Language selection

Search

Patent 2359641 Summary

Third-party information liability

Some of the information on this Web page has been provided by external sources. The Government of Canada is not responsible for the accuracy, reliability or currency of the information supplied by external sources. Users wishing to rely upon this information should consult directly with the source of the information. Content provided by external sources is not subject to official languages, privacy and accessibility requirements.

Claims and Abstract availability

Any discrepancies in the text and image of the Claims and Abstract are due to differing posting times. Text of the Claims and Abstract are posted:

  • At the time the application is open to public inspection;
  • At the time of issue of the patent (grant).
(12) Patent Application: (11) CA 2359641
(54) English Title: CHEWING GUM WITH DENTAL HEALTH BENEFITS EMPLOYING CALCIUM LACTATE
(54) French Title: GOMME A MACHER CONTENANT DU LACTATE DE CALCIUM ET AMELIORANT LA SANTE DENTAIRE
Status: Deemed Abandoned and Beyond the Period of Reinstatement - Pending Response to Notice of Disregarded Communication
Bibliographic Data
(51) International Patent Classification (IPC):
  • A23G 4/00 (2006.01)
  • A61K 8/365 (2006.01)
  • A61K 9/00 (2006.01)
  • A61K 9/68 (2006.01)
  • A61K 31/19 (2006.01)
  • A61Q 11/00 (2006.01)
(72) Inventors :
  • MAZUREK, PAMELA M. (United States of America)
  • BARABOLAK, ROMAN M. (United States of America)
(73) Owners :
  • WM. WRIGLEY JR. COMPANY
(71) Applicants :
  • WM. WRIGLEY JR. COMPANY (United States of America)
(74) Agent: CASSAN MACLEAN
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 2000-01-21
(87) Open to Public Inspection: 2000-07-27
Examination requested: 2001-07-16
Availability of licence: N/A
Dedicated to the Public: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US2000/001733
(87) International Publication Number: US2000001733
(85) National Entry: 2001-07-16

(30) Application Priority Data:
Application No. Country/Territory Date
60/117,195 (United States of America) 1999-01-26

Abstracts

English Abstract


A chewing gum and method for the remineralization of tooth enamel is provided.
The chewing gum comprises an insoluble base portion, a water soluble portion,
a flavor, and a therapeutically effective amount of calcium lactate.


French Abstract

La présente invention concerne une gomme à mâcher et un procédé permettant de reminéraliser l'émail dentaire. La gomme à mâcher contient une partie base insoluble, une partie soluble dans l'eau, un arôme et une quantité thérapeutiquement efficace de lactate de calcium.

Claims

Note: Claims are shown in the official language in which they were submitted.


WE CLAIM:
1. A sugar free chewing gum for promoting the remineralization of tooth
enamel comprising:
a water insoluble base portion;
a water soluble portion;
a flavor; and
calcium lactate.
2. The chewing gum of Claim 1 wherein the chewing gum contains at least
one other therapeutic agent.
3. The chewing gum of Claim 1 including at least 40 mg of calcium lactate.
4. The chewing gum of Claim 1 including at least 60 mg of calcium lactate.
5. The chewing gum of Claim 1 including at least 80 mg of calcium lactate.
6. The chewing gum of Claim 1 wherein the calcium lactate is divided
among two or more pieces.
7. The chewing gum of Claim 1 wherein the gum is in the form of a stick.
8. The chewing gum of Claim 1 wherein the gum is in the form of a tab.
9. A method for promoting the remineralization of tooth enamel comprising
the steps of chewing a chewing gum that includes a therapeutically effective
amount of
calcium lactate.
10. The method of Claim 9 wherein two pieces of chewing gum are chewed
at a time.
-17-

11. The method of Claim 9 wherein the gum is chewed at least twice a day.
12. The method of Claim 9 wherein the chewing gum produces a calcium ion
concentration in the saliva of the mouth of the chewer of at least 200 ppm.
13. The method of Claim 9 wherein the chewing gum produces a calcium ion
concentration in the saliva of the mouth of the chewer of at least 350 ppm.
14. The method of Claim 9 wherein the chewing gum produces a calcium ion
concentration in the saliva of the mouth of the chewer of at least 500 ppm.
15. The method of Claim 9 wherein a calcium ion concentration is maintained
for at least 2 minutes.
16. A chewing gum for remineralizing tooth enamel comprising:
a water insoluble portion;
a water soluble portion;
a flavor; and
sufficient calcium lactate to produce a calcium ion concentration in the mouth
of
the chewer of at least 200 ppm.
17. The chewing gum of Claim 16 wherein the chewing gum contains other
therapeutic agents.
18. The chewing gum of Claim 16 including at least 40 mg of calcium lactate.
19. The chewing gum of Claim 16 including at least 60 mg of calcium lactate.
20. The chewing gum of Claim 16 including at least 80 mg of calcium lactate.
21. The chewing gum of Claim 16 wherein the gum is in the form of a stick.
-18-

