The present invention involves a novel chewing gum formulation and a method of making the same. The chewing gum formulation is used to form a final chewing gum composition which contains an active ingredient which is released from the chewing gum as the gum is masticated in the mouth of the user. The chewing gum made from the chewing gum composition of the present invention is initially a compressed body, such as a tablet, which quickly dissociates into a multiplicity of small pieces upon initial chewing followed by a reformation of the pieces into a coherent mass of chewing gum after a few seconds of chewing. Both the chewing gum formulation and the chewing gum composition are in the form of a free-flowing particulate which is capable of being directly compressed at high speed by a standard tableting machine into chewing gum tablets.

SUMMARY OF THE INVENTION

One of the objects of the present invention is to provide a chewing gum composition, comprising a chewing gum formulation and an active ingredient, that is directly compressible at high speed on a standard tableting machine to form chewing gum tablets.

Another object of the present invention is to provide a chewing gum, in the form of a compressed tablet, which is capable of rapidly releasing an active ingredient into the mouth of the user. The terms "rapid release" and "rapidly released", as used in the present patent application, mean that at least 50 to 75% by weight, preferably at least 70 to 80% by weight, of the active ingredient is released to the saliva in the mouth of the user within from thirty seconds to five minutes (preferably from thirty seconds to three minutes, most preferably from 1 to 3 minutes) of the initial chew under normal chewing conditions of about one chew per second.

Another object of the present invention is to provide a method of making a chewing gum formulation which can be used to produce a chewing gum composition having the above-described properties which does not involve: a) the careful addition of the sweetener and secondary ingredients to an initial melt of the gum base; or b) subjecting the gum base or chewing gum formulation to cold temperatures to form a friable mass.

These and other objects and advantages of the present invention can be appreciated by referring to the following description or may be learned by the practice of this invention.

The chewing gum formulation of the present invention is a free-flowing particulate which is capable of being directly compressed at high speed by a standard tableting machine into chewing gum tablets that provide a quick dissociation of the chewing gum into a multiplicity of small pieces upon initial chewing (i.e., the chewing gum tablet begins to dissociate on the first chew and reaches maximum dissociation in about two to twenty chews, preferably reaching maximum dissociation in about two to ten chews) followed by a reformation of the pieces into a coherent mass of chewing gum after a few seconds of active chewing (i.e., reformation in about 1 to 20 seconds after achieving the maximum dissociation of the chewing gum tablet, preferably in about 2 to 10 seconds after achieving the maximum dissociation of the chewing gum tablet, assuming one chew per second). These results are achieved through the use of a combination of ingredients that can be processed to a directly compressible particulate without the careful addition of the sweetener and secondary ingredients to an initial melt of the gum base or the use of cold temperatures to make the gum base or formulation friable or the use of a grinding aid to enable the comminution of the chewing gum formulation or composition.

When the chewing gum formulation is mixed with an active ingredient to form a chewing gum composition, the chewing gum composition should also be capable of being directly compressed at high speed by a standard tableting machine into chewing gum tablets that provide a quick dissociation of the chewing gum into a multiplicity of small pieces upon initial chewing followed by a reformation of the pieces into a coherent mass of chewing gum after a few seconds of chewing.

Before the addition of the active ingredient and the compression step, the chewing gum formulation of the present invention is in a free-flowing particulate form and comprises the following ingredients: a) a gum base; b) a granulating agent; c) a processing aid; and, optionally, d) a sweetening agent.

In addition, one or more flavoring or coloring agents can be added to the chewing gum formulation, during or after the production of the chewing gum formulation. Usually, the one or more flavoring or coloring agents are mixed with the chewing gum formulation during the production of the chewing gum composition. In addition, one or more common lubricants (e.g., magnesium stearate, sodium stearyl fumarate, hydrogenated vegetable oils, talc and stearic acid) are added to either the chewing gum formulation or the chewing gum composition to aid in the tableting of the formulation or composition. In any event, the lubricants are added to the formulation or composition before tableting. The lubricants are added in an amount of from 1 to 8% by weight, preferably from 1 to 5% by weight, most preferably from 1 to 3% by weight of the chewing gum formulation or composition.

