U.S. patent application number 09/789797 was filed with the patent office on 2001-08-09 for infused vegetable, herb, and/or seed fiber product and dietary supplements containing same.
Invention is credited to Mann, Douglas L..
Application Number | 20010012525 09/789797 |
Document ID | / |
Family ID | 26769439 |
Filed Date | 2001-08-09 |
United States Patent
Application |
20010012525 |
Kind Code |
A1 |
Mann, Douglas L. |
August 9, 2001 |
Infused vegetable, herb, and/or seed fiber product and dietary
supplements containing same
Abstract
Disclosed is a method of producing a reconstituted fruit, herb,
and/or seed fiber product, the product produced using the method,
and dietary supplements containing the product. The steps used to
produce the product include expressing juice from a fruit, herb, or
seed; concentrating the juice by removing water; infusing pomace
obtained during expression of the juice with the concentrated
juice, and drying the steeped pomace to obtain a dry,
non-hygroscopic, free-flowing nutritional supplement.
Inventors: |
Mann, Douglas L.; (Buzzards
Bay, MA) |
Correspondence
Address: |
Charles S. Sara
DEWITT ROSS & STEVENS S.C.
Suite 401
8000 Excelsior Drive
Madison
WI
53717-1914
US
|
Family ID: |
26769439 |
Appl. No.: |
09/789797 |
Filed: |
February 20, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09789797 |
Feb 20, 2001 |
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09303808 |
Apr 30, 1999 |
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6231866 |
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60083566 |
Apr 30, 1998 |
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Current U.S.
Class: |
424/727 ;
424/732; 424/737; 424/757; 424/765 |
Current CPC
Class: |
A23L 2/08 20130101; A23L
19/09 20160801; A23L 33/105 20160801 |
Class at
Publication: |
424/727 ;
424/732; 424/757; 424/765; 424/737 |
International
Class: |
A61K 035/78 |
Claims
What is claimed is:
1. A method of producing a dietary supplement comprising: (a)
expressing juice from plant material thereby yielding a juice
portion and a pomace portion; (b) concentrating the juice portion
to yield a juice concentrate; (c) mixing the juice concentrate with
the pomace portion to yield juice-infused pomace; and then (d)
drying the juice-infused pomace to yield the dietary
supplement.
2. The method according to claim 1 wherein the mixing in step (c)
is done at a temperature of between about 40.degree. F. and
75.degree. F.
3. The method according to claim 1, further comprising, after step
(d): (e) comminuting the dietary supplement to a roughly uniform
particle size.
4. The method according to claim 3 wherein the dried product is
comminuted to a mesh size between about 50 and about 80.
5. The method according to claim 3, further comprising, after step
(e): (f) formulating the dietary supplement into unit dosage
form.
6. The method according to claim 1, wherein in step (a), juice is
expressed from cranberries.
7. The method according to claim 6, wherein the concentration of
the juice concentrate is between about 50 and about 65 brix.
8. The method according to claim 6, wherein the concentration of
the juice concentrate is about 50 brix.
9. The method according to claim 8, wherein the juice concentrate
and the pomace portion are mixed at a ratio between about 1:1
(juice concentrate to pomace) and about 1:4 wt/wt.
10. The method according to claim 1, wherein in step (a), juice is
expressed from plants selected from the group consisting of
blueberries, aronia, bilberries, and raspberries.
11. The method according to claim 1, wherein in step (a), juice is
expressed from plants selected from Nigella sativa, saw palmetto,
Echinacea, and alfalfa.
12. A dietary supplement produced by the process recited in claim
1.
13. A dietary supplement produced by the process recited in claim
6.
14. The dietary supplement of claim 13, which contains between
about 50 and about 5000 mg in a unit dosage form.
15. The dietary supplement of claim 13, which contains between
about 300 and about 1000 mg in a unit dosage form.
16. The dietary supplement of claim 13, which contains between
about 500 mg in a unit dosage form.
17. A dietary supplement produced by the process recited in claim
10.
18. A dietary supplement produced by the process recited in claim
11.
19. A dietary supplement consisting of concentrated plant juice and
plant pomace, wherein the concentrated plant juice is infused into
the plant pomace to yield infused pomace and the infused pomace is
then dried.
Description
FIELD OF THE INVENTION
[0001] 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
[0002] 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.
