U.S. patent application number 10/307454 was filed with the patent office on 2003-04-24 for topical zinc compositions and methods of use.
This patent application is currently assigned to Allterra, Inc.. Invention is credited to Godfrey, Helen Rebecca.
Application Number | 20030077332 10/307454 |
Document ID | / |
Family ID | 23298532 |
Filed Date | 2003-04-24 |
United States Patent
Application |
20030077332 |
Kind Code |
A1 |
Godfrey, Helen Rebecca |
April 24, 2003 |
Topical zinc compositions and methods of use
Abstract
Compositions including zinc compounds and select amino acids in
a carrier base, and methods of skin treatment with such
compositions, are described. The compositions are useful for
healing skin and minimizing the irritation incurred from contact
with the zinc compound without loss of zinc availability during
absorption into the integument.
Inventors: |
Godfrey, Helen Rebecca;
(Huntingdon Valley, PA) |
Correspondence
Address: |
Breiner & Breiner, L.L.C.
P.O. Box 19290
Alexandria
VA
22320-0290
US
|
Assignee: |
Allterra, Inc.
Huntingdon Valley
PA
|
Family ID: |
23298532 |
Appl. No.: |
10/307454 |
Filed: |
December 2, 2002 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10307454 |
Dec 2, 2002 |
|
|
|
09332508 |
Jun 14, 1999 |
|
|
|
Current U.S.
Class: |
424/642 ;
514/184; 514/494; 514/561; 514/564 |
Current CPC
Class: |
A61K 33/30 20130101;
A61K 2300/00 20130101; A61K 2300/00 20130101; Y10S 514/922
20130101; Y10S 424/06 20130101; A61K 31/198 20130101; A61K 31/198
20130101; A61K 33/30 20130101; A61P 17/00 20180101; Y10S 514/836
20130101; Y10S 514/974 20130101; A61P 17/02 20180101 |
Class at
Publication: |
424/642 ;
514/494; 514/561; 514/564; 514/184 |
International
Class: |
A61K 033/32; A61K
031/555; A61K 031/315; A61K 031/198 |
Claims
It is claimed:
1. A solid or semi-solid composition for topical skin application
comprising: a pharmaceutically acceptable carrier base; at least
one zinc compound; and at least one amino acid; wherein said at
least one amino acid is present in an amount corresponding to from
approximately 2 to 20 molar equivalents relative to zinc in the
composition, said composition contains from about 1 mg to about 20
mg zinc for each gram of said composition, and zinc is released
from said composition onto skin to which the composition is
applied.
2. The composition of claim 1 wherein said at least one amino acid
is a monocarboxylic amino acid capable of forming a complex with
said at least one zinc compound.
3. The composition of claim 1 or 2 wherein said at least one amino
acid is glycine, L-lysine, D,L-lysine, or a combination
thereof.
4. The composition of claim 1 wherein said at least one amino acid
is glycine.
5. The composition of claim 1 wherein said at least one zinc
compound is zinc oxide, Zinc(Amino Acid).sub.2, or a combination
thereof; and wherein the amino acid is glycine, L-lysine,
D,L-lysine, or a combination thereof.
6. The composition of claim 1 wherein said at least one zinc
compound is zinc oxide and said at least one amino acid is
glycine.
7. The composition of claim 2 wherein said at least one zinc
compound is a complex of divalent zinc with said monocarboxylic
amino acid.
8. The composition of claim 7 wherein said complex is a zinc
glycine complex having a formula
Zn(C.sub.2H.sub.4NO.sub.2).sub.2.multidot.nH.sub- .2O in which n
has a value of 1, 11/2, or 2, combined with from 0.3 to 6.2 parts
by weight of anhydrous glycine.
9. The composition of claim 7 wherein said complex is a zinc
D,L-lysine complex having a formula
Zn(C.sub.6H.sub.13N.sub.2O.sub.2).sub.2.multidot- .4H.sub.2O
combined with from 0.9 to 3.5 parts by weight of anhydrous
glycine.
10. The composition of claim 1 wherein said carrier base is a
cream, balm, gel, ointment, emollient, or lotion.
11. The composition of claim 1 wherein said composition is present
on a skin dressing.
