Note: Descriptions are shown in the official language in which they were submitted.
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EDIBLE FILMS HAVING DISTINCT REGIONS
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Application No.
60/408,935 filed September 6, 2002, which is incorporated herein by reference.
TECHNICAL FIELD
[0002] The present invention is related to an edible film having distinct
regions,
wherein at least one region has a composition that is different from at least
one other region.
BACKGROUND OF THE INVENTION
[0003] Edible films providing a single action are known and used in the art.
For
example, WO 00/18365 discloses a breath freshening film adapted to dissolve in
a mouth of a
consumer comprised of a water soluble polymer and an essential oil, such as
thymol, methyl
salicylate, eucalyptol and menthol.
[0004] U.S. Pat. No. 4,713,243 discloses a bioadhesive film for delivering
therapeutic agents to the oral cavity which is capable of adhering to a wet
mucosa surface,
composed of a water soluble polymer matrix, a water-insoluble polymer, and a
plasticizer. More
specifically, the film contains an effective amount of medicament for the
treatment of
periodontal disease. The film is flexible when wet so as to be unobtrusive to
the user after it has
been properly positioned and placed in the mouth.
[0005] U.S. Pat. No. 5,354,551 discloses a water soluble film pre-segmented
into
dosage units. The film contains conventional toothpaste ingredients and is
formulated with
swellable polymers such as gelatin and corn starch as film forming agents
which upon
application to the oral cavity slowly disintegrate, thereby releasing an
active agent incorporated
in the film.
[0006] U.S. Pat. No. 6,177,096 discloses a film composition containing
therapeutic
or breath freshening agents for use in the oral cavity prepared from a water
soluble polymer such
as hydroxypropylmethyl cellulose, hydroxypropylcellulose and a polyalcohol
such as glycerol,
polyethylene glycol. When applied to the oral cavity, the film exhibits
instant wettability
followed by rapid dissolution.
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[0007] Despite the existence in the prior art of rapidly dissolvable oral
films, there
is not a film that possess more than one distinct region. The films of the
present invention
provide more than one distinct region. Benefits of having distinct regions are
that it provides
diversification to enhance consumer appeal or provides diversification to
provide different
sensations for a consumer in one product. Yet further, the distinct regions of
the film of the
present invention overcome the need to encapsulate compounds to provide
multiple functions.
Presently, if a film provided more than one functional compound in the same
region, at least one
compound would need to be encapsulated to prevent deleterious interactions of
the compounds.
Encapsulation of compounds delays the effect of the compounds, which is not a
desire of the
present invention. Since the film quickly dissolves in the mouth, the effect
of the compounds
needs to be instant, not delayed. Thus, the present invention has used
distinct regions to separate
compounds, thus preventing compounds from interacting with one another and
providing
immediate release of the compounds to result in an immediate effect or action
in the oral cavity.
[0008] Thus, the present invention is the first to provide an edible film
having
multiple regions, wherein each region can contain a different composition
resulting in multiple
actions.
BRIEF SUMMARY OF THE INVENTION
[0009] The present invention is drawn to an edible film having at least two
separate
and distinct regions. The film is rapidly dissolved in the oral cavity.
[0010] An embodiment of the present invention is an edible film having at
least
two distinct regions, wherein at least one region independently comprises a
first composition that
is different from at least one other region. More specifically, the first
composition comprises at
least one functional component and/or non-functional component which is
different from
components in other compositions in other regions of the film. Still further,
the film comprises
at least one other region having a second composition that is different from
the first composition.
Thus, each region of the film, which is distinct and/or independent for other
regions of the film,
contains a composition having at least a functional component and/or non-
functional component
which is different. The compositions of each of these regions may also contain
a variety of other
ingredients for example, but not limited to water, sodium, potassium, and/or
other additives that
are known and used in the art. The regions can be indicated by visual cues,
for example, color
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inclusions, color swirls, or color regions. The film can be administered to a
human or
companion animal, for example, a horse, cat or dog.
[0011] Thus, the film may comprise a region having a first composition having
a
first functional component. The functional component is selected from the
group consisting of
hydration agent, refreshment agent, heating agent, comfort agents, breath
masking agent, flavor
masking agent, tartar reducing agent, plaque reducing agent, pharmaceutical
agent and
nutraceutical agent. More specifically, the functional component is a
hydration agent.
[0012] Yet further, the film may comprise an other region having a second
composition having a second function component. The first and second
functional components
are selected from the group consisting of hydration agent, refreshment agent,
heating agent,
comfort agents, breath masking agent, flavor masking agent, tartar reducing
agent, plaque
reducing agent, plaque disclosing agent, pharmaceutical agent and
nutraceutical agent. More
specifically, the first functional component is a hydration agent and the
second functional
component is a refreshment agent. In preferred embodiments, the hydration
agent is an acidulent
selected from the group consisting of citric acid, malic acid, succinic acid,
adipic acid, tartaric
acid, acetic acid, and lactic acid. More preferably, the hydration agent is a
combination of citric
acid, malic acid and succinic acid. Still further, the refreshment agent is
selected from the group
consisting of L-menthol, N-ethyl-p-methane-3-carboxamide, N,2,3-trimethyl-2-
isopropyl
butanamide, monomethyl succinate, Cooler II, Cooler V, Physcool, and Intensate
000379. More
preferably, the refreshment agent is Intensate 000379.
[0013] Another embodiment of the present invention is a method of preparing an
edible film having at least two distinct regions indicated by a color swirl,
the method comprising
the steps of: mixing at least one water soluble polymer, a first component and
a first coloring
agent to form a first homogenous mixture; mixing at least one water soluble
polymer, a second
component and a second coloring agent to form a second homogenous mixture;
casting the first
homogenous mixture to form a film; drizzling the second homogenous mixture
onto the film;
smearing the second homogenous mixture with the first homogenous mixture to
form a film
having at least two distinct regions indicated by the color swirl of the first
and second
homogenous mixtures; drying the film; and cutting the film into film strips.
More specifically,
the first and second components are either a functional component or a non-
functional
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component, preferably at least one is functional, more preferably both are
functional
components.
[0014] Another embodiment is a method of preparing an edible film having at
least
two distinct regions indicated by their different color, the method comprising
the steps of:
mixing at least one water soluble polymer and a first component to form a
first homogenous
mixture; mixing a second component and a coloring agent to form a second
homogenous
mixture; casting the first homogenous mixture to form a film; depositing the
second homogenous
mixture onto the film; drying the film, wherein the dried film contains at
least two regions as
indicated by the different colors of the first and second homogenous mixtures;
and cutting the
film into film strips. In preferred embodiments, the first and second
components are a functional
component or a non-functional component , preferably at least one is
functional, more preferably
both are functional components. Preferably, depositing comprises printing or
spraying.
Depositing comprises words, dots, strips, stars, circles, squares, animal
shapes, or food shapes.
More preferably, printing is ink jet printing. Still further, a second
coloring agent is added to the
first homogenous mixture.
