy. There have been many documented "home remedies" for skin cancer, which have had disastrous consequences, eg the use of boot polish (Adele Green, Queensland Institute of Medical Research, pers. Comm.) The major danger is the production of scar tissue, underneath which the tumour cells continue to grow.

Active Ingredients

1. Sodium bicarbonate

Sodium bicarbonate or sodium hydrogen carbonate is the chemical compound with the formula NaHC0 ₃ . Sodium bicarbonate is a white solid that is crystalline but often appears as a fine powder. It has a slightly salty, alkaline taste resembling that of washing soda (sodium carbonate). The natural mineral form is nahcolite. It is a component of the mineral natron and is found dissolved in many mineral springs.

Since it has long been known and is widely used, the salt has many related names such as baking soda, bread soda, cooking soda, and bicarbonate of soda. In colloquial usage, its name is shortened to sodium bicarb, bicarb soda, or simply bicarb. The word saleratus, from Latin sal eratus meaning aerated salt, was widely used in the 19th century for both sodium bicarbonate and potassium bicarbonate. The term has now fallen out of common usage.

History

The ancient Egyptians used natural deposits of natron, a mixture consisting mostly of sodium carbonate decahydrate, and sodium bicarbonate. The natron was used as a cleansing agent like soap.

In 1791, a French chemist, Nicolas Leblanc, produced sodium carbonate, also known as soda ash. In 1846, two New York bakers, John Dwight and Austin Church, established the first factory to develop baking soda from sodium carbonate and carbon dioxide.^

This compound, referred to as saleratus, is mentioned in the famous novel Captains Courageous by Rudyard Kipling as being used extensively in the 1800s in commercial fishing to prevent freshly-caught fish from spoiling. ¹²¹

Applications Cooking

Sodium bicarbonate, referred to as "baking soda" is primarily used in cooking (baking), as a leavening agent. It reacts with acidic components in batters, releasing carbon dioxide, which causes expansion of the batter and forms the characteristic texture and grain in pancakes, cakes, quick breads, and other baked and fried foods. Acidic compounds that induce this reaction include phosphates, cream of tartar, lemon juice, yogurt, buttermilk, cocoa, vinegar, etc. Sodium bicarbonate can be substituted for baking powder provided sufficient acid reagent is also added to the recipe.^ Many forms of baking powder contain sodium bicarbonate combined with one or more acidic phosphates or cream of tartar.

Sodium bicarbonate was sometimes used in cooking vegetables, to make them softer, although this has gone out of fashion, as most people now prefer firmer vegetables that contain more nutrients. However, it is still used in Asian cuisine to tenderize meats. Baking soda may react with acids in food, including Vitamin C (L-ascorbic acid). It is also used in breadings such as for fried foods to enhance crispness.

Thermal decomposition causes sodium bicarbonate alone to act as a raising agent by releasing carbon dioxide at baking temperatures. The carbon dioxide production starts at temperatures above 80 °C. The mixture for cakes using this method can be allowed to stand before baking without any premature release of carbon dioxide.

Neutralization of acids and bases

Many laboratories keep a bottle of sodium bicarbonate powder within easy reach, because sodium bicarbonate is amphoteric, reacting with acids and bases. Furthermore, as it is relatively innocuous in most situations, there is no harm in using excess sodium bicarbonate. Also, sodium bicarbonate powder may be used to smother a small fire, as heating of sodium bicarbonate releases carbon dioxide. ¹¹¹¹

A wide variety of applications follows from its neutralization properties, including reducing the spread of white phosphorus from incendiary bullets inside an afflicted soldier's wounds. ¹ ^ Sodium bicarbonate can be added as a simple solution for raising the pH balance of water (increasing total alkalinity) where high levels of chlorine (2-5 ppm) are present as in swimming pools. ¹ ^ ¹

Medical uses

Sodium bicarbonate is used in an aqueous solution as an antacid taken orally to treat acid indigestion and heartburn. ¹¹ ^ It may also be used in an oral form to treat chronic forms of metabolic acidosis such as chronic renal failure and renal tubular acidosis. Sodium bicarbonate may also be useful in urinary alkalinization for the treatment of aspirin overdose and uric acid renal stones. It is used as the medicinal ingredient in gripe water for infants.

