Note: Descriptions are shown in the official language in which they were submitted.
36~
Bankit 4
METHOD AND COMPOSITIONS FOR
SODIU~ SELENITE ADMINISTRATIO~
BACRGROUND OF THE INVENTION
~1) Field of the Invention
- The present invention relates to a method and
composition ~or the oral administration of sodium selenite
s to mammals, particularly humans. In particular the present
inventlon relates to a Elavored aqueous solution oE sodium
selenite con`taining edible acids, preferably citric and
ascorbic acids in amounts which do not impair the
ef~ectiveness of the sodium selenite.
(2) Prior Art
.
Selenium compounds, both organic and inorganic,
as mineral supplements with vitamins have been used for
years to ~aintain good health. Recently it has been ~ound
that sodium selenite in dosages '~etwean ~bout 200 and 300
micrograms per day ia particularly effective in inhibiting
the occurrence of tumors in healthy mammal3 ~Selenium in
Biology and ~edicine, A~I Publishing Company~ Inc.~ pages
~8 to 102 ~19al)). ~sentially the ccmQoun~ is used i~ a
pr¢phylactic amount for this purposeO
Sodium selenite has been found to be inactivated
by acids in a composition with a pH of less than about pH
2.75. ~he acidity of the composition plus the high ac;dity
of the stomach o pH 1.2 to 1.5 retar~s the absorption of
the sodium selenite into the blood stream. Ascorbic acid
(Vitamin C3 has been ~ound to ~ask the af fects of sodium
selenite (~iscovery of the ~ole of Selenium in Glutathione
Peroxidase, AVI Publishing Compan~, page 1~ (1981)).
. T~e problem has been to formulate a palatable
flavored fruit drink, particularly cltrus flavored in the
presence of citric acid and ascorbic acid, which are
desirable ~lavor contributing ingredients, such that the
drink has a pH of not less than about 2.75~ A ~ormal fruit
,. ~ .
...... ..
~Z~3611
--2--
drink has a ~H o~ about 2.5 or less. 80th ascorbic acid
and citric acid are also re~arded as being important for
good health and are preferred.
Objects
It is therefore an object of the present
invention to provide a flavored drink including sodium
selenite and containing an edible acid particularly c.itric
acid and ascorbic acid in amounts which do not impair the
- effectiveness of sodium selenite. Further it i~ an object
of the present invention to provide a composition which is
palatahle. These and o.ther objects will become
increasingly apparent by reference to the following
- ~escription~
General Description
The present invention relates to a method for
maintaining the health of a mammal with sodiùm selenite
which comprises orally feeding the mammal an efEective
amount of a flavored aqueous solution including sodium
selenite admixed with an edible acid in an amount which
retains the health maintaining 2ffectiveness of the ~odium
selenit~ without the acid such t'nat the health oF the
mammal is maintained.
- ~lso the present invention relates to a sodium
selenite composition for maintaining the health o a mammal
which comprises in an aquëous solution: sodium selenite; an
edible acid; and flavoring, wherein the composition
contains '~etween about 1 and 3 x 10-4 percent by weight ..
sodium seienite and b~tween about 0.3 and ~.6 percent by
weight acid, such that the pH is not less tnan pH 2.75.
In particular t'ne present invention relates to a
method ~or maintaining the health of a mammal ~ith sodium
selenite which comprises: orally ~eeding the mammal an
~f~ective amount of a`flavor-d aqueous solution including
so~ium seLenite admixed with citric and ascoroic acids in
3~ ~mounts which retain the health maintaining effectiveness
of the so~ium selenite witho~t the acids such that the
health of the mammal is maintained. Further the present
.
,
,
lZ~3~
--3--
invention relates to a sodium selenite composition for
maintaining the health o~ a mammal which comprises in an
aqueous solution: sodium selenite; citric acid and
ascorbic acid; and flavoring, wherein the composition
contains between about l and 3 x 10-4 percent b~ weight
sodium selen;te and between about 0.3 and 0.6 percen~ by
weigh~ acid, such that the pH is not less than pH 2./5~
The tenm "flavor" includes taste and olEactory sens~tion
contributing ingredients such as flavor oils.
