US 2003O138466A1

(19) United States

(12) Patent Application Publication (10) Pub. No.: US 2003/0138466A1
Bhagwat et al. (43) Pub. Date: Jul. 24, 2003
(54) ANTIOXIDANT DERMATOLOGICAL Publication Classification
COMPOSITION
(51) Int. Cl." ......................... A61K 35/78; A61K 38/05;
(75) Inventors: Dileep Bhagwat, Bronxville, NY (US); A61K 31/385; A61K 7/00;
Bradley P. Glassman, Fairfield, NJ A61K 31/355; A61K 31/375;
(US); Daniel Glassman, Fairfield, NJ A61K 31/07; A61K 31/17
(US) (52) U.S. Cl. ......................... 424/401; 424/766; 514/458;
514/474; 514/18; 514/725;
Correspondence Address: 514/440, 514/588
MERCHANT & GOULD PC
P.O. BOX 2903
MINNEAPOLIS, MN 55402-0903 (US) (57) ABSTRACT
(73) Assignee: Bradley Pharmaceuticals, Inc. Enhanced dermatological compositions are described herein
using from about 21 to about 40 wt-% urea with antioxidant
(21) Appl. No.: 09/998,537 skin protectants Suitable for the treatment of icthyosis,
Xerosis, Severely dry skin, dermatitis, eczema, debridement
(22) Filed: Nov. 28, 2001 and tissue Suffering and other Similar skin conditions.
US 2003/0138466 A1
ANTIOXIDANT DERMATOLOGICAL
COMPOSITION
FIELD OF THE INVENTION
0001. This invention relates to a semi-solid composition
containing antioxidants and urea for treating and protecting
the skin.
BACKGROUND OF THE INVENTION
0002. As the outermost layer of skin, the stratum cor
neum (SC) is continuously exposed to an oxidative envi
ronment, including air pollutants, ultraViolet radiation,
chemical oxidants, and aerobic microorganisms. Human SC
reveals characteristic antioxidant and protein oxidation gra
dients with increasing antioxidant depletion and protein
oxidation towards the Outer layers. SC antioxidants, lipids,
and proteins are oxidatively modified upon treatments with
ultraViolet A/ultraViolet B, OZone, and benzoyl peroxide.
Thiele J. J., Schroeter C., Hsieh S. N., Podda M., Packer L.,
Curr Probl Dermatol. 2001:29:26-42.
0003. Furthermore, the skin is increasingly exposed to
ambient UV-irradiation thus increasing its risk for photo
oxidative damage with long term detrimental effects like
photoaging, which is characterized by wrinkles, loSS of skin
tone, and resilience. Scharffetter-Kochanek K, Brenneisen P.
Wenk J, et al., Exp Gerontol. 2000; 35:307-316
0004. The importance of antioxidants is their role in
Scavenging free radicals, which are created by natural oxi
dative process occurring in the environment.
0005 There is a need for topical products with antioxi
dant formulations to prevent UV-induced carcinogenesis and
photoaging as well as to modulate descquamatory skin dis
orders.
SUMMARY OF THE INVENTION
0006 Accordingly, the present invention includes an
improved treatment for the care and protection of the skin,
particularly Severely dry skin, using a combination of about
21 to about 40 wt-% of urea and about 0.1 to 20 wt-% of an
antioxidant in a Suitable defined formulation.
0007 Thus, one aspect of the present invention is a
dermatological composition including from about 21 to
about 40 wt-% urea, from about 0.1 to 20 wt-% of an
antioxidant, and the balance being dermatologically accept
able excipients.
0008. The use of such high concentrations of urea com
bined with antioxidant skin protectants have been found to
provide added efficacy and Suitability for treating and pro
tecting skin, and, particularly for treating icthyosis, Xerosis,
Severely dry skin, dermatitis, eczema, debridement and
tissue Softening as well as other skin conditions.
0009 Still another aspect of the present invention is a
method of treating Xerosis, ichthyosis, Severe dry skin,
dermatitis, and eczema by applying to Skin in need of
treatment an effective amount of a Semi-Solid dermatological
composition containing about 21 to about 40 wt-% urea and
about 0.1 to 20 wt-% of an antioxidant.
