Title:  Edible film formulations containing maltodextrin

United States Patent:  6,740,332

Issued:  May 25, 2004

Inventors:  Zyck; Daniel J. (North Riverside, IL); Dzija; Michael R. (LaGrange Park, IL); Chapdelaine; Albert H. (Naperville, IL)

Assignee:  Wm. Wrigley Jr. Company (Chicago, IL)

Appl. No.:  044105

Filed:  January 9, 2002

Abstract

Improved edible films for mucoadhesion are provided. The films include at least three types film forming agents other than pullulan, such as maltodextrins, hydrocolloids and fillers. Preferably, the maltodextrin has a dextrose equivalent of less than 20. Medicaments and other additive agents can also be incorporated into the edible films. In this regard, the edible films can be utilized to deliver or release the medicaments into an oral cavity, thereby providing effective oral treatment with respect to, for example, oral cleansing and breath freshening.

SUMMARY OF THE INVENTION

The present invention provides improved edible film formulations and methods of making and using same. The edible films include at least three types of film forming agents other than pullulan that are readily available and can be made at lower costs. In this regard, the mixture of film forming agents, such as maltodextrins, hydrocolloids and fillers, can be used to prepare "stand alone" films that can provide oral cleansing and breath freshening effects while displaying clean flavor and mouth feel, rapid dissolution and ease of manufacture. Medicaments and other additive agents can also be incorporated into the edible films thereby providing effective oral treatment, such as oral cleansing and breath freshening.

To this end, in an embodiment of the present invention, a stand alone edible film for oral mucoadhesion is provided. The stand alone edible film includes at least three types of film forming agents and not including pullulan.

In an embodiment, the film forming agents include a hydrolyzed starch, a hydrocolloid and a filler. The hydrolyzed starch has a dextrose equivalent of less than 20.

In another embodiment of the present invention, an edible film is provided including a maltodextrin, a hydrocolloid and a bulk filler and not including a pullulan. In an embodiment, the maltodextrin has a dextrose equivalent of up to 20.

In yet another embodiment, a method of producing an edible film for oral mucoadhesion is provided. The method includes the steps of preparing a base solution including at least three types of film forming agents other than pullulan and processing the base solution to form the edible film.

In still yet another embodiment, a method of oral treatment is provided. The method includes the steps of providing a food-grade film including at least three types of film forming agents and a medicament; orally consuming the food-grade film and releasing the medicament in an oral cavity.

It is, therefore, an advantage of the present invention to provide edible films for mucoadhesion that include at least three types of film forming agents other than pullulan.

Another advantage of the present invention is to provide edible films that include a medicament for cleansing an oral cavity and freshening breath upon consumption.

A further advantage of the present invention is to provide a method for delivering the medicament into an oral cavity for treating same.

Yet a still further advantage of the present invention is to provide a method for oral treatment that utilizes edible film formulations which can effectively release a medicament in the oral cavity upon consumption.

Moreover, an advantage of the present invention is to provide a stand alone film.

Additional features and advantages of the present invention are described in, and will be apparent in, the detailed description of the presently preferred embodiments.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

The present invention provides edible film formulations for oral mucoadhesion and methods of using and making same. In particular, the edible films of the present invention include at least three types of film forming agents other than pullulan.

Applicants have uniquely discovered that the use of a mixture of at least three types of film forming agents, such as maltodextrins, fillers and hydrocolloids (e.g., sodium alginate), can be effectively utilized to prepare "stand alone" edible films. The edible films are composed of ingredients that are readily available, can be prepared at lower costs and display similar properties as compared to edible films composed of pullulan. In this regard, the edible films can provide a physiologically acceptable film, which is suitably adapted to adhere to oral surfaces of an oral cavity and rapidly dissolve therein.

