U.S. patent application number 11/638844 was filed with the patent office on 2007-04-19 for tooth whitening substances.
Invention is credited to Robert Stanley Dirksing, Frederick James Rohman, Paul Albert Sagel.
Application Number | 20070086961 11/638844 |
Document ID | / |
Family ID | 46282483 |
Filed Date | 2007-04-19 |
United States Patent
Application |
20070086961 |
Kind Code |
A1 |
Sagel; Paul Albert ; et
al. |
April 19, 2007 |
Tooth whitening substances
Abstract
A tooth whitening substance formed into a thin layer is
provided. The tooth whitening substance includes a polyox resin and
a tooth whitening active. The polyox resin adheres the thin layer
to a plurality of teeth for a sufficient time to allow the tooth
whitening active to act upon the plurality of teeth.
Inventors: |
Sagel; Paul Albert; (Mason,
OH) ; Dirksing; Robert Stanley; (Cincinnati, OH)
; Rohman; Frederick James; (Maineville, OH) |
Correspondence
Address: |
THE PROCTER & GAMBLE COMPANY;INTELLECTUAL PROPERTY DIVISION
WINTON HILL BUSINESS CENTER - BOX 161
6110 CENTER HILL AVENUE
CINCINNATI
OH
45224
US
|
Family ID: |
46282483 |
Appl. No.: |
11/638844 |
Filed: |
December 14, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11157769 |
Jun 21, 2005 |
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11638844 |
Dec 14, 2006 |
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10410037 |
Apr 9, 2003 |
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11157769 |
Jun 21, 2005 |
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09681729 |
May 29, 2001 |
6551579 |
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10410037 |
Apr 9, 2003 |
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09605220 |
Jun 28, 2000 |
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09681729 |
May 29, 2001 |
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09196364 |
Nov 19, 1998 |
6096328 |
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09605220 |
Jun 28, 2000 |
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09042909 |
Mar 17, 1998 |
6136297 |
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09196364 |
Nov 19, 1998 |
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08870664 |
Jun 6, 1997 |
5894017 |
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09042909 |
Mar 17, 1998 |
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Current U.S.
Class: |
424/53 ;
424/57 |
Current CPC
Class: |
A61K 33/40 20130101;
A61K 31/341 20130101; A61K 8/8111 20130101; A61K 8/0208 20130101;
A61K 9/0063 20130101; A61K 8/22 20130101; A61K 2800/262 20130101;
A61K 9/006 20130101; A61K 8/8141 20130101; A61K 8/4973 20130101;
A61K 8/66 20130101; A61Q 11/00 20130101; A61K 8/02 20130101; A61K
8/347 20130101; A61K 31/09 20130101 |
Class at
Publication: |
424/053 ;
424/057 |
International
Class: |
A61K 8/46 20060101
A61K008/46 |
Claims
1. An oral care delivery system comprising: (a) a strip of
material; (b) an oral care composition; wherein said oral care
composition comprises an anti-tartar agent; (c) wherein said
delivery system is applied to the surfaces of a plurality of
teeth.
2. The oral care delivery system of claim 1, wherein said phosphate
is pyrophosphate.
3. The oral care delivery system of claim 1, wherein said oral care
composition further comprises a tooth whitening composition.
4. The oral care delivery system of claim 1, wherein said tooth
whitening composition is a peroxide.
5. The oral care delivery system of claim 1, wherein said oral care
composition further comprises water.
6. The oral care delivery system of claim 1, wherein said oral care
composition further comprises a gelling agent.
7. The oral care delivery system of claim 1, wherein said strip of
material is flexible.
8. The oral care delivery system of claim 1, wherein said strip of
material is polyethylene.
9. The oral care delivery system of claim 1, wherein said strip of
material is sized to cover a front surface of a plurality of
teeth.
10. The oral care delivery system of claim 9, wherein said strip of
material is further sized to cover soft tissue adjacent said
plurality of teeth.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of of U.S. application
Ser. No. 11/157,769, filed Jun. 21, 2005, which is a continuation
of U.S. application Ser. No. 10/410,037, filed Apr. 9, 2003, which
is a continuation of U.S. application Ser. No. 09/681,729, filed
May 29, 2001, which is a continuation of U.S. application Ser. No.
09/605,220, filed Jun. 28, 2000, which is a continuation of U.S.
application Ser. No. 09/196,364, filed Nov. 19, 1998, now U.S. Pat.
No. 6,096,328, which is a continuation-in-part of U.S. application
Ser. No. 09/042,909, filed Mar. 17, 1998, now U.S. Pat. No.
6,136,297, which is a continuation-in-part of U.S. application Ser.
No. 08/870,664, filed on Jun. 6, 1997, now U.S. Pat. No.
5,894,017.
FIELD OF THE INVENTION
[0002] The present invention relates to tooth whitening substances,
and more particularly, to tooth whitening substances including a
polyox resin.
BACKGROUND OF THE INVENTION
[0003] A recognized consumer need is a low cost commercial tooth
whitening substance that is comfortable to wear that can deliver a
sufficient amount of a tooth whitening active to a plurality of
teeth. Further, there is continuing need to provide a tooth
whitening substance which can adhere to a plurality of teeth as a
thin film.
