ORAL PRODUCTS FIELD OF THE INVENTION
[0001] The present invention relates to a method and apparatus for producing oral products containing relatively high levels of actives, and to oral dosage forms and the like.
BACKGROUND OF THE INVENTION
[0002] Oral products based on polymer materials carrying active contents, such as vitamins, are known. However, prior art techniques have produced oral products which are unpleasant to taste, leave a bitter after taste, have poor mouth feel and/or are slow to dissolve. Particular problems occur when the active content makes up a considerable or high proportion of the total by % weight of the dry composition.
[0003] The present invention seeks to provide improved methods and apparatus for producing oral products. Orals products with natural extracts and containing relatively high levels of actives are disclosed, as well as methods and apparatus for producing oral products.
SUMMARY OF THE INVENTION [0004] According to an aspect of the present invention there is provided an edible product comprising: pureed natural extracts from at least one fruit or vegetable, and a polymer having film forming capabilities. [0005] According to an aspect of the present invention there is provided an edible product comprising: pureed natural extracts from at least one fruit or vegetable, a polymer having film forming capabilities, and an active material. [0006] Preferably the active material comprises from one or more of: vitamins, minerals, nutrients, herbals, neutraceutals, combinations thereof. [0007] Preferably the edible product further comprises one or more additives. [0008] Preferably the edible product further comprises at least one flavoring.
[0009] Preferably the edible product further comprises at least one plasticizer.
[0010] Preferably the edible product further comprises at least one stabilizer.
[0011] Preferably the edible product further comprises at least one emulsifier.
[0012] Preferably the edible product further comprises at least one surfactant.
[0013] Preferably the active comprises one or more vitamins in an amount greater than 15 % by weight of the dry composition. Preferably, the vitamins are present in an amount greater than 20% by weight of the dry composition. Still more preferably, the vitamins are present in an amount greater than 25% by weight of the dry composition. Typically, the vitamins are present in an amount between 25 and 40% by weight of the dry composition. In some embodiments the vitamins exceed 40% by wt.
[0014] According to an aspect of the present invention there is provided an oral dosage form, and method of preparation thereof, containing a fruit and/or vegetable puree, a film forming polymer, at least one active.
[0015] Preferably the active comprises from one or more of: vitamins, minerals, nutrients, herbals, neutraceutals, combinations thereof.
[0016] Preferably the oral product comprises flavorings in an amount sufficient to mask the taste of the active, where the active has an unpleasant taste or an after taste.
[0017] According to an aspect of the present invention there is provided an edible oral product comprising: a natural puree extract, a film forming polymer, an active and flavorings.
[0018] Preferably the puree is present in an amount between 90 and 10 dry weight. Still more preferably the puree is present in an amount between 80 and 20 dry weight percent. Even more preferably the puree is present in an amount between 30 and 60 dry weight percent.
[0019] Preferably the film forming polymer is present in an amount between 0 and 50 dry weight percent. Still more preferably the film forming polymer is present in an amount between 2 and 30 dry weight percent. Even more preferably the film forming polymer is present in an amount between 4 and 20 dry weight percent.
[0020] Polymer may also be present in the active-flavor mix, for example as a stabilizer or other agent.
[0021] Preferably active is present in an amount between 80 and 10 dry weight percent. Still more preferably the active is present in an amount between 15 and 60 dry weight percent. Even more preferably the active is present in an amount between 20 and 45 dry weight percent.
[0022] Preferably flavorings and/or other additives are present in an amount between 0 and 50 dry weight percent. Still more preferably flavorings are present in an amount between 3 and 40 dry weight percent. Even more preferably the flavorings are present in an amount between 5 and 20 dry weight percent.
[0023] According to an aspect of the present invention there is provided a method and apparatus for preparing any one of the above-mentioned oral products.
[0024] According to another aspect of the present invention there is provided a method of forming an edible product, comprising: preparing a polymer base, adding one or more natural extracts.
[0025] According to another aspect of the present invention there is provided a method of forming an edible product, comprising: preparing a polymer base, adding one or more natural extracts, adding an active which either fortifies or adds to natural contents of the extract.
[0026] According to another aspect of the present invention there is provided a method of forming an edible product, comprising: preparing a polymer base, adding one or more natural extracts, adding an active which either fortifies or adds to natural contents of the extract, adding flavorings.
