CA2478619A1 - Coated chewing gum comprising an active substance having systemic activity - Google Patents

Abstract

A coated chewing gum comprising a core of chewing gum and a coating comprising a coating material and one or more active substance(s) in solid form. The use of an active substance in solid form in the coating of a coated chewing gum provides a fast onset of the effect, a better stability of the active substance, and an increased effect thereof in all chewing phases.

Description

A Coated Chewing Gum, a Method for Preparation thereof and the Use of One or More Active Substancefs) in Solid Form Technical Fietd The present invention relates to a coated chewing gum comprising a core of chewing gurn and a coating comprising a coating material as wail as one or more active sub-stances) in solid form. Furthermore, the invention relates to a method for the prepa-ration of a coated chewing gum and the use of one or mAre active substanceis) in solid form in the coating of a coated chewing gum.
Technical Background Coated chewing gum is prepared by coating a core of chewing gum with a number of layers of coating. The coating most often takes place in rotating coating kettles in which cores of chewing gum are rotated and coating suspension is applied in small portions that disperse evenly over the surfaces of the cores. Subsequently, the coated cores are dried by means of air.
These coating operations may be applied in up to approx. 90 increments until the pre-farted coating thickness is obtained, and the product has the preferred measures and the preferred weight.
The coating suspension is often an aqueous solution of a sugar or the like applied at an elevated temperature to ease the coating process.
In order to provide a fast flavour onset, often one or more flavours) islare applied and possibly other active substances between the applications of the coating s~,rspension.
The active substances) islare added in liquid -loan in one or more increments).
SO
t'~ chewia~g gurr~ with a completed casting is normally finally treated with a surface layer of a wax or the like.

WO 99!44436 PC'TIDK99/00108 The tablets with a completed coating are then subjected to a hardening process during the following approx. 8 weeks. Sugar alcohols such as sorbitol and xylitol thus form crystals whereby the chewing gum obtains a harder and a "crunchy" coating. The cry-stallisation process also provides a mope porous coating structure. Thus, a migration of water, moisture and flavour takes place through the formed micro channels.
This causes the chewing gum to gradually lose its flavour, ethereal oils, it any, are oxidised, and the chewing gum loses moisture and gets harder.
Furthermore, the use of active substances in liquid form in the coating layers has the disadvantage that some of the active substances are lost to the surroundings during the casting process.
it has now been found that by using active substances in solid form in the coating 1 S layers of conventional chewing gum, an increased stability of the active substance is obtained. Furthermore, a taster onset of the effect is achieved, and by using flavour in solid form, a longer lasting explosion of taste compared with chewing gum coated with a Liquid flavour. Finally, according to the invention, a more environmentally desirable manufacturing process is obtained since the use of an active substance in solid form causes less evaporation of volatile substances.
Disclosure of the Invention Thus, the invention relates to a coated chewing gum comprising a core of chewing 2b gum and a coating which comprises a coating material, and one or more active substance(s), which chewing gum is characterised in that the active substances) islare added in solid form.
Furthermore, the invention relates to a method for the preparation of a coated ct~e~~ing gsar~n according to the invention, which rrmthod is characterised in that it corr~prises the following steps:
1 t preparation of a core of chewing gum in is rr;anner known per se, WO 99!44436 PC'T/BK99/00108 2) preparation of a coating suspension, also in a manner known per se, 3) repeated applications of the coating suspension onto the cores of chewing gum also in a manner known per se, pøeferable at a temperature in the interval 30-90°C, preferably 35-75°C, 4) Applying on the coating of one or mare active substances) in solid form in one or more increments) after the application of the caating suspension, and optionally repeating step 3) and 4) 5) optionally, application of one or more liquid active substances) in one or more increments) between the applications of the coating suspension, 6) optionally, finally application of a surface layer.
Applying of the solid active substances) is/are preferable performed without drying of the coating suspension in order to enable adherence of a substantial amount of the substances) in solid form to the coating. The drying time for the coating suspension depends on the specific coating formulation, however, the active substances) is/are added to the coated chewing gum substantially without delay after the coating pro-cesses are finished. if desired, the coated chev~~ing gum may be wetted before adding the active substances) in solid form in case the coating has been allowed to dry for.
too long time whereby the coated chewing gum is no longer sticky.
The coating process may be repeated as many tunes as needed in order to obtain the desired! thickness of the coating. In the coating process, the active substances) in solid form may be added between one or more of the ordinary coating processes.
The last layer of the coating process may also include the active s~~bstance(s) i~~s solid forma ix is also withi~v the prese~vt inventior~~ to use difie:wnt active sGabsta~~ces in solid form in the same coati~~g layer or use one active substance in one layer, and a second active s~xbstance in another iayero Such combinations of a~;tive substances rrt~y be flavour and high potent sweeteners or a medicament together with an substance decreasing an undesirable taste or~ tf~e medicament.

WO 99!44436 PCTIDK99/00108 As the active substances) is/are located in the outer part of the coating, the active substances) islare exposed to the consumer within a short period of chewing.
Accordingly, in a further embodiment, the invention relates to the use of one or more active substances) in solid form in the coating of a coated chewing gurn in order to obtain a fast onset of the effect.
A further advantage of the admixture of the active substances) in solid form is that the solid form is more resistant to decomposition. Accordingly, the invention also relates to the use of one or mare active substances) iri solid form in the coating of a coated chewing gum in order to obtain a better stability of the active substance(s).
Finally, the invention relates to the use of one or more active substances) in solid form in the coating of a coated chewing gum in order to obtain an increased effect of the active substances) in all chewing phases.
Brief Description of the Drawinct The invention is further illustrated by means of the drawing, in which 20 Fig. 1 shows the release of flavour as .a function of time by using menthof/-anetho!/eucalyptus flavour in encapsulated form and liquid form, respectively, Fig. 2 shows the release of flavour as a function of time by using the same amount of eucalyptus/anethol/menthol flavour in encapsulated form and liquid form, respectively, 25 Fig. 3 shows the release of flavour as a function of time by using liquid euca-lyptus/anethol/mentho! flavour and with and without encapsulated menthol, Fig. ~ shows the stability ~>s chewing gum with apple/cinnarr~on flavtaur with encap_ suladed ancd non-encapsuiatec~ aspartame, res~eGtiv~:ly, in sus~~~sic~n form in the 30 coatingz 1'"ig. 5 shows a flavour profile in the ir~ritial phase of chewing guru v~i~h fruiC flavour (IemonlarangeJmango) with a~~~! without eawapsulated citric acid in t~~e coating, WO 99!44436 PCT/DK99l00108 Fig. 6 shows a flavour profile in the initial phase of a chewing gum with fruit flavour (lemon/orange/mango) with and without encapsulated "cooling agent" in the coating, Fig. 7 shows the same in the intermediate phase, Fig. 8 shows the same in the end phase, Fig. 9 shows a flavour profile in the initial phase of chewing gum with rnenthod/-anethol/eucalyptus flavour and with encapsulated thyme extract in the coating.
Fig. 10 shows the same in the intermediate phase, Fig. 11 shows the same in the end phase, Fig. 12 shows a ftavaur profile in the initial phase of chewing gum with menthol/-anethol/eucalyptus flavour and with encapsulated extract of black pepper in the coating, Fig. 13 shows the same in the intermediate phase, and Fig. 14 shows the same in the end phase.
The scope of the invention will appear from the detailed description below.
However, it should be understood that the detailed description and the specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the scope of the invention will become apparent for those skilled in the art from the detailed description.
Detailed ~escfii tior~ ofi the Invention 'The active substances are selected among flavours, acids, sadts, high patent sweeteners, and functional substancesa CA 02478619 2004-09-23 ..

