Login| Sign Up| Help| Contact|

Patent Searching and Data


Title:
ADVANCED ENCAPSULATION PROCESS FOR CONTROLLED RELEASE OF ACTIVE INGREDIENTS FROM A CHEWING GUM
Document Type and Number:
WIPO Patent Application WO/2017/030919
Kind Code:
A1
Abstract:
A chewing gum component for use in a chewing gum composition is provided including a component body and a plurality of regions of at least one active ingredient encapsulated within an encapsulating material. The plurality of regions is disposed within said component body. Less than 10% of an average active concentration in said component body is in contact with an exterior surface of said component body.

Inventors:
BOGHANI, Navrov (100 Deforest Avenue, East Hanover, New Jersey, 07936, US)
JANI, Bharat (100 Deforest Ave, East Hanover, New Jersey, 07936, US)
HIERRO, Anny (100 Deforest Ave, East Hanover, New Jersey, 07936, US)
Application Number:
US2016/046659
Publication Date:
February 23, 2017
Filing Date:
August 12, 2016
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
INTERCONTINENTAL GREAT BRANDS LLC (100 Deforest Avenue, East Hanover, New Jersey, 07936, US)
International Classes:
A23G4/20
Domestic Patent References:
2000-05-11
2012-10-26
2016-08-04
Foreign References:
EP1474993A12004-11-10
EP0600701A21994-06-08
US20150223489A12015-08-13
US5116627A1992-05-26
Attorney, Agent or Firm:
HAYTER, Alicia (Cantor Colburn LLP, 20 Church Street22nd Floo, Hartford Connecticut, 06103, US)
Download PDF:
Claims:
CLAIMS:

What is claimed is:

1. A chewing gum component for use in a chewing gum composition, the chewing gum component comprising:

a component body; and

a plurality of regions of at least one active ingredient encapsulated within an encapsulating material, said plurality of regions being disposed within said component body, wherein less than 10% of an average active concentration in said component body is in contact with an exterior surface of said component body.

2. The chewing gum component according to claim 1, wherein less than 1% of said average active concentration in said component body is in contact with an exterior surface of said component body.

3. The chewing gum component according to claim 1, wherein said body has a longest dimension less than 1000 microns.

4. The chewing gum component according to claim 3, wherein a cross-section of said body is generally circular in shape.

5. The chewing gum component according to claim 3, wherein said

encapsulating material is insoluble in water.

6. A chewing gum component for use in a chewing gum composition, the chewing gum component comprising:

a plurality of component bodies, each of the plurality of bodies including a plurality of regions of at least one active ingredient encapsulated within an encapsulating material, said plurality of regions being disposed with said component body, wherein said plurality of component bodies has a size distribution with a standard deviation of less than 50% of an average longest dimension of each of said plurality of bodies.

7. The chewing gum component according to claim 6, wherein said plurality of component bodies has a narrow size distribution with a standard deviation of less than 10% of the average longest dimension of each of said plurality of component bodies.

8. The chewing gum component according to claim 6, wherein each of said plurality of component bodies has a longest dimension less than 1000 microns.

9. A chewing gum component for use in a chewing gum composition, the chewing gum component comprising

a component body; and a plurality of regions of at least one active ingredient encapsulated within an encapsulating material, said plurality of regions being disposed within said component body, wherein a release profile of said at least one active ingredient is linear for at least a minute after exposure of said component body to a dissolving liquid.

10. The chewing gum component according to claim 9, wherein said profile of said at least one active ingredient is continuously linear for at least 30 minutes after exposure of said component body to a dissolving liquid.

11. A chewing gum component for use in a chewing gum composition, the chewing gum component comprising

a component body; and

a plurality of regions of at least one active ingredient encapsulated within an encapsulating material, said plurality of regions being disposed with said component body, wherein less than about 10% of said at least one active ingredient is configured to dissolve after 3 minutes of exposure to water.

12. The chewing gum component according to claim 11, wherein less than about 5% of said at least one active ingredient is configured to dissolve after 3 minutes of exposure to water.

13. A method of manufacturing a comestible, comprising:

forming an extrudate of a first component;

cutting said extrudate at intervals into a plurality of pieces, wherein a longest dimension of said plurality of pieces is less than 1000 microns; and

forming a gum including said plurality of pieces as an ingredient.

14. The method according to claim 13, wherein said extrudate is cut into said plurality of pieces at regular intervals.

15. The method according to claim 13, wherein said extrudate is cut into said plurality of pieces at irregular intervals.

