WO1999052556A1

WO1999052556A1 - Use of exalt or sucrelesse in a lozenge, syrup or spray

Info

Publication number: WO1999052556A1
Application number: PCT/US1999/007754
Authority: WO
Inventors: Joel Dulebohn; Ronald J. Carlotti
Original assignee: Natura, Inc.
Priority date: 1998-04-10
Filing date: 1999-04-08
Publication date: 1999-10-21
Also published as: AU3483299A

Abstract

The present invention relates to blocking of the bitter taste of metal ions, such as potassium, magnesium, zinc, iron, calcium, and other bitter compounds such as caffeine, menthol. The bitter blocker is a mixture of amino acid(s), organic acid(s) and/or inorganic acid(s), with or without metallic ion(s). This material can also deliver metals or active ingredients such as pharmaceuticals, therapeutic agents, vitamins, purified enzymes, whole cell, viruses, antibodies, proteins, fungicides and pesticides.

Description

USE OF EXALT OR SUCRELESSE IN A LOZENGE, SYRUP OR SPRAY

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Serial Number 60/081,287, filed April 10, 1998, incorporated by reference as if fully set forth herein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

Not applicable.

BACKGROUND OF THE INVENTION

Many active ingredients, such as metals, vitamins, artificial sweeteners, pharmaceuticals, therapeutic agents have a bitter taste or an unpalatable and undesirable aftertaste. There is interest blocking the bitter taste and eliminating the aftertaste of these materials. Also, these nutrients are not stable under processing conditions or long-term storage. Carriers that can stabilize these nutrients in nutraceutical or functional foods are important.

A "nutraceutical" or "functional" food is designed to enhance the nutritional value of general food products while maintaining sensorial properties, thus allowing consumers to balance their diet without changing their eating habits. Nutraceutical food sale is one of the fastest growing segments in the food industry, with a 10% annual growth rate. Over the next decade sales are projected to grow from 10 billion to 25 billion. These sales will be influenced by a growing population of aging people, concerns about the costs of long-term care, and consumers who are willing to buy high-margin products. (A. Williamson, Dairy Field, p. 24, 1998)

There are many food products that are now fortified with minerals and vitamins to help people get their vital nutrients. In a national survey conducted by the Centers for Disease Control and Prevention, college students are eating too few fruits and vegetables and too much fat, and one in five is overweight. Nearly 75% of the students had not eaten the recommended servings of fruits and vegetables during the day preceding the survey. (D.E. Pszczola, Food Technology. 52(3), 1998)

In fortification of many foods, the food, manufacturers usually have to overdose the food with the vitamins and minerals. This is done because of the degradation of the vitamins and minerals under precessing conditions and storage. In cereals the production losses have been found to be in the range of 40% for vitamin C; 30% for vitamins A and thiamin; and 15% for folic acid, riboflavin, calcium pantothenate, vitamin B12 and pyridoxine . Niacin and vitamin E (as α-tocopherol) have been shown to be the most stable of the vitamins added at the initial stage of processing. (A.J. David, Cereal Food World 40 (6) :434. 1995) In another example, zinc has been used to reduce the duration of the common colds. For example, U.S. patent 5,409,905 describes using zinc complex with organic acids. U.S. patent 4,758,439 describes zinc complex with amino acid to reduce the unpalatable and undesirable taste. The ratio of metal to amino acid varies from 1:2 to 1:20.

There are several techniques used to try to stabilize the minerals and vitamins. For example, the minerals or vitamins are encapsulated with oil and fat, cyclodextrins, and blending the nutrients with sugar and/or salt . Each of these techniques has advantages and disadvantages. There is no carrier that can both stabilize the vital nutrients and block bitter taste.

There is a need for a novel material that can block the bitter and off-taste of minerals and vitamins for food. There is also a need for a carrier of minerals, vitamins and other active ingredients which do not have the limitations of the currently available compositions.

BRIEF SUMMARY OF THE INVENTION

In one embodiment, the present invention is a method of blocking a bitter taste in a preparation, comprising the steps of combining a carrier comprising a reaction product of a basic amino, a carboxylic acid, and a metallic ion, preferably selected from the group consisting of Group IA, IIA, Ti , V, Cr, Mn, Co, Ni , Cu, Zn and Se, in water with a bitter preparation, and testing the preparation for presence or absence of bitter taste.

