U.S. patent application number 10/739803 was filed with the patent office on 2004-07-15 for oral care compositions and methods.
Invention is credited to Boff, Beth Ann, Boyd, Thomas J., Carale, M. Teresa R., Xu, Guofeng.
Application Number | 20040136924 10/739803 |
Document ID | / |
Family ID | 29735932 |
Filed Date | 2004-07-15 |
United States Patent
Application |
20040136924 |
Kind Code |
A1 |
Boyd, Thomas J. ; et
al. |
July 15, 2004 |
Oral care compositions and methods
Abstract
A composition comprising a film or a plurality of film fragments
entrained in a carrier. The film or plurality of film fragments can
comprise a functional material. The film or plurality of film
fragments can comprise repeated shapes. Also disclosed is a
composition comprising a plurality of discernable lamellar
fragments entrained in a carrier. Also disclosed is a method for
administering a functional material to a human or animal subject in
need thereof, the method comprising applying to the subject a
composition comprising a film or a plurality of film fragments
entrained in a carrier, wherein the film comprises the functional
material.
Inventors: |
Boyd, Thomas J.; (Metuchen,
NJ) ; Xu, Guofeng; (Princeton, NJ) ; Carale,
M. Teresa R.; (Houston, TX) ; Boff, Beth Ann;
(Piscataway, NJ) |
Correspondence
Address: |
HARNESS, DICKEY, & PIERCE, P.L.C
7700 BONHOMME, STE 400
ST. LOUIS
MO
63105
US
|
Family ID: |
29735932 |
Appl. No.: |
10/739803 |
Filed: |
December 18, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10739803 |
Dec 18, 2003 |
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10331312 |
Dec 30, 2002 |
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6669929 |
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Current U.S.
Class: |
424/48 ;
424/49 |
Current CPC
Class: |
A61K 8/731 20130101;
A61K 8/042 20130101; A61Q 11/00 20130101; A61K 2800/621 20130101;
A61K 2800/594 20130101; A61K 8/0266 20130101; A61K 2800/262
20130101; A61K 2800/651 20130101; A61K 8/0283 20130101; A61K 8/732
20130101 |
Class at
Publication: |
424/048 ;
424/049 |
International
Class: |
A61K 009/68; A61K
007/16 |
Claims
What is claimed is:
1. An oral or personal care composition, comprising a film
entrained in a carrier, wherein said film comprises a functional
material.
2. A composition according to claim 1, wherein said film comprises
a water soluble polymer selected from the group consisting of
cellulose ethers, methacrylates, polyvinylpyrollidone, and mixtures
thereof.
3. A composition according to claim 1, wherein either or both of
said carrier and said functional material comprises a therapeutic
active selected from the group consisting of abrasives, anticaries
agents, tartar control agents, antiplaque agents, periodontal
actives, breath freshening agents, malodour control agents,
whitening agents, stain prevention actives, salivary stimulants,
and combinations thereof.
4. A composition according to claim 1, wherein said film comprises
a plurality of first film fragments having one or more of a first
therapeutic active, a first dissolution rate, a first shape and a
first color, and a plurality of second film fragments having one or
more of a second therapeutic active, a second dissolution rate, a
second shape and a second color.
5. A composition according to claim 1, wherein said functional
material is a flavorant.
6. A composition according to claim 1, wherein said carrier is
suitable for use in a dentifrice, and said film comprises a
compatibility enhanced active selected from the group consisting of
cationic antimicrobials, calcium salts, fluoride salts, proteins,
and mixtures thereof.
7. A composition according to claim 1, wherein said film comprises
a controlled release composition comprising said functional
material and said film has a Dissolution Value of at least about 5
seconds and not more than about 200 sec.
8. A composition according to claim 1, wherein said carrier
comprises a gel, paste, a colloid, or a fibrillar network.
9. A composition according to claim 1, wherein said film are
substantially lamellar, having a thickness of from about 0.1 mils
to about 10 mils and a length of at least about 0.2 mm and not more
than about 2.5 mm.
10. A composition according to claim 1, wherein said film has an
aspect ratio of at least about 5:1 and not more than about
500:1.
11. A composition according to claim 1, wherein said film is
visibly discernable.
12. A composition according to claim 1, wherein said fragments are
either or both of a non-random shape or of a repeating shape.
13. A composition according to claim 12, wherein said shape is
substantially square.
14. A composition according to claim 1, wherein said film comprises
a formulation colorant selected from the group consisting of
pigments, lakes, dyes, and mixtures thereof.
15. A composition according to claim 1, wherein said film comprises
a plurality of layers, and wherein said film comprises a polymeric
film and a coating on at least one surface of said film.
16. An oral or personal care composition, comprising a plurality of
film fragments in a carrier, wherein said fragments are visibly
discernable and have either or both of a non-random shape or a
repeating shape.
17. A composition according to claim 16, wherein said film
fragments comprise a water soluble polymer selected from the group
consisting of cellulose ethers, methacrylates,
polyvinylpyrollidone, and mixtures thereof.
18. A composition according to claim 1, wherein either or both of
said carrier and said film fragments comprise a therapeutic active
selected from the group consisting of abrasives, anticaries agents,
tartar control agents, antiplaque agents, periodontal actives,
breath freshening agents, malodour control agents, whitening
agents, stain prevention actives, salivary stimulants, and
combinations thereof.
19. A composition according to claim 16, wherein said film
comprises a plurality of first film fragments having one or more of
a first therapeutic active, a first dissolution rate, a first shape
and a first color, and a plurality of second film fragments having
one or more of a second therapeutic active, a second dissolution
rate, a second shape and a second color.
20. A composition according to claim 16, wherein said film
fragments comprise a flavorant.
21. A composition according to claim 16, wherein said carrier is
suitable for use in a dentifrice, and said film comprises a
compatibility enhanced active selected from the group consisting of
cationic antimicrobials, calcium salts, fluoride salts, proteins,
and mixtures thereof.
22. A composition according to claim 16, wherein said film
comprises a controlled release composition comprising a functional
material and said film has a Dissolution Value of at least about 5
seconds and not more than about 200 sec.
23. A composition according to claim 16, wherein said carrier
comprises a gel, paste, a colloid, or a fibrillar network.
24. A composition according to claim 16, wherein said film
fragments are substantially lamellar, having a thickness of from
about 0.1 mils to about 10 mils and a length of at least about 0.2
mm and not more than about 2.5 mm.
25. A composition according to claim 16, wherein said film
fragments have an aspect ratio of at least about 5:1 and not more
than about 500:1.
26. A composition according to claim 16, wherein said shape is
substantially square.
27. A composition according to claim 16, wherein said film
fragments comprise a formulation colorant selected from the group
consisting of pigments, lakes, dyes, and mixtures thereof.
28. A composition according to claim 16, wherein said film
fragments comprise a plurality of layers, and wherein said film
fragments comprise polymeric film fragments and a coating on at
least one surface of said film fragments.
29. A method for administering a functional material to a human or
animal subject, comprising the step of topically applying to said
subject a composition comprising a film entrained in a carrier,
wherein said film comprises said functional material
30. A method according to claim 29, wherein said film comprises a
water soluble polymer selected from the group consisting of
cellulose ethers, methacrylates, polyvinylpyrollidone, and mixtures
thereof.
31. A method according to claim 29, wherein either or both of said
carrier and said functional material comprises a therapeutic active
selected from the group consisting of abrasives, anticaries agents,
tartar control agents, antiplaque agents, periodontal actives,
breath freshening agents, malodour control agents, whitening
agents, stain prevention actives, salivary stimulants, and
combinations thereof.
32. A method according to claim 29, wherein said film comprises a
plurality of first film fragments having one or more of a first
therapeutic active, a first dissolution rate, a first shape and a
first color, and a plurality of second film fragments having one or
more of a second therapeutic active, a second dissolution rate, a
second shape and a second color.
33. A method according to claim 29, wherein said functional
material is a flavorant.
34. A method according to claim 29, wherein said carrier is
suitable for use in a dentifrice, and said film comprises a
compatibility enhanced active selected from the group consisting of
cationic antimicrobials, calcium salts, fluoride salts, proteins,
and mixtures thereof.
35. A method according to claim 29, wherein said film comprises a
controlled release composition comprising said functional material
and said film has a Dissolution Value of at least about 5 seconds
and not more than about 200 sec.
36. A method according to claim 29, wherein said carrier comprises
a gel, paste, a colloid, or a fibrillar network.
37. A method according to claim 29, wherein said film are
substantially lamellar, having a thickness of from about 0.1 mils
to about 10 mils and a length of at least about 0.2 mm and not more
than about 2.5 mm.
38. A method according to claim 29, wherein said film have an
aspect ratio of at least about 5:1 and not more than about
500:1.
39. A method according to claim 29, wherein said film is visibly
discernable.
40. A method according to claim 29, wherein said fragments are
either or both of a non-random shape or of a repeating shape.
41. A method according to claim 40, wherein said shape is
substantially square.
42. A method according to claim 29, wherein said film comprises a
formulation colorant selected from the group consisting of
pigments, lakes, dyes, and mixtures thereof.
43. A method according to claim 29, wherein said film comprises a
plurality of layers, and wherein said film comprise a polymeric
film or fragment and a coating on at least one surface of said
film.
44. A composition for enhancing personal health, hygiene or
appearance, comprising a carrier having distributed therein a
plurality of fragments having an aspect ratio of at least about
5:1, wherein said fragments comprise a matrix and a functional
material.
45. A composition according to claim 44, wherein said functional
material comprises a therapeutic active which provides a systemic
health benefit.
46. An oral care composition, comprising a carrier having
distributed therein a plurality of lamellar fragments, wherein said
fragments comprise a matrix and a functional material.
47. A process for making an oral care composition comprising a
carrier having distributed therein a plurality of lamellar
fragments, said process comprising: (a) providing said carrier; (b)
adding said lamellar fragments to said carrier to form a mixture;
and (c) homogenizing said mixture.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATION
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 10/331,312 filed Dec. 30, 2002 and claims
priority to U.S. Provisional Application, Attorney Docket No.
2664-000002 entitled Oral and Personal Care Compositions and
Methods, filed Dec. 16, 2003. Each of the aforementioned
applications are incorporated in their entireties by reference.
INTRODUCTION
[0002] This application relates to oral and personal care
compositions, and more particularly to compositions comprising a
film entrained in a carrier. Such compositions include, for
example, dentifrices.
[0003] Compositions for enhancing health, hygiene or appearance,
such as oral care compositions, skin care compositions and hair
care compositions, are used by millions of people. These
compositions are used for a wide variety of purposes, including for
enhancing personal health, hygiene, and appearance, as well as for
preventing or treating a variety of diseases and other conditions
in humans and in animals.
[0004] The formulation of such compositions presents a number of
challenges. They must be pharmaceutically and/or cosmetically
acceptable for their intended use. Compositions that contain
therapeutic active materials preferably deliver the active at
effective levels, avoiding undue chemical degradation. Similarly,
compositions containing cosmetically functional materials must
deliver the material to, e.g., the oral cavity, skin or hair at
effective levels under the conditions that they are typically used
by the consumer.
[0005] Moreover, the aesthetic appeal of all such compositions is
important, and can have significant effects on consumer acceptance
and usage. Aesthetic effects have been acknowledged to play an
important role in consumer acceptance of many products. Although
such products have met with consumer approval, the art seeks to
further improve the aesthetic effects as well as the cosmetic and
therapeutic benefits of these products. Indeed, many such
compositions known in the art are deficient in one or more
attributes. Thus, there is an ongoing need for new oral and
personal care compositions, and methods of their use.
SUMMARY
[0006] The present invention provides, in various embodiments, oral
and personal care compositions comprising a film entrained in a
carrier, wherein said film comprises a functional material. In one
embodiment, the film comprises a plurality of film fragments. In
various embodiments, the present invention provides compositions
comprising a plurality of lamellar fragments in a carrier.
[0007] In some embodiments, the film can comprise a polymer, such
as a water soluble polymer, water dispersible polymer, a water
insoluble polymer or a mixture thereof. In various embodiments, the
composition can be suitable for use as an oral care composition, a
hair care composition, or a skin care composition. In various
embodiments the film comprises a functional material. In various
embodiments, such functional materials include therapeutic active
materials, flavorants, cosmetic materials, fragrances, and
formulation colorants.
[0008] The present invention also provides methods for
administering a functional material to a human or animal subject in
need thereof, comprising topically applying to said subject a
composition comprising a film entrained in a carrier, wherein said
film comprises said functional material. In various methods, such
methods further comprise disrupting the film after the topical
application. In various embodiments, the compositions can comprise
a film comprising one or more functional materials which are
released at different times or concurrently in a controlled release
manner such as by sustained or delayed release.
