Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
1999-12-01
2002-11-05
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S489000, C514S023000, C514S300000
Reexamination Certificate
active
06475514
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to patches for the administration of an athletic supplement to subjects engaged in rigorous exercise or heavy outdoor work. The invention also relates to methods of administering nutrients to subjects using the patch of the invention.
BACKGROUND OF THE INVENTION
Strenuous exercise that occurs during athletic events, such as marathons, causes trauma to the body. For instance, exercise causes the release of adrenocorticotropin (ACTH) which leads to the increased production and release of cortisol. High levels of cortisol cause the release of amino acids from muscle tissue and prevent absorption of glucose, causing the catabolic breakdown of muscle tissue. Many cortisol blockers can be used to prevent the catabolic breakdown of muscle tissue, including leucine, antioxidants, and glutamic acid.
Exercise also causes the loss of many nutrients. Many types of sports drinks have been developed and marketed with the intent to replace the nutrients lost during athletic events. These sports drinks, such as Gatorade utilize sugar and electrolytes with water to prevent loss of carbohydrates and water during exercise. In general these drinks include sugars, electrolytes, vitamins, minerals, amino acids, and other important nutrients. In some cases pyruvate has also been added to such drinks to improve performance and help to prevent the detrimental breakdown of protein as an energy source.
There are several types of sports drinks currently available. One type includes sugar and water, such as the drink marketed by Coca-Cola Company under the trade name “Max”. Max contains a 5% solution of dextrose and maltodextrin. Other types of sports drinks include sugar, water and electrolytes, and in some cases vitamins. These types of drinks include Gatorade and Exceed. Gatorade, for instance, contains a 6% solution of sucrose and glucose, 220 mg of sodium and 50 mg of potassium per serving and some vitamin C. Even other drinks, such as Body Fuel 450, include sugar, water, electrolytes, vitamins and minerals. The most comprehensive of these drinks include the following ingredients:
1-100 g of at least 1 carbohydrate,
2-2500 mg of at least 1 electrolyte,
0.1-750 mg of at least 1 ammonia neutralizer,
at least one energy enhancer, preferably selected 2000 mg vitamins of the vitamin B group, 10-40,000 mg L-carnitin, creatine and choline, and 1-100 mg branched chain amino acids,
at least one antioxidant, preferably selected from &bgr;-carotene in a quantity of 2 &mgr;g-200 &mgr;g, vitamin C in a quantity of 10-250 mg, vitamin E in a quantity of 8-30 I. selenium in a quantity of 10-300 &mgr;g,
1-30 mg of at least 1 membrane stabilizer,
1-200 &mgr;g of at least 1 neuromuscular enhancer, and
water in a quantity at least sufficient to provide a solution such that each of the above components are substantially dissolved and which is ready for consumption by drinking.
One problem with all of these drinks is that they are dependent upon gastrointestinal absorption in order for the nutrients to be administered and disseminated among the body. Under conditions of dehydration and electrolyte imbalance, normal absorption may not occur. Additionally, not all of the nutrients are metabolized at the same rate, and thus may not be effectively used during the period of the athletic event.
Much research has indicated that amino acids of the branched chain type including valine, leucine and isoleucine, are essential to maintaining and repairing cellular integrity during athletic stress. One problem with these amino acids, however, is their adverse palatability, making it difficult to incorporate them into sports drinks.
Additionally, the sports drinks require that energy be utilized to digest and process the nutrients therein. This process requires thee use of energy which could otherwise be used to fuel the muscles and provide energy to the athlete.
SUMMARY OF THE INVENTION
The present invention relates to methods and products for replenishing nutrients and supplying additional components to a subject involved in strenuous exercise which avoids many of the limitations associated with sports drinks.
The invention in one aspect is a patch for administering nutrients utilized during exercise and other periods of high energy consumption. The patch is particularly useful for athletes during sporting events such as marathons in which the nutrients are used rapidly by the body. The nutrients are delivered from the patch directly to the blood stream where they can supply the necessary energy or maintenance of homeostatic conditions in the body. There is no need for the nutrients to pass through the gastrointestinal tract where absorption would be a limiting factor.
In one aspect the invention is an article of manufacture including a patch for topical delivery of an athletic supplement to a subject which includes at least two compounds selected from the group consisting of a carbohydrate, an electrolyte, a vitamin, an amino acid, chromium, and a mineral. Preferably the patch includes at least three of these compounds. Preferably the athletic supplement includes at least one carbohydrate.
In one embodiment the athletic supplement includes an electrolyte. In another embodiment the athletic supplement includes a vitamin. In another embodiment the athletic supplement includes an amino acid. In yet another embodiment the athletic supplement includes chromium. According to another embodiment the athletic supplement includes an energy enhancer. Preferably, the athletic supplement includes a vitamin, an amino acid, chromium, and an energy enhancer.
The patch may include many different concentrations of the components of the athletic supplement. In a preferred embodiment the athletic supplement is at least 1 to 100 grams of carbohydrate and 2 to 2500 milligrams of electrolyte.
In addition to the above-described components, the athletic supplement may also include at least one of the following compounds: sodium chloride, potassium chloride, anhydrous magnesium sulphate, dodecahydrated disodium hydrogen phosphate, hydrated sodium dihydrogen phosphate, dextrose, sucrose, ascorbic acid, pyridoxine hydrochloride, sodium citrate, and citric acid.
The patch may be any type of conventional patch, such as a transdermal patch, a sublingual patch, or a buccal patch. Preferably, the patch is a transdermal patch for administering the athletic supplement to skin of the subject. In a preferred embodiment the patch includes a permeation enhancing amount of at least one skin permeation enhancer. Preferably the skin permeation enhancer is selected from the group consisting of menthol, eucalyptol, glyceryl monostearate and d-limonene. In another preferred embodiment the patch is a sublingual patch.
According to another aspect of the invention an article of manufacture is provided. The article of manufacture includes a patch for topically administering an athletic supplement to a subject, wherein the device is formulated to deliver the athletic supplement within 24 hours. In one embodiment the patch is a transdermal patch for administering the athletic supplement to skin of the subject.
The patch may be designed to release the athletic supplement over any period of time within 24 hours. In one embodiment the patch is formulated for administering the athletic supplement within 12 hours. In another embodiment, the patch is formulated for administering the athletic supplement within 6 hours. In yet another embodiment the patch is formulated for administering the athletic supplement within 4 hours.
According to another embodiment the patch includes a permeation enhancing amount of at least one skin permeation enhancer selected from the group consisting of menthol, eucalyptol, glyceryl monostearate and d-limonene.
Preferably the athletic supplement includes at least one carbohydrate.
In one embodiment the athletic supplement includes an electrolyte. In another embodiment the athletic supplement includes a vitamin. In another embodiment the athletic supplement includes an amino acid. In yet another embodiment the
Blitzer Andrew
Pretorius Terry
Ghali Isis
Page Thurman K.
Wolf Greenfield & Sacks P.C.
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