12. A method of treating skin comprising-- (a) applying a zinc
compound-containing composition to an area of skin; (b) spreading
said composition in a manner that causes said composition to coat
said area; and (c) repeating (a) and (b) as necessary; wherein said
composition comprises a pharmaceutically acceptable carrier base,
at least one zinc compound, and at least one amino acid, wherein
said at least one amino acid is present in an amount corresponding
to from approximately 2 to 20 molar equivalents relative to zinc,
said composition contains from about 1 mg to about 20 mg zinc for
each gram of said composition, and zinc is released from said
composition onto said area of skin.
13. A method of treating skin comprising-- (a) applying a zinc
compound-containing composition to a skin dressing; and (b)
applying said skin dressing to an area of skin so that said
composition is in contact with said area; wherein said composition
comprises a pharmaceutically acceptable carrier base, at least one
zinc compound, and at least one amino acid, and wherein said at
least one amino acid is present in an amount corresponding to from
approximately 2 to 20 molecular equivalents relative to zinc, said
composition contains from about 1 mg to about 20 mg zinc for each
gram of said composition, and zinc is released from said
composition onto said area of skin.
14. The method of claim 12 or 13 wherein said at least one amino
acid is a monocarboxylic amino acid capable of forming a complex
with said at least one zinc compound.
15. The method of claim 12 or 13 wherein said at least one amino
acid is glycine, L-lysine, D,L-lysine, or a combination
thereof.
16. The method of claim 12 or 13 wherein said at least one amino
acid is glycine.
17. The method of claim 12 or 13 wherein said at least one zinc
compound is zinc oxide, Zinc(Amino Acid).sub.2, or a combination
thereof.
18. The method of claim 12 or 13 wherein said at least one zinc
compound is zinc oxide and said at least one amino acid is
glycine.
19. The method of claim 14 wherein said at least one zinc compound
is a complex of divalent zinc with said at least one amino
acid.
20. The method of claim 12 or 13 wherein said carrier base is a
cream, balm, gel, ointment, emollient or lotion.
Description
FIELD OF INVENTION
[0001] The present invention relates to zinc-containing
compositions and methods for topical use of such compositions to
treat cutaneous wounds, irritations, lesions, abrasions or the
like. More particularly, the invention relates to zinc-containing
compositions containing an amino acid to minimize external
irritation from the zinc when applied to the skin without
diminishing the amount of free zinc available for absorption.
BACKGROUND OF THE INVENTION
[0002] The value of zinc in tissue growth and repair is well
documented. Zinc is essential for the function of at least 70
enzymes and is involved in a variety of metabolic processes. Zinc
is a limiting factor in the formation of RNA and DNA. Zinc is also
a limiting factor in zinc-dependent enzymes such as RNA and DNA
polymerases, deoxythymidine kinase, and reverse transcriptase,
which are responsible for the regulation of RNA and DNA metabolism.
Diminished zinc availability slows protein synthesis, thereby
slowing the replication of cells and inhibiting tissue repair.
Approximately half of the total body zinc content of 2-3 gm (based
on an average 70 kg adult) is found in ossified tissues and is,
therefore, not readily available for metabolic processes. Although
the skin boasts a higher zinc concentration than most tissues (10
micrograms/g of tissue), this is quickly depleted during the
regeneration process. It has been shown experimentally that the
activity of deoxythymidine kinase in rapidly regenerating
connective tissue decreases as early as six days after animals are
placed on a zinc-deficient diet, demonstrating that an external
supply of zinc for use in tissue repair is essential. In fact, zinc
supplementation has been shown to markedly improve wound healing in
zinc-deficient individuals, while topical zinc improves wound
healing in zinc-deficient and in normal individuals.
[0003] Zinc salts are known to inhibit bacterial and viral growth.
Ophthalmic preparations of zinc sulfate to treat herpetic keratitis
have been recommended since 1943. Oral preparations of zinc citrate
used to treat gingivitis and periodontitis have been shown to
reduce plaque formation and inhibit bacterial growth. Oral
preparations of several zinc salts have been shown to reduce the
symptoms and duration of the common cold caused by rhinovirus, but
they are unpalatable and cause mouth irritation and nausea. Until
the development of a palatable and less irritating zinc
salt-with-amino-acid formulation, patients often refused to
continue treatment with the oral preparations containing zinc
salts.
[0004] Successful topical treatment of skin infections and lesions
with zinc salts is well documented. Topical zinc pyrithione is an
effective anti-fungal, effective in treating Malassezia furfur, the
causative agent in several skin disorders including pityriasis
versicolor. Topical zinc pyrithione has also been used to treat
psoriasis and dandruff by inhibiting the over-proliferation of
cells characterized by these conditions. Application of a zinc
chloride solution before and after UV exposure in hairless mice
reduced the number of sunburn cells in the epidermis and was
reported in 1976 as a successful topical treatment of basal cell
carcinoma in a human patient. Erythromycin-zinc lotion is
sebosuppressive and potentially beneficial to the acneic
patient.