In one embodiment of the present invention, at least one active ingredient is added to the chewing gum formulation to form a chewing gum composition which is then subjected to compression to form chewing gum tablets.

In another embodiment of the present invention, chewing gum tablets are formed directly from the chewing gum formulation and one or more active ingredients are then applied to the surface of the chewing gum tablets (e.g., by dip or spray coating techniques). In this embodiment of the present invention, one or more flavoring or coloring agents can also be applied to the surface of the chewing gum tablets, either simultaneously with the one or more active ingredients or in one or more separate steps.

The gum base can be any gum base that can be uniformly distributed as small particles (liquid or solid) throughout the chewing gum formulation when the gum base is mixed with the other components of the chewing gum formulation in a mixing apparatus. It is preferred that the gum base be in solid form and friable (i.e., when subjected to the mixing action in the mixing apparatus) at the time it is added to the mixing apparatus in which it will be mixed with the other components of the chewing gum formulation. In a preferred embodiment of the present invention, the gum base is (or can be made into) a free-flowing (non-tacky) particulate at temperatures in the range of from about 10.degree. C. to about 35.degree. C. The term "gum base", as used herein, means either one or more pure gums without any additives or blends of one or more pure gums and one or more additives (e.g., those that are sold commercially as gum bases for chewing gum).

The granulating agent can be one or more substances that do not adversely react with the other components of the chewing gum composition and/or the active ingredient(s) and result in a chewing gum formulation and/or chewing gum composition with the aforementioned properties when mixed with the other components according to the process of the present invention. The granulating agent is preferably water-soluble so that the final chewing gum product will have better organoleptic properties. The granulating agent may also function as a sweetening agent, as discussed below.

The sweetening agent can be one or more sweeteners of any type as long as the sweeteners do not adversely react with the other components of the chewing gum composition and/or the active ingredient(s) and, when used in the method of the present invention, form a chewing gum formulation and/or chewing gum composition with the aforementioned properties. Examples of potential sweeteners for use in the chewing gum formulation of the present invention are carbohydrates, particularly sugars such as sucrose, dextrose and glucose, polyols (e.g., sorbitol, mannitol, maltitol, xylitol, isomalt and erythritol), glycine, aspartame, cyclohexyl sulfamate, saccharine, acesulfame K, stevioside and ammonium glycyrrhizinate. The sweetening agent is preferably added as a dry particulate or powder. Preferred sweeteners are sugars, such as sucrose or dextrose, and polyols, such as sorbitol, mannitol or isomalt.

Certain substances can function as both a sweetening agent and a granulating agent (e.g., sugars, such as sucrose, fructose and dextrose, and polyols, such as sorbitol, mannitol or isomalt). When one or more of these substances is used in the chewing gum formulation and/or composition as a granulating agent, there may be no need for a separate or different sweetening agent.

In a highly preferred embodiment of the present invention, sorbitol is used as a granulating agent which also contributes to the sweetness of the final chewing gum product. In this embodiment of the present invention, the amount of sorbitol present is from 10 90.9% by weight, preferably from 45 to 90.9% by weight, of the chewing gum formulation.

The processing aid can be one or more substances that help to keep the chewing gum formulation in free-flowing particulate form, both during the formation of the chewing gum formulation and afterwards. Further, the presence of the processing aid may also result in a chewing gum formulation and/or composition that is less sticky, which reduces the amount of the chewing gum formulation that sticks to the interior surfaces and blades of the mixing equipment and therefore remains inside the mixing equipment after each production run. By reducing the amount of the chewing gum formulation that remains inside the mixing equipment after each production run, the yield of chewing gum formulation from each production run is increased (e.g., yields of chewing gum formulation of 85% to 90%, preferably from 90% to 95%, or even higher, are obtained). Further, the mixing equipment can be cleaned more easily and thoroughly, thereby resulting in less down time between production runs. These advantages also apply to the mixing equipment used to produce the chewing gum composition (e.g., there is less material sticking to the interior surfaces and moving parts of the mixing equipment so the equipment can be cleaned more easily and thoroughly than with other chewing gum formulations). The ability to easily and thoroughly clean the mixing equipment between production in a simple and cost-effective manner results in a process which should be acceptable under the cGMP guidelines of the United States Food and Drug Administration (FDA) (e.g., by preventing cross-contamination of active ingredients).