In particular the present invention relates to a
mildl~ acidic, citrus Elavored drink including sodium
selenite and including (1) citrus pulpwash solids and
ci~rus Elavorings w'nich provide signiicant amounts of
ascoroic acid and (2) citric acid. The resulting
composition is palatable and is useful for maintaining the
health of the mammal, particularly humans.
Specific Vescription
Table l sets forth the ormulation o a
concentrate which is diluted with water ~5 volumes of water
to one volume of the so'lution) for administration to the
~ammal. The ingredients are shown in decreasing percents
by volume~ The principal ingredients are sodium selenite,
citric acid, ascorbic acid and flavorings. In addition~
citrus pulpwash, a source of small amounts of.ascorbic
-25 'acid, is included as well as various well known stabilizers
or emulsi~iers and shelf life extenders (spoilage
inhi~itorsl such as potassium sorbate and sodium benzoate.
The citric acid is added to achieve the desired pH in the
diluted product taking into consideration the ascorbic acid
3Q pre'sent in the pulpwash solids and in the citrus
concentrates~ The concentrate can be stored and shipped
without`separation of the ingredients. The concentrate has
a shelf li~e oE at least three to ~our months ~hen packaged
in contain2rs which,do not allow transpiration of oxygen
from the atmosphere.
:. .
:
::
:~ :
~243~
.~ _
TABLE 1
% Volume % tlolume
Water 14 . 510 Reliotropine ~Flavor)0.018
Fructose aqueous solu- Gum Arablc
S tion 62 Brix 54.600 (S'cabilizer) 0.()18
orange Pulp Wash Solid Benza}d~hyde
(Includes ascorbic (Stabilizer) 0~018
acld) 9.460
I.emon Oil lX
10 Pineapple Concentrate ~Flavor ) 0. 013
(F lavor ) 9 . 460
Vanillin lFlavor) 0.01
Grapef ruit Concentrate
(Fla~or, includes lQgFthyl Vanillin 0.011
by wt.ascorbic acid)4.730
Raspberry Juice
*Citric Acid ~cid) Concentrate
(Tangy Flavor) 2.270~Flavor) 0.011
Pass;on Fruit Con- Ethyl Valerate
centrate. (Flavor) 1.820~Stabilizer~ 0.00g
Lime Concentrate Propy lene Glycol
(Flavor, includes (5'~.abilizer) 0.011
10% by wt~ ascorbic
acid) 1.820Aldehyde C-14
~5 *Sodium Benzoate (Shelf (Flavor) 0.009
~ life extender) . 0.182 Oenanthic Ether
(Flavor) 0.009
*Xanthan gum
~Stabilizer) 0.182Allyl Caproate
. - (Flavor) 0.009
Sodium Selenita (1%
by weight solution ) 0 .150 Californîa orange Oil
Distilled 1ime Oil . lX (Flavor) 0.009
(FLavor) . 0.064 Ethyl 3utyrate
-Firmenich~ Apple -(Stabilizer) 0.009
~50.047/A (Flavor) 0.064
Retone 18 (Flavor) 0.055 Potassium Sorbate.
- (Shelf Lifè
Amyl ~utyrate (Flavor) 0.051Extender3 0.009
4Q 1inalyl Formate Grapefruit Oil 5Z
(Stabilizer for ~Flavor~ 0.009
oils) 0.046
Florida Orange Oil
Grapefruit Oil lX 5X (Flavor~ a.oog
(Flavor) 0.036
Aldehyde C-22~Flavor)0O006
Grenadine Aldehyde
(Flavor) 0.027Oil of Bitter Almond
(Flavor) 0.004
~Z43~
Aldehyde C-l~ (Flavor) 0.027
. Imitation Rose Oil
Ester Gum 8 B.~. ~Flavor~ 0.006
(Stabilizer) 0.027
Genuine Oil o Cognac
Imitation Neroli oil (Flavor) 0,004
~Fla~r) 0.027
F D & C Red ~40
Amyl Valerate (Flavor) 0.027 (Coloring) o.ao4
Citral ~lavorj 0.027 Firmenich~ Orange Oil
#59.432/T(~lavor) 0.002
Florida Vrange Oil
lX ~Flavor) 0.026 Aldehyde C-l9 (Flavor ) 0 . 002
Paramethyl Benzyl Amyl Acetate
Anthranilite (Stabilizer) 0.002
(St~bilizer) 0O024
Ethyl Vanillin
Ethyl Alcohol (Flavor) 0.022 (Flavor~ 0.002
100. 00%
Ethyl Acetate (Flavor) 0.020
* As solids by
Orange Terpenes (Flavor ) 0 . 018Bulk Volume
Table 2 shows the percent by weîght oE the principal
ingredie~ts in the (5:1) final product which is the diluted
concentrate (5:1).
