Cosmetic base composition with therapeutic properties

Cosmetic Base composition exhibiting therapeutic properties includes an acyl fatty acid lactylate ester or alkali metal salt thereof, a sucrose fatty acid ester, and a solvent.

FIELD OF THE INVENTION 
The present invention relates generally to cosmetic base compositions and 
more particularly to an improved cosmetic base composition that exhibits 
unexpected utility as a pharmaceutical compound. The base composition of 
the present invention includes a therapeutically useful combination of two 
ingredients, wherein the first ingredient is an ester of a fatty acid or 
an alkali metal salt thereof, and the second ingredient is a sucrose fatty 
acid ester. The ester of a fatty acid used in the composition of the 
present invention may be a mono- or a poly- ester, preferably stearoyl 
lactylic acid or an alkali metal salt thereof. The sucrose fatty acid 
ester used in the composition of the present invention is preferably 
sucrose cocoate. 
BACKGROUND OF THE INVENTION 
The use of fatty acids, fatty acid salts and sucrose esters in cosmetic 
compositions and other dermatological compositions is known. Various fatty 
acids, fatty acid salts and sucrose esters have also been employed in 
pharmaceutical compositions, but never as the therapeutic ingredient. 
Smith, U.S. Pat. Nos. 3,896,238, 4,150,114 and 4,046,886 disclose the use 
of a sucrose ester in combination with an alkyl sulfoxide or phosphine 
oxide in compositions for enhancing the penetration of pharmacologically 
active agents into the skin. Preferred sucrose esters include mono- and 
diacyl esters wherein the acyl substituents contain eight to twenty carbon 
atoms with sucrose monooleate the most preferred. Specifically disclosed 
are sucrose monooctanoate, sucrose monocaprate, sucrose monolaurate, 
sucrose monomyristate, sucrose monopalmitate, sucrose monostearate, 
sucrose monooleate, sucrose monoeicosanate, as well as the di- and 
tri-esters of the aforementioned compounds. 
Japanese patent Jpn. Kokai Tokkyo Koho 81 75,437 discloses a composition 
which has utility as a base for a suppository containing a sucrose fatty 
acid ester displaying hydrophile-lypophile balance (HLB) value properties 
in the range of 1 to 5. 
Kreps, U.S. Pat. No. 3,098,795 and Koulbanis, U.S. Pat. No. 4,422,952 
disclose the utility of fatty acid esters as emulsifiers. 
Sucrose fatty acid esters, and in particular, cocoates, have been used in 
detergent compositions. Brazilian patent Braz. Pedido PI No. 78 05,654 
discloses a detergent composition containing sucrose coconut oil fatty 
acid mono- and di-esters useful as an effective soap in soft or hard 
water. 
Japanese patent Jpn. Kokai Tokkyo Koho No. 75 29,608 discloses dishwashing 
detergent compositions containing a sucrose coconut oil fatty acid ester. 
Sucrose fatty acid esters have also been used in the cosmetic industry. 
French patent 2,421,605 discloses a non-foaming cosmetic compound for 
cleaning the hair and scalp containing sucrose palmitate stearate. 
Japanese patent Jpn. Kokai Tokkyo Koho No. 81 24,034 discloses an emulsion 
for a cosmetic cream containing sucrose fatty acid esters, preferably 
sucrose laurate. 
Japanese patent Jpn. Kokai Tokkyo Koho No. 81 55,306 discloses cosmetic 
emulsions containing sucrose palmitate or sucrose stearate. 
Marketing brochure, "Cosmetic Raw Materials", RITA corporation, p 5 (1985) 
and Technical Information Brochure PSE 141 G, RITA corporation, pp. 1-4 
(9185), disclose the use of sucrose cocoate sold under the name of 
Grilloten for cosmetic use in body lotions, eye makeup removers, face 
cleansing creams, lotions, shampoos, foam bath products, liquid soaps, 
baby bath products, hair conditioners, cream rinses, and roll-on 
deordorants. 