Aromas, which may be incorporated into the chewing gum according to the invention, are selected among natural, naturally identical or synthetic flavours, as well as plant extracts. Examples of applicable flavours are for example peppermint, periwinkle, eucalyptus, spearmint, anethol, menthol, powdered anise, and fruit flavours such as orange, lemon, mango, pineapple, lime, strawberry, cherry, black currant, blueberry, raspberry, wild berry, cranberry, apple, pear, banana, prune, and plum flavour,. etc.
The plant extracts which may be applied instead of or together with one or more of the above-mentioned flavours) are preferably selected among extracts of liquorice, coffee, tea, herbs such as sage, thyme, basil, bergamot, balm, valerian, camomile, lavender, aloe vera, and spices such as pepper, cinnamon, capsicum, paprika, tarragon, fennel, mustard, dill, caraway, parsley, tomato, etc.
The use of plant extracts in coated chewing gum provides the possibility of preparing 7 5 novel combinations of flavour and new flavour experiences.
1n a preferred embodiment of the invention the active substances) is/are a natural vegetable flavouring agent such as fruit and herbs. Accordingly the substance may be selected among coconut, grape fruit, orange, lime, lemon, mandarin, pineapple, strawberry, raspberry, mango, passion fruit, kiwi, apple, pear, peach, apricot, cherry, pineapple, grapes, banana, cranberry, blueberry, black currant, red currant, gooseberry, and iingonberry, thyme, basil, valerian, fennel, parsley, camomile, tarragon, lavender, dill, cumin, bergamot, sage, aloe vera, spearmint, peppermint, eucalyptus and mixtures thereof.
It is furthermore an advantage that the natural flavourine~ agent is dried. A
dried agent may have a more intense flavour and may further increase the stability of the flavour because many of the notes of the taste are still present in the more or less intact Celts of the fr~.ait or herb. The Limited content of water is also an important factor with res~aect to stal~illtye In a fs~rther aspectr the water content of the natural flavouring agent is less than ~'5°r~
by ~sv~:igi~t, such as less than 60%, prefecable less than ~0%, more preferred less than 30%, such as less than 25%. However, in si2uatio~ss ~n~i~e~re a less water conteaat i4~

desired (for stabiity reasons or with respect to have an increased flavour sensations, the water content of the natural flavouring agent is less than 20% by weight, such as less than 15%, more preferred less than 10% such as between 1.5-7°~;,rnore preferred between 2-6°~.
In a preferred embodiment, the natural flavouring agent is freeze-dried.
The natural flavouring agent in solid form may be in the form of a powder, slices or pieces, or combinations thereof. When a natural vegetable flavour is used, it is generally accepted or even desired that a feeling of small pieces of the flavour agent be recognised by the consumer in the chewing process. Accordingly, the natural flavouring agent may be in a form where the particle size is up to 3mm or even more.
However smaller pieces are preferred and in a further aspect, the particle size is less than 3mm, such as less than 2mma more preferred less than 1 mm, calculated as the longest dimension of the particle.
In other situations it may be an advantage to have different sizes of the particles and an example is wherein the natural flavouring agent is in a form where the particle size is from about 3p. to 2mm, such as from 4p to 1 mm. However, the skilled person may select any combination dependent on the desired final properties of the coated chewing gum.
As seeds from fruits may have a special flavour, the natural flavouring agent may comprise seeds from a fruit e.g. from strawberry, blackberry and raspberry, and which seeds are substantially intact.
In a still further aspect of the invention, the natural vegetable flavouring agent ats~
provides the gum formulation with natural colour_ With seeds of a vegetable or fruit flavouring agents such as strawberry and/or orange, it leas iacen possible to obtain a marbling colouring of the chewing gum as well as a uniform colouring.
Accc~c~dinc~ly, in a further aspect of the invention, the active substance in solid fc~rrr~ may be a colouring agent.