The edible films of the present invention can be utilized to deliver or release oral care agent(s). Such agents include, anti-microbial agents and salivary stimulants to treat, for example, halitosis, dental plaque, gingivitis, xerostomia, dry mouth, like oral conditions or combinations thereof. Further, the oral care edible film can act as a breath freshener effective against malodor.

The oral cleansing and breath freshening effects of the edible film of the present invention can be achieved by entrapping the oral care agents within the oral cavity to provide extended efficacy. In this regard, the highly dissolvable edible film can act as a medium through which a pharmaceutically active oral agent can be administered via a mucous membrane of the oral cavity.

In an embodiment, the edible or food-grade film of the present invention includes at least three types of film forming agents other than pullulan. The edible films can also include a medicament for oral cleansing and/or breath freshening. Further, the edible films can include a variety of other suitable ingredients, such as softeners, colorants, flavoring agents, emulsifiers, surfactants, thickening agents, binding agents, sweeteners, fragrances, other like ingredients or combinations thereof.

In an embodiment, the edible films preferably include a mixture of at least three types of film forming agents, such as maltodextrins, fillers and hydrocolloids. It should be appreciated that the edible film of the present invention can be composed of one or more different compounds associated with each of the at least three types of film forming agents.

Maltodextrins belong to a category of chemical products known as "starch hydrolysates." Manufacturers produce starch hydrolysates by putting starch through a hydrolysis, a chemical reaction with water. Hydrolysis breaks down the starch and converts some of the starch to dextrose. With adjustments, this process yields more or less dextrose.

Maltodextrins are therefore classified by dextrose equivalence or DE. Dextrose equivalents are a measure of the reducing sugars present calculated as dextrose and expressed as a percentage of the total dry substance. Maltodextrins can have a dextrose equivalent of up to 20. At above 20 DE, the product is then classified as corn syrup solids, is completely soluble, and therefore imparts significant sweetness.

Maltodextrins having lower DE values generally offer higher viscosity and better film formation while higher DE values yield more sweetness, solubility, plasticity, and hygroscopicity. Further, for the purposes of this invention, lower DE values offer several processing advantages over higher DE values. Lower DE values improves flexibility of the film which reduces cracking and flaking during slitting and cutting. Being less hygroscopic, lower DE maltodextrins pick up less moisture during slitting and cutting, helping to prevent blocking during shelf life.

In an embodiment, the maltodextrin has a DE of less than 20. In another embodiment, the maltodextrin has a DE of less than or equal to 10. In a further embodiment, the maltodextrin has a DE of 1 or less.

In an embodiment, maltodextrin having a DE of less than 20, constitutes between 5% to about 60% by dry weight, or 20% to about 40% by dry weight of the edible film. Maltodextrins can be derived from several different cereal sources, corn (waxy and common), followed by potato, rice and tapioca.

The hydrocolloid can provide thickness and decrease brittleness of the edible films. The hydrocolloid can include any suitable type, amount and number of hydrocolloids. In an embodiment, the hydrocolloid can constitute between about 10% to about 50% by dry weight of the edible film, preferably about 30% to about 40% by dry weight. The hydrocolloid can be derived from, for example, natural seaweeds, natural seed gum, natural plant exudates, natural fiber extracts, biosynthetic gums, gelatins, biosynthetic process starch or cellulosic materials, alginates, sodium alginate, calcium alginate, carrageenans, guar gum, locust gum, tara gum, gum arabic, ghatti gum, agar gum, xanthan gum, pectin, other like hydrocolloid source material or combinations thereof.

Any suitable food-grade bulk filler can also be added to the edible film. This can reduce any "slimy" texture as well as provide structure to the film thereby making it more palatable. In an embodiment, the filler can constitute about 1% to about 30% by dry weight of the film, preferably about 5% to about 15% by dry weight. The filler can include, for example, microcrystalline cellulose, cellulose polymers, such as wood, magnesium and calcium carbonate, ground limestone, silicates, such as magnesium and aluminum silicate, clay, talc, titanium dioxide, mono-calcium phosphate, di-calcium phosphate, tri-calcium phosphate, other like bulk fillers or combinations thereof.

