Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
1992-05-22
2002-09-17
Venkat, Jyothsna (Department: 1627)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C514S904000
Reexamination Certificate
active
06451341
ABSTRACT:
BACKGROUND OF THE INVENTION
Vitamins and minerals may be broadly defined as substances that are essential for the maintenance of normal metabolic function but are not synthesized in the body. These substances must be furnished from an exogenous source. A healthy individual ingesting a well-balanced diet receives adequate amounts of vitamins and minerals from food. Vitamins obtained in this manner are not generally regarded as drugs.
However, there are many situations in which the concentration of one or more vitamins or minerals in the body tissues may be suboptimal. When such circumstances arise or can be anticipated, it is the common practice to administer vitamins or minerals in a chemically pure form. When employed in this manner, vitamins and minerals may be regarded as drugs and a knowledge of their pharmacological properties is desirable. For example, large doses of various vitamins are frequently employed for the treatment of disorders that are not etiologically related to vitamin deficiency. The implication is that such large doses may exert pharmacodynamic actions that are useful in therapy. It should be noted, however, that excessive administration of certain vitamins, notably vitamin A, can cause untoward toxic effects.
In today's fast paced society many physicians and dieticians believe that a daily dietary vitamin and mineral supplement acts prophylactically to prevent pathologies associated with vitamin and mineral deficiencies. These supplements typically include several vitamins and minerals, and are referred to as multi-vitamin formulations. Examples of these preparations include One-A-Day® and Centrum® multi-vitamins. Researchers have suggested that multi-vitamins which include large quantities of vitamins and minerals are effective both for prophylactic purposes and for the treatment of an enormous variety of illnesses. Many millions of individuals living in the United States regularly ingest multi-vitamin preparations.
Some of these multi-vitamin preparations contain amounts of vitamins and minerals that are in excess of the RDA daily requirements. In the case of the water-soluble vitamins, there is little harm done to the body because of the low toxicity of this class of compounds. The low toxicity of the water-soluble vitamins is attributable to the fact that excess quantities of these substances are rapidly excreted in the urine. In the case of the lipid-soluble vitamins, the compounds accumulate in the body fat and can cause untoward toxic effects.
It is extremely important to distinguish between supplemental and therapeutic vitamin preparations. The latter contains much larger quantities of the individual vitamins and minerals than do the supplemental preparations. The present invention is directed to supplemental preparations.
The use of dietary multi-vitamin supplements should be considered by the physician in a wide variety of situations. Such situations may result from (1) inadequate vitamin intake, (2) mal-absorption syndromes, and (3) increased tissue requirements.
Vitamin deficiency due to an inadequate intake arises in a variety of circumstances. There are still large parts of the world and even considerable areas in the United States where, owing to poverty, the population eats a diet inadequate in terms of vitamin content. Moreover, there are areas where the prevalence in the diet of one particular type of food results in a relatively high incidence of vitamin deficiencies. Eccentric diets resulting from psychiatric disturbance, individual idiosyncrasies, religious beliefs, or food fads are other major causes of vitamin deficiency. A decrease in food consumption because of excess use of alcoholic beverages, poor appetite, dieting to combat obesity, or restricted diets prescribed by physicians for the management of specific diseases represents a further group of situations in which vitamin deficiency can arise.
A disturbance in absorption of vitamins is also seen in a variety of conditions. Examples are diseases of the liver and biliary tract, prolonged diarrhea from any cause, hyperthyroidism, pernicious anemia, and a variety of other disorders of the digestive system. Moreover, since a substantial proportion of certain vitamins is provided by the bacteria of the gastrointestinal tract, treatment with antimicrobials that alter the intestinal bacterial flora may lead inevitably to a decreased vitamin absorption.
Increased tissue requirements for vitamins also occur under a variety of conditions so that a nutritional deficiency may develop on a diet that had previously been adequate. Such situations can occur in both health and disease. In healthy individuals, for example, there is a greater requirement for various nutrients, including vitamins, during growth, during periods of hard physical work, exercise, during pregnancy, lactation, and menstruation. Diseases associated with an increased metabolism, such as hyperthyroidism, and conditions accompanied by fever or tissue wasting also increase the body's requirements for vitamins. There is also good evidence that vitamin requirements increase during stress and after injury.
Multiple-vitamin therapy, using supplemental dietary multi-vitamins, is desirable in a variety of situations. Since deficiency of a single vitamin is rarely encountered clinically, it is customary practice in cases of suspected vitamin deficiency, as well as in prophylactic treatment, to recommend that multiple-vitamin therapy be administered. Typical of the multi-vitamins available are One-A-Day and Centrum multi-vitamins. (Table 3). Multi-vitamins such as these provide a great number of the essential vitamins and minerals needed by healthy individuals. Further, these preparations include electrolytes, and trace elements.
Recently, it has been determined that antioxidants, and free radical scavenging agents are protective against the development of certain cancers. Although, multi-vitamin preparations currently available include many needed vitamins and minerals, they do not include the antioxidants and/or free radical scavengers which have been shown to enhance the immune system and to prevent certain cancers, cardiovascular disorders, inflammatory diseases and to slow aging. Further, currently available multi-vitamin preparations do not include cardio-protective inositol or polyunsaturated fatty acids having an eicosapentaenoic acid: docosahexenoic acid ratio of about 18:12 commonly referred to as Omega-3 fish oils. Still further, several enzymes, amino acids, and dietary supplements which are known to be necessary and beneficial in supplementing an individual's diet are not included in presently available multi-vitamin formulations. Accordingly, a new multi-vitamin dietary supplement is needed which incorporates many of these beneficial ingredients into a stable pharmaceutical preparation.
The U.S. Pat. No. 4,599,234 issued to Amer, Jul. 8, 1986, describes a diet comprising a source of selenium, butylated hydroxytoluene or butylated hydroxyanisole, and &bgr;-carotene that reduces the effect of carcinogens presented in the diet. The issued claims indicate a weight ratio of selenium:BHT:&bgr;-carotene of 1:0.5:0.05. In contrast, the optimal ratio of these ingredients in the formulation of the present invention is 1:2000:120. Taking into account the range of concentrations of these ingredients indicated in this invention, the closest ratio to that of Amer is 1:100:15.
The U.S. patent issued to Newmark (4,022,913) May 10, 1977 describes high potency compositions of vitamin A acetate and/or vitamin A alcohol stabilized against the formation of crystals by vitamin A palmitate. The compositions can contain antioxidants such as BHA, BHT propyl gallate, Vitamin E, and Vitamin C which are customarily utilized as a preservative in this type of preparation. Newmark does not teach that any of these antioxidants are cancer-protective.
The present invention concerns development of a multi-vitamin dietary supplement formulation which includes several dietary supplements which are cancer-protective. By including cancer-
DeLuca Daryl L.
Slaga Thomas J.
Sparks William S.
Mayfield Denise L.
Venkat Jyothsna
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