Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1999-10-07
2001-04-10
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S400000, C424S442000, C424S451000, C424S464000, C424S465000
Reexamination Certificate
active
06214373
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to nutritional compositions for treating subjects having an inflammatory bowel disease. In particular, the nutritional composition of the present invention relates to a composition providing nutrients that supply the unmet needs for nutrition of subjects suffering from an inflammatory bowel disease such as ulcerative colitis or Crohn's disease, or from celiac disease. The invention also provides a new method for treating inflammatory bowel diseases by supplying selected nutrients in a novel composition suitable for peroral administration.
BACKGROUND OF THE INVENTION
The term “Inflammatory Bowel Disease” (IBD) is commonly used to refer to a group of related, but distinct, chronic inflammatory conditions affecting the gastrointestinal tract. Diagnosis of these chronic inflammatory conditions is generally made into one of two groups, Crohn's disease and ulcerative colitis. Both of these disorders involve recurring inflammatory processes within the bowel. Crohn's disease may involve any segment of the gastrointestinal tract, although characteristically the region of greatest involvement is the small bowel and the proximal colon. In ulcerative colitis the inflammation is, by definition, limited to the mucosa of the large bowel. The present invention is concerned with nutritional support for a person having either Crohn's disease or having ulcerative colitis. The present invention provides a new composition for supplying the nutritional needs of subjects afflicted with these disorders. The new composition is also useful for supplying the nutritional needs of subjects with celiac disease. A new method of treating subjects having these disorders is also provided by the present invention, the method for treating the subjects comprising oral administration of the new composition.
Crohn's disease and ulcerative colitis are both believed to involve immune mechanisms. At present, no exact causes for these disorders are known. No cures for these disorders are available either. Subjects afflicted with these disorders are generally treated currently with therapies that are directed at reducing the inflammatory processes in the subjects, and that are directed at reducing the effects of the inflammatory processes in the subjects. Current medical treatment is intended to decrease the number, frequency and severity of acute exacerbations of inflammatory bowel disease and to preventing secondary complications, but at best, the results are disappointing. Immunosuppressant drugs are frequently used for IBD, including sulfasalazine, azathioprine and steroids.
Subjects afflicted with these disorders suffer from chronic nutritional deficiencies because of malabsorption and the poor condition of their gastrointestinal mucosa. These subjects frequently suffer from an inability to properly absorb vitamins and minerals.
Therapeutic methods have been proposed for treating the nutritional needs peculiar to subjects with IBD. These include total parenteral nutrition as well as supplementation of the subject's diet with conventional oral vitamin or mineral supplements. Frequently, these proposed methods are found insufficient to provide adequate nutrition for the subject.
Subjects suffering from IBD have been reported to suffer from a deficiency of iron. It is known that some forms of iron are more easily absorbed from the gastrointestinal tract than are others. The composition of the present invention supplies iron in a form that is easily absorbed by a subject when administered orally. Absorbability of Different Iron Compounds, H. Brise and L. Hallberg, Acta Med. Scand. (Suppl.) vol. 376, 23-37 (1962). Preferably ferrous fumarate is used in the inventive composition to ensure adequate amounts of easily absorbable iron for a subject.
Subjects with an IBD such as Crohn's disease can also suffer from a zinc deficiency. It has been reported that this deficiency can cause abnormalities of the retina. “Zinc-Deficiency-Induced Retinal Dysfunction in Crohn's Disease,” C. J. McClain, et al., Digestive Diseases and Sciences, vol. 28, 85-87 (1983). The inventive composition provides zinc in an excess over that provided in conventional vitamin and mineral combinations, and in an amount sufficient to prevent or alleviate the retinal problems associated with IBD.
Subjects suffering from IBD also have a need for increased amounts of vitamin C. “Scurvy and Vitamin C Deficiency in Crohn's Disease,” B. D. Linaker, Postgraduate Medical Journal, vol. 55, 26-29 (1979). The inventive composition provides vitamin C in an amount in excess over that provided in conventional multi-vitamin preparations, where the amount is selected to be therapeutic for a subject having IBD.
The composition according to the present invention provides a subject with oral nutritional therapy that is tailored for the particular needs of a subject having IBD. The composition comprises necessary vitamins and minerals. Some of the vitamins and minerals are present in excess over the amounts provided in conventional multi-vitamin preparations that are commercially available. This is because it has been discovered that a subject with IBD has greater needs for particular vitamins or minerals than for others. The inventive composition disclosed here provides this nutritional therapy without the need for administration of individual vitamin preparations in the amounts needed by such subjects. The inventive composition is suited for oral administration to a subject in need of vitamin and mineral therapy due to IBD. That is, the present invention provides a more convenient preparation for nutritional therapy for subjects with IBD than has been previously available.
In particular, the inventive composition has the following preferred excesses of vitamin amounts over conventional multivitamin compositions. Vitamin B
12
is supplied in the composition at a level that, when the inventive composition is administered to a subject twice daily, provides about 17 thousand percent of the recommended daily value for this vitamin. Vitamins B
6
and E are both supplied at about 500 percent of the recommended daily value. Vitamin B
2
is supplied at about 590 percent of the recommended daily value. Vitamin B
1
is supplied at about 670 percent of the recommended daily value. Vitamin C is supplied at about 333 percent of the recommended daily value. Vitamin D is supplied at about 200 percent of the recommended daily value. The recommended daily value is defined in “Recommended Dietary Allowances,” National Academy Press, (1989).
Minerals are supplied with the following deviations from the amounts found in conventional commercial compositions (as administered twice daily). Iron is supplied at about 167 percent of the recommended daily value. And, zinc is supplied at about 150 percent of the recommended daily value. The amount of calcium supplied by the inventive composition is reduced in the inventive composition to supply about 20 percent of the recommended daily value.
The amounts of each vitamin and mineral in the composition disclosed here have been selected to prevent or alleviate the deficiencies for these nutrients that have been found in subjects with ulcerative colitis or Crohn's disease.
The composition provided by the present invention is also useful for treatment of subjects afflicted with celiac disease, also called celiac sprue or gluten enteropathy. Subjects with celiac disease frequently suffer from nutrient deficiencies caused by the malabsorption that results from their functionally impaired intestinal mucosa. The new composition is suited for providing the vitamin and mineral nutrition that these subjects lack. Although such subjects are currently given nutritional supplements, the composition according to the present invention is particularly well suited to providing their nutritional needs. Children with celiac disease are known to be frequently deficient in iron and adults are frequently deficient in folate. The new composition disclosed here is useful for
Bennett Rachel M.
Page Thurman K.
Snowden-Sutton Associates, Inc.
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