In another embodiment, the present invention is a method of delivering a metal ion in a preparation,

-3- comprising the step of sequestering the metal ion in a reaction product comprising a reaction product of a basic amino, a carboxylic acid, and a metallic ion, preferably selected from the group consisting of Group IA, IIA, Ti, V, Cr, Mn, Co, Ni , Cu, Zn, Se, Fe, Mo, Sn and Au in water, wherein said amorphous reaction product is selected from the group consisting of gel or glass. The metal ion, preferably zinc, is delivered in an active or available form after dissolution of the preparation. In another embodiment, the present invention is a method of blocking a bitter taste in a preparation, comprising the steps of adding a carrier comprising a salt containing lysine, chloride ion, and succinic acid, wherein said composition contains more lysine molecules than chloride ions or succinic acid molecules, and testing the preparation for presence or absence of bitter taste.

It is an object of the present invention to provide a material and method that can block bitter, metallic, unpalatable and undesirable aftertaste, preferably from minerals, caffeine, and menthol.

An additional object is to use the carrier as a release vehicle for active ingredients such as pharmaceuticals, therapeutic agents, vitamins, purified enzymes, whole cell, viruses, antibodies, proteins, fungicides and pesticides.

Other objects, advantages and features of the present invention will become apparent after one of skill

-4- in the art has reviewed the specification, claims and drawings .

DETAILED DESCRIPTION OF THE INVENTION

In General In one embodiment, the present invention is the use of EXALT or SUCRELESSE to block the bitter taste of any internally consumed product in which bitter taste is a detriment. In a preferred embodiment, the present invention is a method of creating a lozenge, cough syrup or nasal spray comprising the below-described EXALT or

SUCRELESSE compounds. EXALT and SUCRELESSE are described in the specification below, references contained herein, and in U.S. Patent Nos . 5,766,636 and 5,229,161.

In another embodiment, the present invention is the use of SUCRELESSE to deliver active or available metal ion. In a preferred embodiment, SUCRELESSE is used to deliver zinc ions. Methods of Blocking Bitter Taste

We have determined that EXALT can block the bitter taste of compounds such as potassium, caffeine, menthol and can block the metallic taste from metallic complexes. EXALT can also be used to modify the off-taste of nasal spray. Similarly, SUCRELESSE can block the bitter taste of potassium, caffeine, menthol, and the metallic taste from metallic complexes. When added in the processing of food at any time during the processing. SUCRELESSE can also be used to modify the off-taste of nasal spray.

-5- To practice the present invention, one would formulate the product with a sufficient amount of EXALT or SUCRELESSE to inhibit bitterness. The Examples below demonstrate lozenges, cough syrup and nasal spray formulated with EXALT and SUCRELESSE. In particularly preferred embodiments for bitter-blockers, the amount of

EXALT or SUCRELESSE within the composition is between .1% and 25%. Most preferred are compositions with between 1% and 5%. One would determine whether a bitter or metallic taste has been removed from a preparation by testing the preparation orally. Most preferably, one would use blind taste panels to confirm that bitter taste had been reduced. Method of Delivering Active or Available Zinc or Other Metal Ions

We have determined that SUCRELESSE can deliver active or available metal ions, preferably zinc, in a therapeutic manner to a human patient. We have analyzed lozenges containing SUCRELESSE and determined that the zinc is at least 50%, and preferably 80%, available or free. By "available" we mean that the zinc is in an ionic form.

Preferred methods of testing availability of metal ions, including zinc, and other active ingredients are disclosed in Diets and Dulebohn, "Method for the Estimation of Metal Ion Bioavailability, " U.S. provisional application, filed April 8, 1999. This provisional application is incorporated by reference as if fully set forth herein.

Method of Delivering other Active Ingredients

As demonstrated in the Examples below, the present invention is also a method of delivering other active ingredients .

The active ingredients that can be used with the carriers to form the compositions of the present invention include (without limitation) flavoring agents, colors, cosmetic agents luminescence and therapeutic agents. The only limitation on the active ingredient is that it is not adversely affected by the ingredients of the carrier.

