U.S. patent application number 11/202127 was filed with the patent office on 2005-12-01 for skin protectant spray compositions.
This patent application is currently assigned to Pfizer Inc.. Invention is credited to Healy, Michael Sean, Nelson, Dennis George Anthony.
Application Number | 20050266035 11/202127 |
Document ID | / |
Family ID | 22749979 |
Filed Date | 2005-12-01 |
United States Patent
Application |
20050266035 |
Kind Code |
A1 |
Healy, Michael Sean ; et
al. |
December 1, 2005 |
Skin protectant spray compositions
Abstract
A liquid, water-repellent, substantially anhydrous,
spray-pumpable skin protectant composition is disclosed. The
composition is designed for spraying directly onto skin, has
suitable adherence to the skin, and resists running. The
composition contains one or more actives for whichever indication
the composition has been formulated, one or more rheology
modifiers, and a carrier. The rheology modifiers help give the
composition rheological properties such that it can be sprayed
using a spray pump dispenser (i.e., a propellant-free,
non-pressurized dispenser) but still resist running after it has
been applied to the skin. The rheological modifiers can be waxes
and/or associative thickeners such as some forms of silica. The
carrier can be mineral oil or a mineral oil replacement (e.g.,
isohexadecane, cyclomethicone). Film-forming components also help
the composition resist running. One indication for which the
composition may be formulated is diaper rash. The diaper rash
composition is designed for spraying onto the skin of a baby or
other human (e.g., incontinent adult) for treating diaper rash. The
active ingredient for diaper rash may be dimethicone and preferably
also zinc oxide.
Inventors: |
Healy, Michael Sean;
(Denville, NJ) ; Nelson, Dennis George Anthony;
(Mountain Lakes, NJ) |
Correspondence
Address: |
PFIZER, INC.
201 TABOR ROAD
MORRIS PLAINS
NJ
07950
US
|
Assignee: |
Pfizer Inc.
|
Family ID: |
22749979 |
Appl. No.: |
11/202127 |
Filed: |
August 11, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11202127 |
Aug 11, 2005 |
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10275994 |
Nov 7, 2002 |
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6949249 |
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10275994 |
Nov 7, 2002 |
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PCT/IB01/00717 |
Apr 30, 2001 |
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60202467 |
May 8, 2000 |
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Current U.S.
Class: |
424/401 |
Current CPC
Class: |
A61K 8/898 20130101;
A61K 31/355 20130101; A61K 8/31 20130101; A61K 31/355 20130101;
A61K 33/30 20130101; A61P 17/16 20180101; A61K 2300/00 20130101;
A61K 2300/00 20130101; A61K 2300/00 20130101; A61K 2800/31
20130101; A61K 2800/75 20130101; A61K 33/30 20130101; A61Q 17/00
20130101; A61P 17/12 20180101; A61K 36/185 20130101; A61K 8/585
20130101; A61K 8/27 20130101; A61K 8/25 20130101; A61K 8/046
20130101; Y10S 514/865 20130101; A61Q 19/00 20130101; A61K 36/185
20130101 |
Class at
Publication: |
424/401 |
International
Class: |
A61K 007/00 |
Claims
1. A skin-protectant composition comprising: (a) at least about
0.001% w of at least one active ingredient for protecting skin; (b)
at least about 0.001% w of at least one rheology modifier; and (c)
carrier; wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for protecting the
skin, has suitable adherence to the skin, and resists running.
2. The composition of claim 1 wherein the at least one active
ingredient is selected from the group consisting of mineral oil,
dimethicone, zinc oxide, allantoin, calamine, kaolin, petrolatum,
white petrolatum, cod liver oil, lanolin, talc, topical starch,
aluminum hydroxide gel, cocoa butter, glycerine, shark liver oil,
zinc acetate, and zinc carbonate.
3. The composition of claim 1 wherein the at least one rheology
modifier comprises wax.
4. The composition of claim 3 wherein the wax comprises mineral
wax.
5. The composition of claim 4 wherein the mineral wax has a melting
range of from about 65 degrees Centigrade to about 71 degrees
Centigrade.
6. The composition of claim 1 wherein the at least one rheology
modifier comprises an associative thickener.
7. The composition of claim 6 wherein the associative thickener
comprises silica.
8. The composition of claim 7 wherein the silica comprises
colloidal silicon dioxide.