[0005] Herpes of the lips occurs in 50% of the population, while
genital herpes is now one of the most common venereal diseases.
Zinc salts irreversibly inhibit herpes virus replication in vitro
and are effective in treating herpes infections in vivo. Zinc ions
irreversibly inhibit herpes simplex virus (HSV) glycoprotein
functions by accumulating in the sulfhydryl groups of glycoprotein
B in the viral membrane, blocking synthesis of DNA. In the closely
related rhinovirus, it is theorized that free zinc ions also
sequester in the membrane, inhibiting viral binding with ICAM
receptor sites in mucous membranes. Other closely related viruses
may similarly be affected by zinc ions. U.S. Pat. No. 5,545,673
cites in vitro evidence that HIV infectivity was reduced or
completely eliminated when concentrated viral stocks were incubated
with 1-1.5% zinc acetate for 2 hours. HSV has significant homology
to varicella-zoster virus. Eruptions of herpes zoster are thought
to be more frequent in the elderly not because of immune
dysfunction, but because of slowed mobilization of the immune
system. It follows that prompt treatment with a zinc salt would be
extremely beneficial as it would markedly decrease viral load and
painful lesions independent of immune system activation.
[0006] Zinc salt solutions applied to herpetic lesions decrease
viral load and markedly improve healing rates, relieving the
symptoms of herpes as healing occurs. Long-term topical application
of zinc salt solutions appears to greatly reduce or eliminate
recurrences of genital herpetic lesions as well as prevent
post-herpetic erythema multiform. It has been postulated that the
delivery of a high concentration (compared to natural tissue and
body fluid levels of ionic zinc) of the virucidal agent to the
infection site may prevent retrograde spread of virus along
involved ganglia.
[0007] Zinc oxide has been shown in numerous studies to accelerate
the healing of both chronic and acute wounds. This effect may be in
part due to stimulation of epidermal basal cells, noted in mice,
and in part due to increased insulin-like growth factor-1 and mRNA
(messenger RNA), noted in granulation tissue of full-thickness
wounds in domestic pigs. Zinc paste bandages containing inorganic
zinc compounds, e.g., zinc sulfate and zinc oxide, have long been a
standard treatment of venous stasis ulcers. Zinc chloride paste has
been shown effective in debridement and formation of granulation
tissue on chronic leg ulcers. Zinc oxide has been shown to promote
cleansing and re-epithelialization of leg ulcers and to reduce
infections and deterioration of ulcers.
[0008] Unfortunately, topical application of some zinc solutions
can cause painful or irritating side effects if not used in very
low concentrations. Zinc sulfate solutions of 0.2-1% can cause
severe irritation, unpleasant dryness and stimulate the emetic
reflex when applied circumorally.
[0009] Reports of dermal irritancy in animal dermal abrasion models
examining wound healing show the following: 1% aqueous zinc
chloride is severely irritant; 20% aqueous zinc acetate is slightly
less irritant; 20% suspension zinc oxide, 1% aqueous zinc sulfate,
and 20% suspension zinc pyrithione, are not overtly irritant. The
less irritant zinc salts, such as zinc oxide (which is only
slightly soluble in water), were only marginally effective in
stimulating epidermal healing in comparison to the more irritating
and more water-soluble zinc salts.
[0010] Further, it is interesting to note that in other studies the
zinc solutions, particularly of zinc sulfate, do not maintain
constant local concentration levels when applied to the skin as
does zinc oxide. The zinc in these studies is not slowly
solubilized to provide a constant level for absorption, being
already in frank solution. This indicates that a zinc preparation
that provides a higher concentration of solubilized zinc in a
minimally irritating formulation allowing controlled absorption
would be of great clinical value.
[0011] Compositions for treating various skin irritations are also
known including zinc and another material or materials. Such are
described, for example, in the following U.S. Patents:
[0012] U.S. Pat. No. 4,937,234 describes a pharmaceutically
acceptable composition providing minerals(s) (e.g. Zn) in a
bioavailable form by the inclusion of certain amino acids (see col.
