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Title:  Nutritional composition for treating inflammatory bowel diseases

United States Patent:  6,214,373

Inventors:  Snowden; Robert B. (Churchville, PA)

Assignee:  Snowden-Sutton Associates, Inc. (Churchville, PA)

Appl. No.:  414666

Filed:  October 7, 1999

Abstract

A nutritional composition and method useful for treatment of inflammatory bowel diseases is disclosed, the composition comprising selected vitamins and mineral salts for oral administration to a subject having an inflammatory bowel disease. The composition comprises an excess of vitamin D and vitamin B12, contains vitamin C and iron in quantities promoting good absorption, contains water miscible forms of the fat soluble vitamins, and no phosphate or carbonate salts. Preferably, the iron is present as ferrous fumarate. And, preferably the composition is essentially free of magnesium.            

DETAILED DESCRIPTION OF THE INVENTION

I have developed a new nutritional composition, useful for treating subjects having an inflammatory bowel disease such as Crohn's disease or ulcerative colitis. The new nutritional composition combines in a mixture, selected vitamins in proportions that make the composition especially well suited for treating such subjects. The composition also includes selected minerals in proportions that are also especially well suited for treating these subjects. The minerals are preferably present in the composition as salts that will neither give rise to, nor promote the formation of gas in the subject's digestive system.

An oral multinutrient composition is provided, specially formulated to meet the special nutritional needs of individuals who do not obtain sufficient quantities of certain of the essential vitamins and minerals from their diet. The composition has been formulated to meet the particular needs of subjects who have inflamed gastrointestinal mucosa, and resulting poor absorption or increased excretion of nutrients, or who are on severe dietary restrictions; as in gastrointestinal conditions such as inflammatory bowel disease (IBD) or celiac disease. The composition contains water-miscible forms of the fat soluble vitamins A, D, E and K to enable better absorption and utilization of these vitamins. Vitamin D, important for maintaining bone mass, is supplemented at 2 times the Daily Value, since it is not optimally absorbed by subjects having IBD, and may be inhibited by steroids used in the treatment of IBD.

The new composition contains vitamin C and iron in the ratio and quantities shown to increase iron absorption when given together. Iron is preferably provided as ferrous fumarate, which is highly soluble in the gastrointestinal tract, is well tolerated orally, and was less toxic than ferrous sulfate or ferrous gluconate in laboratory studies. The composition contains folic acid, the daily administration of which has been found in a number of studies to be associated with a reduced risk for the development of colorectal cancer or dysplasia in individuals with ulcerative colitis. The composition preferably contains about 1000 mcg (micrograms) of vitamin B12 (cyanocobalamin). Vitamin B12 may be poorly absorbed in patients with IBD, particularly in extensive Crohn's disease.

The new composition contains zinc, important for wound healing and immune function, which is supplemented at about 150% of the recommended daily value because it may be lost through increased excretion in individuals with IBD. The composition contains calcium diphosphate, a "non-gassy" or non-carbonate form of calcium. Conventional mineral supplements usually contain calcium carbonate, which can cause gas evolution that can exacerbate diarrhea and create discomfort in subjects with IBD.

The new composition preferably contains essentially no magnesium in either the nutritional ingredients themselves or in any excipients used in a unit dosage form. This is because magnesium can act as a cathartic in subjects having IBD.

The new composition is preferably lactose free, and preferably contains no sugar, colorant, artificial sweetener or flavoring.

It is preferred that the inventive composition be administered orally in a solid unit dosage form such as a tablet, a caplet, or a capsule. The preferred dosage for use in adults is two unit dosage forms daily in a single or divided dose. The preferred dosage for children under the age of 12 may be selected by a physician. The tablet, caplet or capsule may also comprise a pharmaceutically acceptable excipient. Some examples of excipients that are suitable for use in practicing the invention include, but are not limited to the following: carboxymethylcellulose, microcrystalline cellulose, starch, and modified starch.

The inventive composition can also be formulated as a liquid for oral administration. In this case the composition would be formulated as an oral solution. liquid formulations may also comprise pharmaceutically acceptable diluents and additives such as glycerin, sorbitol, mannitol, maltitol, propylene glycol; and aqueous solutions of these

Whether the inventive composition is in a solid dosage form or is in a liquid dosage form, the formulation of the dosage form is preferably a pharmaceutically acceptable formulation. Any additional constituents other than the vitamins and minerals claimed here should be ones that are approved for pharmaceutical use by a government regulatory agency, such as the United States Food and Drug Administration.

It is to be understood that the composition and method of this will have utility for non-human subjects as well as for humans. That is, the appended claims are intended to include veterinary uses of the new composition and method according to the invention. Animals also suffer from disorders that are similar to IBD and celiac disease, and the composition of the present invention will be useful for treating such animals

The composition that has been discovered for treating a subject having IBD comprises the vitamins and minerals of Table 1, in the range of amounts shown. The metals are to be provided as salts, with the amount of each metal shown being the amount of the elemental metal provided by its salt in the composition.

