Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Phosphorus or phosphorus compound
Reexamination Certificate
2002-08-08
2004-09-14
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Phosphorus or phosphorus compound
C424S464000, C424S489000, C424S687000, C514S167000, C514S168000, C514S249000, C514S345000, C514S052000, C514S819000, C514S825000, C514S904000, C514S905000, C514S960000
Reexamination Certificate
active
06790462
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to dietary supplements, more particularly to calcium-containing dietary supplements.
BACKGROUND OF THE INVENTION
Mineral and vitamin compositions are routinely used as dietary supplements, either as general nutritional supplements or as therapeutic preparations directed to treat specific medical problems.
Calcium is an important nutrient for growing children to help in bone formation and for adults to help prevent bone loss. Excessive bone loss may lead to a condition known as “osteoporosis”, in which decreased bone mass causes the bones to be more brittle and thus more susceptible to fracture. It is widely believed that a chronic shortage of dietary calcium is one factor leading to osteoporosis, see
Osteoporosis, Cause, Treatment, Prevention
, U.S. Dept. of Health and Human Services, Public Health Service National Institutes of Health, Maryland 1987. Calcium dietary supplements appear to be of value in helping to prevent osteoporosis.
It also has been suggested that, in addition to calcium, other minerals, such as copper, magnesium and zinc, and certain vitamins, such as vitamin D, play important roles in bone formation and metabolism, see, for example, Strause, L., et. al., “The Role of Trace Elements in Bone Metabolism”,
Nutritional Aspects of Osteoporosis
, New York, Raven Press, p. 223-233, 1992.
Furthermore, there is evidence that elevated levels of homocysteine (Hcy), an amino acid that is formed as a byproduct of metabolism and is found in the blood plasma, provide a better indicator for coronary heart disease than elevated blood cholesterol levels (see McCully, K,
The Homocysteine Revolution, New Canaan, Conn.: Keats Publishing,
1997). It has also been found that the B-complex vitamins administered as nutritional supplements can be effective in reducing plasma levels of Hcy.
A possible link between elevated Hcy and the progression of osteoporosis can be inferred from the effects of two osteoporosis treatments, hormone replacement therapy (HRT) and raloxifene hydrochloride. HRT is an effective treatment for the prevention of osteoporosis, but has an additional documented effect of reduction of Hcy levels as well (see Mijatovic V, van der Mooren M J, “Homocysteine in postmenopausal women and the importance of hormone replacement therapy”,
Clin Chem Lab Med
2001 August;39(8): 764-7). Raloxifene hydrochloride belongs to a class of drugs described as selective estrogen receptor modulators, and in addition to its well documented benefits in the treatment of osteoporosis, it has been shown in two randomized trials on post-menopausal women to reduce Hcy levels (see Saitta A et al, “Cardiovascular effects of raloxifene hydrochloride”,
Cardiovasc Drug Rev
2001 Spring;19(1):57-74).
It has been postulated that elevated levels of Hcy are implicated in many of the diseases associated with aging such as the decline in cognitive abilities, occlusive vascular disease and events leading to osteoporosis by virtue of the formation of adducts with metabolically important molecules, primarily proteins (see Krumdieck C L, Prince C W, “Mechanisms of homocysteine toxicity on connective tissues: implications for the morbidity of aging”,
J Nutr
2000 February;130(2S Suppl.):365S-368S). This irreversible homocysteinylation leads to a reduction or complete loss of function of these proteins which is time and Hcy concentration dependent. Thus the reduction of Hcy achieved through use of suitably formulated nutritional supplements may retard or prevent the progression of these molecular changes to the point where they are manifested as clinical impairment.
There a continuing interest in providing improved calcium dietary supplements which contain other components in addition to calcium in order to promote healthy bone growth and slow or prevent bone loss.
SUMMARY OF THE INVENTION
In a first aspect, the present invention is directed to a dietary supplement composition, comprising phosphorus and from greater than 1.3 to less than 2.2 parts by weight calcium per part by weight phosphorus.