2, lines 56-59), with the molar amount of an acidic mineral salt
(e.g., zinc gluconate) to an amino acid (e.g., lysine) being from
about 0.05M:1.0M to about 1.0M:0.05M and neutralized to a pH of
6-8. Zinc oxide is mentioned only as not being water insoluble. In
Example 13, zinc oxide is solubilized in water by the addition of
ascorbic acid. Various skin irritations can be healed.
[0013] U.S. Pat. No. 4,711,780 describes a composition to treat
surface epithelium to promote epithelial regeneration. The
composition includes a mixture of a zinc salt, vitamin C, and a
sulfur amino acid. Zinc oxide is not disclosed. The composition is
stated to be useful in treating a wide variety of conditions,
including of the skin, such as burns, cuts, fever blisters, poison
ivy, chigger bites, diaper rash, genital herpes blisters, and
sunburn. Depending on the locus of treatment, the composition will
take different forms as appropriate, such as water, oil or gel
vehicle; spray, or powder or medicated bandage.
[0014] U.S. Pat. No. 5,582,817 describes a composition for treating
various skin diseases, see col. 6, lines 48-58. The composition
includes a zinc salt, a zinc complex, or a salt of a zinc complex.
The complex or salt thereof may be based on a zinc compound and an
amino acid. Zinc oxide is mentioned and used only as a "relatively
insoluble metal salt". The co-use of a solubilizing agent is not
disclosed. The composition is stated to have unexpected action in
inducing metallothionen and suppressing the production of sunburn
cells by UV rays.
[0015] U.S. Pat. No. 5,708,023 describes a composition for
application to a surface (such as skin) including an
irritant-inactivating agent and a substance which prevents the
irritant-inactivating agent from binding to the surface.
Pharmaceutically acceptable cationic substances may also be used to
block binding sites, e.g., cations from relatively soluble zinc and
zinc salts (e.g., zinc gluconate, zinc acetate and zinc sulfate).
Examples of other pharmaceutically acceptable cationic substances
disclosed are quaternary ammonium compounds which are then further
defined as including amino acids. This further characterization,
however, of quaternary ammonium compounds is in error. While
quaternary ammonium compounds have four (4) groups (none of which
is hydrogen) attached to one (1) nitrogen atom, which then
possesses a positive(+) charge of 1, all 21 natural and
biologically important amino acids have the structure
R--CH(NH.sub.2)--COOH. Clearly amino acids do not satisfy the
described cationic substance. Examples of irritants suitable for
treatment include HIV and the hepatitis virus.
[0016] U.S. Pat. No. 5,260,066 describes a cryogel (a hydrogel
containing PVA) bandage containing a therapeutic agent such as
inorganic and organic zinc salts as antimicrobials, and amino acids
such as glycine. Zinc oxide is not disclosed.
[0017] Many existing topical formulations are inadequate because
they produce such local irritation that they are not easily
tolerated. Others also frequently lack a sufficient effective
concentration of zinc ion due to the low solubility of zinc oxide
in the absence of suitable solubilizing agents. Further, existing
formulations have unpalatable tastes, making circumoral application
impractical.
[0018] It would be highly desirable to have a topical zinc
formulation and method of use that addresses the deficiencies in
existing treatments.
OBJECTS AND BRIEF DESCRIPTION OF THE INVENTION
[0019] A primary object of the present invention is to provide a
topical zinc composition for the management and healing of
cutaneous wounds, irritations, abrasions and the like, including
herpes-type lesions.
[0020] Another object of the invention is to provide a topical zinc
composition that supplies a high effective concentration of
available zinc and minimizes skin irritation.
[0021] Another object of the invention is to provide a topical zinc
composition containing a select amino acid.
[0022] Another object of the invention is to provide a method of
treating skin with a topical zinc composition containing a select
amino acid.
[0023] The composition of the present invention includes (1) a
pharmaceutically acceptable zinc compound, preferably zinc oxide or
a divalent zinc complex, (2) a select amino acid, preferably
glycine, and (3) a pharmaceutically acceptable carrier base, such
as a solid or semi-solid carrier base. The zinc compound is present
in the carrier base together with a large excess of the amino acid
(2 to 20 molar equivalents to the zinc) to provide a composition
with high zinc ion availability and minimal skin irritance when
topically applied to the skin.
[0024] A composition of the invention is used by applying the
composition to an affected area of skin surface, and spreading the
composition so as to contact and coat the area. Application to an
affected area can be repeated periodically as needed until
sufficient healing is achieved. The composition can also be applied
to an occlusive or non-occlusive bandage. When the bandage is
positioned on the skin, the composition contacts the skin to heal
the affected area.