22. The chewing gum of Claim 16 wherein the gum is in the form of a tab.
23. The chewing gum of Claim 16 wherein the gum is in the form of a stick
wherein the calcium lactate is divided among two or more pieces.
24. The chewing gum of Claim 16 wherein the gum comprises sufficient
calcium lactate to produce a calcium ion concentration in the mouth of the
chewer of at
least 350 ppm.
25. The chewing gum of Claim 16 wherein the gum comprises sufficient
calcium lactate to produce a calcium ion concentration in the mouth of the
chewer of at
least 500 ppm.
-19-

Description

Note: Descriptions are shown in the official language in which they were submitted.


CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
SPECIFICATION
TITLE
"CHEWING GUM WITH DENTAL HEALTH BENEFITS
EMPLOYING CALCIUM LACTATE"
BACKGROUND OF THE INVENTION
The present invention relates generally to chewing gums. More specifically,
the
present invention relates to chewing gums that can provide dental benefits.
Except for the common cold, dental caries (tooth decay) is the most prevalent
human disorder. See, The Merck Manual, Sixteenth Edition, p. 2480. Even
though,
many steps have been taken to reduce dental caries and tooth decay, such as
fluoridation
and improved dental care, tooth decay continues to be a significant problem.
This is
especially true in the adult population; 80% of the tooth decay occurs in 20%
of the
population. See Featherstone, An Updated Understanding of the Mechanism of
Dental
Decay and its Prevention, Nutrition Quarterly, Vol. 14, No. l, 1990, pp. 5-11.
To protect a normal tooth, a thin layer of dental enamel forms a protective
coating
over the tooth. This coating consists mainly of calcium, phosphate, and other
ions in a
hydroxyapatite-like structure. The enamel contains 2 to 5 percent carbonate;
this
carbonate content snakes the enamel susceptible to acid dissolution. See,
Featherstone,
id. at 6.
The interaction of three factors is believed to result in dental caries: a
susceptible
tooth surface; the proper microflora; and a suitable substrate for the
microflora. Although
several acidogenic micro-organisms that are present in the mouth can initiate
carious
lesions, Streptococcus mutans is believed to be the primary pathogen. See, The
Merck
Manual, supra.
It is known that foods containing fermentable carbohydrates can promote dental
caries. Tooth decay begins when the Streptococcus mutans, that reside
principally in the
plaque that adheres to a tooth surface, metabolize the fermentable
carbohydrates
consumed by the host. During the metabolism of the fermentable carbohydrates
by the
bacteria, lactic acid and other organic acids are secreted as a by-product.
These acids
reduce the pH of the surrounding plaque/tooth environment.
-1-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
When the pH of the plaque/tooth environment drops below a critical level of
5.5
to 5.7, hydroxyapatite (calcium phosphate hydroxide, Ca,o(P04)6(OH)2), the key
component of tooth enamel, begins to dissolve. This critical pH can change
depending
on the concentration of the key ions. Typically, the dissolution begins below
the tooth's
porous surface.
With repeated acid attacks, caused by the further metabolism of fermentable
carbohydrates by the bacteria, subsurface lesions expand. The body's natural
remineralization mechanism, however, at this point, can still reverse the
decay process.
But, if the lesions expand to the point that the enamel surface breaks, a
cavity is formed
and the process is no longer reversible.
The natural remineralization process involves, in part, the flow of saliva
over the
plaque. The saliva can raise the pH of the environment. Additionally, calcium
and
phosphate ions in the saliva precipitate out to replace the hydroxyapatite
that was
dissolved by the organic acids created during the metabolism of the
fermentable
carbohydrates.
However, typically, this remineralization process only occurs at significant
levels
when the pH is above the critical level.. Therefore, if the saliva does not
sufficiently raise
the pH, significant remineralization will not occur. But, the remineralization
process may
be enhanced by fluoride in the oral cavity that speeds up new crystal growth
and makes
a flurorapatite-like material that is precipitated on the surface of the
crystals inside the
caries lesion. See, Featherstone, id. at 7.
A number of salts have been reported in certain experiments to counteract
demineralization. One of the difficulties is providing a viable vehicle for
delivering the
salts. Still further, a number of safety issues are raised by some of the
salts.
Furthermore, sensory problems with respect to some of the salts prevent these
salts from
being taken on a regular basis by a patient to provide prophylactic benefits.
U.S. Patent No. 5,378,171 discloses a sugar chewing gum with dental health
benefits that includes calcium glycerophosphate.
-2-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
SUMMARY OF THE INVENTION
The present invention provides a composition and method for the
remineralization
of enamel. Pursuant to the present invention, sugar free chewing gum is
provided that
includes a therapeutically effective amount of calcium lactate.
It has been found that calcium lactate counteracts the decaying process.
Calcium
lactate is believed to function by promoting remineralization of the tooth
enamel caused
by dental caries. Calcium lactate has been found to be an effective enamel
remineralization agent that is acceptable from sensory and safety standpoints.
