Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from panax or acanthopanax
Reexamination Certificate
2001-11-15
2004-05-11
Prats, Francisco (Department: 1654)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from panax or acanthopanax
C424S736000, C424S752000, C424S756000, C424S766000
Reexamination Certificate
active
06733797
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention (Technical Field)
This invention relates to health supplement compositions, specifically those utilizing antioxidants or phosphatides, and their use.
2. Background Art
Note that the following discussion refers to a number of publications by author(s) and year of publication, and that due to recent publication dates certain publications are not to be considered as prior art vis-a-vis the present invention. Discussion of such publications herein is given for more complete background and is not to be construed as an admission that such publications are prior art for patentability determination purposes.
Health supplements are used by millions of Americans everyday, ranging from single ingredient vitamin supplements to multi-vitamins to prescription supplements incorporating hormone therapy and other medicinal treatments. A broad number of these health supplements are readily available to the public in over-the-counter formulations, many touting condition specific uses, such as the recent spate of “ultimate anti-aging formulations.” One of these formulations contains 65 components and suggests ingestion of over 10,000 mg of the combination per day which, due to limitations of tablet size, requires ingesting ten tablets each day. More popular brands of multivitamins contain between 26 ingredients (Theragran-M—by Mead Johnson) and 53 ingredients (Maxilife Phyto—by Twinlab). These “shotgun” approaches of incorporating all possible useful ingredients face not only serious criticisms, but also present serious potential dangers to a user. (See, Sardi, B. “What's Best in a Multivitamin,” 2d Ed. (1998), San Dimas, Calif., Sardi Publications, pp. 67-77.) For example, riboflavin (vitamin B
2
) is known to be toxic in doses above 10 mg per day. Many supplement formulations exceed this limit, posing a potential health risk to the users.
Many health supplement formulations include substantial numbers of herbal compounds. Herbal compounds naturally contain numerous active chemical groups. These active chemical groups compete for overall effect. For example, lemon fruit has an acid content, but counterintuitively, has an alkaline effect within the human body. Grapefruit contains antioxidant herbal substances which can interfere with drugs such as felodipine (Plendil®) or nifedipine (Procardia®). It is intuitive that indiscriminate combinations of numerous herbs, each containing numerous key constituents, might have a subtractive overall effect. Garlic is often used in formulations for its antioxidant properties, but may have the side effect of combining with other components in the formulation to exceed safe limits of selenium (200 mcg/day), due to garlic's relatively high selenium content. Therefore, many supplements on the market incorporating herbal compounds may be more harmful than “healthful.”
One promising way to incorporate important supplement components while reducing the potential for high dose toxicity is to utilize synergistic relationships among components. “Pharmacologic synergy” is a complementary, superadditive response resulting from the combination of two or more agents. For example, there are numerous examples of synergy between antioxidant vitamins. U.S. Pat. No. 5,994,322 to Masuda cites a lecithin-vitamin B
12
combination as synergistic. The oxidative synergy of vitamin E and phospholipid have been demonstrated as better than vitamin E alone. (See, Tesories, L., et al., “Synergistic Interactions Between Vitamin A and Vitamin E Against Lipid Peroxidation in Phosphatidylcholine Liposomes,” Archives Biochemistry Biophysiology, (1996), vol. 326(1), pp. 57-63.) Vitamin A and vitamin E have more antioxidant synergy with phosphatidylcholine liposomes than the respective single components. Other studies on synergy between numerous compounds for a focused outcome are surprisingly sparse.
On the flip side, other supplement formulations do not provide enough of certain supplements. Although many health supplements contain choline, a member of the B vitamin group, their formulations do not adequately address the needs created by phospholipid physiology. Phosphatidylcholine (either as a phosphomonoester or phosphodiester), is the serum transport form of choline. As can be seen in FIG. 1, phosphatidylcholine (monoester form) has a substitution on either R
1
or R
2
, but not on both. (Choline is depicted for comparison to phosphatidylcholine.) This form of choline is a principle component of all cell membranes. It is especially important to have a sufficient amount of phosphatidylcholine to maintain intact nerve cell membranes. For example, cholinergic nerve cells in particular, when faced with a reduced level of serum phosphatidylcholine, will resort to autocannibalism of the phosphatidylcholine in their cell membranes to maintain their primary mission: producing the neurotransmitter acetylcholine. This degenerates nerve cell membranes, resulting in conditions such as Alzheimer's Disease related dementia. (See, Summers, W. K. Correspondence: Oral Tetrahydroaminoacridine in the Treatment of Senile Dementia, Alzheimer's Type, New England Journal of Medicine, vol. 316, p. 1605, (1987).) The choline in phosphatidylcholine is also the principle source of choline metabolized into two other forms of phosphatides: sphingolipids and plasmalogens. Both of these forms are necessary for proper function of the central nervous system.
One of the more important focuses of health supplements is the reduction of free radicals. Free radicals are associated with aging of the brain. (See, Halliwell, B., Gutteridge, J. M. C. “Free Radicals in Biology and Medicine” (3
rd
ed.), (1999) New York, Oxford University Press.) Oxidative injury to the nervous system has been documented in diseases such as AIDS-associated dementia, Alzheimer's disease, benign senile forgetfulness (pre-Alzheimer's disorder), Down's syndrome-associated dementia, Lewy body dementia, multi-infarct dementia, multiple sclerosis, Parkinson's disease-associated dementia, tardive dyskinesia, Wernicke-Korsakoff syndrome, and alcoholism-associated dementia. Indeed, oxidative injury may be the final common pathway leading to cell death. (See, Joaquin, A. M. et al., “Functional Decline in Aging and Disease: A Role for Apoptosis,” Journal American Geriatrics Society, (2001), vol. 49, pp. 1234-1240.) Numerous studies have shown benefit from the use of antioxidants in many of these disorders. (See, Halliwell, B., Gutteridge, J. M. C., “Free Radicals in Biology and Medicine” (3
rd
ed.), (1999) New York, Oxford University Press.)
Antioxidants are substances that protect against oxidative stress damage caused by free radicals. There are four generally recognized groups of antioxidants: plant extracts, vitamins, amino acids, and minerals. Vitamins are organic substances provided in relatively small quantities from the environment that are necessary for the maintenance of health. Precursors (e.g., carotene for vitamin A), vitamins having multiple forms (e.g., pyridoxine, pyridoxal, pyridoxamine), and essential oligopeptides are typically referred to as “vitamers,” hereinafter to be understood as interchangeable with the term “vitamin.”
As discussed above, prior art supplement compositions generally take a “shotgun” approach of providing supplements instead of providing specific formulations for other than a generalized “anti-aging” or “energy” formulation. However, U.S. Pat. No. 6,048,846 to Cochran discloses a combination of supplement components designed to fight the causes of disease. The essential combination disclosed is use of at least one hormone with the supplement components. However, hormone administration can be dangerous given the potential downstream effects. This is the result of interaction with other hormones in feedback systems. The dosage range of hormones is often specific to timing of administration within the relevant physiological cycle. The '846 Patent formulation also does not necessarily result in an antioxidant net effect. For
Coe Susan D.
Peacock Deborah A.
Prats Francisco
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