DETAILED DESCRIPTION OF PRESENTLY PREFERRED EMBODIMENTS OF THE
INVENTION
[0025] According to the present invention, it has been found that
compositions containing a zinc compound; an appropriate carrier
base, for example a cream, balm, lotion, water-bearing ointment or
the like; and certain amino acids, in which the molecular ratio of
amino acid to zinc is in the range of 2:1 to 20:1, causes minimal
irritation while providing sufficient free zinc ions for local
absorption into the integument and zinc availability for viral
inhibition and healing. The composition contains from about 1 mg to
about 20 mg of zinc for each gram of the composition.
[0026] Zinc compounds which can be used in combination with certain
amino acids can be in any of the forms commonly used such as the
sulfate, chloride, acetate, gluconate, ascorbate, citrate,
aspartate, picolinate, orotate and transferrin salts, as well as
zinc oxide and complexes of divalent zinc with an amino acid. It
has been found that zinc oxide solubilized with glycine is
particularly preferred.
[0027] Amino acids useful for the purpose of this invention are
glycine, L-lysine, and D,L-lysine.
[0028] Suitable useful complexes are formed by reacting zinc oxide
with monocarboxylic acids of the named amino acids and have the
composition Zn(Amino Acid).sub.2. These complexes are
water-soluble, particularly in the presence of excess amino acid,
release substantially all of the zinc as Zn.sup.2+ ion into aqueous
solution, are minimally irritating because the amino acid modifies
the irritant effect of the zinc, and have very good flavors, taste
being an important consideration as the invention can be applied
circumorally. However, amino acids, such as aspartic and glutamic
acids, are not useful for forming the above complexes. These amino
acids are dicarboxylic.
[0029] Appropriate carrier base compounds can contain components
selected from a broad range of pharmaceutically acceptable
materials known in the art of preparation of topical solid or
semi-solid formulations, such as creams, moisturizing creams,
lotions, emollients, balms and the like. Such a base formulation
can include, but is not limited to purified water, sunflower oil,
stearic acid, cocoa butter, monoglyceryl stearate, stearic
triglyceride, stearyl alcohol, aloe barbadensis gel, jojoba oil,
.alpha.-tocopheryl acetate (Vitamin E), carrot extract, jasmine
extract, chamomile extract, calendula extract, red clover blossom
extract, methyl paraben, propyl paraben, caramel, retinyl palmitate
and fragrance oil.
[0030] It is important that no component of such base formulation
possesses the potential for strong chelation of ionic zinc, for the
presence of such compound will inactivate the zinc ions which
provide the desired physiological benefit of availability for
enzyme use to enhance tissue proliferation and healing as well as
antiviral activity. The chemical principles which govern the
chelation of metal ions by organic compounds are well known such
that one skilled in the art can determine by visual inspection of a
written chemical structure whether or not a given chemical compound
has the potential for strong chelation of ionic zinc (taking into
account pH changes which can be caused by the base). It is well
known, for example, that such varied structures as those
represented by citric acid, tartaric acid, 8-hydroxyquinoline,
orthophenanthroline, and ethylenediaminetetraacetic acid (EDTA),
are structurally and electronically configured so as to form very
tight, i.e. highly stable, chelated complexes with zinc ion. Thus,
any structures which are chemical analogs of the aforementioned
strong chelating compounds, or any others of of such compounds, are
to be avoided in formulating the carrier base.
[0031] The compositions of the invention are also suitable for
application to the skin by means of an occlusive or non-occlusive
bandage or dressing. The compositions of the invention can be
carried on a bandage in a conventional manner. When the bandage is
positioned on the skin over an area to be treated, the composition
comes into contact with the skin and acts on the skin in the same
manner as described above in relation to directly applied
compositions.
[0032] Thus, zinc-containing compositions prepared according to the
present invention, include pharmaceutically acceptable zinc oxide
and a select amino acid. The compositions possess a very pleasant
flavor, modify the irritant effect of zinc, and release ionic zinc
into a semi-aqueous solution and/or suspension at concentrations
that are calculated to be on the order of one thousand times the
normal blood level of zinc. The very high concentration gradient
between available ionic zinc at the epithelial surface and the
blood and tissue fluid zinc concentrations coupled with the effect
of the components of the creams, balms, ointments, etc. (with
respect to facilitation of the penetration of the zinc ions through
the epithelial layer) provides the strong anti-viral and
wound-healing enhancement properties of zinc to be made available
where they are needed in order to effectively treat the skin.