CA 02478619 2004-09-23 "
WO 99!44436 PCTIDK99/00108 Various acids may also be applied as active substances, such as citric acid, malic acid, tartaric acid, lactic acid, and ascorbic acid or any other acid allowed in food and which is suitable. These may most conveniently be applied together with chewing gum with fruit flavour in order to obtain an improved freshness during the first phase of the chewing period.
Furthermore, according to the invention, instead of or together with one or more of the above-mentioned active substance(s), salts may be applied, such as sodium chloride, potassium chloride, ammonium chloride, sodium bicarbonate, and carbamide.
Hereby an improved chewing gum taste during the initial chewing period is obtained, and in case of sodium bicarbonate and carbamide also an improved dental care effect.
in order to obtain a sweet taste during the initial chewing period, together with or instead of one or more of the above-mentioned active substances) sweeteners may be incorporated in the coating, preferably highly potent sweeteners.
Especially suitable sweeteners are e.g. aspartame, acesulfame K, saccharin, cyclamate, neohespiridine, thaumatin, gtycyrrhizin, and salts thereof, moneltin, sucrolase, and alitame.
Finally, in order to obtain a specific effect together with or instead of one or more of the above-mentioned active substance(s), one or more functional substances) can be incorporated in the coating such as vitamins and nutrients, "cooling agents", flavour enhancers, enzymes, agents for care and treatment of the oral cavity, antiseptic agents, pharmaceuticals and herbal medicine.
"Cooling agents" and flavour enhancers are substances manufactured by so-caned "flavour houses", and which substances are also known as "flavour enhancer", "cooling fitavour", "physcol", "optacoo!", and the like. They are applied in order to make the taste stronger and fresh.
Examples of cooling agents a~-a eag. lactic acid menthy! ester, disclosed ir:
EP
07g~-Z59:~1, mono mentl-a~;lsuccinate, and salts thereof, disclosed en'~11Q9~107771, and ~-("!-rnenthoxymenttzyl)-2-phenyl-1.3-dioxolan and derivati~.=es thereof, disclosed in US ~3,b~.5.424, WO 99/44436 PCTlDK99/00108 Among the vitamins and the nutrients that may be incorporated in the chewing gum according to the invention special mention can be made, without Limitation, of the vitamins A, B,, B2, B5, Bs, B,2, ~3, E, IC, folic acid, niacin, biotin, (3-carotene, ascorbic acid, and salts thereof, amino acids, glycerophosphates, minerals in the form of salts, complexes and compounds containing calcium, phosphorus, magnesium, iron, zinc, copper, iodine, manganese, chromium, selenium, molybdenum, potassium, sodium, or cobalt and ubiquinon.
Among agents for the care and treatment of the oral cavity, special mention may be 7 0 made of hydrogen peroxide, carbamide and carbamide releasing compounds, CPP
(caseinphosphopeptidey, fluorine corr~pounds such as sodium fluoride, sodium monofluorophosphate, and stannofluoride, arginine, zinc compounds, strontium chloride and potassium nitrate.
Among antiseptic agents, special mention may be made of guanidine and biguanidine, such as chlorhexidine acetate, quaternary ammonium compounds such as benzatkonium chloride, cetylpyridinium chloride, and cetrimide, phenols such as tymol, trictosan, parachlorophenol, and cresol, hexachlorophen as well as salicylanilide compounds.
Enzymes may atso be incorporated in the chewing gum according to the invention, e.g. papain, trypsin, arriytogtucosidase, lactase, glucoseoxidase, streptokinase, streptodornase, dextranase, and mutanase.
Among pharmaceuticals, special mention rnay be made of caffeine, salicylic acid, and derivatives thereof, such as acetylsalicylic acid, choline salicylate, and magnesium saticylate, paracetamol, salts of pentazocine, buprenorphine, and buprenorphine hy-drochloride, codeine hydrochloride and phosphate, morphine and salts tl7erec~fi methadone hydrochloride, ketohenvidone, ~ blocl~ers, calcium arr~~gonistsY
verahar~~il hydrochloride, verapamil, nifedipine, nitroglycerin, erythrityl tetraraitrate, stry~,hni~~e and salts thereof, lidocaine, tetracaine hydrochloride, etorphine hydrochtc~r-idc, atropine, insulin, alfa-arwyiase, polypeptides such as oxytocin, gaarradorelin, dr~d )r.l-lPl.:y, desmopressira acetate ~T~nAV't'?, isoxsuprine hydrochloride, ergo~:=_~snine corr~pous°id~, chloroq~sia~e phosphate and sulfate, isosorhide, demoxytocin, heparin, lupeol, sucralfate and satts thereof, nicotine and salts and derivatives thereof, tobeline, cinnarizine, dimenhydrinate, difenhydramine, cyclizine, scopolamine, miconazole, nystatin, metronidazole, hydrocortisone, astemizole, benzocaine, gtibenglamide, onsaedantronum, acyclovir, sumatriptan, tropisetron, pizotifen, cisapride, 5 domperidone~ itraconazote, omeprazole, terfenadine, ftuconazole, naratriptan, zolmiriptan, rizatriptan, eletriptan, almotriptan, sildenafil, tolfenamic acid, tramadol, cetirzine, and loratidine.
Among herbal medicine special mention may be of pink jo biloba, ginseng, saw 10 palmetto, stevia, ginger, propoiis, echinacea, St. John's Wort, Siberian ginseng, guarana, and garlic in the form of drugs, extracts or in purified form.
Furthermore, it is possible by means of the present invention to add substances, which cannot resist the thermal and mechanical influences that normally occur during the manufacturing of cores of chewing gum, such substances being certain vitamins, enzymes, and pharmaceuticals.
The active substances) is/are added in the form of dry active substance, preferably spray-dried active substance, or in the form of encapsulated active substance.
In a preferred embodiment of the present invention, the active substance is present in an encapsulated form. The active substance is preferably present in the farm of a powder with particles having a size of 3-300 pm.
The use of encapsulated active substance provides a larger stability of the substance, and the active substance migrates very slowly to the surface of the coated chewing gum. Furthermore, the contact of the encapsulated active substances with the air is limited, whereby possible oxidation processes take place very slowly. The tatter are of particular significance irr connection with flavours, especially ir' the form of ethereal oils, such as pepperr~nint, lemon, time, and orange.
In addition, by encapsulating the active substance, it is achieved that its reaction with other substances is prevented, substances tike e.g. sodium bscarborsate m~ith acid and asp~~ game with aldehyde-cowtaining flavours, arid espe~~iatty ire case of suiast~ar~ces sviih ar3 unpleasant taste, e.g. certain pharmaceuticals, -rte taste may be camouftage~l.

WO 9914443b PCTlDK99/00108 In addition, it has been found that by chewing chewing gum that.is coated with encapsulated flavour, not only a strong taste explosion is achieved, but also an enhanced taste in all chewing phases. Tt~e latter is due to the fact that flavour capsules from the coating layer of the chewing gum are opened both during the initial chewing and in following chewing period.
Furthermore, using an encapsulated active substance may prevent a discoloration of the coating, e.g. plant extracts such as thyme or black pepper. Finally, it may be desirable to prevent water-solubility, e.g. in connection with the use of acids and salts as the active substance.
When an encapsulated active substance is used, conventionally used encapsulation agents are used as the encapsulation agent, for instance, but without limitation, fatty substances, waxes, gelatin, gum arabic, starch, cellulose, cellulose derivatives, shellac, polyvinyl acetate (PVA), polyethylene (PE), casein, zein, B
cyclodextrine, silica, yeast cells, and a mixture of the above encapsulation agents.
Preferred encapsulation agents comprise fatty substances such as hydrogenated soy bean, cottonseed, coconut, sunflower, palm kernel, rapeseed, and ricinus oil, or waxes such as bees' wax, candelilla wax, carnauba wax, paraffin wax, and polyethylene wax, ete.
Especially preferred is the use of a mixture of hydrogenated rape oil and carnauba wax.
Encapsulated flavour and methods for encapsulation are known from, e.g., EP 0 752 A2, EP 0453 397 A1, EP 0 455 598 B1, and US 4,3~6,106.
In a particularly preferred embodiment of the coated chewing gum according to the present invention, the coating also comprises besides the coating material as well as one or more active substances) mn Solid form, one or more iirta~id active substance(s).
This provides a 9arger flexibility of the process of che~~ing gum manufact~rre, and, when encapsulated active substarac:e is concerned, a rwciuctior~ irs costs, since the encapsulation makes the process r~~rore expensive, anc~ it is t's~us reserved for only the rr'c~si sensitive active substances.