[0027] Preferable the natural extracts are pureed fruit and/or vegetable extracts.
[0028] According to another aspect of the present invention there is provided a method of forming an edible product, comprising: preparing a polymer solution, adding one or more pureed natural extracts, preparing an active emulsion, combining the active emulsion and the polymer base, and casting.
[0029] According to another aspect of the present invention there is provided a method of forming an edible product, comprising: preparing a polymer- puree solution, the puree comprising natural extracts of at least one fruit and/or vegetable, preparing an active emulsion, combining the active emulsion and the polymer-puree base, and casting.
[0030] According to another aspect of the present invention there is provided a method of forming an edible product, comprising: preparing a polymer- puree solution, the puree comprising natural extracts of at least one fruit and/or vegetable, preparing an active-flavor emulsion, combining the active emulsion and polymer-puree base, and casting.
[0031] According to another aspect of the present invention there is provided a method of forming a polymer film, comprising: preparing a polymer base, preparing a vitamin emulsion, adding the vitamin emulsion to the polymer base, and casting.
[0032] According to another aspect of the present invention there is provided a method of forming a polymer film containing vitamins and/or minerals, comprising: preparing a flavor emulsion, preparing a polymer base, adding the flavor emulsion to the polymer base, and casting.
[0033] , According to another aspect of the present invention there is provided a method of forming a polymer film containing vitamins and/or minerals, comprising: preparing a vitamin emulsion, preparing a flavor emulsion, preparing a polymer base, adding the vitamin and flavor emulsions to the polymer base, and casting.
[0034] Preferably the film further comprises natural extracts of one or more fruit and/or vegetable. The natural extracts are typically supplied in puree form.
[0035] According to another aspect of the present invention there is provided a method of forming a polymer film containing at least one vitamin and/or mineral, comprising: preparing a vitamin-flavor emulsion, preparing a polymer base, adding the vitamin-flavor emulsion to the polymer base.
[0036] According to another aspect of the present invention there is provided a method of forming a polymer-based film product containing
multivitamins and/or minerals, comprising: preparing a vitamin-flavor emulsion, preparing a polymer base, adding the vitamin-flavor emulsion to the polymer base.
[0037] According to another aspect of the present invention there is provided a method of forming a polymer-based film product containing multivitamins and/or minerals, comprising: preparing a vitamin-flavor emulsion and preparing a polymer base, adding the vitamin-flavor emulsion to the polymer base, wherein the vitamins are present in an amount between 20 and 40% by weight and one or more flavorings are present in an amount between 5 and 20% by weight of the dry composition. Preferably the polymer constituent is present in an amount between 20 and 40% by weight. Typically, the vitamins amount to about 30%) (+/- 5%) by weight, the flavors amount to between 5 and 15% by weight, and the polymer base material amounts to about 30% (+/- 5%) by weight of the dry composition.
[0038] Preferably the vitamin(s) are present in an amount greater than 20% weight of the dry composition. More preferably the vitamin(s) are present in an amount greater than 25% weight of the dry composition. Still more preferably the vitamin(s) are present in an amount greater than 30% weight of the dry composition.
[0039] Preferably, the film contains flavors in an amount greater than 5% by weight of the dry composition. More preferably the film contains flavors in an amount greater than 5% by weight of the dry composition. Still more preferably the film contains flavors in an amount greater than 10% by weight of the dry composition.
[0040] According to another aspect of the present invention there is provided a breath freshening strip.
[0041] According to another aspect of the present invention there is provided a method of making a breath freshening strip.
[0042] According to another aspect of the present invention there is provided an oral product dissolvable in the mouth or throat or buccal cavity.
[0043] Additional objects, advantages and novel features of the invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following and the accompanying drawings or may be learned by practice of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0044] For a better understanding of the present invention and as to how the same may be carried into effect reference will now be made, by way of example only, to the accompanying drawings in which:
[0045] Figure 1 is a schematic diagram of apparatus for producing fortified oral products embodying the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)
[0046] The prefeπed process provides a fortified edible film product containing one or more fruit and/or vegetable purees and a high concentration of active material(s). The fruit and/or vegetable puree is selected from various fruit and vegetable purees, which purees may be readily prepared from natural fruit or vegetable stock or are available from commercial suppliers, in puree form such as California Fruit and Tomato Kitchen Inc. The film forming properties of the puree or mixture of purees is enhanced by using a polymer system to provide a film forming base solution containing the puree (herein after "film forming polymer-puree base solution")
[0047] The active material(s) are selected from various vitamins, minerals, nutrients, herbals, nutraceuticals, and combinations of one or more thereof, to fortify or add to the natural ingredients of the purees. In this specification nutraceuticals should be construed as any foodstuff which has an enhanced nutritional value.