Table 2
. ~ by Weight
Water and sweetener about 90 to ~5 .
Sodium selenite 1 to 3 x 10-4
- Pulp Wash Solids about 1 to 2
Citric Acid 0.3 to 0.6
Citric Concentrates 1.5 to 2.5
Flavorings 2 to 5
Stabilizers and Preservatives 0.1 to 0.2 .
The fruit drink was prepared using conventional
mixing techniques. The ingredients which form the smallest
proportions of the mix were combined. Assuming a total o
100 gallons (378.5 liters) is being prepared, those
ingredients forming less than 0.064 percent by volume~ were
combine~ with sodium benzoate, sodium selenite and xanthan
gum and then in turn combinea in a ~lending tank with
wa~er, pulp wash solids, pineapple concentrate, grape~ruit
,
~ , , .
- -6- ~Z~36~
concentrate~ citric acid, passion fruit concentrate, and
lime co~centrate. The resulting mixture was then combined
at room te~perature with warm (55F (12.8C) or warme~)
fruc~ose solution.
The concentrated mixture was combined with 500
gallons (1892.5 liters) of water to produce the diluted
concentrate as final product Eor administration~ The ~ater
was tested to make certain there is no selenium as an
impurity, This prevents the accidental inclusion of more
than the desired amount o~ selenium in the Einal product.
Six gallons of the final product is used to
~repare 192 servings of 4 oz each in automatic bottling
machinery. Six ~6) gallons of the diluted concentrate
weighs 23,B38.5 grams and thus has a density of about 1.05
1~ gm/cc. The sodium selenite is preferably present in an
amount of 8 mg per gallon which calculates to 2 x 10-4
per~ent and is preferably included in an amount between 1
and 3 x 10-4 percent. The citric acid and ascorbic acid
combine~ are present in an amount of 103.2 grams per
gallon of diluted concentrate. This calculates to 2.59
percent by weight of the acids. The lime and grapefruit
conce~trates are the principal sources of ascorbic acid.
The pulp wash constitutes bet~een about 1 and 2 percent by
volume oE the diluted concentrate. When diluted, the
solution requires refrigeration below 5C (41F) and above
- freezing if stored for periods longer than 15 days unless
~ packaged in non-permeable containers. 'rhe product is
served in single-use, non-permeab~e packages which do not
require refrigeration after opening.`~
The diluted concentrate is designed to deliver
between about 200 to 300 micrograms of sodium selenite per
four ounce (118 cc) serving as a daily dosage unit and has
a pH between about pH 2.75 and pH 3.25. The dilute
composition contains between about 1.8 to 2.5 microgratns
per ml of sodium selenite and between ahout 0.3 and 0.6
percent by weight of citric ana ascorbic acids.
,
- ~243~1~
--7--
The dilute composition was tested in animals and
found to be non-toxic in mice and rabbits. The formation
of spontaneous ma~mory tumors was inhibited in C3H mice.
The composition has been ta~en by human volunteers without
S ill effect.
Other edible acids, such as lactic acid,
phosphoric acid and ace~ic acid might be used ~or flavoring
in the method and compositions of the present invention.
Citric acid is preEerred.
.
, ............................................................. .
- . .. . . . .