By reducing the stickiness of the chewing gum composition, the processing aid also contributes to the ability of the chewing gum composition to be directly compressed at high speed on a standard tableting machine,by reducing or eliminating the tendency of the chewing gum formulation to stick to the punches and dies of the tableting machine.

The superior compaction properties of the chewing gum formulations and chewing gum compositions of the present invention-permit these formulations and compositions to be easily compressed into tablets having a variety of shapes (e.g., complex shapes such as animal figures) and sizes. In one embodiment of the present invention, the chewing gum tablets are produced with a hole (hereinafter referred to as the "through-hole") that passes through the tablet. Although the through-hole in the tablet does not have to be located in the center of the tablet, applicants have found this to be a desirable location for the through-hole. Further, it is preferred that the through-hole is formed during the compression step of the tablet production process and is not formed by punching or drilling the tablet after compression. The through-hole passes from one face of the tablet to the opposite face and has a usual cross-sectional diameter or width of from 1 mm to 20 mm. For most tablets, the maximum diameter or width of the through-hole is 3/4 (or 75%) of the maximum diameter or width of the tablet through which the through-hole passes. In another embodiment of the present invention, after a gum tablet with a through-hole has been formed, the through-hole may be completely or partially filled with a composition that contains one or more substances that are not contained in the remainder of the gum tablet. For example, the composition located in the through-hole of the chewing gum tablet may contain an active ingredient and/or flavor that are/is not contained in the remainder of the chewing gum tablet. In this embodiment of the present invention, the composition located in the through-hole of the tablet may, inter alia, affect the flavor or texture of the tablet and/or may provide one or more active ingredients to the user (i.e., the individual who is chewing the tablet) that would not be provided by the chewing gum tablet alone.

Examples of preferred processing aids are silica and silicate substances such as talc, silica gel, precipitated silica, fumed silica and colloidal silica. In a highly preferred embodiment of the present invention, the processing aid consists essentially of silica gel.

The chewing gum formulation is produced by adding the gum base, in the form of a solid particulate, to a mixture of the granulating agent and at least a portion of the processing aid that is being mixed within a mixer. The particles of the gum base are allowed to mix with the mixture of the granulating agent and the processing aid for a time while the temperature in the mixer is below the melting point of the gum base. The temperature in the mixer is then increased to a temperature which is sufficient to melt at least the surface of the gum base particles and the contents of the mixer are mixed for several minutes at this temperature to obtain a uniform mixture of the gum base, the granulating agent and the processing aid. This uniform mixture is in particulate form (i.e., granules) inside the mixer It is preferred that a portion of the processing aid is added to the mixer after this uniform mixture is obtained and allowed to mix with the uniform mixture particles for a short time so that the processing aid can form a partial coating on the uniform mixture particles before the contents of the mixer are removed from the mixer.

As the gum base, granulating agent and processing aid are mixed in the mixing device, they may, for a time, form a doughy or plastic mass that is not in particulate form. In this situation, the mixer can be outfitted with choppers that break up the doughy or plastic mass and form particles that are then removed from the mixer. Alternatively, the mixture can be removed from the mixer in the form of a doughy or plastic mass and subjected to a subsequent comminution step to form a free-flowing particulate. In any event, the chewing gum formulation may be subjected to a comminution or screening step before use to create or obtain particles of a desired size. -However, it is not necessary or desirable to subject the chewing gum formulation to temperatures below normal room temperature (20 to 30.degree. C. or 68 to 86.degree. F.) for the purpose of rendering the formulation friable. Such a step, if performed, would be an additional or extra step which is not necessary to make the chewing gum formulation friable so that it can be comminuted to a free-flowing particulate form.