SUMMARY OF THE INVENTION
[0004] A tooth whitening substance formed into a thin layer is
provided. The tooth whitening substance includes a polyox resin and
a tooth whitening active. The polyox resin adheres the thin layer
to a plurality of teeth for a sufficient time to allow the tooth
whitening active to act upon the plurality of teeth.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] While the specification concludes with claims which
particularly point out and distinctly claim the present invention,
it is believed that the present invention will be better understood
from the following description of preferred embodiments, taken in
conjunction with the accompanying drawings, in which like reference
numerals identify identical elements and wherein:
[0006] FIG. 1 is a perspective view of a substantially flat strip
of material having rounded corners;
[0007] FIG. 2 is a perspective view of the flat strip of FIG. 1
coated with an oral care substance for treating teeth and gums;
[0008] FIG. 3 is a cross-sectional view thereof, taken along
section line 3-3 of FIG. 2, disclosing an example of the flat strip
of material having a thickness less than that of the substance
coated thereon;
[0009] FIG. 4 is a cross-sectional view showing an alternative
embodiment of the present invention, showing shallow pockets in the
strip of material, which act as reservoirs for additional oral care
substance coated on the strip;
[0010] FIG. 5 is a cross-sectional plan view thereof, showing an
alternative embodiment for applying oral care substances for
treating teeth to adjacent teeth having the strip of material
conforming thereto and adhesively attached to the teeth by means of
the oral care substance located between the teeth and the strip of
material;
[0011] FIG. 6 is a cross-sectional elevation view of a tooth, taken
along section line 6-6 of FIG. 5, disclosing the strip of material
conforming to and adhesively attached to the teeth by means of the
oral care substance located between the teeth and the strip of
material;
[0012] FIG. 7 is a cross-sectional plan view, similar to FIG. 5,
showing a strip of material conforming to the teeth and the
adjoining soft tissue and adhesively attached to both sides of the
teeth by means of the oral care substance located between the teeth
and the strip of material;
[0013] FIG. 8 is a cross-sectional elevation view, taken along
section line 8-8 of FIG. 7, showing a strip of material conforming
to both the tooth and the adjoining soft tissue and adhesively
attached to both sides of the tooth by means of the oral care
substance located between the tooth and the strip of material;
[0014] FIG. 9 is a perspective view of an alternative embodiment of
the present invention, disclosing the flat strip of material coated
with an oral care substance of FIG. 2 for treating teeth and
adjoining soft tissue having a release liner; and
[0015] FIG. 10 is a cross-sectional view of an alternative
embodiment of the present invention, taken along section line 10-10
of FIG. 9, showing a release liner attached to the strip of
material by the oral care substance on the strip of material.
DETAILED DESCRIPTION OF THE INVENTION
[0016] The abbreviation "cm", as used herein, means centimeter. The
abbreviation "mm" as used herein, means millimeter.
[0017] Referring now to the drawings, and more particularly to
FIGS. 1 and 2, there is shown a first preferred embodiment of the
present invention, generally indicated as 10, representing a
delivery system for delivering an oral care substance to an oral
surface. Delivery system 10 has a strip of material 12, which is
initially substantially flat, preferably with rounded corners.
[0018] Applied or coated onto strip of material 12 is an oral care
substance 14. Preferably, oral care substance 14 is homogeneous,
uniformly and continuously coated onto strip of material 12, as
shown in FIG. 3. However, oral care substance 14 may alternatively
be a laminate or separated layers of components, an amorphous
mixture of components, separate stripes or spots or other patterns
of different components, or a combination of these structures
including a continuous coating of oral care substance 14 along a
longitudinal axis of a portion of strip of material 12.
[0019] As shown in FIG. 4, an alternative embodiment, a strip of
material 12 may have shallow pockets 18 formed therein. When oral
care substance 14 is coated on a substance-coated side of strip of
material 12, additional oral care substance 14 fills shallow
pockets 18 to provide reservoirs of additional oral care substance
14.
[0020] FIGS. 5 and 6 show a delivery system 24 of the present
invention applied to a surface of a tooth and plurality of adjacent
teeth. Embedded in adjacent soft tissue 20 are a plurality of
adjacent teeth 22. Adjacent soft tissue is herein defined as soft
tissue surfaces surrounding the tooth structure including: papilla,
marginal gingiva, gingival sulculus, inter dental gingiva, gingival
gum structure on lingual and buccal surfaces up to and including
muco-ginival junction and the pallet.
[0021] In both FIGS. 5 and 6, delivery system 24 represents strip
of material 12 and oral care substance 14, with oral care substance
14 on the side of strip of material 12 facing tooth 22. Oral care
substance 14 may be pre-applied to strip of material 12, or applied
to strip of material 12 by the delivery system user, or applied
directly to the teeth 22 and then covered by strip of material 12.
In either case, strip of material 12 has a thickness and flexural
stiffness which enable it to conform to the contoured surfaces of
tooth 22 and to adjacent soft tissue 20. The strip of flexible
material has sufficient flexibility to form to the contours of the
oral surface, in this figure the surface being a plurality of
adjacent teeth. The strip of material is also readily conformable
to tooth surfaces and to the interstitial tooth spaces without
permanent deformation when the delivery system is applied. The
delivery system is applied without significant pressure.
[0022] FIGS. 7 and 8 show a delivery system 24 of the present
invention applied to both front and rear surfaces of a plurality of
adjacent teeth 22 as well as to adjacent soft tissue 20. Delivery
system 24 represents strip of material 12 and oral care substance
14, with oral care substance 14 on the side of strip of material 12
facing tooth 22.
[0023] FIGS. 9 and 10 shows optional release liner 27. Release
liner 27 is attached to strip of material 12 by oral care substance
14. Oral care substance 14 is on the side of strip of material 12
facing release liner 27. This side is applied to the tooth and gum
surfaces once release liner 27 is removed.
[0024] Strip of Material
[0025] The strip of material serves as a protective barrier for the
oral care substance. It prevents substantial leaching and/or
erosion of the oral care substance by for example, the wearer's
lips, tongue, as well as saliva. This allows the active in the oral
care composition to act upon the oral surface for an extended
period of time, from several minutes to several hours. The term
"act upon" is herein defined as bringing about a desired change.
For example, if the oral care substance is an anti-microbial
substance, it reduces or eliminates proliferation of microbial
growth that has an overall positive impact on the oral cavity
including teeth and gingival tissue.
[0026] The strip of material may comprise polymers, natural and
synthetic woven materials, non-woven material, foil, paper, rubber,
and combinations thereof. The strip of material may be a single
layer of material or a laminate of more than one layer. Regardless
of the number of layers, the strip of material is substantially
water impermeable. Preferably, the material is any type of polymer
or combination of polymers that meet the required flexural rigidity
and are compatible with oral care substances. Suitable polymers
include, but are not limited to, polyethylene, ethylvinylacetate,
polyesters, ethylvinyl alcohol and combinations thereof. Examples
of polyesters include Mylar.RTM. and fluoroplastics such as
Teflon.RTM., both manufactured by DuPont. The preferable material
is polyethylene. The strip of material is generally less than about
1 mm thick, preferably less than about 0.05 mm thick, and more
preferably from about 0.001 to about 0.03 mm thick. A polyethylene
strip of material is preferably less than about 0.1 mm thick and
more preferably from about 0.005 to about 0.02 mm thick.
