METHOD FOR RELIEVING NICOTINE WITHDRAWAL SYMPTOMS

Abstract

A method of releasing nicotine from a compressed chewing gum tablet, wherein the chewing gum tablet includes two modules; a first module including nicotine and tablet material, and a second module including gum base and nicotine.

Claims

1. (canceled)

2. Method of releasing nicotine from a compressed chewing gum tablet, the chewing gum tablet comprising two modules; a first module comprising nicotine and tablet material, a second module comprising gum base and nicotine, and wherein a user of said chewing gum tablet performs the steps of: (a) positioning the chewing gum tablet in the mouth, (b) dissolving at least a portion of the first module of the chewing gum tablet in a first period of time, and thereafter: (c) chewing the remaining part of the chewing gum tablet in a second period of time.

3. Method of releasing nicotine according to claim 2, wherein a user of said chewing gum tablet performs the steps of: (a) positioning the chewing gum tablet in the mouth, (b) dissolving at least a portion of the first module of the chewing gum tablet in a first period of time, (c) chewing the remaining part of the chewing gum tablet in a second period of time, wherein the steps (a) to (c) are defined in instructions provided to the user together with said chewing gum tablet.

4. Method of releasing nicotine according to claim 2, wherein the first period of time has a duration of 10 to 240 seconds.

5. Method of releasing nicotine according to claim 2, wherein the second period of time has a duration of at least 60 seconds.

6. Method of releasing nicotine according to claim 5, wherein the second period of time has a duration of at least 4 minutes.

7. Method of releasing nicotine according to claim 2, wherein the second period of time has a duration of 5 to 30 minutes.

8. Method of releasing nicotine according to claim 2, wherein at least a part of the nicotine contained in the second module is mixed into the compressed granules comprising gum base prior to granulation.

9. Method of releasing nicotine according to claim 2, wherein at least a part of the nicotine contained in the second module is contained in compressed granules having no gum base.

10. Method of releasing nicotine according to claim 2, wherein the compressed chewing gum tablet comprises buffer in an amount of 0.01-50%.

11. Method of releasing nicotine according to claim 2, wherein a part of the second modules is comprised by compressed granules comprising one or more chewing gum ingredients selected from the group consisting of bulk sweeteners, flavors, dry binders, tabletting aids, anti-caking agents, emulsifiers, antioxidants, and any combination thereof.

12. Method of releasing nicotine according to claim 2, wherein said gum base comprises two or more ingredients selected from the group consisting of elastomers, elastomer plasticizers, resins, polyvinyl acetate, hydrogenated resins, polyterpene resins, fillers, hydrogenated starch hydrolysate, fats and waxes, and any combination thereof.

13. Method of releasing nicotine according to claim 2, wherein the first module comprising nicotine and tablet materials is formed of compressed granules of tablet material and granules comprising nicotine.

14. Method of releasing nicotine according to claim 2, wherein at least a part of the granules of the first module further comprise chewing gum ingredients selected from the group consisting of bulk sweeteners, flavors, dry binders, tabletting aids, anti-caking agents, emulsifiers, antioxidants, high intensity sweeteners, colors, and any combination thereof.

15. Method of releasing nicotine according to claim 14, wherein at least a part of the bulk sweetener of the first module is selected from the group of compressible sweeteners having a compressibility which is lower than the compressibility of the compressible bulk sweeteners of the second module.

16. Method of releasing nicotine according to claim 2, wherein the first module is comprised of compressed particles of nicotine and tablet material, wherein the tablet material comprises mucoadhesives and/or disintegrants.

17. Method of releasing nicotine according to claim 2, wherein the nicotine in the first module is non-buffered and wherein the nicotine in the second module is buffered.

18. Method of releasing nicotine according to claim 2, wherein the nicotine types in the first and second modules are different.

19. Method of releasing nicotine according to claim 2, wherein the nicotine contained in the first module comprises nicotine salts.

20. Method of releasing nicotine according to claim 2, wherein the nicotine contained in the second module comprises nicotine bound to an ion exchange resin.