9. The composition of claim 1 wherein the at least one rheology
modifier comprises wax and an associative thickener.
10. The composition of claim 9 wherein the wax comprises mineral
wax and the associative thickener comprises silica.
11. The composition of claim 10 wherein the mineral wax has a
melting range of from about 65 degrees Centigrade to about 71
degrees Centigrade and the silica comprises colloidal silicon
dioxide.
12. The composition of claim 1 wherein the carrier comprises
mineral oil or a mineral oil replacement.
13. The composition of claim 12 wherein the carrier comprises a
mineral oil replacement selected from the group consisting of
alkanes having at least 10 carbon atoms, benzoate esters, aliphatic
esters, noncomodogenic esters, volatile silicone compounds, and
volatile silicone substitutes.
14. The composition of claim 1 further comprising at least one
film-forming agent.
15. (canceled)
16. The composition of claim 15 wherein the polymer comprises a
silicon-containing polymer.
17. The composition of claim 15 wherein the polymer comprises
synthetic wax.
18. (canceled)
19. The composition of claim 18 wherein the active ingredient is
selected from the group consisting of mineral oil, dimethicone,
zinc oxide, allantoin, calamine, kaolin, petrolatum, white
petrolatum, cod liver oil, lanolin, talc, and topical starch.
20. A skin-protectant composition comprising: (a) at least about
0.001% w of at least one active ingredient for protecting skin; (b)
at least about 0.001% w of a rheology modifier that is an
associative thickener and optionally at least about 0.001% w of at
least one additional rheology modifier; and (c) carrier; wherein
the composition is liquid, is water-repellent, is substantially
anhydrous, is spray-pumpable, is designed for spraying onto the
skin of a baby or other human for protecting the skin, has suitable
adherence to the skin, and resists running.
21-23. (canceled)
24. The composition of claim 20 wherein the at least one additional
rheology modifier is present in the composition and comprises
wax.
25-33. (canceled)
34. A skin-protectant composition comprising: (a) at least about
0.001% w of at least one active ingredient for protecting skin; (b)
at least about 0.001% w of a rheology modifier that is an
associative thickener and optionally at least about 0.001% w of at
least one additional rheology modifier; (c) at least about 0.001% w
of at least one film-forming agent; and (d) carrier; wherein the
composition is liquid, is water-repellent, is substantially
anhydrous, is spray-pumpable, is designed for spraying onto the
skin of a baby or other human for protecting the skin, has suitable
adherence to the skin, and resists running.
35-78. (canceled)
Description
BACKGROUND OF THE INVENTION
[0001] 1. Technical Field
[0002] This invention concerns topical formulations and, more
particularly, topical skin protectant formulations that can be
sprayed.
[0003] 2. Background
[0004] Drugs and other substances are often applied to human skin
to protect it from harmful stimuli. The U.S. Food And Drug
Administration ("FDA") has in the past defined a "skin protectant"
as a drug that protects injured or exposed skin or mucous membrane
surfaces from harmful or annoying stimuli (21 CFR .sctn. 347.3
(1983)). Thus, a "skin protectant" can be used to protect and/or
treat skin in connection with various indications, including diaper
rash; minor burns; cuts; scrapes; sunburn; chaffed, chapped,
cracked, or windburned skin or lips; skin irritation; and oozing
and/or weeping of skin caused by poison ivy, poison oak, and/or
poison sumac.
[0005] The skin of infants is known to be highly sensitive,
particularly to chemical substances. One common skin problem of
infants is diaper dermatitis, more commonly called "diaper rash."
"Diaper rash" has been defined by the FDA as an inflammatory skin
condition in the diaper area (perineum, buttocks, lower abdomen,
and inner thighs) caused by one or more of the following factors:
moisture, occlusion, chaffing, continued contact with urine or
feces or both, or mechanical or chemical irritation (21 CFR .sctn.
347.3 (1990)), and that definition will be used herein. The FDA has
also indicated that mild diaper rash appears as simple erythema and
that more severe conditions may be accompanied by papules,
vesicles, oozing, and ulceration. Adults (e.g., incontinent adults)
may also suffer from diaper rash.