Jul. 24, 2003
DETAILED DESCRIPTION
0010. The dermatological composition of the present
invention is a Semi-Solid at room temperature but is easily
absorbed into the Stratum corneum. A preferred application
of the formulation is a cream which contains a petroleum
based liquid and Solid fraction as Skin protectants.
0011 The cream composition has advantageous proper
ties for the treatment of Severe dry skin clinically charac
terized as Xerosis and for the temporary relief of itching
asSociated with various pathological dermatological condi
tions. The formulation produces a keratolytic action found
beneficial in the treatment of icthyosis, atopic dermatitis.
The formulation also produces added protection against
debridement and tissue Suffering from Oxidative events.
Application of the cream to the Skin as needed provides
relief of the conditions.
0012. In addition to containing about 21 to about 40 wt-%
of urea, the composition of the present invention includes an
effective amount of antioxidant skin protectants, for
example, from about 0.1 to about 20 wt-% based on the total
weight of the composition.
0013 Antioxidants include, but are not limited to, toco
pherols (vitamin E), tocopherol derivatives, tocotrienols,
ascorbic acid (vitamin C), ascorbic acid derivatives, caro
tenoids, vitamin A or derivatives thereof, butylated hydroxy
toluene, butylated hydroxyanisole, gallic esters, flavonoids
Such as, for example, quercetin or myricetin, Selenium,
grape Seed extract, catechins Such as, for example, epicat
echin, epicatechingallate, epigallocatechin or epigallocat
echingallate, Sulfur-containing molecules Such as, for
example, glutathione, cysteine, lipoic acid, N-acetylcys
teine, chelating agents Such as, for example, ethylenedi
amine tetraacetic acid or other customary antioxidants.
0014. One antioxidant, vitamin E, is of particular interest.
The term “vitamin E” includes tocopherol (vitamin E) and
derivatives thereof Such as, for example, Cl-, f-, y-, 6-, e-, ,
, and m-tocopherol, and C-tocopherol acid Succinate. Vita
min E is known as an antioxidant and protective Vitamin for
phospholipids of the cell membrane. It maintains the per
meability and stability of the cell membrane, Lucy. Annals
N. YAcademy of Science 203, p. 4 (1972). It further has been
known that Vitamin E has a membrane-Sealing effect. In
erythrocytes, the Simplest cells of the human body, there has
been found that vitamin E provides a protective effect for the
cell membrane. AS with all antioxidants, Vitamin E protects
cells, including, epidermal cells which are Susceptible to a
wide range of oxidating events.
0015 The cream composition also includes a combina
tion of Semi-Solid and liquid petroleum fractions. The Semi
solid skin protectant is contained in about 5.5 to about 20
wt-% and includes petrolatum or a Synthetic or Semi
Synthetic hydrocarbon of the same nature as petrolatum.
Mixtures of Such ingredients can also be used. The preferred
Semi-Solid material is petrolatum, commercially available
from a wide variety of Sources.
0016. The liquid portion skin protectant is a liquid pet
rolatum and contained in the composition in about 10 to
about 20 wt-%. This material can include any synthetic or
Semi-Synthetic oleaginous liquid fraction. A preferred
embodiment is mineral oil which is a liquid mixture of
hydrocarbons obtained from petroleum.
US 2003/0138466 A1 Jul. 24, 2003

0.017. Another preferred ingredient encompassed in the

composition of the present invention is propylene glycol -continued
which may be contained up to about 5 wt-% in the compo Ingredient % W/W
sition, preferably in the range of from about 1 to about 5
wt-%. Petrolatum 6.OO
Mineral oil 7.1
0.018. In addition to the above embodiments, the present Glyceryl stearate 186
composition also contains dermatologically acceptable Cetyl alcohol O.63
excipients, Such as for example emulsifiers and thickeners. Propylene glycol 3.00
Among these are for example a C to Cs Straight or Xanthan gum O.OS
Trolamine O.15
branched chain fatty alcohols or fatty acids or mixtures Purified water Q.S. 1OOOO.
thereof. Preferably these include cetyl alcohol, stearyl alco
hol, Stearic acid, palmitic acid, or mixtures thereof. Fatty
acids or fatty alcohols may be present in from about 0.25 to Glossary of Ingredients
2 wit-%.