[0048] One or more natural or artificial flavors are added to provide a pleasant taste. Preferably, there is none or only a minimal residual taste of the active material which often has an unpleasant taste, good mouth feel and rapid solubility. The masking of the flavor of the active material(s) is preferably achieved by producing a "vitamm-flavor" emulsion which is incorporated into a film forming base solution containing the puree and polymer system. The polymer is preferably a water soluble, edible polymer with suitable film forming capabilities.
[0049] One or more plasticizers may be added to the film forming solution to improve the flexibility of the resulting film product and to reduce brittleness.
[0050] One or more surfactants may be added to the film forming solution, for example to the puree mixture to reduce surface tension and thereby improve wetability of the components of the mixture to the casting substrate.
Overview:
[0051] In general, the method includes preparing a film forming polymer- puree base solution, preparing an active-flavor emulsion, adding the active-flavor emulsion to the film forming polymer-puree base solution, mixing the film forming polymer-puree base solution and active-flavor emulsion, and casting a film according to predetermined drying parameters. The active-flavor emulsion and the film forming polymer-puree base solution are mixed and conditioned separately in a manner which enables any desire level, and particularly high levels of actives and high levels of flavors to be introduced to the film forming polymer-puree base solution before it is cast. The cast film is then generally cut to yield individual oral products of desired dimensions. Preferably, the active-flavor emulsion is a vitamin-flavor emulsion of some kind. However, alternatively, or in addition the active-flavor
emulsion may be a mineral-flavor emulsion, a nutraceutical-fiavor emulsion or a combination emulsion.
[0052] With reference to Figure 1, suitable apparatus includes a main mixing tank 10, connected to an emulsion tank 20. The emulsion tank 20 is down stream of the main mixing tank 10 and connected in a loop 25 with a commercially available emulsifier 30 (e.g. a Silverson Emulsifier). The apparatus is further connected in the down stream direction to a casting line (not shown), optionally via a filter and/or a casting tank.
[0053] The main tank 10 is used to mix the film forming polymer-puree base solution according to procedures and temperatures suitable for the type of base film system being used. The main tank 10 is provided with high shear mixing equipment, used for example to mix the polymer base solution, plasticizers and other additives and to introduce the fruit and/or vegetable puree to produce the film forming polymer-puree base solution.
[0054] The emulsion tank 20 is used to mix the active-flavor emulsion. The emulsion tank 10 is provided with high shear mixing equipment, such as a blade, which imparts high agitation to keep the mix dissolved, namely to keep the droplet size of the emulsified components as low as possible, for example 50 microns or less. In general, vitamins are added to water, mixed and emulsified, by being passed through the emulsifier 30 and back into the emulsion tank 10. Flavors in various forms can then be added, mixed and emulsified to yield a vitamin- flavor emulsion.
[0055] After combining the vitamin-flavor emulsion and the film forming polymer-puree base solution, the film is cast.
[0056] The casting step is one of a general solution casting technique, which consists of dissolving one or more synthetic resins in an organic
solvent, casting the solution onto a suitable substrate, removing the solvent whereby a film is formed on the carrier, and stripping the film from the carrier.
[0057] In preferred embodiments, the polymer-puree base solution mixed with the active-flavor emulsion is cast and the casting surface might be selected from the group consisting of drums and belts of stainless steel, copper and silicon rubber, and drums and belts of any material coated with an insoluble polymeric material, mylar or release paper, and others. The film product is cut into strips of a dimension suitable for the application.