WO 9914443b PCT/DK99100108 In one embodiment of the invention, the coating suspension comprises an aqueous solution of a sugar, a sugar alcohol, an artificial sweetener or mixtures thereof, preferably an aqueous solution of saccharose, dextrose, sorbitol, xytitol, tagatose, mannitol, maltitol, isomalt, aspartame, acesulfame K, saccharin, cyclamate, thaliine, and neohespiridine.
The coating suspension is applied in approx. 2 to 90 increment(sf, preferably in approx. 30-60 increments to achieve a uniform coating with a suitable thickness.
The active substances) islare applied by sprinkling or by blowing the substances into the rotating ketttes a number of times such as from 1 to 10 times between the dosages of the coating suspension, preferably approx. 1 to 4 times to achieve a suitable effect.
The following is a general description of the preparation of chewing gum.
Preparation of Chewing Gum The preparation process comprises the following:
Mixing of conventional chewing gum components in kneading kettles (mixers) with strong horizontalPy placed Z-shaped arms, which processes the raw materials and produces a homogeneous gum mass.
The kneading kettles are heated to a temperature of 30-$0°C, typically approx. 45°C.
The mixing process starts with gum base quantities that have been weighed out, and the processing of these lasts for 1-20 minutes, typically approx. 10 mirrutes.
Then one or rmore sweeteners) in powder form or ire liquid farm islare added. The sl~ssag~; of sweeteners and the following processing bast fros~ 1 to 20 minuW s; typically approx.
7 minutes.
Then the flavours an;_s the rerrsaining compone~~ts as EA added aid kneaded for a further 1 to 10 minutes, typically approx. 5 minutes. Thc~ ~ac~a~-~ixtuiw of flavours ara~~ the ren-~ai~i~g components r~s~ay als~a take place in the begin~irac~ of the krleadirig process, WO 99144436 PC.'1'/DK99/00108 i.e. before the admixture of the sweeteners. It is also possible to add flavours in two or more portions during the kneading process.
When the kneading is completed, the kneading kettle is tipped, and the gum mass is taken aut into carts, onto trays or' the tike.
The next process is the forming of the chewing gum. Before the forming can take place, the chewing gum mass, however, must be cooled. When taken out, the chewing gum mass has a temperature of 50-70°C, and in Order to form the chewing gum, the temperature must be reduced to 30-45°C. The cooling of the chewing gum either takes place by storing the che~iving gum mass in carts or on trays for quite a long time or by transporting a thin chewing gum carpet through a cooling tunnel.
The forming of the chewing gum may take place by extrusion through a specially formed nozzle, or the chewing gum may be formed after extrusion by means of rollers, punching machines, tentering wheels, and the like.
The chewing gum may be formed into cores, sticks, balls, cubes, cylinders, and many other shapes.
In order to prevent the chewing gum from sticking to the rollers and other tools, the chewing gum is frequently powdered with a powder, which may consist of i.a.
icing , sugar, talc, corn flour, and the like.
The formed chewing gum can be cooled immediately to roorr~ tervperature in a cooling tunnel and be packed (especially in case of bubble gum and soft bubble gurry, or the cooling may take place on trays at the store for semimanufactured products at a controlled temperature and moisture.
The formed and cooled :hewing gum is then treated by rneans ~.oatirog and polishing processes hefore the packing.

CA 02478619 2004-09-23 ' WO 99!44436 PCT/DK99/OOI08 Coating and Polishing of Cores of Chewing Gum The coating of cores takes place in tilted, round or horizontally placed cylindrical coating kettles that rotate during the whole process. The coating kettles are made from copper, stainless steel or fiberglass-reinforced polyester, and are often equipped with a piping system that supplies and exhausts air and doses the coating suspension.
The coating process may take place as follows:
Cores of chewing put into movement in rotating coating kettles are added to the coating suspension in small portions that disperse evenly over the surfaces of the cores after a short or long smoothing out time. (The smoothing out time is the period of time during which the suspension disperses over the cores, approx. 10-90 seconds, preferably approx. 30-60 seconds). Afterwards the cores are dried by means of air.
The operation is repeated up to 90 times, preferably approx. 30-40 times, until the cores are completely covered and have the preferred measure and the preferred weight.
In order to ease the coating process of chewing gum, a suspension is used which is heated up to 90°C, preferable up to about 75°C, and air wh9ch is heated up to at least 35°C such as about 40°C.
Between the dosages of the coating suspension, one or more active substances) in solid form islare added in one or more increments) in order to provide the chewing gum with a fast effect, e.g. flavour release during the chewing. It is an important aspect of the invention that the drying period is extended to after applying the active substances. When the active substances are added just after the coating process is completed, the ca~ating suspension is still soft and the active substances may be more or less embedded in the coating in the solid form: The skilDed person will be ab9e to estimate o~~ to establish by a simple test when the ~activ~ s~.abstance should be added for ~btaining a s~!fficient adherence of the active ingredient to t~~e coating.
As appears from t~~e Example~~, the dr,~ing pe~~ia~~ is 0 seco4-~cis, ho~.vever, drying periods yap to 50 seconds sucl..~ as Lup t~s ,2.5 seconds are wit.l~~in the present irwention and e~c~-~ longer periods rr~a~y ire ~.~cceprabie depea~ecfing an tlrs:
~~ry'sng pgwperties of the i CA 02478619 2004-09-23 ' WO 99/44436 PCTfDK99/00108 coating suspension, the particle size of the active substance as well as whether it is desired that the active substance should be fully embedded in the coating or should form a superficial layer on the coating.
5 Furthermore, between the dosages of the coating suspension and the addition of one or more active substances) in solid form, one or more active substances) in liquid form may be added.
!n order to achieve a neat and smooth surface of the chewing gum tablets with the 10 completed coating, these may subsequently be subjected to a polishing. The polishing also takes place in rotating coating kettles in which a polishing suspension or a polishing powder is added to the coated cores in one or more portion(s). The polishing suspension often consists of wax, emulsifier, shellac, gum arabic, water, etc.
The polishing powder often consists of wax only, or of wax mixed with emulsifier, gum 15 arabic or talc, etc.
The present invention is further illustrated below by means of some examples.

WO 99/44436 PC'TIDK99I00108 Examples As a starting point, partly sugar-containing, partly sugar-free cores of chewing gum are used which are rolled out into sheets by means of stamping rollers, i.e.
coherent sheets of cores of chewing gum which have a weight of approx. 0.9g/piece.
A coating kettle DRIA 1200, supplied by Driam Metailprodukt GmbH, Germany, is used for the coating of the above-mentioned cores. DRIA 1200 is a horizontally placed and cylindrical kettle intended for the coating of 50kg of chewing gum cores.
The equipment has computer controlling of the amount of dosages of liquid and solid substances as welt as controlling of the smoothing out times, the drying times, air quantities, the temperature of the drying air, and the airflow direction. For dosage of an active substance in a solid form, a pneumatic conveyor having a dispersing arm which ensures an even dispersion of the powder over all the tablets. The coating kettle can be set at various velocities from 1 to 15 rpm.
During the coating process; 50kg of chewing gum cores are filled into the coating kettle that can be set to a rotation of 8 rpm. During this rotation, the cores of chewing gum are separated from each other. Drying air is applied to the equipment, and surplus talc, which has been added during the rolling out of the cores of chewing gum, is removed. This separation and k~lovving through of air fast for approx. 5 minutes.
Then the rotation speed of the coating kettle is increased to 1 1 rpm, and the first dosage of the coating suspension may take place.
it is also possible to use small d2kg) or large dlOOkg) fitted, round coating kettles and sprinkle active substance in solid form manually in 1-10 irecrerrrentds) bevween tile dosages of the coating suspension. Dosage of active substance in mere increments ensures an even dispersion of the powder over all the cores of chev~fing gural.
f=or th4 coating of sugar-conthining cores of chewing gurry a s~rccharose susper~a:~ion je~as used ir5 the foDl~wing examples, and a sorbitol suspension vas used f~~r the coating of sugar-free cores.