[0015] Still further, another embodiment is a method of preparing an edible
film
having at least two distinct regions indicated by color regions, the method
comprising the steps
of: mixing at least one water soluble polymer and a first component to form a
first homogenous
mixture; mixing at least one water soluble polymer; a second component and a
coloring agent to
form a second homogenous mixture; casting the first homogenous mixture to form
a film;
depositing the second homogenous mixture onto the film; drying the film,
wherein the dried film
contains at least two regions as indicated by colored regions of the first and
second homogenous
mixtures; and cutting the film into film strips. In preferred embodiments, the
first and second
components are a functional component or a non-functional component. Still
further, a second
coloring agent is added to the first homogenous mixture.
[0016] Another embodiment is an edible glitter composition for delivery of at
least
two components which is rapidly dissolved in the oral cavity, wherein the
glitter comprises a first
component and a second component. The first and second components are a
functional
component or a non-functional component. Still further, the edible glitter
comprises visual cues,
wherein the first component is one color and the second component is a second
color.
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[0017] In preferred embodiments, the functional component is selected from the
group consisting of hydration agent, refreshment agent, heating agent, comfort
agent, breath
masking agent, flavor masking agent, tartar reducing agent, plaque reducing
agent,
pharmaceutical agent and nutraceutical agent. More preferably, the non-
functional component is
a flavoring agent or a coloring agent.
[0018] The foregoing has outlined rather broadly the features and technical
advantages of the present invention in order that the detailed description of
the invention that
follows may be better understood. Additional features and advantages of the
invention will be
described hereinafter which form the subject of the claims of the invention.
It should be
appreciated that the conception and specific embodiment disclosed may be
readily utilized as a
basis for modifying or designing other structures for carrying out the same
purposes of the
present invention. It should also be realized that such equivalent
constructions do not depart
from the invention as set forth in the appended claims. The novel features
which are believed to
be characteristic of the invention, both as to its organization and method of
operation, together
with further objects and advantages will be better understood from the
following description
when considered in connection with the accompanying figures. It is to be
expressly understood,
however, that each of the figures is provided for the purpose of illustration
and description only
and is not intended as a definition of the limits of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
A. Definitions
[0019] As used herein, the use of the word "a" or "an" when used in
conjunction
with the term "comprising" in the claims and/or the specification can mean
"one," but it is also
consistent with the meaning of "one or more," "at least one," and "one or more
than one."
[0020] As used herein, the term "edible film" or "film" refers to a film that
is
shaped and sized to be placed in the oral cavity. The film is flexible and
adheres to a surface in
the mouth, usually the roof of the mouth or the tongue, and quickly dissolves,
generally in less
than 20 seconds. It is contemplated that the edible films of the present
invention can be
administered to or consumed by a mammal. Preferred mammals include a human or
a
companion animal, e.g., horse, dog or cat. Depending upon the mammal or
consumer (human or
companion animal), one of skill in the art is able to determine the size and
which ingredients
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and/or compositions are suitable and desirable for the consumer. Preferably
the film will be
sized to fit on the tongue of the consumer and is generally in the range of
lmm to 30mm in
length, lOmm to 30mm in length, and more preferably l5mm-25 mm in length or
any variation
therebetween. Yet further, the edible film also refers to glitter or any other
film particle.
[0021] As used herein, the term "composition" refers to a mixture of
components
or ingredients that form a distinct region of the edible film. For example, a
composition may
comprise at least one functional component and a combination of non-functional
components to
form the mixture. In various embodiments, the composition may contain only non-
functional
components.
[0022] As used herein, the term "functional component" refers to a compound
that
results in a physiological or psychological effect. It is envisioned that the
physiological or
psychological effect is a result of the compound as the edible film containing
the compound is
placed in the oral cavity or is a result of the compound contained in the
edible film after
absorption into the systemic circulation (bloodstream) of the consumer.
Exemplary functional
components include, but are not limited to hydration agents, refreshment
agents, heating agents,
comfort agents, breath masking agents, flavor masking agents, tartar reducing
agents, plaque
reducing agents, pharmaceutical agents and nutraceutical agents.
[0023] As used herein, the term "non-functional component" refers to a
compound
that does not result in a physiological or psychological effect. Non-
functional components can
include, but is not limited to selected flavoring agents, coloring agents,
film forming agents,
plasticizing agents, surfactants, emulsifying agents, stabilizing agents,
thickening agents or
binding agents. One of skill in the art realizes that selected non-functional
components may also
be functional, for example selected flavoring agents and/or coloring agents
may invoke a given
physiological or psychological effect.
[0024] As used herein, the term "distinct regions" refers to an area of the
edible
film that are distinct from each other in composition and preferably visually
distinguishable. The
size of these regions is preferably greater than lmm, 2mm, 3mm, 4mm, or Smm in
diameter.
Each region contains a composition having at least one component that is
either a functional
component or a non-functional component. It is contemplated that the film of
the present
invention contains at least two distinct regions where each region contains a
composition that is
different from the other region. The composition comprises either a functional
and/or non-
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functional component. Still further, it is envisioned that any given region
may contain a
composition having more than one functional component and non-functional
component or it
may contain a composition having only non-functional components.
B. Edible Films
[0025] The present invention is drawn to edible films having distinct regions.
It is
envisioned that the films contain at least two distinct regions. Each region
contains a
composition that is different from the composition in at least one other
region of the film. In
preferred embodiments, at least one region contains a composition having at
least a functional
component that results in a physiological and/or psychological effect.
[0026) It is contemplated that the film of the present invention contains at
least two
distinct regions where at least one region comprises a composition that is
different from
compositions in at least one other region of the film. If the film comprises
two distinct regions,
then the ratio of the one region to the second region the film may be 50:50.
Other ratios that may
be preferable depending upon the compositions of the regions include 10:90,
20:80, 30:70,
40:60, 60:40, 70:30, 80:20, and 90:10 or any variation there between. The
desired ratio is the
ratio of the regions such that an effective amount of the composition having a
functional
component in the given region is administered to the consumer to achieve the
desired effect, such
as a physiological and/or psychological effect.
[0027] In preferred embodiments, it is envisioned that by providing distinct
regions
of the edible film, in which a region contains a composition having a
functional component, the
present invention provides an edible film having regions designed to match
receptors in the oral
cavity. For example, it is well known by those of skill in the art that the
chemoreceptors or
"taste buds" are the sense organs that respond to gustatory or taste stimuli.
The chemoreceptors
are located in the lining of the mouth and throat, however, most of the
chemoreceptors are
associated with the small elevated projections or papillae on the tongue.
There are four primary
taste sensations, sweet, sour, bitter and salty. The ability to detect other
flavors and tastes is due
to the combination of the primary sensations and the also the combination of
the sense of smell.
Chemoreceptors that are specific for the primary taste sensations are
correlated to specific areas
of the tongue, for example, sweet is at the tip or middle of the tongue; salty
is located on the tip
and front sides of the tongue; sour is located on the sides of the tongue; and
bitter is located on
the back of the tongue. Thus, it is envisioned that by using correlating
regions of the film to
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specific chemoreceptors on the tongue, the present invention can be used to
target the primary
sensation chemoreceptors to enhance or stimulate the taste sensation.