16. The method according to claim 13, wherein each of said plurality of pieces is substantially uniform in size.

17. The method according to claim 13, wherein said longest dimension is between about 200 microns and about 700 microns.

18. The method according to claim 13, wherein said first component is a composition including regions of one or more active ingredients encapsulated within an encapsulating material.

19. The method according to claim 18, wherein said active ingredient includes at least one sweetener.

20. The method according to claim 18, wherein said encapsulating material is a polyvinyl acetate.

21. The method according to claim 13, wherein cutting said extrudate includes supplying said extrudate to a pelletizer having a wheel including a plurality of blades, the wheel being configured to rotate about an axis arranged substantially perpendicular to a direction of travel of said extrudate.

22. The method according to claim 21, wherein less than 1% of said particles of active ingredient are ruptured by said plurality of blades during said cutting.

23. The method according to claim 22, wherein none of said particles of active ingredient are ruptured by said plurality of blades during said cutting.

24. The method according to claim 13, wherein the comestible is a chewing gum.

25. A method of forming a composition, comprising:

forming an extrudate of the composition, the composition including regions of at least one active ingredient encapsulated in an encapsulating material within said composition; and cutting said extrudate at intervals into a plurality of pieces, wherein release of said at least one active ingredient from said encapsulating material is initiated via a release trigger.

26. The method for forming a composition according to claim 25, wherein said release trigger is a mechanical action.

27. A method of manufacturing a composition, comprising:

forming an extrudate of a first component;

cutting said extrudate of said first component at intervals into a plurality of first pieces, said plurality of first pieces having a first release profile;

forming an extrudate of a second component; and

cutting said extrudate of said second component at intervals into a plurality of second pieces, said plurality of second pieces having a second release profile.

28. The method according to claim 27, wherein said first release profile and said second release profile are different.

29. The method according to claim 27, wherein said first component includes a first active ingredient and said second component includes a second active ingredient, said first active ingredient and said second active ingredient being substantially identical.

30. The method according to claim 27, wherein said first component includes a first active ingredient and said second component includes a second active ingredient, said first active ingredient being different than said second active ingredient.

31. The method according to claim 27, wherein said composition is a chewing gum.

32. The method according to claim 27, wherein said composition is a

pharmaceutical.

33. A method of customizing a dissolution rate of a comestible, comprising: providing a plurality of pieces of first component, said plurality of pieces of said first component including at least a first encapsulated active ingredient having a first release profile;

providing a plurality of pieces of second component, said plurality of pieces of said second component including at least a second encapsulated active ingredient having a second release profile, said second release profile being different than said first release profile; and mixing said plurality of pieces of first component and said plurality of pieces of second component.

34. The method according to claim 33, wherein said plurality of pieces of first component and said plurality of pieces of second component are substantially similar in size.

35. The method according to claim 33, wherein said plurality of pieces of first component and said plurality of pieces of second component are different in size.

36. The method according to claim 33, wherein said first encapsulated active ingredient and said second encapsulated active ingredient are the same.

37. The method according to claim 33, wherein said first encapsulated active ingredient and said second encapsulated active ingredient are different.

38. The method according to claim 33, wherein said composition is a chewing gum.

39. The method according to claim 33, wherein said composition is a

pharmaceutical.

40. The method according to claim 33, wherein an encapsulating material of said plurality of pieces of first component and an encapsulating material of said plurality of pieces of second component have a different molecular weight.

Description:
ADVANCED ENCAPSULATION PROCESS FOR CONTROLLED RELEASE OF ACTIVE INGREDIENTS FROM A CHEWING GUM

FIELD

[0001] The disclosure relates generally to an ingredient used in a comestible composition, and more particularly, to the individual pieces and a method of forming the individual pieces of an ingredient of a comestible composition.

BACKGROUND

[0002] Conventional methods for preparing one or more active ingredients for use in a comestible include forming an extrudate having one or more active ingredients

encapsulated therein. The extrudate is then convectively cooled to a temperature such that the extrudate may be broken into plurality of pieces before being ground into a powder.

When the extrudate is broken, the pieces formed are non-uniform in shape and size. As a result, various amounts of energy are required to grind each piece into particles of a desired size, thereby making the milling operation inefficient.

[0003] Accordingly, a system and method capable of continuously and efficiently preparing an active ingredient for use in a comestible is desirable.

SUMMARY

[0004] According to one embodiment of the invention, a chewing gum component for use in a chewing gum composition is provided including a component body and a plurality of regions of at least one active ingredient encapsulated within an encapsulating material. The plurality of regions is disposed within said component body. Less than 10% of an average active concentration in said component body is in contact with an exterior surface of said component body.

[0005] In addition to one or more of the features described above, or as an alternative, in further embodiments wherein less than 1% of said average active concentration in said component body is in contact with an exterior surface of said component body.