In the following embodiments, the coating suspension had the following composition:
1. Saccharose suspension =
Sugar juice (70%) 94.45 Water 4.68 Gelatine (Bloom value 120-160) 0.87 Total 100.00 2. Sorbitol suspension Sorbitol liquid/neosorb 70!02 97.88 Water 1.59 Titanium dioxide 0:55 Total 3 00.00 The Examples 1, 2, and 3, shows conventional coating of sugar-containing and sugar-free cores of chewing gum, respectively.

n WO 99/44436 PC'T/DK99/OOI08 Example 1 Coating in DRIA 1200 equipment of 50kg of sugar-containing chewing gum cores with peppermint taste.
Saccharose Amount of dosage Smoothing out Drying time Drum suspension g time sec.

Dosage No. sec. rpm 13 600 + 222 ~ 60 400 11 40 wax powder 50g 300 300 8 A 600g saccharose suspension + 222g peppermint oiD.

CA 02478619 2004-09-23 - ,:
WO 99/44436 PC'TlDK99104108 Example 2 Coating in DRIA 1200 equipment of 50kg of sugar-free chewing gum cores with peppermint taste.
Sorbitol Amount of dosage Smoothing out Drying timeDrum suspension g time sec.

Dosage No. sec. rpm 6 700 + 200 # 60 300 1 1 27 wax powder 50g 360 360 8 A 700g sorbitol suspension + 2008 peppermint oil.

Example 3 Coating in tilted kettles of 2kg sugar-free chewing gum cores with a mixture of Liquid eucalyptus, menthol, and anethol.

Sorbitol Amount of dosage Smoothing out Drying Number of suspension g time time revolutions Dosage No. sec. sec. rpm 3 20 60 60 50 .

12 20~* 60 120 50 13 9.9 liquid 10 0 50 flavour 34-35 20 120 240 50 . .

38 wax powder 2g 300 300 50 ~" A sorbitol suspension with 3.5°~6 aspartame and 7.5% acesulfame K

CA 02478619 2004-09-23 ~ ' -Example 4 Coating in DRIA i 2O0 equipment of 50kg sugar-containing chewing gum cores with peppermint oil encapsulated in a 3: i mixfure of hydrogenated rape oii and carnauba wax.
Saccharose Amount of dosage Smoothing out Drying time Drum suspension g time sec.

Dosage No. sec. rpm 14 400 ~ powder 60 0 11 18 400 powder 60 0 1 1 25-37 1000 30 4i O 11 38-41 ?00 260 280 11 43 wax powder 50g 300 300 8 ~" A powder with a flavour concentration of 28%.

CA 02478619 2004-09-23 ' ' y WO 99!44436 PCTlDK99100108 Example 5 Coating in DRIA 1200 equipment of 50kg sugar-free chewing gum cores with peppermint oil encapsulated in a 3:1 mixture of hydrogenated rape oil and carnauba wax.
Sorbitol Amount of dosage Smoothing out.Drying time Drum suspensiong time sec.

Dosage sec_ rpm No.

1-2 400 0 250 i 1 7 360~powder 60 0 11 8-9 700 10 300 i 1 350 i0 0 1i i 1 360~powder 60 0 1 1 14-i 8 700 45 300 11 27-28 700 240 240 i 1 29 wax powder 50g 360 360 8 ~" A powder with a flavour concentration of 28°l°.

WO 99/d4436 PCT/DK99100108 Example 6 Coating in tilted round kettles of 2kg sugar-free chewing gum cores with peppermint oil encapsulated in silica.
Sorbitol Amount of dosageSmoothing Drying timeNumber of out suspension g time sec. revolutions Dosage No. sec. rpm 3 20 60 fi0 50 12 20 ~' 60 120 50 14 17 * ~ powder 40 0 50 36 wax powder 2g 300 300 50 ~' A sorbitol suspension with 2.75 % aspartame.
~" A powder with a flavour concentration of 50%

f CA 02478619 2004-09-23 ' - '"
WO 99/44436 PC'T/DK99I00108 Example 7 Coating in tilted kettles of 2kg sugar-free chewing gum cores with peppermint oil encapsulated in gelatine.
Sorbitol Amount of Smoothing out Drying time Number of suspension dosage time sec. revolutions Dosage No. g sec. rpm 12 20 ~ 60 120 50 14 17 ~" ~ powder 40 0 50 17-18 30 60 i 20 50 i9 20 10 0 50 20 17 ~" ~' powder 40 0 50 23-24 30 60 i 20 50 3fi-37 20 120 240 50 38 wax powder 2g 300 300 50 ~" A sorbitoi suspension with 2.75 % aspartame.
~' A powder with a flavour concentration of 25%

CA 02478619 2004-09-23 ' WO 991ddd36 PGTlDK99/QU108 Facample 8 Coating in tilted kettles of 2kg sugar-free chewing gum cores with a mixture of eucalyptus, menthol, and anethol, encapsulated in a 3:1 mixture of hydrogenated rape 5 oi! and carnauba wax.
Sorbitol Amount of Smoothing Drying time Number of suspension dosage out time sec. revolutions Dosage No_ g sec. rpm 2 20 ~ 90 120 50 3 20 ~ 60 60 50 12 20* 60 120 50 14 40 ~ ~' powder 40 0 5 0 20 40 ~' * powder 40 0 50 38 wax powder 2g 300 300 50 A sorbito! suspension with 3.75% aspartame, and 7.5% acesulfame IC
~~ A powder with a flavour concentration of 24.5°r6.

Example 9 Coating in tilted kettles of 2kg sugar-free chewing gum cares with a mixture of euca lyptus, menthol, and anethol, encapsulated in a 3:1 mixture of hydrogenated rape oil and carnauba wax.
Sorbitof Amount of Smoothing Drying timeNumber of suspension dosage out time sec. revolutions Dosage No. g sec. rpm 12 20 ~" 60 120 50 14 20*~'powder 40 0 50 20 20~*~"powder 40 0 50 38 wax powder 300 300 50 2g A sorbitol suspension with 3,51o aspartame and 7.5%
acesulfame K.

A powder 5 l.
witi~ a flavour concentration of 2~~.

CA 02478619 2004-09-23 ' WO 99!44436 PCT!DK99100108 Example 10 Coating in tilted kettles of 2kg sugar-free chewing gum cores with a mixture of liquid eucalyptus, menthol, and anethol, as weld-as menthol encapsulated in gum arabic.
Sorbitot Amount of Smoothing Drying Number of suspension dosage out time time revolutions Dosage No. g sec. sec. rpm 12 20* 60 120 50 13 9.9 liquid 10 0 50 ftavour 17-i 8 30 60 120 50 20 7'" powder 40 0 50 z 1-22 20 5 120 50 3fi-37 20 120 240 50 38 wax powder 300 300 50 ~" A sorbitotension with .5 1o rne K;~r".~-.~__._....~..-..~
susp 3.5 ~ aspartame acesulfa and 7 ~ ~ A powder h a fiavr~ur vioit concentration of 80/~.