[0028] For example, specific embodiments of targeting the chemoreceptors of
the
tongue can include a film having a distinct sour region on the sides of the
film strip, sweet
regions in the center or front of the film strip or bitter regions on the back
of the film strip.
[0029] One such embodiment of the present invention is an edible film having
at
least two distinct regions in which at least one region comprises a first
composition having a first
functional component, a sweet agent, and at least one region comprises a
second composition
having a second functional component, a sour agent. The combination of
sweetlsour
components provides the consumer with dual sensations or enhanced sensations.
Furthermore,
the film can be designed to that the film matches the chemoreceptors on the
tongue, which
allows the consumer to adjust the intensity of the flavors by adjusting the
placement of the film
in the oral cavity.
[0030] The sweet agent of the present invention can include both natural and
artificial sweeteners. Suitable sweeteners include water soluble sweetening
agents such as
monosaccharides, disaccharides and polysaccharides (e.g., xylose, ribose,
glucose (dextrose),
mannose, galatose, fructose (levulose), sucrose (sugar), maltose); water
soluble artificial
sweeteners such as the soluble saccharin salts (e.g., sodium or calcium
saccharin salts, cyclamate
salts); and dipeptide based sweeteners, such as L-aspartic acid derived
sweeteners (e.g., L-
aspartyl-L-phenylalaine methyl ester (aspartame)). Preferred sweet agents of
the present
invention include non-nutritive sweeteners, for example, but not limited to
aspartame
(NutraSweet, Augusta, GA), acesulfame potassium (Nutrinova, Somerset, NJ)
sucralose
(Splenda, Splenda Inc. McIntosh, AL) and neotame.
[0031] Sour agents can include acids or acidulents, for example, but not
limited to
citric acid, malic acid, succinic acid, adipic acid, tartaric acid, acetic
acid, lactic acid, and
mixtures thereof.
[0032] Yet further, edible films having distinct regions targeted to the
primary
sensation chemoreceptors of the tongue can also include markers on the film to
indicate the
direction in which the film should be applied to the tongue or markers to
indicate the distinct
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regions. These markers and/or directions can be applied to the film during
standard processing
of the edible films.
[0033] It is also contemplated that the regions of the inventive edible film
can be
used to provide enhanced physiological activity in the oral activity. For
example, one region in
the inventive film can have a greater amount or increased concentration of a
functional
component, such as salivation agent, to enhance the initial salivation effect
and promote
mechanical action or movement of the film throughout the oral cavity. In
particular, the
concentrated functional component may enhance salivation such that the film is
rapidly dissolved
in the oral cavity.
[0034] Yet further, the distinct regions may also prevent and/or minimize
deleterious interaction between components. Typically, to prevent interaction
between
components, at least one component is encapsulated. An encapsulated component
prevents
interaction with the non-encapsulated component, however, the encapsulated
component is
delayed in providing its action or effect. Thus, by presenting the components
in distinct regions
of the inventive edible film, the present invention eliminates the necessity
of encapsulating
components to prevent deleterious interaction. Yet further, since the
components are not
encapsulated, the components are instantly exposed in the oral cavity to
result in an immediate
effect instead of a delayed effect if the components where encapsulated.
[0035] Visual cues are also used in the present invention to indicate the
distinct
regions of the edible film. The visual cues include, color inclusion, color
swirl and color
printing. The coloring agents are used in amounts effective to produce the
desired color. The
coloring agents useful in the present invention include pigments such as
titanium dioxide, and
natural and artificial FD&C approved colors, which may be incorporated in
amounts of up to
about 5 wt %, and preferably less than about 1 wt %.
C. Film Components
[0036] The compositions in the given distinct regions of the film comprise at
least
one water soluble polymer and other non-functional components. Preferably, the
composition
also comprises a functional component.
[0037] The water soluble polymer used in the films according to the present
invention include, but are not limited to pullulan, hydroxypropylmethyl
cellulose, hydroxyethyl
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cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl
cellulose, polyvinyl
alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragacanth gum,
guar gum, acacia
gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl
polymer,
amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin,
pectin, chitin,
chitosan, levan, elsinan, collagen, gelatin, zero, gluten, soy protein
isolate, tapioca starch, whey
protein isolate, casein and mixtures thereof. The concentration of the water
soluble polymer
used in the film is from about 0.01 to about 99 wt %, preferably about 30 to
about 80 wt %, more
preferably from about 45 to about 70 wt % and even more preferably from about
60 to about 65
wt %.
1. Functional components
[0038] Functional components result in a physiological or psychological
effect. It
is envisioned that the physiological or psychological effect is a result of
the compound as the
edible film containing the compound is placed in the oral cavity or is a
result of the compound
contained in the edible film after absorption into the systemic circulation of
the consumer
(bloodstream). Exemplary functional components include, but are not limited to
hydration
agents, refreshment agents, heating agents, comfort agents, breath masking
agents, flavor
masking agents, tartar reducing agents, plaque reducing agents, pharmaceutical
agents and
nutraceutical agents.
[0039] In a preferred embodiment of the present invention, the edible film
comprises at least two distinct regions, in which one or more regions comprise
a composition
having a first functional component, which can be a hydration agent, and at
least one other
region comprises a second composition having a second functional component,
which can be a
refreshment agent. It is envisioned that this combination of functional
components provides an
edible film that a consumer can use to alleviate dry mouth. Dry mouth can be
caused by a
variety of environmental, emotional or physiological factors. Thus, the
hydrating/refreshing
edible film of the present invention can be used before or after exercise or
during hot summer
days to hydrate and refresh the oral cavity of the consumer. Yet further, it
is contemplated that
the hydrating/refreshing edible film can be used to alleviate dry mouth, which
is induced by
stress, fear, or any other emotional, environmental or physiological factor.
[0040] The functional hydration agent of the present invention can contain a
salivation agent. For the purposes of the present invention, the term
hydration and salivation can
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be used interchangeably. The salivation agent is present in an amount
effective to promote
salivation in the oral cavity, thus instant hydration. Any orally acceptable
agent that promotes
salivation in the oral cavity can be used as a hydration agent. Exemplary
hydration agents
include acidulents, salts, salt enhancers, monosodium glutamate (MSG), MSG
enhancers, flavors
and mixtures thereof. Acidulents are preferred hydration agents. Exemplary
acidulents include,
but are not limited to citric acid, malic acid, succinic acid, adipic acid,
tartaric acid, acetic acid,
lactic acid and mixtures thereof. In specific embodiments, the hydration agent
is a combination
of citric acid, malic acid and succinic acid.
[0041] As used herein a refreshment agent includes, but is not limited to
vanilla,
fat, menthol, cooling agents, dextrose and xylitol. Preferred refreshment
agents that are used in
the present invention are cooling agents. It is envisioned that the cooling
agents that are used in
the present invention activate the trigeminal nerve. Preferred cooling agents
include, but are not
limited to L-menthol, N-ethyl-p-methane-3-carboxamide, N,2,3-trimethyl-2-
isopropyl
butanamide and monomethyl succinate. See e.g., Parrish, M.A., "Market Warms To
Physiological Coolants", Manufacturing Chemist, pp. 31-32 (February 1987).
