MXPA06007523A - Compressed biodegradable chewing gum - Google Patents

Abstract

Theinvention relates to gum base granules and compressed chewing gum comprising at least one biodegradable polymer. According to an embodiment of the invention, a mechanically stable compressed chewing gum tablet has been obtained by applying at least one biodegradable polymer as a part of the gum base of the compressed chewing gum tablet.

Description

COMPRESSED BIODEGRADABLE MASK GUM FIELD OF THE INVENTION The present invention relates to granules for chewing gum and to a chewing gum made based on such granules for chewing gum.

BACKGROUND OF THE INVENTION Several different processes for making chewing gum are known in the art. The different processes can be classified in general, basically in two different processes; that is, chewing gum mechanically mixed based on a compound of a gum base or compressed chewing gum based on more or less discrete gum base particles. The first type of chewing gum generally has the benefits of a fairly pleasing texture between several different parameters, most likely due to the mechanical mixing of the polymers and, for example, the flavors. A disadvantage of such a process and chewing gum is, however, that different ingredients, such as encapsulated flavor, active ingredients, etc., can be more or less destroyed or degraded by the mixing process. The second type of chewing gum generally has the benefits of relatively quiet handling of vulnerable additives, such as the flavors or active ingredients mentioned above. A disadvantage of such a chewing gum is, however, that the resulting chewing gum tablet can typically disintegrate too easily, especially during the initial chewing of the gum. Various proposals have been made in the prior art in order to obtain a compressed chewing gum. Typically, such techniques are directed to the adaptation of the manufacturing process. WO 03/011045, discloses a technique wherein gluing or sticking the chewing gum mixture to the tabletting process equipment is treated by controlling the size of the granules in the mixture. A problem related to the prior art is that chewing gum residues are quite annoying, both with respect to environmental leaflets and with respect to pieces of chewing gum, which are not properly disposed of, etc. A further problem related to compressed chewing gum, is that the applied granules must have properties, so that they are mechanically stable when compressed, thus preventing premature disintegration of the tablet.

SUMMARY OF THE INVENTION The present invention relates to base granules for gum comprising at least one biodegradable polymer. According to one embodiment of the invention, a mechanically stable compressed chewing gum has been obtained by applying at least one biodegradable polymer as a part of the gum base of the compressed chewing gum tablet. Thus, experiments have shown that a tablet of compressed chewing gum which has an improved mechanical stability characteristic can be obtained by applying partially or solely biodegradable polymers as the base for gum forming the polymer matrix. Furthermore, according to one embodiment of the invention, it has been established that a tablet formed according to the invention is relatively stable when compared to conventional compressed chewing gum tablets based on the non-degradable polymers prior to the intended initial chewing. It should be emphasized that although the present invention focuses mainly on a few, particularly particularly advantageous groups of biodegradable polymers, the present invention is generally applied to biodegradable polymers in the sense that the surprising effect of obtaining a mechanically stable compressed tablet, in comparison with the chewing gum mixed in a conventional manner, it is generally applied despite the premasked degradation. In one embodiment of the invention, the gum base substantially comprises at least one biodegradable polymer. According to one embodiment of the invention, a rubber base is advantageously made solely based on one or more biodegradable polymers. Again, experiments have shown that such a rubber base is advantageously applied based on the granules of the rubber base. In one embodiment of the invention, at least one of the biodegradable polymers comprises polyester, produced through the reaction of at least one alcohol or a derivative thereof and at least one acid or a derivative thereof. According to a preferred embodiment of the invention, at least one of the polymers is produced through a reaction of at least one alcohol and at least one acid. This type of polymer has advantageous properties when applied to a chewing gum or a rubber base, both with respect to the processing and finally obtained texture. In one embodiment of the invention, at least one of the biodegradable elastomers comprises the polyester obtained by the polymerization of at least one cyclic ester. In one embodiment of the invention, at least one of the plasticizers of the biodegradable elastomer comprises the polyester obtained by the polymerization of at least one cyclic ester. In a further and preferred embodiment of the invention, the chewing gum comprises at least one elastomer plasticizer comprising at least one of the polyesters obtained by the polymerization of at least one cyclic ester and at least one elastomer comprising at least one of the polyesters produced through the reaction of at least one alcohol or a derivative thereof and at least one acid or a derivative thereof. An advantage of mixing the two types of polymers is that the high degree of degradability offered by the biodegradable polymers, applied as plasticizers of the elastomer, can be combined with the advantageous properties of the biodegradable elastomer with respect to the robustness, with respect to the added softeners, the texture, release and processability. In one embodiment of the invention, the rubber base has a water content of less than 5.0%, preferably less than 1.5% by weight of the rubber base.

It is typically preferred to keep the moisture content low, when treated with biodegradable polymers. However, according to the invention, since the use of compression techniques delays the pre-marked degradation, a higher moisture content is provided in the compressed chewing gum, when compared to the traditionally mixed biodegradable chewing gum. In other words (sic) In one embodiment of the invention, the rubber base has a water content of less than 1.0%, preferably, substantially 0% by weight of the rubber base. In one embodiment of the invention, the size of the granules of the rubber base is within the range of 0.01 mm • 0.01 mm to 2 mm • 2 mm, preferably, within the range of 0.1 mm • 0.1 mm to 1.0 mm • 1.0 mm. In one embodiment of the invention, at least one biodegradable polymer constitutes an amount of about 1% to about 100% by weight of the gum base. In one embodiment of the invention, the base for granulated rubber comprises at least one biodegradable elastomeric polymer of high molecular weight, in an amount from about 0% to about 75% by weight of the gum base. In one embodiment of the invention, the molecular weight of the at least one biodegradable elastomeric high molecular weight polymer is from about 10,000 g / mol to 800,000 g / mol of Mn. In one embodiment of the invention, the base for granulated rubber comprises at least one solvent of the low molecular weight elastomer, in an amount of from about 0% to about 90% by weight of the gum base. In one embodiment of the invention, the molecular weight of at least one solvent of the low molecular weight elastomer is from about 1000 g / mol to 50000 g / mol of Mn. In one embodiment of the invention, the granules of the gum base comprise a sweetener in an amount of less than 50% by weight. In one embodiment of the invention, the rubber base is substantially free of lubricants, anti-sticks and glidants. In one embodiment of the invention, the natural resins provide an improved and sticky texture of the rubber base when applied to the chewing gum formulation. In one embodiment of the invention, the base for gum is substantially free of wax. In one embodiment of the invention, the base for gum is substantially free of fat.

In one embodiment of the invention, the gum base comprises a filler in an amount of about 0% to about 50% by weight of the gum base. In one embodiment of the invention, the granules of the gum base comprise active ingredients, at least a part of the active ingredients has been broken in the chewing gum, forming granules or at least a part of the chewing gum, forming granules before compression. In one embodiment of the invention, the gum base comprises a synthetic resin in an amount of about 15% to about 99%, preferably about 15% to about 80%, by weight of the gum base. In one embodiment of the invention, the gum base comprises emulsifiers and / or fats in an amount of about 10% to about 40% by weight of the gum base. In one embodiment of the invention, the gum base comprises a wax in an amount of about 2% to about 30% by weight of the gum base. In one embodiment of the invention, at least a portion of the flavoring agents has been broken in the rubber base or at least a portion of the rubber base before compression.

In one embodiment of the invention, the at least one biodegradable polymer comprises at least one polyester obtained by the polymerization of at least one compound selected from the group consisting of cyclic esters, alcohols or derivatives thereof and carboxylic acids or derivatives thereof . In one embodiment of the invention, the granules of the rubber base comprise at least one non-biodegradable polymer. further, the invention relates to a compressed chewing gum made based on at least one biodegradable polymer. In one embodiment of the invention, the compressed chewing gum is made based on the granules of the gum base of any of claims 1-25. In one embodiment of the invention, at least part of the chewing gum polymers are non-biodegradable. In one embodiment of the invention, the chewing gum granules are combined and compressed together with the ingredients of the chewing gum, preferably the powdered ingredients of the chewing gum, such as sweeteners, flavor, filler and emulsifiers. In one embodiment of the invention the water content is less than 5.0%, preferably less than 1.5% by weight of the gum base. 52-373 In one embodiment of the invention, the water content is substantially 0%. In one embodiment of the invention, the base for biodegradable gum comprises at least two biodegradable polymers. In one embodiment of the invention, the granules of the base for biodegradable rubber are used together with conventional non-biodegradable rubber base granules.

