WO1999021437A1 - Alkaline additive - Google Patents

Abstract

A highly alkaline, ultra low sodium solution of saturated tripotassium phosphate may be used as an additive to dosages such as concentrated drops, tablets, capsules, beverages, tea bags or other dosage forms. The additive further includes calcium, zinc, magnesium and up to 79 trace minerals from ancient sea salt. The trace minerals are chelated with amino acids and taken from technical magnesium chloride marine deposits that are low in sodium. The amino acids are from a non-porcine source. The additive, which is considered nutritionally nil in sodium content, can be used as a concentrated aqueous drop, or dried and used as an additive for dietary supplement dosage forms including tablets, capsules, chewing gums, tea bags, bottled water, beverages and others.

Description

^W° "^/21437 ALKALINE ADDITIVE PCT/US98/22422

BACKGROUND OF INVENTION

1. Field of Invention

The field of the present invention is generally related to improving human health. More specifically, this invention focuses on a source of alkaline (high pH) additive for dietary supplements, concentrated/^'drops, tablets, capsules and ι related dietary supplement dosage forms.

2. Description of Prior Art

For nearly a century commercial value has been attached to the practice and the inventions related to alkaline water. These take the forms of several machines, for example: MICROWATER (DBS, South San Francisco, California); WATER WISE (Leesburg, Florida).

These machines separate the normal or acidic drinking water (or beverage) into an acidic portion which is disposed of and an alkaline (high pH) portion which is consumed for better health. These machines are universally bulky and universally require an electric power source.

For further examples of the commercial value attached to alkaline products, one can look to the phenomenal success of "Gaterade" and similar drinks in North America and "ProSweat" drinks in the Far East in addition to tablets, capsules, teas and other dosage forms containing alkaline electrolytes. So many businesses and culturally focused Europeans and Americans travel extensively today that a successful Far Eastern product is a valid benchmark of worldwide commercial interest and value. This is part of "Globilization" of the economy and of technology.

The scientific literature for electrolyte replacement is voluminous, including Swartz and Lyon: Base and Electrolyte Balance - Normal Regulation and Clinical Disorders; Carrol and Oh, Electrolyte and Acid - Base Metabolism, Philadelphia, J B Lippincott, 1978; Kokko and Tanen, Fluid and Electrolytes, 2nd Ed., Philadelphia, W B Sanders, 1990, and others.

In addition to mainline scientific support of alkaline and electrolyte supplementation, the alternative medicine community advocates the supplementation of drinking water with alkaline additives. This includes Sang Whang's seminal "Reverse Aging", Dr. Ted Baroody's "Alkalize or Die", Dr. F. Batmanghelidg's "Your Body's Many Cries for Water" and Herman Aihara's "Acid and Alkaline" - Macrobiotic Institute, Oroville, California. A central theme in the alternative medicine press is the eating of alkaline vegetables and the drinking of alkaline beverages.

Pitkin, et al, U.S. Patent No. 3,062,714 relates to an antacid composition, utilizing in part a phosphate salt that may be potassium as an active ingredient.

The U.S. Patent No. 3,215,626 to Console describes a method of producing mineralized drinking water by adding potassium tripolyphosphate.

The U.S. Patent 3,294,543 to Eller describes a method for providing supplemental phosphorous to livestock by administering a water based solution of sodium triphosphate.

Hirsbrunner, U.S. Patent No. 4,399,128 utilizes a combination of milk solids and tripotassium phosphate as a carrier in the preparation of dry pharmaceutical composition.

In U.S. Patent No. 4,462,839 to McGinley, et al, an enteric coating for pharmaceutical products utilizes tripotassium phosphate.

U.S. Patent No. 4,592,892 to Ueno, et al, relates to an aqueous food sterilizing agent utilizing in part an alkaline carbonate that may be potassium carbonate. The U.S. Patent No. 4,851 ,242, Dubois, et al. describes a nutritional product for animals consisting of aggregates of organic sea limestones of recent formation, part of which is tripotassium phosphate.

The U.S. Patent No. 5,306,511 to Whang pertains to a concentrated additive solution that is added to normal drinking water to form an alkaline drinking water. Such water is of increased oxygen content with a pH said to be in the range of 9 to 12. The concentrated additive solution is formed from a combination of potassium hydroxide (KOH) and sodium hydroxide (NaOH).