A wide variety of therapeutic agents and food ingredients have a bitter taste. The bitter taste is blocked when the ingredient is placed in a carrier of the present invention. Many of these ingredients are esters, acids and aldehydes which are potentially compatible with the components of the carrier. Additionally, many of these ingredients are water insoluble or only slightly soluble in water. These ingredients are usually dissolved in a vegetable oil carrier. The oil can be added to the viscous gel of the present invention and uniformly suspended as small droplets of oil in the aqueous gel. When the gel carrier is dried these oil droplets become entrapped or encapsulated in the glass carrier. This entrapment can be seen under a light microscope as small oil globules immobilized in a glass.

-7- Representative examples of SUCRELESSE synthesized with an additive are given in U.S. patent 5,766,636, particularly Example 15 which demonstrates SUCRELESSE prepared with 0.01 gm of vitamin A acetate. One would prepare SUCRELESSE, in a manner similar to the preparations in U.S. patent 5,766,636 and in the Examples below, and add an additional step of ensuring that the active ingredient is in a "available" form. By "available" we mean that at least 50%, and preferably 80%, of the ingredient is in a bioavailable form. Preferred Compositions

The preferred compositions of the present invention are gels and glasses which contain metal and/or active ingredients and a carrier (SUCRELESSE or EXALT) which is the amorphous reaction product of an amino acid, organic acid and/or inorganic acid, a metallic oxide or salt or water .

The term "SUCRELESSE" as used herein refers to a carrier comprising the amorphous reaction product of a basic amino acid, a carboxylic acid, a metallic ion selected from the group consisting of Group IA, IIA, Ti, V, Cr, Mn, Co, Ni , Cu, Zn Se, Fe, Mo, Sn and Au. The reaction product is preferably selected from the group consisting of a gel or a glass. The term "EXALT," as used herein refers to a composition comprising lysine, chloride ion, and succinic acid, where in the composition contains more lysine molecules than chloride ions or succinic acid molecules. Preferably, the lysine, chloride ion and succinic acid are present in a molar ratio of about 2:1:1. In another embodiment, "EXALT" is used herein to refer to composition comprising salts of the following formula unit :

NH₃+X-

YOOC NH₃ ⁺-OOC_fc

'COO-+NH₃ COOY

in which n is 1 to 16 formula units; Y is H, Na or K and can be the same or different, and X is OH or a halogen, such as Cl or I or F, wherein at least 1 but not all X's are Cl .

The term "gel" as used herein means aqueous compositions having high viscosity and rubber-like properties similar to concentrated sugar solutions, such as KARO syrup. The term "gel" is not intended to denote any polymerization or cross linking of the components of the aqueous compositions.

The novel gel compositions of the present invention may be prepared by either adding the active ingredient to the carrier ingredients and forming a gel, or by forming a gel from the carrier ingredients and adding the active ingredient to the gel . Novel glass compositions of the present invention can be prepared by drying the gel -containing active ingredien (s) . The glass can be ground and sieved to desired size particles. Alternatively, a granular composition can be obtained by drying a gel carrier to form a glass, grinding the glass to the desired size particles and blending the ground glass particles with the active ingredients to obtain a uniform, granular composition. In one embodiment, the present invention is a lozenge designed to deliver a therapeutic amount of zinc to a human patient. For zinc addition to a lozenge, the zinc can be either a zinc halide, zinc organic acid complex, zinc amino acid complex or zinc being complex with both amino acid and organic acids. U.S. patent 5,409,905 describes using zinc complex with organic acids. U.S. patent 4,758,439 describes using zinc complex with amino acid and states that the amino acid reduce the unpalatable and undesirable taste, with ratios of metal to amino acid varies from 1:2 to 1:20.

SUCRELESSE can be made with Zn ions to deliver zinc or can be made with other metal ions to block the metallic taste of the second metal ion.