FIGURES The invention will be described with reference to the following figures, which illustrate the formation of degradation products as measured by the GC / MS upper space: Figure 1 illustrates the formation of degradation products in compressed chewing gum It contains three different rubber bases: One base for standard rubber and two different bases for biodegradable rubber. Figure 2 illustrates the formation of the degradation products in the compressed chewing gum and in the chewing gum mixed in a conventional manner. Figure 3 illustrates the formation of degradation products in chewing gum containing different amounts of water. 52-373 DETAILED DESCRIPTION Unless stated otherwise, as used herein, the term "molecular weight" means the number average molecular weight (Mn). The short form PD designates polydispersity. The vitreous transition temperature can be determined by, for example, DSC (DSC: differential scanning calorimetry). The DSC can be applied generally to determine and study the thermal transitions of a polymer and in a specific way, the technique can be applied for the determination of a second order transition of a material, that is, a thermal transition that involves a change in the capacity calorific, but that has no latent heat. The vitreous transition is a transition of second order. Generally, in the following examples of the detailed description, two different types of polymers can be referred to as polyester of type 1 and polyester of type 2. Polyester of type 1 generally refers to a polyester produced through the reaction of less an alcohol or a derivative thereof and at least one acid or a derivative thereof. An additional specification of this type of polyester polymers is given in the specification and the claims. Type 2 polyester generally refers to a polyester polymer obtained by the 52-373 polymerization of at least one cyclic ester. An additional specification of this type of polyester polymers is given in the specification and the claims. In the present context, the terms composed of environmentally or biologically degradable polymers refers to the components of the base for chewing gum which, after discarding the chewing gum, are capable of undergoing physical, chemical and / or biological degradation, whereby the residues of the discarded chewing gum are more easily removed from the site where they were thrown or finally disintegrated into pieces or particles that are no longer recognized as remnants of chewing gum. The degradation or disintegration of such degradable polymers can be effected or induced by physical factors such as temperature, light, humidity, by chemical factors such as hydrolysis caused by a change in pH or by the action of enzymes capable of degrading the polymers. In other useful embodiments, all of the polymer components of the gum base are degradable or biodegradable polymers. Preferably, the final products of the degradation are carbon dioxide, methane and water. According to a preferred definition of biodegradability, according to the invention, biodegradability is a property of certain molecules 52-373 organic, which when exposed to the natural environment or placed within a living organism, react through an enzymatic or microbial process, often in combination with a pure chemical process such as hydrolysis, to form simpler compounds, and finally, carbon dioxide, nitrogen oxides and water. Accordingly, suitable examples of environmental or biologically degradable polymers for the base for chewing gum, which may be applied in accordance with the gum base of the present invention, include polyesters, poly (ester carbonates), polycarbonates, amides of polyesters, polypeptides, amino acid homopolymers such as polylysine, and proteins, including derivatives thereof, such as, for example, protein hydrolysates, including a hydrolyzate of zein, degradable. Particularly useful compounds of this type include polyester polymers obtained by the polymerization of one or more cyclic esters, such as lactide, glycolide, trimethylene carbonate, d-valerolactone, β-propiolactone and e-caprolactone, and polyesters obtained by the polycondensation of a mixture of polyacids and open chain polyols, for example, adipic acid and di (ethylene glycol). Hydroxycarboxylic acids such as 6-hydroxycaproic acid can also be used to form the 52-373 polyesters or can be used in conjunction with mixtures of polyacids and polyols. Such degradable polymers can be homopolymers, copolymers or terpolymers, including block and graft copolymers. The following examples are given for illustration, but not as limitations of the invention.

EXAMPLE 1 Preparation of type 2 polyester resin A resin sample was produced using a 10 L cylindrical, jacketed experimental glass reactor equipped with a glass stirring bar and with Teflon stirring blades and with an outlet in the background . The heating of the reactor content was achieved by circulation of silicone oil, thermostated at 130 ° C, through the outer jacket. The e-caprolactone (358.87 g, 3.145 moles) and the 1,2-propylene glycol (79.87 g, 1050 moles) were charged to the reactor together with stannous octoate (1.79 g, 4.42 x 10-3 moles) as the catalyst and reacted approximately 30 minutes at 130 ° C. Next, molten D, L-lactide (4.877 kg, 33.84 mol) was added and the reaction continued for about 2 hours. At the end of this period, the bottom outlet was opened and the molten polymer was allowed to drain into a Teflon coated paint can. 52-373 The product characterization indicated Mn = 6,000 g / mol and Mw = 7,000 g / mol (gel permeation chromatography with a MALLS online detector) and Tg = 25-30 ° C (DSC, 10 ° heating rate) C / minute).

Preparation of Type 2 Polyester Elastomer An elastomer sample was synthesized within a glove box with dry N2, as follows. In a cauldron of 500 mL resin, equipped with a mechanical stirrer in the upper part (rod of 10 mm), 3,152 pentaerythritol and 0.5768 g of Sn (Oct) 2 were charged. (3.56 mL of a 4.27% (weight / volume) solution in methylene chloride), under a purge of dry N2 gas. The methylene chloride was allowed to evaporate under the N2 purge for 15 minutes. Next, e-caprolactone was added (1148 g, 10 mol), trimethylene carbonate (31 g, 0.30 mol) and d-valerolactone (511 g, 5.1 mol). The resin pot was immersed in an oil bath at a constant temperature of 130 ° C and stirred for 13.4 hours. Subsequently, the cauldron was removed from the oil bath and allowed to cool to room temperature. The elastic solid product was removed in small pieces, using a blade, and placed in a plastic container. The product characterization indicated Mn = 88,812 g / mol and Mw = 297,000 g / mol (chromatography of 52-373 gel permeation with a MALLS detector in line) and a Tg = -59.4 ° C. (DSC, heating speed 10 ° C / minute).