Exemplary steps in a sample process are described below:
[0058] a. Preparation of Film Forming Polymer-Puree Solution (tank 10 i. Select polymer system. In this example Pectin is selected for its ability to enhance the film forming properties of purees by assisting with bonding of the natural fibres and sugars contained in the purees. ii. Place water in tank 10 and surfactants and heat to 140F (or 130F -150F) while agitating. iii. Add the Pectin polymer system while agitating at high speed. In this example this means mix with enough blade speed to achieve a vortex of the mixture. Continue to mix the water and polymer system at high speed and begin cooling to approximately 100F in order to form a true solution of all components. iv. Add the plasticizer and other additives to the mix at less than 120F. v. Degass the resulting mixture and vacuum under low agitation to remove all bubbles. vi. As the Pectin solution falls to a temperature of approximately 100F combine in the desired puree and mix until the mixture is uniform in texture.
b. Preparation of Active-Flavor Emulsion (in tank 20) i. Heat water to temperature of about 130 F (120 — 150F). ii. Add active material(s) (e.g. vitamins) to water under high agitation (in this example this step includes adding water soluble and fat soluble vitamins). iii. Add emulsifiers and stabilizers under high agitation. iv. Add flavors (e.g. one or more of flavor oil, flavor emulsion, flavor powders) under high agitation. v. Mix and emulsify entire solution [until homogenous], preferably for a minimum of about 20 minutes. c. Combine Active-Flavor Emulsion and Polymer-Puree Solution In this case the apparatus facilitates vacuuming the active-flavor emulsion into the polymer-puree base solution. d. Degassing Resultant Solution Degassing occurs while under conditions of vacuum and slow agitation until solution is free of bubbles.
e. Casting The degassed resultant mixture can then be cast on a casting surface to produce the fortified film product by: i. removing said water from said cast, degassed mixture on said casting surface thereby forming the edible film on said casting surface. ii. the edible film consists essentially of about 4-8% of said water [after drying].
Step (a) in the process above can and be substituted for mixing film forming polymer-puree solutions based on alternative polymer systems. For example alternative polymer systems might be selected from one or more of Hydroxypropylmethyl cellulose (HPMC), Carboxymethyl cellulose (CMC), Alginates, Pullulan, Gum Arabic, Guar gums, Carrageenan and Starch or any other polymer systems or the like which are edible and have suitable film forming
characteristics. With most of the aforementioned alternative polymer systems the preparation of the polymer-base solution to which the puree is added is substantially as described in step (a) for a Pectin solution. However, one polymer system which requires a different preparation is HPMC. Method(s) for the preparation of HPMC and CMC base solutions are set out below.
Preparation of HPMC base solution (in tank 10) i. Add water and surfactants to mixing vessel and heat while agitating to 180F (170 - 190F). ii. Add the HPMC polymer system while agitating at high speed. iii. Mix the said water and polymer system at high speed while cooling the mixture to approx 120F to form a true solution of all components. iv. Add the plasticizers and other additives to the mix at less than 120F. v. Degas the said mixture and vacuum under low agitation to remove all bubbles. vi. Continue as in step (a)vi above. Cellulose Gum (CMC) Base Solutions i. Heat solution to 140F. ii. Add CMC under high agitation. iii. Mix thoroughly to confirm complete dissolution and particles are suspended. iv. Start slow cooling of solution. v. Slowly add desired ingredients (additives, plasticizers, sweeteners, acids, preservatives, etc.) under high agitation to prevent lumps/gels in solution. vi. If flavor oils are to be added, emulsify flavor oils with emulsifying and/or stabilizing agents to stabilize film. Examples of emulsifiers/stabilizers include Gum Arabic, Xanthan Gum, and Caπageenan. These
materials may need to be predispersed/dissolved in water prior to adding to base solution. vii. Add flavor package and continue to mix. viii. Confirm all materials are dispersed/dissolved in solution. ix. De-air solution by vacuuming or let de-air to atmosphere for 12-24 hours. x. Continued as in step (a)vi above.
[0060] Specific examples of fortified/supplemented fruit and vegetable film products include: 1. Broccoli film product 2. Tomato film product 3. Carrot film product 4. Peach film product 5. Plum film product Appendix A provides exemplary formulations for these products by way of example. This list is obviously not intended to be limiting since it will be apparent that any fruit and/or vegetable film product, including multi- fruit film products and multi-vegetable film products and mixed fruit- vegetable film products can be fortified or supplemented in the described manner.