Pursuant to the present invention, calcium lactate can be used in chewing gum:
Chewing gum is an especially good vehicle for delivering calcium lactate
because it can
deliver the ingredient over prolonged periods of time. Additionally, chewing
gum can
be conveniently used almost anywhere, at anytime, as opposed to a rinse or
dentifrices.
To this end, a method for remineralizing enamel is provided comprising the
step
of providing a chewing gum that includes a therapeutically effective amount of
calcium
lactate.
In an embodiment, two pieces of chewing gum are chewed at a time.
In an embodiment of the method, the gum is chewed at least twice a day.
In an embodiment of the method, the chewing gum produces a calcium ion
concentration in the saliva of the mouth of the chewer of at least 200 ppm.
In an embodiment of the method, the gum is chewed for at least two minutes.
The present invention also provides a chewing gum for reducing the generation
of dental caries comprising a water insoluble base, water soluble portion and
flavor, and
calcium lactate.
In an embodiment, the chewing gum is sugarless.
2~ In an embodiment, the chewing gum is wax-free.
In an embodiment, the chewing gum is a low calorie chewing gum.
In an embodiment, the chewing gum contains other therapeutic agents.
In an embodiment, the chewing gum includes at least 40 mg of calcium lactate.
In an embodiment, the chewing gum is in the form of a stick.
In an embodiment, the chewing gum is in the form of a pellet.
In an embodiment, the chewing gum includes an additional therapeutic agent.
-3-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
An advantage of the present invention is to provide a method for preventing,
or
reducing the risk of, dental caries of the remineralization of enamel.
Another advantage of the present invention is to treat dental caries.
Additionally, an advantage of the present invention is to provide a chewing
gum
that can be used to improve dental health.
Further, an advantage of the present invention is to provide a chewing gum
that
does not have the sensory drawbacks of other sources of calcium.
Moreover, an advantage of the present invention is to provide an easy and
enjoyable way to improve dental health.
Still further, an advantage of the present invention is to provide a
composition and
method for delivering a therapeutic agent over a prolonged period of time to
the oral
region.
Additional features and advantages of the present invention are described in,
and
will be apparent from, the detailed description of the presently preferred
embodiments.
DETAILED DESCRIPTION OF THE
PRESENTLY PREFERRED EMBODIMENTS
The present invention provides a method and composition for remineralizing
tooth enamel and thereby preventing and/or treating dental caries. Pursuant to
the present
invention, a chewing gum is provided that includes a therapeutically effective
amount of
calcium lactate. The chewing gum of the present invention, by including a
therapeutically effective amount of calcium lactate, can improve dental health
when
chewed.
Calcium lactate is believed to function by the remineralization of tooth
enamel.
Calcium lactate when provided in a chewing gum can produce a calcium ion
concentration in the saliva during chewing which is effective to remineralized
carious
lesions in teeth. For example, it has been found that 80 mg of calcium lactate
in chewing
gum will produce saliva calcium levels greater than 500 parts per million,
this level has
been shown to remineralize teeth.
It is believed that the calcium ion concentration in the saliva should be
above 200
ppm in order to initiate the remineralization process. Preferably the calcium
ion
concentration should be above 350 ppm and most preferably above 500 ppm. These
-4-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
levels should be provided for at least one minute, preferably more than two
minutes, and
most preferably more than four minutes upon chewing the gum.
It has been found that these levels can be accomplished by the inclusion of at
least
40 mg, preferably at least 60 mg and most preferably at least 80 mg of calcium
lactate
in a piece of chewing gum. In some cases, it may be desirable to divide the
prescribed
dosage among two or more smaller pieces of gum which are intended to be chewed
together.
In another embodiment of the invention, a method for the remineralization of
carious lesions in teeth is provided that comprises providing a sugarless
chewing gum
comprising calcium lactate. The gum is chewed for at least two minutes
(preferably at
least 5 minutes and most preferably at least 20 minutes) whereby the calcium
is released
by the gum in a quantity sufficient to produce a calcium concentration which
is effective
to remineralized the carious lesions. This treatment is repeated at least
twice, preferably
at least three times, and most preferably at least five times daily until the
lesion has been
1 S remineralized.
The chewing gum composition may be any chewing gum formula and most
preferably a sugarless formulation. Such formulas typically contain a major
amount of
a sugar alcohol bulking agent, a substantial portion of gum base, minor
amounts of
syrups, softeners, flavors, color and high intensity sweeteners. Low calorie
gums which
contain reduced levels of sugar alcohols and increased levels of base and/or
low calorie
or calorie-free bulking agents are also anticipated. The product may be formed
into tabs,
sticks, chunks or coated pellets. A piece size of 1 to 4 grams is preferred.