[0003] 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.
[0004] 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.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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 saliva 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.
[0014] 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.
[0015] 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
[0016] 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.
[0017] In another respect, the invention pertains to an all natural
method for producing powdered ingredients which are non-hygroscopic
and which have enhanced flow characteristics without the use of
unnatural excipients.
[0018] In yet another respect, the invention concerns an all
natural unique method of orally delivering nutraceutical
compositions into the human body in such a manner that the
bioactive compounds contained therein are-more effectively absorbed
and utilized in the human body.
[0019] In yet another respect, the invention pertains to a
cranberry-based nutraceutical composition containing active
components which inhibit the adhesion of bacteria to surfaces in
the urinary tract and which assists in the promotion and
maintenance of a healthy urinary tract.
[0020] In yet another respect, the invention pertains to a method
for producing a cranberry-based nutraceutical tea.
[0021] In yet another respect, the invention pertains to a method
of producing a highly concentrated, unpurified dietary fiber
product derived from plants.
[0022] A first embodiment of the invention is directed to a dietary
supplement produced by infusing plant-derived fiber with juice
concentrate derived from the same or different plant and drying the
infused fibers. The term "plant-derived fiber" is also sometimes
referred to in this and other publications as "pomace," "marc," and
"press cake." For purposes of this application, the plant-derived
fiber portion will be referred to as pomace.
[0023] In a first step, juice is expressed from plant material of
fruits, vegetables, herbs, spices, etc. (hereinafter referred to
collectively as plants) and seeds of plants, thereby yielding a
juice portion and a pomace portion. The juice portion is
concentrated to yield a juice concentrate, and the juice
concentrate is then infused with the pomace portion, whereby the
concentrate is absorbed into the pomace. The pomace so treated is
then dried and milled and optionally tabletted or capsulated.
[0024] A second embodiment of the invention is directed to a
dietary supplement alternatively produced by infusing pomace with
oil or other extract derived from the same or a different plant and
drying the infused fibers. In a first step, the oil or other
extract is expressed from plant material of plants, thereby
yielding an oil or extract portion and a pomace portion. The oil or
extract portion is then infused with the pomace portion, whereby
the oil or extract is absorbed into the pomace. The pomace so
treated is then dried and milled, and optionally tabletted or
capsulated.
[0025] A third embodiment of the invention is directed to a highly
concentrated, unpurified nutritional dietary fiber product produced
from pomace derived from the same or different plant and made into
a powdered form. In a first step, juice is expressed from plants,
thereby yielding a juice or oil portion and a pomace portion. The
juice or oil portion is discarded. The pomace is then dried,
optionally blended with a gum or other water-soluble fiber, and
milled.
[0026] A fourth embodiment of the invention is drawn to the product
produced using the process described immediately above.
[0027] The invention is an edible 100% plant matter composition
which can be used as a nutritional ingredient in place and instead
of other highly concentrated, unpurified fiber products such as
bran, gum or psyllium-seed husk. it can also be presented in unit
dosage form to promote and maintain a healthy life. In the case
where cranberries are utilized as the plant material source, the
composition is a cranberry fiber products containing some of the
bioactive values of cranberries.
[0028] The preferred composition comprises cranberry pomace, which
is dried and blended with a gum or alternatively another
water-soluble plant fiber and then milled to a roughly uniform
size, and optionally formed into tablets or capsules, in the
absence of any colorants, sweeteners, unnatural binders, excipients
or any other accessory ingredient.
[0029] The composition has the same non-hygroscopic and flow
features as described above in the second embodiment of the
invention. In short, this composition is also comprised entirely of
plant-derived fiber.
[0030] The composition is manufactured by first removing from the
plan matter all plant-derived juice, oil or other liquid extract
during a pressing operation. The pomace is then dried, optionally
blended with a gum or other water-soluble fiber, milled and shipped
in bulk. The composition makes an excellent natural nutritional
ingredient and can be used as a food additive for fortification of
fiber bars, cereals, breads, drinks and the like, or it can be
optionally pelletted, tabletted or capsulated for use as dietary
supplement to be orally ingested.
[0031] The preferred plant fiber for use in this embodiment of the
invention is the pomace taken directly from the presses used to
express the juice, oil or other liquid extract from the plant
material.