The U.S. Patent No. 5,424,074 to Koli, et al, pertains to a magnesium added potassium supplementing pharmaceutical composition to provide the human body with potassium with high-efficiency.

Having understood the commercial interest, the mainline scientific interest, the alternative medicine interest, and the attempts to meet these needs, it was discovered that objections occur to the existing technology:

1. eating vegetables is problematic because many of the so called alkaline vegetables are only pH 6 (mildly acidic) so that they aren't' really alkaline. Actual alkaline vegetables are too few;

2. drinking naturally occurring alkaline water is problematic because these natural lye, high pH (alkaline) springs are obscure and hard to find. No nationwide firm is supplying this need;

3. the machines that produce high pH water are expensive (nearly $1 ,500.00) and are prohibitively expensive for persons living on a fixed income. Moreover, these bulky machines are absolutely unacceptable to those who must travel, as more and more Europeans and North Americans are doing;

4. Alkaline teas and tea .bags are expensive to use regularly and are not readily available on a nationwide basis; 5. hydroxide (lye) drops as suggested in the prior art are dangerous to skin, are illegal in most Far East countries, and can cause blindness if mistakenly placed in children's eyes. Many people are simply afraid, generally, to use a lye based (sodium/potassium hydroxide) product orally in human electrolyte replacement;

6. there are no nationally distributed products combining alkaline electrolytes added to regular vitamin-botanical dietary supplements; and

7. most of the prior art is high in sodium which is not recommended by nutritionists, especially respecting persons with cardiovascular problems.

SUMMARY OF THE INVENTION

An object of the invention is a low sodium additive for alkaline dietary supplement dosages that is mild in terms of acute and sub acute skin and eye toxicity, yet still capable of producing beverages with pH above 9.

Another object is such an additive that is inexpensive, available in dry dosage form, easy to pack and travel with and requires no power source.

Still another object is such an additive that offers up to 79 additional trace minerals including calcium, zinc and magnesium.

A further object is such an additive that offers amino acid chelated trace minerals.

The foregoing and other objects, features and advantages of the present invention are accomplished in accordance with the teachings of the present invention, one illustrative embodiment of which comprises a highly alkaline, ultra low sodium solution of organic potassium salts and saturated tripotassium phosphate that may be used as an additive to dosages such as concentrated drops, tablets, capsules, beverages- or other dosage forms. The additive further includes calcium, zinc, magnesium and up to 79 trace minerals from ancient sea salt. The trace minerals are chelated with amino acids and taken from technical magnesium chloride marine deposits that are low in sodium. The amino acids are from a non-porcine source. The additive, which is considered nutritionally nil in sodium content, can be used as a concentrated aqueous drop, or dried and used as an additive for dietary supplement dosage forms including tablets, capsules, chewing gums, tea bags, bottled beverages and others.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The purpose of the invention is to provide a low sodium, safe additive to a dietary supplement dosage form to effect an increase in the pH to about 8-10, preferably 9. The beverage or products thus created or modified are not intended to treat or cure any disease. They do, however, neutralize acids and they do enable the user or patient to achieve an alkaline lifestyle.

Initially purified water is charged into a previously sanitized stainless steel steam jacketed vessel equipped with a propeller mixer. Alternatively, the purified water may be heated to 80 - 90 degrees C via a heat exchange unit.

In the next step type A fish protein is mixed into the hot water with the propeller mixer set at about 300 to 600 r.p.m.

Citric acid and a trace mineral (special marine sea salt) concentrate is introduced along with a high protolytic activity papaine enzyme.

As this mixture is slowly cooled, the hot peptides are cleaved with the hot acidic enzyme. The free amino acids chelate the trace minerals.

Slow mixing with slow cooling is continued until the mixture reaches about 50 degrees C. A preservative (sodium benzoate) is added.

At this point an electrolyte mass made up of saturated tripotassium phosphate is added and then organic potassium salts are added including magnesium chloride, zinc lactat and small amounts of calcium chloride. The slurry resulting therefrom is somewhat opaque and may require settling before final filtration. The product is cooled without mixing for 24 hours for complete coagulation of the non-soluble portions.

In the next operation the product is decanted, run through a fine filter (range of microns preferably 10 - 175) cartridge and packaged, or processed further.