~O 99/44436 PCT/DK99/00108 Example 11 Coating in tilted kettles ofi 2kg sugar-firee chewing gum cores with a mixture of liquid eucalyptus, menthol, anethol, as well as ammonium chloride encapsulated in a 3:1 mixture of hydrogenated rape oil and carnauba wax.
Sorbitol Amount of Smoothing Drying timeNumber of suspension dosage out time sec. revolutions Dosage No. g sec. rpm 12 20~ 60 120 50 13 9.9 liquid 10 0 50 flavour 18 ~ 20 10 0 50 19 40 ~'~ powder 40 0 50 20-21 20 5 120 50 .

23 40 ~* ~ powder 40 0 50 26-2~ 30 60 120 50 31-3 y 30 60 120 60 38-39 20 120 240 50 .

40 wax powder 2g 300 300 50 ~"A sorbitol ae~ame e K.-.~~~ ~~.R~.~_._._...
suspension and '~.51o , with 3.5~o acesuffam asp #~A powr~er ion ofi with a ar~ar7lonium 30!.
chloride cor~cei~to~st i CA 02478619 2004-09-23 ' v Example 12 Coating in tilted kettles of 2kg sugar-free chewing gum cores with a mixture of liquid eucalyptus, menthol, and powdered anise,. as welt as naturally extract of black pepper encapsulated in a 3:1 mixture of hydrogenated rape oil and camauba wax.
Sorbitol Amount of Smoothing Drying Number of suspension dosage out time time revolutions Dosage No. g sec. sec. rpm 14 20 ~' powder 40 0 50 15-16 20 5 i 20 50 19 10 liquid 10 0 50 flavour 38 wax powder 300 300 50 2g A powder of eoncentratic~r~~of naturally 20/~.
extract of black pepper in a WO 99!44436 PCT/DK99/00108 Example 7 3 Coating in fitted kettles of 2kg sugar-free chewing gum cores with a mixture of liquid eucalyptus, menthol, and powered anise as well as naturally basil extract encapsula-5 ted in a 3:1 mixture of hydrogenated rape oil and carnauba wax.
Sorbitol Amount of Smoothing out Drying timeNumber of suspension dosage time sec. revolutions Dosage No. g sec. rpm 2 20 90 '120 50 14 20~powder 40 0 50 19 10 Liquid 10 0 50 flavour 25-28 40 30 'I 20 50 38 wax powder 300 300 50 2g A powder of ~~
naturally basil extract ~in a concentration ~of 14%-.

WO 99144436 PCTlDK99100108 Example '! 4 Coating in tilted kettles of 2kg sugar-free chewing gum cores with a mixture of liquid eucalyptus, menthol, and powdered anise., as well as naturally thyme extract encapsu-laced in a 3:1 mixture of hydrogenated rape oil and carnauba wax.
Sorbitol Amount of Smoothing Drying time Number of out suspension dosage time sec. revotutions Dosage No. g sec. rpm 74 20~powder 40 0 50 19 10 liquid 10 0 50 flavour 25-28 40 30 12C) 50 38 wax powder 300 300 50 A powder~of --..._.__.....~_.._..
naturally thyme extract in a eoncer~tration of 15~/~;

Example 15 Coating in tilted kettles of 2kg sugar-free chewing gurn cores with a mixture of mixture of liquid fruit flavours lorange, lemon, and mango) as we!! as citric acid encapsulated in a 3:1 mixture of hydrogenated rape oi! and carnauba wax.
Sorbito! Amount of Smoothing Drying time Number of out suspension dosage time sec. revolutions Dosage No. g sec. rpm 3 20 ~ 60 60 50 10-11 30 30 '120 50 12 20'* 60 120 50 14 30 ~" ~' 40 O 50 powder 17 ~ 20 10 0 50 18 30~'~powder 40 O 50 21 5.7 liquid 10 0 50 flavour 39-~40 20 120 240 50 41 wax powder 300 300 50 2g ~" A sorbitol suspension with 7.5°Jo aspartame.
isr~cap~zklated c:itria acid ir~s a concentration of 3~~/0.

Exampte 16 Coating in tilted kettles of 2kg sugar-free chewing gum cores with a mixture of liquid fruit flavours (orange, lemon, and mango)~s well as ascorbic acid encapsulated in a 3:1 mixture of hydrogenated rape oil and carnauba wax.
Sorbitol Amount of Smoothing Drying time Number of out suspension dosage time sec.. revolutions Dosage No. g sec. rpm 12 20~* 60 120 50 14 30~ "powder40 0 50 18 30 * ~* 40 0 50 powder 21 5.7 liquid 10 0 50 flavour 39-40 20 '120 240 50 41 wax powder 300 300 50 2~3 A sorbitol~suspension with _-__~~iu-~~-.._..__.__ _.._..__~_.
7.5% aspartame.~-~

~ncaps.ulated ascorbic acid in a concentration of 50%.

CA 02478619 2004-09-23 - '-"' WO 99!44436 PCTIDK99lOO10$

Example 17 Coating in tilted kettles of 2kg sugar-free chewing gum cores with a mixture of mix-ture of liquid fruit flavours iorange, lemon, and mango) as well as cooling agent en-capsulated in gum arabic.
Sortiitol Amount of Smoothing Drying time Number of out suspension dosage time sec. revolutions Dosage No. g sec. rpm 3 20 ' 60 60 50 12 20~ 60 120 50 14 20 ~' ~" 40 0 50 powder 21 5.7 liquid 10 0 50 flavour 41 wax powder 300 300 50 2g A sorbitot ension with ~. __,.-.-susp 7.5!~ aspartame.

Iwncapsutated coc~(ir~g Coo4io g g P~~v~r~er" nternats~na9 agent, ' Fiavoa~trin fr~c;'r~
t t"tavCDlIfS ntraticn or and FC~C~ranCG~, 20~%.
tutd., ~nglan~9, iri a ce~nce WO 99!44436 PCTlDK99100108 Example 18 Coating in fitted kettles of 2kg sugar-free chewing gurn cores with a mixture of liquid flavours (apple and cinnamon as well as._aspartame encapsulated in a 3:1 mixture of 5 hydrogenated rape oil and carnauba wax.
Sorbltol Amount of Smoothing out Number of Drying time suspension dosage time se:c. revolutions Dosage iJo. g sec. rpm 14 25~powder 40 0 50 19 6.6 liquid 10 0 50 flavour 38 wax powder 300 300 50 _.~.. Encapsulatedaspartame M.~_.__.__..~....._._ in a concentration .__.._ of 10%.

