Title:  Antiflatulent composition

United States Patent:  6,200,605

Appl. No.:  182695

An antiflatulent composition is disclosed which comprises a polysaccharide and a preservative. The composition is useful to control gas formation at the site of generation of flatulence.

BRIEF SUMMARY OF THE INVENTION

So to address a long-felt need for an effective antiflatulent, the inventor envisioned a supplement to the normal human diet which would comprise a food preservative, for example a food preservative generally recognized as safe that is also a metabolic end-product of microbial fermentation. (Preservatives generally recognized as safe are enumerated, and conditions of their approved use are listed, in 21 CFR 582, which is incorporated by reference.) Among such compounds are traditional food preservatives such as vinegar, consisting primarily of acetate and a fraction of SCFAs, in use for thousands of years to prevent food spoilage.

However, the ingestion of vinegar as such has not been shown to confer relief of flatulence.

Another preservative occurring as a metabolite in nature is benzoate. Ingestion of meaningful quantities of benzoate was found by the present inventor to induce severe and acute diuresis which was concluded to be potentially harmful. No antiflatulent property was noted.

From the observation of benzoate-induced diuresis, and from benzoate's lack of noticeable antiflatulent activity when ingested alone, it was inferred that a large proportion of benzoate must have been absorbed before it could arrive at the colon.

Hence a dietary supplement formulation was envisioned and developed that would include an end product of microbial fermentative metabolism safe for human consumption but not capable of being absorbed to a large degree before arriving at the lumen of the distal portions of the colon.

A composition consisting of citrus pectin and calcium propionate was developed and tested. The composition possessed considerable antiflatulent activity.

The utilization of a dietary supplement composition consisting of substances generally recognized as safe in order to diminish flatulence had not been known in the art. Such a composition proved useful to address a long-felt need for an effective antiflatulent. Related art did not in any way contemplate the use of, for instance, SCFAs as antiflatulents.

The invention is to be distinguished from drugs known in related art such as antibiotics which may kill microbes selectively or indiscriminately or which inhibit the synthesis of certain classes of macromolecules by microbes resident in the intestinal lumen. The current invention does not relate to such drugs since it has to do with the presentation of relatively non-toxic presumptive products of their own metabolism to anaerobic microbes resident in the colonic lumen.

The invention is also to be distinguished from so-called colonic delivery systems, such as those described in U.S. Pat. No. 5,525,634, that present drugs to the intestinal epithelial cells for absorption into the body. The current invention does not relate to such devices since it has to do with the presentation of relatively non-toxic presumptive products of their own metabolism to anaerobic microbes resident in the colonic lumen, not for absorption into the body.

The art teaches away from antiflatulent use of SCFAs. For example, while SCFAs were noted as being present in normal human feces, SCFAs administered in solution were shown to be rapidly absorbed from the colon. McNeil, N I et al. (1978) Short chain fatty acid absorption by the human large intestine. Gut 19, 819-822. The use of SCFAs, preservatives or microbistats (i.e., compositions used not to kill but rather to slow or control the growth of microbes) to manipulate flatulence has therefore not been contemplated in the art.

It should be noted that flatulence is a common adverse event associated with a variety of important classes of medications, including proton pump inhibitors (Langtry H D & Wilde M I, Drugs 56, 447), HIV protease inhibitors (Moyle G J et al., J Clin Pharmacol 38, 736), nonsteroidal anti-inflammatory drugs (Bocanegra T S et al., J Rheumatol 25, 1602), and alpha-glucosidase inhibitors (Chan J C et al., Diabetes Care 21, 1058). From these reports, all published in 1998, one can justifiably infer that there is a need for an antiflatulent which the known art has not addressed.

Claim 1 of 4 Claims

I claim:

1. An antiflatulent composition consisting essentially of:

a polysaccharide;

a preservative; and

a pharmaceutically acceptable carrier or diluent, wherein the mass ratio of preservative to polysaccharide is at least 1:50 and wherein:

(a) the polysaccharide is selected from the group, consisting of pectin, pectinic acid, high methoxyl pectin, low methoxyl pectin, amidated pectin, and

(b) the preservative is selected from the group consisting of acetic acid, benzoic acid, butyric acid, citric acid, lactic acid, propionic acid, sorbic acid, syringic acid, and vanillic acid; the sodium, potassium and calcium salts of each of said acids; butylated hydroxyanisole and butylated hydroxytoluene.

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