[0032] However, it is within the scope of the invention to mix the
pomaces and juices. For example, there may be value in infusing the
concentrated juice of cranberries into the pomace derived from
apples, blueberries, carrots, squash or other plants. The pomace
need not be dried prior to its use in the invention.
[0033] In use, the composition, capsulated or not, is ingested
orally as a dietary supplement to promote the general health of the
user. The composition can also be used as a food additive for
fortification of fiber bars, cereals, breads, and drinks.
[0034] In addition to its clear health benefits, another distinct
advantage of the present invention is that it that it utilizes
plant-derived pomace, which would otherwise be discarded as waste.
For example, when cranberry juice concentrate is added to the
cranberry pomace, the resulting reconstituted cranberry product
makes an excellent nutritional supplement which does not require
nutritionally insignificant excipients such as sweeteners,
desiccants, binding agents, and the like.
[0035] Further benefits of the present invention are manifest. By
reconstituting concentrated juice with the natural fibers, the
nutritionally- and pharnacologically-active ingredients present in
the vegetable, fruit, herb, or seed are concentrated in comparison
to their concentrations as found in nature. Consequently, the
bioactive compounds found naturally in the plants are fortified.
Also, on a per weight basis, the resultant product is far richer in
beneficial vitamins, anthocyanins, proanthocyanins, antioxidants,
and other beneficial components.
[0036] Moreover, the process and the resultant product utilize the
entire natural source, including the vegetable, fruit, skin, seeds,
and fibrous portions thereof, and not simply an extract of the
natural plant source.
[0037] In essence, the process yields a powdered version of an
entire vegetable, fruit, herb, or seed. The resultant product
contains the complete complement (juice, skin, seeds, fiber) of the
source vegetable matter, not just the juice portion. By utilizing
only low-temperature processing, the resultant product preserves
the natural enzyme activities found in the fresh vegetable, fruit,
herb or seed. In its preferred form, the process does not require
any unnatural substances; hence the finished product does not
contain any unnatural substances. However, it is within the scope
of the present invention to add other ingredients if desired.
[0038] Additionally, the final product is capable of being finely
milled and can therefore easily be formulated into any number of
unit dosage forms, such as tablets or capsules. The product need
not be refrigerated and is storage stable for at least a period of
months, if not years. This makes formulation, storage, and
transport of the product extremely attractive.
[0039] When formulated into unit dosages, such as tablets or
capsules, the product of the invention is easily delivered orally.
Because the bioactive ingredients are infused into a generally
fiber matrix, the bioactive components are shielded from
degradation during transit through the stomach, thereby delivering
a maximum concentration of bioactive ingredients in the intestines.
The natural pectin components of the product slow down the
digestive process in the intestines and provide a natural sustained
release of the active compounds from the fiber matrix, thereby
enhancing the bioavailability of the active compounds. The
insoluble fiber portion, while indigestible, serves as a bulking
agent to promote regularity and good intestinal health and
functioning.
[0040] Virtually any plant material, including whole plants, whole
fruits, whole vegetables, spices, herbs, seeds, skin, bark, leaves,
roots, tubers, or parts thereof, may be used in the present
invention. It is preferred that an entire fruit or vegetable or an
entire plant be used, although this is not required. The preferred
plant materials to be utilized in the invention fall into two
categories: Category I: whole cranberries, blueberries, bilberries,
aronia and raspberries; and Category II: Nigella sativa, saw
palmetto, alfalfa, and Echinacea. Preferably, each of these
materials is formulated separately to yield a powdered product
derived from a single plant source. However, if desired, mixtures
of various plant materials may be commingled and processed
simultaneously.
[0041] Further advantages of the invention will appear from a
complete reading of the Detailed Description, below.
DETAILED DESCRIPTION OF THE INVENTION
[0042] The discussion which follows is limited to a description of
the particular, preferred formulation of the present
invention,-which is a dried formulation derived from whole
cranberries. This limitation, however, is for brevity only. As
noted above, virtually any plant material, including whole plants,
whole fruits, whole vegetables, spices, herbs, seeds, skin, bark,
leaves, roots, tubers, or parts thereof, may be used in the present
invention. It is preferred that an entire fruit or vegetable or an
entire plant be used, although this is not required. The preferred
plant materials to be utilized in the invention fall into two
categories: Category I: whole cranberries, blueberries, bilberries,
aronia and raspberries; and Category II: Nigella sativa, saw
palmetto, alfalfa, and Echinacea, with the most preferred being
cranberries. The process as described below for cranberries is the
same process which is used when processing any plants set forth in
Category I or similar.