[0009] Compositions and methods of this invention afford benefits
over compositions and methods among those known in the art. Such
benefits include one or more of increased consumer acceptability,
enhanced aesthetics, improved stability for active or other
functional materials, and controlled delivery of functional
materials. Further benefits and embodiments of the present
invention are apparent from the description set forth herein.
DESCRIPTION
[0010] The present invention provides compositions and methods, for
administration to, or use with, a human or other animal subject.
Preferably, specific materials and compositions to be used in this
invention are, accordingly, pharmaceutically- or
cosmetically-acceptable. As used herein, such a "pharmaceutically
acceptable" or "cosmetically acceptable" component is one that is
suitable for use with humans and/or animals to provide the desired
therapeutic, sensory, decorative, or cosmetic benefit without undue
adverse side effects (such as toxicity, irritation, and allergic
response) commensurate with a reasonable benefit/risk ratio. The
following definitions and non-limiting guidelines must be
considered in reading and interpreting the description of this
invention set forth herein.
[0011] The headings (such as "Introduction" and "Summary,") and
sub-headings (such as "Film" and "Carrier") used herein are
intended only for general organization of topics within the
disclosure of the invention, and are not intended to limit the
disclosure of the invention or any aspect thereof. In particular,
subject matter disclosed in the "Introduction" may include aspects
of technology within the scope of the invention, and may not
constitute a recitation of prior art. Subject matter disclosed in
the "Summary" is not an exhaustive or complete disclosure of the
entire scope of the invention or any embodiments thereof.
[0012] The citation of references herein does not constitute an
admission that those references are prior art or have any relevance
to the patentability of the invention disclosed herein. All
references cited in the Description section of this specification
are hereby incorporated by reference in their entirety.
[0013] The description and specific examples, while indicating
embodiments of the invention, are intended for purposes of
illustration only and are not intended to limit the scope of the
invention. Recitation of multiple embodiments having stated
features is not intended to exclude other embodiments having
additional features, or other embodiments incorporating different
combinations of the stated features. Specific Examples are provided
for illustrative purposes of how to make, use and practice the
compositions and methods of this invention and, unless explicitly
stated to recite activities that have been done (i.e., using the
past tense), are not intended to be a representation that given
embodiments of this invention have, or have not, been
performed.
[0014] As used herein, the words "preferred" and "preferably" refer
to embodiments of the invention that afford certain benefits, under
certain circumstances. However, other embodiments may also be
preferred, under the same or other circumstances. Furthermore, the
recitation of one or more preferred embodiments does not imply that
other embodiments are not useful, and is not intended to exclude
other embodiments from the scope of the invention. As used herein,
the word "include," and its variants, is intended to be
non-limiting, such that recitation of items in a list is not to the
exclusion of other like items that may also be useful in the
materials, compositions, devices, and methods of this
invention.
[0015] The present invention provides oral or personal care
compositions, comprising a film entrained in a carrier, wherein
said film comprises a functional material. As referred to herein,
an "oral or personal care composition" is any composition that is
suitable for administration or application to a human or animal
subject for enhancing the health, hygiene or appearance of the
subject, including the prevention or treatment of any physiologic
condition or disorder, and providing sensory, decorative or
cosmetic benefits and combinations thereof. Compositions among
those provided herein include oral care compositions, skin care
compositions, hair care composition, topical pharmaceutical
compositions, and ocular compositions. By "oral care composition"
as used herein is meant a composition for which the intended use
can include oral care, oral hygiene, or oral appearance, or for
which the intended method of use can comprise administration to the
oral cavity. By "skin care composition" as used herein is meant a
composition for which the intended use can include promotion or
improvement of health, cleanliness, odor, appearance, or
attractiveness of skin.
[0016] Film:
[0017] Embodiments of this invention comprise a film. As referred
to herein, a "film" is a material having a substantially lamellar
structure. A "lamellar" structure has, or is capable of having, a
size in one or two dimensions (e.g., the x- or y-dimensions) that
is substantially greater than the thickness of the structure in a
third dimension (e.g., the z-direction). Lamellar structures among
those useful herein include those that are substantially planar,
layered, or lamelliform. In one embodiment, the lamellar structure
is substantially planar, having a size in both the x- and
y-dimensions that is substantially greater than the z-direction. In
other embodiments, the lamellar structure is non-planar. In one
embodiment, a film of this intention comprises a substantially
continuous surface that can appear as a substantially flat surface,
although in some embodiments the film is deformed. In such
embodiments, the film can have any of a number of shapes, including
having a smooth curved surface.
[0018] Films among those useful herein may be rigid or plastic,
comprising any of a variety of materials, including materials
selected from the group consisting of film forming materials,
clays, waxes, and mixtures thereof. In one embodiment, the film
comprises a film forming polymer. Film forming polymers among those
useful herein include materials selected from the group consisting
of water soluble polymers, water dispersible polymers, water
insoluble polymers, and mixtures thereof.
[0019] In some embodiments, a film comprises at least one film
forming material. In certain embodiments, a film forming material
is a polymer. Polymers useful herein include hydrophilic polymers
and hydrophobic polymers. In certain embodiments, the polymer is a
water soluble polymer. In some embodiments, the polymer is a water
soluble, breakable polymer that dissolves during use, such as, for
example, during toothbrushing. The dissolution can occur as a
result of, for example, shearing and/or exposure to a solvent
comprising a high concentration of water, such as saliva. In some
embodiments, the polymer is insoluble but breakable in water by
being dispersible, i.e., the polymer breaks down into small
fragments, for example, as a result of shearing. In some
embodiments, a polymer is insoluble but swellable. In
configurations in which a polymer does not break down during use,
the polymer can be a water-repellant polymer or an aqueous-stable
hydrophilic polymer such as certain types of cellulose, for example
paper. In some embodiments, a film fragment can comprise a mixture
of film forming materials.
[0020] Water soluble polymers among those useful herein include
cellulose ethers, methacrylates, polyvinylpyrollidone, and mixtures
thereof. In one embodiment, the polymer is a cellulose ether,
including those selected from the group consisting of hydroxyalkyl
cellulose polymers such as hydroxypropyl methyl cellulose (HPMC),
hydroxypropyl cellulose, hyrdoxyethyl cellulose, methyl cellulose,
carboxymethyl cellulose, and mixtures thereof. Other polymers among
those useful herein include polyvinylpyrrolidone, cross-linked
polyvinyl pyrrolidone, polyvinylpyrrolidone-vinyl acetate
copolymer, polyvinylalcohol, polyacrylic acid, poly acrylate
polymer, cross-linked polyacrylate polymer, cross-linked
polyacrylic acid (e.g, Carbopol.RTM.), polyethylene oxide,
polyethylene glycol, poly vinylalkyl ether-maleic acid copolymer
(such as Gantrez.RTM.) and carboxy vinyl polymer; natural gums such
as sodium alginate, carrageenan, xantham gum, gum acacia, arabic
gum, guar gum, pullulan, agar, chitin, chitosan, pectin, karaya
gum, zein, hordein, gliadin, locust bean gum, tragacantha and other
polysaccharides; starches such as maltodextrin, amylose, high
amylose starch, corn starch, potato starch, rice starch, tapioca
starch, pea starch, sweet potato starch, barley starch, wheat
starch, waxy corn starch, modified starch (e.g. hydroxypropylated
high amylose starch), dextrin, levan, elsinan and gluten; and
proteins such as collagen, whey protein isolate, casein, milk
protein, soy protein and gelatin.
[0021] Non-limiting examples of water dispersable and swellable
polymers include modified starch, alginate esters, divalent or
multivalent ion salts of alginates. Non-limiting examples of water
insoluble polymers include polymers soluble in at least one organic
solvent, such as cellulose acetate, cellulose nitrate,
ethylene-vinyl acetate copolymers, vinyl acetate homopolymer, ethyl
cellulose, butyl cellulose, isopropyl cellulose, shellac, silicone
polymer (e.g. dimethylsilicone), PMMA (poly methyl methacrylate),
cellulose acetate phthalate and natural or synthetic rubber;
polymers insoluble in organic solvents, such as cellulose,
polyethylene, polypropylene, polyesters, polyurethane and
nylon.
[0022] Films of this invention, in some embodiments, comprise
inorganic materials. Such materials including those selected from
the group consisting of mica, mica coated with titanium dioxide,
clay, mother-of-pearl, and combinations thereof. In some
embodiments, the film forming material comprises graphite. In some
embodiments, a film forming material comprises a hydrophobic
organic non-polymeric material such as a wax, for example bees wax,
or a paraffin.
[0023] In one embodiment, the film comprises an hydroxyalkyl
cellulose such as hydroxypropyl methyl cellulose,
hydroxyethylpropyl cellulose, hydroxybutyl methyl cellulose,
hydroxy propyl methyl cellulose and carboxymethyl cellulose.
Preferably in one such embodiment, the cellulose polymer is a low
viscosity HPMC. When HPMC is used as the film forming agent it is
preferred that the HPMC have a viscosity in the range of about 1 to
about 1000 millipascal seconds (mPa.multidot.s) as determined as a
2% by weight aqueous solution of the HPMC at 20.degree. C. using a
Ubbelohde tube viscometer. Preferably the HPMC has a viscosity of
about 3 to about 500 mPa.multidot.s at 20.degree. C. HPMC is
available commercially, for example, from the Dow Chemical Company
under the trade designation Methocel, including, for example,
Methocel E5LV, Methocel E50, and Methocel K100. Methocel E5 LV is a
USP grade, low viscosity HPMC having 29.1% methoxyl groups and 9%
hydroxyproxyl group substitution. It is a white or off-white
free-flowing dry powder. As a 2 wt. % solution in water as measured
with a Ubbelohde tube viscometer it has a viscosity of 5.1 mPa-s at
20.degree. C. In one embodiment, the hydroxyalkyl mnethyl cellulose
is incorporated in the film matrix in amounts ranging from about 10
to about 80% by weight and preferably about 30 to about 60% by
weight.
[0024] In various embodiments, the compositions of the present
invention comprise a plurality of lamellar fragments entrained in a
carrier. In one embodiment, the composition comprises a film,
wherein the film comprises lamellar fragments of the film material.
In one embodiment, the composition comprises a carrier having
distributed therein a plurality of lamellar fragments, wherein said
fragments comprise a matrix and a functional material. In one such
embodiment, the matrix comprises a film. Such fragments may be of
any of a variety of shapes or forms, including semi-solid or solid
discrete portions, fragments, particles, flakes, or combinations
thereof. In various embodiments, the film comprises a first
plurality of fragments and a second plurality of fragments, wherein
the first plurality of fragments differ in composition or
appearance from the second plurality of fragments. Such difference
in composition or appearance can be in any aspect of the
composition of the fragment (e.g., different film components,
different functional material, different formulation colorant),
different appearance (e.g., shape, color, texture, refractive
index, reflective index), or combinations thereof.
[0025] In various embodiments, the fragments exhibit perceivable
contrast with the carrier. The perceivable contrast can be sensory
contrast, such as optical contrast, tactile contrast, taste
contrast, or olfactory contrast. In some configurations, optical
contrast can be color contrast, or a difference in refractive index
or reflective index. In some configurations, color contrast can be
imparted by one or more colorants that comprise different
components of the composition. In various embodiments, the present
invention provides compositions comprising a plurality of film
fragments in a carrier, wherein said fragments are visibly
discernable. As referred to herein, "visibly discernable" refers to
one or more characteristics of a fragment which cause the fragment
to have a different physical appearance, preferably to the naked
eye, relative to the carrier in which the fragment is entrained.
Such characteristics include color, opacity, refractive index,
reflective index, size, shape, and combinations thereof.
[0026] In various embodiments, the fragments have a non-random
shape. In one embodiment, a "non-random" shape is a shape which
results from a manufacturing process of shaping, cutting, or other
forming process by which a specific shape is imparted to a
fragment. In such embodiments, a non-random shape is distinguished
from such shapes that result from simple precipitation or grinding
of a material. In one embodiment, a "non-random" shape is
"repeating," wherein the composition comprises a plurality of
fragments have substantially the same shape. Such repeating shape
may have any of a variety of forms, and may be selected based on a
variety of aesthetic or functional criteria. In certain
embodiments, the shape of a film fragment can be a recognizable
shape. In certain embodiments, a film fragment can comprise a
nonrandom shape. Such shapes include simple geometric shapes, such
as polygons and elliptical shapes, such as triangles,
quadrilaterals (such as a square, a rectangle, a rhombus),
pentagons, hexagons, oval, and circles. In one embodiment, the
repeating shape is a square. Repeating shapes include, in other
embodiments, shapes that are representative of figures or animate
or inanimate objects, such as stars, hearts, gems, flowers, trees,
shamrocks, a letter of an alphabet, numbers, animals, people, and
faces. In various embodiments, the composition comprises a single
repeating shape. In other embodiments, the composition comprises a
plurality of fragments having a plurality of repeating shapes. In
one embodiment, the compositions of the present invention comprise
a plurality of first film fragments having a first repeated shape
and a plurality of second film fragments having a second repeated
shape, wherein the first repeated shape is different from the
second repeated shape.