The product is now a clear liquid and can be dispensed as a clear drop in a small dropper assembly, operating closure, droplet cap or preferably "drop- tainer". When processed further it can be dried on a drum drier and added to the formulation of conventional vitamin-mineral-botanical dosage forms including tablets, capsules, bottled water, chewing gum, tea bags, beverages and the like.

The invention is further characterized by the tripotassium phosphate being in the 10 - 50% range of the total weight of the product, the organic potassium being in the 0.1 - 3% range, the minerals being in the 1-40 PPM range, the amino acids being in the 2-500 PPM range, the citric acide being in the 0.01 -.25% range and the papaine enzymes being in the 2-500 PPM.

The above procedure is the most preferred embodiment of this invention. Moderate ranges occur around these percentages and procedures and are included in this patent. Those skilled in the art of enzymatic hydrolysis of type A protein, required to "amino acid chelate" these trace minerals, know that the essence of hydrolysis involves all three factors acting simultaneously: heat, enzyme concentration and acid pH. This is why we use citric or similar acid when the end product is to be alkaline upon the completion of the formulation.

The ranges above are the embodiment of the patent. The preferred ranges are: 15-35% of tripotassium phosphate, .03-3% organic potassium salts, 3-25 PPM of trace miner als, 5-25 PPM of the type A gelatin (amino acids), 0.03- 18% citric acid and 5-250 PPM high protease papaine enzyme. The preferred filtering range would be using a 20-125 micron cartridge.

The most preferred embodiment of the patent would be 30-30% of the tripotassium phosphate, .05 -2% organic potassiusm salts, 5-15 PPM trace minerals, 20-100 PPM type A gelatin (amino acids), 0.05 - 10% citric acid, 20-40 PPM hi protease papaine enzyme. The most preferred filtration cartridge size is 25-50 micron.

The most preferred ingredient ranges balance efficacy with taste consideration with economical considerations and production ease considerations.

In all cases the dosage form will effect an increased alkalinity in the human system. For example, when two drops of this low sodium additive drop (or one unit of the tablet, capsule, tea bag, etc.) is used in or with a single 8-10 ounce beverage, the resultant pH will be approximately 8-10, preferably 9.

Example

One suitable example of the invention in liquid form for human consumption, which is by no means exclusive, is as follows: purified water qs 100% type A fish gelatin 0.01 hi protolytic papaine enzyme 0.001 citric acid 0.20 technical magnesium chloride 0.10 (marine source) sodium benzoate 0.10 tripotassium phosphate 35% magnesium chloride 0.03 potassium bicarbonate 0.06 zinc lactate 0.05 potassium citrate 0.10 calcium chloride 0.05 potassium lactate 60% 2.00

Although this invention has been described in terms of a preferred embodiment, various changes and modifications can be made without departing from the spirit and scope of the invention.

Another suitable example of this invention is a tablet for human consumption, which is by no means exclusive: ascorbic acid 400 mg sodium ascorbate 600 mg avicel pH 101 70 mg starch 1500 70 mg

AlkaZone liquid (drum dried) 100 mg (see example 1) magnesium carbonate 40 mg magnesium stearate 10 mg stearic acid triple pressed fine granular 35 mg

TriPac 150 mg

Ac-di-sol 5 mg

Cabosil M-5 4 mg

While this invention has been described in terms of a preferred embodiment, various changes and modifications can be made by those skilled in the art of tablet making without departing from the spirit and scope of the invention.

Claims

CLAIMS What is claimed is:

1. A low sodium additive for alkaline dietary supplement dosages comprised of saturated tripotassium phosphate, with the concentration of tripotassium phosphate being from 10-50 percent by weight.

2. the invention defined by claim 1 including trace amounts of calcium

3. the invention defined by claim 1 including trace amounts of magnesium.

4. the invention defined by claim 1 including trace amounts of zinc.

5. the invention defined by claim 1 with the addition of 79 trace minerals from the sea.

6. the invention defined by claim 5, wherein the trace minerals are selected from low sodium technical magnesium chloride mahne deposits.

7. the invention defined by claim 6 including free amino acids.

8. the invention defined by claim 7 wherein the amino acids are selected from a non-porcine gelatin source.

9. the invention defined by claim 8 wherein the non-porcine alkaline source is type A fish protein.

10. the invention defined by claim 8 wherein the trace minerals are chelated with non porcine free amino acids.