[0043] The dietary supplement disclosed herein which is formulated
from cranberries has been given the name CRAN-MAX, which term shall
be used to designate the product described hereinbelow.
[0044] CRAN-MAX is produced by infusing cranberry juice concentrate
into cranberry pomace from which the juice has already been
expressed. By removing the juice from the pomace, concentrating the
juice, and then reuniting the juice with the pomace, a dietary
supplement which is far richer in vitamins, anthocyanins and
proanthocyanins (OPC's), antioxidants, and other compounds found
naturally in cranberries (but in far reduced concentrations) is
produced. CRAN-MAX can be taken in pill or capsule form to afford
an individual the known benefits of cranberry without ingesting
unwanted additives such as sweeteners and colorants found in
commercially available cranberry concoctions.
[0045] The first step in producing CRAN-MAX is to express juice
from cranberries. This is accomplished by any of several means
known to the art. The physical maceration and expression of juice
from the fibrous matrix of plant material has been known for
millennia. Juice from fresh cranberries is expressed as soon as
practicable after harvest using any type of suitable means for
pressing. For small batches, a hand-powered hydraulic basket press
is perfectly suitable. For larger volumes of cranberries,
industrial-sized equipment is required. Any debris is removed from
the juice by filtration. It is preferred that the juice be
processed immediately after expression or promptly frozen for
storage until further processing is undertaken. Likewise, the
pomace is either used promptly or frozen until needed.
[0046] Fresh, single-strength cranberry juice generally has a
concentration of about 5-7 brix, depending upon the source and
condition of the fruit. For use in the formulation of CRAN-MAX, the
single-strength juice is concentrated to at least about 50 brix or
higher. This can be done by any means known in the art, such as
reduced-pressure evaporation, conventional dehydration, and the
like. Preferably the concentration of the cranberry juice
concentrate falls between about 50 and about 65 brix.
[0047] The pomace can be used directly or promptly frozen for
storage until further processing is undertaken. The pomace is then
dried prior to being mixed with the juice concentrate.
[0048] The juice concentrate and the pomace are preferably mixed at
a ratio ranging from between about 1:1 (juice concentrate to
pomace) to 1:4 (wt/wt) based upon a 50 brix juice concentrate and
the calculated dry weight of the pomace. See Example 3, below for a
1:1 formulation of CRAN-MAX starting from 50 brix juice
concentrate.
[0049] The pomace and concentrated juice are then combined in a
batching vessel along with an amount of guar gum for binding
purposes. Additional nutritional and/or nutraceutical substances
from the group consisting of vitamins, minerals, herbs, and the
like, may be added during the mixing stage. The ratio of juice
concentrate to pomace is established prior to the addition of any
further ingredients.
[0050] The juice and pomace and any additives are mixed thoroughly
to ensure that the entire bulk of the pomace is contacted by the
concentrated juice. Preferably, this mixing is done at a
temperature between about 40.degree. F. and 75.degree. F. The
mixture is allowed to steep for up to 24 hours to allow the liquid
to be fully absorbed into the pomace.
[0051] The pomace/concentrate mixture is then dried. This can be
done on drying racks in a conventional dehydrator or by vacuum
drying means, or by any other means for drying known to the art of
food and pharmaceutical processing. Low-temperature drying means
(not to exceed about 140.degree. F.) are greatly preferred. It is
preferred that the moisture content of the dried mixture be no more
than about 3% by weight.
[0052] The dried product so derived using cranberries as the
starting plant material is called CRAN-MAX. The CRAN-MAX is then
milled to a uniform size if desired. Generally, milling to a mesh
size of between about 50 and about 80 yields a product which
readily flows and can easily be packaged, transported, and
formulated into dosage form (if desired). A 50-80 mesh CRAN-MAX
powder is easily pelletized of capsulated using suitable and
conventional machinery.
[0053] CRAN-MAX powder is non-hygroscopic and therefore does not
require the use of desiccants. It should also be noted here that
the product similarly produced from another plant source is also
non-hygroscopic and does not require the use of desiccants.