As previously
mentioned, with smaller pieces sizes, it may be desirable to split the calcium
lactate
dosage between two or more pieces to reduce the concentration for improved
sensory
acceptability.
Chewing gum generally consists of a water insoluble gum base, a water soluble
portion, and flavors. The water soluble portion dissipates with a portion of
the flavor
over a period of time during chewing. The gum base portion is retained in the
mouth
throughout the chew.
The insoluble gum base generally comprises elastomers, resins, fats and oils,
softeners, and inorganic fillers. The gum base may or may not include wax. The
-S-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
insoluble gum base can constitute approximately 5 to about 95 percent, by
weight, of the
chewing gum, more commonly, the gum base comprises 10 to about 50 percent of
the
gum, and in some preferred embodiments, 20 to about 35 percent, by weight, of
the
chewing gum.
In an embodiment, the chewing gum base of the present invention contains about
20 to about 60 weight percent synthetic elastomer, 0 to about 30 weight
percent natural
elastomer, about 5 to about 55 weight percent elastomer plasticizer, about 4
to about 35
weight percent filler, about S to about 35 weight percent softener, and
optional minor
amounts (about one percent or less) of miscellaneous ingredients such as
colorants,
antioxidants, etc.
Synthetic elastomers may include, but are not limited to, polyisobutylene with
GPC weight average molecular weight of about 10,000 to about 95,000,
isobutylene-
isoprene copolymer (butyl elastomer), styrene-butadiene copolymers having
styrene-
butadiene ratios of about 1:3 to about 3:1, polyvinyl acetate having GPC
weight average
molecular weight of about 2,000 to about 90,000, polyisoprene, polyethylene,
vinyl
acetate-vinyl laurate copolymer having vinyl laurate content of about 5 to
about 50
percent by weight of the copolymer, and combinations thereof.
Preferred ranges are, for polyisobutylene, 50,000 to 80,000 GPC weight average
molecular weight, for styrene-butadiene, l:l to 1:3 bound styrene-butadiene,
for
polyvinyl acetate, 10,000 to 65,000 GPC weight average molecular weight with
the
higher molecular weight polyvinyl acetates typically used in bubble gum base,
and for
vinyl acetate-vinyl laurate, vinyl laurate content of 10-45 percent.
Natural elastomers may include natural rubber such as smoked or liquid latex
and
guayule as well as natural gums such as jelutong, lechi caspi, perillo, sorva,
massaranduba balata, massaranduba chocolate, nispero, rosindinha, chicle,
gutta hang
kang, and combinations thereof. The preferred synthetic elastomer and natural
elastomer
concentrations vary depending on whether the chewing gum in which the base is
used is
abhesive or conventional, bubble gum or regular gum, as discussed below.
Preferred
natural elastomers include jelutong, chide, sorva and massaranduba balata.
Elastomer plasticizers may include, but are not limited to, natural rosin
esters
such as glycerol esters of partially hydrogenated rosin, glycerol esters
polymerized rosin,
-6-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
glycerol esters of partially dimerized rosin, glycerol esters of rosin,
pentaerythritol esters
of partially hydrogenated rosin, methyl and partially hydrogenated methyl
esters of rosin,
pentaerythritol esters of rosin; synthetics such as terpene resins derived
from alpha-
pinene, beta-pinene, and/or d-limonene; and any suitable combinations of the
foregoing.
S the preferred elastomer plasticizers will also vary depending on the
specific application,
and on the type of elastomer which is used.
Fillers/texturizers may include magnesium and calcium carbonate, ground
limestone, silicate types such as magnesium and aluminum silicate, clay,
alumina, talc,
titanium oxide, mono-, di- and tri-calcium phosphate, cellulose polymers, such
as wood,
and combinations thereof.
Softeners/emulsifiers may include tallow, hydrogenated tallow, hydrogenated
and
partially hydrogenated vegetable oils, cocoa butter, glycerol monostearate,
glycerol
triacetate, lecithin, mono-, di- and triglycerides, acetylated monoglycerides,
fatty acids
(e.g. stearic, palmitic, oleic and linoleic acids), and combinations thereof.
Colorants and whiteners may include FD&C-type dyes and lakes, fruit and
vegetable extracts, titanium dioxide, and combinations thereof.
The base may or may not include wax. An example of a wax-free gum base is
disclosed in U.S. Patent No. 5,286,500, the disclosure of which is
incorporated herein by
reference.
In addition to a water insoluble gum base portion, a typical chewing gum
composition includes a water soluble bulk portion and one or more flavoring
agents. The
water soluble portion can include bulk sweeteners, high intensity sweeteners,
flavoring
agents, softeners, emulsifiers, colors, acidulants, fillers, antioxidants, and
other
components that provide desired attributes.
Softeners are added to the chewing gum in order to optimize the chewability
and
mouth feel of the gum. The softeners, which are also known as plasticizers and
plasticizing agents, generally constitute between approximately 0.5 to about 1
S% by
weight of the chewing gum. The softeners may include glycerin, lecithin, and
combinations thereof. Aqueous sweetener solutions such as those containing
sorbitol,
hydrogenated starch hydrolysates, corn syrup and combinations thereof, may
also be used
as softeners and binding agents in chewing gum.