[0061] Definitions: In this specification the terms below should be construed to have the indicated meanings:
1. "Water soluble film" - a film comprising water soluble materials, and including edible water soluble film materials. a. Examples of edible film formers in this category include:
i. HPMC ii. CMC iii. Pectin iv. Alginates v. Pallulan vi. Any other polymer system or the like, vii. Or any combination of above
2. "Base Solution" - a liquid mixture of ingredients that contain mostly water, water soluble or dispersible materials, and additives.
3. "Active" - any material that has nutritional or medical value in the body after consumption. For example actives include vitamins, minerals, nutrients, herbals, nutraceuticals, and combinations of one or more thereof.
4. "Additives" a. materials that perform specific functions in the finished film b. Examples of additives include sweeteners (such as multi-dextrin, sucrolose, sachrin, ace sulphane potassium, aspertame), preservatives (such as sodium citrate, sodium benzoate), plasticizers (such as glycerin, propylene glycol, propylene glycol), stabilizers (such as sodium citrate and sodium benzoate), stiffening agents (such as micro crystalline cellulose materials, Solkafloc - made by International Fibers Corporation).
5. "Stabilizing agents" - additives that protect emulsion by increasing the viscosity and minimizing oil from combining together and separating into two layers (oil and water layer) a. Examples of stabilizers include: i. Gum arabic ii. Carrageenan iii. Xanthan gum iv. Alginates
6. "Emulsifiers" - materials that stabilize emulsion by creating smaller oil droplet size during homogenization and keep oil in water. a. surfactants which act as emulsifying agents may include one or more of: i. Tween 80 ii. Sodium laural sulphate 7. "Viscosity enhancing agents" include: i. HPMC ii. Carrageenans iii. Xanthan gum iv. Gum Arabic 8. "Emulsify" - process of mixing at least two materials that do not mix well (e.g. oil and water) at high shear and breaking oil droplets into smaller droplets and dispersing them throughout the medium. 9. "Emulsion" - a mixture of at least two immiscible liquids, one material is contained within 2nd material a. Example: oil (fats) and water
[0062] While the foregoing has described what are considered to be the best mode and/or other preferred embodiments of the invention, it is understood that various modifications may be made therein and that the invention may be implemented in various forms and embodiments, and that it may be applied in numerous applications, only some of which have been described herein. It is intended by the following claims to claim any and all modifications and variations that fall within the true scope of the inventive concepts.
Appendix A
Example 1, Broccoli film product (broccoli puree/polymer/active):
Appendix A, continued
Example 2, Tomato film product (tomato puree/polymer/active):
Appendix A, continued
Example 3, Carrot film product (carrot puree/polymer/active):
Appendix A, continued
Example 4, Peach film product (peach puree/polymer/active):
"DE >S Actual %
POLYMER-PUREE MIX Peach - Fruit puree 12.58 57.20% HPMC Mβfhocβl KlOO 2.00 9.09% 66.30% ACTIVE-FLAVOR MIX Spray Dry Gum Arabic ' "" 0.80 3.64% Crystal Tex 627 - Tapioca Dextrin 1.00 4.55% Peach Flavor 1.00 4.55% Polysorbate 80 (tween 80) 0.20 0.91% FD&C Yellow 5 Dye 0.010 0.05% 13.69% Sodium Citrate 0.0200 0.09% Vitamin A Palmitatβ 0.2440 1.11% Thlamine Hydrochloride Mienopowdar (Vitamin 81) 0.1090 0.50%
Ri oflaviπ Freeflow 95 (Vitamin B2) 0.1150 0.52%
Niacinamide Freeflow (Vitamin B3) 1.4600 6.64%
Calcium d-pantαthenate (Vitamin B5) 0.5450 2.48%
Pyroxidine Hydrochloride (Vitamin B6) 0.1090 0.50%
Cyanocobalamin 1% (Vitamin B12) 0.0200 0.09%
Ascorbic Add - Vitamin C 1.1400 5.18%
Vitamin D 0.0500 0.23%
Vitamin 1% 0.2200 1.00%
Vitamin E Acetate 0.3700 1.68% 20.02% |
Total Solids Wt 21.99 100.000%
Water Lbs.
Total Lbs Solution
% Solids
Water/Gals
Appendix A, continued
Example 5, Plum film product (plum puree/polymer/active):