[0054] The composition described herein, whether from cranberries
or another plant source, either alone or in combination with other
nutritionally significant compounds can be used in the formulation
of dietary supplements, nutraceuticals, or pharmaceutical
compositions for nutritional and/or medical use. Nutraceuticals are
foods that have specific medicinal as well as nutritional benefits.
The composition may be optionally formulated with an acceptable
carrier therefor and optionally other therapeutically active
ingredients. The carrier, if one is utilized, must be
pharmaceutically acceptable in the sense of being compatible with
the other ingredients of the formulation and not deleterious to the
recipient thereof.
[0055] The formulations are suitable for oral administration
only.
[0056] The formulations may conveniently be presented in unit
dosage form and may be prepared by any of the methods well known in
the art of pharmacy. All methods include the step of shaping the
product into desired unit dosage form or packaging the product into
unit dosages, such as capsules. If a carrier is used, such methods
also generally include the steps of bringing the active compound
into association with a carrier and one or more optional accessory
ingredients. In general, the formulations are prepared by uniformly
and intimately bringing the active compound into association with a
liquid or solid carrier and then shaping or packaging into discrete
unit dosages.
[0057] Formulations of the present invention suitable for oral
administration may be presented as discrete units such as capsules,
cachets, tablets, boluses or lozenges, each containing a
predetermined amount of the CRAN-MAX product as a powder or
granules or small fibers.
[0058] A tablet may be made by compression or molding, optionally
with one or more accessory ingredients. Compressed tablets may be
prepared by compressing the CRAN-MAX in a suitable machine in a
free-flowing form, e.g., a powder or granules, optionally mixed
with accessory ingredients, e.g., binders, lubricants, inert
diluents, surface active or dispersing agents. Molded tablets may
be made by molding in a suitable machine, a mixture of powdered
CRAN-MAX with any suitable carrier (optional). The amount of
CRAN-MAX present may be in a unitized amount of between about 100
mg to about 500 mg.
[0059] The amount of the composition required to be effective for
promoting and maintaining sound health, will, of course, vary with
the plant material used in the formulation of the composition and
the individual mammal being treated and is ultimately at the
discretion of the individual, or medical or veterinary
practitioner.
[0060] In general, the pharmaceutical compositions of this
invention contain from about 50 to about 5000 mg of CRAN-MAX, and
preferably from about 300 to about 1000 mg. of CRAN-MAX, preferably
in a unit dosage form. The recommended dosage of CRAN-MAX is 500 mg
a day, preferably in a single dose, which has been determined by
laboratory analysis and confirmed by clinical evaluation. See
Example 7 below.
[0061] CRAN-MAX powder contains more antioxidant activity than
straight cranberry juice and has an organic acid content that is
comparable to that of commercially-available, single-strength
cranberry juice (see the Examples).
[0062] Plants in Category 2 referenced above require a different
process than that used for plants in Category 1 referenced above.
The process described below for saw palmetto is the same process
which is used when processing any plants set forth in Category 2,
or similar.
[0063] The dietary supplement disclosed herein which is formulated
from saw palmetto has been given the name SAW-MAX, which term shall
be used to designate the product described below.
[0064] SAW-MAX is produced by infusing saw palmetto oil into saw
palmetto pomace. The saw palmetto oil is obtained from saw palmetto
seeds from which the oil has been expressed. By infusing the oil
from the seeds into the pomace, a dietary supplement which is far
richer in saw palmetto (but in far reduced concentrations) is
produced. SAW-MAX can be taken in pill or capsule form to afford an
individual the known benefits of saw palmetto in a more potent
form.
[0065] The first step in producing SAW-MAX is to dry the -saw
palmetto berries (containing seeds) after they have been picked
from the plants. This can be done on drying racks in a conventional
dehydrator or by vacuum drying means, or by any other means for
drying known to the art of food and pharmaceutical processing.
Low-temperature drying means (not to exceed about 140.degree. F.)
are greatly preferred. It is preferred that the moisture content of
the dried mixture be no more than about 3-5 % by weight.
[0066] The dried berries (containing seeds) are then milled to
about 30 mesh. The berries are then subjected to an extraction
process used to express oil from the seeds. This is accomplished by
CO.sub.2 super critical extraction, a means known to the art. Oil
from the seeds in the berries is expressed during this process in
an amount by weight of between 6% and 12% of the weight of the
seeds. The pomace residue is gathered and milled to a mesh size of
between about 60 to about 80.