Sodium bicarbonate has been known to be used in first aid, in treating scalding, to prevent blistering and scarring with instructions to cover the scalded area with a liberal layer of sodium bicarbonate and water paste and seek medical assistance. This is due to the endothermic reaction that occurs between sodium bicarbonate and water and sodium bicarbonate's mild antiseptic properties^

Intravenous sodium bicarbonate is an aqueous solution that is sometimes used for cases of acidosis, or when there are insufficient sodium or bicarbonate ions in the blood. ^{11 1} In cases of respiratory acidosis, the infused bicarbonate ion drives the carbonic acid/bicarbonate buffer of plasma to the left and, thus, raises the pH. It is for this reason that sodium bicarbonate is used in medically supervised cardiopulmonary resuscitation. Infusion of bicarbonate is indicated only when the blood pH is marked (<7.1-7.0) low. ¹¹²¹ It is used as well for treatment of hyperkalemia. Since sodium bicarbonate can cause alkalosis, it is sometimes used to treat aspirin overdoses. Aspirin requires an acidic environment for proper absorption, and the basic environment diminishes aspirin absorption in the case of an overdose. Sodium bicarbonate has also been used in the treatment of tricyclic antidepressant overdose.^ It can also be applied topically as a paste, with three parts baking soda to one part water, to relieve insect bites. ¹²²¹

Adverse reactions to the administration of sodium bicarbonate can include metabolic alkalosis, edema due to sodium overload, congestive heart failure, hyperosmolar syndrome, hypervolemic hypernatremia, and hypertension due to increased sodium. In patients consuming a high-calcium or dairy-rich diet, calcium supplements, or calcium-containing antacids such as calcium carbonate (e.g., Turns), the use of sodium bicarbonate can cause milk-alkali syndrome, which can result in metastatic calcification, kidney stones, and kidney failure.

Sodium bicarbonate can be used to cover an allergic reaction of poison ivy, oak, or sumac to relieve some of the itching that is associated with it (an alternative to buying hydrocortisone cream).^

Personal hygiene

Sodium bicarbonate is also used as an ingredient in some mouthwashes. It works as a mechanical cleanser on the teeth and gums, neutralizes the production of acid in the mouth and also acts as an antiseptic to help prevent infections.

A paste made from sodium bicarbonate and a 3% hydrogen peroxide solution can be used as an alternative to commercial non-fluoride toothpastes^ ¹ ""' ⁰ " " ^eededi , and sodium bicarbonate in combination with other ingredients can be used to make a dry or wet deodorant. It may also be used as a shampoo. ¹²²¹

Baking soda in sports

Small amounts of sodium bicarbonate have been shown to be useful as a supplement for athletes in speed- based events, like middle distance running, lasting from about one to seven minutes. ^[231f241 But overdose is a serious risk because sodium bicarbonate is slightly toxic ¹² ^ and in particular gastrointestinal irritation is of concern. ¹²⁴¹ Additionally this practice causes a significant increase in dietary sodium.

References

1. "Physical Constants of Inorganic Compounds". CRC Handbook, p. 4-85.

2. Λ a * "Aqueous solubility of inorganic compounds at various temperatures". CRC Handbook, p. 8- 1 16.

3. ^{A 2} - "Sodium Bicarbonate" . UNEP Publications.

http://www.chem.unep.ch i te sids oecdsids Sodium%20bicarbonate. df.

4. ^{Λ 2} - Goldberg, Robert N.; Kishore, Nand; Lennen, Rebecca M.. "Thermodynamic quantities for the ionization reactions of buffers in water" . CRC Handbook, pp. 7-13.

5. ^{Λ 2 έ} Zumdahl, Steven S. (2009). Chemical Principles 6th Ed.. Houghton Mifflin Company, p. A23.