21. Method of releasing nicotine according to claim 2, wherein the nicotine contained in the second module comprises nicotine bound to an inorganic filler.

22. Method of releasing nicotine according to claim 2, wherein the second module is encapsulated in the first module.

23. Method of releasing nicotine according to claim 2, wherein the first and second modules are compressed in one compressing step.

24. Method of releasing nicotine from a compressed chewing gum tablet, the chewing gum tablet comprising two modules; a first module comprising nicotine and dissolvable tablet material, a second module comprising a non dissolvable gum base and nicotine, and wherein a user of said chewing gum tablet performs the steps of: (a) positioning the chewing gum tablet in the mouth, (b) dissolving at least a portion of the dissolvable tablet material of the first module of the chewing gum tablet in a first period of time, and thereafter: (c) chewing the remaining part of the chewing gum tablet in a second period of time including any undissolved portion of the dissolvable tablet material of the first module of the chewing gum tablet.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0089] For a more complete understanding, reference is now made to the following description taken in conjunction with the accompanying Drawings in which:

[0090] FIG. 1 illustrates one embodiment of a time scale showing a dissolving period and a chew period.

DETAILED DESCRIPTION

[0091] FIG. 1 illustrates some basic understanding, which may serve to explain some relevant features of the present invention.

[0092] The figure shows an axis T, referring to time.

[0093] The time T progresses from t=0 as illustrated to the left of the figure and is determined by the time a user puts a chewing gum tablet as explained in the present application into the mouth.

[0094] In a first period of time, T.sub.DISSOLVE, the user dissolves the dissolvable part of the chewing gum tablet, preferably without chewing the tablet.

[0095] In principle, the time scale illustrates that the starting time of the dissolving period may be later than t=0 where a user puts the chewing gum tablet into the mouth. In practice t=0, i.e. the time where a user puts the chewing gum into the mouth, will typically be the starting of the dissolving of the chewing gum tablet in the mouth of the user and thereby the starting of the first period of time. The starting time may deviate from t=0 as long as the dissolving phase, the first period of time, results in a substantial release of nicotine from the chewing gum tablet.

[0096] In a second period of time, T.sub.CHEW, the user chews the remaining part of the chewing gum tablet. Optional remains from the dissolvable part of the chewing gum tablet will then be chewed together with the non-dissolvable part of the chewing gum.

[0097] The amount of released nicotine during both phases may among many factors depend on the amount and type of nicotine included in the first and second modules.

[0098] The release and absorption of nicotine from the second module will largely be established as in prior art nicotine chewing gum, where the release of nicotine is obtained according to certain established release-profiles and by means of suitable chewing gum structures and formulations. Moreover such release may also be adjusted e.g. by means of coating of the particles to be released.

[0099] The amount of released and absorbed nicotine from the first module is more critical and may depend strongly on whether the user is instructed to use the chewing gum properly, i.e. that the user should avoid chewing the chewing gum during the first period of time and then start chewing after a certain period of time. If a user starts chewing too soon, a substantial portion of the nicotine from the first module may be swallowed because of poor absorption in the mouth. Since nicotine, when swallowed, can cause adverse gastrointestinal symptoms, such as hiccupping and nausea, a user should be well instructed in the use of the chewing gum. Another side-effect of such wrong use of the chewing gum tablet is that expensive nicotine is simply lost as the digested portion of the nicotine gives little of the desired effect.

[0100] It should be noted that the Y-axis is undefined. That is because the Y-axis only serves to illustrate that an undisclosed amount of nicotine is released from the chewing gum tablet during the two periods of time. The figure does not give any essential information regarding the effective amount over time or in total. This will depend of content of nicotine in the modules/layers of the chewing gum tablet, gum base structure, etc.

[0101] The below examples are specific embodiments of the invention.

EXAMPLES

Example 1

Preparation of Gum Base and Preparation of Granules

[0102] Gum base is prepared with a content of absorption enhancer and gum base is prepared without a content of absorption enhancer. There are applied enhancers such as pH control agents as shown in the compositions outlined in table 1.