[0067] The expressed oil and pomace are preferably mixed at a ratio
ranging from 1:3 (oil to pomace) to 1:6 (wt/wt). The oil and pomace
are then combined in a batching vessel. Additional nutritional
and/or nutraceutical substances from the group consisting of
vitamins, minerals, herbs and the like, may be added during the
mixing stage. The ratio of oil to pomace is established prior to
the addition of any further ingredients.
[0068] The oil and pomace and any additives are thereupon
thoroughly blended in a ribbon blender to ensure that the entire
bulk of the pomace is contacted by the oil. Preferably, this
blending is done at a temperature between about 40.degree. F. and
75.degree. F. The blending takes 3 to 5 hours for the oil to be
completely saturated into the pomace.
[0069] The product so derived using saw-palmetto berries as the
starting plant material is called SAW-MAX. It readily flows and can
easily be packaged, transported, and formulated into dosage form
(if desired). The powder is easily pelletized or capsulated using
suitable and conventional machinery.
[0070] SAW-MAX powder is non-hygroscopic and therefore does not
require the use of desiccants. It should also be noted here that
the product formulated from any product similarly produced from
another plant source in Category 2 is also non-hygroscopic and does
not require the use of desiccants.
[0071] The composition described herein, whether from saw-palmetto
or another similar plant source, either alone or in combination
with other nutritionally significant compounds can be used in the
formulation of dietary supplements, nutraceuticals or
pharmaceutical compositions for nutritional and/or medical use. The
composition may be optionally formulated with an acceptable carrier
therefor and optionally other therapeutically active ingredients.
The carrier, if one is utilized, must be pharmaceutically
acceptable in the sense of being compatible with the other
ingredients of the formulation and not deleterious to the recipient
thereof.
[0072] The formulations are suitable for oral administration only.
The formulations may conveniently be presented in unit dosage form
and may be prepared by any of the methods well known in the art of
pharmacy. All of the above methods described above under CRAN-MAX
are similarly applicable in this case.
[0073] Another aspect of the invention, an all natural method of
orally delivering nutraceutical products, has been given the name
BIO-SHIELD, which term shall be used to designate the method
described below.
[0074] The BIO-SHIELD method comprises using a composition produced
using the method described above for producing CRAN-MAX or SAW-MAX,
placing this composition into a capsule or tablet and then orally
ingesting it.
[0075] Because the bioactive ingredients are infused into a fiber
matrix, the bioactive components are shielded from degradation
during transit through the stomach, thereby delivering a maximum
concentration of bioactive ingredients into the intestines. The
natural pectin components of the product slow down the digestive
process in the intestines and provide a sustained release of the
active compounds from the fiber matrix, thereby enhancing the
bioavailability of the active compounds.
[0076] Another aspect of the invention is a highly concentrated,
purified fiber product given the name FIBER-X, which term shall be
used to designate the product described below. FIBER-X is produced
from the pomace of any of the plants described herein, following
removal of the juice or oil component. The fiber is rich in the
bioactive compounds found in those plants and has value as a
nutritional bulking agent.
[0077] Two different sequences are employed, depending upon whether
the plant source is a Category 1 or Category 2 plant, as referenced
above.
[0078] Where the plant source is a Category 1 plant, the extracted
juice is discarded. The pomace remaining after pressing is
thereupon dried and milled, using the same drying and milling
methods and specifications as described above for CRAN-MAX.
[0079] Where the plant source is a Category 2 plant, the same
drying, initial milling and extraction methods and specifications
are the same as those described above under SAW-MAX. However, in
this case the oil obtained from the extraction process is
discarded. The pomace residue has a small amount (1-2% by weight)
of oil contained within its fiber matrix, along with other
bioactive compounds found naturally in the plant. The pomace is
remilled again to a mesh of between about 60 and about 80.
[0080] The dried product so derived from either of these methods is
called FIBER-X which is a 100% edible plant matter composition. In
each case depending upon the plant material source utilized, the
composition is a fiber product containing some of the particular
bioactive values of that plant source.