[0006] In addition to one or more of the features described above, or as an alternative, in further embodiments said body has a longest dimension less than 1000 microns.

[0007] In addition to one or more of the features described above, or as an alternative, in further embodiments a cross-section of said body is generally circular in shape. [0008] In addition to one or more of the features described above, or as an alternative, in further embodiments encapsulating material is insoluble in water.

[0009] According to another embodiment, a chewing gum component for use in a chewing gum composition is provided including a plurality of component bodies. Each of the plurality of bodies includes a plurality of regions of at least one active ingredient encapsulated within an encapsulating material. The plurality of regions is disposed with said component body. The plurality of component pieces has a size distribution with a standard deviation of less than 50% of an average longest dimension of each of said plurality of pieces.

[0010] In addition to one or more of the features described above, or as an alternative, in further embodiments said plurality of component bodies has a narrow size distribution with a standard deviation of less than 10% of the average longest dimension of each of said plurality of component bodies.

[0011] In addition to one or more of the features described above, or as an alternative, in further embodiments each of said plurality of component bodies has a longest dimension less than 1000 microns.

[0012] According to another embodiment, a chewing gum component for use in a chewing gum composition is provided including a component body and a plurality of regions of at least one active ingredient encapsulated within an encapsulating material. The plurality of regions is disposed within said component body. A release profile of said at least one active ingredient is linear for at least a minute after exposure of said component body to a dissolving liquid.

[0013] In addition to one or more of the features described above, or as an alternative, in further embodiments said profile of said at least one active ingredient is continuously linear for at least 30 minutes after exposure of said component body to a dissolving liquid.

[0014] According to another embodiment, a chewing gum component for use in a chewing gum composition is provided including a component body and a plurality of regions of at least one active ingredient encapsulated within an encapsulating material. The plurality of regions is disposed within said component body. Less than about 10% of said at least one active ingredient is configured to dissolve after 3 minutes of exposure to water.

[0015] In addition to one or more of the features described above, or as an alternative, in further embodiments less than about 5% of said at least one active ingredient is configured to dissolve after 3 minutes of exposure to water. [0016] According to another embodiment, a method for manufacturing a comestible is provided including forming an extrudate of a first component. The extrudate is cut at intervals into a plurality of pieces. A longest dimension of each of said plurality of pieces is less than 1000 microns. A gum is formed including said plurality of pieces as an ingredient.

[0017] In addition to one or more of the features described above, or as an alternative, in further embodiments said extrudate is cut into said plurality of pieces at regular intervals.

[0018] In addition to one or more of the features described above, or as an alternative, in further embodiments extrudate is cut into said plurality of pieces at irregular intervals.

[0019] In addition to one or more of the features described above, or as an alternative, in further embodiments each of said plurality of pieces is substantially uniform in size.

[0020] In addition to one or more of the features described above, or as an alternative, in further embodiments said longest dimension is between about 200 microns and about 700 microns.

[0021] In addition to one or more of the features described above, or as an alternative, in further embodiments said first component is a composition including regions of one or more active ingredients encapsulated within an encapsulating material.

[0022] In addition to one or more of the features described above, or as an alternative, in further embodiments said active ingredient includes at least one sweetener.

[0023] In addition to one or more of the features described above, or as an alternative, in further embodiments said encapsulating material is a polyvinyl acetate.

[0024] In addition to one or more of the features described above, or as an alternative, in further embodiments cutting said extrudate includes supplying said extrudate to a pelletizer having a wheel including a plurality of blades. The wheel is configured to rotate about an axis arranged substantially perpendicular to a direction of travel of said extrudate.

[0025] In addition to one or more of the features described above, or as an alternative, in further embodiments less than 1% of said particles of active ingredient are ruptured by said plurality of blades during said cutting.

[0026] In addition to one or more of the features described above, or as an alternative, in further embodiments none of said particles of active ingredient are ruptured by said plurality of blades during said cutting.

[0027] In addition to one or more of the features described above, or as an alternative, in further embodiments the comestible is a chewing gum.

[0028] A method of forming a composition is provided including forming an extrudate of the composition. The composition includes regions of at least one active ingredient encapsulated in an encapsulating material within said composition. The extrudate is cut at intervals into a plurality of pieces. Release of said at least one active ingredient from said encapsulating material is initiated via a release trigger.

[0029] In addition to one or more of the features described above, or as an alternative, in further embodiments the release trigger is a mechanical action.

[0030] According to another embodiment, a method for manufacturing a composition is provided including forming an extrudate of a first component and cutting said extrudate of said first component at intervals into a plurality of first pieces. The plurality of first pieces has a first release profile. An extrudate of a second component is formed and cut at intervals into a plurality of second pieces. The plurality of second pieces has a second release profile.