Preparation of Type 1 Polyester Elastomer An elastomer sample was produced using a 500 L resin kettle equipped with an overhead stirrer, a nitrogen gas inlet tube, a thermometer and a distillation dome for the removal of methanol. 83.50 g (0.43 mol) of dimethyl terephthalate, 99.29 g (0.57 mol) of dimethyl adipate, 106.60 g (1.005 mol) of di (ethylene glycol) and 0.6 g of calcium acetate monohydrate are charged to the caldron. Under nitrogen, the mixture is heated slowly with stirring until all the components melt (120-140 ° C). The heating and stirring continue and the methanol is continuously distilled. The temperature rises slowly in the range of 150-200 ° C until the evolution of methanol ceases. The heating is stopped and the contents allowed to cool to approximately 100 ° C. The reactor cover is removed and the molten polymer is carefully poured into a receiving container. The product characterization indicated Mn = 50,000 g / mol and Mw = 100,000 g / mol (gel permeation chromatography with an in-line MALLS detector) and a Tg = -30 ° C. (DSC, heating speed 10 ° C / minute). 52-373 Referring to the type 1 polyester described above, polymers of this type can be prepared, generally within the scope of the invention, by step-growth polymerization of di, tri or higher functional alcohols, or esters thereof with aliphatic or aromatic di, tri or higher carboxylic acids or esters thereof. Likewise, hydroxy acids or anhydrides or halides of polyfunctional carboxylic acids can also be used as monomers. Polymerization can involve polyesterification or transesterification and can be catalyzed. The use of branched monomers suppresses the crystallinity of polyester polymers. The mixing of different monomer units along the chain also suppresses the crystallinity. In order to control the reaction and the molecular weight of the resulting polymer, it is possible to stop the polymer chains by the addition of monofunctional alcohols or acids and / or to use a stoichiometric imbalance between the acid groups and the alcohol groups or the derivatives of any of them. Also, the addition of aliphatic carboxylic acids or long chain aromatic monocarboxylic acids can be used to control the degree of branching in the polymer, and conversely, sometimes multifunctional monomers are used to create 52-373 ramifications. In addition, after the polymerization, monofunctional compounds can be used to cover the end of the free hydroxyl and carboxyl groups. In general, polyfunctional carboxylic acids are solids with a high melting point, which have a very limited solubility in the reaction medium of the polycondensation. Frequently, esters or anhydrides of polyfunctional carboxylic acids are used to overcome this limitation. Polycondensations involving carboxylic acids or anhydrides produce water as the condensate, which requires that it be removed at high temperatures. Thus, polycondensations involving the transesterification of the ester of a polyfunctional acid are often the preferred process. For example, the dimethyl ester of terephthalic acid can be used in place of the terephthalic acid itself. In this case, methanol is condensed more than water, and the former can be removed more easily than water. Usually, the reaction is carried out in the volume (not the solvent) and high temperatures and vacuum are used to remove the by-product and bring the reactions to term. In addition to an ester or anhydride, a halide of a carboxylic acid may also be used, under certain circumstances. Usually, for the preparation of polyesters of the 52-373 type 1, the preferred polyfunctional carboxylic acids or derivatives thereof are saturated or unsaturated aliphatics or aromatics and contain from 2 to 100 carbon atoms and most preferably from 4 to 18 carbon atoms. In the polymerization of polyester type 1, some applicable examples of the carboxylic acids, which may be employed as such or as derivatives thereof, include aliphatic polyfunctional carboxylic acids, such as oxalic, malonic, citric, succinic, malic, tartaric, fumaric acid , maleic, glutaric, glutamic, adipic, glucaric, pimelic, suberic, azelaic, sebacic, dodecandioic, etc., and cyclic aliphatic carboxylic acids, such as cyclopropane dicarboxylic acid, cyclobutan dicarboxylic acid, cyclohexane dicarboxylic acid, etc., and carboxylic acids polyfunctional aromatics, such as terephthalic, isophthalic, phthalic, trimellitic, pyromellitic and naphthalene 1,4-, 2,3-, 2,6-dicarboxylic acids and the like. For the purpose of illustration and not limitation, some examples of carboxylic acid derivatives include hydroxy acids such as 3-hydroxy propionic acid and 6-hydroxycaproic acid and anhydrides, halides or acid esters, for example, dimethyl or diethyl esters, corresponding to the aforementioned acids, which means esters such as dimethyl or diethyl oxalate, malonate, succinate, fumarate, maleate, glutarate, adipate, 52-373 pimelate, suberate, azelate, sebacate, dodecandioate, terephthalate, isophthalate, phthalate, etc. Generally speaking, methyl esters are sometimes more preferred than ethyl esters due to the fact that higher alcohols are more difficult to remove than lower alcohols. In addition, the usually preferred polyfunctional alcohols contain from 2 to 100 carbon atoms, such as, for example, polyglycols and polyglycerols. In the polymerization process of polyester 1, some applicable examples of alcohols, which may be employed as such or as derivatives thereof, include polyols such as ethylene glycol, 1,2-propanediol, 1,3-propanediol, 1,3-butanediol , 1,4-butanediol, 1,6-hexanediol, diethylene glycol, 1,4-cyclo-exandiol, 1,4-cyclohexanedimethanol, neopentyl glycol, glycerol, trimethylolpropane, pentaerythritol, sorbitol, mannitol, etc. For purposes of illustration and not limitation, some examples of alcohol derivatives include triacetin, glycerol palmitate, glycerol sebacate, glycerol adipate, tripropionin, etc. In addition, with respect to the polymerization of type 1 polyester, the compounds that stop the chains used are sometimes monofunctional compounds. They are preferably monohydric alcohols containing 1-20 carbon atoms or acids 52-373 monocarboxylics containing 2-26 carbon atoms. General examples are alcohols or medium or long chain fatty acids, and specific examples include monohydric alcohols such as methanol, ethanol, butanol, hexanol, octanol, etc., and lauryl alcohol, myristyl alcohol, cetyl alcohol, stearyl alcohol, alcohol stearic, etc., and monocarboxylic acids such as acetic, lauric, myristic, palmitic, stearic, arachidic, cerotic, dodecylnic, palmitoleic, oleic, linoleic, linolenic, erucic, benzoic, naphthoic and substituted naphthoic acids, 1-methyl 2 Naphthoic and 2-isopropyl-1-naphthoic acid, etc. Typically, an acid catalyst or a transesterification catalyst is used in the polymerization of polyester type 1 and non-limiting examples thereof are metal catalysts such as manganese, zinc, calcium, cobalt or magnesium acetates, and antimony oxide (III ), germanium oxide or halide and tetraalkoxygermanium, titanium alkoxide, zinc or aluminum salts. Referring to the examples with respect to type 2 polyester, polymers of this type can generally be obtained by ring-opening polymerization of one or more cyclic esters, including glycolides, lactides, lactones and carbonates. The polymerization process can take place in the presence of a 52-373 appropriate catalyst such as stannous octoate and can be initiated.

EXAMPLE 2 Preparation of the bases for gum and the granulates of the base for gum The bases for gum are composed as described in the following table 1: Table 1: Formulations of the bases for gum, The numbers refer to% by weight.

The individual gum bases were prepared as follows: The elastomers are added to a mixing cauld provided with mixing means such as, for example, Z-shaped arms placed horizontally. The elastomers are broken into small pieces and softened by the mechanical action in the cauldron and by the addition of a softener. A suitable softener may, for example, comprise the taste, ie, in the modalities described at present, menthol flavor. The softener system comprising emulsifiers, fats and / or wax is slowly added to the mixture and mixing continues until a homogeneous gum base is obtained. "The mixing time is typically in the range of 30 minutes to 4 hours, depending of the composition and mixing technology The mixing temperature will typically vary in the range of 50 ° C to 120 ° C. The mixture is then discharged into the tundish or granulated and allowed to cool to room temperature from the temperature of Obviously, other preparation methods according to the invention can be applied.The rubber bases obtained are subsequently processed in order to obtain a granulate of the base for rubber of small granules of the base for rubber. , which can be tabletted later by means of compression, with the additional ingredients of the chewing gum The process applied to obtain the granulate 52-373 of the base for rubber involves the initial establishment of the macrogranules of the base for gum, for example, of a size of approximately 0.5 * 0.5 centimeters, by cutting or stamping. The macrogranules are combined with a bulk sweetener, sorbitol, in a ratio 1 to 1. The obtained mixture is frozen and crushed or ground during cooling. The granules of the gum base obtained are then screened in order to obtain the desired particle size. According to one embodiment of the invention, the particle size of the granules is kept below about 1 mm • 1 mm. According to a further embodiment of the invention, it is possible when applying biodegradable polymers, to carry out the grinding without the conventional addition of the sorbitol. Obviously, various other granulation techniques can be applied, according to the invention, such as the methods described in WO 8603967, EP 513978, US 4405647, US 5866179, WO 9721424, PCT / DK03 / 00070 and PCT / DK03 / 00465, including in the present as a reference.

EXAMPLE 3 Preparation of the Chewing Gum The formulation for the compressed chewing gum is composed as shown in Table 2: Table 2: Formulation of the compressed chewing gum. The numbers refer to the% by weight of the final complete chewing gum.

The resulting compressed chewing gums were prepared according to the conventional process known in the art, comprising the steps of combining the granules of the gum base with the additional powder ingredients of the chewing gum, optionally sifting the combination, tabletting the mixture sifted by compression and optionally, coating the tablet. In addition to the preparation of the tablets of compressed chewing gum mentioned above, additional tablets of uncompressed chewing gum were also prepared. These were prepared for the purpose of comparison and the process used included conventional mechanical mixing of the chewing gum formulation, which is substantially identical to the 52-373 formulation of compressed chewing gum. The different types of tablets prepared are indicated in Table 3: Table 3: Types of tablets as prepared with different types of bases and coatings and with different processes, which include compression or conventional mixing.

Additional types of tablets were prepared with variation in water content. The water was added through the addition of different amounts of syrup from 52-373 maltitol (contains 30% water). The manufacturing process of these tablets included conventional mixing.

Table 4: Types of tablets, which contain the biobase A and which have different water contents. The values shown are the additional percentages to the existing water content of 1.5% in the chewing gum mixed in a conventional manner.

EXAMPLE 4 Evaluation on chewing gum degradation in water A visual evaluation, pH measurements and a GC / MS analysis were carried out to evaluate the degradation of the chewing gum without chewing during and after the first Degradation week in water. The results of the visual evaluation with respect to the chewing gum tablets, which were placed in demineralized water, are given in the following table 5. It should be noted that the table contains the evaluation of the samples exposed at 40 ° C together with 52-373 different samples of identical tablet types exposed at 60 ° C. Each sample was kept at the same temperature during the evaluation period. The ratings applied are: 0: the core of the tablet is substantially intact and the liquid is clear, 1: the core of the tablet is substantially intact and there is a small formation of free particles in the liquid, 2: initial crushing is observed of the core of the tablet, by the greater formation of free particles in the liquid, 3: the particles predominate, the core of the tablet gradually decreases, 4: the nucleus is now completely dissolved in small particles. 2-373 Table 5: Visual evaluation of the effects of degradation on chewing gum tablets placed in demineralized water at 40 ° C or 60 ° C. Each entry represents two samples that show the same result. The numbers alone indicate the degree of disintegration of the chewing gum pieces involved. ? T "denotes a degree of 52-373 thickening of the chewing gum piece, where Ti represents a small elongation and T2 a larger elongation. "" indicates that the solution has obtained a white color, which can be attributed to the dissolution of the coating material. A * marks the appearance of a yellow color in the demineralized water.