[0027] The shape of the strip of material is any shape and size
that covers the desired oral surface. Preferably the strip of
material has rounded corners. Rounded corners is defined as not
having any sharp angles or points. In one example, the length of
the strip of material is from about 2 cm to about 12 cm and
preferably from about 4 cm to about 9 cm. The width of the strip of
material will also depend upon the oral surface area to be covered.
In one example, the width of the strip of material is from about
0.5 cm to about 4 cm and preferably from about 1 cm to about 2
cm.
[0028] The strip of material may contain shallow pockets. When the
oral care substance is coated on a strip of material, additional
oral care substance fills shallow pockets to provide reservoirs of
additional oral care substance. Additionally, the shallow pockets
help to provide texture to the delivery system. The film will
preferably have an array of shallow pockets. Generally, the shallow
pockets are approximately 0.4 mm across and 0.1 mm deep. When
shallow pockets are included in the strip of material and oral care
substances are applied to it in various thicknesses, the overall
thickness of the delivery system is generally less than about 1 mm.
Preferably, the overall thickness is less than about 0.5 mm.
[0029] Flexural stiffness is a material property that is a function
of a combination of strip thickness, width, and material modulus of
elasticity. This test is a method for measuring the rigidity of
polyolefin film and sheeting. It determines the resistance to
flexure of a sample by using a strain gauge affixed to the end of a
horizontal beam. The opposite end of the beam presses across a
strip of the sample to force a portion of the strip into a vertical
groove in a horizontal platform upon which the sample rests. A
microammeter, wired to the strain gauge is calibrated in grams of
deflection force. The rigidity of the sample is read directly from
the microammeter and expressed as grams per centimeter of sample
strip width. In the present invention, the strip of material has a
flexural stiffness of less than about 5 grams/cm as measured on a
Handle-O-Meter, model #211-300, available from Thwing-Albert
Instrument Co. of Philadelphia, Pa., as per test method ASTM
D2923-95. Preferably, the strip of material has a flexural
stiffness less than about 3 grams/cm, more preferably less than
about 2 grams/cm, and most preferably from about 0.1 grams/cm to
about 1 grams/cm. Preferably, the flexural stiffness of the strip
of material is substantially constant and does not change during
normal use. For example, the strip of material does not need to be
hydrated for the strip to achieve the low flexural stiffness in the
above-specified ranges.
[0030] This relatively low stiffness enables the strip of material
to cover the contours of the oral surface with very little force
being exerted. That is, conformity to the contours of the oral
surface of the wearer's mouth is maintained because there is little
residual force within the strip of material to cause it to return
to its shape just prior to its application to the oral surface,
i.e. substantially flat. The strip of material's flexibility
enables it to contact soft tissue over an extended period of time
without irritation. The strip of material does not require pressure
forming it against the oral surface.
[0031] The strip of material is held in place on the oral surface
by adhesive attachment provided by the oral care substance. The
viscosity and general tackiness of the oral care substance cause
the strip of material to be adhesively attached to the oral surface
without substantial slippage from the frictional forces created by
the lips, teeth, tongue and other oral surfaces rubbing against the
strip of material while talking, drinking, etc. However, this
adhesion to the oral surface is low enough to allow the strip of
material to be easily removed by the wearer by simply peeling off
the strip of material using ones finger, fingernail or rubbing with
a soft implement such as a cotton balls and swabs or gauze pads.
The delivery system is easily removable from the oral surfaces
without the use of an instrument, a chemical solvent or agent or
excessive friction. The chemical solvents include organic solvent
known for use in the oral cavity such as alcohols, and other safe
solvents such as water, that can be used to dilute the gelling
agent.
[0032] The peel force required to remove the strip of material from
the oral surface is from about 1 gram to about 50 grams for a 1.5
cm strip width (approximately 17 grams/cm) is all that is required.
Preferably, the peel force is from about 10 grams to about 40 grams
and more preferably from about 20 grams to about 30 grams. The low
peel force is desired for consumer handling purposes. The low peel
force is possible because of the non-aggressive nature of the oral
care substance necessary to adhere the strip of material having
lower flexural stiffness. That is a strip of material having high
flexural stiffness higher would require an aggressive adhesive to
stop the strip of material from pulling it away from the contours
of the oral surface it is attached to.
[0033] The strip of material may be formed by several of the film
making processes known in the art. Preferably, a strip of material
made of polyethylene is made by a blown process or a cast process.
Other processes, including extrusion or processes that do not
affect the flexural rigidity of the strip of material are also
feasible. Additionally, the oral care substance may be incorporated
onto the strip during the processing of the strip. The oral care
substance may be a laminate on the strip.
[0034] Oral Care Substances
[0035] The oral care substance preferably contains an active at a
level where upon directed use, promotes the benefit sought by the
wearer without detriment to the oral surface it is applied to.
Examples of the oral conditions these actives address include, but,
are not limited to appearance and structural changes to teeth,
whitening, stain bleaching, stain removal, plaque removal, tartar
removal, cavity prevention and treatment, inflamed and, or bleeding
gums, mucosal wounds, lesions, ulcers, aphthous ulcers, cold sores
tooth abscesses, and the elimination of mouth malodor resulting
from the conditions above and other causes such as microbial
proliferation.
[0036] The amount of oral care substance applied to the strip of
material or oral surface depends upon the size and capacity of the
piece of material, concentration of the active, and the desired
benefit sought. Generally, less than about 1 gram of oral care
substance is required. Preferably, from about 0.05 grams to about
0.5 grams and more preferably from about 0.1 gram to about 0.4
grams of the oral care substance is used. The amount of oral care
substance per square cm of material is less than about 0.2
grams/cm.sup.2, preferably from about 0.005 to about 0.1
grams/cm.sup.2, and more preferably from about 0.01 grams/cm.sup.2
to about 0.04 grams/cm.sup.2.