TABLE-US-00001 TABLE 1 Gum base compositions. Amounts are given in percent by weight of each composition. Component GB 1 GB 2 Elastomer 10 10 PVA 21 21 Natural resin 29 29 Filler 11.5 16.5 Na.sub.2CO.sub.3-pH control agent 5 0 Emulsifier 4 4 Softener (wax and fat) 19.4 19.4 Antioxidant 0.1 0.1 (900 ppm) (900 ppm)

[0103] The preparation of the gum base is carried out by first adding elastomer, polyvinyl acetate, filler and sodium carbonate to a heated (about 120° C.) and running z-blade mixer. After about twenty minutes of mixing, natural resin is added to the running mixer and mixing is continued for about five minutes followed by addition of further natural resin. After about five minutes of continued mixing, emulsifier and further elastomer are added to the running mixer, and mixing is continued for about five minutes before addition of softener and antioxidant to the running mixer. Mixing is continued for about half an hour to one hour, and the final gum base mass is emptied from the mixer into coated or lined pans, extruded or cast into any desirable shape. Those skilled in the art will recognize that many variations of the above-described procedure may be followed.

[0104] To form the gum base as granules, the prepared gum base is transferred either directly or in the form of pellets to an extruder (here a Leistritz ZSE/BL 360 kw 104, available from Leistritz GmbH, Germany), which extrudes the gum base through a die plate into a liquid filled chamber (here a granulator A5 PAC 6, available from GALA GmbH, Germany). Descriptions of the extruder and the granulator may be found in e.g. WO 2004/098305, incorporated herein by reference.

[0105] The already prepared gum base composition is added at a first inlet of the extruder. Menthol flavor crystals in an amount of about 3% by weight of the gum base is dosed to a second inlet and mixed into the gum base composition in the extruder. The addition of menthol could be omitted to form gum base granules entirely based on the already prepared gum base. However, an improved taste and texture of the granules can be obtained by adding additional ingredients such as the above or other flavors or additives.

[0106] The extruder delivers the gum base-comprising composition at a feed rate of 400 kg/h to the die plate. An extruder screw speed set at 247 rpm is applied, and the temperature in the extruder is in the range of 40° C. to 70° C. along about ¾ of the extruder barrel length, until the composition passes a heating device in the outlet end of the extruder. Here the composition is heated to an extruder exit temperature of about 109° C. The extruder and the granulator produce a pressure difference of about 70-75 bar.

[0107] The composition is extruded through the die plate, which is here a die plate having 696 holes with a diameter of 0.36 mm and being heated to a temperature of about 177° C. In the granulator chamber the extruded composition is cut to granules by a cutter with 8 blades and cutter speed set at 1999 rpm. The particles are cooled and transported to the strainer unit (here a centrifugal dryer TWS 20, available from GALA GmbH, Germany) in water with temperature about 11° C. and flow about 22 m.sup.3 /h. The average cooling and transport time in water is approx. 60 seconds. The particle rate is 400 kg/h and the average diameter of the obtained particles is here obtained to be 0.93 mm.

[0108] The cooling and transport stage carried out in water in this example could be carried out in other media such as e.g. air as well. Also various alternative apparatuses, die plates, settings, etc. could be applied in order to obtain smaller or larger average particle sizes of the prepared granules.

[0109] The granules are applied in the compressed chewing gum according to the below examples.

Example 2

Two-Layer Compressed Gum Tablets

[0110] Two-layer tablets with contents of the pharmaceutically active ingredients of Nicotine are prepared with the compositions given in table 2.