Test Results A number of sensory tests were carried out as documentation of the achieved effect by the use of active substances in soli~form in the coating of a coated chewing gum.
The tests were carried out with 5 to 8 trained tasters per test. The coated chewing gum was served in tasteless plastic cups coded with a randomised three-figure num-ber. There was a 3-minute-break between each product tested, and each product was tested twice.
The tests were carried out partly in the form of a measurement of the flavour release as a function of time tome intensity tests), in which the products were tested after 5, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 240, 300, 420, and 540 seconds, partly in the form of determination of a taste profile, in which the products were tested in intervals; the initial phase : 0 - 1 minute, the intermediate phase 1 - 3 minutets), and the end phase 3 - 4 minutes.
Test 1 A measurement was carried out of the flavour release as a function of time from a chewing gum coated according to Example 8, i.e. with a mixture of eucalyptus, menthol, and anethol encapsulated in fat and wax. The flavour release from this chewing gum was compared with a chewing gum coated according to Example 3, i.e.
with liquid eucalyptus, menthol, and anethol. The result of the test appears from Fig.
1 which shows that the use of encapsulated flavour in the coating layer partly results in an extremely high taste onset ttaste explosion) during the first 60 seconds, and partly ent~aar~ces the taste in all chewing phases.
Test 2.
in this test, measurement of the flavour release as a fursc~iryrs of time by the use of the same amourx of eucalyptuslrmentholla~aethol flavo°4x~ i~~;e lir~~.~ici form tExample 3t arrd encaps~~lated in fat and wax tExampte. 9i, rE~spuctiveiy, was carried out. The resuti ~s~t the test appears from Fig. 2, which shows that the case of active substance in scalicl CA 02478619 2004-09-23 - ' ..

form provides a strong taste explosion in the initial phase, and a significantly enhanced effect in the first 4-5 minutes can be observed.
Test 3 In this test, the effect of addition of menthol encapsulated in gum arabic to the coating of a chewing gum coated irvith liquid eucatyptus, menthol, and anethot, cf.
Example 10, was examined and compared with a chewing gum coated according to Example 3, i.e. onty with liquid eucalyptus, menthol, and anethot.
The result of the test is shown in Fig. 3 which shows that addition of encapsulated menthol causes a strong taste explosion in the initial phase and an enhanced taste effect in all the chewing phases.
i 5 Test 4 A stability test was carried out of a chewing gum coated in accordance with Example 18, i.e. coated with appte/cinnamon flavour as welt as aspartame encapsulated in fat and wax. By way of comparison, a corresponding chewing gum in which the aspar-tame was non-encapsulated was tested.
The result of the test is shown in Fig. ~ which shows that the chewing gum con-taining non-encapsulated aspartame loses its stability already after approx.
30 days after coating since it develops a bitter taste. The lack of stability is probably due to a reaction between aspartame and aldehyde-containing flavours. In a corresponding chewing gum with encapsulated aspartame in the coating no change in.the taste is observed even after 90 days.
Thus, encapsulation of astaartame has a stror;g stability-imprrwinca, effect Test 5 A test was carriee~ out with chewing gurr~ coated according tc Exarr~ple i 5, i.e. with a mixture of liquid fruit flavours (orange, lemon, and mango? as well as citrc acid CA 02478619 2004-09-23 - - ' WO 99144436 PC'T/DK99/00108 encapsulated in fat and wax in order to determine the taste profile in the initial phase.
By way of comparison, a taste profile was recorded for a corresponding chewing guru coated with the same fruit flavours (orange, Lemon, and mango), but without encap-sulated citric acid in the coating layer: The result of the test is shown in Fig. 5.
As will be apparent, a chewing gum with citric acid has a larger taste intensity and stronger citric notes than a corresponding product without citric acid.
Test 6 A test was carried out in order to determine the taste profile in the initial phase, the intermediate phase, and the end phase, respectively, of a chewing gum coated according to Example 17, i.e, with a mixture of liquid fruit flavours (orange, lemon, and mango) and with and without cooling flavour encapsulated in gum arable.
The result of the test is shown in Figs. fi, 7, and 8 which show that the chewing gum with the cooling agent has a larger taste intensity and stronger citric notes in the initial phase. As is apparent from Figs. 7 and 8, this tendency is maintained in the intermediate phase and in the end phase as well in spite of the fact that the cooling agent was placed in the coating layer only.
Thus, the chewing gum according to the invention shows an increased effect of the active substance in all the chewing phases. , Test 7 zs In this test the taste profile of a chewing gum coated according to Example 14, i.e.
with a mixture of liquid eucalyptus, menthol, and powdered anise as well as natural thyme extract encapsulated in fat and wax, was determined, The use of encapsulated thyme provides the possibility of developing a chewing gum with an entirely new combination of tastes without having to observe the occurrence of discoloration of the coating layer by the use of liquid extract.

Test 8 In this test the taste profile of a chewing gum coated according to Example I2, i.e.
with a mixture bf liquid eucalyptus, men'Chol, and powdered anise as wet! as natural extract of black pepper encapsulated in fat and wax, was determined. The result of this test is shown in Figs. 12, I 3, and I 4. In the same way as in test 7, the possibility of creating new combinations of tastes without discoloration of the coating layer is achieved, The invention being thus described, it will be obvious that it may be varied in many ways. Such variations are not to be regarded as deviations from the idea and the scope of the invention, and all such, modifications as would be obvious to persons skilled in the art, are intended to be included within the scope of the following claims.

Claims (26)

1. A coated chewing gum comprising a core of chewing gum and a coating, wherein said coating comprises a coating material and one or more active substance(s), said active substance(s) being in the form of a powder when applied to the coating and said active substance(s) being selected from the group consisting of a pharmaceutical, a herbal medicine, a vitamin and a nutrient.

2. The coated chewing gum according to claim 1, wherein the pharmaceutical is selected from the group consisting of caffeine, salicylic acid, and derivatives thereof, such as acetylsalicylic acid, choline salicylate, and magnesium salicylate, paracetamol, salts of pentazocine, buprenorphine, and buprenorphine hydrochloride, codeine hydrochloride and phosphate, morphine and salts thereof, methadone hydrochloride, ketobemidone, beta-blockers, calcium antagonists, verapamil hydrochloride, verapamil, nifedipine, nitroglycerin, erythrityl tetranitrate, strychnine and salts thereof, lidocaine, tetracaine hydrochloride, etorphine hydrochloride; atropine, insulin, alfaamylase, polypeptides such as oxytocin, gonadorelin, and LHRH, desmopressin acetate (DDAVP), isoxsuprine hydrochloride, ergotamine compounds, chloroquine phosphate and sulfate, isosorbide, demoxytocin, heparin, lupeol, sucralfate and salts thereof, nicotine and salts and derivatives thereof, lobeline, cinnarizine, dimenhydrinate, difenhydramine, cyclizine, scopolamine, miconazole, nystatin, metronidazole, hydrocortisone, astemizole, benzocaine, glibenglamide, onsaedantronum, acyclovir, sumatriptan, tropisetron, pizotifen, cisapride;
domperidone, itraconazole, omeprazole, terfenadine, fluconazole, naratriptan, zolmiriptan, rizatriptan, eletriptan, almotriptan, sildenafil, tolfenamic acid, tramadol, cetirzine, and loratidine.