[0037] The oral care substance of the present invention can be in
the form of a viscous liquid, paste, gel, solution, or other
suitable that can provide sufficient adhesion. Preferably, the oral
care substance is in the form of a gel. The oral care substance
will have a viscosity of from about 200 to about 1,000,000 cps at
low shear rates (less than one 1/seconds). Preferably, the
viscosity is from about 100,000 to about 800,000 cps and more
preferably from about 400,000 to about 600,000 cps.
[0038] Oral Care Actives
[0039] Suitable for oral care actives include any material that is
generally considered as safe for use in the oral cavity that
provides changes to the overall health of the oral cavity, and
specifically the condition of the oral surfaces the oral care
substance contacts. The level of oral care substance in the present
invention is from about 0.01% to about 40%, preferably from about
0.1% to about 20%, more preferably from about 0.5% to about 10%,
and most preferably from about 1% to about 7%, by weight of the
oral care substance.
[0040] Oral care compositions or substances of the present
invention may include many of the actives previously disclosed in
the art. The following is a non all-inclusive list of oral care
actives that may be used in the present invention:
[0041] 1. Teeth Whitening Actives
[0042] Teeth whitening actives may be included in the oral care
substance of the present invention. The actives suitable for
whitening are selected from the group consisting of the peroxides,
metal chlorites, perborates, percarbonates, peroxyacids, and
combination thereof. Suitable peroxide compounds include hydrogen
peroxide, calcium peroxide, carbamide peroxide, and mixtures
thereof. Most preferred is carbamide peroxide. Suitable metal
chlorites include calcium chlorite, barium chlorite, magnesium
chlorite, lithium chlorite, sodium chlorite, and potassium
chlorite. Additional whitening actives may be hypochlorite and
chlorine dioxide. The preferred chlorite is sodium chlorite.
[0043] 2. Phosphates
[0044] Anti-tartar agents known for use in dental care products
includes phosphates. Phosphates include pyrophosphates,
polyphosphates, polyphosphonates and mixtures thereof.
Pyrophosphates are among the best known for use in dental care
products. Pyrophosphate ions are delivered to the teeth derive from
pyrophosphate salts. The pyrophosphate salts useful in the present
compositions include the dialkali metal pyrophosphate salts,
tetra-alkali metal pyrophosphate salts, and mixtures thereof.
Disodium dihydrogen pyrophosphate (Na.sub.2H.sub.2P.sub.2O.sub.7),
tetrasodium pyrophosphate (Na.sub.4P.sub.2O.sub.7), and
tetrapotassium pyrophosphate (K.sub.4P.sub.2O.sub.7) in their
unhydrated as well as hydrated forms are the preferred species.
While any of the above mentioned pyrophosphate salts may be used,
tetrasodium pyrophosphate salt is preferred.
[0045] The pyrophosphate salts are described in more detail in Kirk
& Othmer, Encyclopedia of Chemical Technology, Third Edition,
Volume 17, Wiley-Interscience Publishers (1982), incorporated
herein by reference in its entirety, including all references
incorporated into Kirk & Othmer. Additional anticalculus agents
include pyrophosphates or polyphosphates disclosed in U.S. Pat. No.
4,590,066 issued to Parran & Sakkab on May 20, 1986;
polyacrylates and other polycarboxylates such as those disclosed in
U.S. Pat. No. 3,429,963 issued to Shedlovsky on Feb. 25, 1969 and
U.S. Pat. No. 4,304,766 issued to Chang on Dec. 8, 1981; and U.S.
Pat. No. 4,661,341 issued to Benedict & Sunberg on Apr. 28,
1987; polyepoxysuccinates such as those disclosed in U.S. Pat. No.
4,846,650 issued to Benedict, Bush & Sunberg on Jul. 11, 1989;
ethylenediaminetetraacetic acid as disclosed in British Patent No.
490,384 dated Feb. 15, 1937; nitrilotriacetic acid and related
compounds as disclosed in U.S. Pat. No. 3,678,154 issued to Widder
& Briner on Jul. 18, 1972; polyphosphonates as disclosed in
U.S. Pat. No. 3,737,533 issued to Francis on Jun. 5, 1973, U.S.
Pat. No. 3,988,443 issued to Ploger, Schmidt-Dunker & Gloxhuber
on Oct. 26, 1976 and U.S. Pat. No. 4,877,603 issued to Degenhardt
& Kozikowski on Oct. 31, 1989; all of these patents are
incorporated herein by reference. Anticalculus phosphates include
potassium and sodium pyrophosphates; sodium tripolyphosphate;
diphosphonates, such as ethane-1-hydroxy-1,1-diphosphonate,
1-azacycloheptane-1,1-diphosphonate, and linear alkyl
diphosphonates; linear carboxylic acids; and sodium zinc
citrate.
[0046] Agents to may be used in place of or in combination with the
pyrophosphate salt include such known materials as synthetic
anionic polymers including polyacrylates and copolymers of maleic
anhydride or acid and methyl vinyl ether (e.g., Gantrez), as
described, for example, in U.S. Pat. No. 4,627,977, to Gaffar et
al., the disclosure of which is incorporated herein by reference in
its entirety; as well as, e.g., polyamino propoane sulfonic acid
(AMPS), zinc citrate trihydrate, polyphosphates (e.g.,
tripolyphosphate; hexametaphosphate), diphosphonates (e.g., EHDP;
AHP), polypeptides (such as polyaspartic and polyglutamic acids),
and mixtures thereof.
[0047] 3. Fluoride Ion Source
[0048] Fluoride ion sources are well know for use in oral care
compositions as anticaries agents. Fluoride ions are contained in a
number of oral care compositions for this purpose, particularly
toothpastes. Patents disclosing such toothpastes include U.S. Pat.
No. 3,538,230, Nov. 3, 1970 to Pader et al; U.S. Pat. No.
3,689,637, Sep. 5, 1972 to Pader; U.S. Pat. No. 3,711,604, Jan. 16,
1973 to Colodney et al; U.S. Pat. No. 3,911,104, Oct. 7, 1975 to
Harrison; U.S. Pat. No. 3,935,306, Jan. 27, 1976 to Roberts et al;
and U.S. Pat. No. 4,040,858, Aug. 9, 1977 to Wason.