If a sweetening agent is used to produce the chewing gum tablets of the present invention, the sweetening agent may be added to the mixer during the production of the chewing gum formulation. Alternatively, the sweetening agent may be mixed with the chewing gum formulation during the production of the chewing gum composition. In certain embodiments of the present invention, the sweetening agent may even be applied to the chewing gum tablets during or after the compression step. The timing of the addition of the sweetening agent depends primarily on the identity and properties of the sweetening agent. For example, if the sweetening agent is a bulk sweetener, such as sugar or a polyol, at least a portion of the sweetening agent will be added during the production of the chewing gum formulation, usually before the addition of the gum base. If the sweetening agent is an intense sweetener, such as aspartame or saccharine, then at least a portion of the sweetening agent (usually all of the sweetening agent) will be mixed with the chewing gum formulation during the production of the chewing gum composition or added to the chewing gum composition after it has been produced. When a combination of one or more bulk sweeteners and one or more intense sweeteners are used as the sweetening agent, then the bulk sweetener(s) is(are) usually added to the mixer during the production of the chewing gum formulation (usually before the addition of the gum base) and the intense sweetener(s) is(are) usually mixed with the chewing gum formulation during the production of the chewing gum composition or added to the chewing gum composition after it has been produced.

When the substance or substances used as the granulation agent are also used as the sweetening agent, then the total amount of the substance or substances in the chewing gum formulation is usually from 45 to 90.9% by weight, preferably from 55 to 85% by weight, most preferably from 60 to 80% by weight. When the sweetening agent is not also the granulating agent or one of the granulating agents or is added to supplement the sweetening effect provided by a substance that also functions as a granulating agent, then the amount of the sweetening agent (or supplemental sweetening agent) is usually from 0.1 to 45% by weight of the chewing gum formulation or from about 0.1 to 40% by weight of the chewing gum composition. When both a sweetening agent and a granulating agent are used, it may be desirable to limit the maximum amount of granulating agent to 90.8% by weight of the chewing gum formulation.

In one embodiment of the present invention, a chewing gum composition is formed by mixing the chewing gum formulation, in the form of a free-flowing particulate, with at least one active ingredient. When the active ingredient(s) is(are) in particulate form, it(they) is(are) dry-mixed with the chewing gum formulation to form the chewing gum composition. When the active ingredient(s) is(are) in the form of a suspension or solution of the active ingredient(s) in a liquid (e.g., water), the solution or suspension containing the active ingredient(s) is contacted with the chewing gum formulation in such a manner that an amount of the active ingredient(s) is(are) deposited on the surface of the chewing gum formulation particles or inside any porosity that may be present in the particles, and then the particles are dried, if necessary (e.g., by evaporation), to form the chewing gum composition particles that are then compressed to form chewing gum tablets. The solution or suspension containing the active ingredient(s) may be contacted with the chewing gum formulation particles in any manner (e.g., by dipping the formulation into the solution or suspension or by spraying the solution or suspension onto the formulation) and any number of times, to form the final chewing gum composition.

The active ingredient(s) may also be added to the chewing gum formulation as both a dry particulate and as a solution or suspension in a liquid. For example, when only one active ingredient is to be added to the chewing gum formulation, a portion of the active ingredient may be added as a dry particulate in one step and a portion of the active ingredient may be added as a solution or suspension in another step. When more than one active ingredient is to be added to the chewing gum formulation, one or more of the active ingredients may be added as a dry particulate and one or more of the active ingredients may be added as a solution or suspension.

When the active ingredient is added to the chewing gum formulation and the chewing gum formulation is in the form of a particulate or powder, most or all of the active ingredient is loosely bound to the outer surfaces of the particles of the chewing gum formulation (e.g., especially when the active ingredient is in the form of a powder and the active ingredient is added to the chewing gum formulation by dry blending the active ingredient and the chewing gum formulation). This means that in the final chewing gum tablet, most of the active ingredient is disposed in the spaces between the particles of the chewing gum formulation and/or loosely bound to the outside surfaces of the particles of chewing gum formulation. When the chewing gum tablets are chewed, the outside surfaces of the chewing gum formulation particles are quickly exposed to the saliva in the mouth of the individual chewing the tablet and this leads to a rapid release of the active ingredient to the saliva. This is especially noticeable when the chewing gum tablet dissociates into a multiplicity of pieces upon initial chewing. The release of the active ingredient (i.e., to the saliva of the individual chewing the gum) by the chewing gum tablets of the present invention is substantially faster than the release of the same active ingredient from a chewing gum that was formed by conventional techniques where the active ingredient is added to a melt of the chewing gum and this mixture is then formed into the final chewing gum pieces.