The types of tablets designated C, F and I are not included in Table 5 due to the fact that the initial fast dissolution of the coating of the film, disturbed the visual evaluation, because the water surrounding the tablet was milky from the first day of the evaluation. When the table 5 is evaluated, it is noted that the compressed chewing gum made based on the biodegradable polymers is more stable before chewing than the counterpart with the conventional polymer. This result is highly surprising, since it would be expected that a degradation before chewing would result in a weakening of the already weak structure that characterizes compressed chewing gum tablets, in general. In addition, an additional observation is that biobase A containing polymers of type 2 appears to be more stable than biobase B containing a combination of polymers of type 2 and type 1. The following table shows the results of 52-373 measure the pH of the demineralized water in which the chewing gum tablets mentioned above were placed.

Table 6: pH in the demineralized water, where the chewing gum tablets were placed.

The results that appear for chewing gum, including the standard gum base, show that 52-373 the pH does not change from day 1 to day 7, with respect to both tests of the compressed chewing gum and the chewing gum mixed in a conventional manner. This verifies that the observed changes for the chewing gum containing the biodegradable polymers are due to the presence of these biodegradable polymers, and not to the other ingredients of the chewing gum. Note that the pH falls at a slower rate when the biodegradable polymers are applied in the compressed chewing gum, as compared to the conventionally mixed chewing gum. In other words, prior to chewing, the manufacturing process of compressed chewing gum tablets appears to result in delayed degradation before chewing, when compared to chewing gums made based on biodegradable chewing gum by conventional mixing . The test of the influence of the water content on the degradation, provided the following results, as they were visually evaluated and measuring the pH values of the demineralized water, where the chewing gum tablets were placed: 52-373 Table 7: Visual evaluation of the tablets (composition of the chewing gum mixed in a conventional manner) with different water contents. The base for rubber used in the biobase A. "T" denotes a degree of thickening of the piece of chewing gum, where TI represents a small elongation and T2, T3 and T4 indicate larger elongations consecutive. The "shrinkage" grades are scored in the range of 1 to 4, where 4 represents the largest observed shrinkage of the chewing gum piece. "Disintegration 1" indicates a slight disintegration. The results in table 7 show that the additional water in the chewing gum makes the degradation proceed more quickly and the tendency is to increase the higher the water content. 52-373 Table 8: pH in the demineralized water, where the chewing gum tablets (chewing gum composition mixed conventionally) with different water contents were placed. The base for gum used is biobase A. Each result shown is an average of two samples.

It was noted that the pH is low and does not fall in the period from day 1 to day 7, but on the contrary, it is quite low already on day 1, which indicates that the pH is falling drastically in a short interval of time, such as a few hours. To confirm this observation, two samples were placed in demineralised water, at a pH measured during the first hours. The sample result in the following table: 52-373 Table 9: Development of the pH during the first 22 hours of the degradation of the chewing gum in demineralized water.

It seems that the pH value falls to 3 in one day, and it is also observed that a higher water content as in the T-type tablet causes the pH to fall more quickly. The method used in the evaluation through GC / MS included sampling in the upper space (Turbo Matrix 40 by Perkin Elmer), thus, both the chewing gum residues and the demineralized water, in which they were placed, after the degradation, were transferred to vials where the release of the components was obtained to the upper space . After a period of equilibrium a sample of the air from the upper space was injected into a GC / MS system (Clarus 500 by Perkin Elmer) and in the 52-373 resulting chromatograms, the areas of the relevant peaks were evaluated, whereby the degradation of different chewing gums were compared, as described in the following. Figures 1 to 3 are obtained from measurements by GC / MS of the upper space of the chewing gum samples, which were left for degradation in water for one week at 40 ° C. Figure 1 shows the areas of the GC / MS peak of the headspace that correspond to the formation of a degradation product of the compressed chewing gum samples. It appears that there are no degradation products resulting from the chewing gum comprising only the standard gum base. With respect to the biodegradable chewing gum, it is noted that the amount of the degradation product of the chewing gum comprising the biobase B, which is a combination of the polyesters of type 1 and 2, is greater than the corresponding amount in the chewing gum comprising the biobase A, which comprises only the polyesters of type 2. Figure 2 shows the same areas of the peak as figure 1, with the addition of the results measured in the chewing gum tablets prepared by a process which includes conventional mixing. The remarkable result is a greater amount of a degradation product that comes from conventional chewing gum tablets, rather than compressed chewing gum tablets. Figure 3 shows that the increase in water content results in an increased amount of the degradation product.

EXAMPLE 5 Evaluation of chewing gum degradation in air The following sensory evaluation was carried out on chewing gum samples, which are not chewed. In tables 10 and 11 here, the sensory evaluation is shown below: 2-373 52-373 Table 10: Sensory evaluation in samples of compressed and conventional chewing gum, after one week of degradation in air. According to the measurements of the degradation product observed in Figure 2, it appears from the sensory evaluation in Table 10 (results at 60 ° C), that conventional chewing gum is generally worse than 52-373 compressed chewing gum, with respect to parameters such as unpleasant notes and flavor. In other words, when compressed chewing gum is left for degradation in air at elevated temperatures, it appears to exhibit a higher degree of stability than conventional chewing gum. 2-373 52-373 Table 11: The sensory evaluation in the chewing gum samples after one week of degradation in air, the difference between the samples is the water content.