In a second aspect, the present invention is directed to a particulate dietary supplement composition, comprising phosphorus and from greater than 1.3 to less than 2.2 parts by weight calcium per part by weight phosphorus.
In a third aspect, the present invention is directed to a directly compressible dietary supplement composition, comprising phosphorus, from greater than 1.3 to less than 2.2 parts by weight calcium per part by weight phosphorus, a dissolution aid and a lubricant, wherein said directly compressible dietary supplement composition is capable of being directly compressed to form tablet of dietary supplement composition.
In a fourth aspect, the present invention is directed to a dietary supplement composition in tablet form, comprising calcium and phosphorus, wherein the tablet has a total weight of from 400 to 2000 milligrams per tablet and comprises greater than about 200 milligrams calcium per tablet and from greater than 1.3 to less than 2.2 parts by weight calcium per part by weight phosphorus.
In a fifth aspect, the present invention is directed to a liquid dietary supplement composition, comprising calcium and phosphorus, wherein the liquid comprises greater than about 100 milligrams calcium per 100 milliliters of liquid and from greater than 1.3 to less than 2.2 parts by weight calcium per part by weight phosphorus.
In a sixth aspect, the present invention is directed a dietary supplement composition comprising phosphorus, from greater than 1.3 to less than 2.2 parts by weight calcium per part by weight phosphorus and a compound selected from Vitamin D, Vitamin B
12
, folate and Vitamin B
6
.
Comparison of daily calcium intake and daily phosphorus intake set forth in IOM Daily Reference Intakes of Ca, P, Mg and F, 1997, pp. 390-391 (ISBN 0-309-06403-1) with the recommended daily intakes set forth in 21 U.S. Code of Federal Regulations 101.9 reveals a correlation between calcium and phosphorus deficiencies, particularly among women from 31 to 70 years of age and among children from 4 to 8 years of age. The supplement composition of the present invention provides supplemental calcium and phosphorus in the relative amounts required to simultaneously correct the calcium and phosphorus deficiencies which characterize the demographic group of those women greater than 31 years of age that are in the 50
th
percentile or lower in calcium and phosphorus intake. In preferred embodiments, the supplement composition of the present invention combines the benefits of supplemental calcium and phosphorus in the above described ratios with the effects of certain B-complex vitamins to provide further benefit in the prevention of osteoporosis in men and women.
REFERENCES:
patent: 4751085 (1988-06-01), Gaull
patent: 4781925 (1988-11-01), Michelucci et al.
patent: 5340603 (1994-08-01), Neylan et al.
patent: 5480872 (1996-01-01), Cope et al.
patent: 00/28973 (2000-05-01), None
Chemical Abstracts 139:213468 (2003).*
Chemical Abstracts 134:366115 (2001).*
Medline Abstract, Accession No. 94003720 (1994).*
Database Google, Product Information Sheet on TVM Plus (Multivitamin), www.cybervitamins.com.com, 1995.
Database Google, Product Information Sheet on Posture-D, www.drugstore.com, 1999.
Database HCAPLUS on STN, No. 1982:51078, Guenther et al. ‘Effect of Vitamin D3 on the Useability of Mineral Phosphorus Compounds,’ abstract, Kraftfutter, 1981, 64(10), 500,m 506-6, 508.
Database HCAPLUS on STN, No. 1981:423212, Lee et al. ‘Effects of Supplementation of the Diets with Calcium and Calcium-Rhich Foods on Bone Density of Elderly Females with Osteoporosis,’ abstract, American Journal of Clinical Nutrition, 1981, 34(5), 819-23.
Database HCAPLUS on STN, No. 1964:63083, Chandler et al. ‘Investigation of Calcium , Phosphorus, and Vitamin D3 Relations in Rats by Multiple Regression Techniques,’ abstract, J. Nutr. 1962, 78, 28-36.
Pak John
Rhodia Inc.
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