0.019 Another ingredient useful in the composition of the 0023 The formulation of the present invention has been
present invention may be glyceryl Stearate, which is a defined above and more Specifically exemplified in the
monoester of glycerine and Stearic acid, or other Suitable following examples. Since the formulation employs various
forms of glyceryl Stearate for example glyceryl Stearate SE, ingredients, Some of the ingredients have been defined
which is a commercially available Self-emulsifying grade of generically and by common name. In addition, the following
glycerol Stearate that contains Some Sodium and/or potas is a glossary of technical names and trade names with
sium Stearate. Glyceryl Stearate may be in the composition manufacturing Sources for Some of the ingredients employed
anywhere from about 1 to about 3 wt-%. in the formulation of the present invention.
0020 Xanthan gum is another ingredient which may be 0024 Mineral Oil
used in the present invention. Xanthan gum is a high 0.025 Definition
molecular weight heteropolysaccharide gum produced by 0026 Mineral oil is a liquid mixture of hydrocarbons
pure-culture fermentation of a carbohydrate with Xanthomo obtained from petroleum.
naS campestris. The gum is also commercially available
from various Sources. 0027 Technical Names
0021. As part of the dermatologically acceptable excipi 0028. Heavy Mineral Oil
ents, the composition includes thickeners which provide a 0029) Light Mineral Oil
high Viscosity cream designed to remain in place upon
application to the skin. Preferred thickeners include a mix 0030) Liquid Paraffin
ture of a carbomer and triethanolamine. The mixture is
combined together and added to the composition in an 0.031) Paraffin Oil
amount totaling anywhere from about 0.05 to 5 wt-%. 0032 Trade Names
Triethanolamine is purchased as Trolamine NF from BASF. 0033) Benol White Mineral Oil (Witco/Sonneborn)
The carbomers come in various molecular weights and
identified by numbers. These are otherwise known as Car 0034) Blandol White Mineral Oil (Witco/Son
bopol. A preferred embodiment of the present invention is neborn)
Carbopol 940. The carbomer or Carbopols are resins which 0035 Britol 6 (Witco Corporation)
are known thickening agents. They are homopolymers of
acrylic acid crosslinked with an allyl ether of pentaerythritol, 0.036 Britol 7 (Witco Corporation)
an allyl ether of Sucrose or an allyl ether of propylene. The 0037 Britol 9 (Witco Corporation)
carbomer is present in the composition as a thickener and
also is used to Suspend and Stabilize the emulsion. Although 0.038 Britol 20 (Witco Corporation)
Carbopol 940 is preferably used in the present invention, 0.039 Britol 24 (Witco Corporation)
other analogs may also be used such as carbomer 910, 2984,
5984, 954, 980, 981, 941 and 934. Carbopol ETD 2001, 0040 Britol 35 (Witco Corporation)
2020, and 2050 and Ultrez 20 are also commercially avail 0041 Britol 50 (Witco Corporation)