The evaluation in Table 11 reveals that several unpleasant "old" or acid notes emerge from the chewing gum containing additional water. The trend increases or accelerates when the chewing gum is maintained at 60 ° C compared to 40 ° C. It is likely that such acidic notes correspond to measurable values of pH decrease. The granules of the rubber base are made based on a rubber base. As used herein, the term "gum base" generally refers to the water-insoluble portion of the chewing gum, which typically constitutes 10 to 90% by weight, including the range of 15-50% by weight of the total formulation of chewing gum. The formulations for the base for chewing gum typically comprise one or more elastomeric compounds of synthetic or natural origin, at least two resinous compounds, which, according to the invention, are both of synthetic or natural origin, fillers, softeners and smaller amounts of miscellaneous ingredients such as antioxidants and dyes, etc. 52-373 In the present context, the chewing gum additives include bulk sweeteners, high intensity sweeteners, flavoring agents, softeners, emulsifiers, coloring agents, binding agents, acidulants, fillers, antioxidants and other components such as substances pharmaceutically or biologically active, which confer the desired properties to the finished product of the chewing gum. Examples of suitable sweeteners are listed below. Suitable bulk sweeteners include both sugar and non-sugar sweetening components. Bulk sweeteners typically constitute from about 5 to about 95% by weight of the chewing gum, more typically from about 20 to about 80% by weight, such as from 30 to 60% by weight of the gum. Useful sugar sweeteners are saccharide-containing components, commonly known in the field of chewing gums, 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. The sorbitol can be used as a sweetener 52-373 that is not sugar. Other non-sugar sweeteners useful 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. The 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, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monelin, stereoside and the like, together or in combination. In order to provide a perception of sweetness and flavor that lasts longer, 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 cooling, fluid bed coating, coacervation, encapsulation in yeast cells and extrusion of fibers can be used to achieve the desired release characteristics. The level of use of the artificial sweetener will vary considerably and will depend on such factors as the potency of the sweetener, the speed of the 52-373 release, the sweetness of the desired product, the level and type of flavor used and cost considerations. Thus, the active level of artificial sweetener can vary from about 0.02 to about 8% by weight. When carriers used for encapsulation are included, the level of use of the encapsulated sweetener will be proportionally higher. Combinations of sugar sweeteners and / or non-sugar sweeteners can be used in the chewing gum formulation processed according to the invention. In addition, the softener may also provide additional sweetness such as with aqueous solutions of sugar or alditol. If a low-calorie gum is desired, a low-calorie bulk agent can be used. Examples of low calorie bulk agents include polydextrose, Raftilose, Raftiline, fructooligosaccharides (NutraFlora), palatinose oligosaccharides; hydrolysates of guar gum (for example, Sun Fiber) or non-digestible dextrins (for example, Fibersol). However, other low-calorie bulk agents can be used. Additional chewing gum ingredients, which may be included in the chewing gum mixture processed in accordance with the present invention, include surfactants and / or solubilizers, especially when pharmaceutical ingredients are present or 52-373 biologically active. As examples of types of surfactants to be used as solubilizers in a chewing gum composition according to the invention, reference is made to HP Fiedler, Lexikon der Hilfstoffe für Pharmacie, Kosmetik und Angrenzende Gebiete, pages 63-64 (1981), and lists of approved emulsifiers for foods from individual countries. Anionic, cationic, amphoteric or non-ionic solubilizers can be used. Suitable solubilizers include lecithins, polyoxyethylene stearate, polyoxyethylene sorbitan fatty acid esters, fatty acid salts, mono and diacetyl tartaric acid esters of edible mono- and diglycerides of edible fatty acids, citric acid esters of mono and diglycerides of fatty acids edible, sucrose esters of fatty acids, polyglycerol esters of fatty acids, polyglycerol esters of interesterified castor oil (F476), sodium stearoylate, sodium lauryl sulfate and sorbitan esters of fatty acids and hydrogenated castor oil polyoxyethylated (for example, the product sold under the trade name CREMOPHOR), block copolymers of ethylene oxide and propylene oxide (for example, products sold under the tradenames PLURONIC and POLOXAMER), ethers of polyoxyethylene fatty alcohols, esters of polyoxyethylene sorbitan fatty acid, sorbitan esters of acids 52-373 fatty acids and esters of polyoxyethylene stearic acid. Particularly suitable solubilizers are polyoxyethylene stearates, such as, for example, polyoxyethylene stearate (8) and polyoxyethylene stearate (40), the polyoxyethylene sorbitan fatty acid esters sold under the trade name TWEEN, for example TWEEN 20 (monolaurate), TWEEN 80 (monooleate), TWEEN 40 (monopalmitate), TWEEN 60 (monostearate) or TWEEN 65 (tristearate), mono and diacetyl tartaric acid esters of mono and diglycerides of edible fatty acids, citric acid esters of mono and diglycerides of edible fatty acids, sodium stearoyl acetate, sodium lauryl sulfate, polyoxyethylated hydrogenated castor, block copolymers of ethylene oxide and propylene oxide and polyoxyethylene fatty alcohol ether. The solubilizer can be a single compound or a combination of several compounds. The term "solubilizer" is used in the present text to describe both possibilities, the solubilizer used must be suitable for use in food and / or medicine. In the presence of an active ingredient, the chewing gum can preferably also comprise a carrier known in the art. A significant advantage of the present process is 52-373 that the temperature throughout the entire operation can be maintained at a relatively low level, as will be described in the following. This is an advantageous feature with respect to preserving the aroma of the added flavoring components, which may be prone to deterioration at higher temperatures. The aromatic agents and flavoring agents that are useful in the chewing gum produced by the present process are, for example, natural and synthetic flavors (including natural flavors), in the form of natural vegetable components dried by freezing, essential oils, essences, extracts, powders, including acids and other substances capable of affecting the flavor profile. Examples of liquid and powdered flavorings include coconut, coffee, chocolate, vanilla, grapefruit, orange, lime, mint, licorice, caramel aroma, honey flavor, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry , tropical fruits, cherries, cinnamon, peppermint, wintergreen, spearmint, eucalyptus and mint, fruit essences such as apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple and plum. The essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg and oils from the fruits mentioned above. 52-373 In a preferred embodiment, the flavor is one or more natural flavoring agents, 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 preferably less than 1 mm, calculated as the longest dimension of the particle. The natural flavoring agent can also be in a form in which 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 of a fruit, for example, strawberry, blackberry and raspberry. Various synthetic flavors, such as a mixed fruit flavor, may also be used in accordance with the present invention. As indicated above, the aromatic agent can be used in smaller amounts than those conventionally used. The aromatic and / or flavoring agents may be used in an amount of about 0.01 to about 30% by weight of the final product depending on the desired intensity of the flavor and / or flavor used. Preferably, the flavor / flavor content is in the range of about 0.2 to 3% by weight of the total composition. According to the invention, they can be added 52-373 encapsulated flavors or active ingredients, to the final combination before compression. The different methods for encapsulating flavors or active ingredients, which may relate to flavors or active ingredients mixed in the base for the gum and the flavors or active ingredients compressed in the chewing gum, may include, for example, Spray drying, Cooling by sprinkling, film coating, coacervation, double emulsion method (extrusion technology) or granulation. The materials used for the encapsulation methods mentioned above may include, for example, Gelatin, wheat protein, soy protein, sodium caseinate, casein, gum arabic, modified starch, hydrolyzed starches (maltodextrins), alginates, pectin, carrageenan, Xanthan gum, locust bean gum, chitosan, beeswax, candelilla wax, carnauba wax, hydrogenated vegetable oils, zein and / or sucrose. The active ingredients can be added to the chewing gum. Preferably, these ingredients should be added after any significant mixing or heating. In other words, the active ingredients should preferably be added immediately before compression of the final tablet.

