Food or edible material: processes – compositions – and products – Normally noningestible chewable material or process of... – Packaged – structurally defined – or coated
Reexamination Certificate
2000-12-22
2003-11-11
Corbin, Arthur L. (Department: 1761)
Food or edible material: processes, compositions, and products
Normally noningestible chewable material or process of...
Packaged, structurally defined, or coated
C424S048000, C424S440000
Reexamination Certificate
active
06645535
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 a neutralizing antacid other than calcium carbonate and which is added to the chewing gum coating such that it will have a controlled fast release from chewing gum for maximum effectiveness.
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. Antacids readily neutralize acids in the gastrointestinal (GI) tract and are commonly available in or as antacid tablets. Some typical consumer antacid products are: TUMS, which contains calcium carbonate; MILK of MAGNESIA, which contains magnesium hydroxide, and MAALOX PLUS, which contains a combination of aluminum hydroxide and magnesium hydroxide. Calcium carbonate is perhaps the most frequently used antacid. However, some individuals may not wish to ingest large doses of calcium. Calcium carbonate is also not the most effective antacid on a weight basis.
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, talc or magnesium trisilicate 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 readily released. 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.
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 produced having calcium carbonate as 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 beneficial if antacids other than calcium carbonate could be administered in a form that was fast acting. It would be preferable to have not only fast relief, but relief of a longer duration. Thus, there is a need for a way to make coated chewing gum products that use an antacid other than calcium carbonate, and preferably provide antacid relief for a long duration, as well as being acceptable to the consumer from taste and other standpoints.
SUMMARY OF THE INVENTION
It has been found that antacids, other than calcium carbonate, can be added as a suspension to the coating syrup to thus be included in the gum coating. These antacids will quickly dissipate to provide fast relief.
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 and a neutralizing antacid suspended in the coating syrup, the coating syrup containing from about 25% to about 50% by weight of the solids in the syrup of a neutralizing antacid selected from the group consisting of aluminum salts, bismuth salts, magnesium salts, sodium bicarbonate, potassium bicarbonate, potassium citrate, sodium potassium tartrate, tricalcium phosphate and mixtures thereof; and applying the coating syrup to the cores and drying the syrup to produce a coating on the cores.
In a preferred embodiment, the antacid has a particle size of greater than about 3 microns, which makes the antacid have a more prolonged period of relief.
In a second aspect, the invention is a method of delivering an antacid to an individual that provides relief in the gastrointestinal tract comprising the steps of:
providing chewing gum cores; providing a coating syrup comprising a bulk sweetener and a neutralizing antacid suspended in the coating syrup, the coating syrup containing from about 25% to about 50% by weight of the solids in the syrup of a neutralizing antacid selected from the group consisting of aluminum salts, bismuth salts, magnesium salts, sodium bicarbonate, potassium bicarbonate, potassium citrate, sodium potassium tartrate, tricalcium phosphate and mixtures thereof; applying the coating syrup to the cores and drying the syrup to produce a coating on the cores; and chewing the antacid coated chewing gum product in the mouth and swallowing the coating, the coating dispersing and dissolving to provide an antacid in the gastrointestinal tract.
Preferred embodiments of the invention include the addition of acid blockers such as histamine H
2
-receptor antagonists. These agents inhibit or block the secretion of gastric acid by binding to a specific histamine receptor on the parietal (acid secreting) cell membranes located in the stomach. These agents, which may be added to the chewing gum center or to the antacid coating, are used for extended relief of gastrointestinal disturbances and extended relief from stomach acidity. Examples of histamine H
2
-receptor antagonists are cimetidine, ranitidine and its active salt, nizatidine and famotidine, with famotidine being preferred.
It is believed that the neutralizing antacids other than calcium carbonate, when used in a coating made with a syrup having the antacid dispersed therein, will give a fast release of the antacid. In the preferred embodiment, providing a larger particle size antacid in a chewing gum coating makes it more effective and longer lasting. Thus, an advantage of a preferred embodiment of the present invention is administering an antacid to an individual that has a larger particle size than is typically administered orally, giving extended relief while still achieving the effect of fast relief.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
As used herein, the term “chewing gum” includes bubble gum and all other types of chewing gum. Unless specified otherwise, all percentages are weight percentages.
As mentioned above, products made by the present invention will include an antacid. The antacid will preferably be included as part of the coating syrup used to prepare a coated chewing gum product. A typical syrup may contain a polyol, suspended antacid, a binding agent, a high-intensity sweetener and a whitener.
In a preferred embodiment of the present invention, the antacid is contained in the coating of chewing gum products, which allows a chewing gum coating to be a carrier for the antacid. Accordingly, as the chewing gum is chewed, the active antacid in the gum coating is released into the saliva and ingested to give relief from gastrointestinal disturbances in the GI tract.
Antacid materials are given in the Merck Index or the Code of Federal Regulations. Such antacids, other than calcium carbonate, are suggested for u
Barkalow David G.
Greenberg Michael J.
Marske Scott W.
Mazzone Philip
Schnell Philip G.
Brinks Hofer Gilson & Lione
Corbin Arthur L.
Shurtz Steven P.
WM. Wrigley Jr. Company
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