[0031] In addition to one or more of the features described above, or as an alternative, in further embodiments said first release profile and said second release profile are different.

[0032] In addition to one or more of the features described above, or as an alternative, in further embodiments said first component includes a first active ingredient and said second component includes a second active ingredient. The first active ingredient and second active ingredient are substantially identical.

[0033] In addition to one or more of the features described above, or as an alternative, in further embodiments said first component includes a first active ingredient and said second component includes a second active ingredient. The first active ingredient and second active ingredient are different.

[0034] In addition to one or more of the features described above, or as an alternative, in further embodiments said composition is a chewing gum.

[0035] In addition to one or more of the features described above, or as an alternative, in further embodiments said composition is a pharmaceutical.

[0036] According to another embodiment, a method for customizing a dissolution rate of a comestible is provided including providing a plurality of pieces of first component. The plurality of pieces of first component includes at least a first encapsulated active ingredient having a first release profile. A plurality of pieces of second component is provided. The plurality of pieces of second component includes at least a second encapsulated active ingredient having a second release profile. The second release profile is different than said first release profile. The plurality of pieces of first component and the plurality of pieces of second component are mixed. [0037] In addition to one or more of the features described above, or as an alternative, in further embodiments said plurality of pieces of first component and said plurality of pieces of second component are substantially similar in size.

[0038] In addition to one or more of the features described above, or as an alternative, in further embodiments said plurality of pieces of first component and said plurality of pieces of second component are different in size.

[0039] In addition to one or more of the features described above, or as an alternative, in further embodiments said first encapsulated active ingredient and said second encapsulated active ingredient are the same.

[0040] In addition to one or more of the features described above, or as an alternative, in further embodiments said first encapsulated active ingredient and said second encapsulated active ingredient are different.

[0041] In addition to one or more of the features described above, or as an alternative, in further embodiments wherein said composition is a chewing gum.

[0042] In addition to one or more of the features described above, or as an alternative, in further embodiments wherein said composition is a pharmaceutical.

BRIEF DESCRIPTION OF THE FIGURES

[0043] The accompanying drawings incorporated in and forming a part of the specification embodies several aspects of the present disclosure and, together with the description, serves to explain the principles of the present disclosure. In the drawings:

[0044] FIG. 1 is a perspective view of a piece of first component for use in a comestible according to an embodiment of the present disclosure;

[0045] FIG. 2 is a schematic diagram of a system for forming the piece of first component of FIG. 1 according to an embodiment of the present disclosure;

[0046] FIG. 3 is a schematic view of portion of a gum manufacturing system according to an embodiment of the present disclosure;

[0047] FIG. 4 is a cross-sectional view of a final gum product including a plurality of pieces of a first component according to an embodiment of the present disclosure; and

[0048] FIG. 5 is a graph of a dissolution curve of encapsulated aspartame according to an embodiment.

[0049] The detailed description explains embodiments of the invention, together with advantages and features, by way of example with reference to the drawings. DETAILED DESCRIPTION

[0050] The following disclosure will detail particular embodiments according to the present invention, which provides pieces of an ingredient, including an encapsulate compositions, particularly for use in chewing gum and other such confections.

[0051] The comestible discussed herein include any type of edible product, such as but not limited to chewing gum (at any stage including elastomer, partially finished base, finished chewing gum base, and finished chewing gum), confection (which may be synonymous with chewing gum and candy), sweet and savory biscuits and cakes, nuts, and grains. For ease of description, the comestible will be referred as chewing gum for the remainder of the description. Certain compositions of chewing gum may have a non-uniform texture and/or a multi-layered composition.

[0052] As used herein, a product referred to as "chewing gum" or "gum" includes, but is not limited to, compositions ranging from and inclusive of compounded elastomer to finished gum, which may include compounded elastomer in addition to some compounding aids, master batch gum base, compounded elastomer in addition to some subsequent gum ingredients, compounded elastomer in addition to some gum base ingredients and some subsequent gum ingredients, gum base, gum base in addition to some subsequent gum ingredients, master batch finished gum, and finished gum.

[0053] Before explaining the various systems and methods according to the present invention, it is helpful to discuss the general composition of several typical stages of chewing gum manufacture in which encapsulate may be used, namely finished gum.

[0054] A "finished chewing gum" or "finished gum," as used herein, will refer to chewing gum that is generally ready for preparation to distribute the product to the consumer. As such, a finished gum may still require temperature conditioning, forming, shaping, packaging and coating. However, from a compositional standpoint, the chewing gum itself is generally finished. Not all finished gums have the same ingredients or the same amounts of individual ingredients. By varying the ingredients and amounts of ingredients, textures, flavor and sensations, among other things, can be varied to provide differing characteristics to meet the needs of users.

