Dietary supplement non-fluoride toothpaste and methods of making and using the same

Abstract

Provided herein is a storage stable non-fluoride toothpaste composition enriched with a dietary supplement containing both oil soluble and water soluble vitamins. The dietary supplement is incorporated into the toothpaste, the dietary supplement containing a water soluble vitamin portion including at least one water soluble vitamin and an oil soluble vitamin portion. The oil soluble vitamin portion includes at least one oil soluble vitamin, a carrier oil and an emulsifier. The toothpaste is thereby formulated in a manner such that oral application will result in systemic delivery of at least a portion of the dietary supplement to meet a 2% RDI threshold even when 3 or less serving sizes are orally applied.

1 - 27 . (canceled) 
     
     
         28 . A non-fluoride containing dietary supplement enriched toothpaste suitable for ingestion, said toothpaste comprising:
 a) a dentally acceptable oral vehicle having a pasty consistency;   b) an oil phase containing a carrier oil, an emulsifier and a dietary supplement comprising at least one oil soluble vitamin; and   c) an aqueous phase containing water and a dietary supplement comprising at least one water soluble vitamin;   wherein a serving size amount of the toothpaste contains at least 2 percent of a reference daily intake (RDI) of the dietary supplement.   
     
     
         29 . The toothpaste of  claim 28  wherein the serving size amount contains at least about 10% to 80% of the RDI of the dietary supplement. 
     
     
         30 . The toothpaste of  claim 28  wherein the serving size amount contains at least about 10% to 150% of the RDI of the dietary supplement. 
     
     
         31 . The toothpaste of  claim 28  wherein the serving size amount contains at least about 50% to about 150% of the RDI of the dietary supplement. 
     
     
         32 . The toothpaste of  claim 28  wherein the serving size amount contains at least about 50% of the RDI of the dietary supplement. 
     
     
         33 . The toothpaste of  claim 28  wherein the serving size amount contains at least about 80% of the RDI of the dietary supplement. 
     
     
         34 . The toothpaste of  claim 28  wherein the serving size amount comprises from about 0.5 to about 3.0 grams. 
     
     
         35 . The toothpaste of  claim 28  wherein the serving size amount comprises from about 1.0 to about 3.0 grams. 
     
     
         36 . The toothpaste of  claim 28  wherein the serving size amount comprises from about 1.0 to about 1.5 grams. 
     
     
         37 . The toothpaste of  claim 28  wherein the serving size amount comprises about a ¾ inch to 1 inch strip of toothpaste applied to a toothbrush. 
     
     
         38 . The toothpaste of  claim 28  wherein the oil soluble vitamin is selected from the group consisting of Vitamin D-3, Vitamin E and mixtures thereof. 
     
     
         39 . The toothpaste of  claim 28  wherein the carrier oil is selected from the group consisting of corn oil, soy bean oil, safflower oil, sunflower oil, cannola oil, olive oil, coconut oil and mixtures thereof. 
     
     
         40 . The toothpaste of  claim 28  wherein the carrier oil is coconut oil. 
     
     
         41 . The toothpaste of  claim 28  wherein the emulsifier is selected from the group consisting of glycerol fatty acid esters, sucrose fatty acid esters, sorbitan fatty acid esters, propylene, glycol fatty acid esters, polysorbate, lecithin and mixtures thereof. 
     
     
         42 . The toothpaste of  claim 28  wherein the emulsifier is soy lecithin. 
     
     
         43 . The toothpaste of  claim 28  wherein the toothpaste undergoes no significant changes in color, odor, pH or viscosity after six months to two years of storage of the toothpaste under room temperature conditions and at elevated temperatures for up to six months. 
     
     
         44 . The toothpaste of  claim 28  wherein the water soluble vitamin is selected from the group consisting of Vitamin B-1, Vitamin B-6, Vitamin C, niacin, Vitamin B-12, pantothenate and mixtures thereof. 
     
     
         45 . The toothpaste of  claim 28  further comprises glucono delta lactone, glycerin, xylitol, monoammonium glycyrrhizinate, sorbitol, cellulose gum, sweetener, whitener and flavorant. 
     
