Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2000-12-05
2003-05-27
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
C426S072000, C426S074000
Reexamination Certificate
active
06569445
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to food bars for consumption by pregnant women, lactating women, or women having childbearing potential that are attempting to become pregnant containing one or more vitamins and/or minerals, and one or more anti-constipation and regularity-maintaining agents, to methods for preparing these food bars, and to methods for enhancing the nutrition of pregnant women and their developing fetuses, of lactating women and their babies, and of women having childbearing potential that are attempting to become pregnant. In particular, the present invention relates to food bars comprising one or more vitamins and/or minerals recommended for consumption by pregnant women, lactating women, or women having childbearing potential that are attempting to become pregnant in an amount that is effective for enhancing the nutrition of pregnant women, lactating women, or women having childbearing potential that are attempting to become pregnant, or of their developing fetuses or babies, and one or more anti-constipation and regularity-maintaining agents in an amount that is effective for reducing or eliminating constipation, and/or for maintaining regularity of bowel movements, in pregnant women, lactating women, or women having childbearing potential that are attempting to become pregnant.
2. Background
The daily Recommended Dietary Allowances of water-soluble vitamins for non-pregnant and pregnant women, and the rationale for increased allowances during pregnancy, is set forth in
Nutrition During Pregnancy
(Nat'l Academy Press, 1990), and below.
Recommended Dietary Allowance
Non-
pregnant
Pregnant
Rationale for Increased
Vitamin
Women
Women
Allowance for Pregnancy
Vitamin C
60
mg
70
mg
To provide for fetal needs. At
term, fetal plasma levels are 50%
higher than maternal levels.
Thiamin
1.1
mg
1.5
mg
To accommodate maternal and
fetal growth and increased energy
allowance during pregnancy.
Riboflavin
1.3
mg
1.6
mg
To provide for increased maternal
and fetal synthesis.
Niacin (NE)
1
15
mg
17
mg
Based upon energy increase of
300 kcal/day for pregnancy.
Vitamin B
6
1.6
mg
2.2
mg
Based partially on the additional
protein allowance of 10 g/day for
pregnancy.
Folate
190
&mgr;g
400
&mgr;g
Based on 50% food folate
absorption. To build or maintain
maternal folate stores and to
provide for increased folate
turnover in rapidly growing tissue.
Vitamin B
12
2.0
&mgr;g
2.2
&mgr;g
Fetal needs (0.1-0.2 &mgr;g/day) based
on analysis of stillborn fetuses.
Metabolic needs of pregnancy
estimated at 0.2 &mgr;g/day.
1
1 NE (niacin equivalent) = 1 mg of niacin or 60 mg of tryptophan.
The daily Recommended Dietary Allowances (RDAS) and Estimated Safe and Adequate Daily Dietary Intakes (ESADDIs) compared with the U.S. Recommended Daily Allowances (U.S. RDAs) established by the U.S. Food and Drug Administration of protein, vitamins and minerals for non-pregnant, pregnant and lactating women is set forth in
Nutrition During Pregnancy
(Nat'l Academy Press, 1990), and below.
U.S. RDA
RDA or ESADDI
Pregnant
for Pregnant
Non-Pregnant
or Lactating
Nutrient
Adult Women
Women
Women
RDA
Protein
60
g
65
g
65
g
Vitamin A
800
mg RE
1
5,000
IU
8,000
IU
Vitamin D
10
&mgr;g
400
IU
400
IU
Vitamin E
10
mg of &agr;-TE
2
30
IU
30
IU
Vitamin K
65
&mgr;g
Not Established
Not Established
Vitamin C
70
mg
60
mg
60
mg
Thiamin
1.5
mg
1.5
mg
1.7
mg
Riboflavin
1.6
mg
1.7
mg
2.0
mg
Niacin
17
mg NE
3
20
mg
20
mg
Vitamin B
6
2.2
mg
2.0
mg
2.5
mg
Folacin
400
&mgr;g
400
&mgr;g
800
&mgr;g
Vitamin B
12
2.2
&mgr;g
6
&mgr;g
8
&mgr;g
Calcium
1,200
mg
1,000
mg
1,300
mg
Phosphorus
1,200
mg
1,000
mg
1,300
mg
Magnesium
300
mg
400
mg
450
mg
Iron
30
mg
18
mg
18
mg
Zinc
15
mg
15
mg
15
mg
Iodine
175
&mgr;g
150
&mgr;g
150
&mgr;g
Selenium
65
&mgr;g
Not Established
Not Established
ESADDI
Biotin
30-100
&mgr;g
300
&mgr;g
300
&mgr;g
Pantothenic
4-7
mg
10
mg
10
mg
Acid
Copper
1.5-3.0
mg
2
mg
2
mg
Manganese
2.5-5.0
mg
Not Established
Not Established
Fluoride
1.5-4.0
mg
Not Established
Not Established
Chromium
50-200
&mgr;g
Not Established
Not Established
Molybdenum
75-250
&mgr;g
Not Established
Not Established
1
1 RE (retinol equivalent) = 1 &mgr;g of retinol, 6 &mgr;g of &bgr;-carotene or 12 &mgr;g of other provitamin A carotenoids.