[0027] In various embodiments, the size of the fragments is not
critical, and may be determined pursuant to any of a variety of
criteria, including manufacturing convenience, affect on visual
appearance, surface area, affect on texture in the composition, and
combinations thereof. In some embodiments, the film fragments can
be up to about 1 inch (25.4 mm) in length in the longest dimension.
As referred to herein, "long dimension" is the dimension of a
fragment in length or width (i.e., in the x- and y-dimensions, as
the fragment is, or is deformed to be, in a planar shape) in a
dimension substantially perpendicular to the "thickness" or
shortest dimension of the fragment (i.e., the z-dimension). It is
understood that in various embodiments comprising a plurality of
fragments, the fragments may be present in a range of sizes due to
a variety of factors, including random variation in size,
manufacturing tolerances, and intentional sizing or mixing of the
fragments through sieving or similar means. As referred to herein,
sizes refer to the average size of fragments in a given plurality
of fragments.
[0028] In various embodiments, the fragments are from about 0.2 mm
to about 15 mm in long dimension. In various embodiments, the long
dimension of the fragments is from 0.2 mm to about 10 mm, from
about 0.5 mm to about 10 mm, from about 0.8 mm to about 8 mm, from
about 0.9 mm to about 5 mm, from about 1.0 mm to about 5 mm, or
from about 1.5 mm to about 2.5 mm. In some embodiments, the long
dimension of the fragments is at least about 3 mm, and can be from
about 6 mm to about 13 mm. In certain embodiments, a plurality of
film fragments are greater than about 600 microns in the longest
dimension. In certain embodiments, a plurality of film fragments
are greater than about 1 millimeter in the longest dimension.
[0029] In one embodiment, wherein the fragment comprises
mother-of-pearl, the fragments are greater than about 590 microns
in their longest dimension. In one embodiment, wherein the fragment
comprises mica film fragments coated with a thin layer of titanium
dioxide, the film fragments are greater than 110 microns in their
longest dimension.
[0030] In various embodiments, the fragments of the present
invention have a thickness of from about 1 mil (thousandth of an
inch, 25.4 microns) to about 3 mils (76.2 microns). In various
embodiments, the fragments have a thickness of less than about 4
mils or less than about 100 microns and from about 0.1 mils (2.54
microns) up to about 10 mils (254 microns), from about 0.5 mils
(12.7 microns) up to about 5 mils (127 microns), from about 1.4
mils (35.6 microns) to about 2.0 mils (50.8 microns).
[0031] In some embodiments, the compositions of the present
invention comprise fragments having an aspect ratio of at least
about 5:1. As referred to herein, "aspect ratio" of a fragment is
the ratio of the diameter of the smallest imaginary sphere that can
enclose the object to the diameter of the largest imaginary sphere
that can be completely inside the object and tangent to the
surfaces of the object. For example, the aspect ratio of a sphere
is 1:1; in another example, the aspect ratio of a cylinder that is
2 inches (50.8 mm) long and 1/4 inch (6.35 mm) in diameter is
slightly over 8:1; in yet another example, a film fragment of the
present invention that is 1 mil (25.4 microns) in thickness, 1 inch
(25.4 mm) in length, and 1 inch (25.4 mm) wide has an aspect ratio
of about 1414:1.
[0032] In some embodiments, the compositions of the present
invention comprise fragments having an aspect ratio of at least
about 10:1. In various embodiments, the fragments have an aspect
ratio of from about 5:1 to about 10,000:1, from about 5:1 to about
500:1, from about 10:1 to about 1,000:1, from about 10:1 to about
100:1, from about 20:1 to about 100:1, or from about 25:1 to about
35:1.
[0033] In various embodiments, the film comprises a formulation
colorant, that imparts a color to the film, the composition, or
both. In various embodiments, the film fragments contrast with the
carrier, and are white, black, or of any color that is visible
against or contrasts with the carrier background. Formulation
colorants among those useful herein include non-toxic water soluble
dyes or pigment, such as, for example, metallic oxide "lakes." In
certain embodiments, the colorant is approved for incorporation
into a food or drug by a regulatory agency, such as FD&C or
D&C pigments and dyes approved by the FDA for use in the United
States. Colorants among those useful herein include FD&C Red
No. 3 (sodium salt of tetraiodofluorescein), Food Red 17, disodium
salt of
6-hydroxy-5-{(2-methoxy-5-methyl-4-sulphophenyl)azo}-2-naphthalenesulfoni-
c acid, Food Yellow 13, sodium salt of a mixture of the mono and
disulphonic acids of quinophtalone or 2-(2-quinolyl) indanedione,
FD&C Yellow No. 5 (sodium salt of
4-p-sulfophenylazo-1-p-sulfophenyl-5-hydroxy- pyrazole-3 carboxylic
acid), FD&C Yellow No. 6 (sodium salt of
p-sulfophenylazo-B-naphtol-6-monosulfonate), FD&C Green No. 3
(disodium salt of
4-{[4-(N-ethyl-p-sulfobenzylamino)-phenyl]-(4-hydroxy-2-sulfonium-
phenyl)-methylene}-[1-(N-ethyl-N-p-sulfobenzyl)-A-3,5-cyclohexadienimine],
FD&C Blue No. 1 (disodium salt of
dibenzyldiethyl-diaminotriphenylcarbino- l trisulfonic acid
anhydrite), FD&C Blue No. 2(sodium salt of disulfonic acid of
indigotin), and mixtures thereof in various proportions. In one
embodiment, the colorant comprises a water insoluble inorganic
pigment, such as titanium dioxide, chromium oxide green,
phthalocyanine green, ultramarine blue, ferric oxide, or a water
insoluble dye lake. In some embodiments, dye lakes include calcium
or aluminum salts of an FD&C dye such as FD&C Green #1
lake, FD&C Blue #2 lake, D&C Red #30 lake or FD&C #
Yellow 15 lake. In certain embodiments, a water soluble dye, such
as, for example, FD&C Blue #1, is contained within a
water-insoluble polymer such as, for example polyethylene such as
that found in polyethylene beads (e.g., Microblue Spectrabeads,
sold by Micropowders, Inc.). In certain embodiments, the film
comprises a dye such as D&C Red #30. In certain embodiments, a
white colorant is used, for example titanium dioxide (TiO.sub.2),
titanium dioxide coated mica (e.g., Timiron), a mineral, or a clay.
In certain embodiments, the colorant is a non-bleeding dye. In
various embodiments, the film comprises a colorant at a level of
from about from 0.5% to about 20% by weight of the film, or from
about 1% to about 15% by weight of the film, or from about 3% to
about 12% by weight of the film. In one embodiment, the
compositions of the present invention comprise a first plurality of
film fragments comprising a first color, and a second plurality of
film fragments comprising a second color. Preferably, the second
color is different than the first color.
[0034] In some embodiments, color space coordinates of phases of a
composition, such as, for example, a film and a carrier (e.g.,
toothpaste), can be determined separately. In certain embodiments,
the coordinates for a product film/carrier pairing can be quite far
apart (such as disclosed in Example 12, infra), and can contribute
to a compositions aesthetic appeal, for example by contributing to
a striking nature of a composition's aesthetic appeal. In certain
alternative embodiments, the coordinates for a product film/carrier
pairing can be not particularly large yet still have a noticeable
aesthetic effect. In certain embodiments, the L a* b* system
established by the Commission Internationale d'Eclairage (CIE) is
used to establish color values. (See, for example, McClelland, D.,
Macworld.RTM. Photoshop.RTM. 4 Bible, IDG Books Worldwide, Inc.
1997, pp.157-184.) In addition, the quantity .DELTA.E* can also be
indicative of noticeable color differences. .DELTA.E** can be
determined using the following equation.
.DELTA.E*={(.DELTA.L*).sup.2(.DELTA.a*).sup.2+(.DELTA.b*).sup.2}.sup.1/2
[0035] where .DELTA.L* is the difference in lightness, and
.DELTA.a* and .DELTA.b* are the differences in the color space
coordinates, a* and b*. In certain configurations, color value
measurements can be made using a chromameter, with data collection
in the L*a*b* color coordinate mode using standard procedures.
[0036] The film of the present invention, in various embodiments,
disintegrates during use of the composition. In other embodiments,
the film does not disintegrate during use of the composition. In
some embodiments, the film releases a material, such as a
functional material, into the carrier. As referred to herein,
"disintegrate" refers to physical disruption of the film or
fragment material, so as to produce a film or film fragments of
reduced size compared to the original film. Such disruption may be
through mechanical, chemical, or physical-chemical means. The
disintegration can result, for example, from shearing, grinding, or
exposure to elevated temperatures during use. In various dentifrice
embodiments of the present invention, such disintegration results
from brushing of the composition on the teeth of the subject using
the composition. In one embodiment, the film disintegrates so as to
release a functional material (as further described herein). In
some embodiments, a film fragment can disintegrate into small
pieces that are not visually discernable. In some embodiments, the
film fragments disintegrate to collectively form a colloid or
gel.
[0037] In various embodiments, the composition of the present
invention passes a disintegration test. In a preferable
Disintegration Test, one gram of a composition comprising a sample
of film fragments is placed on top of a 2 inch (50.8 mm) magnetic
star bar. The stir bar is placed into a transparent vessel, such as
a 500 ml beaker containing 300 ml of water at 30.degree. C. The
water comprising the stir bar is then stirred for 5 minutes at 750
rpm. The water is then analyzed for the presence of broken and
unbroken film fragments. The analysis can comprise straining the
water through a mesh that is less than half an original long
dimension of the film shape. This test will show if any pieces did
not break up.
[0038] In one embodiment, the film of the present invention has a
Dissolution Value operable to effect release of said functional
material during use of said composition. As referred to herein, the
Dissolution Value is measured in a test where a one-inch round
circle of film is placed in a container of water, without stirring,
at about 30.degree. C. The Dissolution Value is then determined as
the time lapsed until the film has disintegrated so that no piece
of the film remains having a size greater than 0.25 (0.63 cm)
inches in any dimension. In certain dentifrice embodiments, a
plurality of fragments, disintegrate or dissolve under conditions
of normal use within about two minutes. In various embodiments, the
Disintegration Value can be from about 2 seconds to about 200
seconds, from about 5 seconds to about 120 seconds, or from about
50 seconds to about 100 seconds. In various embodiments,
dissolution values can be at least about 5 seconds, from about 10
to about 200 seconds, from about 30 to about 120 seconds, or from
about 40 to about 100 seconds.
[0039] In some embodiments, the film comprises materials selected
from the group consisting of water insoluble polymers, non-polymer
film forming materials, and mixtures thereof to form stable film
fragments, i.e., film fragments that do not disintegrate under
normal intended use. In various embodiments, the films comprise a
plurality of first film fragments having a first Disintegration
Value, and a second plurality of second film fragments having a
Distintegration Value that is significantly different than said
first Disintegration Value.
[0040] The film of the present invention optionally comprises
materials that affect the physical or functional characteristics of
the film. Such additional substances can be, for example,
emulsifiers, plasticizers, fillers, or texture modifiers. Fillers
among those useful herein include inert starch particles and
cellulose. Texture modifiers include cold water swellable,
physically modified and pregelatenized starches, to increase the
stiffness of polymeric films, such as those comprising hydroxyalkyl
methyl cellulose. In the preparation of such starch products, the
granular starch is preferably cooked in the presence of water and,
optionally, an organic solvent at a temperature not higher than
10.degree. C. higher than the gelatinization temperature. The
obtained starch is then dried.
[0041] Pregelatinized corn starch useful herein is available
commercially. A preferred starch is available under the trade
designation Cerestar Polar Tex-Instant 12640 from the Cerestar
Company. This Cerestar starch is a pregelatinized, stabilized and
crosslinked waxy maize starch. It is readily dispersible and
swellable in cold water. In its dry form, it is a white free
flowing powder with an average flake size no greater than 180
micrometers and 85% of the flakes are smaller than 75 micrometers.
It has a bulk density of 441bs/ft.sup.3. The Cerestar starch has
excellent cold storage and freeze-thaw stability. It has a rapid
hydration rate and can reach extremely high viscosity without
cooking. It has a smooth and creamy texture similar to cook-up
starches. It also has excellent paste clarity and a bland flavor.
In one embodiment, the pregelatinized starch is present in the film
matrix in an amount ranging from about 5 to about 50% by weight and
preferably about 10 to about 35% by weight. The hydroxyalkyl
cellulose to starch ratio (by weight) may vary from about 1:3 to
about 5:1 and preferably about 1:1 to about 4:1.