Lactylic mono fatty acid ester, in particular strearoyl lactylic acid and 
the sodium salt of this ester, has been used in compositions for cosmetic 
bases. Osipow, et al., Fatty Acid Lactylates, pp. 1-12 (1969) discloses 
that stearoyl lactylic acid and its sodium salt are used as a cosmetic 
gelling agent. He further discloses that capryl lactylate, sodium lauroyl 
lactylate and sodium stearoyl lactylate are non-toxic and that the first 
two compounds exhibit anti-microbial activity. 
Osipow, Pat. No. 3,472,940, Kreps, Pat. No. 3,098,795, Lynch, Pat. No. 
4,529,605, and Teng, Pat. No. 4,193,989 also disclose the use of fatty 
acid esters in cosmetic compositions. 
Other uses of fatty acid esters are disclosed in Cannell, U.S. Pat. No. 
4,301,820, which teaches its use in permanent waving compositions, and 
Cannell, Pat. No. 4,424,820, which teaches its use in hair straightening 
compositions. 
Thompson, U.S. Pat. No. 2,733,252 discloses a process for preparation of 
the fatty acid esters of lactylic acid and slats thereof in a commercial 
environment. This disclosure alludes to the possible use of such esters as 
biologically active agents. 
SUMMARY OF THE INVENTION 
The present invention provides cosmetic base compositions adapted to 
topical application to animal tissue, said compositions having utility as 
skin conditioners and cleansers and capable of exhibiting such unexpected 
therapeutic properties as promoting wound healing, increasing total lipid 
synthesis, increasing thickness of epidermis layer, increasing cell 
proliferation, stimulating synthesis of glycosaminoglycans and reducing 
skin dryness. 
The compositions of this invention comprises from about 0.1% to about 15% 
by weight of a sucrose fatty acid ester and from about 0.3% to about 455 
by weight of acyl fatty acid lactylate ester or alkali metal salt thereof 
and from about 50% to about 99.6% polar solvent. 
A preferred composition of this invention comprises from about 0.5% to 
about 5% by weight of a sucrose fatty acid ester and about 1.5% to about 
15% by weight of an acyl fatty acid lactylate ester or alkali metal salt 
thereof and from about 80% to about 98% by weight of a suitable solvent, 
preferably polar. 
A presently most preferred optimal composition of this invention comprises 
about 1% by weight sucrose fatty acid lactylate ester and about 3% by 
weight acyl fatty acid ester or alkali metal salt thereof and about 96% 
polar solvent. 
The sucrose fatty acid ester component of compositions of the present 
invention ordinarily comprise a mixture of monoacyl and diacyl sucrose 
esters. Preferred sucrose fatty acid esters exhibit a 
hydrophilic/lipophilic balance (HLB) of from about 8 to about 16 and 
preferably from about 10 to about 13. The sucrose fatty acid esters are 
preferably selected from the group consisting of sucrose cocoate, sucrose 
ricinoleate, sucrose laurate and sucrose stearate. 
The acyl fatty acid or alkali metal acyl fatty acid salt component of 
compositions of the present invention is preferably selected from the 
group consisting of stearoyl lactylic acid, stearoyl lactyl lactylic acid, 
isostearoyl lactylic acid, isostearoyl lactyl lactylic acid, stearoyl 
lactylate, sodium stearoyl lactylate, stearoyl lactyl lactylate, sodium 
stearoyl lactyl lactylate, isostearoyl lactylate, sodium isostearoyl 
lactylate, isostearoyl lactyl lactylate, and sodium isostearoyl lactyl 
lactylate. 
Solvents for use in compositions of the present invention may include 
water, glycerin, cetearyl alcohol or any other suitable solvent. 
The present invention also unexpectedly provides an inexpensive emulsifying 
agent exhibiting penetration enhancing properties for use with other 
therapeutically active agents including shea butter. The unexpected 
independent therapeutic properties of the compositions of the present 
invention are demonstrable in histological as well as biochemical studies. 
Compositions of the present invention, depending on formulation, ordinarily 
provide a white, creamy lotion, salve, or ointment which is greaseless, 
odorless and nontoxic.