[0049] Application of fluoride ions to dental enamel serves to
protect teeth against decay. A wide variety of fluoride
ion-yielding materials can be employed as sources of soluble
fluoride in the instant compositions. Examples of suitable fluoride
ion-yielding materials are found in Briner et al; U.S. Pat. No.
3,535,421; issued Oct. 20, 1970 and Widder et al; U.S. Pat. No.
3,678,154; issued Jul. 18, 1972, both patents being incorporated
herein by reference. Preferred fluoride ion sources for use herein
include sodium fluoride, potassium fluoride and ammonium fluoride.
Sodium fluoride is particularly preferred. Preferably the instant
compositions provide from about 50 ppm to 10,000 ppm, more
preferably from about 100 to 3000 ppm, of fluoride ions in the
aqueous solutions that contact dental surfaces when used with the
strip of material used in the mouth.
[0050] 4. Antimicrobial Agents
[0051] Antimicrobial agents can also be present in the oral care
compositions or substances of the present invention. Such agents
may include, but are not limited to,
5-chloro-2-(2,4-dichlorophenoxy)-phenol, commonly referred to as
triclosan, and described in The Merck Index, 11th ed. (1989), pp.
1529 (entry no. 9573) in U.S. Pat. No. 3,506,720, and in European
Patent Application No. 0,251,591 of Beecham Group, PLC, published
Jan. 7, 1988; phthalic acid and its salts including, but not
limited to those disclosed in U.S. Pat. No. 4,994,262, Feb. 19,
1991, substituted monoperthalic acid and its salts and esters as
disclosed in U.S. Pat. Nos. 4,990,329, Feb. 5, 1991, 5,110,583, May
5, 1992 and 4,716,035, Dec. 29, 1987, all to Sampathkumar;
preferably magnesium monoperoxy phthalate, chlorhexidine (Merck
Index, no. 2090), alexidine (Merck Index, no. 222; hexetidine
(Merck Index, no. 4624); sanguinarine (Merck Index, no. 8320);
benzalkonium chloride (Merck Index, no. 1066); salicylanilide
(Merck Index, no. 8299); domiphen bromide (Merck Index, no. 3411);
cetylpyridinium chloride (CPC) (Merck Index, no. 2024;
tetradecylpyridinium chloride (TPC); N-tetradecyl-4-ethylpyridinium
chloride (TDEPC); octenidine; delmopinol, octapinol, and other
piperidino derivatives; nicin preparations; zinc/stannous ion
agents; antibiotics such as augmentin, amoxicillin, tetracycline,
doxycycline, minocycline, and metronidazole; and analogs and salts
of the above; essential oils including thymol, geraniol, carvacrol,
citral, hinokitiol, eucalyptol, catechol (particularly 4-allyl
catechol) and mixtures thereof; methyl salicylate; hydrogen
peroxide; metal salts of chlorite and mixtures of all of the
above.
[0052] 5. Anti-inflammatory Agents
[0053] Anti-inflammatory agents can also be present in the oral
care compositions or substances of the present invention. Such
agents may include, but are not limited to, non-steroidal
anti-inflammatory agents or NSAIDs such as ketorolac, flurbiprofen,
ibuprofen, naproxen, indomethacin, aspirin, ketoprofen, piroxicam
and meclofenamic acid. Use of NSAIDs such as Ketorolac are claimed
in U.S. Pat. No. 5,626,838, issued May 6, 1997, herein incorporated
by reference. Disclosed therein are methods of preventing and, or
treating primary and reoccurring squamous cell carcinoma of the
oral cavity or oropharynx by topical administration to the oral
cavity or oropharynx an effective amount of an NSAID.
[0054] 6. Nutrients
[0055] Nutrients may improve the condition of the oral cavity and
can be included in the oral care compositions or substances of the
present invention. Nutrients include minerals, vitamins, oral
nutritional supplements, enteral nutritional supplements, and
mixtures thereof.
[0056] Minerals that can be included with the compositions of the
present invention include calcium, phosphorus, fluoride, zinc,
manganese, potassium and mixtures thereof. These minerals are
disclosed in Drug Facts and Comparisons (loose leaf drug
information service), Wolters Kluer Company, St. Louis, Mo.,
.COPYRGT.1997, pp 10-17; incorporated herein by reference.
[0057] Vitamins can be included with minerals or used separately.
Vitamins include Vitamins C and D, thiamine, riboflavin, calcium
pantothenate, niacin, folic acid, nicotinamide, pyridoxine,
cyanocobalamin, para-aminobenzoic acid, bioflavonoids, and mixtures
thereof. Such vitamins are disclosed in Drug Facts and Comparisons
(loose leaf drug information service), Wolters Kluer Company, St.
Louis, Mo., .COPYRGT.1997, pp. 3-10; incorporated herein by
reference.
[0058] Oral nutritional supplements include amino acids,
lipotropics, fish oil, and mixtures thereof, as disclosed in Drug
Facts and Comparisons (loose leaf drug information service),
Wolters Kluer Company, St. Louis, Mo., .COPYRGT.1997, pp. 54-54e;
incorporated herein by reference. Amino acids include, but, are not
limited to L-Tryptophan, L-Lysine, Methionine, Threonine,
Levocarnitine or L-carnitine and mixtures thereof. Lipotropics
include, but, are not limited to choline, inositol, betaine,
linoleic acid, linolenic acid, and mixtures thereof. Fish oil
contains large amounts of Omega-3 (N-3) Polyunsaturated fatty
acids, eicosapentaenoic acid and docosahexaenoic acid.
[0059] Entenal nutritional supplements include, but, are not
limited to protein products, glucose polymers, corn oil, safflower
oil, medium chain triglycerides as disclosed in Drug Facts and
Comparisons (loose leaf drug information service), Wolters Kluer
Company, St. Louis, Mo., .COPYRGT.1997, pp. 55-57; incorporated
herein by reference.
[0060] 7. Enzymes
[0061] An individual or combination of several compatible enzymes
can be included in the oral care composition or substance of the
present invention. Enzymes are biological catalysts of chemical
reactions in living systems. Enzymes combine with the substrates on
which they act forming an intermediate enzyme-substrate complex.
This complex is then converted to a reaction product and a
liberated enzyme which continues its specific enzymatic
function.