[0042] In one embodiment, the film comprises more than one layer.
For example, a film can comprise a first layer comprising a
polymer, one or more additional layers that provide a coating. The
coating can be, for example, a shellac coating. A coating can
comprise a layer on either or both sides of a polymer layer. Thus,
in some embodiments, a process for making a multi-layered film can
comprise forming a first layer of a film, such as a polymer layer,
then coating the first layer with a second or subsequent layer of a
coating material, for example shellac.
[0043] Functional Material:
[0044] In various embodiments, the films of the present invention
comprise a functional material. As referred to herein, a
"functional material" is a material having a desired utility in the
oral or personal care composition. In various embodiments, such
utilities are therapeutic, cosmetic, aesthetic, decorative, sensory
or combinations thereof. In some embodiments, film flakes comprised
by a composition can comprise a plurality of functional materials.
Such functional materials can be incorporated within the film or
comprise a coating on the surface of the film. In one embodiment,
the compositions of the present invention comprise a plurality of
first film fragments having a first functional material, and a
plurality of second film fragments having a second functional
material, wherein the second functional material differs from the
first functional material.
[0045] In various embodiments, the functional material is a
flavorant. In certain oral care embodiments, a flavorant is rapidly
released as the fragments disintegrate during use of the product,
delivering a breath freshening flavor or desired mouthfeel or
sweetness into the oral cavity. Flavorants among those useful
herein include synthetic flavor oils or a flavoring aromatics, oleo
resins and extracts derived from plants, leaves, flowers, fruits
and so forth, and combinations thereof. Representative flavor oils
include 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. Flavorants can be used individually or in
admixture. Commonly used flavors include mints such as peppermint,
artificial vanilla, cinnamon derivatives, and various fruit
flavors. In certain embodiments, the film comprises 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. In various embodiments, the film comprise a flavorant
at a level of from about 1% to about 30% by weight of the film, or
from about 8% to about 25% by weight of the film.
[0046] In some embodiments, the film also comprises a sweetener.
Sweeteners among those useful herein include natural and synthetic
sweeteners. In one embodiment, the sweetener is a water soluble
sweetening agent such as a monosaccharide, a disaccharide or a
polysaccharide. For example, water soluble sweetening agents
include xylose, ribose, glucose (dextrose), mannose, glatose,
fructose (levulose), sucrose (sugar), maltose, a soluble saccharin
salt, i.e., a sodium or a calcium saccharin salt, a cyclamate salt,
dipeptide based sweeteners, such an L-aspartic acid derived
sweetener such as L-aspartyl-L-phenylalaine methyl ester
(aspartame). In various embodiments, the film comprises a sweetener
at a level of from about 0.01% to about 10% by weight of the
film.
[0047] In various embodiments, the film comprises a therapeutic
active. As referred to herein, a therapeutic active is a material
that is useful for the prevention or treatment of a physiological
disorder or condition. Such disorders or conditions include those
of the oral cavity (including the teeth and gingiva), skin, hair,
and eyes. The specific therapeutic active is preferably determined
according to the desired utility of the composition. Such actives
include the following.
[0048] A. antimicrobial agents, such as triclosan, cetyl pyridium
chloride, domiphen bromide, quaternary ammonium salts, zinc
compounds, sanguinarine, fluorides, alexidine, octonidine, EDTA,
essential oils such as thymol, methyl salicylate, eucalyptol and
menthol, and the like,
[0049] B. non-steroidal anti-inflammatory drugs, such as aspirin,
acetaminophen, ibuprofen, ketoprofen, diflunisal, fenoprofen
calcium, naproxen, tolmetin sodium, indomethacin, and the like,
[0050] C. anti-tussives, such as benzonatate, caramiphen edisylate,
menthol, dextromethorphan hydrobromide, chiophedianol
hydrochloride, and the like,
[0051] D. decongestants, such as pseudoephedrine hydrochloride,
phenylepherine, phenylpropanolamine, pseudoephedrine sulfate, and
the like,
[0052] E. anti-histamines, such as 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, and the like,
[0053] F. expectorants, such as guaifenesin, ipecac, potassium
iodide, terpin hydrate, and the like,
[0054] G. anti-diarrheals, such a loperamide, and the like,
[0055] H. H.sub.2-antagonists, such as famotidine, ranitidine, and
the like; and
[0056] I. proton pump inhibitors, such as omeprazole, lansoprazole,
and the like,
[0057] J. general nonselective CNS depressants, such as aliphatic
alcohols, barbiturates and the like,
[0058] K. general nonselective CNS stimulants such as caffeine,
nicotine, strychnine, picrotoxin, pentylenetetrazol and the
like,
[0059] L. drugs that selectively modify CNS function such as
phenyhydantoin, phenobarbital, primidone, carbamazepine,
ethosuximide, methsuximide, phensuximide, trimethadione, diazepam,
benzodiazepines, phenacemide, pheneturide, acetazolamide,
sulthiame, bromide, and the like,
[0060] M. antiparkinsonism drugs such as levodopa, amantadine and
the like,
[0061] N. narcotic-analgesics such as morphine, heroin,
hydromorphone, metopon, oxymorphone, levorphanol, codeine,
hydrocodone, xycodone, nalorphine, naloxone, naltrexone and the
like,
[0062] O. analgesic-antipyretics such as salycilates,
phenylbutazone, indomethacin, phenacetin and the like,
[0063] P. psychopharmacological drugs such as chlorpromazine,
methotrimeprazine, haloperidol, clozapine, reserpine, imipramine,
tranylcypromine, phenelzine, lithium and the like.
[0064] The amount of medicament that can be used in the films, can
be dependent upon the dose needed to provide an effective amount of
the medicament. Examples of doses for specific medicaments that can
be delivered in a film comprised by a composition are reviewed in
Example 23.
[0065] In various embodiments, such utilities are therapeutic,
cosmetic, aesthetic, decorative, sensory, or combinations thereof.
In non-limiting examples, functional materials useful herein
include flavorants, fragrances, essential oils, emulsifying agents,
thickening agents, colorants, cooling agents, sweeteners, binding
agents, surfactants, sulfur precipitating agents, plasticizing
agents, pharmaceutical actives, salivary stimulants, stain
prevention actives, anti-microbial agents, vitamins, herbs and
herbal extracts, amino acids, enzymes or other proteins, abrasives,
anti-caries agents, whitening agents, odor control agents, breath
freshening agents, tartar control actives, plaque control agents,
periodontal actives, antiperspirant actives, deodorant actives,
conditioning agents, moisturizers, hair colorants, and combinations
thereof.
[0066] In various embodiments, therapeutic agents useful herein
include anticaries agents, tartar control agents, antiplaque
agents, periodontal actives, breath freshening agents, malodour
control agents, whitening agents, antibacterials, steroids,
anti-inflammatory agents, vitamins, proteins, conditioning agents,
moisturizers, antiperspirant actives, deodorant actives,
anesthetics, and mixtures thereof.
[0067] In certain oral care embodiments, the film comprises an oral
care active, which is useful for the prevention or treatment of an
oral care disorder or condition. Oral care actives among those
useful herein include abrasives, anticaries agents, tartar control
agents, antiplaque agents, periodontal actives, breath freshening
agents, malodour control agents, tooth desensitizers, salivary
stimulants, whitening agents, and combinations thereof. Active
materials among those useful herein are described in U.S. Pat. No.
6,596,298, Leung et al.
[0068] Tartar control agents among those useful herein include
dialkali or tetraalkali metal pyrophosphate salts such as
Na.sub.4P.sub.2O.sub.7, K.sub.4P.sub.2O.sub.7,
Na.sub.2K.sub.2P.sub.2O.sub.7, Na.sub.2H.sub.2P.sub.2O.sub.7 and
K.sub.2H.sub.2P.sub.2O.sub.7; long chain polyphosphates such as
sodium hexametaphosphate; and cyclic phosphates such as sodium
trimetaphosphate. In some configurations, a polyphosphate is a
beta.-phase calcium pyrophosphate, such as disclosed in U.S. Pat.
No. 6,241,974, White, Jr. In some embodiments, the film comprises
an anticalculus agent at a level of about 15 to 20% by weight of
the film.
[0069] Odor reducing agents useful herein include sulfur
precipitating agents. Such sulfur-precipitating agents include
metal salts, such as a copper salt or a zinc salt. Such salts
include copper gluconate, zinc citrate and zinc gluconate. In
various embodiments, the film comprises sulfur precipitating agents
at a level of from about 0.01 to about 30% by weight of film, from
about 2% to about 2.5% by weight of film, or about 10% to about 20%
by weight of film.
[0070] In a certain embodiments, the functional material comprises
a saliva stimulating agent (a "succulent"), Such agents include
those disclosed in U.S. Pat. No. 4,820,506, Kleinberg et al. In
some configurations, a saliva stimulating agent can include a food
acid such as citric, lactic, malic, succinic, ascorbic, adipic,
fumaric and tartaric acids. In various embodiments, the film
comprises a saliva stimulating agent at a level of from about 0.01
to about 12% by weight of the film, from about 1% to about 10% by
weight of the film, or from about 2.5% to about 6% by weight of the
film. In some embodiments, a saliva stimulating agent can be used
in the amelioration of dry mouth.
[0071] In certain oral care embodiments, the film comprises other
active materials, such as antibacterial agents such as magnolia
extract, triclosan, grapeseed extract, thymol, methyl salicylate,
eucalyptol, menthol, hop acids, cetyl pyridinium chloride,
(including CPC/Zn and CPC+enzymes) and usnic acid;
anti-inflammatory agents such a breath freshening agents (for
example zinc gluconate, zinc citrate, zinc chlorite and alpha
ionone); tooth desensitizers such as potassium nitrate,
desensitizing polymers, and desensitizing minerals;
anti-inflammatory agents such as magnolia extract, ursolic acid;
aloe, and cranberry extract; vitamins such as pantheon, retinyl
palmitate, folic acid, tocopherol acetate and Vitamin A; herbs or
herbal extracts such as rosemary, oregano, chamomilla recutita,
mentha piperita, salvia officinalis, orcommiphora and myrrha;
proteins, such as milk proteins and enzymes such as
peroxide-producing enzymes, amylase, plaque-isrupting agents such
as papain, glucoamylase, glucose oxidase, and "next generation"
enzymes; whitening agents such as hydrogen peroxide, urea peroxide
and phosphate salts; medicinals, such as aspirin (acetyl salicylic
acid), caffeine, and benzocaine; probiotics; abrasives such as
silicas (including high cleaning silica); anti-caries agents such
as stannous salts (e.g., stannous fluoride) or amino fluoride; a
nitric oxide synthase inhibitor such as guanidinoethyldisulfide;
calcium; antiattachmetn ingredients, such as polyumylphosphonic
acid; preservatives such as Solbrol.RTM. (Bayer Chemicals AG);
silicones; chlorophyll compounds, anti-leukoplakia agents such as
beta-carotene; anti-oxidants such as Vitamin E; and combinations
thereof. In some embodiments, the films comprise such active
materials at a concentration of about 0.01 to about 30% by weight
of film, from about 2% to about 25% by weight of the film, or from
about 10% to about 20% by weight of film.
[0072] In certain skin care embodiments, the functional material
comprises a material selected from the group consisting of
surfactants, conditioning agents, moisturizers, enzymes and other
proteins, vitamin, and mixtures thereof.
[0073] In certain hair care embodiments, the functional material
comprises a material selected from the group consisting of
surfactants, colorants, denaturants, film forming polymers,
conditioners, moisturizers, enzymes and other proteins, vitamins,
antidandruff agents, and mixtures thereof.
[0074] In certain antiperspirant or deodorant embodiments, the
functional material comprises a material selected from the group
consisting of fragrances, alcohols, anticholinergics,
antiperspirant salts (such as aluminum and zirconium salts),
moisturizers, and mixtures thereof.
[0075] In various embodiments, the film comprises a compatibility
enhanced active. As referred to herein, a "compatibility enhanced
active" is a functional material that has enhanced utility in a
composition wherein the material is a component of a film, relative
to the utility of the material in a composition wherein the
material is a component of the carrier. Such enhanced utility may
be due to any of a variety of factors, including enhanced delivery
or reduced physical or chemical degradation of the material. In
some embodiments, the compatibility enhanced material is
incompatible with a component or components of the carrier. A
component which is incompatible with a carrier can be, for example,
a component which reacts chemically or forms a precipitate with a
component of the carrier.
[0076] Compatibility enhanced actives among those useful herein
include cationic antimicrobials, calcium salts, fluoride salts,
enzymes and other proteins, and other ingredients incompatible with
anionic components, and mixtures thereof. In one dentifrice
embodiment, a compatibility enhanced active is a cationic
antimicrobial, such an antimicrobial comprising a quaternary group.