DETAILED DESCRIPTION OF THE INVENTION 
The present invention provides compositions useful as therapeutic agents 
comprising a unique combination of ingredients including at least one 
sucrose fatty acid ester and at least one acyl fatty acid lactylate ester 
or salt thereof. The preferred combinations include, (1) sodium stearoyl 
lactylate with sucrose cocoate and, (2) stearoyl lactylic acid with 
sucrose cocoate. 
These compositions may be used alone or in combination with, for example, 
Shea Butter (SHEBU) which enhances the therapeutic effect of the 
composition of the present invention. While not intended to be limiting on 
the invention, it is presently believed that penetration of the Shea 
Butter through epidermal tissue may be facilitated by co-application 
compositions of the present invention. 
The compositions of the present invention herein may also include various 
other agents and ingredients commonly employed in dermatological and 
cosmetic ointments and lotions. For example, thickening agents such as 
carboxymethyl cellulose, coloring agents and the like can be present in 
the compositions of the present invention for enhancing their aesthetic 
nature. 
The following illustrative examples relating to formulations made in 
accordance with the present invention are intended to illustrate typical 
compositions are not intended to be limiting on the scope of the 
invention. All materials utilized in the formulations are commercially 
available. 
EXAMPLE 1 
______________________________________ 
Formulation I 
Ingredient Percent (by volume) 
______________________________________ 
Sodium stearoyl lactylate 
3% 
(Pationic SSL) 
Sucrose cocoate 1% 
(Grilloten LSE 87K) 
Water 96% 
______________________________________ 
______________________________________ 
Formulation II 
Ingredient Percent (by volume) 
______________________________________ 
Sodium stearoyl lactylate 
3% 
(Pationic SSL) 
Sucrose cocoate 1% 
(Grilloten LSE 87K) 
Shea Butter (SHEBU) 
3% 
Water 93% 
______________________________________ 
Formulations I and II above were made utilizing accepted manufacturing 
procedures in the cosmetic industry. In Formulation II the primary 
emulsifyer, sodium stearoyl lactylate, and coemulsifyer, sucrose cocoate, 
were combined and then heated prior to the addition of heated Shea Butter. 
The molten mass was mixed and then allowed to cool to room temperature. 
Both Formulations I and II provided a white, creamy lotion, which was 
greaseless, odorless and nontoxic. 
These formulations were tested at the College of Medicine, University of 
Arizona, to determine the morphology and biochemistry of the skin after 
topical administration of the formulations. More specifically, following 
topical administration to skin of test animals, skin samples were assays 
for alteration of skin thickness, and for variances in: (1) epithelial DNA 
synthesis as a measure of all proliferation; (2) glycosaminoglycan 
content; and, (3) lipid content. 
TREATMENT PROTOCOL 
a total of 24 Sprague-Dawley male rats of 220 gram average body weight were 
anesthetized with 0.05 milliliters (ml) Innovar Vet by subcutaneous 
injection. The skin of the dorsum was closely shaved to expose a 4 by 6 
centimeter area. The rats were evenly and randomly divided into 
experimental and control groups. One third received Formulation I 
treatment alone, one third received Formulation Ii treatment and one third 
received no treatment. A volume of 0.5 ml of Formulation I or Formulation 
II was evenly spread over the shaved skin and the area covered with a 
Tegaderm adhesive occlusion polyurethane film. The Tegaderm adhered to the 
edges of the shaved skin and formed a pocket preventing spreading or loss 
of the base from the application area. 
The treatment was repeated every second day, a total of seven times, during 
a fourteen day treatment period. At the time of sacrifice, the skin from 
the shaved area was removed from all rats. 
Procedure I: Effect of Topically Applied Formulations I and II on Skin 
Monophology 
This procedure was performed to determine if there was any change in 
thickness of the epidermis following treatment with Formulation I or 
Formulation II. One section of dissected skin was fixed for histology in 
Baker's formalin (10%). Skin histology analysis was performed on 5 micron 
thick sections of this sample that were strictly perpendicular to the 
surface plane of the skin. The slices were stained with hemotoxylin and 
eosin and analyzed at 160-fold magnification in a Zeiss Photomic III 
scientific microscope coupled to an RCA television screen camera. The 
thickness of the epidermis was measured by an IPM photoanalyzer whose 
signal was input into a video micrometer for digital micrometry. A summary 
of the results is set out in Table I and shows that the thickness of the 
epidermis increased significantly (p&lt;0.01) in the test groups treated with 
Formulation I and Formulation II as compared to the untreated group 
controls. This was due to an increase in the number of cells as well as an 
increase in the size of the cells. There was not significant difference in 
epithelial thickness between the Formulation I and Formulation II-treated 
groups. 