In SUCRELESSE the metal to amino acid ratio varies from 1:0.1 to 1:1.9. The preferred ration is 1:1.5. In all the Examples described herein of making lozenges, EXALT and SUCRELESSE could be added during the cook or when the flavor and sweetener were added to block

^■10- the metallic taste and bitter taste that is found in lozenges. For the best result the EXALT and SUCRELESSE should be added when the flavoring and sweetener are added . In an especially preferred embodiment of the invention, a gel composition is prepared by dissolving an amino acid, lysine monohydrate, in water (from room temperature to 95°C to form a concentrated solution) and adding a metallic oxide (such as magnesium oxide) and active ingredients (such as pharmaceuticals, therapeutic agents, vitamins, purified enzymes, whole cell, viruses, antibodies, proteins, fungicides and pesticides.) and an organic acid(s) and/or inorganic acid(s). Preferred organic acids are malic and citric acid. A preferred inorganic acid is phosphoric. Preferred ratios of lysine: metal oxide: organic acids are 1.5:1:2.9 and 1.5:1:1.38.

The gel compositions at 50-85% solids content show high viscosity (100 to 10,000 centipoise) behavior, similar to that of concentrated sugar syru s. There is no problem with recrystallizations, such as recrystallization problems known with sugar and other sugar substitutes.

At even higher solid concentrations the gel compositions have the properties of a toffee or chewy candy without crystallization.

In another preferred embodiment, a glass composition is prepared by dehydrating a gel composition of the

-11- present invention by heating it in a microwave, drum dried, spray dried, oven dried and other processes believed to be feasible such as fluid bed agglomerations and cooker extrusion. As the solid is cooled a glass is formed. If desired, the glass can be ground to the desired particle size.

The "basic" amino acids can be used to make the carriers of the present invention. Basic amino acids are defined as in U.S. patent 5,766,636. Representative of the basic amino acids which can be used to make the carriers of the present invention are the free base, salts and hydrates of lysine, ornithine, diaminopimulic acid and amino acids of the formula: NH₂ (CH₂) _nC00H in which n is 1 to 6, such as glycine, β-alanine, 4- aminobutyric acid. 5-aminovaleric acid, 6-aminocaproic acid and 7-aminoheptanoic acid. Some of these amino acids are available as food or pharmaceutical grade ingredients .

The carrier is a mixture of amino acids, metal ions source (such as Group IA, IIA, Ti , V, Cr, Mn, Co, Ni , Cu, Zn, Se, Fe, Mo, Sn and Au) , organic acids and inorganic acids (see references listed below) . The metal hydroxides, such as the hydroxides of magnesium, calcium, sodium and potassium also can be used. In addition, oxides, salts, and carbonates of the metal can also be used. Typically, the organic acids are mono, di , tri, ply carboxylic acids and may contain other functional groups such as NH ^~ , 0H ^~ , PO^ ³ and SO ^'2 . Typically,

-12- the inorganic acids are hydrochloric acid, sulfuric acid, nitric acid and phosphoric acid.

The molar ratio of metal ion: amino acid: acid can vary depending on the applications. The molar ratio of amino acid to metal ion can vary from 0.1 to 20. The acid to metal ion molar can vary from 0.1 to 20. The most common molar ratio for food application is amino acid varying from 0.1 to 4, and the acid varying from 0.1 to 4. These molar ratios keep the carrier in the pH range of 3-8, suitable for the food applications.

For the gel carrier the ratio of the amino acid to the carboxylic acid to the metallic ion source to the water is usually from .5 mole amino acid:l mole carboxylic acid:.5 mole metallic ion source:2 mole metallic ion source: 10 moles water. In the preferred method of preparing the gel carrier, the amino acid is first dissolved in the water and the other ingredients are added to the amino acid solution to obtain a reaction mixture having a pH of about 3 to about 9. The ingredients are allowed to react at temperatures of from room temperature to 95°C. The reaction mixture usually forms a gel from 30 seconds to 30 minutes.

The glass carrier is readily prepared from a viscous gel by dehydrating it under microwave radiation at a setting of 50% power to 100% power for about 0.5 minutes to about 15 minutes or by conventional oven drying methods at temperatures of about 120°C to about 180 °C for about 10 minutes to 60 minutes.