TABLE-US-00002 TABLE 2 Chewing gum compositions of two-layer chewing gum tablets comprising pharmaceutically active sources of Nicotine. The Nicotine strength is 2 mg. Amounts are given in percent by weight of each composition Composition no. Components A B C D Layer 1, weight [mg] 1000 1000 1000 1000 GB 1, granules of ex. 1 50 0 50 0 GB 2, granules of ex. 1 0 50 0 50 Bulk sweetener 23.12 15.12 23.12 15.12 Effersoda (encapsulated 0 8 0 8 buffer system) Peppermint powder 2 2 2 2 Menthol powder 1 1 1 1 Sucralose 0.2 0.2 0.2 0.2 Acesulfame potassium 0.1 0.1 0.1 0.1 Tabletting aid 0.5 0.5 0.5 0.5 Layer 2, weight [mg] 300 300 300 300 Isomalt GalenIQ720 20.11 20.11 20.71 20.71 Peppermint powder 1 1 1 1 Menthol powder 0.25 0.25 0.25 0.25 NPR with nicotine load 1.12 1.12 0 0 15.3% Nicotine Bitartrate 0 0 0.52 0.52 Na.sub.2CO.sub.3 powder 0.5 0.5 0.5 0.5 Acesulfame potassium 0.1 0.1 0.1 0.1

[0111] The compositions of layer 1 are obtained by blending the gum base granules, bulk sweetener, buffer, high potency sweeteners, flavors and tabletting aid and for each composition. The compositions of layer 2 are mixed according to table 2. The chewing gum tablets are compressed in a tabletting press, where tablet weights are adjusted to 1300 g. The bulk sweetener chosen for layer 2 in the tablets A to D facilitates that the surface of layer 2 is hard and smooth. Other bulk sweeteners like Isomalt GalenIQ720, Mannitol, Sorbitol, and Xylitab could have been chosen. The selection is often based on the stability requirement and compatibility to other ingredients in the tablet.

[0112] Moreover, the tablets may by applied according to the provisions of the present invention by a user who during a first period of time dissolves Layer 2 in the mouth, thereby releasing nicotine contained in the layer 2 relatively fast, but still slow enough to ensure that a relatively large amount of the nicotine contained in layer 2 as absorbed in the mouth of the user instead being swallowed, which would largely be the case if the chewing gum was simply chewed as from the beginning.

[0113] The user may advantageously be instructed to dissolve the tablet in the mouth until all or most of layer 2 has been dissolved. The user may thus simply feel that the dissolvable module, layer 2, is gone or almost gone and then start chewing the remaining of a layer 1 and optionally layer 2, thereby gradually releasing the nicotine in the remaining tablet, primarily layer 1.

Example 3

[0114] Two-Layer-Gum Tablets

[0115] Four alternative two-layer tablets are described below. The below tablets E, F, G and H are very advantageous for use according to the provisions of the invention, i.e. as a nicotine releasing chewing gum tablet, where a user dissolves the tablet in a first time period and subsequently chews the remaining part of the tablet.

[0116] The two-layer gum tablets are prepared with the compositions given in table 3.

TABLE-US-00003 TABLE 3 Chewing gum compositions of chewing gum tablets comprising pharmaceutically active sources of Nicotine. Amounts are given in percent by weight of each composition. The Nicotine strength is 1.5 mg in the layer 1 and 0.5 mg in layer 2, but other combinations could be applied. Composition no. Components E F G H Layer 1, weight [mg] 1000 1000 1000 1000 GB 1, granules of ex. 1 50 0 50 0 GB 2, granules of ex. 1 0 50 0 50 Bulk sweetener 22.3 14.3 22.3 14.3 NPR with nicotine load 0.8 0.8 0.8 0.8 15.13% Effersoda (encapsulated 0 8 0 8 buffer system) Peppermint powder 2 2 2 2 Menthol powder 1 1 1 1 Sucralose 0.2 0.2 0.2 0.2 Acesulfame potassium 0.1 0.1 0.1 0.1 Tabletting aid 0.5 0.5 0.5 0.5 Layer 2, weight [mg] 300 300 300 300 Mannitol (Pearlitol 21.13 21.13 0 0 Flash) Maltitol P200 Sweetpearl 0 0 18.63 18.63 Disintegrant 0 0 2.5 2.5 Peppermint powder 1 1 1 1 Menthol powder 0.25 0.25 0.25 0.25 Nicotine Bitartrate with 0.12 0.12 0.12 0.12 purity 99.7% Na.sub.2CO.sub.3 powder 0.5 0.5 0.5 0.5 Acesulfame potassium 0.1 0.1 0.1 0.1

[0117] The compositions of layer 1 are obtained by blending the gum base granules, NPR, bulk sweetener, buffer, high potency sweeteners, flavors and tabletting aid. The compositions of layer 2 are mixed and compressed in a tabletting press.