Procedure II. Measurement of Epithelial DNA Synthesis 
The 100 mg thick skin slices were minced in 3 ml of Minimal Essential Media 
(MEM) with 20 .mu.Ci H.sup.3 -thymidine. The mixture was incubated for 
three hours at 37.degree. C. and cooled to 4.degree. C. The supernatant 
was discarded and the solid phase rinsed with 10 ml of cold saline and 
incubated with 3 ml of 1 N NaOH for 15 minutes (min) at 37.degree. C. The 
solid phase was homogenized in a polytron and reincubated for 35 min at 
37.degree. C. and cooled to room temperature (R.T.). The addition of 1.5 
ml of 2 N HCl neutralized the pH of the mixture which was subsequently 
cooled to 4.degree. C. and an equal volume of 105 Trichloroacetic Acid 
(TCA) was added. The mixture was allowed to stand for 15 min at 4.degree. 
C. Centrifugation for 10 min. at 2000 g produced a pellet. The supernatant 
was discarded and the pellet resuspended in 5 ml 5% TCA. This 
centrifugation step was repeated 3 times in order to remove any free 
H.sup. 3-thymidine. The pellet was resuspended in 2.2 ml of 5% TCA and 
sonicated at maximum amperage for 30 seconds. One ml samples were diluted 
with 10 ml of aquasol and the radioactivity was counted. Digleman, et al., 
J. Surg. Res. 24, pp 45-51 (1978). The results of this procedure are set 
out in Table I. 
Procedure III: Metabolic Labeling of Skin Glycosaminoglycans (GAG) 
Skin tissue was weighed and finely chopped into approximately cubic 
millimeter pieces, transferred to incubation flasks and washed with 
saline. Five to ten ml of incubation medium consisting of MEM with the 
isotope, H.sup.3 -glucosamine present in a concentration of 10-15 
.mu.Ci/ml media were added to the tissue. The flasks were placed in a 
37.degree. C. bath and incubated for 6 hours, then chilled. The tissue was 
washed with cold saline and homogenized by polytron. The homogenate pellet 
was resuspended in 0.1 M phosphate buffer, pH 8, containing 0.1 M Ethylene 
diamine Tetracetic Acid EDTA and incubated at 37.degree. C. for 
approximately one hour to inactivate metallic enzymes. Papin, cysteine and 
HCl were added and the mixture incubated overnight at 60.degree. C. The 
digest was dialyzed against H.sub.2 O, ethanol was added and the mixture 
let stand overnight at 4.degree. C. The precipitate was recovered by 
centrifugation and the pellet dissolved in a small amount of water. 
Reprecipitation with cetylpyridinium chloride at room temperature 
overnight produced GAG. The sample was counted using standard techniques. 
[Original reference: Scott, J.E. Meth. Biochem. Anal. 8, pp. 145-197 
(1960).]The results of this procedure are set out in Table I. 
Procedure IV. Determination of In Vitro Lipogenesis 
Skin slices were incubated in a sealed vial containing 4 .mu.Ci C.sup.14 
-acetate for three hours at 37.8.degree. C. in a total volume of 2 ml 0.1 
M phosphate buffer (pH 7.4) in normal saline plus the coenzyme mixture of 
the following constitution: 
______________________________________ 
ATP 5.0 .mu. moles 
glucose-1-phosphate 
22.5 .mu. moles 
glutathione 30.0 .mu. moles 
coenzyme A 0.2 .mu. moles 
NAD 1.2 .mu. moles 
NADP 1.4 .mu. moles 
magnesium chloride 
30.0 .mu. moles 
______________________________________ 
The reaction was stopped by freezing and the mixture lyophilized to 
dryness. 