ISBN 0-618-94690-X.

6. "Company History". Church & Dwight Co..

http:/ www.churchdwight.com Company co _hίstory.asp.

7. Rudyard Kipling. Captains Courageous^. 25

8. Holleman, A. F.; Wiberg, E. "Inorganic Chemistry" Academic Press: San Diego, 2001. ISBN 0- 12-352651-5.

9. "Decomposition of Carbonates". General Chemistry Online.

ht^://antoine.frostburg.edu/chem/senese/101/inorganic/faq carbonate-decomposition.shto Radiation Cookery Book 45th Edition, Radiation Group Sales Ltd 1954

A ^g - ^£ "Arm & Hammer Baking Soda - Basics - The Magic Of Arm & Hammer Baking Soda". Armhammer.com. http://www.annhammer.eom/basics/magic/#9. Retrieved 2009-07-30.

_; "White Phosphorus". GlobalSecurity.org.

http://www.globalsecurity.org/militarv/systems/munitions/ wp.htm. Retrieved 2007-09-26.

"Outdoor Fun: Pool Care". Arm & Hammer Baking Soda. 2003.

http://www.armhammer.com/myfamilv/tips/outdoors.asp. Retrieved 2007-09-26.

"Sodium Bicarbonate". Jackson Siegelbaum Gastroenterology. 1998.

http://www.gicare.com/pated/sodium bicarbonate.htm.

List of ingredients - Life Brand Gripe Water

_, "New Scientist Last Word Blog: Soda soother". New Scientist.

http://www.newscientist.com/blog/lastword/2008/05/soda-so other.html. Retrieved 22 September 2011.

"Sodium Bicarbonate Intravenous Infusion". Consumer Medicine Information. Better Health Channel. 2004-07-13.

http://www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages /pucsodbi/$File/pucsodbi.pdf.

_ _. "Respiratory Acidosis: Treatment & Medication", emedicine.

http://emedicine.medscape.com/article/301 574-treatment.

Knudsen, K; Abrahamsson, J (Apr 1997). "Epinephrine and sodium bicarbonate independently and additively increase survival in experimental amitriptyline poisoning". Critical Care Medicine 25 (4): 669-74. doi: 10.1097/00003246- 199704000-00019. ISSN 0090-3493. PMID 9142034.

"Insect bites and stings: First aid". Mayo Clinic. 2008-01-15.

http://www.mayoclinic.com/health/first-aid-insect-bites/f a00046.

What is Sodium Bicarbonate Used For?. Virtuowl.com. Retrieved on 2010-09-24.

_; Bouchard, Mallory (2010-05-04). "A Green and Healthy Beauty Secret: Going Shampoo-Free". Four Green Steps, http://www.fourgreensteps.com/infozone/featured/features/a-g reen-and-healthy-beauty- secret-going-shampoo-free.

B ^ee » P ^eta (2008-08-16). "Is bicarbonate of soda a performance enhancing drug". The Times (London), http://women.timesonline.co.uk/tol/life_and style/women/body and_soul/article4539000.ece. Retrieved 2010-05-23.

Λ ^{2 έ} Ercogenic Aids. U. Retrieved on 2011-09-1 1.

Baking soda overdose - All Information. Umm.edu (2009-10-19). Retrieved on 2010-09-24. "Arm & Hammer Baking Soda - Basics - The Magic Of Arm & Hammer Baking Soda".

Armhammer.com. http://www.armhammer.eom/basics/magic/#3. Retrieved 2009-07-30.

Eco Silver Polishing, instructables.com (2006-12-20). Retrieved on 201 1-10-07.

_, "Put a Shine on It", scifun.chem.wisc.edu.

http://scifun.chem.wisc.edu/homeexpts/TARNISH.html. Retrieved 2011-03-06.

_; Orcutt, JA. "Scientist". Pharmacology and Toxicology of Uranium Compounds. McGraw-Hill. http://myweb.brooklyn.Iiu.edu/lawrence/duproiect/duhealth.ht m. Retrieved 21 March 2012.