[0055] As is generally well known, a finished gum typically includes a water soluble bulk portion, a water insoluble gum base portion, and one or more flavoring agents. The water soluble portion dissipates over a period of time during chewing. The gum base portion is retained in the mouth throughout the chewing process. A finished gum is to be defined as a chewing gum that is ready for user consumption. [0056] A "finished chewing gum base" or "finished gum base", as used herein, will refer to chewing gum that includes a sufficient combination of gum base ingredients that need only be combined with subsequent gum ingredients to form a finished gum. A finished gum base is a visco-elastic material that includes at least a viscous component, an elastic component, and a softener component. For example, a typical gum base may include elastomer, at least some of the filler, resin and/or plasticizer, polyvinyl acetate, and a softener (such as an oil, fat or wax). Merely compounded elastomer without the addition of any softener, for example, would not be a finished gum base because it would not be considered useable in a finished gum structure because of its difficulty, if not impossibility, to chew. In one embodiment, the viscosity of the finished gum base or the extrudate output from the extruder described further below is between about 75 pascal-seconds and about 140,000 pascal- seconds.

[0057] A "partial chewing gum base" or "partial gum base," as used herein, will refer to chewing gum that includes a gum base ingredient or combination of gum base ingredients that need be combined with further gum base ingredients and subsequent, non-base gum ingredients to form a finished gum. A partial gum base includes at least an elastic component, and will require addition of at least a viscous and/or softener component to form a finished gum base.

[0058] Chewing gum may include a vast number of ingredients in various categories. The systems and methods discussed below may be used to mix any and all known ingredients including, but not limited to, ingredients in the following ingredient categories: elastomers, bulking agents, elastomer plasticizers (which includes resins), elastomer solvents,

plasticizers, fats, waxes, fillers, antioxidants, sweeteners (e.g. bulk sweeteners and high intensity sweeteners), syrups/fluids, flavors, sensates, potentiators, acids, emulsifiers, colors, and functional ingredients.

[0059] The insoluble gum base in its finished gum base form generally includes ingredients falling under the following categories: elastomers, elastomer plasticizers (resins or solvents), plasticizers, fats, oils, waxes, softeners and fillers. Further discussion of representative ingredients within each category will be provided later on. The gum base may constitute between 5-95% by weight of a finished gum, more typically 10-50% by weight of the finished gum, and most commonly 20-30% by weight of the finished gum.

[0060] The water soluble portion of finished gum will be referred to as subsequent ingredients in this disclosure (as they are added subsequent to manufacture of a) finished gum base, and may include subsequent gum ingredients falling under the following categories: softeners, bulk sweeteners, high intensity sweeteners, flavoring agents, acids, additional fillers, functional ingredients and combinations thereof. Softeners are added to the gum in order to optimize the chewability and mouth feel of the gum. The softeners, which are also known as plasticizers, plasticizing agents or emulsifiers, generally constitute between about 0.5-15% by weight of the finished gum. Bulk sweeteners constitute between 5-95% by weight of the finished gum, more typically 20-80% by weight of the finished gum and most commonly 30-60% by weight of the finished gum. High intensity sweeteners may also be present and are commonly used with sugarless sweeteners. When used, high intensity sweeteners typically constitute between 0.001-5% by weight of the finished gum, preferably between 0.01-3% by weight of the finished gum. Typically, high intensity sweeteners are at least 20 times sweeter than sucrose.

[0061] Flavor should generally be present in the gum in an amount within the range of about 0.1-15% by weight of the finished gum, preferably between about 0.2-5% by weight of the finished gum, most preferably between about 0.5-3% by weight of the finished gum. Natural and artificial flavoring agents may be used and combined in any sensorially acceptable fashion. When included, acids typically constitute between about 0.001-5% by weight of the finished gum. Optional ingredients such as colors, functional ingredients and additional flavoring agents may also be included in gum.