The lipid extraction was performed by the addition of 5 ml chloroform: 
methanol (2:1). Of this extract, 3 ml were transferred to open test tubes 
and washed twice with 3 ml aliquots of 1.0 M sodium acetate, and with 3 ml 
distilled water. The upper-phase was discarded after each washing. 
Methanol (2 ml) was added to the washed extract (lower phase). After 
agitation, 0.5 ml of the mixture was transferred to a counting vial. Ten 
ml of scintillation fluid was added and the sample was counted. 
The remaining washed extract was taken to dryness at 50.degree. C. under a 
continuous N.sub.2 stream. Carrier lipids in chloroform: methanol (2:1) 
were added to the tubes and the total volume adjusted to 200 .mu.l with 
chloroform: methanol (2:1). Eighty .mu.l samples (40 .mu.l per strip) were 
plated and developed on two sets of thin layer chromatography (TLC) 
plates. 
The lipid spots were visualized under UV light following the spraying of 
the TLC plates with an ethanol solution containing 0.2% Rhodamine .beta.. 
The spots corresponding to phospholipids and neutral lipids were scraped 
into counting vials, 2 ml acetic acid and 10 ml scintillation fluid were 
added and the radioactivity counted. Okabe, et al., Acta Medica Okayma 28, 
pp 403-410 (1974). Koblin, et al., Pharmacol & Exper. Therapeutics 211, pp 
317-325, (1979). The results of these procedures are set out in Tables I 
and II. 
TABLE I 
______________________________________ 
THE EFFECT OF THE TREATMENT OF 
RAT INTACT SKIN WITH FORMULATION I 
AND FORMULATION II 
Control no Formulation 
Formulation 
Parameter treatment I II 
______________________________________ 
Epidermal layer 
32.7 .+-. 4.5 
132 .+-. 28 
126 .+-. 36 
thickness 
(microns) 
DNA synthesis H.sup.3 
225 .+-. 160.0 
791 .+-. 580 
1001 .+-. 529 
thymidine 
10.sup.3 .times. cpm/100 mg 
dry wt. 
Total glycosamino- 
122 .+-. 36.0 
263 .+-. 106 
180 .+-. 42 
glycans C.sup.14 - 
glucosamine 
10.sup.3 .times. cpm/g 
skin 
Total lipids 
3,691 .+-. 8,835 
230,703 .+-. 
301,652 .+-. 
C.sup.14 -acetate 29,273 23,606 
dpm/g skin 
______________________________________ 
TABLE II 
______________________________________ 
THE EFFECT OF THE TREATMENT OF RAT 
INTACT SKIN WITH FORMULATION I OR 
FORMULATION II SHEBU ON THE SYNTHESIS OF 
TOTAL AND VARIOUS SPECIES OF LIPIDS 
LIPID SYNTHESIS 
DPM (10.sup.3)/GRAM SKIN 
Parameter Formulation 
Formulation 
Studied Control I II 
______________________________________ 
Total Lipids 
83 .+-. 20 231 .+-. 80.sup.(1) 
302 .+-. 70 
Lysolecithin 
0.24 .+-. 0.1 
0.48 .+-. 0.2.sup.(1) 
0.62 .+-. 0.2 
Sphyngomyelin 
0.11 .+-. 0.3 
0.42 .+-. 0.3 
0.41 .+-. 0.3 
Phosphatidylcholine 
2.2 .+-. 1 3.6 .+-. 1 6.0 .+-. 2 
Phosphatidylserine, 
0.83 .+-. 0.2 
1.8 .+-. 1.sup.(1) 
2.3 .+-. 0.8 
phosphatidylinositol 
Phosphatidyl- 
1.5 .+-. 1 2.8 .+-. 1 5.2 .+-. 2 
ethanolamine 
Phospholipids 
13 .+-. 8 35 .+-. 10.sup.(1) 
50 .+-. 30 
Cholesterol 6.7 .+-. 4 16 .+-. 6.sup.(1) 
21 .+-. 9 
Fatty Acids 11 .+-. 4 25 .+-. 5.sup.(1) 
27 .+-. 9 
Triglycerides 
12 .+-. 3 25 .+-. 10.sup.(1) 
30 .+-. 6 
Cholesterol ester 
19 .+-. 7 100 .+-. 40.sup.(1) 
150 .+-. 60 
______________________________________ 
.sup.(1) Significantly different from control Group I variability is give 
by X .+-. SD 
The results in Tables I and II show that cell proliferation was 
significantly increased over control values in the Formulation I-treated 
skin and Formulation II-treated skin. Glycosaminoglycan synthesis showed 
stimulation with much of the increase due to an increase in hyaluronic 
acid, the primary structural macromolecule in the dermis having the 
highest water binding capacity. The interest in hyaluronic acid is that an 
increase in water content in the cutaneous layers of the skin could 
correct for skin wrinkles on the surface. Total lipid synthesis also shows 
a significant increase. 