Potassium bicarbonate (073508) and Sodium bicarbonate (073505) Fact Sheet United States Environmental Protection Agency. Updated 17 February 2011. Retrieved 25 November 2011.

Registered Biopesticides 04/29/02 United States Environmental Protection Agency. Updated 29 March 2002. Retrieved 25 November 201 1.

"Arm & Hammer Baking Soda - Basics - The Magic Of Arm & Hammer Baking Soda".

Armhammer.com. http://www.armhammer.eom/basics/magic/#8. Retrieved 2009-07-30.

Malik, Ys; Goyal, Sm (May 2006). "Virucidal efficacy of sodium bicarbonate on a food contact surface against feline calicivirus, a norovirus surrogate". International Journal of Food Microbiology 109 (1-2): 160-3. doi:10.1016/i.iifoodmicro.2005.08.033. ISSN 0168-1605. PMID 16540196.

_; William A. Rutala, Susan L. Barbee, Newman C. Aguiar, Mark D. Sobsey, David J. Weber, (2000). "Antimicrobial Activity of Home Disinfectants and Natural Products Against Potential Human Pathogens". Infection Control and Hospital Epidemiology (The University of Chicago Press on behalf of The Society for Healthcare Epidemiology of America) 21 (1): 33-38. doi: 10.1086/501694. PMID 10656352.

Zamani, M; Sharifi, Tehrani, A; Ali, Abadi, Aa (2007). "Evaluation of antifungal activity of carbonate and bicarbonate salts alone or in combination with biocontrol agents in control of citrus green mold". Communications in agricultural and applied biological sciences 72 (4): 773-7. PMID 18396809. 36. Gail Altaian (2006-05-22). "Book Repair for BookThinkers: How To Remove Odors From

Books". The BookThinker (69). http://www.bookthink.com/0069/69alt.htm. . MSM

Dr. Stanley Jacob of the Oregon Health Sciences University of Portland, Oregon, and his associate, Robert Herschler, a research chemist, were the pioneers of MSM research. Their work on MSM was actually an offshoot of their extensive investigations of DMSO, the chemical cousin of MSM.

The story is that Robert Herschler, a research chemist for the paper manufacturing company, Crown Zellerbach, was investigating possible commercial uses for DMSO, which is a by-product of paper milling. DMSO is found in substantial quantities in the water which is used during the milling and processing of trees for paper production.

In his search for commercial or medical uses of DMSO, Herschler apparently contacted Dr. Jacob, a medical researcher, who began to study the biological effects of DMSO on animals.

After testing and observing the biological effects of DMSO on animals over the course of several years, Jacob and Herschler began observing its effects on humans. They discovered and documented several of its remarkable therapeutic benefits. DMSO was found to be effective for a variety of conditions including joint and muscle pains and injuries, rheumatoid arthritis, skin ulcers, psoriasis, bursitis, emphysema and interstitial cystitis (chronic urinary tract infection). In 1963, Jacob and Herschler reported their findings on DMSO; today DMSO is an approved pharmaceutical agent in over 50 countries.

DMSO can be applied intravenously or topically. Because it penetrates well through the skin's outer layers, it is absorbed efficiently into the bloodstream through the topical route (liquid or salve).

But even though it's widely used throughout the world, DMSO has exhibited certain properties that have made it somewhat unpopular, particularly in the United States. One of the biggest factors that has limited the everyday use of DMSO is its side effects, which, although not severe, have nonetheless restricted its application. The resulting bad breath or "after breath" which is associated with the use of DMSO is extremely strong, and there may be a reddening and itching of the skin, making DMSO unappealing to many users. Additionally, DMSO has produced allergic symptoms in some individuals.

However, while continuing their DMSO studies, Jacob and Herschler discovered that the primary healing agent in DMSO appeared to be its cousin, the sulfur compound, MSM (methyl sulfonyl- methane). MSM can be produced by adding another stabilising oxygen molecule to DMSO which yields DM502, another term for MSM. MSM was eventually patented under Robert Herschler's name, but Jacob reports that he signed an agreement with Herschler whereby they would both share the patent and marketing rights to MSM.