[0118] In the present example, Layer 2 may be compressed at a lower pressure when compared to conventional compressed gum.

[0119] The purpose of layer 2 in the chewing gum product is to dissolve quickly within 30 seconds and thereby release the Nicotine bitartrate and if applicable buffer. Furthermore, release of flavors and high potency sweeteners for taste masking.

[0120] The acceptance criteria for friability should be fulfilled so packaging of the resulting chewing gum tablets is possible, but in this embodiment, the bulk sweetener should have relatively good compressibility and still have fast disintegration as compared to the previous example. A bulk sweetener like the above-applied Mannitol Pearlitol Flash from Roquette is suitable for this purpose. Another example is Pharmaburst 500 from SPI Pharma.

[0121] Another solution for making the chewing gum tablet is to provide the formulation with a disintegrant in layer 2 together with a bulk sweetener that is not ideal for fast disintegration by itself. This excipient will speed up the process of dissolving the layer 2 when the tablet is exposed to human saliva.

[0122] The tablets E to H may by applied according to the provisions of the present invention by a user wherein the user during a first period of time dissolves Layer 2 in the mouth, thereby releasing nicotine contained in the layer 2 relatively fast, but still slow enough to ensure that a relatively large amount of the nicotine contained in layer 2 is absorbed in the mouth of the user instead of being swallowed, which would largely be the case if the chewing gum was simply chewed as from the beginning.

[0123] The user may advantageously be instructed to dissolve the tablet in the mouth until all or most of layer 2 has been dissolved. The user may thus simply feel that the dissolvable module, layer 2, is gone or almost gone and then start chewing the remaining part of layer 1 and optionally layer 2, thereby gradually releasing the nicotine in the remaining tablet, primarily layer 1.

[0124] The two-layer chewing gum tablets E to H show even better qualities as regards control of Nicotine release and thereby Nicotine craving as compared with the two-layer compressed gum tablets described in example 2, as layer 2 has a primary content of bulk sweetener with a relatively low compressibility. According to advantageous embodiments of the invention, it is preferred to use bulk sweetener having a low compressibility in the dissolvable module, to ensure that the user may obtain a release from the module relatively fast when the chewing gum tablet has been put into the mouth.

[0125] As an alternative, or a supplement, to these choices of compressible sweeteners, the sweeteners in the dissolvable module may be compressed by a reduced pressure when compared with e.g. the pressure applied for the tablets A to D.

[0126] In some embodiments nicotine is added as a salt such as nicotine bitartrate, nicotine pftalate, nicotine polacrilex, nicotine sulphate, nicotine tartrate, nicotine citrate, or nicotine lactate.

[0127] The composition of gum base formulations can vary substantially depending on the particular product to be prepared and on the desired masticatory and other sensory characteristics of the final product. However, typical ranges of the above gum base components are: 5 to 80% by weight of elastomeric compounds, 5 to 80% by weight of elastomer plasticizers, 0 to 40% by weight of waxes, 5 to 35% by weight of softener, 0 to 50% by weight of filler, and 0 to 5% by weight of miscellaneous ingredients such as antioxidants, colorants, etc. The gum base may comprise about 5 to about 95% by weight of the chewing gum, more commonly; the gum base comprises 10 to about 60% by weight of the gum.

[0128] Elastomers provide the rubbery, cohesive nature to the gum, which varies depending on this ingredient's chemical structure and how it may be compounded with other ingredients. Elastomers suitable for use in the gum base and gum of the present invention may include natural or synthetic types.

[0129] Elastomer plasticizers vary the firmness of the gum base. Their specificity on elastomer inter-molecular chain breaking (plasticizing) along with their varying softening points cause varying degrees of finished gum firmness and compatibility when used in gum base. This may be important when one wants to provide more elastomeric chain exposure to the alkanic chains of the waxes.

[0130] If desired, conventional elastomers or resins may be supplemented or substituted by biodegradable polymers.