The results of Procedures II, III and IV support the results in Procedure I 
and indicate that there is a genuine rejuvination effect exhibited 
following topical application of the formulations made in accordance with 
the present invention. There was an enhanced effect in DNA synthesis (cell 
proliferation) and lipogenesis with the Formulation II-treatment over 
Formulation I treatment alone. However, there was no significant 
difference between the groups in the measurement of glycosaminoglycan 
synthesis. 
EXAMPLE 2 
Additional tests were performed utilizing compositions of the present 
invention to determine their effect on wound healing. 
Eighteen male Sprague-Dawley rats were shaved and prepped over the dorsal 
thoracic region. Six rats received Formulation I treatment, six received 
Formulation II treatment, and six received no treatment. A single 7-8 cm 
long midline "dermal deep" incision was made reaching deep fascia. After 
controlling the bleeding and washing blood clots from the wound, the skin 
was closed using staples. Daily treatments of Formulation I or Formulation 
II were applied liberally over the wound area. At the end of 17 days, the 
rats were sacrificed and the dorsal skin removed. Six to eight strips, 0.5 
cm wide, were cut perpendicular to the wound axis. Wound breaking strength 
was measured on an Instron Tester, Model 1001 and histology specimens were 
taken randomly from each wound. The results of this experiment are 
contained in Table III. 
TABLE III 
______________________________________ 
EFFECT ON THE BREAKING STRENGTH 
OF RAT SKIN WOUNDS TREATED 
WITH FORMULATION I OR FORMULATION II 
Breaking strength 
Number of g/0.5 cm 
Treatment Measurements 
.+-. SEM 
______________________________________ 
None, Control 
24 445.6 .+-. 22.9 
Formulation I 
37 656.4 .+-. 32.3 
Formulation II 
39 681.8 .+-. 38.0 
______________________________________ 
The results in Table III show that treatment with compositions of the 
present invention increased healing as reflected in a significantly higher 
breaking strength of the skin specimens (p&lt;0.01). There was no significant 
difference between the breaking strength of the Formulation I-treated skin 
and the Formulation II-treated skin. Histology of Formulation I-treated 
skin or Formulation II-treated skin as compared to control skin showed 
more collagenation a thicker dermal layer at the site of skin incision, 
more capillaries in the repair tissue and a lack of skin surface defect. 
EXAMPLE 3 
An experiment was performed to determine the effect of treatment utilizing 
compositions of the present invention with and without occlusive bandage. 
In this experiment the dorsal skin of three nude mice was treated with 
Formulation I or Formulation II for six hours by generous application, 
three mice received Formulation I treatment, three mice received 
Formulation II treatment and three mice were untreated. No dressing was 
utilized. A skin biopsy was taken at 6, 24, 48, 72, 96 and 120 hours after 
treatment. Specimens were prepared for histology and stained with 
hematoxylin-eosin. A second group of mice received a single treatment of 
Formulation I and another group treatment with Formulation II. All treated 
areas in these mice were occluded with impermeable Blenderm membrane left 
on the skin for 24 and 48 hours. At the end of each time period, skin 
biopsies were taken for histology. 
The results of these tests are set out in Table IV. 
