Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2002-01-09
2004-05-25
Azpuru, Carlos A (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S434000, C514S777000
Reexamination Certificate
active
06740332
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention generally relates to edible compositions. More specifically, the present invention relates to edible film formulations.
Of course, oral cleansing and breath freshening are an important part of everyday life. In order to facilitate proper oral hygiene, oral cleansing and breath freshening practices should be conducted repeatedly throughout the day.
However, oral cleansing and breath freshening may be difficult or inconvenient at times, depending on the nature of the breath freshening desired and the situation in which the breath freshening must occur. Brushing, flossing, cleaning your tongue and gargling using a variety of devices and compositions are common oral care practices well-suited for the privacy of one's home. But, such devices and compositions are less convenient to use away from the home where bathroom facilities might be scarce, unavailable or unsanitary.
To deal with this issue, less obtrusive oral products have been developed. These include breath-freshening gums, lozenges, mouth sprays and edible films.
A number of different edible film compositions are currently available for consumption. Many of the products use pullulan. However, pullulan is an expensive ingredient and may have limited availability. Other edible materials have been employed as a substitute for pullulan within edible film compositions. These materials include modified starches and cellulosics. Unfortunately, such materials typically lack one or more of pullulan's desirable film properties. These properties include, for example, rapid dissolution, clean mouth feel, clean flavor and ease of manufacture.
A need, therefore exists, for improved edible film formulations that exhibit the desirable film properties that are exhibited by pullulan-based edible films.
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 w
Chapdelaine Albert H.
Dzija Michael R.
Zyck Daniel J.
Azpuru Carlos A
Bell Boyd & Lloyd LLC
Wm. Wrigley Jr. Company
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