The active ingredients can be combined comfortably with the granulate of the base for gum and the additional additives desired, immediately before the final compression of the tablet. Examples of suitable active ingredients are listed below. In one embodiment of the invention, the chewing gum comprises a pharmaceutical, cosmetic or biologically active substance. Examples of such active substances, an extensive list of which is found, for example, in WO 00/25598, which is incorporated herein by reference, includes drugs, dietary supplements, antiseptic agents, pH adjusting agents, anti-smoking agents and substances for the care or treatment of the oral cavity and teeth, such as hydrogen peroxide and compounds capable of releasing urea during chewing. Examples of active substances useful in the form of antiseptics include salts and derivatives of guanidine and biguanidine (eg, chlorhexidine diacetate), and the following types of substances with limited water solubility: quaternary ammonium compounds (eg, ceramine, chloroxylenol, methyl violet, chloramine), aldehydes (for example, paraformaldehyde), decualine derivatives, polinoxylin, phenols (for example, thymol, p-chlorophenol, cresol), 52-373 hexachlorophene, salicylic compounds of anuide, triclosan, halogens (iodide, iodophors, chloroamine, dichlorocyanuric acid salts), alcohols (3,4-dichlorobenzyl alcohol, benzyl alcohol, phenoxyethanol, phenylethanol), see also, Martindale, The Extra Pharmacopoeia, 28th edition, pages 547-578; metal salts, complexes and compounds with limited water solubility, such as aluminum salts (eg potassium sulfate and aluminum A1K (S04) 2, 12H20) and salts, complexes and boron, barium, strontium, iron compounds, should be included. calcium, zinc, (zinc acetate, zinc chloride, zinc gluconate), copper (copper chloride, copper sulfate), lead, silver magnesium, sodium, potassium, lithium, molybdenum, vanadium; other compositions for the care of the mouth and teeth: for example; salts, complexes and compounds containing fluorine (such as sodium fluoride, sodium monofluorophosphate, aminofluorides, stannous fluoride), phosphates, carbonates and selenium. Additional active substances can be found in J. Dent. Res. Vol. 28 No. 2, pages 160-171, 1949. Examples of active substances in the form of agents that adjust the pH in the oral cavity include: acids, such as adipic acid, succinic acid, fumaric acid or salts thereof or salts of citric acid, tartaric acid, malic acid, acetic acid, lactic acid, phosphoric acid and glutaric acid and acceptable bases, such as carbonates, acid carbonates, phosphates, sulfates or oxides of sodium, potassium, ammonium, magnesium or calcium, especially magnesium and calcium. The active ingredients may comprise the compounds mentioned below or derivatives thereof, but are not limited thereto: Acetaminophen, Acetylsalicylic, Buprenorphine, Bromhexine, Celcoxib, Codeine, Diphenhydramine, Diclofenac, Etoricoxib, Ibuprofen, Indomethacin, Ketoprofen, Lumiracoxib, Morphine, Naproxen, Oxicodon, Parecoxib, Piroxicam, Pseudoephedrine, Rofecoxib, Tenoxicam, Tramadol, Valdecoxib, Calcium carbonate, Magaldrate, Disulfiram, Bupropion, Nicotine, Acryromycin, Clarithromycin, Clotrimazole,? Ritromycin, Tetracycline, Granisetron, Ondansetron, Promethazine, Tropisetron , Brompheniramine, Cetericin, Leco-Cetericin, Chlorocycline, Chlorpheniramine, Chlorpheniramine, Diphenhydramine, Doxylamine, Fenofenadine, Guaifenesin, Loratidine, Des-Loratidine, Phenyltoloxamine, Promethazine, Pyridamine, Terfenadine, Troxerutin, Methyldopa, Methylphenidate, Benzalkonium Chloride, Benchthonium Chloride , Cetilpirid Chloride. , Chlorhexidine,? Cabet-sodium, Haloperidol, Allopurinol, Colchinin, Theophylline, Propanolol, Prednisolone, Prednisone, Fluoride, Urea, Miconazole, Actot, Glibenclamide, Glipizide, Metformin, 52-373 Miglitol, Repaglinide, Rosiglitazone, Apomorphine, Cialis, Sildenafil, Vardenafil, Diphenoxylate, Simethicone, Cimetidine, Famotidine, Ranitidine, Ratinidine, Cetricin, Loratadine, Aspirin, Benzocaine, Dextromethorphan,? Fedrin, Phenylpropanolamine, Pseudoephedrine, Cisapride, Domperidone, Metoclopramide, Acyclovir, Dioctyl Sulfosuccinate, Phenolphthalein, Almotriptan,? Letriptan,? Rgotamine, Migea, Naratriptan, Rizatriptan, Sumatriptan, Zolmitriptan, aluminum salts, calcium salts, iron salts, silver salts, zinc salts, amphotericin B , Chlorhexidine, Miconazole, Triamcinolonacetonide, Melatonin, Phenobarbitol, Caffeine, Benzodiazepine, Hydroxyzine, Meprobamate, Phenothiazine, Buccinin, Brometacin, Cinaricin, Cyclin, Diphenhydramine, Dimenhydrinate, Buflomedil, Amphetamine, Caffeine, Ephedrine, Orlistat, Phenylephedrine, Phenylpropanolamine, Pseudoephedrine, Sibutramine , Ketoconazole, Nitroglycerin, Nystatin, Progesterone, Testosterone, Vitamin B12, Vitamin C, Vit Amine A, Vitamin D, Vitamin E, Pilocarpine, Aluminum Aminoacetate, Cimetidine, Esomeprazole, Famotidine, Lansoprazole, Magnesium oxide, Nizatide and / or Ratinidine. The invention is suitable for the increased or accelerated release of active agents selected from the group of dietary supplements, compositions 52-373 oral and dental, antiseptic agents, pH-adjusting agents, anti-smoking agents, sweeteners, flavorings, aromatic agents or drugs. Some of these will be described below. The active agents to be used in connection with the present invention can be any substance that is desired to be released from the chewing gum. The active agents, for which a controlled and / or accelerated release rate is desired, are mainly substances with a limited water solubility, typically below 10 g / 100 ml, inclusive of substances that are totally insoluble in water. Examples are medicines, dietary supplements, oral compositions, anti-smoking agents, highly potent sweeteners, pH adjusting agents, flavorings, etc. Other active ingredients are, for example, acetaminophen, benzocaine, cinnaricin, menthol, carvone, caffeine, chlorhexidine diacetate, cyclicine hydrochloride, 1,8-cineole, nandrolone, miconazole, mydithine, aspartame, sodium fluoride, nicotine, saccharin, cetylpyridinium chloride, other quaternary ammonium compounds, vitamin E, vitamin A, vitamin D, glibenclamide or derivatives thereof, progesterone, acetylsalicylic acid, dimenhydrinate, cyclin, metronidazole, 52-373 sodium acid carbonate, the active components of ginkgo, the active components of propolis, the active components of ginseng, methadone, peppermint oil, salicylamide, hydrocortisone or astemizole. Examples of active agents in the form of dietary supplements are, for example, salts and compounds having the nutritional effect of vitamin B2 (riboflavin), B12, folic acid, niacin, biotin, poorly soluble glycerophosphates, amino acids, vitamins A , D, E and K, minerals in the form of salts, complexes and compounds that contain calcium, phosphorus, magnesium, iron, zinc, copper, iodine, manganese, chromium, selenium, molybdenum, potassium, sodium or cobalt. In addition, reference is made to lists of nutrients accepted by the authorities in different countries, such as, for example, the Code of Federal Regulations of the United States, Title 21, Section 182.5013.182 5997 and 182. 8013-182.8997. Examples of active agents in the form of compounds for the care or treatment of the oral cavity and teeth are, for example, bound hydrogen peroxide or compounds capable of releasing urea during chewing. Examples of active agents in the form of antiseptics are, for example, salts and compounds of 52-373 guanidine and biguanidine (eg, chlorhexidine diacetate) and the following types of substances with limited solubility in water: quaternary ammonium compounds (eg, ceramine), chloroxylenol, methyl violet, chloramine), aldehydes (for example paraformaldehyde), decualine compounds, polinoxylin, phenols (for example thymol, for chlorophenol, cresol) hexachlorophene, salicylic compounds of anuid, triclosan, halogens (iodide, iodophors, chloroamine , salts of dichlorocyanuric acid), alcohols (3,4-dichlorobenzyl alcohol, benzyl alcohol, phenoxyethanol, phenylethanol), see also, Martindale, The Extra Pharmacopoeia, 28th edition, pages 547-578; metal salts, complexes and compounds with limited water solubility, such as aluminum salts (for example, potassium sulfate and aluminum A1K (S04) 2, 12H20) and in addition, salts, complexes and compounds of boron, barium, strontium should be included , iron, calcium, zinc, (zinc acetate, zinc chloride, zinc gluconate), copper (copper chloride, copper sulfate), lead, silver magnesium, sodium, potassium, lithium, molybdenum, vanadium; other compositions for the care of the mouth and teeth: for example; salts, complexes and compounds containing fluorine (such as sodium fluoride, sodium monofluorophosphate, aminofluorides, stannous fluoride), phosphates, carbonates and 52-373 selenium. See also, J. Dent. Res. Vol. 28 No. 2, pages 160-171, 1949, where a wide range of tested compounds is mentioned. Examples of active agents in the form of agents that adjust the pH in the oral cavity include, for example: acceptable acids, such as adipic acid, succinic acid, fumaric acid or salts thereof or salts of citric acid, tartaric acid, malic acid, acetic acid, lactic acid, phosphoric acid and glutaric acid and acceptable bases, such as carbonates, acid carbonates, phosphates, sulfates or oxides of sodium, potassium, ammonium, magnesium or calcium, especially magnesium and calcium. Examples of active agents in the form of antiinflammatory agents include, for example: nicotine, tobacco powder or silver salts, for example, silver acetate, silver carbonate and silver nitrate. In a further embodiment of the invention, the fatty acid esters of sucrose can also be used to increase the release of sweeteners, including for example, the so-called highly potent sweeteners such as, for example, saccharin, cyclamate, aspartame, thaumatin, dihydrochalcones , stevioside, glycyrrhizin or salts or compounds thereof. For one 52-373 increased release of the sweetener, the sucrose fatty acids, preferably, have a palmitate content of at least 40%, such as at least 50%. Additional examples of the active agents are medicines of any type. Examples of active agents in the form of drugs include caffeine, salicylic acid, salicylamide and related substances (acetylsalicylic acid, choline salicylate, magnesium salicylate, sodium salicylate), paracetamol, salts of pentazocine (pentazocine hydrochloride and lactate). pentazocine), buprenorphine hydrochloride, codeine hydrochloride and codeine phosphate, morphine and morphine salts (hydrochloride, sulfate, tartrate), methadone hydrochloride, ketobemidone and ketobemidone salts (hydrochloride), beta blockers, (propranolol), calcium antagonists, verapamil hydrochloride, nifedipine, as well as suitable substances and salts thereof, mentioned in Pharm. Int., Nov. 85, pages 267-271, Barney H. Hunter and Robert L. Talbert, nitroglycerin, erythrifyl tetranitrate, strychnine and salts thereof, lidocaine, tetracaine hydrochloride, etorphine hydrochloride, atropine, insulin, enzymes (eg papain, trypsin, amyloglucosidase, glucose oxidase, streptokinase, streptodornase, dextranase, alpha amylase), polypeptides (oxytocin, 52-373 gonadrelin, (LH.RH), desmopressin acetate (DDAVP), isoxsuprine hydrochloride, ergotamine compounds, chloroquine (phosphate, sulfate), isosorbide, demoxitocin, heparin. Other active ingredients include beta-lupeol, Letigen®, sildenafil citrate and derivatives thereof. Dental products include Carbamide, CPP, Fosfo Casein Peptide; Chlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Chloride, Chlorhexidine Digluconate, Hexetedin, Strontium Chloride, Potassium Chloride, Sodium Bicarbonate, Sodium Carbonate, Fluorine-Containing Ingredients, Fluorides, Sodium Fluoride, Aluminum Fluoride, Ammonium Fluoride , Calcium Fluoride, Stannous Fluoride, Other Fluorine Containing Ingredients, Ammonium Fluorosilicate, Potassium Fluorosilicate, Potassium Fluorosilicate, Ammonium Monofluorophosphate, Calcium Monofluorophosphate, Potassium Monofluorophosphate, Sodium Monofluorophosphate, Octadecenil Ammonium Fluoride, Stearil Dihydrofluoride Trihydroxyethyl Propylenediamine, Vitamins including A, Bl, B2, B6, B12, Folic Acid, Niacin, Pantotenside, Biotin, C, D, E, K. Minerals, including Calcium, Phosphorus, Magnesium, Iron, Zinc, Copper, Iodine , Manganese, Chromium, Selenium, Molybdenum. Other active ingredients include: Qio ", enzymes.Natural drugs include 52-373 Ginkgo Biloba, ginger and fish oil. The invention is also related to the use of drugs for migraine, such as serotonin antagonists: Sumatriptan, Zolmitriptan, Naratriptan, Rizatriptan,? Letriptan; drugs for nausea such as Cyclin, Cinaricin, Dimenhydramine, Difenhydrinat; drugs for hay fever, such as Cetricin, Loratidine, pain relief drugs, such as Buprenorphine, Tramadol, drugs for oral diseases such as Miconazole, Amphotericin B, Triamcinolonacetone; and the drugs Cisapride, Domperidone, Metoclopramide. In a preferred embodiment, the invention relates to the release of Nicotine and its salts. The active ingredients and / or flavors mentioned above can be pre-mixed in the gum base. When the granules of the gum base comprise pre-blended active ingredients, a controlled release of the active ingredients can be obtained by means of at least one double buffer of the active ingredients, the first binder comprises active ingredients combined in the final mixture immediately before the compression, the second buffer comprises active ingredients combined in the rubber base before the combination of the rubber base and the base additives for rubber. 