Other exemplary
cooling agents for use in the present invention include "COOLER II" and
"COOLER V"
available from International Flavors and Fragrances, Inc. (IF&F), Dayton,
N.J., "PHYSCOOL"
available from MANE USA Milford, Ohio and "Intensate 000379" available from
Takasago
International Cooporation (USA), Rockleigh, NY. More preferably, the cooling
agent is
Intensate 000379. Yet further, other cooling agents include dextrose and
xylitol. It is known by
those of skill in the art that the breakdown of dextrose and xylitol are
endothermic reactions, thus
the reaction uses heat to breakdown dextrose and xylitol which results in a
cooling effect in the
oral cavity. Still further, one of skill in the art realizes any compound that
activate trigeminal
nerve may be used as cooling agents.
[0042] Another preferred embodiment of the present invention is an edible film
having at least two distinct regions in which one or more regions comprise a
first composition
having a first functional component, a heating agent, and at least one other
region comprises a
second composition having a second functional component, a cooling agent. The
combination of
hot/cool functional components provides the consumer with dual sensations or
enhanced
sensations. A preferred heating or hot agent is oleo resin of capsicum or
cinnamic aldehyde.
Other exemplary heating agents include, but are not limited to hot flavors,
which are available
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from flavor houses, such as S/S 086042 from International Flavors and
Fragrances, Inc. (IF&F),
Dayton, NJ. The cooling agent can be any cooling agent previously described
herein.
[0043] Another embodiment of the present invention is an edible film having at
least two distinct regions in which one or more regions comprise a first
composition having a
first functional component, a hydration agent, and at least one other region
comprising a second
composition having a second functional component, a comfort agent. The
combination of the
hydration agent and the comfort agent enhances salivation in the oral cavity
of the consumer,
thus providing hydration and comfort to oral cavity of the consumer. The
hydration agent can be
any hydration agent previously described herein.
[0044] The oral comfort agent is an agent that is present in an amount
effective to
comfort, e.g., lubricate, coat and/or moisten, the oral cavity. The oral
comfort agent may be
selected from the group consisting of lipids, proteins, surfactants or
mixtures thereof. Preferably
the oral comfort ingredient is a lipid. The lipid useful in the present
invention may be selected
from the group consisting of partially hydrogenated palm kernel oil, medium
chain triglycerides,
coconut oil, anhydrous milk fat, cocoa butter, corn oil, palm oil, soybean
oil, sunflower oil,
canola oil and mixtures thereof. In preferred embodiments, tallow lard or
chicken fat can be
used as an oral comfort agent for companion animals.
[0045] In yet another embodiment of the invention, the oral comfort agent may
be
protein. Proteins may provide comfort to the oral cavity by moisturizing
and/or forming a film
that can protect and retain moisture. Exemplary proteins include casein, whey,
mucins, egg,
blood proteins and proteins processed by microparticulation.
[0046] Another embodiment of the present invention is an edible film having at
least two distinct regions in which one or more regions comprises a first
composition having a
first functional component, a flavor masking agent, and at least one other
region comprising a
second composition having a second functional component, a pharmaceutical
agent. It is
envisioned that the flavor masking agent masks the pharmaceutical to increase
palatability of the
pharmaceutical. Typically, pharmaceutical ingredients are currently
incorporated into tablets,
capsules or liquids. Such tablets, capsules and/or liquids are often difficult
to administer to a
companion animal or human, such as a child or elderly adult. In addition to
the difficulty of
administering the tablets, capsules and/or liquid, the pharmaceutical
ingredient is not platable.
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Thus, the film of the present invention provides an easy, yet functional
delivery system a
pharmaceutical agent.
[0047] Flavor masking agents are compounds that are designed to inhibit or
alter
the perception of the undesirable flavor and/or aroma. The flavor masking
agent may bind to the
compound that results in the undesirable flavor and/or aroma or it may
breakdown the
undesirable compound into a secondary compound that does not exhibit an
undesirable flavor
and/or aroma. Exemplary flavor masking agents include anti-bitter compounds
(i.e., vanillin and
sweeteners) and anti-sweet compounds (gymnema sylvestre).
[0048] Yet further, flavor masking agents for companion animals may include
flavoring agents that may psychologically affect the animal so that the animal
does not taste the
"bitter" flavor of the pharmaceutical. These flavoring agents can include, but
are not limited to
chicken, beef, pork, lamb, beef tallow, chicken broth, beef broth, fish, or
other meat products,
cheese, and peanut butter.
[0049] Examples of pharmaceutical agents that can be used in the present
invention
include, but are not limited to antimicrobial agents (e.g., triclosan, cetyl
pyridium chloride,
domiphen bromide, quaternary ammonium salts, zinc compounds, sanguinarine,
fluorides,
alexidine, octonidine, EDTA); non-steroidal anti-inflammatory drugs (e.g.,
aspirin,
acetaminophen, ibuprofen, ketoprofen, diflunisal, fenoprofen calcium,
naproxen, tolmetin
sodium, indomethacin); anti-tussives (e.g., benzonatate, caramiphen edisylate,
menthol,
dextromethorphan hydrobromide, chlophedianol hydrochloride); decongestants
(e.g.,
pseudoephedrine hydrochloride, phenylepherine, phenylpropanolamine,
pseudoephedrine
sulfate); anti-histamines (e.g., brompheniramine maleate, chlorpheniramine
maleate,
carbinoxamine maleate, clemastine fumarate, dexchlorpheniramine maleate,
diphenhydramine
hydrochloride, diphenylpyraline hydrochloride, azatadine meleate,
diphenhydramine citrate,
doxylamine succinate, promethazine hydrochloride, pyrilamine maleate,
tripelennamine citrate,
triprolidine hydrochloride, acrivastine, loratadine, brompheniramine,
dexbrompheniramine);
expectorants (e.g., guaifenesin, ipecac, potassium iodide, tenpin hydrate);
anti-diarrheals (e.g.,
loperamide); HZ-antagonists (e.g., famotidine, ranitidine); proton pump
inhibitors (e.g.,
omeprazole, lansoprazole); general nonselective CNS depressants (e.g.,
aliphatic alcohols,
barbiturates); general nonselective CNS stimulants (e.g., caffeine, nicotine,
strychnine,
picrotoxin, pentylenetetrazol); drugs that selectively modify CNS function
(e.g., phenyhydantoin,
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phenobarbital, primidone, carbamazepine, ethosukimide, methsuximide,
phensuximide,
trimethadione, diazepam, benzodiazepines, phenacemide, pheneturide,
acetazolamide, sulthiame,
bromide); antiparkinsonism drugs (e.g., levodopa, amantadine); narcotic-
analgesics (e.g.,
morphine, heroin, hydromorphone, metopon, oxymorphone, levorphanol, codeine,
hydrocodone,
xycodone, nalorphine, naloxone, naltrexone); analgesic-antipyretics (e.g.,
salycilates,
phenylbutazone, indomethacin, phenacetin); psychopharmacological drugs (e.g.,
chlorpromazine,
methotrimeprazine, haloperidol, clozapine, reserpine, imipramine,
tranylcypromine, phenelzine,
lithium).