After the active ingredient(s) is(are) added to the chewing gum formulation to form the chewing gum composition, the chewing gum composition, which is in the form of free-flowing particles, is subjected to compression in a tableting machine to form chewing gum tablets. One of the advantages of the chewing gum formulation and composition of the present invention is that it can be directly compressed at high speed (e.g., at tableting speeds of 75,000 tablets per hour or more, preferably from 75,000 to 100,000 tablets per hour) because it does not stick to the punches and dies used in standard high speed tableting machines. These properties are extremely advantageous because they permit the use of the type of high speed tableting machines that are normally used in the pharmaceutical industry to form the chewing gum tablets of the present invention. The use of such tableting machines is advantageous because the pharmaceutical manufacturer will not have to invest in new equipment to produce the chewing gum tablets of the present invention. Further, the production of the chewing gum tablets at high speed in such tableting machines results in cost-savings because the time required to produce a given amount of chewing gum tablets is far less than with the low output machines that are necessary to produce tablets with other gum formulations.

Any active ingredient can be used with the chewing gum formulations of the present invention as long as that active ingredient can be administered orally and does not react adversely with the other components in the chewing gum formulation. Examples of suitable active ingredients are analgesic substances, anti-inflammatory substances, antacid substances, antibiotic substances, decongestant substances, cough suppressant substances, vitamins, stimulants, anaesthetic substances and antiseptic substances. Preferred active ingredients include acetaminophen, ibuprofen, vitamins, antacids, decongestants, cough suppressants, caffeine, nicotine, glucosamine, chondroitin, phaseolamin, benzocaine and lidocaine.

In certain embodiments of the present invention, the chewing gum tablets have a coating that can be composed of at least one layer. The coating can contain at least one sweetener and/or at least one active ingredient. In one embodiment of the present invention, the chewing gum tablet has a coating that contains a sweetening agent that is the only sweetening agent present in the chewing gum tablet. In another embodiment of the present invention, the coating contains at least one active ingredient that is the only active ingredient present in the chewing gum tablet. In a further embodiment of the present invention, the chewing gum tablet has a coating that contains a sweetening agent that is in addition to a sweetening agent that is contained in the remainder of the tablet. In yet another embodiment of the present invention, the chewing gum tablet has a coating that contains an active ingredient that is in addition to an active ingredient that is contained in the remainder of the tablet. In these latter two embodiments of the present invention, the additional sweetening agent or active ingredient that is contained in the coating may be the same as or different from the sweetening agent or active ingredient that is contained in the remainder of the chewing gum tablet.

 

Claim 1 of 22 Claims

1. A method of producing a chewing gum tablet comprising a chewing gum formulation and at least one active ingredient, wherein the chewing gum tablet dissociates into at least two pieces upon initial chewing followed by a reformation of the pieces into a coherent mass after additional chewing, comprising the steps of: (a) dry mixing a gum base, a granulating agent and at least one processing aid to form a chewing gum formulation that contains less than 2% by weight water; (b) adding one or more additional ingredients, including an active ingredient, to the chewing gum formulation to form a chewing gum composition in the form of a free-flowing particulate that contains less than 2% by weight water; and (c) directly compressing the chewing gum composition into said chewing gum tablet; wherein the gum base is in the form of particles and during the dry mixing step, the temperature of the gum base is raised to an elevated temperature where at least the outer surfaces of the gum base particles melt and further wherein a portion of the processing aid is mixed with the gum base and granulating agent before the temperature is raised to said elevated temperature and at a first temperature that is below the melting point of the gum base and, after the temperature of the gum base is raised to said elevated temperature, mixing continues until a uniform mixture of the gum base, the granulating agent and the processing aid is obtained in the form of particles of said uniform mixture, at which time, the temperature of the gum base is reduced to a point that is below the melting point of the gum base and the remainder of the processing aid is added to and mixed with the particles of said uniform mixture until the remainder of the processing aid forms a partial coating on the outer surfaces of the particles of said uniform mixture.

____________________________________________
If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.