[0033] The following examples illustrate compositions of the
invention and methods for preparing topical application
formulations.
EXAMPLE 1
Zinc-Containing Moisturizing Cream with Vitamin E and Cocoa
Butter
[0034] A moisturizing cream base was prepared containing the
following ingredients: purified water, sunflower oil, stearic acid,
cocoa butter, monoglyceryl stearate, stearic triglyceride, stearyl
alcohol, aloe barbadensis gel, jojoba oil, .alpha.-tocopheryl
acetate (Vitamin E), carrot extract, jasmine extract, chamomile
extract, calendula extract, red clover blossom extract, methyl
paraben, propyl paraben, caramel, retinyl palmitate and fragrance
oil. The base ingredients were utilized in conventional amounts in
view of the purpose to provide a moisturizing cream. A mixture of
0.440 g zinc oxide and 4.05 g anhydrous glycine was dissolved in
6.8 g purified water by heating in a Pyrex beaker to 160.degree. F.
in a 750 watt microwave oven. The clear, hot solution was added to
115 g of the cream base and was blended thoroughly to a smooth
opaque cream which contained 0.279% Zn.sup.2+. The product had
acceptable consistency, flavor and astringency without causing
irritating effects upon application.
[0035] In a test of efficacy against Herpes Simplex Virus (HSV)
Type 1, a labial (lower oral lip) developing cold sore in an
individual known to have recurrent HSV at the specific lower lip
site was treated within 2 hours of the onset of typical prodromal
symptoms (i.e. sensitivity, erythema, mild edema, tingling) by
manual application of approximately 50 mg of the cream to the
developing lesion. Relief of symptoms occurred within minutes.
Cream application was repeated every 3-4 hours for 16 hours.
Treatment was truncated because symptoms were eradicated at that
time. A small, painless open lesion subsequently developed at 24
hours with rapid resolution.
EXAMPLE 2
Aloe Vera Ointment Containing Zinc
[0036] A 35.5 g aloe vera ointment base (including water, glyceryl
stearate, PEG-100 stearate, glycerine, aloe vera gel, magnesium
aluminum silicate, PEG-150 distearate, stearyl alcohol, quaternium
15, fragrance oil, diazolidinyl urea, and methyl paraben) was
combined with 0.187 g zinc oxide and 1.73 g glycine dissolved in
2.9 g purified water at 160.degree. F. in a small Pyrex bowl. The
stirred mass was warmed to 110-115.degree. F., at which point the
mixture could be evenly blended to a smooth, translucent ointment
by rubber spatula. The zinc content of the product was 0.37%. The
product had acceptable flavor, consistency and astringency without
causing irritating effects upon application.
EXAMPLE 3
Vitamin E Ointment with Zinc
[0037] A 45.4 g Vitamin E ointment base including petrolatum,
isopropyl myristate, .alpha.-tocopheryl acetate (Vitamin E
acetate), candelilla wax, cetyl alcohol, retinyl palmitate (Vitamin
A palmitate), lecithin, and natural fragrance was combined with
0.180 g zinc oxide and 1.67 g glycine (dissolved in 2.8 g purified
water at 160.degree. F.) in a small Pyrex bowl and blended together
by vigorous stirring with a rubber spatula. The product was a
smooth, pale, yellow, and slightly-translucent ointment. The zinc
content of the product was 0.29%. The product had acceptable
consistency, flavor and astringency without causing irritating
effects upon application.
EXAMPLE 4
Aloe Vera and Vitamin E Balm with Zinc
[0038] 60 g of an aloe vera extract and tocopherol (Vitamin E) base
including lilly white gel, paraffin, beeswax, panthenol, SHEA
butter, squalene, olive oil, copaiba oil, kukui nut oil, babassu
oil, octyl methoxycinnamate (sunscreen), safflower oil, soy oil and
flavoring was combined with 0.243 g zinc oxide and 2.24 g glycine
(dissolved in 3.76 g purified water at 160.degree. F.) in a small
Pyrex bowl and blended together by vigorous stirring with a rubber
spatula. The product was a pale, smooth, slightly translucent balm.
The zinc content of the product was 0.29%. The product had
acceptable consistency, flavor and astringency without causing
irritating effects upon application.
[0039] As will be apparent to one skilled in the art, various
modifications can be made within the scope of the preceding
description. Such modifications being within the ability of one
skilled in the art form a part of the present invention and are
embraced by the appended claims.
* * * * *