[0050] In preferred embodiments, an edible film having a flavor masking agent
and
a pharmaceutical agent is used to administer pharmaceutical agents to a
companion animal.
Such pharmaceutical agents that are typically administered to companion
animals include, but
are not limited to antibacterial agents (e.g., penicillins, cephalosporins and
cephamycins,
aminoglycosides, quinolones, sulfonamides, tetracyclines, macrolides,
lincosamides,
chloramphenicaol, bacitracins, vancomycin, rifamycins); antifungal agents
(e.g., polyene
macrolide antibiotics, imidazoles, flucytosine, griseofulvin, iodides);
anthelmintics (e.g.,
benzimidazoles, imidaothiazoles, tetrahydropyrimidines, macrocyclic lactones);
non-steroidal
anti-inflammatory agents (e.g., spirin, acetaminophen, ibuprofen, ketoprofen,
flunixin,
indomethacin, meloxicam, ramifenazone); steroidal anti-inflammatory agents
(e.g.,
hydrocortisone, dexamethasone, betamethasone, deflazacort); chondroprotective
agents (e.g.,
hyaluronic acid, orgotein, copper-contain compounds, glycosaminoglycans);
ectoparasiticides
(e.g., organochlorines, organophosphates, pyrethrins, avermectins, amitraz,
diflubenzuron,
cyromazine, methoprene, carbamates, rotenone, phenylpyrazoles); growth
promoter agents (e.g.,
steroid hormones, growth hormone, beta adrenoceptor agonists); anticonvulsant
agents (e.g.,
phenobarbital, diszepam, primidone); tranquilizers/sedative agents (e.g.,
bensodizepines,
butyrophenone, phenothiazines); antipsychotic agents (e.g., acepromazine,
haloperidol,
fluphenazine, risperidone); mood-stabilizing agents (e.g., lithium,
carbamazepine and valprioic
acid); antidepressant agents (e.g., tricyclic antidepressants, fluoxetine);
analgesic agents (e.g.,
ketoprofen, naproxen, phenylbutazone); antitussive agents (e.g., morphine,
codeine) bet-
adrenergic agonists (e.g., epinephrine, albuterol); proton pump inhibitors
(e.g., digoxin and
digitoxin); vasoactive agents (e.g., hydralazine, chlcium channel blockers,
nitroglycerin,
nitroprusside); antiarrhythmics (e.g., quinidine, lidocaine, propranolol);
appetite stimulators (e.g.,
diazepam, prednisone) emetic agents (e.g., apomorphine, xylazine); antiemetic
agents (e.g.,
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acepromazine, cyclizine, ondansetron); anti-diarrheal agents (e.g., kaolin-
pectin, activated
charcoal, loperamide); and laxative agents (e.g., castor oil, magnesium
sulfate, lactulose).
[0051] Yet, another embodiment of the present invention is an edible film
having at
least two distinct regions in which one or more regions comprise a first
composition having a
first functional component, a breath masking agent, and at least one other
region comprising a
second composition having a second functional component, a pharmaceutical
agent. It is
envisioned that the breath masking agent masks the pharmaceutical to increase
palatability of the
pharmaceutical as it freshens the breath of the consumer. Thus, the use of the
film having a
breath masking agent and a pharmaceutical agent provides an easy, yet
functional delivery
system for a pharmaceutical while providing the consumer with fresh breath.
[0052] In specific embodiments, a breath masking agent functions to mask mouth
odor or reduces volatile odor causing bacterial sulfur compounds. Breath
masking agents that
can be used in the present invention include zinc gluconate, citrus oils,
fruit essences, peppermint
oil, spearmint oil, other mint oils, clove oil, oils of wintergreen anise,
menthol, rosemary oil, and
parsley seed oils. The pharmaceutical agent can be any of those discussed
previously herein.
[0053] In specific embodiments, the edible film provides a functional delivery
system for parasite control agents to companion animals. For example,
pharmaceutical agents
such as those effective against heartworms (e.g., diethylcarbamazine,
ivermectin or milbemycin
oxime), intestinal worms (e.g., piperazine salts, dichlorvos, bebantel,
mebendazole,
diethylcarbamizine, milbemycin oxime, pyrantel pamoate, oxibendaxole), fleas,
and/or ticks
(e.g., chlorpyrifos, dichlorvos, malathion, diazinon, lindane, rotenone,
permethrin, resmethrin,
allethrin, fenvalerate, tetramethrin, zmitrax, fipronil, imidacloprid,
lufenuron, dimethyl phthalate
benzyl benzoate), could be incorporated into one of the regions of the film as
one of the
functional components for easy administration to the animal. An exemplary
edible film for a
companion animal is an edible film having a breath masking agent and heartworm
medication.
Thus, the animal receives heartworm medication while freshening its breath.
[0054] Another embodiment is an edible film having at least two distinct
regions in
which one or more regions comprise a first composition having a first
functional component, a
flavor masking agent or a breath masking agent, and at least one other region
comprising a
second composition having a second functional component, a nutraceutical
agent. Similar to the
problems encountered with administering pharmaceuticals, nutraceuticals are
not easily
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administered to children, adults or companion animals. It is envisioned that
the flavor masking
agent or breath masking agent masks the nutraceutical to increase the
palatability of the
nutraceutical.
[0055] Nutraceuticals include herbs, plant extracts, vitamins, minerals, and
antioxidants. Exemplary nutraceuticals that can be used in the present
invention include, but are
not limited to Echinacea purpurea, Echinacea angustifolia, Echinacea pillida,
Gingko biloba, saw
palmetto, ginseng, cat's claw (una de gato), cayenne, bilberry, cranberry,
grapeseed extract, St.
john's wort, cascara sagrada, valerian, elderberry, elder flower, sweet elder,
Sambucous nigra,
Sambucous canadensis, garlic, Camellia sinensis, Camellia thea, Camellia
theifrera, Thea
sinensis, Thea bohea, Thea viridis, goldenseal, wild cherry (Rosacea),
quercetin, stinging nettles
(Urtica), curcumin, bromelain, multiple pancreatic enzymes (protease, protease
II, protease III,
peptidase, amylase, lipase, cellulase, maltase, lactase, invertase), Emblica
officinalis,
eicosapentaenoic acid, docosahexaeonic acid, primrose oil, feverfew, ginger
root, vitamin E (D-
alpha-tocopherol), licorice root (Glycyrrhiza uralensis), aloe vera,
horseradish root, L-glutamine,
ascorbic acid, antiscorbutic vitamin, rose hips, calcium ascorbate, cevitamic
acid, citrus
bioflavonoids complex, acerola, zinc or an effective salt thereof, Astragalus
membranaceous,
Astragalus mongolicus, membranous milk vetch, milk vetch, mongolian milk, dong
quaff,
huangqi, hunag qi, moringa, vitamin A, 13-carotene, minerals such as selenium,
magnesium, and
manganese.