[0062] Enzymes provide several benefits when used for cleansing of
the oral cavity. Proteases break down salivary proteins which are
absorbed onto the tooth surface and form the pellicle; the first
layer of resulting plaque. Proteases along with lipases destroy
bacteria by lysing proteins and lipids which form the structural
component of bacterial cell walls and membranes. Dextranases break
down the organic skeletal structure produced by bacteria that forms
a matrix for bacterial adhesion. Proteases and amylases, not only
present plaque formation, but also prevent the development of
calculus by breaking-up the carbohydrate-protein complex that binds
calcium, preventing mineralization.
[0063] Enzymes useful in the present invention include any of the
commercially available proteases, glucanohydrolases,
endoglycosidases, amylases, mutanases, lipases and mucinases or
compatible mixtures thereof. Preferred are the proteases,
dextranases, endoglycosidases and mutanases, most preferred being
papain, endoglycosidase or a mixture of dextranase and mutanase.
Additional enzymes suitable for use in the present invention are
disclosed in U.S. Pat. No. 5,000,939 to Dring et al., Mar. 19,
1991; U.S. Pat. No. 4,992,420 to Neeser, Feb. 12, 1991; U.S. Pat
No. 4,355,022 to Rabussay, Oct. 19, 1982; U.S. Pat. No. 4,154,815
to Pader, May 15, 1979; U.S. Pat. No. 4,058,595 to Colodney, Nov.
15, 1977; U.S. Pat. No. 3,991,177 to Virda et al., Nov. 9, 1976 and
U.S. Pat. No. 3,696,191 to Weeks, Oct. 3, 1972; all incorporated
herein by reference.
[0064] 8. Mouth and Throat Products
[0065] Other materials that can be used with the present invention
include commonly known mouth and throat products. Such products are
disclosed in Drug Facts and Comparisons (loose leaf drug
information service), Wolters Kluer Company, St. Louis, Mo.,
.COPYRGT.1997, pp. 520b-527; incorporated herein by reference.
These products include, but, are not limited to anti-fungal,
antibiotic and analgesic agents.
[0066] 9. Antioxidants
[0067] Antioxidants are generally recognized as useful in
compositions such as those of the present invention. Antioxidants
are disclosed in texts such as Cadenas and Packer, The Handbook of
Antioxidants, .COPYRGT. 1996 by Marcel Dekker, Inc., incorporated
herein by reference. Antioxidants that may be included in the oral
care composition or substance of the present invention include, but
are not limited to Vitamin E, ascorbic acid, Uric acid,
carotenoids, Vitamin A, flavonoids and polyphenols, herbal
antioxidants, melatonin, aminoindoles, lipoic acids and mixtures
thereof.
[0068] 10. H-2 Antagonists
[0069] Histamine-2 (H-2 or H@) receptor antagonist compounds (H-2
antagonists) may be used in the oral care composition of the
present invention. As used herein, selective H-2 antagonists are
compounds that block H-2 receptors, but do not have meaningful
activity in blocking histamine-1 (H-1 or H!) receptors. Selective
H-2 antagonists stimulates the contraction of smooth muscle from
various organs, such as the gut and bronchi; this effect can be
suppressed by low concentrations of mepyramine--a typical
antihistaminic drug. The pharmacological receptors involved in
these mepyramine-sensitive histamine responses have been defined as
H-1 receptors (Ash, A. S. F. & H. O. Schild, Brit. J. Pharmacol
Chemother., Vol. 27 (1966), p. 427, incorporated herein by
reference). Histamine also stimulates the secretion of acid by the
stomach (Loew, E. R. & O. Chickering, Proc. Soc. Exp. Biol.
Med., Vol. 48 (1941), p. 65, incorporated herein by reference),
increases the heart rate (Trendelenburg, U., J. Pharmacol., Vol.
130 (1960), p. 450, incorporated herein by reference), and inhibits
contractions in the rat uterus (Dews, P. B. & J. D. P. Graham,
Brit. J. Pharmacol. Chemother., Vol. 1 (1946), p. 278, incorporated
herein by reference); these actions cannot be antagonized by
mepyramine and related drugs. The H-2 antagonists useful in the
oral care compositions or substances are those that blockade the
receptors involved in mepyramine-insensitive, non-H-1 (H-2),
histamine responses, and do not blockade the receptors involved in
mepyramine-sensitive histamine responses.
[0070] Selective H-2 antagonists are those compounds found to be
H-2 antagonists through their performance in classical preclinical
screening tests for H-2 antagonist function. Selective H-2
antagonists are identified as compounds which can be demonstrated
to function as competitive or non-competitive inhibitors of
histamine-mediated effects in those screening models specifically
dependent upon H-2 receptor function, but to lack significant
histamine antagonist activity in those screening models dependent
upon H-1 receptor function. Specifically, this includes compounds
that would be classified as described by Black, J. W., W. A. M.
Duncan, C. J. Durant, C. R. Ganellin & E. M. Parsons,
"Definition and Antagonism of Histamine H@-Receptors", Nature, Vol.
236 (Apr. 21, 1972), pp. 385-390 (Black), incorporated herein by
reference, as H-2 antagonists if assessed as described by Black
through testing with the guinea pig spontaneously beating right
atria in vitro assay and the rat gastric acid secretion in vivo
assay, but shown to lack in significant H-1 antagonist activity
relative to H-2 antagonist activity, if assessed as described by
Black with either the guinea pig ileum contraction in vitro assay
or the rat stomach muscle contraction in vivo assay. Preferably
selective H-2 antagonists demonstrate no significant H-1 activity
at reasonable dosage levels in the above H-1 assays. Typical
reasonable dosage level is the lowest dosage level at which 90%
inhibition of histamine, preferably 99% inhibition of histamine, is
achieved in the above H-2 assays.