            TABLE 1
            Vitamin A             1,500 to 5,000 IU
            Vitamin D             200 to 600    IU
            Vitamin E             15 to 100     IU
            Vitamin K             15 to 60      mcg
            Vitamin C             30 to 150     mg
            Vitamin B1            1 to 6        mg
            Vitamin B2             1 to 6        mg
            Vitamin B6             1 to 6        mg
            Vitamin B12            150 to 1,000  mcg
            Folic Acid            0.2 to 0.5    mg
            Niacin                5 to 20       mg
            Biotin                0.1 to 0.2    mg
            Pantothenic acid      2 to 8        mg
            Iron                  6 to 20       mg
            Calcium               50 to 200     mg
            Zinc                  5 to 15       mg
            Selenium              20 to 50      mcg
            Copper                0.5 to 1.5    mg
            Iodine                60 to 80      mcg
            Manganese             0.5 to 1.5    mg
The individual vitamins may be included in the composition in more than one form and still be encompassed by the teachings of the invention. For example, vitamin A may be included as retinyl acetate, beta-carotene, retinoic acid, or retinal. Vitamin E may be included as dl-alpha tocopherol acetate, succinate, or phosphate. Vitamin C may be included as ascorbic acid, ascorbate salts, or vitamin C esters. Vitamin B1 may be included as thiamine mononitrate, hydrochloride, monophosphate chloride, or pyrophosphate chloride. Vitamin B6 may be included as pyridoxine hydrochloride or pyridoxal phosphate.

A preferred composition for use according to the teachings of the invention is the embodiment shown in Table 2.

           TABLE 2
           Vitamin A (retinyl acetate)         2,500  IU
           Vitamin D (cholecalciferol)         400    IU
           Vitamin E (dl-alpha tocopherol acetate) 75     IU
           Vitamin K (phytonadione)            40     mcg
           Vitamin C (ascorbic acid)           100    mg
           Vitamin B1 (thiamine mononitrate)   5      mg
           Vitamin B2 (riboflavin)             5      mg
           Vitamin B6 (pyridoxine hydrochloride) 5      mg
           Vitamin B12 (cyanocobalamin)        500    mcg
           Folic Acid                          0.2    mg
           Niacin (niacinamide)                10     mg
           Biotin                              0.15   mg
           Pantothenic acid                    5      mg
           Iron                                15     mg
           Calcium                             100    mg
           Zinc                                11.25  mg
           Selenium                            35     mcg
           Copper                              1.0    mg
           Iodine                              75     mcg
           Manganese                           1.0    mg
In a preferred embodiment, the inventive composition comprises mineral salts selected from the group consisting of phosphates, sulfates, and fumarates. It is especially preferred that the inventive composition is essentially free of any carbonate. That is, the composition preferably has no significant amount of carbonate present. This is to avoid the possibility of gas generation within the gastrointestinal tract of a subject receiving the composition.

It is also preferred that the inventive composition is essentially free of magnesium, so as to avoid its cathartic effect. Preferably, the inventive composition is also essentially free of lactose, other sugars, colorants, artificial sweeteners and flavorings. These are also to be avoided to prevent the effects of these substances on the gastrointestinal tract of a subject having IBD or celiac disease.

A method of treating a subject who has an inflammatory bowel disease or celiac disease is also contemplated as being associated with the present invention. The new method may be carried out by providing a composition, as disclosed above, and administering the composition orally to the subject. This method may be carried out by administering the composition in either a solid dosage form, or in a liquid dosage form.

The present invention also includes a method of making a medicament that comprises the new composition disclosed here. This method involves mixing the vitamins and minerals in the amounts disclosed here, where the medicament is intended for use in treating ulcerative colitis, Crohn's disease, or celiac disease. The medicament being made can be in either a solid dosage form, or a liquid dosage form.

The present invention is not to be limited in scope by the embodiments disclosed herein in the Tables, which are intended as single illustrations of one aspect of the invention, and any which are functionally equivalent are within the scope of the invention. Indeed, various modifications of the invention, in addition to those shown and described herein, will become apparent to those skilled in the art from the foregoing description. Such modifications are intended to fall within the scope of the appended claims. All patents and any publications mentioned herein are hereby incorporated by reference.

Claim 1 of 18 Claims

I claim:

1. A nutritional composition, comprising:

a mixture of vitamins and minerals having the following composition in a pharmaceutically acceptable formulation:

TBL Vitamin A 1,500 to 5,000 IU Vitamin D 200 to 600 IU Vitamin E 15 to 100 IU Vitamin K 15 to 60 mcg Vitamin C 30 to 150 mg Vitamin B1 1 to 6 mg Vitamin B2 1 to 6 mg Vitamin B6 1 to 6 mg Vitamin B12 150 to 1,000 mcg Folic Acid 0.2 to 0.5 mg Niacin 5 to 20 mg Biotin 0.1 to 0.2 mg Pantothenic acid 2 to 8 mg Iron 6 to 20 mg Calcium 50 to 200 mg Zinc 5 to 15 mg Selenium 20 to 50 mcg Copper 0.5 to 1.5 mg Iodine 60 to 80 mcg Manganese 0.5 to 1.5 mg

 

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If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.

 

 

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