It is believed that the unique mixture of at least three film forming agents other than pullulan, for example, a maltodextrin, a hydrocolloid and a bulk filler, can provide a "stand alone" edible film composition which exhibits many of the same desirable properties exhibited by the more expensive pullulan-based edible film. Applicants have desirably discovered that the pullulan-free edible film formulation of the present invention can exhibit, for example, clean mouth feel, clean favor and ease of manufacture similar to currently available pullulan-based films.

As previously discussed, a variety of other suitable ingredients can be added to the edible film of the present invention. For example, any suitable medicament for oral cleansing, breath freshening or the like can be added to the film formulation. The medicaments can include, for example, a pH control agent, such as urea and buffers, inorganic components for tartar or caries control, such as phosphates and fluorides, a breath freshening agent, such as zinc gluconate, an anti-plaque/anti-gingivitis agent, such as chlorohexidene, CPC, and triclosan, a saliva stimulating agent including, for example, food acids such as citric, lactic, maleic, succinic, ascorbic, adipic, fumaric and tartaric acids, a pharmaceutical agent, a nutraceutical agent, a vitamin, a mineral, other like medicaments or combinations thereof.

The medicaments can be delivered or released into the oral cavity for effective oral treatment, such as oral cleansing and/or breath freshening. In this regard, the film forming agents of the edible film can act to entrap the medicaments within the oral cavity thereby providing extended efficacy thereof. In doing so, it is believed that the pullulan free edible film compositions of the present invention more uniformly release the medicament into the oral cavity for absorption via open wounds or mucous membrane in a greater manner than could be previously achieved. Moreover, it is also believed that the mixture of film-forming agents of the present invention can entrap the medicament within the oral cavity for an extended period of time to prolong and enhance the effects of the medicament. In addition, by extending the contact time of the medicament within the oral cavity, the medicament is absorbed to a greater extent thereby increasing its bioavailability.

If reduced levels of film forming agents are utilized, softeners can be used to reduce the brittleness of the resulting films. The softeners, which are also known as plasticizers or plasticizing agents, generally constitute between about 0% to about 20% by dry weight of the film, preferably about 2% to about 10% by dry weight. The softeners can include plasticizers containing, for example, sorbitol and other polyols, glycerin, polyethylene glycol, propylene glycol, hydrogenated starch hydrolysates, corn syrups, other like material or combinations thereof.

The edible film formulations of the present invention can also include colorants or coloring agents which can be used in any suitable amount to produce the desired color. Coloring agents can include, for example, natural food colors and dyes suitable for food, drug and cosmetic applications. The colorants are typically known as FD&C dyes and lakes.

A variety of flavoring agents can also be added to the edible films. Any suitable amount and type of artificial and/or natural flavoring agents can be used in any sensorially acceptable fashion. For example, the flavor can constitute about 0.1% to about 20% by dry weight of the film, preferably about 10% to 15%. The flavoring agent can include, for example, essential oils, synthetic flavors or mixtures including but not limited to oils derived from plants and fruits such as citrus oil, fruit essences, peppermint oil, spearmint oil, other mint oils, clove oils, oil of wintergreen, anise and the like, flavor oils with germ killing properties such as menthol, eucalyptol, eugenol, thymol, like flavoring agents or combinations thereof.

The flavor can be enhanced and evenly distributed throughout the product by emulsification. Any suitable amount and type of natural and/or synthetic food-grade emulsifier can be used. For example, the emulsifier can include lecithin, food-grade non-ionic emulsifiers, such as fatty acids (C₁₀ -C₁₈), mono and diacyl glycerides, ox bile extract, polyglycerol esters, polyethylene sorbitan esters, propolyene glycol, sorbitan monopalmitate, sorbitan monosterate, sorbitan tristerate, other like emulsifiers or combinations thereof.