•13- EXAMPLES

EXALT and SUCRELESSE preparation

EXALT is prepared by dissolving 2 moles of lysine

(lysine HC1 or lysine HOH) to one mole of succinic acid and adjusting the pH of the solution with base (NaOH or

KOH) or an acid (HC1) . (See Turk, R. , "Metal Free and

Low Metal Salt Substitutes Containing Lysine," July 20,

1993, U.S. Patent 5,229,161, hereby incorporated by reference.) Two typical and preferred examples are shown below:

Example one : 500 gm of water 73.62 gm of NaOH pellets 129.24 gm Succinic acid 399.6 gm of Lysine HC1

Example two : 1240 gm of water 150 gm KOH pellets 190 gm succinic acid 600 gm lysine HCl

Typically, preparation of EXALT is as follows: Heat the water to 60°C and then dissolve the NaOH (or KOH) .

Add the succinic acid, and when dissolved, add the lysine

HCl. The preparation can be at room temperature, but it takes longer to dissolve the ingredients. Typically, the solution can be dried by the following methods: Microwave, spray dried, oven dried, drum dried, and other processes believed to be feasible such as fluid bed agglomeration and cooker extrusion. EXALT can be added to ingestible products as a solid or as a liquid. As a liquid, it can be retorted for soup and gravy applications. As a solid, EXALT can be cooked

-14- in bakery products or spray dried in powder cheese mixes. The upper temperature limit of stability is approximately 300°C. EXALT can be added in the processing of the food at any time.

SUCRELESSE

SUCRELESSE is a mixture of amino acids, a metal ion source (such as Group IA, IIA, Ti, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, Se, Mo, Sn and Au) , organic acids and inorganic acids. (See references listed below.) Typically, the organic acids are mono, di , tri, and poly carboxylic acids containing other functional groups such as NH ^~ ,

OH ^' , PO ^~2 and SO^ ² . Typically, the inorganic acids are hydrochloric acid, sulfuric acid, nitric acid and phosphoric acid. The molar ratio of metal ion: amino acid: acid can vary depending on the applications. The molar ratio of amino acid to metal ion can vary from 0.1 to 20. The acid to metal ion molar ratio can vary from 0.1 to 20. The most common molar concentration for food application is amino acid varying from 0.1 to 2 molar, and the acid varying from 0.1 to 2 molar. These molar ratios keep the SUCRELESSE in the pH range of 3 - 8, which is appropriate for most food applications.

Examples of preparations of SUCRELESSE are shown below:

Example 3 236.2 gm water

273.3 g lysine HOH (1.66 mole) 44.8 gm MgO (1.11 mole) 108.8 gm malic acid (0.81 mole) 152.3 gm citric acid HOH (0.72 mole)

^■15- The water was heated on a hot plate to approximately

40-70°C (this can be done at room temperature) . The lysine was then added. When dissolved, the MgO was added and stirred for a few minutes. The malic and citric acids were slowly added. The mixture was stirred until a clear solution was formed. The final pH was 5.3.

The ratio of lysineHOH: metal oxide: organic acids is

1.5:1.0:1.38.

Example 4 43.2 gm water

33 g lysine HOH (0.20 mole)

5.4 gm MgO (0.134 mole)

39 gm malic acid (0.291 mole)

20.4 gm citric acid HOH (0.097 mole) The water was heated on a hot plate to approximately 40-70°C (this can be done at room temperature) . The lysine was added. When dissolved, the MgO was added and stirred for a few minutes. The malic and citric acids were slowly added. The mixture was stirred until a clear solution was formed. The pH is around 3.7.

The ratio of lysine HOH: metal oxide: organic acids is

1.5:1.0:2.89.

Example 5 196 gm water 220 g lysine HOH (1.34 mole) 36 gm MgO (0.89 mole) 88 gm malic acid (0.656 mole) 122 gm citric acid HOH (0.581 mole)

The water was heated on a hot plate to approximately 40-70°C (this can be done at room temperature) . The lysine was added. When dissolved, the MgO was added and stirred for a few minutes. The malic and citric acids

^■16- were slowly added. The mixture was stirred until a clear solution was formed.

The ratio of lysineHOH: metal oxide: organic acids is 1.5:1.0:1.49. Example 6

100 gm water 40 gm lysine HOH 16 gm ZnO 24 gm malic acid 20 gm citric acid HOH

The water was heated on a hot plate to approximately 40-70°C (this can be done at room temperature) . The lysine was added. When dissolved, the ZnO was added and stirred for a few minutes. The malic and citric acids were added. The mixture was stirred until a clear solution was formed. The pH of the solution was around 5.0.