Jacob, Herschler and other researchers continued to conduct extensive laboratory and clinical trials with MSM. These studies revealed numerous extraordinary therapeutic benefits - without the odour, allergies or side effects experienced with DMSO. MSM research and health benefits

In laboratory and clinical testing, MSM has shown remarkable promise for side-effect-free healing. In his work with MSM at the Oregon Health Sciences University in Portland, Oregon, Dr. Jacob, a pioneer MSM researcher, has reported a wide variety of MSM health benefits. These reports stem from several years of observation in both animal and human studies.

As Jacob and Herschler report: "MSM, an odourless, somewhat bitter, white crystalline chemical, demonstrates usefulness as a dietary supplement to man and lower animals. Our research suggests that a minimum concentration in the body may be critical to both normal function and structure. We are intrigued by the fact that MSM is a factor in all normal diets of vertebrates and somewhat mystified by the seeming needs of the body of adults for a concentration level above that available from a diet presumed as 'normal'." At the Oregon Health Sciences University, Jacob has administered MSM to over 15,000 patients for a variety of conditions. Dr. Jacob observed excellent results in administering MSM in doses of 250 to -750 milligrams per day to his patients, but he also reports that much higher doses (up to 5000 mg per day) can produce definitive therapeutic improvements without side effects. In the next few pages, we'll look at specified illnesses and specific MSM research which will give you a better idea of how to use MSM effectively to improve your health.

For Therapeutic Purposes

Because of the non-toxic nature for MSM, researchers have found that even high dosages can be taken safely for therapeutic purposes. The amount you need really depends on the severity of your symptoms, the overall condition of your immune system and how effectively your body is able to utilise the MSM. Other factors such as body size and weight can also affect the amount of MSM you need to take. I've given several suggested dosage levels for specific illnesses in the preceding pages, but I'll give you a few more general guidelines that may help you to better determine how much and what form of MSM to take:

1. MSM must be taken frequently in order to be therapeutically effective. When taking MSM to improve symptoms of illness, MSM should be taken everyday.

2. Researchers have generally used total daily dosages ranging from 250 mg to 2000 mg per day in treating illness. In severe cases, up to 5000 mg/day for a limited time have been administered without side effects.

Noticeable results are usually seen in 1 to 21 days for less severe symptoms. For more serious conditions, researchers report that higher doses (2000-5000 mg/day) can be taken. When using large doses, it's best to divide your dosage into equal parts to be taken throughout the day (for instance, for a 2000 mg dose, take 1000 mg twice a day, or 500 mg four times a day, etc.). If you have a serious condition and want to try high dosages of MSM, working with you health practitioner is always a good idea in order to monitor changes, improvements, etc. in your individual condition.

Drug Interactions

Because of its non-toxic nature, MSM is non-allergenic and does not interfere or interact with any other types of pharmaceutical medicines. Researchers report that MSM can be taken in conjunction with all other forms of medication.

Water is very important to help flush toxins out of the body. More water, the faster the results, and the fewer side effects will be experienced from the detoxification process. Some individuals find that MSM gives them extra energy so in order to avoid sleep difficulties, avoid taking any MSM after 6pm. Possible side effects: One may experience headaches and fatigue for the first few days due to the detoxification process. If this occurs, drink more water. Do not be alarmed as this is a natural part of the healing process.

3. Magnesium chloride

Structure, preparation, and general properties

MgCl ₂ crystallizes in the cadmium chloride motif, which features octahedral Mg. A variety of hydrates are known with the formula MgCl ₂ (H ₂ 0) _x , and each loses water with increasing temperature: x = 12 (-16.4 °C), 8 (-3.4 °C), 6 (116.7 °C), 4 (181 °C), 2 (ca. 300 °C). ^m In the hexahydrate, the Mg ²⁺ remains octahedral, but is coordinated to six water ligands. ¹ ^ The thermal dehydration of the hydrates

MgCl ₂ (H ₂ 0)x (x = 6, 12) does not occur straightforwardly. ¹²¹

As suggested by the existence of some hydrates, anhydrous MgCl ₂ is a Lewis acid, although a very weak one.

