Drug – bio-affecting and body treating compositions – Chewing gum type
Reexamination Certificate
2000-09-01
2003-12-16
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Chewing gum type
C424S439000, C424S440000, C424S441000
Reexamination Certificate
active
06663849
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to methods for producing coated chewing gum products. More particularly, the invention relates to producing coated chewing gum products containing an antacid which is added to the chewing gum coating such that it will have a fast initial release and an increased residence time in the gastrointestional tract for maximum effectiveness.
Coated chewing gum products are well known. Many prior art patents disclose chewing gum products coated with sugar sweeteners or polyol sweeteners. U.S. Pat. No. 4,317,838, for example, discloses a method of applying a sugarless coating to chewing gum. The coating may include calcium carbonate as an anti-sticking agent. Synthetic sweeteners, including many different high-intensity sweeteners, are also suggested for use in the coating.
Another area of interest is the use of medicaments in chewing gum. In some instances, it is contemplated that an active medicament that is added to the chewing gum may be released readily. An active medicament may be added to the gum coating, which is a water soluble matrix, such that during the chewing period, the medicament may be released quickly, resulting in a fast release. This would allow a chewing gum coating to be a carrier for an active medicament, specifically an antacid with these fast release characteristics. For example, U.S. Pat. No. 4,867,989 discloses a chewing gum composition coated with an outer shell containing layers of a mineral compound and a coating syrup, but this patent states that the mineral compound must be added separately and not dispersed in the syrup used to make the coating.
Antacids are usually taken on an “as needed” basis to relieve gastrointestinal disturbances mostly due to dietary indiscretions. These antacids are generally insoluble inorganic salts such as calcium carbonate, magnesium carbonate, calcium hydroxide, magnesium hydroxide, or aluminum hydroxide.
These antacids readily neutralize acids in the gastrointestinal tract and are commonly available in or as antacid tablets.
Previously, antacids have been added to chewing gum and in a chewing gum coating, but some products have not been totally consumer acceptable. The large amount of active antacid needed for effectiveness does not lend itself to giving a good tasting product. Also, the presence of sugar in the antacid chewing gum or coated on the chewing gum of some products is not consumer acceptable because sugar causes dental caries.
A sugarless coated chewing gum product having an antacid in a sorbitol base coating is currently being sold under the trademark CHOOZ.® It has been found that by adding the antacid to a gum coating, the antacid is quickly released from the chewing gum into saliva and into the gastrointestinal (GI) tract. Relief from GI disturbances is quickly obtained, but does not last long. It would be desirable to have not only fast relief, but extended relief from GI disturbances. Thus, there is a need for a way to make coated chewing gum products that have an increased residence time in the GI tract, as well as being acceptable to the consumer from taste and other standpoints.
SUMMARY OF THE INVENTION
It has been found that materials can be included in a coating syrup that is used to make a chewing gum coating containing an antacid that will make a more viscous solution than previously used coating ingredients. The result is an increase in the residence time of the antacid in the gastrointestinal tract, therefore, giving extended relief. Also, it has surprisingly been found that the antacid, like calcium carbonate, can be added as a suspension to the coating syrup to thus be included in the gum coating.
In a first aspect, the invention is a method of making antacid coated chewing gum products comprising the steps of providing chewing gum cores; providing a coating syrup comprising a bulk sweetener; calcium carbonate and a binding agent; and applying the coating syrup to the cores and drying the syrup to produce a sugarless coating on the cores; wherein the coating on the cores produces a high viscosity in saliva when the gum is chewed, in that 4.5 grams of said coating dispersed in 30 ml of water has a Brookfield viscosity at 23° C. of at least 1.6 centipoise. The bulk sweetener is preferably a disaccharide polyol such as maltitol, hydrogenerated isomaltulose, or lactitol, which gives an increased viscosity of the gum coating containing the antacid. This increased viscosity allows the antacid to remain in the gastrointestinal tract for a longer period of time, giving not only fast relief, but also longer lasting relief from stomach acidity.