[0081] FIBER-X can be used as a nutritional ingredient in place and
instead of other highly concentrated, unpurified fiber products
such as bran, gum or psyllium-seed husk. In bulk, the composition
makes an excellent natural nutritional ingredient and can be used
as a food additive for fortification of fiber bars, cereals,
breads, drinks and the like.
[0082] Optionally, it can be presented in unit dosage form to
promote and maintain a healthy life, pelletted, tabletted or
capsulated for use as a dietary supplement to be orally
ingested.
[0083] The preferred composition comprises cranberry pomace, which
is dried and blended with a gum or alternatively another
water-soluble plant fiber and then milled to a roughly uniform
size, and optionally formed into tablets or capsules, in the
absence of any colorants, sweeteners, unnatural binders, excipients
or any other accessory ingredient.
[0084] The composition has the same non-hygroscopic and flow
features a described above in the second embodiment of the
invention. In short, this composition is also comprised entirely of
plant-derived fiber.
[0085] Another aspect of the invention is a nutraceutical tea,
comprising the blend produced using the entire method described in
CRAN-MAX above with the exception that the product produced is
milled instead to a tea cut of between 12 and 16 mesh.
EXAMPLES
[0086] The following Examples are included solely to aid in a more
complete understanding of the subject invention. The Examples do
not limit the scope of the invention described herein in any
fashion.
EXAMPLE 1
Production of CRAN-MAX.
[0087] CRAN-MAX was produced by combining 1430 pounds cranberry
fiber, 65 % moisture content, with 99 gallons of cranberry juice
concentrate (50 brix, 10.2 pounds per gallon), to yield a total
weight of 2430 pounds. Both the cranberry fiber and the concentrate
were delivered frozen and thawed immediately prior to
formulation.
[0088] The fiber and concentrate were mixed thoroughly, whereby the
concentrate was absorbed completely into the fiber. The mixture was
then vacuum dried (final moisture 1.75%) and milled to 50 mesh.
This yielded a free-flowing, non-hygroscopic powder formulation
having a natural rose-colored hue.
EXAMPLE 2
Production of CRAN-MAX Plus Vitamin C
[0089] A batch of CRAN-MAX was prepared in the same fashion as
described in Example 1 with the exception that 250 pounds of
ascorbic acid (Vitamin C) was added to the concentrate prior to
mixing the concentrate with the fiber. The ascorbic acid was added
to the concentrate with continuous agitation, and this mixture then
added to the fiber. The combination was thoroughly mixed, vacuum
dried (1.75 % final moisture), and milled to 50 mesh. The resultant
product was also a free-flowing, non-hygroscopic powder having a
natural rose-colored hue.
EXAMPLE 3
Production of CRAN-MAX Using Cranberry Juice Concentrate of Varying
Brix
[0090] CRAN-MAX was produced using a 1 to 1 weight ratio of fiber
to 50 brix juice concentrate. Wet fiber (396 g) having a moisture
content of 63.84% by weight, yielded a dry fiber weight of 143
grams. To the wet fiber was added 143 grams of 50 brix concentrate,
which is equivalent to adding 0.157 pound juice solids to the
fiber. The mixture was dried and milled as in Example 1.
[0091] To formulate an equivalent amount of CRAN-MAX using 65 brix
concentrate, 110 g of concentrate was added to the same amount of
fiber. The calculation appears as follows:
[0092] (amt of 65 brix concentrate)(7.135 pound solids @65
brix)=0.157
[0093] (amt of 65 brix concentrate)=0.022 gal=83.3 ml=110 g
concentrate
EXAMPLE 4
Comparison of Organic Acid Content in CRAN-MAX V. Cranberry
juice
[0094] Samples of CRAN-MAX prepared as described in Example 1 and
commercially purchased cranberry juice were analyzed by reverse
phase HPLC using an organic acids column and UV detection means to
determine the percentage of quinic, malic, and citric acids found
therein. The results are presented in Table 1:
1TABLE 1 Organic Acids (%).sup.a Sample Quinic Malic Citric Total
CRAN-MAX 2.1 5.0 3.8 10.9.sup.b Commercial 1.6 6.8 2.7 11.1.sup.c
Cranberry Juice .sup.aValues determined by reverse-phase HPLC with
UV detection based on appropriate standard solutions. .sup.b% w/w
.sup.c% w/v
EXAMPLE 5
Antioxidant Activity of CRAN-MAX
[0095] A sample of CRAN-MAX produced according to Example 1 was
analyzed for its oxygen-radical absorbance capacity (ORAC) using a
standard assay.
