Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from palmaceae
Reexamination Certificate
2001-02-20
2002-08-27
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from palmaceae
C424S725000, C424S737000, C424S777000
Reexamination Certificate
active
06440467
ABSTRACT:
FIELD OF THE INVENTION
The invention is directed to: (i) a method of producing a reconstituted vegetable, fruit, herb, and/or seed product, the product produced using the method, and dietary supplements containing the product; (ii) other methods which provide all natural solutions for carrying and delivering nutraceutical supplements into the human body; and (iii) a unique cranberry nutraceutical product which can be used effectively to promote and maintain a healthy urinary tract.
DESCRIPTION OF THE PRIOR ART
Currently, powdered forms of cranberries and of many other fruits, produced for use as ingredients, are made from the juice portion of the fruit only. The juice is extracted from the whole fruit by pressing and then concentrating. During this stage, the plant-derived fiber portion, otherwise known as the pomace or marc, of the fruit is discarded, and the natural pectin in the juice is removed. The remainder fruit juice product is then spray dried, using a high-heat drying method to remove most of the moisture, which reduces it to a powder. This final powder ingredient is a substantially-depleted version of the whole fruit plant, bearing little resemblance to the values contained in the complete fruit.
These powdered fruit ingredients, now devoid of many of the important active components and enzymes which synergistically existed in the whole fruit plant, deliver little therapeutic value when incorporated into nutraceutical products.
For example, many of the cranberry dietary supplements sold in the marketplace today indicate a dosage requirement of as many as six to twelve tablets or capsules a day because of the weak efficacy of the powdered cranberry ingredient used.
Thus, there is a distinct need for a new method which will produce new powdered fruit ingredients, and for new cranberry and other fruit powdered compositions, which are not so depleted as described and which instead incorporate all, or even more, of the values contained in the original fruits.
In another respect, powdered fruit ingredients tend to be hygroscopic and easily agglutinatable. This characteristic substantially affects the flow capability of these ingredients when being transferred into capsules or softgels for use as dietary supplements. To overcome this problem, unnatural excipients are currently added to the fruit ingredients in order to facilitate encapsulation. However, the use of these excipients presents further problems of then being able to meet tapped bulk density specifications. Further, for the natural products industry, the use of unnatural excipients is not desired.
Thus there is a distinct need in the marketplace: (i) for a method which will enable the production of powdered fruit ingredients which are non-hygroscopic; (ii) for a method which will improve the flow characteristics of these ingredients sufficiently to eliminate the need to use excipients during encapsulation; and (iii) for an all-natural method of achieving these objectives.
In yet another respect, the objective of nutraceutical dietary supplements is to deliver active compounds into the human body on an efficacious basis. However, many of these supplements after oral ingestion are substantially degraded by stomach acids before they can deliver their payload to the intestine for assimilation into the blood stream. For example, most of the cranberry powdered ingredients being currently employed in dietary supplements dissolve quickly in the stomach and thus have limited bioavailability. While there are various drug delivery systems used in the pharmaceutical industry to increase efficacy, there is an absence of methods available for natural delivery of nutraceutical products.
Thus there is now a clear and compelling need in the marketplace for a method of naturally delivering nutraceutical products effectively into the human body.
In yet another respect, cranberries have a long and well-documented history of being used in the maintenance of urinary tract health. Modern research has shown that cranberry fruit contains compounds which are bacteriostatic and particularly aid in the prevention of urinary tract infections (UTI's). It is believed that this activity is manifested by compounds which limit the ability of bacteria to adhere to surfaces within the urinary tract. Research has shown that at least one of these compounds is similar in activity to the Tamms-Horsfall glycoprotein, a compound which inhibits the adherence of
E. coli
to the bladder wall. See: Avorn, et al., “Reduction of Bacteriuria and Pyuria After Ingestion of Cranberry Juice,”(1994)
J. Amer. Med. Assoc.
271:751-754; Fowler, “Urinary Tract Infections in Women,”
Urol. Clinics of N. Amer.
(1986) 13(4):673-683. A recent study further found that the compounds in cranberry directly affected the cell structure of
E. coli
, and disabled the bacteria so that it was unable to adhere to urothelium and to be less capable of survival. See Ahuja, J., et al.,
J. Urol
1998:159: 559-562.
Based on the known effects of cranberry juice in the maintenance of urinary tract health, many people now include cranberry juice as part of their regular diets. However, most commercially-available cranberry juice cocktails contain large amounts of added sugar and colorants, additives which many health-conscious individuals find objectionable. Diabetics, for example, often find the sugar content of commercially-prepared cranberry juice cocktails to be so high as to offset any benefits provided by the juice itself.
As a consequence, there has been a long-felt need for a dietary supplement which: (i) provides the proven health benefits of cranberry juice without the disadvantages inherent in the cranberry juice concoctions which are currently offered in the market place; and (ii) is powerful enough to only require one tablet a day as the recommended daily dosage to be effective.
And yet in another respect, many other fruits, vegetables, herbs, and seeds in addition to cranberries have been scientifically shown or are widely believed through apocryphal evidence, to have other beneficial health effects. For example, bilberries and blueberries are reported to reduce macular nerve degeneration and to improve eyesight. Saw palmetto has been found to reduce prostate swelling. St. John's Wort is believed by many to have antidepressant activity. Garlic is thought to have antibacterial activity. Ginkgo biloba is believed to improve memory, and ginseng is believed to improve attentiveness. Additionally, extracts of
Nigella sativa
have been shown scientifically to inhibit the growth and proliferation of certain cancers and to increase immune function. See U.S. Pat. Nos. 5,482,711 and 5,653,981 to
Medenica
. Various natural ingredients have been ascribed to act as aphrodisiacs.
In their natural forms, most of these fruits, vegetables, herbs, and seeds cannot be directly ingested (due to palatability as well as other concerns). Many of the extracts produced from them have only captured a portion of the bioactive compounds. There is thus a distinct need for a new processing method which can capture the full synergistic and beneficial activity of these plants in a palatable concoction which retains the beneficial activity of the natural forms, and also provides for easy transport, easy formulation into unit dosages, and long-term shelf life without the need for refrigeration.
And in a final respect, tea has been used for centuries as both a beverage and an herbal remedy. The cranberry teas in the market are flavored beverages. There is a distinct need in the marketplace for a method to make a nutraceutical cranberry tea.
SUMMARY OF THE INVENTION
This invention relates to a method of naturally reconstituting a whole plant to make a powdered nutritional pharmacological ingredient from the plant which is far richer in vitamins, anthocyanins, proanthocyanins, antioxidants and other components on a concentrated basis than are otherwise naturally proportionately present in the plant.
In another respect, the invention pertains to an all natural method for producing powdered ingredie
DeWitt Ross & Stevens SC
Sara Charles S.
Tate Christopher R.
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