TABLE IV 
______________________________________ 
Thickness of the epidermis (microns) 
Group 24 hrs 48 hrs 
______________________________________ 
Control- 27.3 .+-. 3.8 
-- 
intact skin 
no dressing 
Control- 41.6 .+-. 9.1 
38.7 .+-. 8.8 
occlusive 
dressing only 
Formulation I 73.2 .+-. 10.2 
76.2 .+-. 9.2 
Formulation II 86.6 .+-. 9.4 
82.1 .+-. 10.1 
______________________________________ 
Variability given as X .+-. SD 
The results set out in Table IV show that after six hours of the treatment 
without occlusion, no differences were observed between treated and 
untreated skin. However, treatment of the intact skin of nude mice for 24 
or 48 hours under occlusive membrane significantly increased the thickness 
of the epidermal layer in both the Formulation I and Formulation 
II-treated skin. 
EXAMPLE 4 
Another formulation was made in accordance with the present invention and 
was tested to determine its effect on the sensitivity of rats skin to U.V. 
light. 
______________________________________ 
Formulation III 
Ingredient Percent (by volume) 
______________________________________ 
Stearoyl lactylic acid 
3% 
Sucrose cocoate 1% 
(Grilloten LSE 87K) 
Water 96% 
______________________________________ 
Formulation III was made utilizing the same manufacturing procedures used 
for Formulation I and II. Formulation III provided a white, creamy lotion, 
which was greaseless, odorless and non-toxic. 
Six Sprague-Dawley male rats were pretreated with cod liver oil, 2 ml/rat 
for three days. They were anesthetized with 0.05 ml Innovar-Vet and a six 
by fifteen cm area on the dorsal surface was shaved and scrubbed with 70% 
ethanol. The rats were placed in restraining cages and exposed to UV light 
for 2.5 hours. Ethane excretion measurements were made at two, six, 
eighteen and twenty-four hours after UV light exposure using the method of 
Eskilson, et al. Dept. of Surgery, U. of Arizona, College of Medicine, 
Tucson, AZ. The method is based on the finding that radiation induces 
lipid peroxidation and peroxidation-related changes in the skin. Three 
rats were pretreated for three days with a cream containing 10% 
Formulation III. Three rats were untreated controls. The results are set 
out in Table V. 
TABLE V 
______________________________________ 
EFFECT OF TOPICAL APPLICATION 
OF FORMULATION III ON THE 
SENSITIVITY OF RAT SKIN TO ULTRAVIOLET LIGHT 
Ethane Excretion (cumulative nano moles) 
Hours after treatment and UVL exposure 
Group 2 6 18 24 
______________________________________ 
Control 2.68 .+-. 0.49 
2.36 .+-. 1.70 
3.63 .+-. 1.84 
4.64 .+-. 0.78 
Formulation 
0.00 .+-. 0 
2.05 .+-. 0.37 
2.10 .+-. 0.26 
1.86 .+-. 0.51 
III Treated 
______________________________________ 
Variability is given by X .+-. SD, n = 3 
Statistical significance tested by Student ttest 
The results showed a significant reduction in ethane excretion in rats 
treated with Formulation III indicating possible utility of the 
composition of the present invention as a sunscreen. 
EXAMPLE 5 
A further experiment was performed to determine the effect on 
epithelialization of the composition of the present invention. In this 
experiment pigs were wounded in a standard split thickness model. Two 
types of wound dressing coverages were compared with Duoderm.RTM., a 
commercial product to determine their effect on epithelialization of the 
wound. Gauze, Formulation II soaked gauze and Duoderm were administered 
sterile and dry onto the wound. The dressings were left on the wound for 
60 hours. The results are set out in Table VI. 
TABLE VI 
______________________________________ 
EVALUATION OF VARIOUS DRESSING 
MATERIALS ON THE RATE OF EPITHELIALIZATION 
OF STANDARD SPLIT THICKNESS WOUND IN PIGS 
Group % Epithelialization 
______________________________________ 
gauze 74.5 .+-. 11.6 
FORMULATION II 89.7 .+-. 11.1 
Duoderm 91.6 .+-. 7.1 
______________________________________ 
Data presented as X .+-. SD. There were 24 determinations made in each 
group. Statistical evaluation and Duncan's multiple range test, the 
results at 95% confidence limit are shown below. 