[0056] In preferred embodiments, the nutraceuticals for companion animals
include, but are not limited to mineral supplements, B vitamins, herbal
compounds, plant-based
extracts or antioxidants (i.e., provitamin A carotenes (i.e., trans and cis
beta-carotenes, all trans
and cis alpha-carotenes, and all trans and cis gamma-carotenes), vitamin C,
vitamin E, zeta-
carotene, trans lycopene, cis lycopenes, phytofluene, phytoene, and tumeric
extract (i.e.,
curcumin), fatty acids and mixtures thereof.
[0057] Yet another aspect of the present invention provides an edible film
having at
least two distinct regions in which one or more regions comprises a first
composition having a
first functional component, a breath masking agent, and at least one other
region comprising a
second composition having a second functional component, a plaque disclosing
agent. It is
envisioned that the breath masking agents function in masking mouth odor or
reducing volatile
odor causing bacterial sulfur compounds while the plaque disclosing agent
identifies dental
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plaque that is usually transparent and colorless and not easily visible. Thus,
the film can be used
to identify areas of the mouth where plaque buildup is a problem thereby
increasing the
awareness of the consumer and probably motivating the consumer to seek early
removal of
dental plaque.
[0058] Plaque disclosing agents that can be used include FD & C Red No. 40, or
Allura Red, (the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-
sulfophenyl)azo]-2
naphthalenesulfonic acid), F D & C Red No. 3 (erythrosine), and D&C Red No. 22
(eocine).
Other potential plaque-disclosing agents include FD&C Blue No.l, FD&C Blue No.
2, D&C
Green No. 5, and a mixture of FD&C Blue No. 1 and FD&C Yellow No. 5.
[0059] Another embodiment of the present invention is an edible film having at
least two distinct regions in which one or more regions comprise a first
composition having a
first functional component, a tarter reducing agent and/or a plaque reducing
agent, and at least
one other region comprising a second composition having a second functional
component, a
flavor masking agent or breath masking agent. Thus, the film reduces tarter
and plaque, or
freshens breath while it reduces tarter.
[0060] Dental calculus, or tartar, is recognized as a recurring calcified
deposit on
the surfaces of the teeth of domestic animals, including dogs and cats, as
well as humans. It is
generally recognized that dental calculus develops in a sequential process
that involves the
accumulation of dental plaque and the subsequent calcification of the plaque
by saliva, which has
very high concentrations of calcium and phosphate. Although calculus, per se,
is not directly
responsible for the development of oral diseases, it is recognized as a
secondary, or contributing,
factor in the development of periodontal disease. Once formed, calculus
deposits can only be
removed through concerted mechanical procedures, i.e., a dental prophylaxis.
Thus, the
prevention of dental calculus is of importance not only for cosmetic reasons,
but also because of
dental calculus' secondary role in the development of periodontal disease, and
the resultant
systemic infections, alveolar bone recession, tooth loss and adverse
mouth/breath odors.
[0061] Thus, the edible film of the present invention may employ sequestering
agents or plaque and tarter reducing agents, which form soluble calcium
complexes with the
calcium in saliva and dental plaque fluids thereby preventing the usual
calcification of dental
plaque on the surfaces of teeth. Exemplary agents that are used to sequester
or reduce plaque
and/or tarter include organic compounds, such as the hydroxycarboxylic acids,
including citric
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acid, ascorbic acid, malic acid, fumaric acid, glutaric acid, acetic acid,
tartaric acid, oxalic acid,
and the like, and their alkali salts, such as sodium citrate, potassium
citrate, etc., as well as their
aminopolycarboxylic acid derivatives, for example, ethylenediaminetetraacetic
acid. Other tarter
and/or plaque reducing agents also include polyphenols (i.e., tea) or sodium
hexametaphosphate
(HMP) See for example, US Patents 5,618,518, 5,296,217, and 5,204,089, which
are
incorporated herein by reference.
2. Non-functional components
[0062] In addition, to the functional components, non-functional components
such
as selected flavoring agents or coloring agents, may be added to the film to
impart desirable taste
and appearance. Such components may be independently added to the region
containing a
functional component or to a region that does not contain a functional
component. For example,
it may be desirable to add a colorant to one region while leaving a second
region colorless. Yet
further, a coloring agent can be added to both regions. It may also be
desirable to employ the
same or different flavoring agents to a film having at two regions in that
each region contains a
different composition having a different functional component or to a film
having two regions in
that one region contains a composition having a functional component and the
second region
contains a composition having a non-functional component.
[0063] In preferred embodiments, a selected flavoring agent is also added to
an
edible film having a hydration agent in one region and a refreshment agent in
a second region.
The flavor agent can be for example orange, citrus or peppermint. In further
embodiments, a
coloring agent can also be used in combination with the flavoring agent. For
example, if the
flavoring agent is citrus, then the coloring agent can be Yellow 6 or if the
flavoring agent is
peppermint, then the coloring agent can be Blue 2.
[0064] Other exemplary selected flavoring agents that are used in the present
invention include those known to the skilled artisan, such as natural and
artificial flavors. These
flavorings can be chosen from synthetic flavor oils and flavoring aromatics,
and/or oils, oleo
resins and extracts derived from plants, leaves, flowers, fruits and so forth,
and combinations
thereof. Representative flavor oils include, but are not limited to spearmint
oil, cinnamon oil,
peppermint oil, clove oil, bay oil, thyme oil, cedar leaf oil, oil of nutmeg,
oil of sage, and oil of
bitter almonds. Also useful are artificial, natural or synthetic flavors such
as vanilla, chocolate,
coffee, cocoa, citrus oil (e.g., lemon, orange, grape, lime and grapefruit)
and fruit essences (e.g.,
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apple, pear, peach, strawberry, raspberry, cherry, plum, pineapple, apricot).
These flavorings can
be used individually or in admixture. Prefer ed flavors include mints such as
peppermint,
artificial vanilla, cinnamon derivatives, and various fruit flavors, whether
employed individually
or in admixture. Other flavorings such as aldehydes and esters including
cinnamyl acetate,
cinnamaldehyde, citral, diethylacetal, dihydrocarvyl acetate, eugenyl formate,
p-methylanisole,
and so forth may also be used. Generally, any flavoring or food additive, such
as those described
in Chemicals Used in Food Processing, publication 1274 by the National Academy
of Sciences,
pages 63-258, may be used. Further examples of aldehyde flavorings include,
but are not limited
to acetaldehyde (apple); benzaldehyde (cherry, almond); cinnamic aldehyde
(cinnamon); citral,
e.g., alpha citral (lemon, lime); neral, e.g., beta citral (lemon, lime);
decanal (orange, lemon);
ethyl vanillin (vanilla, cream); heliotropine, e.g., piperonal (vanilla,
cream); vanillin (vanilla,
cream); alpha-amyl cinnamaldehyde (spicy fruity flavors); butyraldehyde
(butter, cheese);
valeraldehyde (butter, cheese); citronellal (modifies, many types); decanal
(citrus fruits);
aldehyde C-8 (citrus fruits); aldehyde C-9 (citrus fruits); aldehyde C-12
(citrus fruits); 2-ethyl
butyraldehyde (berry fruits); hexenal, e.g., trans-2 (berry fruits); tolyl
aldehyde (cherry, almond);
veratraldehyde (vanilla); 2,6-dimethyl-5-heptenal, e.g., melonal (melon); 2-6-
dimethyloctanal
(green fruit); and 2-dodecenal (citrus, mandarin).