In the Dow process, magnesium chloride is regenerated from magnesium hydroxide using hydrochloric acid:

Mg(OH) ₂ (s) + 2 HC1→ MgCl ₂ (aq) + 2 H ₂ 0(1) It can also be prepared from magnesium carbonate by a similar reaction.

In most of its derivatives, MgCl ₂ forms octahedral complexes. Derivatives with tetrahedral Mg ²⁺ common. Examples include salts

Applications

Magnesium chloride serves as precursor to other magnesium compounds, for example by precipitation:

MgCl ₂ (aq) + Ca(OH) ₂ (aq)→ Mg(OH) ₂ (s) + CaCl ₂ (aq) It can be electrolysed to give magnesium metal: ¹ ^

MgCl ₂ Q)→Mg(D + Cl ₂ (.g) This process is practiced on a substantial scale.

Magnesium chloride is used for a variety of other applications besides the production of magnesium: the manufacture of textiles, paper, fireproofing agents, cements and refrigeration brined and dust and erosion control. Mixed with hydrated magnesium oxide, magnesium chloride forms a hard material called Sorel cement.

Magnesium ion Mg ²⁺ (usually added as the chloride) is an important component in the polymerase chain reaction, a procedure used to amplify DNA fragments. It is generally used in experimental biology whenever RNA and DNA and their enzymes are to function in vitro, since Mg ⁺ is a necessary associate ion for nucleotides in biology, such as ATP.

Magnesium chloride is also used in several medical and topical (skin related) applications. It has been used in pills as supplemental sources of magnesium, where it serves as a soluble compound which is not as laxative as magnesium sulfate, and more bioavailable than magnesium hydroxide and magnesium oxide, since it does not require stomach acid to produce soluble Mg ²⁺ ion. It can also be used as an effective anaesthetic for cephalopods, some species of crustaceans, ¹⁶¹ and several species of bivalve, including oysters.^

Medical and veterinary use

Medically-prescribed magnesium supplements such as Slo-Mag and Mag-SR contain magnesium chloride which is slowly released from a matrix. However, since magnesium is absorbed by the body in ionic form (after the salt dissolves in water) such supplements have no advantage over any soluble magnesium salt (for example, magnesium citrate or magnesium aspartate).

One veterinary study in 1989 indicated some effectiveness against tumors when magnesium chloride was used as a feed additive.^

Toxicology

Magnesium ions are bitter-tasting, and magnesium chloride solutions are bitter in varying degrees, depending on the concentration of magnesium. '

Magnesium toxicity from magnesium salts is rare in healthy individuals with a normal diet, because excess magnesium is readily excreted in urine by the kidneys. A few cases of oral magnesium toxicity have been described in persons with normal renal function ingesting large amounts of magnesium salts, but it is rare. If a large amount of magnesium chloride is eaten, it will have effects similar to magnesium sulfate, causing diarrhea, although the sulfate also contributes to the laxative effect in magnesium sulfate, so the effect from the chloride is not as severe.

Notes & references

1. ^A Holletnan, A. F.; Wiberg, E. "Inorganic Chemistry" Academic Press: San Diego, 2001. ISBN 0- 2-352651-5.

2. ^A Wells, A. F. ( 1984) Structural Inorganic Chemistry, Oxford: Clarendon Press. ISBN 0-1 -855370-6.

3. ^A see notes in Rieke, R. D.; Bales, S. E.; Hudnall, P. M.; Burns, T. P.; Poindexter, G S. "Highly Reactive Magnesium for the Preparation of Grignard Reagents: 1-Norbomane Acid" Organic Syntheses, Collected Volume 6, p.845 (1988).

http://www.orgsvn.org/orgsvn/pdfs/CV6P0845.pdf

4. ^A N. N. Greenwood, A. Earnshaw, Chemistry of the Elements, Pergamon Press, 1 84.