The results show a significant increase in the rate of epithelialization 
with the Duoderm-treated and Formulation II-treated animals. 
Examples 1-5 demonstrate the unexpected therapeutic properties of the 
compositions of the present invention. Topical application of either 
Formulation I, Formulation II or Formulation III shows significant 
dermatological rejuvinative and protective properties as demonstrated in 
histological, as well as, biochemical studies. Histological examination of 
experimental tissue showed that animal skin treated with Formulation I or 
Formulation II shows a significant increase in the thickness of the 
epidermis, as well as, a mild increase in keratinocytes and fibroblasts. 
Wound healing was accelerated. Assays designed to measure an increase in 
biochemical activity reinforced these observations. Increased total lipid 
synthesis, DNA synthesis, and glycosaminoglycan synthesis suggested a 
rejuvenation effect. The results of treatment with Formulation I, 
Formulation II or Formulation III on animal skin indicate a healthier and 
less dry skin which heals faster in response to injury. Also, application 
of Formulation I or Formulation III decreases sensitivity to U.V. light, 
thus exhibiting utility as a sunscreen agent. When SHEBU is used in 
conjunction with Formulation I, an enhanced therapeutic effect is observed 
and is expected to be observed when used with Formulation III. For 
example, increased DNA synthesis and increased lipogenesis was 
demonstrated with use of Formulation II compared to use of Formulation I 
alone. This enhancement effect, however, does not demonstrate itself on 
the histological level. Treatment with Formulation I or Formulation II 
produced the same increase in epithelial thickness and acceleration of 
wound healing. No significant difference was demonstrated between the two 
groups. 
The following formulations in accordance with the present invention were 
made using standard cosmetic manufacturing procedures. 
______________________________________ 
Series I 
Percent (by Volume) 
Ingredient A B C D E F 
______________________________________ 
Sucrose Cocoate 
1 2 4 8 3 12 
(Grilloten LSE 87K) 
Stearoyl Lactylic Acid 
3 6 12 24 1 4 
Water 96 92 84 68 96 84 
______________________________________ 
______________________________________ 
Series II 
Percent (by Volume) 
Ingredient A B C D E F G H I J 
______________________________________ 
Sucrose Cocoate 
1 1 1 1 8 16 1 2 4 8 
(Grilloten LSE 87K) 
Stearoyl Lactylic 
3 3 3 24 48 
Acid 
Water 96 92 84 68 
Propylene Glycol 
96 96 
Glycerin 96 
Sodium Stearoyl 3 3 6 12 24 
Lactylate 
Cetearyl Alcohol 96 68 36 
______________________________________ 
______________________________________ 
Series III 
Percent (by Volume) 
Ingredient A B C D 
______________________________________ 
Sucrose Cocoate 40% 
1.4 1.4 
(Crodesta SL 40) 
Stearoyl Lactylic Acid 
3 75 
Sodium Stearoyl Lactylate 
3 75 
Water 95.6 95.6 
Sucrose Cocoate 25 25 
(Grilloten LSE 87K) 
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All formulations combined easily. The formulations utilizing primary 
emulsifiers and coemulsifiers exhibited acceptable stability. All 
formulations provided a white, creamy lotion which was greaseless, 
odorless and non-toxic. 
Useful as a replacement for (or adjunct to) sodium stearoyl lactylate in 
compositions of the invention is the sodium salt of an acyl lactic acid or 
acyl monohydroxy monocarboxylic acid as well as the sodium salts of 
palmitoyl lactylic acid, stearoyl lactyl lactylate, and the calcium salts 
of stearoyl lactylate and stearoyl-2-lactylate. 
Useful as a replacement for (or adjunct to) sucrose cocoate in compositions 
of the invention are sucrose laurate, sucrose ricinoleate and sucrose 
stearate. These sucrose fatty acid esters all exhibit a 
hydrophilic/lipophilic balance between 8 and 16. 
From the foregoing it is seen that compositions of the present invention 
exhibit a wide variety of highly desirable therapeutical and cosmetic base 
properties. The formulations disclosed in the examples may be varied 
dependent on the particular application, user and the like.