Examples of such antimicrobials include cetyl pyridinium chloride
(CPC), chlorhexidine, and ethyllauroylarginine HCl. Such actives
are generally incompatible with carriers comprising the surfactant
sodium lauryl sulfate (SLS, a common component of dentifrices) or
silicate abrasives. For example, in such a composition, the CPC and
SLS typically form a complex upon mixing. The formation of the
complex renders both compounds ineffective for their intended
purposes in a dentifrice. However, incorporation of CPC in a film
in a dentifrice composition of this invention comprising both film
and a carrier which comprises SLS will maintain both substances in
the dentifrice in an effective state. Other examples of
compatibility enhanced actives useful in dentifrice compositions of
this invention include the anti-caries agent sodium fluoride (NaF),
which is a component of some dentifrices, can be incompatible with
calcium, which is also comprised by some dentifrices, because
calcium fluoride (CaF.sub.2), can form a precipitate. However, if
one of these components (for example, sodium fluoride) is comprised
by film fragments in an oral care composition, the composition can
provide effective amounts of both calcium and the anti-caries
agent.
[0077] In certain embodiments, the film comprises a preservative. A
preservative can be added in amounts from about 0.001 wt % to about
5 wt %, preferably from about 0.01 wt % to about 1 wt % of the
film. Non-limiting examples of preservatives include sodium
benzoate and potassium sorbate.
[0078] In various embodiments, the present invention provides a
dentifrice having entrained therein flakes of a water hydratable
film comprised of a homogeneous mixture of a water soluble
hydroxyalkyl cellulose polymer and, optionally, starch, the film
matrix having entrained therein an agent selected from therapeutic,
cosmetic, sensory, and decorative agents. In one embodiment there
is provided an aesthetically decorative dentifrice having
distributed throughout film flakes in which a decorative colorant
is entrained in the film matrix, the dentifrice vehicle being
substantially clear so that the aesthetically decorative effect can
be viewed by the user. In various embodiments, therapeutic agents
such as antibacterial agents and fluoride anticaries salts, are
entrained in the film flake matrix. In various embodiments, sensory
agents such as breath freshening agents, mouthfeel agents, and
sweetening agents are entrained in the film flake matrix. In one
such embodiment, the flavorants are rapidly released as the flakes
disintegrate during toothbrushing, delivering a pleasing burst of
sweetness or breath freshening flavor into the oral cavity.
[0079] In certain embodiments, the entrainment of the therapeutic,
cosmetic, sensory and decorative agents in the film matrix
suspended in the dentifrice or other composition isolates these
agents from interaction with reactive ingredients present in the
composition so that the agents are maintained substantially
separate from the reactive composition ingredients during
manufacture and storage while subsequently being released from the
film matrix when the composition is used.
[0080] The films of the present invention may be made in a variety
of ways, including methods among those known in the art for making
films. In various embodiments, components of a film forming slurry,
such as those disclosed in the Examples below, are mixed to form a
film forming slurry composition. The slurry is cast on a releasable
substrate and dried to form a sheet of film material. In one
embodiment, the substrate material has a surface tension that
allows the film slurry to spread substantially uniformly across the
substrate surface, thereby avoiding formation of a destructive bond
between the film and the substrate. Non-limiting examples of
suitable substrates include glass, stainless steel, Teflon and
polyethylene- or silicone-impregnated paper. Following casting, the
film is then dried. Drying of the slurry can be carried out at high
temperature with the aid of a drying oven, a drying terminal, a
vacuum drier, or any other suitable drying equipment known in the
art. In other embodiments, the film is made by extrusion of the
film composition through a die, followed by cutting to a desired
thickness, and drying. In other embodiments, the film is made by
solvent casting.
[0081] In some embodiments, film fragments comprising a repeating
shape, such as, for example, a geometric or representational shape,
are formed from a slurry or a dried film. In certain
configurations, forming of a shape can be by any method known to
skilled artisans, such as, for example, adding a slurry to a
substrate comprising a mold. In certain embodiments, a dried film
can be cut or punched into a shaped film fragment.
[0082] The film fragments are incorporated in the base dentifrice
of the present invention at a broad range of concentrations. In
various dentifrice embodiments, the carrier comprises fragments at
a level of from about 0.005% to about 5% by weight of the
composition, or from about 0.05 to about 0.5% by weight of the
composition.
[0083] Carrier:
[0084] The compositions of the present invention comprise a carrier
in which a film, or fragments, is entrained. As referred to herein,
a "carrier" is any material or composition in which a film can be
entrained and is suitable for administration or application to the
human or animal subject to whom the composition is administered or
applied. As referred to herein, "entrained" refers to the embedding
or suspension of a film in a carrier. In various embodiments
comprising a plurality of fragments, such fragments may be
entrained by embedding, suspension, dispersion or other
distribution of the fragments in the carrier. In various
embodiments, the fragments are distributed substantially
homogenously throughout the carrier. In other embodiments, the
fragments are not distributed homogenously in the carrier. In
certain embodiments, the distribution of a plurality of film
fragments is substantially isotropic within the carrier.
[0085] The compositions of the present invention may be described
as comprising two phases, wherein one phase comprises a carrier and
a second phase comprises a film or fragment. By "phase" as used
herein is meant a physical phase as understood in the physical and
material sciences, i.e., a portion of a material whose properties
and composition are uniform. However, a phase as used herein can be
discontinuous, i.e., a phase can comprise a plurality of separate
components. For example, a plurality of polymer film fragments of
identical composition is considered to comprise a single phase. In
some embodiments, a film fragment can be entirely embedded within
the material comprising the first phase, or totally or partially
exposed on the surface of the first phase. For example, if the
composition is a dentifrice comprising both a gel and film
fragments, a film fragment can be totally surrounded by the gel, or
partially or totally exposed on the surface of the gel. In certain
embodiments, compositions comprise more than two phases. Such
multi-phase compositions include those having two carriers, each of
which contributes a phase to the composition, in addition to film
fragments as described herein. Other multi-phase compositions
include those having a single carrier and two or more pluralities
of fragments, wherein the pluralities of fragments have differing
compositions.
[0086] In certain embodiments, a composition comprising at least
two phases can comprise one or more components which, while not
necessary for the structure or stability of a composition, provide
a beneficial or aesthetic effect. In some configurations, a
component providing a beneficial or aesthetic effect can be a
component which is incompatible with at least one phase of the
composition. Such a component can be included in a different phase
of the composition.
[0087] In various embodiments, the carrier is a liquid, semi-solid
or solid. A "liquid" can be a liquid of low or high viscosity. A
liquid can be a liquid of so that flow is imperceptible under
ambient conditions. For example, a soap, such as an ordinary bar of
hand soap, can be considered a liquid herein. A liquid can be a
thixotropic liquid. A "semi-solid" as used herein can be a gel, a
colloid, or a gum. As used herein, semi-solids and liquids are
fluids distinguished on the basis of viscosity: a semi-solid is a
high viscosity fluid, while a liquid has lower viscosity. There is
no definitive dividing line between these two types of fluids. A
semi-solid can, in certain embodiments, have a viscosity as high as
thousands of mPa.multidot.s. Carriers among those useful herein
include liquids, pastes, ointments, and gels, and can be
transparent, translucent or opaque.
[0088] In certain embodiments, the compositions of the present
invention are oral care compositions, suitable for administration
to the oral cavity. Such compositions include dentifrices,
mouthwashes, dental gels, lozenges, beads, gums, oral strips,
mints, liquid toothpastes, sprays, paint-on gels, lip balms,
whitening strips, breath strips, oral chews, and combinations
thereof. An oral care composition disclosed herein can be used, for
example, for cavity prevention, whitening, plaque prevention or
reduction, gingivitis prevention or reduction, tartar control,
sensitivity prevention or reduction, or breath malodor prevention
or reduction, and stain prevention.
[0089] In certain embodiments, a composition comprising at least
two phases can be a skin care composition, for example, a soap, a
lotion, a body wash, a bath gel, a shampoo, a conditioner, a
deodorant, an antiperspirant, a fragrance, a perfume, a cosmetic or
combinations thereof, such as a antiperspirant/deodorant (ABDO). In
certain embodiments, a composition comprising at least two phases
can be a hair care composition, such as, for example, a shampoo or
a conditioner, or a combination thereof.
[0090] The specific composition of the carrier preferably depends
on the intended use of the composition. In various embodiments, the
carrier is aqueous, comprising from about 5% to about 95% water or
from about 10% to about 70% water. In other embodiments, the
carrier is substantially non-aqueous. In a dentifrice carrier,
water content can be from about 5% to about 70%, from about 10% to
about 50%, or from about 20% to about 40%.
[0091] The carrier may comprise any of a variety of materials,
including emulsifiers, thickeners, fillers, and preservatives. In
some embodiments, the carrier comprises a functional material, such
as those described above. In some embodiments, the carrier
comprises the same functional material as the film.
[0092] In one embodiment, the carrier is suitable for use as a
dentifrice. In some embodiments, the carrier comprises a humectant,
such as glycerine, sorbitol or an alkylene glycol such as
polyethylene glycol or propylene glycol. In some configurations,
the carrier comprises a humectant at a level of from about 10% to
about 80% by weight, or about 20% to about 60% by weight of the
composition. Carrier compositions among those useful herein are
disclosed in U.S. Pat. No. 5,695,746, Garlick, Jr., et al, and U.S.
Pat. No. 4,839,157, Mei-King Ng et al.
[0093] In various dentifrice embodiments, the carrier comprises
thickeners, gelling agents or combinations thereof. Thickeners or
gelling agents useful herein include inorganic, natural or
synthetic thickeners or gelling agents. In some configurations, the
carrier comprises the thickener and gelling agent at total levels
of from about 0.10% to about 15% by weight, or from about 0.4% to
about 10% by weight of the composition. Examples of thickeners and
gelling agents useful herein include inorganic thickening silicas
such as: an amorphous silica, for example Zeodent.RTM. 165 (Huber
Corporation); Irish moss; iota-carrageenan; gum tragacanth; or
polyvinylpyrrolidone. In certain embodiments, the carrier comprises
a polishing agent, such as a silica, a calcined alumina, sodium
bicarbonate, calcium carbonate, dicalcium phosphate or calcium
pyrophosphate. In various embodiments, the carrier can be a
visually clear composition.
[0094] In various dentifrice embodiments, comprising a visually
clear carrier, the composition comprises at least one polishing
agent. Polishing agents among those useful herein include collodial
silica, such as, for example, Zeodent.RTM. 115 (Huber Corporation),
and alkali metal aluminosilicate complexes (i.e., a silica
comprising alumina). In some configurations, a polishing agent can
have a refractive index close to that of a gelling agent combined
with water and/or humectant. In various embodiments, the carrier
comprises the polishing agent at a level of from about 5% to about
70% by weight of the composition.
[0095] In certain dentifrices, the carrier comprises a surfactant
or mixture of surfactants. Surfactants among those useful herein
include water-soluble salts of at least one higher fatty acid
monoglyceride monosulfate, such as the sodium salt of the
monsulfated monoglyceride of hydrogenated coconut oil fatty acids;
cocamidopropyl betaine; a higher alkyl sulfate such as sodium
lauryl sulfate; an alkyl aryl sulfonate such as sodium dodecyl
benzene sulfonate; a higher alkyl sulfoacetate; sodium lauryl
sulfoacetate; a higher fatty acid ester of 1,2-dihydroxy propane
sulfonate; and a substantially saturated higher aliphatic acyl
amides of a lower aliphatic amino carboxylic acid, such as those
having 12 to 16 carbons in the fatty acid, alkyl or acyl radicals;
and mixtures thereof. Amides can be, for example, N-lauroyl
sarcosine, and the sodium, potassium, and ethanolamine salts of
N-lauroyl, N-myristoyl, or N-palmitoyl sarcosine. In various
embodiments the carrier comprises the surfactant at a level of from
about 0.3% to about 5% by weight of composition, or about 0.5% to
about 3% by weight of composition.
[0096] The present invention also provides methods for making a
dentifrice carrier. In one embodiment, water and at least one
humectant are dispersed in a conventional mixer until a first
homogeneous gel phase is formed. A polishing agent is added into
the first homogeneous gel phase. The first homogeneous gel phase
and the polishing agent are mixed until a second homogeneous gel
phase is formed. A thickener, flavorant and surfactants are added
to the second homogeneous gel phase. These ingredients are mixed at
high speed under vacuum of about 20 to 100 mmHg.
[0097] In some embodiments, a composition comprising a carrier and
a plurality of film fragments can be suitable for use as a body
cleansing formulation, such as, for example, a soap, or a
soap-based gel formulation. In these embodiments, a carrier can
comprise a cleansing formulation such as, in non-limiting example,
a polyethylene glycol diisostearate such as disclosed in U.S. Pat.