[0096] The assay utilizes
2,2'-azobis(2-amidinopropane)dihydrochloride) (AADH) as a peroxyl
radical generator and -phycoerythrin as an indicator protein.
"TROLOX" a water-soluble Vitamin E analog, is used as a reference
point for antioxidant activity. One ORAC Unit is defined as the
oxygen-radical absorbance capacity of a 1 solution of "TROLOX." The
assay is constructed by combining the phycoerythrin and the
composition to be tested into an aqueous solution and then adding
the AADH and monitoring the reaction solution by fluorescence at
565 nm (excitation at 540 nm).
[0097] Serial dilutions of CRAN-MAX, cranberry juice, and "TROLOX"
were assembled and aliquots of phycoerythrin added thereto. The
results are depicted in Table 2:
2TABLE 2 Sample ORAC Units per g "TROLOX" Equivalent Commercial
Cranberry 9,196 0.007 Juice Cocktail CRAN-MAX 26,227 0.020 Trolox
1,315,780 1.000
EXAMPLE 6
Calculation of Weight Ratio: Whole Cranberry to CRAN-MAX
[0098] A 100 lb. sample of cranberries was juiced in standard
fashion, yielding 5 pounds of cranberry fiber, a ratio of 20 to 1.
One hundred pounds of whole cranberries will have an average yield
of 1.25 gallons of juice concentrate at 50 brix and 10.24
lbs./gallon, which is equivalent to 12.8 lbs at 50 brix which is
equivalent to 6.4 lbs dry solids. 6.4 lbs juice solids per 100 lbs
whole cranberries yields a ratio of 15.6 to 1. Combining the juice
solids with the cranberry fibers in the combined CRAN-MAX
formulation thus yields a final ratio of 34.6 to 1. At this ratio,
500 mg CRAN-MAX contains the same juice solids as about 10 oz. of
cranberry juice concentrate.
EXAMPLE 7
Clinic Evaluations
[0099] Three patients in a urological practice were given a
self-assessment questionnaire developed by the American Urological
Association for assessing symptoms related to benign prostatic
hypertrophy. The patients evaluated the questions on a scale of 0
to 5, 0 designating "none," "never," or "not at all" and 5
designating "5 or more times (in the stated period)" or "almost
always." The 7 questions contained in the self-assessment
questionnaire were:
[0100] 1. Over the last month or so, how many times did you most
typically get up to urinate from the time you went to bed at night
until the time you got up in the morning?
[0101] 2. Over the past month or so, how often have you had a
sensation of not emptying your bladder completely after you
finished urinating?
[0102] 3. Over the past month or so, how often have you had to
urinate again less than two hours after you finished urinating?
[0103] 4. Over the past month of so, how often have you found that
you stopped and started again several times when you urinated?
[0104] 5. Over the past month or so, how often have you found it
difficult to postpone urination?
[0105] 6. Over the past month or so, how often have you had a weak
urinary stream?
[0106] 7. Over the past month or so, how often have you had to push
or strain to begin urination?
[0107] Each of the three patients (two female, one male) completed
the questionnaire and their scores tallied by adding the total
numeric value of their responses. The results were as follows:
Score of Self-Assessment at Beginning of Trial
[0108] Patient 1 7.5
[0109] Patient 2 9
[0110] Patient 3 8
[0111] With full information and consent, each patient was then
given a 500 mg daily dose of CRAN-MAX, in a single dose, for a
course of 30 days. The patients then completed the self-assessment
questionnaire. The scores after the 30 course of treatment with
CRAN-MAX were as follows:
Score of Self-Assessment After 30-Day Treatment Period
[0112] Patient 1 2.5
[0113] Patient 2 6
[0114] Patient 3 3
[0115] Thus, for these three patients, treatment with CRAN-MAX over
a course of 30 days resulted in a marked improvement of their
self-assessment of urinary frequency, urgency, etc.
[0116] It is understood that the invention is not confined to the
particular construction and arrangement of parts herein illustrated
and described, but embraces such modified forms thereof as come
within the scope of the claims.
* * * * *