CA 02359641 2001-07-16
w0 00/42861 PCT/US00/01733
Bulk sweeteners include both sugar and sugarless components. Bulk sweeteners
typically constitute 5 to about 95% by weight of the chewing gum, more
typically, 20 to
80% by weight, and more commonly, 30 to 60% by weight of the gum.
Sugar sweeteners generally include saccharide-containing components commonly
known in the chewing gum art, including, but not limited to, sucrose,
dextrose, maltose,
dextrin, dried invert sugar, fructose, levulose, galactose, corn syrup solids,
and the like,
alone or in combination.
Sugarless sweeteners include, but are not limited to, sugar alcohols such as
sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates, maltitol, and
the like, alone
or in combination.
High intensity artificial sweeteners can also be used, alone or in combination
with
the above. Preferred sweeteners include, but are not limited to sucralose,
aspartame, salts
of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts,
glycyrrhizin,
dihydrochalcones, thaumatin, monellin, and the like, alone or in combination.
In order
to provide longer lasting sweetness and flavor perception, it may be desirable
to
encapsulate or otherwise control the release of at least a portion of the
artificial
sweetener. Such techniques as wet granulation, wax granulation, spray drying,
spray
chilling, fluid bed coating, coacervation, and fiber extension may be used to
achieve the
desired release characteristics.
Usage level of the artificial sweetener will vary greatly and will depend on
such
factors as potency of the sweetener, rate of release, desired sweetness of the
product,
level and type of flavor used and cost considerations. Thus, the active level
of artificial
sweetener may vary from 0.02 to about 8%. When carriers used for encapsulation
are
included, the usage level of the encapsulated sweetener will be
proportionately higher.
Combinations of sugar and/or sugarless sweeteners may be used in chewing gum.
Additionally, the softener may also provide additional sweetness such as with
aqueous
sugar or alditol solutions.
If a low calorie gum is desired, a low caloric bulking agent can be used.
Example
of low caloric bulking agents include: polydextrose; Raftilose, Raftilin;
Fructooligosaccharides (NutraFlora); Palatinose oligosaccharide; Guar Gum
Hydrolysate
(Sun Fiber); or indigestible dextrin (Fibersol). However, other low calorie
bulking agents
_g_