[0062] Referring now to the FIGS., during the formation of a gum or other comestible, a plurality of pieces 20 of a first component may be mixed with one or more other ingredients, such as in a gum manufacturing system for example, to form a finished gum product. FIG. 1 illustrates an example of one of the plurality of pieces 20 of a first component in more detail. The plurality of pieces 20 generally have a diameter less than 1000 microns, such as between 200 and 700 microns. In one embodiment, each of the plurality of pieces 20 is substantially identical in size. As a result, the pieces 20 typically used in a batch of gum, such as ten pounds of pieces 20 for example, have a narrow size distribution with a standard deviation of less than 50%, and more specifically less than 10%, of the average longest dimension thereof. The illustrated piece 20 of a first component has a generally circular cross-section and is spherical in shape; however pieces 20 having other shapes, such as cylindrically shaped pieces for example are also within the scope of the invention. For example, the pieces 20 may have any shape such that the ratio of a largest dimension to a smallest dimension is less than 3: 1, or alternatively, less than 2: 1. In addition, each piece 20 has a tensile strength of at least 6000 psi. [0063] In the illustrated, non-limiting embodiment, the pieces 20 of first component include a composition containing both an "active ingredient" and an "encapsulating ingredient," the active ingredient being surrounded or encapsulated by the encapsulating ingredient. In some embodiments, the active ingredient may be relatively sensitive to high energy mixing environments (such as heat and shearing forces that can be associated with some types of mixing). Any active ingredients typically used in a comestible, such as but not limited to high intensity sweeteners (including natural sweeteners and synthetic sweeteners), food acids, and miscellaneous ingredients (including texture modifiers, coloring agents, salts, oral care ingredients, and other ingredients), are within the scope of the present disclosure. Any encapsulating ingredients typically used in comestible, such as but not limited to polymer or resin, are also contemplated in the formation of the pieces 20 of first component. In some embodiments, the encapsulating ingredients are insoluble in water. In other embodiments, the encapsulating ingredients may be soluble in water.

[0064] For example, active ingredients may include, but are not limited to sweeteners and food acids. Sweeteners used may be selected from a wide range of materials including water-soluble sweeteners, water-soluble artificial sweeteners, water-soluble sweeteners derived from naturally occurring water-soluble sweeteners, dipeptide based sweeteners, and protein based sweeteners, including mixtures thereof. Without being limited to particular sweeteners, representative categories and examples include: (a) water-soluble sweetening agents such as dihydrochalcones, monellin, steviosides, glycyrrhizin, saccharin salts, i.e., sodium or calcium saccharin salts, cyclamate salts, acesulfame salts, such as the sodium, ammonium or calcium salt of 3,4-dihydro-6-methyl-l,2,3-oxathiazine-4-one-2,2-dioxide, the potassium salt of 3,4-dihydro-6-methyl-l,2,3-oxathiazine-4-one-2,2-dioxide (Acesulfame-K), the free acid form of saccharin and monatin; (b) dipeptide based sweeteners, such as L- aspartic acid derived sweeteners, such as L-aspartyl-L-phenylalanine methyl ester

(Aspartame) and L-alphaaspartyl-N-(2,2,4,4-tetramethyl-3-thietanyl)-D-alanin amide hydrate (Alitame), methyl esters of L-aspartyl-L-phenylglycerine and L-aspartyl-L-2,5- dihydrophenyl-glycine, L-aspartyl-2,5-dihydro-L-phenylalanine; L-aspartyl-L-(l- cyclohexen)-alanine, neotame and advantame; (c) water-soluble sweeteners derived from naturally occurring water-soluble sweeteners, such as Reb-A, chlorinated derivatives of ordinary sugar (sucrose), e.g., chlorodeoxysugar derivatives such as derivatives of chlorodeoxysucrose or chlorodeoxygalactosucrose, known, for example, under the product designation of Sucralose; examples of chlorodeoxy. sucrose and chlorodeoxygalactosucrose derivatives include but are not limited to: l-chloro-l'-deoxysucrose; 4-chloro-4-deoxy-alpha- D-galactopyranosyl-alpha-D-fructofuranoside, or 4-chloro-4-deoxygalactosucrose; 4-chloro- 4-deoxy-alpha-D-galactopyranosyl- 1-chloro-l-deoxy-beta-D-fructo-furanoside, or 4, Γ- dichloro-4,l'-dideoxygalactosucrose; l',6'-dichloro l',6'-dideoxysucrose; 4-chloro-4-deoxy- alpha-D-galactopyranosyl-l,6-dichloro-l,6-dideoxy-beta-D- fructofuranoside, or 4,Γ,6'- trichloro-4, ,6'-trideoxygalactosucrose; 4,6-dichloro-4,6-dideoxy-alpha-D-galactopyranosyl- 6-chloro-6-deoxy-beta-D-fructofuranoside, or 4,6,6'-trichloro-4,6,6'-trideoxygalactosucrose; 6, ,6'-trichloro-6,r,6'-trideoxysucrose; 4,6-dichloro-4,6-dideoxy-alpha-D-galacto-pyranosyl- l,6-dichloro-l,6-dideox y-beta-D-fructofuranoside, or 4,6,l',6'-tetrachloro 4,6,1 ',6'- tetradeoxygalacto-sucrose; and 4,6,l',6'-tetradeoxy-sucrose, and mixtures thereof; or (d) Other protein based sweeteners such as thaumaoccous danielli (Thaumatin I and II) and talin. Food acids may include citric acid, malic acid, fumaric acid, tartaric acid, lactic acid and adipic acid.