able and can be used Since they are Similar in chemistry and
function. 0.042 Carnation White Mineral Oil (Witco/Son
0022. A typical formulation representing the particular neborn)
and most preferred embodiment of the present invention is 0.043 Crystosol NF 70 (Witco Corporation)
illustrated as follows: 0044) Crystosol NF90 (Witco Corporation)
0.045 Crystosol U.S. Pat. No. 200 (Witco Corpora
tion)
Ingredient % W/W
0046) Crystosol U.S. Pat. No. 240 (Witco Corpora
Anti-oxidant
Urea USP
5.0
40
tion)
Carbopol 940 O.2O 0047 Crystosol U.S. Pat. No. 350 (Witco Corpora
tion)
US 2003/0138466 A1
0048) Drakeol 5 (Penreco)
0049) Drakeol 6 (Penreco)
0050 Drakeol 7 (Penreco)
0051) Drakeol 8 (Penreco)
0052 Drakeol 9 (Penreco)
0053) Drakeol 10 (Penreco)
0054) Drakeol 13 (Penreco)
0055) Drakeol 15 (Penreco)
0056) Drakeol 19 (Penreco)
0057) Drakeol 21 (Penreco)
0058 Drakeol 32 (Penreco)
0059) Drakeol 34 (Penreco)
0060) Drakeol 35 (Penreco)
0061 Draketex 50 (Penreco)
0062) Ervol White Mineral Oil (Witco/Sonneborn)
0063) GloriaWhite Mineral Oil (Witco/Sonneborn)
0.064 Kaydol White Mineral Oil (Witco/Sonneborn)
0065 Klearol White Mineral Oil (Witco/Son
neborn)
0.066) Parol 70 (Penreco)
0067 Parol 80 (Penreco)
0068) Parol 100 (Penreco)
0069 PD-23 White Mineral Oil (Witco/Sonneborn)
0070) Peneteck (Penreco)
0.071) Protol White Mineral Oil (Witco/Sonneborn)
0072) Superla Mineral Oil #5 NF (Amoco Lubri
cants)
0073) Superla Mineral Oil #6 NF (Amoco Lubri
cants)
0074) Superla Mineral Oil #7 NF (Amoco Lubri
cants)
0075) Superla Mineral Oil #9 NF (Amoco Lubri
cants)
0076) Superla Mineral Oil #10 NF (Amoco Lubri
cants)
0.077 Superla Mineral Oil #13 NF (Amoco Lubri
cants)
0078 Superla Mineral Oil #18 USP (Amoco Lubri
cants)
0079 Superla Mineral Oil #21 USP (Amoco Lubri
cants)
0080) Superla Mineral Oil #31 USP (Amoco Lubri
cants)
0081) Superla Mineral Oil #35 USP (Amoco Lubri
cants)
0082) Univhite Oil 55 (UPI)
0083) Univhite Oil 70 (UPI)
Jul. 24, 2003
0084) Univhite Oil 85 (UPI)
0085) Univhite Oil 130 (UPI)
0086) Univhite Oil 185 (UPI)
0087 Univhite Oil 205 (UPI)
0088 Univhite Oil 350 (UPI)
0089 Glyceryl Stearate
0090 Empirical Formula
C2H2O
0091) Definition
0092 Glyceryl Stearate is the monoester of glycerin and
Stearic acid. It conforms generally to the formula:
CH2(CH2) C- OCH2CHCH2OH
OH
0093) Technical Names
0094) 2,3-Dihydroxypropyl octadecanoate
O095 Glyceryl monoStearate
0096) MonoStearin
O097 Octadecanoic acid, 2,3-dihydroxypropyl ester
0098 Octadecanoic acid, monoester with 1,2,3-pro
panetriol
0099 Trade Names
0100 Aldo HMS (Lonza Inc./Lonza Ltd.)
0101 Aldo MS (Lonza Inc./Lonza Ltd.)
0102) Aldo MSLG (Lonza Inc./Lonza Ltd.)
0103) Alkamuls GMS (Rhone-Poulenc)
01.04] Arlacel 129 (ICI)
01.05 Atmos 150 (ICI)
01.06 Atmul 84 (ICI)
01.07 Atmul 124 (ICI)
0108) Capmul GMS (Karishamns Lipid Specialties)
0109) Ceral MN (Fabriquimica)
0110 Ceral MNT (Fabriquimica)
0111 Cerasynt GMs (ISP Van Dyk)
0112) Cerasynt SD (ISP Van Dyk)