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
can be used.
A variety of flavoring agents can be used. The flavor can be used in amounts
of
approximately 0.1 to about 15 weight percent of the gum, and preferably, 0.2
to 5%.
Flavoring agents may include essential oils, synthetic flavors or mixtures
thereof
including, but not limited to, oils derived from plants and fruits such as
citrus oils, fruit
essences, peppermint oil, spearmint oil, other mint oils, clove oil, oil of
wintergreen,
anise and the like. Artificial flavoring agents and components may also be
used. Natural
and artificial flavoring agents may be combined in any sensorially acceptable
fashion.
Additional oral health ingredients may be added including but not limited to,
antiplaque/anti-gingivitis agents (such as chlorhexidine, CPC, triclosan), pH
control
agents (including Urea and buffers,) other inorganic components for tarter or
caries
control (phosphates, fluoride) and biological agents (antibodies, enzymes).
The only
requirement is that the agents be safe and effective and that they do not
react undesirably
with each other such as may happen with phosphate salts.
Preferably the calcium lactate is mixed into the chewing gum mass but it may
also
be added to a coating syrup or used as a dry charge in a coating process in
the case of a
coated chewing gum.
The following examples, which as of this time have not been made, illustrate
some embodiments of the invention. Of course, many others are possible.
-9-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
EXAMPLES
1 2 3 4
Gum Base 30.0% 32.60% 30.0% 70.0%
Sorbitol 40.0 - 25.4 10.4
Maltitol - 30.00 - -
Xylitol 0.5 15.00 30.0 -
Mannitol 7.0 5.00 2.0 2.0
Calcium Lactate 3.0 4.00 4.0 6.0
Aspartame 0.5 - 0.2 -
Acesulfame K - 0.15 0.1 -
Sucralose - 0.15 - 0.2
Alitame - - 0.1 -
Neotame - - - 0.1
Sorbitol Solution 15.0 - 5.0 -
(70% solids)
Hydrogenated Starch- 9.00 - 5.0
Hydrolysate Syrup
(85% solids)
Glycerin 3.0 3.00 2.0 5.0
Color - 0.10 0.2 0.3
Flavor 1.0 1.00 1.0 1.0
(Spearmint)(Cinnamon)(Peppermint)(Wintergreen)
Total 100% 100% 100% 100%
Form 3g stick 3g stick 2g tab lg tab
-10-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
EXAMPLES
7 8 9 10
Gum Base 25.0% 35.00% 35.0% 30.0%
Sorbitol 31.9 - 35.0 39.50%
Polydextrose - 40.88 - -
Xylitol 15.0 - 5.0 5.00
Mannitol 5.0 5.00 5.0 4.00
Calcium Lactate 3.0 2.00 4.0 4.00
10Aspartame 0.5 0.50 0.3 0.50
Chlorhexidine - 0.17 - -
Triclosan - 0.25 - -
Urea 3.5 - - 0.50
S. Mutans Monclonal- - - 0.50
15Antibodies
Glycerin 5.0 5.00 5.0 15.00
Hydrogenated Starch10.0 10.00 9.9 -
Hydrolysate Syrup
(85% solids)
20Color 0.1 0.20 0.1 0.15
Flavor 1.0 1.00 0.7 0.85
(Sweet Fruit)(Peppermint)(Menthol) (Spearmint)
Total 100.0% 100.00% 100.0% 100.00%
Form 3g stick 3g stick lg pellet 3g stick
center
Notes on Examples:
25 Examples 4 and 8 are low caloric chewing gums.
Example 9 may be coated with xylitol, sorbitol, palatinit or maltitol with
added
chlorhexidine, triclosan and/or cetylpyridinium chloride (CPC). Recommended
dose is
two pellets.
-11-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
In-vitro testing was conducted to determine what level of calcium in saliva
would
remineralize softened tooth enamel. Enamel specimens were removed from
extracted
human teeth, polished and decalcified by exposure to O.1M lactic acid
solution. This
treatment resulted in lesions with a surface hardness range of 25 to 45
Vickers Hardness
Number (VHN) and an average lesion depth of 40-70 microns.
Solutions of calcium and fluoride in artificial saliva (prepared from a
formula in
Caries Research, 16:201, 1982) were prepared to treat the enamel. The saliva
formula
includes l.SmM (40 ppm) of calcium per liter. Two calcium levels were tested,
0 and
500 ppm and each level was prepared with 0, 0.05 and 0.10 ppm fluoride to
simulate the
effect of tooth brushing. The "Zero" calcium level had no calcium added to the
40 ppm
already present. The 500 ppm calcium level had 460 ppm additional calcium to
bring the
total concentration up to S00 ppm. The six solutions thus prepared are
summarized in
Table 1.
Table 1