2
1 &agr;-TE (tocopherol equivalent) = 1 mg of RRR-&agr;-tocopherol = 1.49 IU of RRR-&agr;-tocopherol = 0.74 IU of all-RAC-&agr;-tocopherol (the synthetic form).
3
1 NE (niacin equivalent) = 1 mg of niacin or 60 mg of dietary tryptophan.
Morning sickness generally causes a loss of appetite and a feeling of nausea, and is experienced by a significant number of pregnant women. Because they experience morning sickness, and because the pills that contain the full dose of recommended prenatal vitamins and minerals generally are very large in size, many pregnant women are often reluctant to take their prenatal vitamin and mineral pills. Further, when they do take these pills, these pregnant women often experience difficulty swallowing and retaining these pills, and take the pills without food. Vitamins and minerals that are taken without food are not absorbed as well as those taken with some food. Problems, thus, arise concerning patient compliance (the daily consumption of vitamin and mineral supplements), maintaining or enhancing the health of pregnant woman, and the absorption of the quantity of vitamins and minerals that are associated with proper fetal development. Moreover, regurgitation after consuming a vitamin and mineral pill causes loss of some or all of the nutrients that were originally present in the pill.
Morning sickness generally occurs most frequently during the first trimester of pregnancy. Defects in the neural tube of a developing fetus (spina bifida) can also occur during the first trimester of pregnancy, for example, during the first month of gestation, before a woman may have become aware of her pregnancy. These defects are known to be linked to an inadequate intake of folic acid. It is well known that folic acid prevents neural tube defects. Thus, folic acid should be consumed in sufficient quantities by women of child-bearing ages. Folic acid has also been shown to have beneficial cardiac effects, and to decrease the risk of cervical dysplasia.
Calcium is critical for proper fetal development, and is essential for the production of milk by women. The administration of calcium to a pregnant or lactating woman also acts to prevent early osteoporosis in the woman as a result of a calcium drain in the woman during pregnancy or lactation.
A recent University of North Carolina at Chapel Hill study that was described in an article appearing in a November, 2000, issue of
Science Daily
magazine and entitled, “New Research Shows Calcium Deficiency Permits Faster Lead Release from Pregnant Women's Bones,” showed that pregnant women who do not consume enough calcium in their diets, or through supplements, show greater increases in lead in their bloodstreams than pregnant women with normal calcium levels. Bone tissue, which contains about 95% of the body's lead, demineralizes more rapidly in pregnant women who are getting less calcium in comparison with other pregnant women. Such demineralization releases locked-up lead into the blood, particularly during the second half of pregnancy, and may cause harm to both pregnant women and their fetuses. (Past research has linked lead to many adverse conditions, including nervous system and possible cardiovascular problems.) This study also showed that calcium consumption can minimize bone demineralization in pregnant women, and that one variable associated with a reduced lead level is a higher calcium intake. Calcium intake at the recommended daily allowance level was found to protect somewhat against lead, and higher calcium levels were found to correspond with even less lead. The protective effect of calcium was found to become stronger as pregnancy progressed.
Many other vitamins, minerals and other nutritional supplements, such as those set for
Manning Paul B.
McGrath, Jr. James W.
Schramm Jack H.
Bennett Rachel M.
Feder Scott B.
Hastreiter Roberta L.
Lord, Bissell & Brook
Page Thurman K.
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