[0131] Agglomeration which may be used on e.g. tablet material and active ingredients in an embodiment of the invention may be performed for instance by fluid bed agglomeration, a process known to the person skilled in the art.

[0132] The chewing gum may include component known in the chewing gum art. For example, the chewing gum may include elastomers, bulking agents, waxes, elastomer solvents, emulsifiers, plasticizers, fillers, and mixtures thereof.

[0133] The chewing gum according to the invention may comprise coloring agents. According to an embodiment of the invention, the chewing gum may comprise color agents and whiteners such as FD&C-type dyes and lakes, fruit and vegetable extracts, titanium dioxide and combinations thereof.

[0134] Further useful chewing gum base components include antioxidants, e.g. butylated hydroxytoluene (BHT), butyl hydroxyanisol (BHA), propylgallate and tocopherols, and preservatives.

[0135] A gum base formulation may, in accordance with the present invention, comprise one or more softening agents e.g. sucrose esters including those disclosed in WO 00/25598, which is incorporated herein by reference, tallow, hydrogenated tallow, hydrogenated and partially hydrogenated vegetable oils, cocoa butter, degreased cocoa powder, glycerol monostearate, glyceryl triacetate, lecithin, mono-, di- and triglycerides, acetylated monoglycerides, lanolin, sodium stearate, potassium stearate, glyceryl lecithin, propylene glycol monostearate, glycerine, fatty acids (e.g. stearic, palmitic, oleic and linoleic acids) and combinations thereof. As used herein the term “softener” designates an ingredient, which softens the gum base or chewing gum formulation and encompasses waxes, fats, oils, emulsifiers, surfactants and solubilisers.

[0136] To soften the gum base further and to provide it with water-binding properties, which confer to the gum base a pleasant smooth surface and reduce its adhesive properties, one or more emulsifiers is/are usually added to the composition, typically in an amount of 0 to 18% by weight, preferably 0 to 12% by weight of the gum base. Useful emulsifiers can include, but are not limited to, glyceryl monostearate, propylene glycol monostearate, mono- and diglycerides of edible fatty acids, lactic acid esters and acetic acid esters of mono- and diglycerides of edible fatty acids, acetylated mono and diglycerides, sugar esters of edible fatty acids, Na-, K-, Mg- and Ca-stearates, lecithin, hydroxylated lecithin and the like and mixtures thereof are examples of conventionally used emulsifiers which can be added to the chewing gum base. In case of the presence of a biologically or pharmaceutically active ingredient as defined below, the formulation may comprise certain specific emulsifiers and/or solubilisers in order to disperse and release the active ingredient.

[0137] Waxes and fats are conventionally used for the adjustment of the texture and for softening of the chewing gum base when preparing chewing gum bases. In connection with the present invention, any conventionally used and suitable type of natural and synthetic wax and fat may be used, such as for instance rice bran wax, polyethylene wax, petroleum wax (refined paraffin and microcrystalline wax), sorbitan monostearate, tallow, propylene glycol, paraffin, beeswax, carnauba wax, candelilla wax, cocoa butter, degreased cocoa powder and any suitable oil or fat, as e.g. completely or partially hydrogenated vegetable oils or completely or partially hydrogenated animal fats.

[0138] A chewing gum base formulation may, if desired, include one or more fillers/texturisers including as examples, magnesium and calcium carbonate, sodium sulphate, ground limestone, silicate compounds such as magnesium and aluminum silicate, kaolin and clay, aluminum oxide, silicium oxide, talc, titanium oxide, mono-, di- and tri-calcium phosphates, cellulose polymers, such as wood, and combinations thereof.

[0139] In addition to a water insoluble gum base portion, a typical chewing gum includes a water soluble bulk portion and one or more flavoring agents. The water-soluble portion may include bulk sweeteners, high-intensity sweeteners, flavoring agents, softeners, emulsifiers, colors, acidulants, buffering agents, fillers, antioxidants, and other components that provide desired attributes.

[0140] Combinations of sugar and/or non-sugar sweeteners can be used in the chewing gum formulation processed in accordance with the invention. Additionally, the softener may also provide additional sweetness such as aqueous sugar or alditol solutions.