3. The coated chewing gum according to claim 1 or 2, wherein the herbal medicine is selected from the group consisting of ginkgo biloba, ginseng, saw palmetto, stevla, ginger, propolis, echinacea, St. John's Wort, Siberian ginseng, guarana, and garlic.

4. The coated chewing gum according to any of the preceding claims, wherein the vitamin is selected from the group consisting of A, B1, B2, B5, B6, B12, D3, E, K, folic acid, niacin, biotin, beta-carotene, ascorbic acid, and salts thereof.

5. The coated chewing gum according to any of the preceding claims, wherein the nutrient is selected from the group consisting of amino acids, glycero-phosphates, minerals in the form of salts, complexes and compounds containing calcium, phosphorus, magnesium, iron, zinc, copper, iodine, manganese, chromium, selenium, molybdenum, potassium, sodium, or cobalt and ubiquinon.

6. The coated chewing gum according to any of the preceding claims, wherein the active substance(s) is/are in an encapsulated form.

7. The coated chewing gum according to claim 6, wherein the active substance(s) is/are encapsulated in one or more material(s) selected among fatty substances, waxes, gelatine, gum arabic, starch, cellulose, cellulose derivatives, shellac, polyvinyl acetate, polyethylene, casein, zein, B cyclodextrine, silica, yeast cells, and a mixture of the above encapsulation materials, preferably a mixture of fatty substances and carnauba wax.

8. The coated chewing gum according to any of the preceding claims, wherein the coating furthermore comprises one or more active substance(s) selected from group consisting of a flavour, a high potent sweetener, a salt and an acid.

9. The coated chewing gum according claim 8, wherein the flavour is selected from the group consisting of natural flavours, naturally identical flavours, synthetic flavours, plant extracts and natural vegetable flavouring agents.

10. The coated chewing gum according to claim 9, wherein the natural vegetable flavouring agent is selected among fruits and herbs.

11. The coated chewing gum according to any of claims 8-10, wherein the acid is selected from the group consisting of citric acid, malic acid, tartaric acid, lactic acid, and ascorbic acid.

12. The coated chewing gum according to claim 8-11, wherein the high potent sweetener is selected from the group consisting of aspartame, acesulfame K, saccharin, cyclamate, neohespiridine, thaumatin, glycyrrhizin, and salts thereof, monellin, sucrolase, and alitame.

13. The coated chewing gum according to any of claims 8-12, wherein the salt is selected from the group consisting of sodium chloride, potassium chloride, ammonium chloride, sodium bicarbonate, and carbamide.

14. A method for the preparation of a coated chewing gum, said method comprising the following steps:
1) preparing a core of chewing gum in a manner known per se, 2) preparing a coating suspension, also in a manner known per se, 3) applying the coating suspension onto the cores of chewing gum in a manner known per se, thus forming a layer of coating suspension, 4) applying one or more active substances) in the form a powder, in one or more increment(s), onto the cores of chewing gum of step 3), said active substances) being selected from the group consisting of a pharmaceutical, a herbal medicine, a vitamin and a nutrient, 5) repeating step 3) and 4), 6) optionally, applying one or more liquid active substances) in one or more increments) between the applications of the coating suspension, 7) optionally, finally applying a polishing suspension.

15. The method according to claim 14, wherein step 4) further comprises that the layer of coating suspension on the core of chewing gum is still soft when the active substances) is/are applied.

16. The method according to claim 14 or 15, wherein the pharmaceutical is selected from the group consisting of caffeine, salicylic acid, and derivatives thereof, such as acetylsalicylic acid, choline salicylate, and magnesium salicylate, paracetamol; salts of pentazocine, buprenorphine, and buprenorphine hydrochloride, codeine hydrochloride and phosphate, morphine and salts thereof, methadone hydrochloride, ketobemidone, beta-biockers, calcium antagonists, verapamil hydrochloride, verapamil, nifedipine, nitroglycerin, erythrityl tetranitrate, strychnine and salts thereof, lidocaine, tetracaine hydrochloride, etorphine hydrochloride, atropine, insulin, alfaamylase, polypeptides such as oxytocin, gonadorelin, and LHRH, desmopressin acetate (DDAVP), isoxsuprine hydrochloride, ergotamine compounds, chloroquine phosphate and sulfate, isosorbide, demoxytocin, heparin, lupeol, sucralfate and salts thereof, nicotine and salts and derivatives thereof, lobeline, cinnarizine, dimenhydrinate, difenhydramine, cyclizine, scopolamine, miconazole, nystatin, metronidazole, hydrocortisone, astemizole, benzocaine, glibenglamide, onsaedantronum, acyclovir, sumatriptan, tropisetron, pizotifen, cisapride, domperidone, itraconazole, omeprazole, terfenadine, fluconazole, naratriptan, zolmiriptan, rizatriptan, eletriptan, almotriptan, sildenafil, tolfenamic acid, tramadol, cetirzine, and loratidine.

17. The method according to any of the claims 14-16, wherein the herbal medicine is selected from the group consisting of ginkgo biloba, ginseng, saw palmetto, stevia, ginger, propolis, echinacea, St. John's Wort, Siberian ginseng, guarana, and garlic.

18. The method according to any of the claims 14-17, wherein the vitamin is selected from the group consisting of A, B1, B2, B5, B6, B12, D3, E, K, folic acid, niacin, biotin, beta-carotene, ascorbic acid, and salts thereof.

19. The method according to any of the claims 14-18, wherein the nutrient is selected from the group consisting of amino acids, glycero-phosphates, minerals in the form of salts, complexes and compounds containing calcium, phosphorus, magnesium, iron, zinc, copper, iodine, manganese, chromium, selenium, molybdenum, potassium, sodium, or cobalt and ubiquinon.

20. The method according to any of claims 14-19, wherein the active substance is in an encapsulated form.

21. The method according to claim 20, wherein the active substance is encapsulated in one or more materials) selected among fatty substances, waxes, gelatine, gum arabic, starch, cellulose, cellulose derivatives, shellac, polyvinyl acetate, polyethylene, casein, zein, B cyclodextrine, silica, yeast cells, and a mixture of the above encapsulation materials.

22. The method according to any of claims 14-21, wherein the coating suspension comprises an aqueous solution of a sugar, a sugar alcohol, an artificial sweetener or mixtures thereof.

23. The method according to any of claims 14-22, wherein the coating suspension comprises an aqueous solution of one or more constituents) selected among saccharose, dextrose, sorbitol, xylitol, tagatose, mannitol, maltitol, isomalt, aspartame, acesulfame K, saccharine, cyclamate, taline, and neohespiridine.

24. The method according to any of claims 14-23, wherein the coating suspension i5 applied in 2 to 90 increments.

25. The method according to any of claims 14-24, wherein the active substances) applied in the form of a powder is/are applied in 1 to 10 increment{s) between .the dosages of the coating suspension.

26. The use of one or more active substances) selected from the group consisting of a pharmaceutical, a herbal medicine a vitamin and a nutrient,. for the preparation of a coated chewing gum by applying a powder of said active substances) to the coating of the coated chewing gum.