Solution Fluoride (ppm) Calcium (ppm)
1 0 0
2 0 500
3 0.05 0
4 0.05 500
5 0.10 0
6 0.10 500
Enamel samples were exposed to 20 minutes of acid challenge followed by 60
minutes of one calcium/fluoride solution (above) then 30 minutes of pure
saliva. This
cycle was repeated three times daily, four days per week for 3 weeks. The
samples were
tested for hardness after each week. Each treatment was performed on 12
samples. The
results are reported in Table 2.
-12-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
Table
2
Change
in
Hardness
Baseline One Two Three
VHN Week Week Week
Soln.F Ca n MeanS.D.n MeanS.D.n MeanS.D.n MeanS.D.
(PPm)(PPm)
I 0 0 12 36.957.9612 3.343.6512 5.075.94I2 S.8SS.4S
2 0 S00 12 35.798.5212 7.234.7012 10.935.6312 11.607.70
3 ~ 0 I 38.038.53I 3.606.42I 7.946.05I 7.74IO.IS
O.OS I I I I
4 O.OSS00 12 33.296.2412 6.IS3.7012 13.7912.0912 IS.925.38
S O.I 0 12 33.958.3012 937 5.08I2 10.826.0812 12.656.40
-..- ..~ _..
-.
rb OI ~ 12 _37.526.2512 10.144.9612 13.284.7R12 16.999.12
~ 500
Analysis of variance was used to determine the contribution of the two
variables
(fluoride and calcium) to the remineralization effect. The results are given
as Tables 3
and 4.
Table 3
Change in VHN Hardness Due to Fluoride
(Comparison Groups*)
F (ppm) Week 1 Week 2 Week 3
0.00 5.27(A) 8.01 (B) 8.72(C)
0.05 4.88(A) 10.88(B) 11.88 (C D)
0.10 9.76 12.04(B) 14.82(D)
*Results pairwise comparisons of treatments/effects.arked with
of Groups m the same
letter
did not
differ
significantly
(p<0.05).
Table 4
Change in VEIN Hardness Due to Calcium
(p values **)
Ca (ppm)Week 1 Week 2 Week 3
0 5.43 7.97 8.77
500 7.84 (0.0389) 12.65 (0.0079) 14.84 (0.0012)
** Probability that the difference between 0 and 500 ppm values is due totally
to chance.
-13-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
From this analysis it was concluded that fluoride had little effect on
remineralization but that 500 ppm calcium in saliva significantly increased
remineralization of decalcified enamel over time. It is very likely that lower
levels would
also be effective given the magnitude of the effect and the strength of the
statistical
S significance.
Four chewing gum compositions were prepared according to the formulas of
Examples 11, 12, 13, and 14.
Table 5
Example 11 Example Example Example
12 13 14
Gum Base 31.40% 32.40% 32.40 32.40
Sorbitol 38.78 38.75 41.75 41.75
Xylitol 15.60 15.60 15.60 15.60
Mannitol 4.00 4.00 4.00 4.00
Glycerin 3.00 3.00 3.00 3.00
Calcium Lactate4.00 3.00 - -
Flavor 2.40 2.40 2.40 2.40***
Encapsulated 0.59 0.63 0.63 0.63
Acesulfame K
Encapsulated 0.12 0.12 0.12 0.12
Aspartame
Acesulfame K 0.05 0.04 0.04 0.04
Red Color 0.06 0.06 0.06 0.06
Total 100.00 100.00 100.00 100.00
Form 2.Og Tab 2.7g Stick2.Og Tab 2.7g Stick
(Inventive) (Inventive)(Comparative)(Comparative)
Calcium Lactate 80mg 8lmg 0 0
per piece
*** Example 14 used a different flavor from the other three Examples.
-14-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
Eight volunteers chewed the gums of Examples 1 l and 12 for six minutes with
saliva samples collected over two minute intervals. The saliva samples were
analyzed
for calcium by Direct Current Plasma. The two products delivered similar
calcium levels
reported in Table 6.
Table 6
Salivary Calcium Concentration (ppm)
Time (min) Example 11 Example 12
Base line (no gum) 70 82
0-2 597 599
2-4 365 386
4-6 302 341
To demonstrate the sensory acceptability of the calcium lactate, consumer
blind
taste tests were run using Examples 11, 12, 13 and 14. Eighty children (6-10
years old,
50:50 male:female) rated each sample on a five point scale ("5" being the best
rating) for
overall preference. The results were:
Example Example 12 Example 13 Example 14
11
Tab with Stick with 3% Tab Control Stick
4% Control
Calcium Calcium For Ex. 11 For Ex. 12
Lactate Lactate
Overall 4.23 4.38 4.28 4.49
Preference
("5" = best)
Based on these results it was concluded that calcium lactate had little or no
effect
on consumer preference. Note that the higher score for Ex. 14 may have been
due to its
use of a different flavor from the other samples.
-15-