[0141] Useful sugar sweeteners are saccharide-containing components commonly known in the chewing gum art including, but not limited to, sucrose, dextrose, maltose, dextrins, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, and the like, alone or in combination.

[0142] Sorbitol can be used as a non-sugar sweetener. Other useful non-sugar sweeteners include, but are not limited to, other sugar alcohols such as mannitol, xylitol, hydrogenated starch hydrolysates, maltitol, isomaltol, erythritol, lactitol and the like, alone or in combination.

[0143] High-intensity artificial sweetening agents can also be used alone or in combination with the above sweeteners. Preferred high-intensity sweeteners include, but are not limited to sucralose, aspartame, salts of acesulfame, alitame, neotame, twinsweet, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside and the like, alone or in combination. In order to provide longer lasting sweetness and flavor perception, it may be desirable to encapsulate or otherwise control the release of at least a portion of the artificial sweetener. Techniques such as wet granulation, wax granulation, spray drying, spray chilling, fluid bed coating, coascervation, encapsulation in yeast cells and fiber extrusion may be used to achieve the desired release characteristics. Encapsulation of sweetening agents can also be provided using another chewing gum component such as a resinous compound.

[0144] Usage level of the high-intensity artificial sweetener will vary considerably and will depend on factors such as potency of the sweetener, rate of release, desired sweetness of the product, level and type of flavor used and cost considerations. Thus, the active level of high-potency artificial sweetener may vary from about 0 to about 8% by weight, preferably 0.001 to about 5% by weight. When carriers used for encapsulation are included, the usage level of the encapsulated sweetener will be proportionately higher.

[0145] If a low-calorie gum is desired, a low-caloric bulking agent can be used. Examples of low caloric bulking agents include polydextrose, Raftilose, Raftilin, fructooligosaccharides (NutraFlora®), palatinose oligosaccharides; guar gum hydrolysates (e.g. Sun Fiber®) or indigestible dextrins (e.g. Fibersol®). However, other low-calorie bulking agents can be used.

[0146] The chewing gum according to the present invention may contain aroma agents and flavoring agents including natural and synthetic flavorings e.g. in the form of natural vegetable components, essential oils, essences, extracts, powders, including acids and other substances capable of affecting the taste profile. Examples of liquid and powdered flavorings include coconut, coffee, chocolate, vanilla, grape fruit, orange, lime, menthol, liquorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almonds, pineapple, strawberry, raspberry, tropical fruits, cherries, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essence such as from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essence. The essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits mentioned above.

[0147] The chewing gum flavor may be a natural flavoring agent, which is freeze-dried, preferably in the form of a powder, slices or pieces or combinations thereof. The particle size may be less than 3 mm, less than 2 mm or more preferred less than 1 mm, calculated as the longest dimension of the particle. The natural flavoring agent may be in a form where the particle size is from about 3 μm to 2 mm, such as from 4 μm to 1 mm. Preferred natural flavoring agents include seeds from fruit e.g. from strawberry, blackberry and raspberry.

[0148] Various synthetic flavors, such as mixed fruit flavors may also be used in the present chewing gum centers. As indicated above, the aroma agent may be used in quantities smaller than those conventionally used. The aroma agents and/or flavors may be used in the amount from 0.01 to about 30% by weight of the final product depending on the desired intensity of the aroma and/or flavor used. Preferably, the content of aroma/flavor is in the range of 0.2 to 5%, more preferably 0.5 to 3%, by weight of the total composition.

[0149] In an embodiment of the invention, the flavoring agents comprise natural and synthetic flavorings in the form of natural vegetable components, essential oils, essences, extracts, powders, including acids and other substances capable of affecting the taste profile.

[0150] In one embodiment of the invention, the flavor may be used as taste masking in chewing gum comprising active ingredients, which by themselves have undesired taste or which alter the taste of the formulation.

[0151] Active ingredients may advantageously be applied in a chewing gum according to am embodiment the invention. Active ingredients generally refer to those ingredients that are included in a delivery system and/or compressible chewing gum composition for the desired end benefit they provide to the user