0113 Cithrol GMS N/E (Croda Surfactants Ltd.)
0114) CPH-53-N (Hall)
0115) CPH-144-N (Hall)
0116 Cutina GMS (Henkel)
0117 Cutina MD (Henkel)
0118 Cutina MD-A (Henkel)
0119) Dimodan PM (Grinsted)
US 2003/0138466 A1 Jul. 24, 2003

0120 Dimodan PM 300 (Grinsted) 0163) Tegin 4011 (Goldschmidt)

0121) Elfacos GMS (Akzo BV) 0164) Tegin 4100 (Goldschmidt)
0122) Emerest 2400 (Henkel/Organic Products) 0165) Tegin GRB (Goldschmidt)
0123) Empilan GMS NSE (Albright & Wilson) 0166) Tegin ISO (Goldschmidt)
0124 Emuldan FP 40 (Grinsted) 0167) Tegin M (Goldschmidt)
0125) Emuldan HA 60 (Grinsted) 0168) Tegin MAV (Goldschmidt)
0126) Emuldan HLT 40 (Grinsted) 0169 Unitina MD (UPI)
O127) ESTOL GMS90 1468 (Unichema) 0170) Unitina MD-A (UPI)
0128 ESTOL GMSveg 1474 (Unichema) 0171 Unitolate GS (UPI)
0129 Geleol (Gattefosse) 0172 Witconol 2400 (Witco)
0130 Grillomuls S 40 (Grillo-Werke) 0173 Witconol 2401 (Witco)
0131) Grillomuls S 60 (Grillo-Werke) 0174) Witconol MST (Witco SA)
0132) Grillomuls S90 Grillo-Werke) 0175) Witconol MST (Witco)
0133) Hefti GMS-33 (Hefti) 0176) Zohar GLST (Zohar)
0134) Hefti GMS-99 (Hefti) 0177 Glyceryl Stearate SE
0135) Hodak GMS (Calgene) 0178 Definition
0136 Imwitor 191 (Huls AG/Huls America) 0179 Glyceryl Stearate SE is a self-emulsifying grade of
0137) Imwitor 900 (Huls AG/Huls America) glyceryl Stearate (q.v.) that contains Some Sodium and/or
potassium Stearate.
0138) Kemester 5500 (Witco) 0180 Trade Names
0139) Kemester 6000 (Witco) 0181) Aldo MSD (Lonza Inc./Lonza Ltd.)
0140 Kessco GMS (Akzo BV) 0182 Ceral ME (Fabriquimica)
0141) Lanesta 24 (Lanaetex) 0183) Ceral MET (Fabriquimica)
0142) Lasemul 92 AE (Industrial Quimica) 0184 Ceral TN (Fabriquimica)
0143) Lasemul 92 AE/A (Industrial Quimica) 0185 Cerasynt Q (ISP Van Dyk)
0144) Lasemul 92 N 40 (Industrial Quimica) 0186 Cithrol GMS S/E (Croda Surfactants Ltd.)
0145) Lexemul 503 (Inolex) 0187) Cutina KD-16 (Henkel)
0146) Lexemul 515 (Inolex) 0188) Dermalcare GMS/SE (Rhone-Poulenc)
0147) Lexemul 55G (Inolex) 0189) Dracorin GMS SE O/W 2/008475 (Dragoco)
0148 Lipo GMS 410 (Lipo) 0190. Emerest 2407 (Henkel/Organic Products)
0149) Lipo GMS 450 (Lipo) 0191) Empilan GMS SE (Albright & Wilson)
O150 Lipo GMS 600 (Lipo) 0192) Emuldan HA32/S3 (Grinsted)
0151) Nikkol MGS-DEX (Nikko) 0193) ESTOL BMSse 1462 (Unichema)
0152) Norfox GMS (Norman, Fox & Co.) 0194) Hefti GMS-33-SES (Hefti)
0153 Norfvox GMS-SE (Norman, Fox & Co.) 0195 Hodag GMS-D (Calgene)
0154) Prodhybase GLA (Prod'Hyg) 0196) Imwitor 960 (Huls Ag/Huls America)
O155) Protachem 26 (Protameen) 0197) Kemester 6000 SE (Witco)
0156) Protachem G 5509 (Protameen) 0198) Lamecreme KSM (Grunau)
O157) Protachem G-5566 (Protameen) 0199. Lanesta 40 (Lanaetex)
0158 Protachem GMS-540 (Protameen) 0200) Lexemul 530 (Inolex)
0159) Protachem HMS (Protameen) 0201) Lexemul T (Inolex)
0160 Sterol GMS (Auschem) 0202) Lipo GMS 470 (Lipo)
0161) Tegin 90 (Goldschmidt) 0203) Mazol GMSD-K (PPG)
0162 Tegin 515 (Goldschmidt) 0204) Prodhybase GLN (Prod'Hyg)
US 2003/0138466 A1 Jul. 24, 2003

0205) REWOMULMG SE (Rewo Chemische) 0243 Definition

0206 Tegin (Goldschmidt) 0244 Stearic acid is the fatty acid that conforms gener
ally to the formula:
0207 Tegin Spezial (Goldschmidt)
CH(CH)COOH
0208 Tegin V (Goldschmidt) 0245 Trade Names
0209) Unitolate GMS-D (UPI) 0246 Crosterene SA4310 (Croda Universal Ltd.)