The flavors can be emulsified by any suitable emulsification process, such as mechanical processing, vigorous stirring, intense pressure fluctuations that occur in turbulent flow such as homogenization, sonication, colloid milling and the like.

The present invention provides methods of producing the edible film formulations. In general, the edible film formulations are prepared by forming a base solution that includes at least three types of film forming agents, such as maltodextrins, hydrocolloids and fillers and processing the base solution to form an edible film. Typically, the base solution is prepared by adding an initial mixture of dry ingredients to water that is stirred.

To the base solution, additional ingredients, such as flavor/emulsifier blends, sweeteners, softeners, color, the like or combinations thereof, can be added. In an embodiment, the solution is stirred continuously and heated at a temperature ranging from about 40^oC. to about 50^oC. The solution then can be dried in any suitable manner, thereby, forming the edible film.

It should be appreciated that any suitable type, number and arrangement of process procedures or steps (i.e., mixing, heating, drying, cooling, addition of ingredients), process parameters (i.e., temperature, pressure, pH, process times) or the like can be utilized.

By way of example and not limitation, the following examples illustrate various embodiments of the edible film formulations of the present invention.

PREPARATION OF EXAMPLES 1-5

Examples 1-5 were prepared by making edible films from maltodextrin. A mixture of dry ingredients, such as maltodextrin, sodium alginate and microcrystalline cellulose, was slowly added to water while stirring. The solution was continually stirred and heated to boiling. After which, it was removed from the heat and cooled to a temperature of about 35^oC. to about 40^oC. The other ingredients, such as flavor/emulsifier blends, sweeteners, softeners and color, were added to the solution while stirring and at a temperature of about 35^oC. to about 40^oC. The solution was spread onto a glass plate by utilizing a draw down blade. A film was formed on the glass plate by drying the solution in an oven for about 15 minutes at 40^oC. After which, the film was removed from the plate and cut into desired pieces.

The edible films of Examples 1-5 were compared for sensory analysis. All of the films exhibited differences in texture and mouth feel. Example 1 provided good mouth feel, clean flavor, fast dissolution and flexibility. In comparison, Example 2 had good flexibility, but was found to be too sticky to handle. In Example 3, the addition of gum arabic showed no improvement in flexibility. Example 4 was slightly slimy and showed no improvement in flexibility. Example 5 was slimy, slow to dissolve, yet sufficiently flexible.

PREPARATION OF EXAMPLES 11-15

Examples 11-15 were prepared by making edible films from maltodextrin. A mixture of dry ingredients, such as maltodextrin and sodium alginate, was slowly added to water while stirring. The solution was continually stirred and heated. The other ingredients, such as flavor/emulsifier blends, sweeteners, softeners and color, were added to the maltodextrin/alginate solution while stirring and at a temperature of about 50^oC. to about 60^oC. The solution was spread onto a glass plate by utilizing a draw down blade. A film was formed on the glass plate by drying the solution in an oven for about 15 minutes at 50^oC. After which, the film was removed from the plate and cut into desired pieces.

Benchmark sensory analysis of Examples 11-15 demonstrated comparable sensory properties. Analysis also determined that while having similar sensory profiles, the 1 DE maltodextrin film offered several processing advantages over 10 DE maltodextrin film. The 1 DE film improved the flexibility of the film, which reduced cracking and flaking during slitting and cutting. Since lower DE maltodextrins are less hygroscopic, the 1 DE film picked up less moisture during slitting and cutting which helped prevent blocking during shelf life. Overall, the lower DE maltodextrin films provided better film-forming capabilities than maltodextrin films with higher DE's.

It should be understood that various changes and modifications of the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. It is therefore intended that all such changes and modifications be covered by the appended claims.

Claim 1 of 34 Claims

We claim:

1. A stand alone edible film for oral mucoadhesion comprising at least three types of film forming agents and not including pullulan.

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