CA 02359641 2001-07-16
WO 00/42861 PCT/US00/01733
It should be understood that various changes and modifications to the
presently
preferred embodiments described herein will be apparent to those skilled in
the art. Such
changes and modifications can be made without departing from the spirit and
scope of
the present invention and without diminishing its intended advantages. It is
therefore
intended that such changes and modifications be covered by the appended
claims.
-16-

Representative Drawing

Sorry, the representative drawing for patent document number 2359641 was not found.

Administrative Status

2024-08-01:As part of the Next Generation Patents (NGP) transition, the Canadian Patents Database (CPD) now contains a more detailed Event History, which replicates the Event Log of our new back-office solution.

Please note that "Inactive:" events refers to events no longer in use in our new back-office solution.

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Event History , Maintenance Fee  and Payment History  should be consulted.

Event History

Description Date
Inactive: IPC deactivated 2011-07-29
Inactive: First IPC derived 2006-03-12
Inactive: IPC from MCD 2006-03-12
Inactive: IPC from MCD 2006-03-12
Inactive: IPC from MCD 2006-03-12
Inactive: IPC from MCD 2006-03-12
Inactive: IPC from MCD 2006-03-12
Application Not Reinstated by Deadline 2005-05-10
Inactive: Dead - No reply to s.29 Rules requisition 2005-05-10
Deemed Abandoned - Failure to Respond to Maintenance Fee Notice 2005-01-21
Inactive: Abandoned - No reply to s.30(2) Rules requisition 2004-05-10
Inactive: Abandoned - No reply to s.29 Rules requisition 2004-05-10
Inactive: S.30(2) Rules - Examiner requisition 2003-11-10
Inactive: S.29 Rules - Examiner requisition 2003-11-10
Inactive: Agents merged 2002-05-08
Amendment Received - Voluntary Amendment 2002-03-01
Inactive: Cover page published 2001-12-10
Inactive: First IPC assigned 2001-11-19
Inactive: Applicant deleted 2001-11-19
Letter Sent 2001-11-19
Inactive: Acknowledgment of national entry - RFE 2001-11-19
Application Received - PCT 2001-11-02
All Requirements for Examination Determined Compliant 2001-07-16
Request for Examination Requirements Determined Compliant 2001-07-16
Letter Sent 2001-07-16
Application Published (Open to Public Inspection) 2000-07-27

Abandonment History

Abandonment Date Reason Reinstatement Date
2005-01-21

Maintenance Fee

The last payment was received on 2003-12-31

Note : If the full payment has not been received on or before the date indicated, a further fee may be required which may be one of the following

  • the reinstatement fee;
  • the late payment fee; or
  • additional fee to reverse deemed expiry.

Patent fees are adjusted on the 1st of January every year. The amounts above are the current amounts if received by December 31 of the current year.
Please refer to the CIPO Patent Fees web page to see all current fee amounts.

Fee History

Fee Type Anniversary Year Due Date Paid Date
Basic national fee - standard 2001-07-16
Registration of a document 2001-07-16
Request for examination - standard 2001-07-16
MF (application, 2nd anniv.) - standard 02 2002-01-21 2002-01-21
MF (application, 3rd anniv.) - standard 03 2003-01-21 2003-01-09
MF (application, 4th anniv.) - standard 04 2004-01-21 2003-12-31
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
WM. WRIGLEY JR. COMPANY
Past Owners on Record
PAMELA M. MAZUREK
ROMAN M. BARABOLAK
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
Documents

To view selected files, please enter reCAPTCHA code :



To view images, click a link in the Document Description column (Temporarily unavailable). To download the documents, select one or more checkboxes in the first column and then click the "Download Selected in PDF format (Zip Archive)" or the "Download Selected as Single PDF" button.

List of published and non-published patent-specific documents on the CPD .

If you have any difficulty accessing content, you can call the Client Service Centre at 1-866-997-1936 or send them an e-mail at CIPO Client Service Centre.

({010=All Documents, 020=As Filed, 030=As Open to Public Inspection, 040=At Issuance, 050=Examination, 060=Incoming Correspondence, 070=Miscellaneous, 080=Outgoing Correspondence, 090=Payment})


Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Description 2001-07-15 16 623
Claims 2001-07-15 3 69
Abstract 2001-07-15 1 38
Acknowledgement of Request for Examination 2001-07-15 1 179
Reminder of maintenance fee due 2001-11-18 1 112
Notice of National Entry 2001-11-18 1 203
Courtesy - Certificate of registration (related document(s)) 2001-11-18 1 113
Courtesy - Abandonment Letter (R30(2)) 2004-07-18 1 166
Courtesy - Abandonment Letter (R29) 2004-07-18 1 166
Courtesy - Abandonment Letter (Maintenance Fee) 2005-03-20 1 174
PCT 2001-07-15 6 274
Fees 2002-01-20 1 39