0210) Witconol 2407 (Witco) 0247 Dar-Chem 14 (Darling)
0211 Cetyl Alcohol 0248 Emersol 120 (Henkel/Emery)
0212 Empirical Formula 0249) Emersol 132 (Henkel/Emery)
CHO 0250) Emersol 150 (Henkel/Emery)
0213 Definition 0251) Glycon DP (Lonza Inc./Lonza Ltd.)
0214 Cetyl alcohol is the fatty alcohol that conforms 0252) Glycon P-45 (Lonza Inc./Lonza Ltd.)
generally to the formula:
CH(CH2)CH-OH 0253) Glycon S-65 (Lonza Inc./Lonza Ltd.)
0215 Technical Names 0254) Glycon S-70 (Lonza Inc./Lonza Ltd.)
0216) 1-Hexadecanol 0255 Glycon S-90 (Lonza Inc./Lonza Ltd.)
0217) n-Hexadecyl alcohol 0256) Glycon TP (Lonza Inc./Lonza Ltd.)
0218) Palmityl alcohol 0257) Hy-Phi 1199 (Darling)
0219 Trade Names 0258 Hy-Phi 1303 (Darling)
0220) Adol 52 (Witco) 0259 Hy-Phi 1401 (Darling)
0260) Hystrene 4516 (Witco)
0221) Adol 520 (Witco)
0261) Hystrene 5016 (Witco)
0222 Adol 52-NF (Witco)
0262) Hystrene 7018 (Witco)
0223) Adol 520-NF (Witco)
0263 Hystrene 97.18 (Witco)
0224 Cachalot C-50 (Michel)
0264) Industrene 5016 (Witco)
0225) Cachalot C-51 (Michel)
0265) Industrene 7018 (Witco)
0226 Cachalot C-52 (Michel)
0266 Kartacid 1890 (Akzo BV)
0227 Cetaffine (Laserson & Sabetay) 0267 Neo-Fat 18 (Akzo)
0228 Cetal (Amerchol) 0268) Neo-Fat 18-54 (Akzo)
0229) Cetyl alcohol (Rhone-Poulenc) 0269) Neo-Fat 18-55 (Akzo)
0230) CO-1695 (Procter & Gamble) 0270) Neo-Fat 18-61 (Akzo)
0231) Crodacol C-70 (Croda, Inc.) 0271) Pearl Stearic (Darling)
0232) Crodacol C90 (Croda Chemicals Ltd.) 0272 PRIFAC 2981 (Unichema)
0233 Crodacol C-95 (Croda, Inc.) 0273) Pristerene 4900 (Unichema)
0234 Fancol CA (Fanning) 0274) Pristerene 4901 (Unichema)
0235) Hyfatol 16-95 (Aarhus) 0275 Pristerene 4902 (Unichema)
0236 Hyfatol 16-98 (Aarhus) 0276) Pristerene 4904 (Unichema)
0237) Lanette 16 (Henkel) 0277 Pristerene 4905 (Unichema)
0238) Lanol C (SEPPIC) 0278) Pristerene 4910 (Unichema)
0239) Laurex 16 (Albright & Wilson) 0279) Pristerene 4911 (Unichema)
0240 Lipocol C (Lipo) 0280 Pristerene 4915 (Unichema)
0241 Stearic Acid 0281 Pristerene 4921 (Unichema)
0242 Empirical Formula 0282) Pristerene 4968 (Unichema)
0283) Pristerene 9550 (Unichema)
US 2003/0138466 A1 Jul. 24, 2003

0284) Safacid 18 (Pronova) 0321) Technical Name