[0065] Encapsulation of an active ingredient will result in the protection of the active ingredient from dissolution as a result of contact with water or saliva, thereby extending the relative life of the active ingredient within a finished gum product. In addition, encapsulation of an active ingredient may also result in the protection of the active ingredient during the remainder of the production process. As components of the comestible to be encapsulated may be sensitive to temperature, mixing, extruding, or other factors, the encapsulation allows for efficient handling and protection of these sensitive components during production.

Protection of the active ingredient as referenced above is achieved via a mixing of the active ingredient(s) with an encapsulating ingredient(s). Indeed, a composition of at least one encapsulated active ingredient as defined herein includes an active ingredient(s), such as that discussed above, mixed for production or extrusion with an encapsulating ingredient(s) such as that discussed immediately below.

[0066] Examples of encapsulating materials/ingredients include polymers or resins, wherein the characteristics of the polymer or resin ingredient control the release profile and the protection of the active ingredient to be encapsulated. In some embodiments, the encapsulating material may be polyvinyl acetate, polyethylene, crosslinked polyvinyl pyrrolidone, polymethylmethacrylate, polylactidacid, polyhydroxyalkanoates, ethylcellulose, polyvinyl acetatephthalate, polyethylene glycol esters, methacrylicacid-co- methylmethacrylate, polyvinylacetate-viynyl alcohol copolymer or any other ingredient suitable for polymer matrix type encapsulation.

[0067] As discussed above, it may be desirable to encapsulate certain ingredients or components used in pharmaceuticals or comestibles, such as chewing gum for example. Such compositions described herein include at least one active ingredient or component to be protected and released in a certain release profile, and at least one additional encapsulating ingredient such as, but not limited to a polymer or resin for example.

[0068] Referring again to FIG. 1, the exemplary piece 20 of a first component includes a plurality of regions containing an active ingredient 22, such as one or more liquid or powdered sweeteners for example, disposed within an encapsulating material 24 and positioned between a center and an exterior surface 26 of the piece 20. The , the

encapsulating material may be a polyvinyl acetate, for example having a molecular weight between 8,000 and 200,000, and more specifically between 12,000 and 100,000. In one embodiment, the plurality of regions 22 are water soluble, but the encapsulating material is not. Within each of the plurality of pieces 20, the regions of active ingredient 22 are generally uniformly distributed throughout the encapsulating material 24. By forming the pieces 20 of composition when the material is soft and malleable, the regions of active ingredient 22 within each piece 20 remain generally whole. As a result, the regions of active ingredient 22 are completely encapsulated within the encapsulating material 24 such that a limited portion of the regions of active ingredient 22 are exposed at or generally adjacent e.g. just below the exterior surface 26 of each piece 20. In one embodiment, less than 10%, and more specifically less than 1%, of the average active concentration within each piece 20 is exposed at or directly adjacent an exterior surface 26 of each piece 20. In addition, the portion of any region of active ingredient 22 partially extending beyond the exterior surface 26 of each piece 20 as defined by the encapsulating material 24, has a distance of less than 20% of the longest dimension of the piece 20.

[0069] Typically, encapsulation of an active ingredient (e.g., the flavor, sweetener, etc.), will result in a delay in the release of the predominant amount of the active ingredient during consumption of a comestible, such as a gum structure, that includes the encapsulated active ingredient. The initial release of the active ingredient from the encapsulating material of the pieces 20, such as when the pieces 20 are an ingredient in a gum, permits the majority of the active ingredient to be digested. This initial release generally occurs in response to release trigger, such as by rupturing the encapsulated active ingredient particles 22 due to chewing, or dissolving the encapsulated ingredients via saliva or solvents in the alimentary canal. However, in pharmaceutical applications, a chemical catalyst, such as stomach acid for example, may be configured to break down the encapsulating material and expose the active ingredient contained therein. [0070] Because the regions of active ingredient 22 are generally not exposed at the exterior surface 26 of a piece 20, the release profile of each piece 20 is significantly slower than the release profiles of conventional encapsulated active ingredients. For example, with reference to FIG. 5, a piece 20 as described herein with a first active ingredient, such as aspartame for example, has a dissolution rate of less than or equal to about 10% after 36 minutes. Conventional pieces of the same encapsulated first active ingredient, however, have a dissolution rate of about 30% or 55% after the same length of time. In addition, the release profile of a piece 20 as described herein is linear or generally linear, particularly in the first minute of release, whereas conventional pieces of the same encapsulated first active ingredient have an initially asymptotic release profile.