[0065] In preferred embodiments, selected flavoring agents that are used in an
edible film that is being consumed or administered to a companion animal can
differ from those
that are used for a film that is to be consumed by a human. Exemplary
flavoring agents that are
typically used for companion animals include, but are not limited to chicken,
beef, pork, lamb,
beef tallow, chicken broth, beef broth, fish, or other meat products, cheese,
and peanut butter.
[0066] Exemplary coloring agents include, but are not limited to Colorants can
also
include natural food colors and dyes suitable for food, drug and cosmetic
applications. These
colorants are known as FD&C dyes and lakes. The materials acceptable for the
foregoing
spectrum of use are preferably water-soluble, and include FD&C Blue No. 2,
which is the
disodium salt of 5,5-indigotindisulfonic acid. Similarly, the dye known as
Green No. 3 comprises
a triphenylmethane dye and is the monosodium salt of 4-[4-N-ethyl-p-
sulfobenzylamino)
diphenyl-methylene]-[1-N-ethyl-N-p-sulfonium benzyl)-2,5-cyclo-hexadienimine].
A full
recitation of all FD&C and D&C dyes and their corresponding chemical
structures may be found
in the Kirk-Othmer Encyclopedia of Chemical Technology, Volume 5, Pages 857-
884.
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[0067] The edible film of the present invention can further comprise other non-
functional components such as water, additional film forming agents,
plasticizing agents,
surfactants, emulsifying agents, stabilizing agents, thickening agents and
binding agents.
[0068] Preferred plasticizing agents include triacetin in amounts ranging from
about 0 to about 20 wt %, preferably about 0 to about 2 wt %. Other suitable
plasticizing agents
include monoacetin and diacetin.
[0069] Preferred surfactants include mono and diglycerides of fatty acids and
polyoxyethylene sorbitol esters, such as, Atmos 300 and Polysorbate 80. The
surfactant can be
added in amounts ranging from about 0.5 to about 15 wt %, preferably about 1
to about 5 wt
of the film. Other suitable surfactants include pluronic acid, sodium lauryl
sulfate, and the like.
[0070] Preferred stabilizing agents include xanthan gum, locust bean gum and
carrageenan, in amounts ranging from about 0 to about 10 wt %, preferably
about 0.1 to about 2
wt % of the film. Other suitable stabilizing agents include guar gum and the
like.
[0071] Preferred emulsifying agents include triethanolamine stearate,
quaternary
ammonium agents, acacia, gelatin, lecithin, bentonite, veegum, monoglyceride,
diglyceride,
tweens and the like, in amounts ranging from about 0 to about S wt %,
preferably about 0.01 to
about 0.7 wt % of the film.
[0072] Preferred thickening agents include methylcellulose, carboxyl
methylcellulose, and the like, in amounts ranging from about 0 to about 20 wt
%, preferably
about 0.01 to about 5 wt %.
[0073] Preferred binding agents include starch, in amounts ranging from about
0 to
about 10 wt %, preferably about 0.01 to about 2 wt % of the film.
D. Production of an edible film having distinct regions
[0074] For the production of an edible film having distinct regions, it is
understood
and within the scope of the present invention that the first and second
component can be either a
functional component and/or a non-functional component as previously described
and
incorporated herein.
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[0075] One such method of producing a film having at least two distinct
regions is
by using glitter as a region. For example, an edible film having at least one
region containing a
first composition, which has a first functional or non-functional component,
is cast into a film. A
second composition containing either a functional or non-functional component
is cast into a
film, dried, and upon drying forms glitter particles. To form at least a
second region on the film,
the glitter is applied to the film. In further embodiments, the glitter may
also contain a second
functional component that is different than the functional component contained
in the film. Yet
further, the glitter may contain a functional component and the film may
contain only a non-
functional component.
[0076] The glitter may contain a coloring agent and the film may be colorless
or
both the glitter and the film may contain different coloring agents. Yet
further, the glitter may be
applied to the film in form of strips, stars, circles, squares, letters,
words, shapes, etc.
[0077] As used herein, the term edible glitter refers to edible particles.
Particles of
edible glitter may be of any useful size. Preferably, no more than about 5
percent of the
particulates will to pass through an ASTM 40 Mesh sieve, and no less than 98
percent of the
particulates will be able to pass through an ASTM 4 mesh sieve. More
preferably, no more than
15 percent of the edible glitter particles will pass through an ASTM 20 Mesh
sieve, and no less
than 98 percent of the particulates will be able to pass through an ASTM 4
mesh sieve. The
ASTM Mesh size refers to the number of mesh openings per inch. Typically, a 4
Mesh sieve has
an open area of 65.9 percent and an opening size of 5,160 Vim, a 20 Mesh sieve
has an open area
of 46.2 percent and an opening size of 860 pm, and a 40 Mesh sieve has an open
area of 36
percent and an opening size of 380 pm.
[0078] A further embodiment of the present invention is an edible glitter for
delivery of at least one functional component which is rapidly dissolved in
the oral cavity. The
glitter comprises at least one water soluble polymer, a first component and a
second component.
In preferred embodiments, the first component is a non-functional component
and the second
component is a non-functional component. More preferably, the first and second
components
are two different functional components. Visual cues are used to indicate the
presence of the two
action components. The first component is one color and the second component
is a second
color. Any of the functional and the non-functional components that are
discussed previously
herein can be used to produce the edible glitter.
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[0079] In further embodiments, the present invention provides a method of
preparing an edible film having at least two distinct regions indicated by a
color swirl. The film
is prepared by mixing at least one water soluble polymer, a first component
and a first coloring
agent to form a first homogenous mixture. Next, at least one water soluble
polymer, a second
component and a second coloring agent is mixed to form a second homogenous
mixture. After
all components are mixed, the first homogenous mixture is cast to form a film.
Once the film is
cast, the second homogenous mixture is drizzled onto the film and smeared with
the first
homogenous mixture to form a film having color swirl of the first and second
homogenous
mixtures. After the color swirl is formed, the film is dried and cut into
strips. Preferably, the firs
and second components are functional.
[0080] Another embodiment is a method of preparing an edible film having at
least
two distinct regions indicated by a color inclusions. First, at least one
water soluble polymer, a
first component and a first coloring agent is mixed to form a first homogenous
mixture. The first
homogenous mixture is dried and flaked, braked or cut into particles. Next, at
least one water
soluble polymer, a second component and a second coloring agent is mixed to
form a second
homogenous mixture, which is cast to form a film. The particles of the first
homogenous
mixture are sprinkled onto the film and the film is dried and cut. Preferably,
the firs and second
components are functional.
