Drug – bio-affecting and body treating compositions – Digestive system regulator containing solid synthetic...
Reexamination Certificate
1999-12-29
2001-06-12
Dees, Jose' G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Digestive system regulator containing solid synthetic...
Reexamination Certificate
active
06245326
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to compositions and methods for improving health, particularly compositions which improve bowel health, have laxative properties and promote lowering of blood cholesterol levels.
BACKGROUND OF THE INVENTION
There are many different laxatives for improving bowel comfort through the easier passage of stool. Some of these rely on pharmacological components to improve Taxation through stimulating contraction of the muscles of the colon wall. However, while these irritant agents improve Taxation, they do little to improve the health of the bowel in the short or long term.
The optimal laxatives are those which rely on alternatives to such pharmacological ingredients. Generally, these are based around compositions which contain bulking agents in the form of indigestible polysaccharides (“dietary fibre” and “resistant starch”) and, as such, promote faecal bulk. It is known that increased intake of dietary fibre and, to a lesser extent, resistant starch increase stool mass and the frequency of defecation in humans. Many fibre-rich preparations relieve simple constipation promptly and effectively and they can be of value in the prevention and management of diverticular disease. In addition to increased faccal bulk, some of the bulking agents produce benefits through the production of short chain fatty acids (SCFA). These acids are produced by the fermentation of dietary carbohydrates by the colonic microflora. It appears that the provision of SCFA to the colonic mucosa is essential for the maintenance of its integrity and for the normal functioning of the organ. Also, SCFA appear to be essential for the prevention of non-infectious large bowel disease and their supply may be especially significant for the distal colon (where the incidence of these diseases is greater). Production of SCFA appears to predominate in the caecum and proximal colon where the supply of substrate is high. As digesta passes along the colon, SCFA availability falls through exhaustion of substrate coupled with absorption and utilisation of the acids.
Recent studies have shown that the major SCFA, specifically acetate, propionate and butyrate (but possibly others including succinate and formate) may have a number of effects. Collectively, they lower digesta pH-an effect which is thought to lower the risk of colonic cancer through limiting the absorption of toxic compounds such as amines. The three major SCFA stimulate fluid and electrolyte transport and so reduce the risk of diarrhoea. They promote the flow of blood to the colon so that tissue perfusion may be improved and also they stimulate muscular contraction. The major SCFA seem to stimulate colonocyte proliferation and butyrate is thought to promote a normal cell phenotype. The latter acid is a major metabolic fuel for colonocytes and a number of in vitro studies have suggested that it lowers the risk of colonic cancer by promoting DNA repair and inhibiting the growth of transformed cells. Thus butyrate would appear to be the most beneficial of the SCFA. Other studies have demonstrated a direct therapeutic benefit in that instillation into the colon of humans with ulcerative colitis leads to a prompt remission of the condition.
In addition to lowering the risk of non-infectious disease, dietary fibre and resistant starch may be of benefit to colonic health by stimulating the growth of non-pathogenic bacteria. Thus the conditions favouring SCFA production and in particular butyrate will have an additional advantage in lowering disease risk.
Whilst some of the bulking agents increase SCFA, this does not necessarily occur with all such agents. For example, one of the commonly used bulking agents, namely psyllium, can act to reduce the level of SCFA in the colon. However, because psyllium also has the effect of promoting a reduction of cholesterol in the blood stream, it is a preferred bulking agent in situations where blood cholesterol reduction is of importance.
Other bulking agents which may have a cholesterol lowering effect include guar gum, pectin, konjac, modified carbohydrates including hydroxy propyl cellulose, hydroxy propyl methyl cellulose, carboxy methyl cellulose and methyl cellulose. Again, whilst they may have a blood cholesterol lowering effect they generally do not act to significantly improve SCFA levels in the colon and in particular may suppress levels of butyrate the most important of the SCFA.
Ideally, the most desirable laxative compositions should be able to reduce blood cholesterol and promote presence of SCFA including butyrate in the colon whilst providing the bulk necessary for healthy laxation.
DISCLOSURE OF THE INVENTION
In one aspect the invention provides a composition suitable for ingestion by animals, the composition including a bulk forming material, a cholesterol reducer and a fatty acid promoter, the relative proportions and nature of the ingredients in the composition being chosen to promote faecal bulk, an increase of butyric acid in the colon and a reduction of plasma low density lipoprotein (cholesterol). The composition may be particularly suitable for human treatment.
For the purposes of this specification bulk forming material refers to any ingestable material which significantly assists formation of faecal bulk in the colon by resisting digestion in the small intestine so that it may be utilised by the flora in the colon to provide a fermentable substrate with the resultant flora contributing to faecal mass. Also the water retentitive properties of the faecal mass may be increased.
The composition will include at least two different components, although it is to be understood that a single component may provide more than one of the attributes of the composition. For example the bulk forming material may also act to reduce levels of cholesterol or it may promote the presence of butyric acid in the colon. There may be more than one bulk forming material one of which may promote butyric acid formation and another promotes cholesterol lowering.
Preferably the composition is water soluble and/or forms a dispersion or suspension in water. Suitably it may be in the form of a drink mix. Alternatively the composition may take the form of a fine powder or tablets. It may be in a form suitable for incorporation into foods such as cakes or biscuits.
Suitably the bulk forming material will form 20% to 60% by weight of the composition, more preferably 30% to 50% by weight and most preferably about 40% by weight.
Preferably the bulk forming material includes fibrous material. It is preferably soluble or dispersable in water. Suitably one or more of any other substances, and most preferably all substances which are included in the composition are soluble or dispersable in water as well.
The bulk forming material may suitably include hydrophilic colloids. The bulk forming material may be fibrous. The fibrous material may be a hydrophilic colloid. The fibrous material may include and/or be derived from, agar, plantago seed (psyllium), kelp (alginates), plant gums such as tragacanth, chondrus, guar and karaya (sterculia), cellulose including synthetic cellulose derivatives such as carboxy methyl cellulose, hydroxyl propyl methyl cellulose and methyl cellulose, pectin and malt extract and any pharmaceutically acceptable combination and/or derivatives of these. Most suitably the bulk forming material comprises psyllium. Suitable derivatives of any of the foregoing fibrous materials may include derivatives having compounds such as fatty acid covalently bonded thereto by a bond hydrolysable in the colon to give or promote free fatty acid in the colon, particularly butyric acid. Other such derivatives could include ones based upon 5 amino salicylic acid.
Where the bulk forming material includes psyllium it may suitably comprise psyllium husk derived from psyllium seeds obtained from plants of the plantago genus. The psyllium husk is obtained from the seed coat of the seeds and is preferably reduced to a particle size which facilitates dispersion in water. Generally speaking it is preferred that
Jozsa Alexander James
Rao Patanjali
Topping David
Dees Jose' G.
Foley & Lardner
George Konata M.
Sigma Pharmaceuticals Pty. Ltd.
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