Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from panax or acanthopanax
Reexamination Certificate
2001-08-28
2002-07-02
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from panax or acanthopanax
C424S497000, C514S565000
Reexamination Certificate
active
06413552
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to the field of muscle stimulation and more particularly to enhancing the production of the energy used to cause contractions and expansions in the muscles of mammals.
Creatine is an important source of providing energy to muscles through its role in adenosine triphosphate (ATP) formation. ATP is the fuel source for muscle contraction. It is formed when adenosine diphosphate (ADP), adds another phosphate group to form ATP. Creatine provides the source for replacing the phosphate group to convert ADP to ATP. As such, it is an integral part of the muscle contraction and expansion process. The more creatine available to muscles, the more ADP can be converted to ATP for use by those muscles. Therefore, for persons involved in strenuous physical activities, such as athletes, a constant source of creatine is vital in order to maintain muscle energy levels.
Creatine is a popular nutritional supplement useful as an energy source for muscles. Chemically, creatine is N-methyl-N-guanylglycine. Creatine is biosynthesized through the transamidination and transmethylation of the amino acids glycine, arginine and methionine.
Creatine is available from several food sources. However, athletes and others wishing to maintain a high level of creatine in their muscles have popularized oral creatine supplements in recent years. These have taken the form of creatine powders, pills, gels, and drinks. Unfortunately, each of these has their drawbacks. A topically applied creatine product holds several advantages over creatine taken orally. Side effects of orally administered creatine are common, including diarrhea, abdominal cramping, flatulence and nausea. One study (Sahelian, R. et al Creatine: Nature's Muscle Builder, 1997) revealed that 38% of men and 25% of women who took oral creatine supplements experienced side effects.
Creatine powders need to be mixed with a liquid and ingested immediately in order to prevent the creatine from being converted to creatinine (an inactive compound) by the liquid. The process of mixing the powder and the liquid is often quite messy. Other preparations such as consumable pills and gels may have a bad taste. Drinks need refrigeration in order to keep the creatine stable in liquid form.
A topically applied creatine product would not have the systemic side effects, mess, inconvenience, and bad taste often associated with orally administered creatine products. In addition, topically applied creatine could be used to augment oral creatine or to potentially reduce the orally ingested dosage.
One of the limitations of using a creatine product is its low solubility in water (1 g in 75 ml). Also, creatine converts to its inactive form, creatinine, at a greater rate when it is mixed with water, alcohol or any other water soluble liquid. Oral creatine gels and liquids have been previously described, but their constitution would render them unfit for topical use because they would be either too sticky, too irritating, or unsuccessful in penetrating the skin. Additionally, none of the currently patented oral creatine products have claimed a topical use.
The invention encompasses a topically applied liquid, gel, cream, ointment, paste, powder, shampoo, solution, lotion, patch, or spray containing stable creatine useful in enhancing muscle strength and energy without traveling through the user's blood stream to the muscle.
U.S. Pat. No. 5,612,375 discloses a process for producing a healthy or nutritious beverage comprising creatine as a main ingredient, in which the effect of creatine is not lost during preservation, and the beverage can be prepared at low cost. A process for producing a creatine beverage comprising the steps of: heating water rendered weakly alkaline; adding from 1 to 3 grams per 100 cc of the heated water, of crystalline creatine powder to the heated water; dissolving the creatine powder by stirring to form a creatine aqueous solution; and adding an additive to the creatine aqueous solution for improving nutrition or palatability, and sterilizing the creatine aqueous solution to obtain a creatine beverage having a pH value of 7 to 10. This invention can be distinguished from the present invention because it covers a beverage containing creatine and the process for producing the beverage and not a process for making a stable topical creatine application suitable for absorption directly through the skin into the underlying muscle without traveling through the blood system eliminating the typical creatine side effects like the present invention.
U.S. Pat. No. 5,773,473 discloses a creatine supplement which contains a combination of creatine and propylene glycol. The supplement preferably contains from about 25-50% creatine and from about 50-75% propylene glycol. The propylene glycol not only makes the supplement more bioavailable than conventional creatine supplements, but also decreases the incidence of side effects. This invention can be distinguished from the present invention because it covers an orally introduced creatine dietary supplement and the process for producing the beverage and not a process for making a stable topical creatine application suitable for absorption directly through the skin into the underlying muscle without traveling through the blood system like the present invention.
U.S. Pat. No. 5,886,042 discloses preventive as well as therapeutic treatment to alleviate cosmetic conditions and symptoms of dermatologic disorders with amphoteric compositions containing alpha hydroxyacids, alpha ketoacids, related compounds or polymeric forms of hydroxyacids. The cosmetic conditions and the dermatologic disorders in which the amphoteric compositions and the polymeric compounds may be useful include dry skin, dandruff, acne, keratoses, psoriasis, eczema, pruritus, age spots, lentigines, melasmas, wrinkles, warts, blemished skin, hyperpigmented skin, kyperkeratotic skin, inflammatory dermatoses, skin changes associated with aging, and skin requiring cleansers. This invention can be distinguished from the present invention because it covers a topical treatment for skin disorders associated with keratinization or inflamation and not a process for making a stable topical creatine application suitable for absorption directly through the skin into the underlying muscle to increase the amount of energy available to the muscle energy.
U.S. Pat. No. 5,908,864 discloses a nutritional gel containing creatine and the method of producing the creatine gel. The creatine gel is made by cross linking maltodextrin and a modified starch through an aqueous endothermal reaction at a temperature of approximately 90 degrees Celsius. A buffering agent, such as potassium phosphate, is added to the gel to maintain a pH value at approximately 7.0. The gel is then cooled and creatine is added. Next, the gel is stabilized bacteriologically by adding a preservative, such as potassium sorbate to the gel. This invention can be distinguished from the present invention because it covers an orally introduced creatine dietary supplement and the process for producing it and not a process for making a stable topical creatine application suitable for absorption directly through the skin into the underlying muscle without traveling through the blood system like the present invention.
U.S. Pat. No. 5,973,005 discloses a stable aqueous solution of creatine acid sulfate which provides a source of creatine to an animal when taken orally. The aqueous solution of creatine acid sulfate (after neutralization and buffering) has a pH of about 7.2 to about 7.8 and is stable for at least six months at room temperature. The creatine acid sulfate is produced by adding creatine monohydrate to a sulfuric acid solution in a stoichiometric amount to result in creatine acid sulfate having a pH initially of 2.0-3.0. The resulting creatine acid sulfate is diluted with water and neutralized to raise the pH and avoid the formation of creatinine. The resulting creatine acid sulfate solution preferably contains a buffering and neutralizing agent
Belasco Jacobs & Townsley LLP
Tate Christopher R.
Townsley Norton R.
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