[0071] Selective H-2 antagonists include compounds meeting the
above criteria which are disclosed in U.S. Pat. Nos. 5,294,433 and
5,364,616 Singer et al., issued Mar. 15, 1994 and Nov. 15, 1994
respectively and assigned to Procter & Gamble; both herein
incorporated by reference. wherein the selective H-2 antagonist is
selected from the group consisting of cimetidine, etintidine,
ranitidine, ICIA-5165, tiotidine, ORF-17578, lupitidine,
donetidine, famotidine, roxatidine, pifatidine, lamtidine, BL-6548,
BMY-25271, zaltidine, nizatidine, mifentidine, BMY-52368,
SKF-94482, BL-6341A, ICI-162846, ramixotidine, Wy-45727, SR-58042,
BMY-25405, loxtidine, DA-4634, bisfentidine, sufotidine,
ebrotidine, HE-30-256, D-16637, FRG-8813, FRG-8701, impromidine,
L-643728, and HB-408. 4. Particularly preferred is cimetidine
(SKF-92334),
N-cyano-N'-methyl-N''-(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)g-
uanidine: ##STR1##
[0072] Cimetidine is also disclosed in the Merck Index, 11th
edition (1989), p. 354 (entry no. 2279), and Physicians' Desk
Reference, 46th edition (1992), p. 2228. Related preferred H-2
antagonists include burimamide and metiamide.
[0073] As previously mentioned, the oral care substance of the
present invention can be in a variety forms, but, most preferable
is a gel, particularluy an aqueous gel. The gel is a high viscosity
matrix formed from gelling agents known in the art. These gelling
agents are safe for oral use, do not readily dissolve in saliva,
and do not react with or inactivate the oral care compounds
incorporated into them. Generally, the gelling agent is a swellable
polymer. Furthermore, the gel formed with these agents provide
sufficient adhesive attachment of the film material to the targeted
area of the mouth. The level of gelling agent to form the gel
composition is from about 0.1% to about 15%, preferably from about
1% to about 10%, more preferably from about 2% to about 8%, and
most preferably from about 4% to about 6%, by weight of the oral
care composition or substance.
[0074] Suitable gelling agents useful in the present invention
include carboxypolymethylene, carboxymethyl cellulose,
carboxypropyl cellulose, polyoxamers, carrageenan, Veegum,
carboxyvinyl polymers, and natural gums such as gum karaya, xanthan
gum, Guar gum, gum arabic, gum tragacanth, and mixtures thereof.
The preferable gelling agent for use in the present invention is
carboxypolymethylene, obtained from B. F. Goodrich Company under
the tradename Carbopol.RTM.. Particularly preferable Carbopols
include Carbopol 934, 940, 941, 956 and mixtures thereof.
Particularly preferred is Carbopol 956. Carboxypolymethylene is a
slightly acidic vinyl polymer with active carboxyl groups. The
normal concentration of various carboxypolymethylene resins in
water, according to the manufacturer, is below about 2%. However,
it has been found that by preparing supersaturated
carboxypolymethylene compositions having an absolute concentration
in the ranges specified above, suitable high viscosity oral gel
compositions may be prepared.
[0075] The concentrated carboxypolymethylene gels have a number of
important characteristics in addition to high viscosity. Enough
carboxypolymethylene is added to the oral gel compositions beyond
that required to provide high viscosity such that a significant
quantity of saliva or water is required to lower the viscosity to
the point that the composition may be diluted and washed out by
saliva. The concentrated carboxypolymethylene composition also has
a unique tackiness or stickiness which retains and seals the strip
material against the targeted oral cavity surface it is affixed to,
particularly teeth. However, care should be taken to avoid too much
carboxypolymethylene thereby making insertion or withdrawal of the
strip material difficult.
[0076] If the oral care substance is an aqueous gel, the water
present in the gel compositions should preferably be deionized and
free of organic impurities. Water comprises from about 0.1% to 95%,
preferably from about 5% to about 90%, and most preferably from
about 10% to about 80%, by weight of the oral care substance. This
amount of water includes the free water that is added plus that
amount that is introduced with other materials.
[0077] A pH adjusting agent may also be added to optimize the
storage stability of the gel and to make the substance safe for
oral tissue. These pH adjusting agents, or buffers, can be any
material which is suitable to adjust the pH of the oral care
substance. Suitable materials include sodium bicarbonate, sodium
phosphate, sodium hydroxide, ammonium hydroxide, sodium stannate,
triethanolamine, citric acid, hydrochloric acid, sodium citrate,
and combinations thereof. The pH adjusting agents are added in
sufficient amounts so as to adjust the pH of the gel composition to
about 4.5 to about 11, preferably from about 5.5 to about 8.5, and
more preferably from about 6 to about 7. pH adjusting agents are
generally present in an amount of from about 0.01% to about 15% and
preferably from about 0.05% to about 5%, by weight of the oral care
substance.
[0078] While the gel described above provides sufficient
adhesiveness, additional gelling agents may also be included in the
formula to help the active ingredients adhere to the tissues of the
oral cavity. Suitable agents include both polymers with limited
water solubility as well as polymers lacking water solubility.
These polymers deposit a thin film on both the oral cavity's soft
and hard tissues when saliva combines with the instant composition.
Suitable limited water solubility adhesives include: hydroxy ethyl
or propyl cellulose. Adhesives lacking water solubility include:
ethyl cellulose and polyox resins. Another possible adhesive
suitable for use in the instant composition is polyvinylpyrrolidone
with a molecular weight of about 50,000 to about 300,000. Still
another possible adhesive suitable for use in the instant
composition is a combination of Gantrez and the semisynthetic,
water-soluble polymer carboxymethyl cellulose.
[0079] An additional carrier material may also be added to the oral
care substance. Carrier materials can be humectants. Suitable
humectants include glycerin, sorbitol, polyethylene glycol,
propylene glycol, and other edible polyhydric alcohols. Humectants
are generally present in an amount of from about 10% to about 95%
and preferably from about 50% to about 80%, by weight of the oral
care substance or composition. In addition to the above materials
of the gel of the present invention, a number of other components
can also be added to the oral care substance. Additional components
include, but are not limited to, flavoring agents, sweetening
agents, xylitol, opacifiers, coloring agents, and chelants such as
ethylenediaminetetraacetic acid. These additional ingredients can
also be used in place of the compounds disclosed above.
[0080] The Release Liner
[0081] The release liner may be formed from any material which
exhibits less affinity for the oral care substance than the oral
care substance exhibits for itself and for the strip of material.
