METHOD OF PRODUCING PHYSIOLOGICAL AND THERAPEUTIC LEVELS OF NITRIC OXIDE THROUGH AN ORAL DELIVERY SYSTEM
A composition and method of providing nitric oxide and nitrite therapy to patients whereby a therapeutic amount is bioavailable within approximately 30 minutes of administration. In embodiments of the invention, nitric oxide is produced in the oral cavity.
1 . A delivery system comprising:
beet root, Vitamin C, and an agent that reduces nitrite to nitric oxide; and
a dispersable medium adapted to be consumed in the oral cavity;
wherein the nitric oxide-producing component is adapted to generate nitric oxide in vivo upon consumption of the dispersable medium.
2 . The delivery system of claim 1 , wherein the dispersable medium is dissolvable in the oral cavity.
3 . The delivery system of claim 1 , wherein the dispersable medium is dissolvable in about five minutes or less.
4 . The delivery system of claim 1 , wherein the delivery system is adapted to generate nitric oxide in the oral cavity.
5 . The delivery system of claim 1 , where the nitric oxide-producing component is adapted to generate nitric oxide in-vivo in response to dissolution of the delivery system in the gastro intestinal tract.
6 . The delivery system of claim 1 , wherein the delivery system is formed of a lozenge, liquid, powder, solid, semi-solid, cream, gel, emulsion, suspension, heterogenic liquid, film, or topical.
7 . The delivery system of claim 1 , wherein the dispersable medium comprises one or more of a sugar, dispersing agent, flavor, sweetener, color, alcohol, maltodextren, or filler.
8 . The delivery system of claim 1 , wherein the nitric oxide-producing component is comprised of a nitrite, nitrate, or reductase or a combination of nitrite, nitrate and reductase.
9 . The delivery system of claim 1 further comprising a barrier for preventing contact of two or more species of the nitric oxide-producing component.
10 . The delivery system of claim 9 , wherein the two or more species are nitrite and nitrite reductase.
11 . The delivery system of claim 9 , wherein the barrier comprises sugar, dispersing agent, flavors, sweetener, color, alcohol, maltodextren, or filler.
12 . The delivery system of claim 1 further comprising a disintegrating agent, a compactible excipient, or both.
13 . The delivery system of claim 12 , wherein the disintegrating agent absorbs fluid upon contact with fluid.
14 . The delivery system of claim 12 , wherein the compactable excipient is adapted to maintain the delivery system in a compressed form.
15 . The delivery system of claim 12 , wherein the compactable excipient is chemically inert, does not absorb fluid, is non-hydroscopic, protects water-sensitive nitric oxide-producing components, does not react with nitric oxide-producing components and/or has a narrow particle size distribution.
16 . The delivery system of claim 12 wherein the disintegrating agent causes the compactable excipient to break apart upon expansion.
17 . The delivery system of claim 1 , wherein the agent that reduces nitrite to nitric oxide is stevia , hemoglobin, myoglobin, or xanthine oxidoreductase.