Coated chewing gum products containing antacid and method of...

Food or edible material: processes – compositions – and products – Normally noningestible chewable material or process of... – Packaged – structurally defined – or coated

Reexamination Certificate

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C424S048000, C424S440000

Reexamination Certificate

active

06569472

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 controlled fast release from chewing gum 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. Antacids readily neutralize acids in the gastrointestinal (GI) 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 produced 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 relief of longer duration. Thus, there is a need for a way to make coated chewing gum products that have a prolonged effectiveness of the antacid, as well as being acceptable to the consumer from taste and other standpoints.
SUMMARY OF THE INVENTION
It has been found that an antacid having a median particle size of at least about 3 microns can be used to make a coating with a high level of antacid, and that this antacid gives a prolonged effectiveness. 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 and calcium carbonate having a median particle size of greater than about 3 microns and being suspended in the coating syrup; and applying the coating syrup to the cores and drying the syrup to produce a coating on the cores, the coating containing from about 25% to about 60% calcium carbonate.
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 calcium carbonate having a median particle size of greater than about 3 microns and being suspended in the coating syrup; applying the coating syrup to the cores and drying the syrup to produce a coating on the cores, the coating containing from about 25% to about 60% calcium carbonate; and chewing the antacid coated chewing gum product in the mouth and swallowing the coating, the coating dispersing and dissolving to provide calcium carbonate as an antacid 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 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 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 a larger particle size antacid in a chewing gum coating makes it more effective and longer lasting. Thus, an advantage of an 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, such as calcium carbonate. 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 calcium carbonate, 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.
The preferred antacids are generally carbonate or hydroxide salts of calcium, magnesium, aluminum, or bismuth, and are generally very water insoluble. Other antacids such as sodium bicarbonate, calcium bicarbonate, and other carbonates, silicates, and phosphates are included in this invention. When these materials are mixed with acids in the GI tract, the acids are readily neutralized to give relief from GI disturbances. 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.
For antacid chewing gum products, calcium carbonate is the most preferred antacid material. This is mostly due to the fact that the most common inert filler in chewing gum base is calcium carbonate. Calcium carbonate, along with talc, which is commonly used in bases for gum products that contain food acids to give tartness to flavors, have been used as fillers in gum base and gum products for many years.
Chewing gum bases that contain calcium carbonate do not readily release their calcium carbonate during chewing. Since calcium carbonate (or in other cases talc) is very water insoluble, it releases from gum either very slowly or over very long extended chewing. As a result, this calcium carbonate is not effective as an antacid. Generally, when calcium carbonate is a

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