The release liner preferably comprises a rigid sheet of material
such as polyethylene, paper, polyester, or other material which is
then coated with a non-stick type material. The release liner
material may be coated with wax, silicone, teflon, fluoropolymers,
or other non-stick type materials. A preferred release liner is
Scotchpak.RTM., produced by 3M. The release liner may be cut to
substantially the same size and shape as the strip of material or
the release liner may be cut larger than the strip of material to
provide a readily accessible means for separating the material from
the strip. The release liner may be formed from a brittle material
which cracks when the strip is flexed or from multiple pieces of
material or a scored piece of material. Alternative, the release
liner may be in two overlapping pieces such as a typical adhesive
strip bandage design. A further description of materials suitable
as release agents is found in Kirk-Othmer Encyclopedia of Chemical
Technology, Fourth Edition, Volume 21, pp. 207-218, incorporated
herein by reference.
[0082] All documents cited are, in relevant part, incorporated
herein by reference; the citation of any document is not to be
construed as an admission that it is prior art with respect to the
present invention.
EXAMPLES
[0083] The strip of material 12 is preferably a 0.013 thick piece
of polyethylene film. The film preferably has an array of shallow
pockets, typically 0.4 mm across and 0.1 mm deep. The strip of
material 12 has a flexural stiffness of about 0.6 grams/centimeter
as measured on a Handle-O-Meter, model #211-300, available from
Thwing-Albert Instrument Co. of Philadelphia, Pa., as per test
method ASTM D2923-95.
[0084] An example of a tooth whitener is a gel described as
follows: combine 70% glycerin, 5% carboxypolymethylene, 10%
carbamide peroxide, and 15% water adjusted to pH 6.5 with sodium
hydroxide. Mix until homogeneous. Commercial tooth whiteners, such
as Opalescence and Nu-Pro Gold are also operable with the delivery
system of the present invention.
[0085] An example of an oral gel composition of the subject
invention containing H-2 antagonists, made by routine processing
methods, comprises mixing 2.50% hydroxyethyl cellulose, 0.09%
sodium fluoride, 0.05% sodium saccharin, 1.00% ranitidine, and
purified water q.s.
[0086] An example of an oral gel composition of the subject
invention containing enzymes, made by routine processing methods,
comprises 61.814% sorbitol, 0.314% Carbopol 956, 0.534% xantham
gum, 1.132% citric acid, 6.291 sodium citrate, 5.033% sodium
lauroyl sarcosinate (30% solution), 7.864% endoglycosidase (3.2%
solution), 0.305% sodium fluoride, water q.s.
[0087] An example of an oral gel composition of the subject
invention containing antimicrobial actives, made by routine
processing methods, comprises from 21.2% to 21.5% glycerin, 6.0%
Carbopol 956, 40.0% propylene glycol, 2.5% sodium hydroxide (50%
solution), from 0.1% to 0.3% Triclosan and water qs.
[0088] Method of Use
[0089] In practicing the present invention, a strip of material is
applied to the desired oral surface by the wearer. The side of the
material facing the oral surface is coated with a oral care
substance that is preferably in a highly viscous state. This oral
care substance provides a vehicle for the active as well as
tackiness between the oral surfaces and the strip of material,
holding the strip of material in place for extended periods of
time. For oral care actives other than teeth whiteners, the period
over which the strip of material is used is from about 1 minute to
about 8 hours for actives that require long term diffusion into the
oral surface, preferably from about 1 to about 120 minutes and most
preferably from about 30 to about 60 minutes.
[0090] There are many methods using the present invention to reduce
or eliminate the proliferation of microbial and bacterial growth in
the oral cavity. Such growth is known to be responsible for
development of oral conditions including, but not limited to mouth
and breath odor, plaque accumulation, gingival inflammation and
bleeding of the gum tissue. Prolonged attachment by certain oral
bacteria has also been implicated in more progressive periodontal
diseases. Numerous articles exist in the literature that describe
the advantages of controlling bacterial growth in regard to
maintaining good oral well-being of the individual.
[0091] Among these methods is one that comprises the steps of first
applying a gel comprising an antimicrobial agent, preferably in a
highly viscous state, to the strip of material of the present
invention. The strip of material with the applied gel is applied to
the oral surface, preferably the front surface of a plurality of
adjacent teeth and their surrounding gum tissue, with adhesive
attachment between the strip of material and the oral surface. This
provides sufficient attachment for holding the delivery system in
place for a sufficient time to allow the antimicrobial agent to act
upon the oral surface. The conformable strip is removed after a
period of time for the antimicrobial agent to be effective. Such a
period includes from just prior to retiring or upon awakening.
Whenever the strip is removed the excess gel residue remaining on
the applied surface may be removed by means such as brushing and,
or rinsing. Such a method has been found particularly useful in the
eliminating mouth odors generated while sleeping.
[0092] The strip of material readily conforms to the oral care
surface by lightly pressing it there against. The strip of material
is easily removed by the wearer by peeling it off using a finger or
fingernail. Preferably each successive treatment uses a fresh strip
of material.
[0093] In the situation were the oral care surface is the surface
of teeth, is not unnecessary to prepare the teeth surface before
applying the delivery system of the present invention. For example,
the wearer may or may not choose to brush his teeth or rinse his
mouth before applying the delivery system. The surfaces of the
teeth are not required to be dried or to be excessively wet with
saliva or water before the strip of material is applied.
[0094] Preferably, the strip of material and substances almost
unnoticeable when worn, preferably transparent. Thinness of the
strip of material may also provide higher temperature of the oral
surface wherein the warmer temperature accelerates the rate of
diffusion of the active material into the oral surface.
[0095] When the wearer removes the strip of material from the
tooth, there may be a residual amount of oral care substance
remaining on the surface. The amount residual oral care substance,
however, will not be great since it has affinity for both the film
and for itself. Any residual oral care substance may be easily
removed by wiping, brushing or rinsing the oral surface.
[0096] While particular embodiments of the present invention have
been illustrated and described, it will be obvious to those skilled
in the art that various changes and modifications may be made
without departing from the spirit and scope of the invention, and
it is intended to cover in the appended claims all such
modifications that are within the scope of the invention.
* * * * *