[0071] In one embodiment, as illustrated in FIG. 2, the pieces 20 of a first component are formed by continuously supplying extrudate 30 of a composition containing an encapsulated active ingredient from an extruder 32 to a downstream cutting mechanism 34. The cutting mechanism 34 may be configured to cut and/or shape the extrudate 30 continuously supplied thereto at regular or irregular intervals, to form a plurality of pieces 20 substantially identical in size and shape. In the illustrated, non-limiting embodiment, the cutting mechanism 34 includes a rotary cutter having a plurality of blades 36 extending outwardly therefrom. The rotary cutter is configured to rotate about an axis R oriented generally perpendicular to a direction of travel of the extrudate 30. As the extrudate moves towards the cutting mechanism 34, the blades continuously cut an end portion of the extrudate 30 to form the plurality of individual pieces 20. The narrow size distribution of the plurality of pieces 20 may be achieved by maintaining the output speed from the extruder 32 and the rotational speed of the rotary cutter constant. Although a specific cutting mechanism 34 for forming pieces 20 of a first component is illustrated and described herein, other methods are within the scope of the present disclosure.

[0072] In addition, the extruder 32 may be configured to output multiple ropes including a first rope configured to be formed into a plurality of first pieces and a second rope configured to be formed into a plurality of second pieces. The plurality of ropes may be provided to the same cutting mechanism 34 simultaneously, or alternatively, may be provided to different cutting mechanisms. Regardless of whether the first and second ropes of extrudate 30 are provided to the same cutting mechanism 34 or separate cutting mechanisms 34, the size and/or shape of the first pieces may but need not be identical or similar to the size and/or shape of the second pieces. [0073] The release profiles of the pieces 20 vary in part based on the dimensions of the plurality of pieces 20. Accordingly, the release profile of a piece 20, and therefore the dimensions of a piece 20, may be adjusted by altering one or more parameters used during the formation of the pieces 20. For example, in embodiments where the pieces 20 are formed by cutting an extruded encapsulate composition, the release profile may be varied by adjusting not only the speed at which the composition is extruded through an extruder 32, but also the rotational speed of the rotary cutter 34. In one embodiment, each of the plurality of pieces 20 has a uniform release rate for an initial period of time, such as between 5 minutes and 20 minutes for example.

[0074] As previously suggested, the pieces 20 may be supplied to a portion of a downstream gum manufacturing system 40, such as a mixer 42 shown in FIG. 3 for example, where the pieces 20 are added as one of a plurality of ingredients used to form a gum product. In such embodiments, the individual pieces 20 are added whole and remain substantially intact in the final gum product such that the pieces 20 may be visible when viewing a cross- section of the final gum product 44, as shown in FIG. 4.

[0075] When one or more pieces 20 are used as an ingredient in a final gum product, such as gum product 44 for example, the release profile of the final gum product will depend on the release profile of the plurality of pieces 20 of encapsulated active ingredient incorporated therein. In one embodiment, the pieces 20 incorporated into a final gum product 44 have a substantially uniform release profile.

[0076] Alternatively, a mixture of pieces 20 having varying release profiles may be included in a final gum product to customize the release profile of the entire gum piece when the gum is chewed. For example, the mixture of pieces 20 may include pieces 20 varying in at least one of size, distribution, and the one or more active ingredients encapsulated therein. By including pieces 20 having varying release profiles within a gum product, the

encapsulated active ingredients within the gum product 44 will be released in stages.

Accordingly, the overall length of time that one or more encapsulated active ingredients are detectable by a user chewing the final gum product 44 may be extended. As a result of this improved controllability of the release profile of a piece 20, the amount of encapsulated active ingredient included in a final gum product 34 may be reduced. In addition, a reduction in the amount of encapsulated active ingredient 22 within the final gum product 44 may also result in a reduction of the amount of softener added to the final gum product 44.

[0077] The pieces 20 of a first component of a comestible composition as described herein have a slowed and more uniform dissolution rate. In addition, because the size distribution of the plurality of pieces 20 is narrow, the release profile of a comestible including a plurality of pieces 20 may be controlled more accurately. By generating pieces 20 having a desired size and shape, the need for additional milling or grinding is eliminated.

[0078] All references, including publications, patent applications, and patents cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0079] The use of the terms "a" and "an" and "the" and similar referents in the context of describing the invention (especially in the context of the following claims) is to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to,") unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0080] Exemplary embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.