0285) Safacid 16/18 CR (Pronova) 0322 n-Hexadecanoic acid
0286 Unifat 54 (UPI) 0323 Trade Names
0287 Unifat 55L (UPI) 0324 Crodacid PD3160 (Croda Universal Ltd.)
0288 Stearyl Alcohol 0325 Edenor L2SM (Henkel)
0289 Empirical Formula 0326 Emersol 142 (Henkel/Emery)
C18H38O 0327 Emersol 144 (Henkel/Emery)
0290 Definition 0328 Hystrene 7016 (Witco)
0291 Stearyl alcohol is the fatty alcohol that conforms 0329) Hystrene 9016 (Witco)
generally to the formula:
0330 Kartacid 1692 (Akzo BV)
CH(CH2)CH-OH
0292 Technical Name 0331 Neo-Fat 16 (Akzo)
0293 1-Octadecanol 0332 Neo-Fat 16-54 (Akzo)
0333 Neo-Fat 16-56 (Akzo)
0294 Trade Names
0334) Neo-Fat 16-S (Akzo)
0295) Adol 63 (Witco)
0335) PRIFAC 2962 (Unichema)
0296 Adol 61-NF (Witco)
0336 Prifrac 2690 (Unichema)
0297 Adol 62-NF (Witco) 0337 Trade Name Mixture
0298 Adol 620-NF (Witco) 0338) N.S.L.E. (Sederma)
0299 Cachalot S-53 (Michel) 0339) Propylene Glycol
0300 Cachalot S-54 (Michel) 0340 Empirical Formula
0301 Cachalot S-56 (Michel) CHO
0302) CO-1895 (Procter & Gamble) 0341) Definition
0303 Crodacol S-70 (Croda, Inc.) 0342 Propylene glycol is the aliphatic alcohol that con
forms generally to the formula:
0304 Crodacol S-95 (Croda, Inc.)
0305 Crodacol S-95 (Croda Chemicals Ltd.) CHCHCH2OH
0306 Fancol SA (Fanning) OH
0307 Hyfatol 18-95 (Aarhus)
0308 Hyfatol 18-98 (Aarhus) 0343 Technical Name
0309 Lanette 18 (Henkel) 0344) 1,2-Propanediol
0310 Lanol S (SEPPIC) 0345 Trade Names
0311 Laurex 18 (Albright & Wilson) 0346 Lexol PG-865 (855) (Inolex)
0312 Lipocol S (Lipo) 0347 12-Propylene Glycol USP (BASF)
0313) Stearal (Amerchol) 0348 Xanthan Gum
0314 Stearyl Alcohol (Rhone-Poulenc) 0349) Definition
0315) Steraffine (Laserson & Sabetay) 0350 Xanthan gum is a high molecular weight hetero
polysaccharide gum produced by a pure-culture fermenta
0316 Unihydag WAX-18 (UPI) tion of a carbohydrate with Xanthomonas campestris.
0317 Palmitic Acid 0351) Technical Names
03.18 Empirical Formula 0352 Corn Sugar gum
CH2O2
0353 Xanthan
0319 Definition
0354) Trade Names
0320 Palmitic acid is the fatty acid that conforms gen
erally to the formula: 0355 Kelgum CG (Calgon)
CH(CH),COOH 0356. Keltrol (Kelco)
US 2003/0138466 A1
0357) Keltrol CG (Calgon)
0358) Keltrol CG 1000 (Calgon)
0359 Keltrol CGBT (Calgon)
0360) Keltrol CG F (Calgon)
0361) Keltrol CG GM (Calgon)
0362 Keltrol CG RD (Calgon)
0363) Keltrol CGSF (Calgon)
0364 Keltrol CGT (Calgon)
0365) Keltrol CG TF (Calgon)
0366) Kelzan (Kelco)
0367) Merezan 8 (Meer)
0368) Merezan 20 (Meer)
0369) Rhodigel (Vanderbilt)
0370 Rhodigel (Rhone-Poulenc)
0371) Rhodopol SC (Rhone-Poulenc)
0372) Xanthan gum (Jungbunzlauer)
0373 Triethanolamine
0374 Empirical Formula
CHON
0375) Definition
0376 Triethanolamine is an alkanolamine that conforms
generally to the formula:
N(CHCH-OH),
0377 Technical Names
0378) Ethanol, 2,2'2"-Nitrilotris-2,2'2"-Nitrilotris
Ethanol
0379 TEA
0380 Trolamine
0381 Trade Name
0382 Triethanolamine Pure C (BASF)
EXAMPLE
0383. The typical formulation illustrated above is pre
pared commercially as follows:
