Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1999-12-01
2002-03-05
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
C424S439000, C424S440000, C426S003000, C426S073000, C426S321000
Reexamination Certificate
active
06352713
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is directed to a novel chewable prenatal nutritional supplement which contains vitamin C, and which optionally contains folic acid, minerals, other vitamins and/or additives. The supplement is substantially non-acidic and therefore provides vitamin C in adequate levels for pregnant woman while minimizing or eliminating gastric upset, dyspepsia and/or tooth enamel erosion. The present invention is also directed to an improved method for providing vitamin C supplementation to pregnant women in a manner designed to eliminate or minimize gastric upset, dyspepsia and/or tooth enamel erosion.
2. Description of the Related Art
It is well established that pregnant women have heightened nutritional requirements. A mother's body provides the environment in which development of the embryo and fetus occur. See
Understanding Nutrition
, 479-480 (Whitney and Rolfes Eds. 6
th
Ed., 1993). Accordingly, the mother's nutritional status during pregnancy directly impacts the development of the fetus and embryo and is therefore implicated with regard to the occurrence of birth defects. See Id. In particular, during the first 20-25 days of pregnancy, the placenta is not yet formed and fetal circulation is not yet established. Therefore, during this period the fetus is nourished via digested maternal uterine cells and the diffusion of blood exudates. See Schorah “Importance of Adequate Folate Nutrition in Embryonic and Early Fetal Development”,
Vitamins and Minerals in Pregnancy and Lactation
, 167-176 (Berger, Ed., Vol. 16, 1988). It is believed that a good nutrient supply during the first 20-25 days of pregnancy is necessary to provide optimal concentrations of essential micronutrients to the endometrium. See Id.
Furthermore, increased occurrence of birth defects have been linked to inadequate nutrition in the women. Cases of infants born with a neural tube defect, i.e., spina bifida or anacephaly, have been documented in women with various nutritional deficiencies, primarily low blood folic acid and vitamin C concentrations. Smithells, “Vitamin deficiencies and neural tube defects”,
Arch Dis Child
, 51:944-50 (1976).
Vitamin C, also known as ascorbic acid, is an essential aspect of proper nutrition for various reasons, including but not limited to its role as an antioxidant. Many nutritional substances important to the body are destroyed by oxidation, but vitamin C, by becoming oxidized itself, can protect these substances.
Understanding Nutrition
, 294 (Whitney and Rolfes Eds. 6
th
Ed., 1993). Food manufacturers will often add vitamin C to their products to protect the food from oxidation. Inside the body, vitamin C protects other vitamins and minerals from oxidation. For example, in the intestines, vitamin C protects iron and thus promotes its bioavailability. Id. at 296-8.
Vitamin C also helps form collagen, the fibrous, structural protein that comprises connective tissue. The amino acids hydroxyproline and hydroxylysine facilitate the binding of collagen into a strong, rope-like structure. Id. The enzyme that hydrolyzes proline and lysine requires vitamin C to complete the reaction. When a person is wounded, collagen glues the tissue back together and forms scars. Cells are also held together by collagen. For example, the cells that make up the capillary walls that expand and contract with the beating of the heart are held together by collagen. As a result, vitamin C may play a role in preventing high blood pressure. Id. at 307-9.
Vitamin C is also crucial in the metabolism of several amino acids. Some of these amino acids are converted into the hormones epinephrine and thyroxin. As a result, the adrenal gland contains a higher concentration of vitamin C than any other organ. During emotional and physical stress, the adrenal gland releases vitamin C to assist in the creation of epinephrine and thyroxin. Id.
Exposure to colds and infection increases the need for vitamin C. Thyroxin, made with vitamin C, regulates the metabolic rate, which speeds up whenever the body needs to produce heat—for example during a fever or in very cold weather. Id. at 326.
Different countries set different daily requirements for vitamin C, but most agree that 10 mg each day will present vitamin C deficiency (scurvy). At 60 mg each day, the body will stop responding to further vitamin C intake. At 100 mg each day, all the body's tissue's are saturated, and the body will begin to excrete excess vitamin C. The Recommended Daily Allowance (RDA) of vitamin C in the United States is 60 mg per day. Id. at 327. However, more vitamin C may be indicated if the patient has just gone through some physiological or psychological stress, consumes alcohol daily or smokes. Pregnant or breast-feeding women also require additional vitamin C, due to the portion of their daily intake that goes to the fetus or breast milk.
Current Pediatric Diagnosis and Treatment
(13
th
Ed. 1997).
Vitamin C deficiency is referred to as scurvy. Because vitamin C is water soluble it is quickly excreted. With an inadequate daily intake of vitamin C, the body's store of vitamin C is depleted at a rate of about 3 percent each day. Two early signs of scurvy are bleeding gums and atherosclerotic plaques. After 5 weeks, degenerating muscles (including the heart), scaly skin and wounds that will not heal appear. Hysteria results, followed by sudden death. Scurvy can be reversed by moderate doses of vitamin C, in the area of 100 mg per day.
Understanding Nutrition
, 328 (Whitney and Rolfes Eds. 6
th
Ed., 1993)
Too much vitamin C can be toxic, causing cramps, nausea and diarrhea. Too much vitamin C can also obscure the presence of diabetes. Toxic levels can start at 2 g a day. Id.
Good sources of vitamin C include citrus fruits, broccoli, cauliflower, strawberries, potatoes and organ meats such as kidney and liver. Grains and milk, except for breast milk, are devoid of vitamin C. Id. at 330.
Folic acid, also known as pteroylglutamic acid and vitamin B
9
, plays an important role in cell division, erythropoiesis and protein synthesis, all of which are processes important to growing tissues. Folic acid is part of an enzyme complex that changes vitamin B
12
into its active form and helps synthesize amino acids into the new DNA required for dividing cells.
Understanding Nutrition
, 311 (Whitney and Rolfes Eds. 6
th
Ed., 1993)
Folic acid has a low bioavailability, and only about half of all dietary folic acid is available to the body. The RDA of folic acid is 150-200 mcg for adult males, 150-180 mcg for adult females and 400 mcg for pregnant females.
Current Pediatric Diagnosis and Treatment
, (13
th
Ed. 1997).
Folic acid deficiency can occur when there is a need for increased cell proliferation, such as that experienced during pregnancy. Pregnant women require more folic acid than normal and are at greater risk for folic acid deficiency. Folic acid supplementation during pregnancy is believed to reduce the risk of neural tube defects, such as spina bifida, in infants. Id.
The acidity of gastric juices in the stomach registers at about 2 on the pH scale, and stomach enzymes work best at a pH lower than 2. However, too much acid can cause stomach pain. Stomach Emptying Rates and Drug Absorption, www.medscape.com. Accordingly, vitamin C (ascorbic acid) supplementation can typically cause an upset stomach.
Various approaches of administering vitamin C have been described in published literature and various references. Further, numerous approaches of administering vitamins in chewable form have also been described in various references.
For example, Fuisz et al., U.S. Pat. No. 5,965,162, disclose a composition and method for preparing multi-vitamin comestible units which disintegrate quickly in the mouth, especially when chewed. The dosage form is prepared by compressing a formulation containing the medicinal substance and other ingredients which facilitate production and use of the tablet. Vitamin C may be used as the medicinal substance.
Kutilek, III et al
Kirschner Mitchell I.
Levinson R. Saul
Paradissis George N.
Drugtech Corporation
Goldberg Joshua B.
Nath Gary M.
Nath & Associates PLLC
Page Thurman K.
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