No. 6,531,119, Hall-Puzzio, et al. In certain embodiments, a
composition comprising a carrier and a plurality of film fragments,
wherein the carrier comprises a cleansing formulation can comprise
a polyethylene glycol diisostearate having an average degree of
ethoxylation of from 40-100. The diisostearate can be, in certain
configurations, a component of a soap-based gel composition. In
some embodiments, the diisostearate can be suitable for use in
stable cosmetic compositions, especially as antiperspirants and/or
deodorants, and which diisostearate is compatible with such
formulations.
[0098] In some embodiments, a composition comprising a carrier and
a plurality of film fragments can be suitable for use as a
cosmetic, such as, for example, a mascara formulation that is
removable with soap and water. In these embodiments, the carrier
can be a mascara formulation such as disclosed in U.S. Pat. No.
6,503,495, Alwattari et al. In certain configurations, these
carrier compositions can comprise from about 3% to about 60%
water-insoluble polymeric material, from about 2% to about 50%
water-soluble, film-forming polymers, and from about 0.05% to about
20.0% organophilic clays. In certain embodiments, these
compositions can be fabricated in a multitude of forms, such as
creams, pastes and solids. In some embodiments, a mascara carrier
composition can comprise a water-insoluble polymeric materials in
an aqueous emulsion. In certain embodiments, water-insoluble
polymeric materials, can be aqueous emulsions or dispersions of
polymeric materials comprising polymers. In some configurations,
the polymers can comprise precursor monomers, mixtures of monomers,
natural polymers and mixtures thereof. In some configurations, a
polymeric material can also include water-insoluble polymeric
materials. In certain configurations, a water-insoluble polymer can
comprise from about 3% to about 60%; from about 4% to about 40%, or
from about 5% to about 30% by weight of the composition. In
non-limiting example, a water-insoluble polymeric material can
comprise monomers selected from the group consisting of aromatic
vinyls, dienes, vinyl cyanides, vinyl halides, vinylidene halides,
vinyl esters, olefins and their isomers, vinyl pyrrolidone,
unsaturated carboxylic acids, alkyl esters of unsaturated
carboxylic acids, hydroxy derivatives of alkyl esters of
unsaturated carboxylic acids, amides of unsaturated carboxylic
acids, amine derivatives of unsaturated carboxylic acids, glycidyl
derivatives of alkyl esters of unsaturated carboxylic acids,
olefinic diamines and isomers, aromatic diamines, terephthaloyl
halides, olefinic polyols and mixtures thereof.
[0099] In some embodiments, a composition comprising a carrier and
a plurality of film fragments can be suitable for use as an
antiperspirant, a deodorant, or an antiperspirant--deodorant
(ABDO), such as, for example, an antiperspirant. A carrier of these
embodiments can comprise an antiperspirant composition such as, for
example, an antiperspirant composition disclosed in U.S. Pat. No.
6,524,562, Guskey. In these embodiments, a carrier can be, for
example, a single-phase system comprising a solubilized
antiperspirant active, a silicone elastomer and a volatile
silicone. In some embodiments, a antiperpirant carrier can also
comprise a structurant.
[0100] In some embodiments, a composition comprising a carrier and
a plurality of film fragments can be suitable for use as a shampoo,
such as, for example, an antidandruff shampoo. A carrier of these
embodiments can comprise an antidandruff composition such as, for
example, an antidandruff composition disclosed in U.S. Pat. No.
4,470,982, Winkler. In certain embodiments, a carrier can be, for
example, an antidandruff shampoo composition comprising anionic
surfactant, a suspending agent and an alkanol amide. In some
embodimens, a surfactant can be an alkyl sulfate, an ethoxylated
alkyl sulfate or mixtures thereof. In some configurations, an alkyl
sulfate can be the sodium, ammonium and triethanolamine alkyl
sulfates having from about 8 to about 22 carbon atoms in the alkyl
chain, or from about 8 to about 18 carbon atoms in the alkyl chain,
or from about 8 to about 18 carbon atoms. In certain embodiments, a
suspending agent can comprise, in non-limiting example, ethylene
glycol esters of fatty acids having from about 16 to about 22
carbon atoms, such as, for example, ethylene glycol stearates, both
mono and distearate, or alkanol amides of fatty acids, having from
about 16 to about 22 carbon atoms, or about 16 to 18 carbon atoms.
An alkanol amide can be a stearic monoethanolamide, stearic
diethanolamide, stearic monoisopropanolamide and stearic
monoethanolamide stearate. In certain embodiments, an amide can be
any alkanolamides of fatty acids known for use in shampoos. In
certain configurations, these can be generally mono- and
diethanolamides of fatty acids having from about 8 to about 14
carbon atoms, such as coconut monoethanolamide, lauric
diethanolamide and mixtures thereof. In certain embodiments, an
antidandruff carrier can comprise a particulate antidandruff agent.
In some configurations, these can be, for example, sulfur, selenium
sulfide, salicylic acid, zinc pyridinethione, other 1-hydroxy
pyridones, such as those disclosed in U.S. Pat. No. 4,185,106,
Dittmar et al, and azole antimycotics disclosed in British Pat. No.
1,502,144, Feb. 22, 1978.
[0101] In some embodiments, a composition comprising a carrier and
a plurality of film fragments can be suitable for use as a lotion,
such as, for example, lotion disclosed in U.S. Pat. No. 6,352,701
to Scholz et al., which is hereby incorporated by reference in its
entirety. In some configurations, a lotion carrier can have a very
nice feel after both single and multiple applications. In some
configurations, a composition comprising a lotion carrier and a
plurality of film fragments can maintain or improve the skin
condition after multiple applications without noticeable slimy or
abnormal feeling during post application hand washing. In some
aspects, when used as a presurgical scrub replacement, a
composition comprising a lotion carrier and a plurality of film
fragments can achieve bacterial, fungal, and viral kill equal to or
better than a traditional soap and water scrub in a shorter period
of time while maintaining or improving the skin's natural barrier
to microbial and chemical contaminants. In certain embodiments, a
composition comprising a lotion carrier and a plurality of film
fragments can provide a viscous composition which includes a high
concentration of a lower alcohol but does not require a polymeric
thickener to make the composition viscous. Further, in certain
aspects, a composition comprising a lotion carrier and a plurality
of film fragments can have a cosmetically elegant feel and may be
dispensed as a lotion or as a foam.
[0102] A composition comprising a lotion carrier and a plurality of
film fragments can comprise a lower alcohol and water in a weight
ratio of about 35:65 to 100:0, between at least 0.5% and 8.0% by
weight thickener system comprised of at least two emulsifiers, each
emulsifier present in at least 0.05% by weight wherein the
emulsifiers can be selected such that the composition free of
auxiliary thickeners has a viscosity of at least 4,000 centipoise
at 23 degrees C. and wherein each emulsifier can be comprised of at
least one hydrophobic group and at least one hydrophilic group,
wherein: (i) the hydrophobic group can be comprised of an alkyl
group of at least 16 carbon atoms; an alkenyl group of at least 16
carbon atoms; or an aralkyl or an aralkenyl group of at least 20
carbon atoms; and (ii) the hydrophilic group of at least one
emulsifier can be comprised of an amide group having the structure
--NHC(O)R'" or --C(O)NHR'" where R'" can be hydrogen or an alkyl
group of 1-10 carbon atoms optionally substituted in available
positions by N; O, and S atoms; an ester group of short chain
alcohols or acids (e.g., L=--C(O)OR' or--OC(O)R' where R' can be
C1-C4 branched or straight chain alkyl optionally substituted in
available positions by hydroxyl groups); a polyglucoside group
having 1glucose units; a polyglycerol ester group having 1-15
glycerol units, a secondary amine group; a tertiary amine group; a
quaternary amine group; an anionic group such as a sulfate, a
sulfonate group, a phosphate group, a phosphonate group, a
carboxylate group, or a zwitterionic group.
[0103] In certain embodiments, the films and carriers of the
present invention are comprised so as to maximize aesthetic
acceptability of the composition. As referred to herein, "aesthetic
acceptability" refers to the acceptability of the composition to
the intended user of the composition according to one or more
non-functional characteristics, such as appearance (including color
and texture), flavor, scent, and mouthfeel. A film fragment or a
composition comprising film fragments can be tested for aesthetic
appeal through the use of hedonic testing, including the use of
methods among known in the art. For example, a standard testing
procedure for sensory evaluation can comprise providing samples to
a panel of testers who rate the samples using a 9-point hedonic
scale as described.
1 Score/rating Std. Hedonic Scale 9 like extremely 8 like very much
7 like moderately 6 like slightly 5 neither like nor dislike 4
dislike slightly 3 dislike moderately 2 dislike very much 1 dislike
extremely
[0104] A film or composition scoring above neutral on a 9-point
hedonic scale, i.e. 5.0 or greater, for at least one, more
preferably two and most preferably all sensory characteristics of
shape, color, flavor, mouthfeel and texture can be considered to be
acceptable with respect to the measured attributes. Thus, for
example, a panel comprising at least ten testers provided with film
fragments comprising a particular shape, or a multi-phase
composition comprising film fragments of a particular shape (e.g.,
a dentifrice comprising square film fragments), can rate the film
fragments or the composition for traits such as, for example shape,
color, flavor, strength, foam, aftertaste, feel clean, impact,
mouthfeel, texture and overall liking according to the above scale.
In certain embodiments, the shape of film fragments affect a users
response to traits such as color, flavor, strength, foam,
aftertaste, feel clean, impact, mouthfeel, texture and overall
liking. In certain embodiments, the nature of the product being
tested, or the purpose of the product indicated to the testers,
affect the hedonic response by a tester.
[0105] The compositions of the present invention are preferably
stable under normal conditions of storage. As referred to herein,
"stable" refers to the lack of significant adverse effect on one,
and preferably all, compositional attributes such as appearance,
flavor, rheology, and chemical composition of the composition.
Preferably, stability in the present compositions includes the
compositional and physical stability of film (including fragments,
if any) in the composition. In various embodiments a composition
comprising a film is stable upon storage at ambient temperature for
at least about two years. It is understood, however, that in some
embodiments, an otherwise stable film can disintegrate during use
(as discussed above), for example, during toothbrushing using a
dentifrice composition.
[0106] In certain embodiments, a composition can comprise, in
addition to film fragments as described herein, two or more
carriers, each of which contributes a phase to the composition.
Such a composition can be stable to color bleeding. For example, a
composition can include film fragments and a striped dentifrice
such as that disclosed in U.S. Pat. No. 6,315,986, Wong et al. In
certain embodiments, the film fragments can be of different
color(s) than the stripe(s) for enhanced aesthetic appeal.
[0107] Manufacturing Processes:
[0108] The present invention provides processes for making
compositions comprising a film entrained in a carrier. In various
embodiments, a plurality of fragments are combined with a carrier.
In some configurations, a carrier and a plurality of film fragments
can be mixed. In some configurations, the mixing can comprise slow
stirring. In one embodiment, the present invention provides a
process for making a composition comprising a carrier having
distributed therein a plurality of lamellar fragments, wherein said
process comprises:
[0109] (a) providing said carrier;
[0110] (b) adding said lamellar fragments to said carrier to form a
mixture; and
[0111] (c) homogenizing said mixture.
[0112] As referred to herein, "homogenizing" refers to the
admixture of the fragments and the carrier so as to attain a
substantially homogeneous distribution of fragments in the carrier.
It should be noted, however, that the resulting composition still
retains two-phase composition. Homogenizing may be accomplished
using any of a variety of conventional homegenizers.
[0113] In another method, the film is added to a component of the
carrier (e.g., to a humectant for a dentifrice). The rest of the
carrier is then made, and the mixture of film is then added to the
carrier.
[0114] Methods of Use:
[0115] The present invention provides methods for the administering
a functional material to a human or animal subject. As referred to
herein, "administering" refers to any method by which a composition
is applied on or administered to the subject. In various
embodiments, the administration is topical, wherein the composition
is applied to an external surface of the subject, such as to a
surface of the oral cavity (e.g., teeth, gingival, and tongue), to
the skin, to the eye, and to the hair. The specific route and
method of administration will depend, of course, on the intended
use of the composition.
[0116] In various embodiments, the present invention provides
methods for administering a functional material to a human or
animal subject in need thereof, comprising topically applying to
said subject a composition comprising a film entrained in a
carrier, wherein said film comprises the functional material. In
one embodiment, the method additionally comprises disrupting the
film after topically applying the film. Such disruption may be
accomplished by any of a variety of methods, including chemical
and/or mechanical means. Chemical means include degradation of the
film by contact with water or a material present at the site of
administration (e.g., saliva in an oral care application). Physical
means include agitation, grinding, and shear forces produced by
application of physical energy to the composition during use (e.g.,
brushing in a dentifrice application).