In a second aspect, the invention is an antacid coated chewing gum product comprising a chewing gum core and an antacid coating on the core, the coating comprising about 30% to about 73% maltitol; about 25% to about 60% precipitated calcium carbonate; and greater than 2% of a binding agent. The use of a binding agent, such as various natural gums and cellulose gums, increases the viscosity of the coating solution and, when chewed, increases the residence time of the antacid in the gastrointestinal tract. These gums include gum arabic, gum talha, guar gum, karaya gum, locust bean gum, alginate gums, xanthan gum, arabinogalactan, various cellulose derivatives, vegetable gums, gelatin and mixtures thereof, with gum arabic being preferred.
In a third aspect, the invention is a method of delivering an antacid to an individual that provides relief in the gastrointestinal tract comprising the steps of: 1) providing an antacid coated chewing gum product having a chewing gum core and an antacid coating on the core, the coating containing about 25% to about 60% calcium carbonate and a disaccharide polyol, the coating producing a Brookfield viscosity when 4.5 grams of coating are dispersed in 30 ml of water at 23° C. of at least 1.6 centipose; and 2) chewing the antacid coated chewing gum product in the mouth and swallowing the coating, the coating dispersing and dissolving to produce an increased viscosity in saliva swallowed with the coating such that the calcium carbonate has an increased residence time in the gastrointestinal tract.
Preferred embodiments of the invention include the addition of histamine H
2
—receptor antagonists. These agents inhibit or block the secretion of gastric acid by binding to a specific histamine receptor on the par ietal (acid secreting) cell membranes located in the stomach. These agents, which may be added to the chewing gum center or to the antacid coating containing calcium carbonate, are used for extended relief of gastrointestinal disturbances and extended relief from stomach acidity. Examples of histamine H
2
—receptor antagonists are cimetidine, ranitidine, nizatidine, and famotidine, with famotidine being preferred.
It is believed that providing the antacid in a chewing gum coating that produces an increased viscosity in the saliva when the coating is dispersed and dissolved upon chewing makes the antacid more effective. Thus, an advantage of an embodiment of the present invention is administering an antacid to an individual in a coated product that provides extended relief while still achieving the effect of fast relief.
REFERENCES:
patent: 1298670 (1919-04-01), Cramer
patent: 1629461 (1927-05-01), Berg et al.
patent: 2892753 (1959-06-01), Schmidt et al.
patent: 2990328 (1961-06-01), Lincoln
patent: 3011949 (1961-12-01), Bilotti
patent: 3029189 (1962-04-01), Hardy et al.
patent: 3047461 (1962-07-01), Hardy et al.
patent: 3075884 (1963-01-01), Bilotti et al.
patent: 3196172 (1965-07-01), Wright, Jr. et al.
patent: 3308022 (1967-03-01), Cummings et al.
patent: 3498964 (1970-03-01), Hayashi
patent: 3554767 (1971-01-01), Daum
patent: 3590057 (1971-06-01), Suzuki et al.
patent: 3845217 (1974-10-01), Ferno et al.
patent: 3877468 (1975-04-01), Lichtneckert et al.
patent: 3901248 (1975-08-01), Lichtneckert et al.
patent: 3995064 (1976-11-01), Ehrgott et al.
patent: 4154814 (1979-05-01), Hand et al.
patent: 4238475 (1980-12-01), Witzel et al.
patent: 4238510 (1980-12-01), Cherukuri
Barkalow David G.
Greenberg Michael J.
Marske Scott W.
Mazzone Philip
Urnezis Philip W.
Brinks Hofer Gilson & Lione
Joynes Robert M.
Page Thurman K.
Shurtz Steven P.
Wm. Wrigley Jr. Company
LandOfFree
Antacid chewing gum products coated with high viscosity... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Antacid chewing gum products coated with high viscosity..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Antacid chewing gum products coated with high viscosity... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3133303