COMPOSITIONS AND METHODS FOR ENHANCING ATHLETIC PERFORMANCE
A powder blend comprising (a) an immediate release powder comprising at least one performance enhancing component and (b) extended release granules comprising a core. The core of the extended release granules comprises at least one performance enhancing component and one or more fatty materials. The immediate release powder is soluble in an aqueous medium, while the extended release granules are formulated to exhibit neutral buoyancy in an aqueous medium.
1 . A performance enhancing immediate and extended release composition comprising:
(a) an immediate release powder comprising at least one first performance enhancing component; and
(b) extended release granules comprising a core, the core comprising at least one second performance enhancing component and one or more fatty materials;
wherein the immediate release powder is soluble in an aqueous medium.
2 . The performance enhancing immediate and extended release composition of claim 1 , wherein the one or more fatty materials comprise powdered fats.
3 . The performance enhancing immediate and extended release composition of claim 2 , wherein the one or more fatty materials are selected from the group consisting of hydrogenated vegetable oil, stearic acid, fractionated vegetable oil, glycerol fatty acid ester, and combinations thereof.
4 . The performance enhancing immediate and extended release composition of claim 1 , wherein the particle size of extended release granules is from about 425 μm to about 850 μm.
5 . The performance enhancing immediate and extended release composition of claim 1 , wherein the extended release granules further comprise a barrier coating layer.
6 . The performance enhancing immediate and extended release composition of claim 5 , wherein the barrier coating comprises ethylcellulose.
7 . The performance enhancing immediate and extended release composition of claim 5 , wherein the barrier coating comprises hydroxypropyl methylcellulose.
8 . The performance enhancing immediate and extended release composition of claim 1 , wherein the core of the extended release granules further comprises one or more swellable polymers.
9 . The performance enhancing immediate and extended release composition of claim 1 , wherein the immediate release powder further comprises at least one viscosity modifier.
10 . The performance enhancing immediate and extended release composition of claim 9 , wherein the viscosity modifier is selected from the group consisting of guar gum, xantham gum, and silica.
11 . The performance enhancing immediate and extended release composition of claim 1 , wherein a bulk density of the extended release granules is from about 0.3 g/cc to about 0.75 g/cc.
12 . The performance enhancing immediate and extended release composition of claim 1 , wherein the at least one performance enhancing first component of the immediate release powder comprises at least one active selected from the group consisting of a vitamin, a mineral, protein, creatine, an amino acid, a carbohydrate, a fatty acid, a stimulant, pyruvate, and a citric acid cycle intermediate.
13 . The performance enhancing immediate and extended release composition of claim 1 , wherein the at least one performance enhancing second component of the extended release granules comprises at least one active selected from the group consisting of a vitamin, a mineral, protein, creatine, an amino acid, a carbohydrate, a fatty acid, a stimulant, pyruvate, and a citric acid cycle intermediate.
14 . The performance enhancing immediate and extended release composition of claim 1 , wherein the extended release granules further comprise at least one excipient selected from the group consisting of a diluent, a binder, a lubricant, a disintegrant, a flavoring agent, a coloring agent, a stabilizer, a surfactant, a glidant, a preservative, and a sweetener.
15 . The performance enhancing immediate and extended release composition of claim 1 , wherein the extended release granules are configured to remain suspended once dispersed in an aqueous medium without either sinking or floating from within about the first 15 seconds of agitation to within about 1 minute and 15 seconds of agitation.
16 . A performance enhancing immediate and extended release oral suspension, said oral suspension comprising:
(a) an immediate release component comprising at least one first performance enhancing component; and
(b) extended release granule component comprising a core, the core comprising at least one second performance enhancing component and one or more fatty materials; and
(c) a dispersion medium.
17 - 40 . (canceled)
41 . A process of reducing fatigue or enhancing exercise performance in a subject comprising administering to the subject the composition of claim 1 , wherein the extended release granules optionally have a bulk density from about 0.3 g/cc to about 0.75 g/cc;
the step of administering prior to or during exercise.
42 . The process of claim 41 wherein said extended release granules comprise caffeine in the core, the release profile of the caffeine in an aqueous medium of not more than 10 weight percent caffeine in 20 minutes and not less than 80 weight percent caffeine in 40 minutes.
43 . The process of claim 41 wherein said extended release granules comprise free leucine in the core, the release profile of the leucine in an aqueous medium of not more than 10 weight percent leucine in 60 minutes and not less than 80 weight percent leucine in 4 hours.
44 . The process of claim 41 wherein said extended release granules comprise norvaline in the core, the release profile of the norvaline in an aqueous medium of not more than 70 weight percent norvaline in 30 minutes.
45 - 46 . (canceled)