52-373 Generally, the release of the flavor and / or the active ingredients can be adjusted by adjusting the balance between the ingredients and the additives for the premixed chewing gum added before compression. The degree of sieving depends mainly on how the granules of the rubber base "react" when the additives for the chewing gum are combined together. If appropriate, an initial preform of the granules is supplemented by spraying the barrier layer on the surface or at least a part of the surface of the preformed granules. This technique and variants thereof can be referred to as an explicit deposition of the barrier layer. However, preferably, the barrier layer is established in a more implicit manner. This technique and variants thereof can be referred to as implicit deposition of the barrier layer. This technique implies that the composite of the barrier layer is initially sprayed or deposited on the contact surfaces of the pressing tools of a compression machine. One applicable technique suitable for the implicit deposition of the barrier layer is described in U.S. Patent 5,643,630. The shredded combination is applied to 52-373 pressing tools of a tabletting machine and compressed into chewing gum tablets. The applied barrier layer may comprise, for example, lubricants, anti-adherents and glidants. Magnesium stearate can, for example, be applied as a pulverized separating compound. The barrier layer can be added to the final tablet, for example, by depositing dosed amounts of spray lubricants and spacer compounds on the material that comes into contact with the surfaces of the press tools of the tabletting machines. The barrier layer can be established by, for example, metal stearates, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycols, polyoxyethylene monostearate, animal fats, silicates, silicates dioxide, talc, magnesium stearates, calcium stearates, fumed silica, powdered hydrogenated cottonseed oils, hydrogenated vegetable oils, hydrogenated soybean oil and mixtures thereof. Optionally, the tableted chewing gum is provided with a suitable coating. According to one embodiment of the invention, the chewing gum element comprises approximately 52-373 5% to about 98% by weight of the full weight of the coated chewing gum. In the present context, a suitable external coating is any coating that results in extended storage stability of the compressed chewing gum products, as defined above, in relation to a chewing gum of the same composition that is not coated. Thus, suitable types of coating include hard coatings, film coatings and soft coatings of any composition, including those currently used in the coating of chewing gum, pharmaceuticals and confectionery. According to a preferred embodiment of the invention, the film coating is applied to the compressed chewing gum tablet. One type of currently preferred outer coating is a hard coating, which term is used with the conventional meaning of that term, including sugar coatings and sugar-free (or sugarless) coatings and combinations thereof. The objects of the hard coating are to obtain a sweet, crunchy layer, which is appreciated by the consumer, and to protect the rubber centers for several reasons. In a typical process of providing centers of chewing gum with a protective coating of sugar, the 52-373 gum centers are treated successively in a suitable coating equipment with aqueous solutions of crystallizable sugar, such as sucrose or dextrose, which, depending on the coating step achieved, may contain other functional ingredients, for example, fillers, colors, etc. In the present context, the sugar coating may contain additional functional or active compounds, including flavoring compounds, pharmaceutically active compounds and / or substances that degrade the polymers. In the production of the chewing gum it can, however, be preferred to replace the cariogenic sugar compounds in the coating with other sweetening compounds, preferably crystallizable, which do not have a cariogenic effect. In the art, such a coating is generally referred to as sugar-free or sugar-free coatings. Presently preferred noncariogenic substances for a hard coating include polyols, for example, sorbitol, maltitol, mannitol, xylitol, erythritol, lactitol, isomalt and tagatose, which are obtained by industrial methods by the hydrogenation of D-glucose, maltose, fructose or levulose, xylose, erythrose, lactose, isomaltulose and D-galactose, respectively. In a typical hard coating process, as 52-373 will describe in detail in the following, a syrup containing sugar and / or crylizable polyol, is applied in the gum centers and the water it contains is evaporated by blowing with dry warm air. This cycle must be repeated several times, typically 10 to 80 times, in order to achieve the required swelling. The term "swelling" refers to the increase in weight of the products, considered at the end of the coating operation, compared to the beginning, and in relation to the final weight of the coated products. According to the present invention, the coating layer constitutes from about 1 to about 75% by weight of the finished chewing gum element, such as from about 10 to about 60% by weight, including about 15 to about 50% by weight . In the further useful embodiments of the invention, the outer coating of the chewing gum element is an element that is subject to a film coating process, and which therefore comprises one or more polymeric agents that form a film, and optionally one or more auxiliary compounds, for example, plasticizers, pigments and opacifiers. A film coating is a thin coating based on a polymer, applied to the center of the chewing gum of any of the above forms. The spesor 52-373 of such a coating is usually between 20 and 100 μm. Generally, the film coating is obtained by passing the centers of chewing gum through a spray zone with atomized drops of the coating material, in a suitable aqueous or organic solvent vehicle, after which the material which adheres to the Rubber centers, dry before the next coating portion is received. This cycle is repeated until the coating is finished. In the present context, suitable film coating polymers include edible cellulose derivatives, such as cellulose ethers, including methyl cellulose (MC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC) and hydroxypropyl methylcellulose (HPMC). Other useful film coating agents are acrylic polymers and copolymers, for example, methacrylate amino ester copolymer or mixtures of cellulose derivatives and acrylic polymers. A particular group of film coating polymers also referred to as functional polymers are polymers which, in addition to their film-forming characteristics, confer a modified release performance with respect to the active components of the chewing gum formulation. Such polymers that modify the release, include copolymers of methacrylate ester, 52-373 ethylcellulose (EC) and enteric polymers designed to resist the acid medium of the stomach, although they dissolve easily in the duodenum. The last group of polymers includes: cellulose acetate phthalate (CAP), polyvinyl acetate phthalate (PVAP), shellac, methacrylic acid copolymers, cellulose acetate trimethylate (CAT) and HPMC. It will be appreciated that the outer film coating according to the present invention can comprise any combination of the above film coating polymers. In other embodiments, the film coating layer of the chewing gum elements comprises a plasticizing agent that has the ability to alter the physical properties of a polymer, to render it more useful for performing its function as a material forming a film. . In general, the effect of the plasticizers will be to make the polymer softer and more manageable, as the plasticizer molecules interpose themselves between the individual polymer strands, thus breaking polymer-polymer interactions. Most of the plasticizers used in the film coating are either amorphous or have very little crylinity. In the present context, suitable plasticizers include polyols such as glycerol, propylene glycol, polyethylene glycol, for example, the grades 52-373 200-6000 thereof, organic esters such as phthalate esters, dibutyl sebacate, citrate and thiacetin esters, oils / glycerides, including castor oil, acetylated monoglycerides and fractionated coconut oil. The choice of film forming polymers and plasticizing agents for the outer coating of the present chewing gum element is made with due consideration to achieve the best possible barrier properties of the coating, with respect to dissolution and diffusion to through the film, of moisture and gases. The film coating of the chewing gum elements may also contain one or more colorants or opacifiers. In addition to providing a dye of the desired color, such agents can help to protect the base for compressed gum against the reactions prior to chewing, in particular, by forming a barrier against moisture and gases. Suitable colorants / opacifiers include organic dyes and their lakes, inorganic coloring agents, for example, titanium oxide and natural colors, such as, for example, β-carotene. Additionally, the film coatings may contain one or more auxiliary substances, such as flavors and waxes or saccharide compounds such as 52-373 polydextrose, dextrins, including maltodextrin, lactose, modified starch, a protein such as gelatin or zein, a vegetable gum and any combination thereof. It is also an aspect of the present invention that the outer coating of the chewing gum element may contain one or more pharmaceutical or cosmetic components including those mentioned hereinbefore. Accordingly, in the additional embodiments of the invention, the hard coated or coated film chewing gum element is an element wherein the outer coating comprises at least one additive component selected from a binder, a component that absorbs moisture, a film forming agent, a dispersing agent, an anti-tack component, a bulking agent, a flavoring agent, a coloring agent, a pharmaceutical or cosmetically active component, a lipid component, a wax component, a sugar and an acid If it is desired to retard the effect of any of these additive components in the outer coating to chewing gum, such components may, according to the invention, be encapsulated using any conventional encapsulating agents such as, for example, a protein. which includes gelatin and protein 52-373 of soybean, a cellulose derivative including any of those mentioned above, a starch derivative, edible synthetic polymers and lipid substances, the latter optionally in the form of liposome encapsulation. In other embodiments of the invention, the chewing gum element is provided with an external coating in the manner generally described in the art as a soft coating. Such mild coatings are applied using conventional methods and may advantageously consist of a sugar mixture or any of the above sugar-free, non-cariogenic sweetening compounds, and a starch hydrolyzate. Again, it should be noted that the coating described above is optional or that it can be postponed until it is adjusted in the last part of the manufacturing process, due to the fact that the applied barrier layer is also acting as a complete or at least partial barrier to transfer moisture from the medium to the tablet. Compared with the conventionally mixed chewing gum, the compression of the rubber base granulate together with the chewing gum additives is a relatively forgiving group of the final chewing gum, at least with respect to the temperature . Nevertheless, the omission of the complete break of the granule, together with the desired additives, according to the conventional chewing gum, will result in a risk of crumbling and disintegration, especially during the initial chewing. According to the invention, a chewing gum is provided which features adhesive granules which can counteract the disintegration caused by the initial chewing, to the extent that the chewing gum remains without crumbling until the granules are finally mixed during chewing of chewing gum. 2-373