The ratio of lysineHOH: metal ion: organic acids is 1.24 :1.0 :1.39. Example 7

10 gm water

10 g lysine HOH (0.061 mole)

10.76 gm zinc (acetate) ₂ 2HOH (0.049 mole) The water was heated on a hot plate and the lysineHOH was added. When the lysine was dissolved, the zinc (acetate) ₂

2HOH was added. A clear solution formed and the pH was around 7.0.

The ratio of lysineHOH: metal ion: organic acids is 1.24 :1.0 :20.

Typically, the solution can be dried by the following methods: Microwave, spray dried, oven dried,

^■17- drum dried, and other processes believed to be feasible such as fluid bed agglomeration and cooker extrusion.

SUCRELESSE can be added to the food as a solid or as a liquid. As a solid, SUCRELESSE can be cooked in bakery products and spray dried. The upper temperature is approximately 300°C.

References for EXALT and SUCRELESSE (all incorporated by reference) :

"Metal Free and Low Metal Salt Substitutes Containing Lysine," July 20, 1993, U.S. patent 5,229,161, Turk, R.

Nowaczyk, P., "Phosphors, Compositions Containing Such

Phosphors and Methods of Use," November 7, 1995, U.S.

Patent 5,464,651.

Turk, R. and Dulebohn, J.I., "Luminescent Materials, Phosphors and Compositions Containing Such Phosphors,"

U.S. Patent 5,618,467.

Turk, R.S, e_t a . , "Room-Temperature Phosphorescence of

Amorphous Metal Complexes of Aliphatic Carboxylic Acids with Basic Amino Acids," Chemistry of Materials 7:385, 1995.

Lozenge Preparation

We describe below the preparation of a typical lozenge of the present invention below. We envision that variations of this preparation are also suitable for the present invention.

Example 8

Ingredient grams percent

75% isomalt solution 150 74.15

SUCRELESSE from example 5 50 24.72

lemon flavor 2.0 0.99

-li acssulfame-k 1.5 0.07 aspartame 1.5 0.07

200 grams of 75% isomalt solution was cooked to

300°F to yield approximately 150 grams of isomalt syrup.

After the syrup was cooled to 250°F, the SUCRELESSE, flavor and sweetener were stirred in. The batch was poured onto a stainless steel table and worked until set enough to go through the drop rollers. After the pieces were formed, they were allowed to cool before packaging.

Example 9

Ingredient grams precent

75% isomalt solution 150 74.63

SUCRELESSE from example 5 50 24.88

lemon flavor 1.0 0.5 200 grams of 75% sorbitol solution was cooked to 400 °F to yield approximately 150 grams of cooked syrup. After the syrup was cooled to 240°F, the SUCRELESSE and the flavor were stirred in. The batch was poured onto a stainless steel table and worked until set enough to go through the drop rollers. After the pieces were formed they were allowed to cool before packaging.

Example 10

Ingredient grams percent

Hystar 5875 150 74.15

SUCRELESSE from example 5 50 24.72 lemon flavor 1.5 0.74 acssulfame-k 1.5 0.07

aspartame 1.5 0.07

200 grams of Hystar 5875 was cooked to 380°F to yield approximately 150 grams of cooked syrup. After the syrup was cooled to 250°F, the SUCRELESSE, flavor and sweetener were stirred in. The batch was poured onto a stainless steel table and worked until set enough to go

•19- through the drop rollers. After the pieces were formed they were allowed to cool before packaging.

Example 11 Ingredient grams precent isomalt M 1960 97.58

SUCRELESSE from example 7 32.2 1.6 superfine peppermint oil 12.0 0.60 acssulfame-k 1.5 0.07 aspartame 1.5 0.07 menthol powder #28-23-B 1.0 0.05 green dye

0.40 0.02

Procedure: The isomalt was cooked with water to

320°F and then cooled to 260°F. The remaining ingredients were stirred in. The material was poured out onto table to cool. When cool enough to hold shape, the material was run through drop rollers.