5. ^{Λ Λ} - Hill, Petrucci, McCreary, Perry, "General Chemistry", 4th ed., Pearson/Prentice Hall, Upper Saddle River, New Jersey, USA.

6. ^Λ http://webs.lander.edu/rsfox invertebrates/homarus.html

7. * Culloty, S.C. & Mukahy, M.F. 1992. An evaluation of anaesthetics for Ostrea edulis (L.). Aquaculture. 107: 249-252.

8. ^A Food Standard Agency. "Current EU approved additives and their E Numbers".

http://www.food.gov.uk safereating/chemsafe/additivesbranch/enumberlist. Retrieved 22 March 2010.

9. * [pubs.aic.ca/doi/pdf/10.4141/cjps85-018 Comparison of Magnesium Sulfate and THIS Mg Chelate Foliar Sprays]

10. ^A Magnesium Chloride Toxicity in Trees

1 1. ^A Effect of Foliar and Soil Magnesium Application on Bacterial Leaf Spot of Peppers

12. ^A Veterinary Medical Research Institute. Iowa State University

13. ^Λ Atherogenesis inhibition induced by magnesium-chloride fortification of drinking water

14. * http://www.advancedaquarist.com/issues/oct2003/chem.htm SUMMARY OF THE INVENTION

In a first aspect, the invention provides a combination of at least two of the specified ingredients, which: (a) is able to kill or inhibit the growth of cancer cells, but does not significantly affect normal neonatal fibroblasts, or spontaneously transformed keratinocytes.

Preferably, the compound(s) is able to inhibit the growth of at least one cell line selected from the group consisting of MM96L, MM229, MM220, MM237, MM2058, B16, LIM1215, HeLa, A549, MCF7, MCC16 and Colo 16 as herein defined. More preferably, the compound(s) is able to inhibit growth of or to induce differentiation in MM96L cells.

Even more preferably the composition is also able to induce normal melanocytes to proliferate.

Preferably, the composition is present in the combination of at least two of the specified ingredients.

In a second aspect, the invention provides a composition comprising of at least two active ingredients as described above, together with a pharmaceutically-suitable carrier or diluent.

More preferably the composition is selected from the group consisting of Sodium Bicarbonate, MSM and Magnesium Chloride.

In a third aspect, the invention provides a method of treatment of a cancer, comprising the step of administering an anti-cancer effective amount of the invention to a mammal in need of such treatment.

In a fourth aspect, the invention provides a method of inhibiting proliferative activity of neoplastic cells, comprising the step of exposing the cells to an anti-proliferative amount of a composition of the invention. The cells may be treated either ex vivo or in vivo.

In a fifth aspect, the invention provides a method of preventing or alleviating damage to skin, caused by ultraviolet irradiation, ionizing radiation, microwave radiation, exposure to ozone, or the like, comprising the step of topically administering an effective amount of a composition of the invention to a subject in need of such treatment. This aspect of the invention may be used in the treatment of solar keratosis, skin damage occurring during radiotherapy, and the like.

In a sixth aspect the invention provides a method of stimulating proliferation of non-neoplastic cells comprising the step of exposing the cells to a proliferation-inducing amount of a composition of the invention. This is useful in inducing regeneration of tissues and is useful in promoting the immune response to disease states.

The mammal may be a human, or may be a domestic or companion animal. While it is particularly contemplated that the invention is suitable for use in medical treatment of humans, it is also applicable to veterinary treatment, including treatment of companion animals such as dogs and cats, and domestic animals such as horses, cattle and sheep, or zoo animals such as felids, canids, bovids, and ungulates.

For the purposes of this specification it will be clearly understood that the word "comprising" means "including but not limited to", and that the word "comprises" has a corresponding meaning. The word ingredient refers to Sodium Bicarbonate, MSM and Magnesium Chloride.