Claims (2)

1. CLAIMS: 1. Granules for rubber base comprising at least one biodegradable polymer, wherein the rubber base has a water content less than 5.0% by weight of the rubber base. 2. The rubber base granules according to claim 1, wherein the rubber base substantially comprises only at least one biodegradable polymer. The granules for gum base according to claim 1 or 2, wherein at least one of the biodegradable polymers comprises a polyester produced through the reaction of at least one alcohol or a derivative thereof, and at least one acid or a derivative thereof. The granules for rubber base according to any of claims 1 to 3, wherein at least one of the biodegradable elastomers comprises the polyester obtained by polymerization of at least one cyclic ester. 5. The rubber base granules according to any of claims 1 to 4, wherein the rubber base has a water content of less than 1.5% by weight of the rubber base. The granules for gum base according to any of claims 1 to 5, wherein the gum base has a water content of less than 1.0%, preferably substantially 0% by weight of the gum base. The granules for gum base according to any of claims 1 to 6, wherein the size of the granules for rubber base is within the range of 0.01 mm • 0.01 mm to 2 mm • 2 mm, preferably, within from the range of 0.1 mm • 0.1 mm to 1.0 mm • 1.0 mm. The granules for gum base according to any of claims 1 to 7, at least one biodegradable polymer in the amount of about 1% to about 100% by weight of the gum base. The granules for gum base according to any of claims 1 to 8, wherein the base for granulated gum comprises at least one biodegradable elastomeric polymer of high molecular weight, in an amount from about 0% to about 75% by weight of the base for rubber. 10. The granules for rubber base according to any of claims 1 to 9, wherein the molecular weight of at least one biodegradable elastomeric polymer of high molecular weight, is 52-373 about 10000 g / mol to 800000 g / mol of Mn. The granules for rubber base according to any of claims 1 to 10, wherein the base for granulated rubber comprises at least one solvent of the low molecular weight elastomer, in an amount of from about 0% to about 90% by weight of the base for rubber. The granules for gum base according to any of claims 1 to 11, wherein the molecular weight of at least one solvent of the low molecular weight elastomer is from about 1000 g / mol to 50000 g / mol of Mn. 13. The rubber base granules according to any of claims 1 to 12, wherein the granules for gum base comprise a sweetener in an amount of less than 50% by weight. The granules for gum base according to any of claims 1 to 13, wherein the gum base is substantially free of lubricants, antiadhesives and glidants. 15. The rubber base granules according to any of claims 1 to 14, wherein the natural resins provide an improved and adhesive texture of the rubber base when applied in the chewing gum formulation. 52-373 16. The rubber base granules according to any of claims 1 to 15, wherein the base for gum is substantially free of wax. 17. The rubber base granules according to any of claims 1 to 16, wherein the base for gum is substantially free of grease. 18. The rubber base granules according to any of claims 1 to 17, wherein the gum base comprises a filler in an amount of about 0% to about 50% by weight of the gum base. 19. The rubber base granules according to any of claims 1 to 18, wherein the granules for gum base comprise active ingredients, at least a portion of the active ingredients has been broken in the granules that form the chewing gum or at least a part of the granules that form the gum before the compression. The granules for gum base according to any of claims 1 to 19, wherein the gum base comprises a synthetic resin in an amount from about 15% to about 99%, preferably about 52-373 15% to about 80% by weight of the gum base. 21. The rubber base granules according to any of claims 1 to 20, wherein the gum base comprises emulsifiers and / or fats in an amount of about 10% to about 40% by weight of the gum base. 22. The rubber base granules according to any of claims 1 to 21, wherein the gum base comprises wax in an amount of about 2% to about 30% by weight of the gum base. The granules for gum base according to any of claims 1 to 22, wherein at least a portion of the flavoring agents has been torn off at the base for gum couple or at least a part of the gum base before compression . 24. The rubber base granules according to any of claims 1 to 23, wherein the at least one biodegradable polymer comprises at least one polyester obtained by the polymerization of at least one compound selected from the group consisting of cyclic esters, alcohols or derivatives of the same and carboxylic acids or derivatives thereof. 25. The rubber base granules according to any of claims 1 to 24, 52-373 wherein the granules for rubber base comprise at least one non-biodegradable polymer. 26. A compressed chewing gum comprising a gum base according to any of claims 1 to 25, wherein the water content is less than 5.0% by weight of the gum base. 27. The compressed chewing gum according to claim 26, wherein at least a part of the chewing gum polymers are non-biodegradable. 28. The compressed chewing gum according to claims 26 to 27, wherein the granules for the chewing gum are combined and compressed together with chewing gum ingredients, preferably powdered ingredients of the chewing gum, such as sweetener, flavor, fillers or emulsifiers. 29. The compressed chewing gum according to claims 26 to 28, wherein the water content is less than 1.5% by weight of the gum base. 30. The compressed chewing gum according to claims 26 to 28, wherein the water content is substantially 0%. 31. Compressed chewing gum according to 52-373 claims 26 to 30, wherein the base for biodegradable gum comprises at least two biodegradable polymers. 32. The compressed chewing gum according to claims 26 to 31, wherein the granules for the base for biodegradable gum are used together with conventional non-biodegradable rubber base granules. 2-373 RESTRICTION OF THE INVENTION The invention relates to granules for rubber base and compressed chewing gum, comprising at least one biodegradable polymer. In accordance with one embodiment of the invention, a mechanically stable compressed chewing gum has been obtained by applying at least one biodegradable polymer as a part of the gum base of the compressed chewing gum tablet.
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