Food or edible material: processes – compositions – and products – Surface coating of a solid food with a liquid – Of whole isolated seed or bean
Reexamination Certificate
2000-02-28
2002-12-17
Weier, Anthony J. (Department: 1761)
Food or edible material: processes, compositions, and products
Surface coating of a solid food with a liquid
Of whole isolated seed or bean
C426S509000, C426S629000, C426S594000
Reexamination Certificate
active
06495180
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to an antacid composition for neutralizing excess stomach acid, and more specifically to an antacid composition that includes potassium hydroxide.
BACKGROUND OF THE INVENTION
The oral administration or consumption of acid neutralizing agents (antacids) to treat excess gastric acid and relieve its associated discomfort is well known. Generally, antacid compositions include, as active ingredients, one or more alkaline substances in combination with other inactive ingredients. The antacid composition's alkaline components effect gastric acid neutralization while the inactive ingredients serve either as a carrier to facilitate administration or to enhance the composition's appeal, palatability, dispensability, and ease of manufacture.
Ideally, an antacid provides rapid and long-lasting relief from the discomfort associated with excess stomach acid. In addition, an effective antacid provides rapid and long-lasting relief in a convenient administrable form and dosage.
A variety of alkaline substances have been previously employed as active ingredients in antacid formulations. For example, U.S. Pat. No. 4,801,608 to Bos et al. describes a bismuth containing composition that is effective for the treatment of peptic ulcers. Aluminum hydroxide containing antacid compositions have been described in U.S. Pat. Nos. 4,514,389 and 4,576,819 to Miyata et al. and U.S. Pat. No. 5,461,082 to Machimura et al. Carbonates and bicarbonates of sodium, potassium, and calcium have also been employed as acid neutralizing agents in various antacid formulations. See, for example, U.S. Pat. No. 4,327,076 to Puglia et al. (calcium carbonate); U.S. Pat. Nos. 4,857,332; 4,904,473, and 4,976,963 to Schricker et al. (calcium carbonate and sodium bicarbonate); and U.S. Pat. No. 5,498,426 to Wilson et al. (calcium carbonate and potassium bicarbonate).
Acid neutralizing agents have also been combined with various carriers in the formulation of antacid compositions. For example, U.S. Pat. No. 2,477,080 to Necheles et al. relates to an antacid preparation composed of an acid neutralizing agent such as magnesium oxide, calcium carbonate, or sodium bicarbonate, and a carrier, carboxymethyl cellulose, to increase the residency time of the acid neutralizing agent in the stomach and thereby afford long-lasting antacid activity.
Although the active ingredients of commercially available, over-the-counter antacid compositions vary, many of these antacids include alkaline earth (e.g., calcium and magnesium) carbonates and hydroxides. More specifically, calcium carbonate is a primary acid neutralizing agent common to many commercially available antacid formulations (e.g., ROLAIDS, TUMS, MYLANTA, MEDACID). In fact, calcium carbonate is the sole active ingredient in TUMS. To counteract its constipative effect, calcium carbonate is often used in combination with magnesium salts such as magnesium carbonate, magnesium hydroxide, and magnesium oxide, in antacid compositions (e.g., ROLAIDS, MYLANTA, MEDACID).
Generally, antacid compositions containing weak acid neutralizing agents such as calcium carbonate and aluminum hydroxide are slow acting and consequently do not provide rapid relief to the discomfort associated with excess stomach acid. More rapid acting antacids may include magnesium hydroxide, a stronger acid neutralizing agent. Although primarily incorporated into calcium carbonate containing antacids for its anticonstipative effect, magnesium hydroxide is also known for its antacid activity.
Other more highly alkaline substances, such as sodium and potassium hydroxide, exhibit a still stronger neutralizing effect. However, despite their great ability to neutralize acid, the sodium and potassium hydroxide have not been used as active ingredients in antacid compositions for human consumption. This is apparently due to the corrosive nature of these strong bases. Potassium hydroxide, for example, can be extremely corrosive to all tissues, and ingestion of significant quantities in some circumstances can produce pain in the throat and epigastrium, hematemesis, collapse, and stricture of the esophagus. In extreme cases, ingestion may be fatal. Sodium hydroxide is similarly caustic and toxic.
Although not specifically incorporated as an active antacid ingredient, potassium hydroxide is included among the ingredients as a potassium source in a ruminant feed composition described in U.S. Pat. No. 4,976,963 to Schricker et al. and in the colloidal antacid described in U.S. Pat. No. 4,801,608 to Bos et al. Schricker's feed pellet includes an antacid component (i.e., a mixture of a sodium or magnesium antacid) and an electrolyte component to provide potassium, sodium, and chlorine (i.e., a potassium, sodium, or chlorine-containing electrolyte) in the diet. Potassium hydroxide is described in the patent as a suitable potassium source. The colloidal bismuth antacid composition of Bos optionally includes potassium hydroxide to maintain the pH of the colloidal suspension in a range so as prevent the precipitation of bismuth from the colloid.
In at least one instance, potassium hydroxide has been utilized as an acid neutralizing agent in a feed additive for nonhuman consumption. U.S. Pat. No. 5,314,852 to Klatte describes a potassium hydroxide-impregnated zeolite that is useful as a feed supplement to ruminant animals (e.g., cows) to provide buffering in several digestive organs. However, Klatte cautions that the activity rate may be too high for some animal feed applications and that potassium hydroxide is much too caustic to feed alone to such animals.
Accordingly, despite the great number of antacid compositions, some of which are noted above, there remains a need for a rapid acting and long-lasting antacid composition that may be orally administered in a safe and effective amount to an individual suffering from the discomfort associated with excess stomach acid. The present invention seeks to fulfill these needs and provides further related advantages.
The consumption of acidic food and beverages often results in physical discomfort in the form of indigestion and heartburn, among other discomforts. Acidic beverages including coffees and teas are particularly troublesome because of their widespread consumption and elevated acid concentrations.
Coffee is a morning ritual for over 125 million Americans, with the average coffee drinker consuming three cups of coffee per day. However, drinking coffee does not affect all people in the same way. While some are able to drink an entire pot of coffee without experiencing any adverse effects, others may experience indigestion and discomfort. In addition to discomfort, potential health risks associated with excessive coffee consumption in general, and with caffeine consumption in particular, have been theorized. At least one study has linked coffee consumption to osteoporosis. Pregnant mothers are often cautioned to limit their intake of coffee as a precaution to ensure the health and safety of their unborn children. It is not well understood what the effects of coffee acids may be on the health of the general population, but at a minimum acidic coffee causes discomfort for many people with digestive tract disorders, such as acid reflux or ulcers.
Coffee is a complex composition derived from the brewing of roasted and ground coffee beans. The constituents of coffee beans include caffeine (1-2%), coffee oil (10-15%), sucrose and other sugars (about 8%), proteins (about 11%), ash (about 5%), and chlorogenic and caffeic acids (about 6%). Other constituents include cellulose, hemicelluloses, trigonelline, carbohydrates, volatile oils, and other acids. The composition of a particular coffee is variable and depends upon such factors as the type of bean, where the coffee is grown and harvested, and how the beans are processed. It is the individual constituents of a coffee that contribute to its natural aroma, flavor, and appeal.
Many different acidic constituents are present in coffee. Coffee's acids include malic acid, t
Christensen O'Connor Johnson & Kindness PLLC
TAMER International, Ltd.
Weier Anthony J.
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