     
         46 . A non-fluoride containing dietary supplement enriched toothpaste suitable fur ingestion, said toothpaste comprising:
 a) a dentally acceptable oral vehicle having a pasty consistency, said oral vehicle including   water,   a thickener selected from the group consisting of cellulose gum, xantham gum, carrageenan, guar gum, locust bean gum, calcium carbonate and mixtures thereof,   an abrasive selected from the group consisting of calcium carbonate, silica and mixtures thereof,   a titanium dioxide whitener,   a humectant selected from the group consisting of glycerin, sorbitol and mixtures thereof,   a sweetener selected from the group consisting of stevia xylitol, monoammonium glycyrrhizinate and mixtures thereof,   a chelating agent including glucono delta lactone, and   a flavorant selected from the group consisting of peppermint, cinnamon, clove, wintergreen, bubble gum and mixtures thereof;   b) an oil phase containing a carrier oil, an emulsifier and a dietary supplement comprising at least one oil soluble vitamin;   wherein the carrier oil is selected from the group consisting of coconut oil, corn oil, soy bean oil, safflower oil, sunflower oil, cannola oil, olive oil and mixtures thereof,   the emulsifier is selected from the group consisting of glycerol fatty acid esters, sucrose fatty acid esters, sorbitan fatty acid esters, propylene glycol fatty acid esters, polysorbate, lecithin and mixtures thereof, and   the oil soluble vitamin is selected from Vitamin D-3, Vitamin E and mixtures thereof; and   c) an aqueous phase containing water and a dietary supplement comprising at least one water soluble vitamin;   wherein the water soluble vitamin is selected from the group consisting of Vitamin B-1, Vitamin B-6, niacin, Vitamin B-12, pantothenate and mixtures thereof,   wherein said toothpaste optionally includes a flavorant and   wherein a serving size amount of the toothpaste of 0.5 to about 3.0 grams contains more than 2 percent of a reference daily intake (RDI) of the dietary supplement, and the toothpaste undergoes no significant changes in color, odor, pH or viscosity after six months to two years of storage of the toothpaste under room temperature conditions and at elevated temperatures for up to six months.   
     
     
         47 . A method for making the toothpaste of  claim 46  comprising the steps:
 a) combining the at least one oil soluble vitamin with the carrier oil and emulsifier in a first container to provide the oil phase; 
 b) combining glycerin, thickener and titanium dioxide whitener in a separate second container, 
 c) combining the water, humectant, sweetener, abrasive, chelating agent and water soluble vitamin in a separate third container, 
 d) combining the content of the first container with those of the third container in such a manner as to form a uniform, smooth paste, then 
 e) combining the contents of the second container with the combined contents of the first and third containers to provide the non-fluoride containing dietary supplement enriched toothpaste. 
 
     
     
         48 . The method of  claim 47  wherein the carrier oil is coconut oil, the emulsifier is soy lecithin, and the thickener is cellulose gum, and the method optionally further comprises adding a flavorant to the combined contents of the first, second and third container. 
     
     
         49 . The method of  claim 47  wherein
 step (a) comprises combining coconut oil and soy lecithin and heating same to a temperature of from about 65° C. to about 70° C. with agitation to form a uniform brownish oil, allowing said brownish oil to cool to a temperature of from about 25° C. to about 30° C., then sequentially adding Vitamin E and Vitamin D-3 with agitation to the brownish oil to provide an oil phase; 
 step (b) comprises combining the glycerin and the cellulose gum with agitation to provide a uniform slurry, then adding the titanium dioxide whitener to the slurry with continuous agitation to provide a premix thickener composition; 
 step (c) comprises sequentially combining with water the following components: glucono delta lactone, xylitol, truvia rebiana, pyridoxine HCl, niacinamide, calcium pantothenate, monoammonium glycyrrhizinate, glycerin, and sorbitol, then adding calcium carbonate and silica with slow agitation to avoid air entrapment to provide an aqueous phase; 
 step (d) comprises combining the oil phase with the aqueous phase with agitation sufficiently slow to avoid air entrapment to provide a uniform, smooth paste; and 
 step (e) comprises combining the premix thickener composition with the uniform, smooth paste to provide the non-fluoride containing dietary supplement enriched toothpaste. 
 
     
     
         50 . A non-fluoride containing dietary supplement enriched toothpaste suitable for ingestion, said toothpaste comprising:
 a) a dentally acceptable oral vehicle having a pasty consistency, said oral vehicle including   water,   a thickener,   an abrasive,   a titanium dioxide whitener,   a humectant selected from the group consisting of glycerine, sorbitol and mixtures thereof,   a sweetener,   a chelating agent, and   flavorant   b) an oil phase containing a carrier oil, an emulsifier and a dietary supplement comprising at least one oil soluble vitamin;   c) an aqueous phase containing water and a dietary supplement comprising at least one water soluble vitamin;   
       wherein the toothpaste is prepared by
 i) combining the at least one oil soluble vitamin with the carrier oil and emulsifier in a first container to provide the oil phase; 
 ii) combining glycerin, thickener and titanium dioxide whitener in a separate second container, and 
 iii) combining water, humectant, sweetener, abrasive, chelating agent and water soluble vitamins in a separate third container, 
 iv) combining the content of the first container with those of the third container in such a manner as to form a uniform, smooth paste, then 
 v) combining the contents of the second container with the combined contents of the first and third containers to provide the non-fluoride containing dietary supplement enriched toothpaste.