# Ingredient
1. Purified water
2 Vitamin E
3 Urea USP
4
5
Carbopol 940
Petrolatum
6 Mineral oil
7 Glyceryl stearate
8 Cetyl alcohol
9 Propylene glycol
1O Xanthan gum
11 Trolamine NF
12 Purified Water O.S.
Jul. 24, 2003
0384. The above product was manufactured as follows:
0385) Step 1
0386 Place #1 in Tank A (water phase) and sprinkle in #4
in Tank A and mix to disperse. After uniformly dispersed,
heat contents of Tank A to about 75 C. while mixing.
0387 Step 2
0388 Add #3 to Tank A and mix to dissolve.
0389 Step 3
0390. In a separate tank add #2, 5, 6, 7, 8. Heat to about
75 C. with mixing (oil phase).
0391) Step 4
0392. In a separate container disperse uniformly #10 in
#9. Add this to Tank A and continue to mix.
0393) Step 5
0394 Add the oil phase (step 3) to the water phase in
Tank A with mixing.
0395) Step 6
0396 Add #11 to Tank A and mix. Slowly cool the batch.
0397) Step 7
0398. Add #12 to Q.S. the batch to final weight.
0399. The bulk product is then packaged into conven
tional containers for use as a cream.
We claim:
1. A dermatological composition comprising:
(a) about 21 to about 40 wt-% urea;
(b) about 0.1 to 20 wt-% of an antioxidant, and the
balance being dermatologically acceptable excipients.
2. The composition of claim 1, where the antioxidant
Selected from the group of tocopherols and derivatives
thereof, tocotrenols, ascorbic acid and derivatives thereof,
Selenium, grape Seed extract, carotenoids, Vitamin A or
derivatives thereof, butylated hydroxytoluene, butylated
hydroxyanisole, gallic esters, flavonoids, catechins, glu
tathione, cysteine, lipoic acid, N-acetylcysteine, ethylenedi
amine tetraacetic acid and mixtures thereof
3. The composition of claim 1, where the antioxidant is
vitamin E.
4. The composition of claim 1, wherein the antioxidant is
vitamin C.
5. The composition of claim 2, where the antioxidant is
Batch Units grape Seed extract.
1084.47 Gm
6. The composition of claim 1, wherein the excipients
15O.OO Gm
comprise skin protectants of an oleaginous nature derived
12OO.OO Gm from petroleum, emulsifiers and thickenerS.
4.50
178.2O
Gm
Gm
7. The composition of claim 6, wherein the skin pro
211.8O Gm
tectants are a mixture of a Semi-Solid petrolatum or a
56.25 Gm Synthetic or Semi-Synthetic hydrocarbon or a mixture
18.78 Gm thereof, and a liquid petrolatum or a Synthetic or Semi
90.OO Gm Synthetic oleaginous liquid derivative thereof, or a mixture
1.50 Gm thereof.
4.50 Gm
3OOO.OO Gm 8. The composition of claim 7, wherein the semi-solid
petrolatum is present in an amount from about 5.5. to about
20 wt-%.
US 2003/0138466 A1
9. The composition of claim 1, which further comprises
up to 5 wt-% of propylene glycol.
10. The composition of claim 1, in the form of a semi
Solid at room temperature.
11. The composition of claim 1, which further comprises
a mixture of a carbomer and triethanolamine in a total
amount from about 0.05 to about 30 wt-%.
12. The composition of claim 1, in the form of a viscous
cream, gel or lotion.
Jul. 24, 2003
13. A method of treating and protecting dry skin com
prising applying to skin in need thereof an effective amount
of a composition according to claim 1.
14. A method of treating Xerosis, icthyosis and Severely
dry skin comprising applying to Skin in need of Such
treatment an effective amount of a composition according to
claim 1.