[0117] In various embodiments, the present invention provides
methods for the treatment of an oral care condition. As referred to
herein, an "oral care condition" is any disorder or condition which
can be prevented or treated by administration of a composition to
the oral cavity, including disorders or conditions of the teeth,
oral mucosa, gingiva and tongue. Such conditions include caries,
gingivitis, periodontitis, and cosmetic conditions such as
yellowing and malodour.
[0118] In one embodiment, the present invention provides a method
for enhancing whole body health, by administering a composition of
the present invention to the oral cavity. By "whole body health" as
used herein is meant overall systemic health characterized by a
reduction in risk of development of systemic diseases, such as
major systemic diseases such as cardiovascular disease, stroke,
diabetes, severe respiratory infection, premature and low birth
weight infants (including associated post-partum dysfunction in
neurologic/developmental function), and associated increased risk
of mortality. In various such embodiments, one or more phases of a
composition comprise a functional material. In various embodiments,
the film comprises the functional material; in other embodiments,
the carrier comprises the functional material; in other
embodiments, both the carrier and the film comprise such functional
materials. In one embodiment, the functional material is an oral
care active. In one embodiment, the functional material can provide
a health benefit that is non-exclusive to oral health, for example
a functional material can contribute to the amelioration, risk
reduction, treatment or prevention of disease, dysfunction, or
other abnormality. Such materials among those useful herein include
those described in PCT Publication WO 02/02128 A2, Doyle et al.
[0119] The disease, dysfunction or abnormality can affect one or
more body parts. A composition can promote whole body health by
promoting oral health. For example, a composition can reduce the
risk of the development of cardiovascular disease, stroke,
atherosclerosis, diabetes, respiratory infection, premature birth,
low birth weight, post-partum dysfunction in neurologic and
developmental functions, and associated risk of mortality. For
example, enhancement of whole body health by treatment of the oral
cavity can be evidenced by the following health indicia: I)
reduction in risk of development of heart attack, stroke, diabetes,
severe respiratory infections, low birth weight infants, and
post-partum dysfunction in neurologic/developmental function and
associated increased risk of mortality;
[0120] 2) reduction in the development of fatty arterial streaks,
atherosclerotic plaques, progression of plaque development,
thinning of the fibrous cap on atherosclerotic plaques, rupture of
atherosclerotic plaques, and the subsequent blood clotting
events;
[0121] 3) reduction in carotid arterial (intimal) wall thickness
(e.g., as assessed by ultra-sound techniques);
[0122] 4) reduction in exposure of blood and systemic circulation
to oral pathogens and/or their toxic components, specifically
leading to reduction in blood levels of oral bacteria,
lipopolysaccharide (LPS) and/or the incidence of oral pathogens
and/or components thereof found in arterial plaques, arterial
structures, and/or distant organs (e.g., heart, liver, pancreas,
kidney);
[0123] 5) reduction in exposure of the lower respiratory track to
the inhalation of bacterial pathogens and the subsequent
development of pneumonias and/or exacerbation of chronic
obstructive lung disease;
[0124] 6) reduction in alterations in circulating hematocrit,
hemoglobin, white blood cell count and/or platelet counts;
[0125] 7) reduction in the incidence of disregulation in
blood/serum levels of inflammatory mediators/cytokines such as
TNF-alpha, IL-6, CD-14, and IL-1;
[0126] 8) reduction in the incidence of disregulation of
blood/serum levels of acute phase reactants including C-reactive
protein, fibrinogen, and haptoglobin;
[0127] 9) reduction in the incidence of disregulation of
blood/serum markers of metabolic disregulation including
homocysteine, glycosylated hemoglobin, 8-iso-PGF-2alpha, and uric
acid;
[0128] 10) reduction in incidence of disregulation of glucose
metabolism as typically assessed by impaired glucose tolerance
test, increased fasting blood glucose levels, and abnormal fasting
insulin levels; and
[0129] 11) reduction in disregulation of blood lipid levels
specifically including blood or serum cholesterol, triglycerides,
LDL, HDL, VLDL, Apolipoprotein B, and/or Apolipoprotein A-1.
[0130] The present invention can be further understood by reference
to the following non-limiting examples.
EXAMPLE 1
[0131] This example illustrates, in table 1, a slurry formulation
that can be used to make menthol-flavored white films.
2 TABLE 1 % Composition % Composition Ingredients of Slurry (dry)
Water 80.65% 5.00% Methylcellulose E15 3.90% 19.15% Methylcellulose
E50 3.90% 19.15% Menthol 4.40% 21.60% Canola Oil 2.60% 12.76%
Titanium dioxide 2.00% 9.82% Solka - floc 300 1.60% 7.86% Tween 80
0.25% 1.23% Glycerin 0.25% 1.23% Triacetin 0.25% 1.23% Cornstarch
0.20% 0.98% % Solids 19.35% Total 100.00%
EXAMPLE 2
[0132] This example illustrates slurry formulations comprising
titanium dioxide (TiO.sub.2). In this example, the formulation of
either Example 1 or Example 2 can be modified by substituting mica
coated titanium dioxide (such as Timiron.RTM., Merck & Co.,
Inc.) for titanium dioxide.
EXAMPLE 3
[0133] This example illustrates, in Table 2, a formulation of a
film slurry composition that can provide a silver film, and a
method of making the film slurry.
3 TABLE 2 % Composition Ingredients Of Slurry Methylcellulose E15*
3.92% Methylcellulose E50* 3.92% Cerestar cornstarch 12640 0.392%
Solka - floc 300 1.57% Tween 80 0.474% Canola Oil 0.949% Timeron
2.00% Water to make 100% *Methylcellulose E15 and methylcellulose
E50 are hydroxypropyl methylcellulose food grade polymers (Methocel
.TM.; Dow Chemical Co.).
EXAMPLE 4
[0134] This example illustrates, in Table 3, a formulation of a
film slurry composition that provides a blue film.
4 TABLE 3 % Composition Ingredients Of Slurry Methylcellulose E15*
3.92% Methylcellulose E50* 3.92% Cerestar cornstarch 12640 0.392%
Solka - floc 300 1.57% Tween 80 0.474% Canola Oil 0.949% Blue Poly
100 1.00% Timeron 1.00% Water to make 100% *Methylcellulose E15 and
methylcellulose E50 are hydroxypropyl methylcellulose food grade
polymers (Methocel .TM.; Dow Chemical Co.).
EXAMPLE 5
[0135] This example illustrates, in Table 4, a dentifrice carrier
in which film fragments, such as those of Example 1, are unstable.
In this example, the instability can be manifested by a spreading
and deforming of the shapes, to 10% greater than the original size,
typically to about 50% greater than the original size. The
spreading and deformation generally occur at room temperature
within one week. Once the shapes are spread out and deformed, the
shapes may be no longer clearly observed through the packaging or
during use (e.g., on the brush in the case of a dentifrice). A
multi-phase composition comprising these film fragments (such as a
dentifrice) that is subjected to mild force, for example through
squeezing a tube or shaking a bottle comprising the composition,
disrupts these film fragments.
5 TABLE 4 Ingredient Wt % Sodium CMC 0.65 Polyethylene glycol 600
(PEG-12) 3.0 Sorbitol (70% in water) 57.69 Sodium saccharin 0.3
Sodium fluoride 0.24 Tetrasodium pyrophosphate 0.5 FD&C Blue #1
dye (1.25% in water) 0.4 Silica abrasive (Sylodent XWA 650) 20
Silica thickener (Zeodent 165) 4.25 Flavor oil 1.15 Sodium lauryl
sulfate (29% in water) 5.172 White, flavored films 0.3 Water
Q.S.
EXAMPLE 6
[0136] This example illustrates, in Table 5, a dentitrice carrier
in which film fragments are entrained and remain stable. In a
composition comprising shaped film fragments of this formulation,
the shapes can withstand squeezing, shaking, etc. without losing
their distinct size and shape.
6 TABLE 5 Ingredient Wt % Sodium CMC 0.65 Polyethylene glycol 600
(PEG-12) 3.0 Sorbitol 57.69 Sodium saccharin 0.3 Sodium fluoride
0.24 Tetrasodium pyrophosphate 0.5 FD&C Blue #1 dye (1.25% in
water) 0.4 Silica abrasive (Sylodent XWA 650) 20 Silica thickener
(Zeodent 165) 4.25 Flavor oil 1.15 Sodium lauryl sulfate (29% in
water) 5.172 Cocamidopropyl betaine (35% in water) 1.25 White,
flavored films 0.3 Water Q.S.
EXAMPLE 7
[0137] This example illustrates, in the following Table, a
dentifrice formulation that can be used to form a stable dentifrice
composite. In a composition comprising shaped film fragments of
this formulation, the shapes can withstand squeezing, shaking, etc.
without losing their distinct size and shape.
7 Ingredients Wt % Xanthan Gum 0.45 Polyethylene glycol 3.0 600
OPEG-12) Sorbitol 66.638 Sodium saccharin 0.3 Sodium fluoride 0.24
Tetrasodium 0.5 pyrophosphate FD&C Blue #1 dye 0.4 (1.25% in
Water) Silica abrasive 10.0 (Sylodent XWA 650) Silica thickner 2.50
(Zeodent 165) Flavor Oil 1.15 Sodium lauryl sulfate 5.172 (29% in
water) Cocamidopropyl 1.25 betaine White, flavored films 0.2 Water
Q.S.
EXAMPLE 8
[0138] This examples illustrates, in Table 6, a slurry formulation
that can be used to make a menthol-flavored white film.
8 TABLE 6 % Composition Ingredients of Slurry Water 72.5
Methylcellulose E5 10 Methylcellulose 3 E50 Menthol 4.375
Cornstarch 4 Canola Oil 2.625 Titanium Dioxide 1 Tween 80 0.5
Propylene Glycol 2 % Solids 27.5 Total 100.00
EXAMPLE 9
[0139] This example illustrates, in Table 7, a slurry formulation
that can be used to make menthol-flavored green film.
9 TABLE 7 % Composition Ingredients of Slurry Water 73.95
Methylcellulose E5 9.55 Menthol 6.875 Cornstarch 4 Canola Oil 4.125
Pigment Green 7 1 (50%) Tween 80 0.5 TP-206 Carageenan 0.10% %
Solids Total 100.00
EXAMPLE 10
[0140] This example illustrates a procedure for making a film
dentifrice composition, such as in Example 6. In this procedure,
carboxymethylcellulose (CMC) is dispersed in polyethyleneglycol 600
(PEG 600). NaF and saccharine are dissolved in water in separate
vessel. Sorbitol is mixed into the CMC/PEG portion, followed by a
water/salts solution. Tetrasodium pyrophosphate (TSPP) is added,
then a blue dye such as FD&C Blue #1. Silicas are then added,
and mixed under vacuum. Betaine, SLS and flavor are added and mixed
under vacuum, followed finally by white flavored films.
EXAMPLE 11
[0141] This example illustrates a procedure for making a
composition disclosed herein, such as in Example 6.
[0142] PART I--FORMULA INGREDIENTS: PURIFIED WATER, SODIUM
FLUORIDE
[0143] Weigh or meter purified water to the slurry tank. With the
agitator on add formula amount of sodium fluoride. Mix for 10
minutes minimum.
[0144] PART II--FORMULA INGREDIENTS: PEG, CMC, TSPP, SACCHARIN
[0145] Weigh or meter PEG to dispersion tank. Add formula amount of
CMC, TSPP and saccharin. Mix for 15 minutes minimum.
[0146] PART III--FORMULA INGREDIENTS: SORBITOL, PART II, PART I
[0147] Weigh or meter formula amount of sorbitol to the main mixer.
Increase vacuum and start agitation. Transfer PART II to the mixer.
Transfer the mixture from PART I to the mixer. Mix for 15 minutes
minimum under full vacuum.
[0148] PART IV--FORMULA INGREDIENTS: COLOR SOLUTION, ZEODENT 165,
XWA 650, FLAVOR
[0149] Stop agitation and release vacuum. Add color solution.
Increase vacuum and start agitation. With the mixer at high speed
(and homogenizer on) add formula amounts of ZEODENT 165, and XWA
650. During the addition of the powders add flavor (if Temperature
<110F). Increase vacuum until 28" minimum is reached. Mix under
full vacuum for 15 minutes.
[0150] PART V--FORMULA INGREDIENTS: LIQUID SLS, BETAINE, FILM
FRAGMENTS
[0151] Add formula amount of BETAINE with no vacuum and mixer speed
at 25%. Apply full vacuum. Add formula amount of LIQUID SLS under
full vacuum, 50% mixing speed and NO Homogenizer. Increase mixing
speed to 100% and mix for 10 minutes minimum under full vacuum.
