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`SPECIFICATION
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`To AII Whom It May Concern:
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`Be it known that We, Donald W. Miller and Jonathan L Vennerstrom ,
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`being a citizens of the Unìted States, .and residing in the City of Omaha, and
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`State of Nebraska, and whose full post office addresses are 2573 South 138th
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`Street, Omaha , Nebraska, 68144 , and 3209 South 73rd Street, Omaha,
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`Nebraska, 68124, have invented new and useful improvements in
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`CREAτINE ORAL SUPPLEMENτATION USING CREATINE
`HYDROCHLORIDE SAL T
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`DN: 7412/PMD/sla/3.21.03
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`001
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`Harvest Trading Group - Ex. 1103
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`BACKGROUND OF THE INVENτION
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`Dietary supplementation with creatine is an approved and accepted
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`means for increasing musc1e performance, and increasing muscle mass.
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`Most current commercial applications involving creatine supplementation use
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`the creatine monohydrate form as the primary embodiment. A limitation of
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`creatine supplements using the creatine monohydrate form is that the
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`products have low aqueous solubility and requires relatively large doses of
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`creatine be consumed with large amounts of fluid.τhe physiochemical
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`properties of creatine monohydrate are such that oral absorption is lim 社ed.
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`There are other salt forms including creatine citrate (creatine e仔'e rvescent)
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`and creatine pyruvate that have been patented and marketed as
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`improvements over creatine monohydrate. Despite the various salt forms
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`currently marketed , there is an unmet need for an improved form of creatine
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`that could be taken in a more convenient dosage form and have better oral
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`absorption characteristics.
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`SUMMARY OF THE INVENTION
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`This invention relates principally to the use of creatine hydrochloride
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`salt for application to aqueous solutions for use as a beverage in the sports
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`environment, liquid meal replacement, nutritional energy bars, and other
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`fortified foods.
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`DN: 7412/PMD/sla/3.21.03
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`Harvest Trading Group - Ex. 1103
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`In essence, this invention relates to the usage of a granular precipitate
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`consisting of creatine hydrochloride salt in a high purity and yield. More
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`specifical 旬， the creatine hydrochloride sa 性， when added to a solution, and
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`, used as a beverage or other form of drink, functions as a nutritional
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`supplement for enhancing muscle performance and developing muscle mass
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`in both humans and livestock.
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`It 泊， therefore , the principle object of this invention to utilize creatine
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`hydrochloride sa柱， apart from other forms of creatine , but in this instance,
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`having high aqueous solubility so as to readily mix with any liquid, or
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`beverage, and having application in the field of athletics to enhance
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`developed and generated strength.
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`Another 0阿ect of this invention is the application of hydrochloride
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`sa 悔， of creatine form , that may be added as a feed additive when fed to
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`livestock, or other animals.
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`These and other objects may become more apparent to those skilled
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`in the art upon review of the summary of the invention as provided herein and
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`upon undertaking a study of the description of its preferred embodiment.
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`DESCRIPTION OF THE PREFERRED EMBODIMENT
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`The present invention involves a process for the production of the
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`hydrochloride salt form of creatine. The process uses creatine monohydrate
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`and acetyl chloride as the reactants and ethanol as the preferred solvent.
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`The product of this reaction is a granular precip 控ate consisting of the creatine
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`DN: 7412/PMD/sla/3.21.03
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`3
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`hydrochloride salt in high purity and yield. The invention also involves an
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`application/use of the creatine hydrochloride salt as a nutritional supplement
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`for enhancing muscle pe斤。 rmance and muscle mass in both humans and
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`livestock. What sets the creatine hydrochloride salt apart from the other
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`forms of creatine is its hígh a司 ueous solubílity. Studies in our laboratory
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`índicate that the aqueous solubility of the creatine hydrochloride is 150 mg/ml
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`or greater, while that of creatine monohydrate and creatine citrate salt is at
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`least an order of magnitude lower (approximately 10-15 mg/ml). As the low
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`oral absorption of creatine supplements are ,believed to be atlributable in part
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`to reduced solubility, the creatine hydrochloride would be expected to have
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`better oral absorption properties.
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`Various other applications for use with this type of a sa址， other than in
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`the spo吋s beverage area, may include its application as a feed additive in
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`livestock. Certainly雪 based upon what ís now known about the product, it
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`15 would have immediate applícations in the solid oral dosage supplementation
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`area , as an additive or a feed supplement in livestock feed. Or, it may be
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`added into a liquid , or any water, that is fed to the livestock, during there
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`consumption of liquids and solids.
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`τhis is contemplated wíthin the essence of this invention that the
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`formulation for the oral supplementation of this invention could be provided in
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`a solid oral dosage form , such as in a capsule form , or table拾， for treatment
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`requirements when taken by the human, animal, and the like. This is known
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`in the art. The formulation for the creatiñe oral supplementation, using the
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`DN: 7412/PMD/sla/3.21.03
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`Creatine Hydrochlori位e Sa缸， is CrHCI. The formulation could be added into a
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`beverage in addition the CrHCI may be provided as an ingredient to a spo吋s
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`drink, liquid meal replacem~nt， or the like, and as can be understood.
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`Furthermore, the concept of this invention for use of this formulation within a
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`supplementation can be used and applied for nutritional and energy
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`purposes. Furthermore, the composition could be added as a fortification to
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`other foods. Finally, it is likely that this composition could be added as a feed
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`suppleme此， to further enhance the energy requirements of the horses, and
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`other animals , as may be desired and required.
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`Variations or modifications to the subject matter may occur to those
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`skilled in the a 此 upon review of the invention as described herein.、 Such
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`variations , if within the spirit of this developmer話， are intended to be
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`encompassed within the scope of the invention as defined herein. The
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`description of the preferred embodiment, as provided , is set forth for
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`illustrative purposes only.
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`DN: 7412/PMD/sla/3.21.03
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`ABSτRACτOF THE INVENTION
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`'Creatine oral supplementation using creatine hydrochloride sa缸， that
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`may be added to a liquid or other beverage, or may be also used as an
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`additive',to solid oral dosages , or as a suppleme前， and which may be
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`consumed by the athlete, or other party looking for immediate
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`、 supplementation of strength, and may be added as a supplement within feed
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`to livestock, in the veterinary area.
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`DN: 7412/PMD/sla/3.21.03
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`Harvest Trading Group - Ex. 1103