Example 12 Ingredient grams precent isomalt M 1918.6 95.94 SUCRELESSE from example 6 65.0 3.25 superfine peppermint oil 12.0 0.60 acssulfame-k 1.5 0.08 aspartame 1.5 0.08 menthol powder #28-23-B 1.0 0.05 green dye

0.40 0.01

Procedure: The isomalt was cooked with water to

Cough Syrup and Nasal Spray

The present invention is also a cough syrup or nasal spray comprising the EXALT or SUCRELESSE compound described above. SUCRELESSE can be made with Zn ions to deliver the zinc or it can be made with other metal ions

-20- to block the metallic taste. SUCRELESSE and EXALT are typically added when the flavor and sweetener are added. Preparation of Carrier with Active Ingredient Example 13 We dissolved 12.2 gm of lysine monohydrate in 26 gm of water and added 2 gm of magnesium oxide, 0.061 gm of folic acid, 4.9 gm of malic acid and 6.8 gm of citric acid monohydrate. The yellow gel was microwaved to give a solid glass. One would then dissolve the glass and examine the preparation to insure that at least 50%, and preferably 80%, of the active ingredient is in a bioavailable form.

-21-

Claims

CLAIMS We claim:

1. A method of blocking a bitter taste in a preparation, comprising the steps of:

(a) combining a carrier comprising a reaction product of a basic amino, a carboxylic acid, and a metallic ion selected from the group consisting of Group IA, IIA, Ti, V, Cr, Mn, Co, Ni , Cu, Zn, Se, Fe, Mo, Sn and Au with a bitter preparation, and

(b) testing the preparation and noting the reduction of bitter taste.

2. A method of delivering a metal ion in a preparation, comprising the step of:

(a) sequestering the metal ion in a reaction product comprising a basic amino, a carboxylic acid, and a metallic ion selected from the group consisting of

Group IA, IIA, Ti, V, Cr, Mn, Co, Ni , Cu, Zn, Se, Fe, Mo, Sn and Au in water, wherein the metal ion is in an available form after dissolution of the preparation, and

(b) testing the product after dissolution to determine that the metal ion is available.

-22-

3. A method of blocking a bitter taste in a preparation, comprising the steps of:

(a) combining a carrier comprising a salt containing lysine, chloride ion, and succinic acid, wherein said composition contains more lysine molecules than chloride ions or succinic acid molecules with a bitter preparation, and

(b) testing the preparation for the reduction of bitter taste.

4. A method of blocking a bitter taste in a preparation, comprising the steps of:

(a) combining a carrier comprising a salt of the following formula:

NH₃+X- NH₃+X-

YOOC NH3⁺"< 'COO-+NH3 COOY j. in which n is 1 to 16 tormula units; Y is H, Na or K and can be the same or different, and X is OH or a halogen, such as Cl or I or F, wherein at least 1 but not all X's are Cl with a bitter preparation, and

(b) testing the preparation for reduction of bitter taste.

^Γûá23-

5. A method of claims 1, 2, 3 or 4 , wherein the preparation is a gel.

6. A method of claims 1, 2, 3 or 4 , wherein the preparation is a glass.

7. A method of claims 1, 2, 3 or 4 , wherein the preparation is a lozenge.

8. The method of claim 1 wherein the carrier comprises zinc.

9. The method of claim 1 wherein the carrier does not comprise zinc and wherein the preparation additionally comprises zinc ions.

10. The method of claim 2 wherein the metal ion is zinc .

11. A method of delivering an active ingredient in an available form, comprising the steps of

(a) combining the ingredient in a preparation with a carrier comprising a reaction product of basic amino acid, a carboxylic acid, and a metallic ion selected from the group consisting of Group IA, IIA, Ti, V, Cr, Mn, Co, Ni, Cu, Zn, Se, Fe, Mo, Sn and Au, wherein the active ingredient is in an available form after dissolution of the preparation,

-24- (b) testing the preparation after dissolution to determine that the ingredient is available.

12. A method of delivering an active ingredient in an available form, comprising the steps of

(a) combining the ingredient with a carrier comprising a salt containing lysine, chloride ion and succinic acid, wherein the composition contains more lysine molecules than chloride ions or succinic acid molecules and wherein the ingredient is in an active form after dissolution of the composition, and

(b) testing the composition after dissolution to determine that the ingredient is available.

-25-