Stop mixer and release vacuum. Add film fragments to mixer. Start
agitation at 25% and mix for two minutes. Increase vacuum to 28"
minimum. Increase agitation to 100% and mix for 10 minutes minimum.
Stop mixer and release vacuum. Inspect the product and take sample.
Pump batch through homogenizer (pump speed 100%, homogenizer speed
50%) to tote or portable storage tank.
EXAMPLE 12
[0152] This example illustrates determination of color contrast by
determination of color space coordinates. Color space coordinates
of the film and the toothpaste separately can be determined
separately. As discussed supra, L a* b* values represent color
values in a color space defined by the system established by the
Commission Internatioanle d'Eclairage (CIE). Table 8 below shows
the L a* b* values for a white film such and a corresponding blue
toothpaste. This analysis reveals large differences in both the
lightness, L*, as well as in the color parameters, a* and b*. As
would be expected for a white film, a* and b* are close to 0 for
the film.
10TABLE 8 L*a*b* Color and Color Difference, .DELTA.E* Sample L* a*
b* .DELTA.E*.sup.a White film with menthol 89.74 -0.49 1.97 -- Blue
whitening toothpaste 36.82 19.10 42.47 69.46 .sup.aColor
difference, .DELTA.E*, is relative to the white film.
[0153] To perform these measurements a Minolta CR-321 chromameter
is used, with data collection in the L*a*b* color coordinate mode.
The samples are each placed on a matching white background. One
layer of film or 1" of toothpaste is placed on the detector and
sandwiched on top by the white background.
EXAMPLE 13
[0154] This example illustrates silver colored, star shaped film
fragments and a method for their production. Components of a film
forming slurry used to make the film fragments are listed in Table
9 below. In preparing the film, the HMPC polymer Methocel E5LV
having a viscosity of 5.1 mPa.multidot.s (2% aqueous solution) are
added to deionized water at 23.degree. C., and the solution stirred
for 5 minutes. To this solution is added the pregelatized starch
Cerestar Polar Tex Instant 12640. The combined ingredients are
stirred vigorously for about one hour until the starch is
completely dispersed and a homogeneous mixture is formed. To this
mixture is added the titanium coated mica. The combination is mixed
for 10 minutes, after which the sodium lauryl sulfate surfactant is
added and mixed in for an additional 15 minutes. Thereafter
spearmint flavor is added, and the slurry is thoroughly mixed for
an additional 40 minutes to form a slurry emulsion. The weight
ratio of HPMC to Starch is 2:1. The emulsion is then cast on a
polyethylene coated paper at 25.degree. C. and dried at 110.degree.
C. to form a solid thin film having a thickness of 2.5 microns. The
film is then punched with a star-shaped punch. Resulting star
shaped film fragments are each 0.25 inch (6.35 mm) in their longest
dimension.
11TABLE 9 SILVER FILM MATRIX Ingredients Wt. % Starch 21.0 HPMC
40.0 Glycerin 5.0 Vegetable oil 3.0 Tween 80 1.0 SLS 1.0 Sodium
saccharin 0.3 Titanium coated mica 3.8 Flavor 24.6 Zinc gluconate
0.3 Total 100
EXAMPLE 14
[0155] This example illustrates a composition and method for the
production of a transparent green dentifrice carrier material. A
transparent green colored base dentifrice composition having the
ingredients listed in Table 9 is prepared, wherein a vehicle
solution comprising the sorbitol and water is made and subjected to
28-30 inches Hg applied vacuum. A mixture of saccharin sodium
fluoride and is added thereto. Subsequently, a green dye is blended
with the vehicle. The mixture is degassed at 28-30 inches Hg
applied vacuum over a 5 minute period. Then Zeodent 115 silica
abrasive and Zeodent 165, an amorphous silica thickening agent and
sodium lauryl sulfate (SLS) are added after preliminary degassing.
The ingredients are mixed. After about 5 minutes mixing, with
application of vacuum, the dentifrice preparation is considered to
be complete.
12TABLE 10 GREEN BASE DENTIFRICE Ingredients Wt. % PEG 600 3.0
Sodium carboxymethyl cellulose 0.55 Sorbitol 74.0 Purified water
6.357 Sodium fluoride 0.243 Tetrasodium pyrophosphate 0.50 Sodium
saccharine 0.30 Zeodent 115 4.0 Zeodent 165 8.8 Sodium lauryl
sulfate 1.2 Flavor 1.0 FD&C Green (2% soln.) 0.05 Total 100
EXAMPLE 15
[0156] This example illustrates a method of producing a composition
comprising a green dentrifrice base carrier formulation and star
shaped film fragments. To make the composition, star shaped film
fragments of Example 13 are combined with transparent green
dentifrice carrier material of Example 14, in a 0.3%
(weight/weight) film:carrier ratio. The composition is thereafter
packaged in a standard toothpaste tube.
[0157] After packaging, a sample of the dentifrice composition is
squeezed from a tube and extruded as a distinctive green,
aesthetically pleasing ribbon composition having suspended therein
clearly visible star shaped silver colored film fragments extending
throughout the extruded composition.
EXAMPLE 16
[0158] This example illustrates red, heart shaped film fragments
and a method for their preparation. Red, heart shaped film
fragments were prepared using a film prepared according to the
procedure of Example 13 using dried film comprising the ingredients
listed in Table 11 below. After drying of the film, shellac (100%
non-bleached) is applied to the film. The final thickness of the
film was 3.0 microns. Heart shaped film fragments, each 0.125 inch
(3.28 mm) in their longest dimension, are then die cut from the
film.
13TABLE 11 RED FILM Ingredients Wt. % HPMC 48.0 Cornstarch 12.0
Propylene glycol 2.0 Tween 80 2.0 Vegetable oil 4.0 Flavor 24.0
D&C #30 4.0 Titanium oxide coated mica 4.0 Total 100
EXAMPLE 17
[0159] This example illustrates a composition and method for the
production of a blue dentifrice carrier material. To produce a blue
dentifrice base, a base formulation is prepared according to the
method described in Example 14, except that a blue colorant is
substituted for the blue colorant in table 10.
EXAMPLE 18
[0160] This example illustrates a composition comprising both a
blue dentifrice carrier base formulation and a plurality of red
heart, shaped film fragments, as well as a method of producing a
composition.
[0161] To make the composition, red heart shaped film fragments of
Example 16 are combined with blue dentifrice carrier material of
Example 17, in a 0.3% (weight/weight) film:carrier ratio. Gentle
mixing is used to distribute the film fragments throughout the base
formulation. The composition is thereafter packaged in a standard
toothpaste tube.
[0162] After packaging, a sample of the dentifrice composition is
squeezed from a tube and is extruded as a distinctive blue,
aesthetically pleasing ribbon composition having suspended therein
clearly visible heart shaped red colored film fragments extending
throughout the extruded composition.
EXAMPLE 19
[0163] This example illustrates a composition of circle-shaped film
fragments comprising a high flavorant concentration and a method
for their production.
[0164] A film having a high flavor concentration (23.75 wt. %) is
prepared following the procedure of Example 13, except that a dry
film comprising the ingredients listed in Table 12 was used. The
dried film is then cut into and film fragments in the shape of
circles.
14 TABLE 12 Ingredients Wt. % HPMC 48.0 Cornstarch 12.0 Tween 80
2.0 Propylene glycol 2.0 Canola oil 4.0 Flavor 23.75 Titanium
coated mica 8.0 Sodium fluoride 0.243 Total 100
EXAMPLE 20
[0165] This example illustrates the production of a composition
that provides a flavor burst. In this example, a plurality of film
fragments of Example 19 is combined with a dentifrice carrier of
Example 14 according to the method of Example 15.
[0166] The resulting composition is tested through use in
toothbrushing. When brushed on teeth, the composition emits a burst
of flavor as the brushing cause the mechanical rupture of the film
fragments with the immediate release of their flavor
constituent.
EXAMPLE 20
[0167] This example illustrates film fragments comprising an oral
care-effective amount of calcium and a method for their
preparation. Film fragments of 2.5 microns thickness containing an
oral care-effective amount of calcium are prepared according to the
procedure disclosed in Example 13 except that the slurry comprised
the ingredients listed in table 13 and the film fragments are not
necessarily star shapes.
15 TABLE 13 Ingredients Wt. % HPMC 43.0 Calcium acetate 21.4 Tween
80 1.8 Propylene glycol 1.8 Canola oil 3.5 Flavor 21.4 Titanium
coated mica 7.1 Total 100
EXAMPLE 21
[0168] This example illustrates a composition comprising both a
carrier comprising fluoride and a plurality of film fragments
comprising calcium, as well as a method of making the composition.
An analysis of some of composition's properties is also
disclosed.
[0169] In this example, a composition comprising film fragments of
Example 20 and a commercial fluoride toothpaste containing 1100
parts per million (ppm) fluoride ion is formed according to the
method of Example 15. The composition comprises film fragments 0.3%
by weight. This composition, designated "Paste A," is then aged at
120.degree. F. for 2 to 8 weeks and analyzed for fluoride content
at weekly intervals. For purposes of comparison, the same
toothpaste but in which the film fragments had not been
incorporated, designated "Paste B," is also analyzed for fluoride
levels during the same intervals. The presence of fluoride ion in
the compositions is determined by separating the carrier from the
film fragments first then analyzing the carrier for the presence of
fluoride using F.sup.- ion-selective electrodes.
[0170] The fluoride assays of the two compositions are shown in
Table 14 below.
16 TABLE 14 Weeks 1 2 3 4 8 Paste F.sup.- (ppm) F.sup.- (ppm)
F.sup.- (ppm) F.sup.- (ppm) F.sup.- (ppm) A 935 962 900 943 899 B
1016 1042 986 1036 1040
[0171] The results set forth in Table 14 show a minimal loss of
fluoride ion over the 8-week assay period in Paste A comprising
calcium acetate as compared to Paste B which did not contain any
calcium salt. When brushed on teeth of the film suspended in the
dentifrice will rapidly disintegrate whereby calcium ion will be
released to interact with the fluoride ion to enhance the
anticaries efficacy of the fluoride ion on the teeth being
brushed.
EXAMPLE 22
[0172] This example illustrates film fragments comprising cetyl
pyridinium chloride (CPC) and a method for their preparation. Film
fragments of 2.5 microns thickness containing an oral
care-effective amount of cetyl pyridinium chloride are prepared
according to the procedure disclosed in Example 13 except that the
dry film comprised the ingredients listed in table 15 below, and
the film fragments are not necessarily star shapes. In Table 15
below lists ingredients of a film comprising CPC.
17 TABLE 15 Ingredients Wt. % HPMC 48.0 CPC 12.0 Tween 80 2.0
Propylene glycol 2.0 Canola oil 4.0 Flavor 24.0 Titanium coated
mica 8.0 Total 100
EXAMPLE 23
[0173] This example illustrates a composition comprising both a
carrier comprising sodium lauryl sulfate (SLS) and plurality of
film fragments comprising cetyl pyridinium chloride (CPC), as well
as a method of producing a composition.
[0174] In this example, a plurality of film fragments of Example 22
are combined with an SLS-containing carrier, such as a dentifrice
carrier as in Example 21 to produce a composition comprising both a
carrier comprising sodium lauryl sulfate (SLS) and plurality of
film fragments comprising cetyl pyridinium chloride (CPC). In the
composition, the CPC will not react with the SLS present in the
carrier. However, the CPC will be released during tooth brushing,
and both the SLS and the CPC can be effective for oral hygiene.
EXAMPLE 24
[0175] This example illustrates, in table 16, a dosage of each of
certain pharmaceuticals that can be delivered using a composition
disclosed herein.
18 TABLE 16 MEDICAMENT DOSE Chlorpheniramine Maleate 4 mg.
Brompheniramine Maleate 4 mg. Dexchlorpheniramine 2 mg.
Dexbrompheniramine 2 mg. Triprolidine Hydrochloride 2.5 mg.
Acrivastine 8 mg. Azatadine Maleate 1 mg. Loratidine 10 mg.
Phenylephrine Hydrochloride 10 mg. Dextromethorphan Hydrochloride
10-20 mg. Ketoprofen 12.5 mg. Sumatriptan Succinate 35-70 mg.
Zolmitriptan 2.5 mg. Loperamide 2 mg. Famotidine 10 mg. Nicotine 2
mg. Diphenhydramine Hydrochloride 25 mg. Pseudoephedrine
Hydrochloride 30 mg.
[0176] The examples and other embodiments described herein are
exemplary and not intended to be limiting in describing the full
scope of compositions and methods of this invention. Equivalent
changes, modifications and variations of specific embodiments,
materials, compositions and methods may be made within the scope of
the present invention, with substantially similar results.
* * * * *