[0081] Yet further, another embodiment is a method of preparing an edible film
having two distinct regions indicated by a color region. First, at least one
water soluble polymer,
a first component and a first coloring agent is mixed to form a first
homogenous mixture. A
second component and a second coloring agent are mixed to form a second
homogenous
mixture. The first homogenous mixture is cast to form a film and the second
homogenous
mixture is deposited onto the film, which is dried and cut. Depositing can be
done by using
standard printing, such as ink jet printing and/or spraying techniques that
are well known and
used in the art. The second homogenous mixture can contain a water soluble
polymer. It is
envisioned that deposition relates to printing/spraying words, dots, strips,
stars, squares, animal
shapes, food shapes, or other designs and/or shapes onto the film. Thus, the
film has a color base
with the first action component and the second action component is deposited
onto the film. It is
also envisioned that the first homogenous mixture can be colorless and the
second homogenous
mixture can contain color.
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[0082] A further embodiment is a method to prepare a striped film. A film
forming
mixture is prepared having a first functional component. A second film forming
mixture is
prepared having a second component, which can be functional or non-function.
Different
coloring agents can be used in the first film forming mixture and the second
film forming
mixture, or only one coloring agent can be added to either first or the second
film forming
mixture. Next. the film forming mixtures are cast in stripes at the same time
to a desired
thickness. These stripes contact each other at the edge forming one film. The
striped film is
dried and cut.
[0083] Casting of the film requires the use of a carrier. The mixture is cast
on a
releasable carrier and dried. The carrier material must have a surface
tension, which allows the
film mixture to spread evenly across the intended carrier width without
soaking to form a
destructive bond between the film and carrier substrates. Examples of suitable
carrier materials
include glass, stainless steel, Teflon and polyethylene-impregnated paper.
Drying of the film
may be carried out at high temperature using a drying oven, drying terminal,
vacuum drier, or
any other suitable drying equipment which does not adversely affect the
ingredients of which the
film is composed.
[0084] After the film is dried, it is segmented into pieces, for example,
dosage
units, strips, particles, glitter or any other piece that is suitable for
delivery of the present
invention. Segmenting is performed by die-cutting, slitting-and-die-cutting,
laser cutting, or any
other technique well known and used in the art. Preferably, the segmented film
has a strip width
and length corresponding to about the size of a postage stamp, generally about
12 to about 30
millimeter in width and about 20 to about 50 millimeters in length. The film
has a thickness
ranging from about I S to about 80 micrometers, and preferably about 30 to 60
micrometers.
E. Examples
[0085] The following examples are included to demonstrate preferred
embodiments
of the invention. It should be appreciated by those of skill in the art that
the techniques disclosed
in the examples which follow represent techniques discovered by the inventors
to function well
in the practice of the invention, and thus can be considered to constitute
preferred modes for its
practice. However, those of skill in the art should, in light of the present
disclosure, appreciate
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that many changes can be made in the specific embodiments which are disclosed
and still obtain
a like or similar result without departing from the spirit and scope of the
invention.
Example 1
Edible Film
[0086] The following table illustrates the ingredients that are combined to
produce
an edible film having a hydration agent and a refreshing agent.
H dration
wet recipe Finished Product
Com osition
88.70 a ueous solution of of mers & additives a 58.00
rox. 80% water
0.00 Water 5.00
3.06 citric acid 10.00
3.06 malic acid 10.00
0.61 succinic acid 2.00
2.75 sodium citrate 9.00
0.08 acesulfame otassium 0.25
0.08 Sucralose 0.25
0.05 ellow 6 0.15
1.62 flavorant (citrus 5.30
100.00
[0087] Dry to approximately 5% moisture
Refreshment
wet recipe Finished Product
Com osition
92.26 a ueous solution of olymers & additives a 81.00
rox. 80% water
4.56 Water 5.00
0.06 acesulfame otassium 0.25
0.06 Sucralose 0.25
1.87 Takasago cooler 000379 8.20
1.21 flavorant citrus) 5.30
100.00
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[0088] Dry to approximately 5% moisture
[0089] Two film mixture solutions are made according to the above recipes. One
solution contains the hydration agent and the second solution contains the
refreshment agent.
The solutions are mixed separately, and then the solutions are cast in a
casting box to form
distinct regions, such as stripes or other designs. During casting, the
solutions can be poured
simultaneously to form strips or one solution can be poured and the second can
be poured on top
to form a design. Once poured, the mixtures remain in distinct regions which
are readily
distinguishable from the color cues though they flow together to form one
strip. The cast film is
dried and cut.
Example 2
Swirled Edible Film
[0090] For an edible film having a color swirl, two film forming mixtures are
prepared as described in Example 1. One film mixture contains the hydration
agent and the
second film mixture contains the refreshment agent. One of the films is cast
to a desired
thickness. The second base is drizzled onto the first, and is smeared with a
blade to achieve a
film with a desired pre-drying thickness. The mixtures remain in distinct
regions, which are
readily distinguishable from the color cues. The film is dried and cut into
the desired size and
shape.
Example 3
Colored Inclusion Edible Film
[0091] For a colored inclusion, a film forming mixture containing a hydration
agent
is prepared as described in Example 1. Next, the film forming mixture is dried
and flaked into
particles. Flaking the dried mixture into particles requires mechanical
manipulation. Next, a
second film forming mixture containing the refreshment is prepared as in
Example 1. The
second film forming mixture is cast to the desired thickness. Then, the
particles from the first
film forming mixture are sprinkled on the wet film mixture. The film is dried
and cut to the
desired size and shape.
Example 4
Colored Regions on Edible Film
[0092] For colored regions, a film forming mixture having a hydration agent is
prepared as in Example 1. A colored solution (with or without film base
polymers) containing
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the refreshment agent is prepared. Next, the film forming mixture having the
hydration agent is
cast to a desired thickness. The, the colored solution is deposited onto the
cast film. Depositing
may include printing and/or spraying words, dots, stripes, or other shapes.
Example 5
Edible Film for Companion Animal
[0093] Briefly, water soluble polymers are mixed with a functional component,
such as a heartworm medication and a coloring agent to form a first film
mixture. Next water
soluble polymers are mixed with a second functional component, such as a
flavor masking agent
and a coloring agent to form a second film mixture. The film mixtures are cast
at the same time
in a casting box to form distinct regions, such as stripes or other designs.
The mixtures remain in
distinct regions, which are readily distinguishable from the color cues. The
film is dried and cut.
[0094] Although the present invention and its advantages have been described
in
detail, it should be understood that various changes, substitutions and
alterations can be made
herein without departing from the invention as defined by the appended claims.
Moreover, the
scope of the present application is not intended to be limited to the
particular embodiments of the
process, machine, manufacture, composition of matter, means, methods and steps
described in
the specification. As one will readily appreciate from the disclosure,
processes, machines,
manufacture, compositions of matter, means, methods, or steps, presently
existing or later to be
developed that perform substantially the same function or achieve
substantially the same result
as the corresponding embodiments described herein may be utilized.
Accordingly, the appended
claims are intended to include within their scope such processes, machines,
manufacture,
compositions of matter, means, methods, or steps.
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