[0006] Strategies for dealing with diaper rash include removing the
source of irritation, reducing the immediate skin reaction,
relieving discomfort, and preventing secondary infection. Many
products used in treating diaper rash are designed to provide a
barrier between the skin and the waste products. Known barrier
ingredients include zinc oxide and petrolatum. Barrier products
containing oily substances such as petrolatum may feel greasy, may
be difficult to apply because of their high viscosity, and may not
be easily removed from hands that apply the products or from the
infant's skin. Clean-up of these products from the hands and from
the infant's skin may be regarded by some as time-consuming, messy,
and inconvenient.
[0007] The FDA will allow claims to be made that the following
substances are useful as skin protectants provided, among other
things, that those substances are used at FDA-specified
concentration levels: mineral oil, dimethicone, zinc oxide,
allantoin, calamine, kaolin, petrolatum, white petrolatum, cod
liver oil, lanolin, talc, topical starch, aluminum hydroxide gel,
cocoa buffer, glycerine, shark liver oil, zinc acetate, and zinc
carbonate, all of which will be referred to herein as "active
ingredients for protecting skin" (21 CFR .sctn. 347.10 (1983 and
1990)). As used herein, the terms "protecting skin," "protecting
the skin," and "protecting human skin" are synonymous and each
include protecting and/or treating skin in connection with various
indications involving the skin, including diaper rash; minor burns;
cuts; scrapes; sunburn; chaffed, chapped, cracked, or windburned
skin or lips; skin irritation; and oozing and/or weeping of skin
caused by poison ivy, poison oak, and/or poison sumac.
[0008] The FDA will allow claims to be made that the following
substances are useful in treating diaper rash provided, among other
things, that those substances are used at FDA-specified
concentration levels: mineral oil, dimethicone, zinc oxide,
allantoin, calamine, kaolin, petrolatum, white petrolatum, cod
liver oil, lanolin, talc, and topical starch, all of which will be
referred to herein as "active ingredients for treating diaper rash"
(21 CFR .sctn. 347.10 (1983 and 1990)). For example, assuming all
the other requirements are met, the FDA will allow a claim to be
made that a composition containing dimethicone is useful for
treating diaper rash if the dimethicone concentration is from 1% w
(percent by weight) to 30% w. A similar claim can be made for a
composition containing zinc oxide if the zinc oxide concentration
is from 1% w to 40% w. A similar claim can be made for a
composition containing mineral oil if the mineral oil concentration
is from 50% w to 100% w. As used herein, the term "treating diaper
rash" includes treating an existing diaper rash condition or
preventing a diaper rash condition or both.
[0009] Compositions that may contact the skin and may contain zinc
oxide, and/or mineral oil, and/or silicon dioxide (silica), and/or
dimethicone or other silicone compounds, some of which compositions
may be in the form of aerosols or sprays and some of which
compositions may be used for treating diaper rash, include those
compositions referred to in U.S. Pat. Nos. Re. 33,107, 2,843,522,
3,770,648, 3,935,862, 4,1043,077, 4,196,218, 4,273,786, 4,278,658,
4,329,366, 4,389,418, 4,514,383, 4,556,560, 4,569,839, 4,574,082,
4,672,074, 4,725,438, 4,800,076, 4,816,254, 4,842,593, 4,847,071,
4,911,932, 4,933,330, 4,938,960, 4,996,238, 4,996,239, 5,043,359,
5,085,856, 5,137,714, 5,208,031, 5,210,102, 5,232,691, 5,234,689,
5,266,318, 5,362,488, 5,389,204, 5,436,007 5,527,519, 5,543,135,
5,545,673, 5,558,872, 5,573,753, 5,576,006, 5,603,863, 5,616,331,
5,635,191, 5,643,588, 5,652,274, 5,662,937, 5,665,426, 5,730,993,
5,733,895, 5,744,146, 5,756,082, 5,756,110, 5,762,945, 5,776,440,
5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522, 5,869,061,
5,869,062, 5,869,071, 5,874,094, 5,885,599, 5,914,101, 5,939,053,
5,945,211, 5,958,397, 5,961,961, 5,962,441, 5,965,137, 5,965,610,
5,968,531, and 5,972,359. (All of the these documents and any other
documents discussed or otherwise referenced or identified herein
are incorporated herein in their entireties for all purposes.)
[0010] Compositions containing zinc oxide that may contact the skin
include those referred to in U.S. Pat. Nos. 2,843,522, 3,770,648,
4,034,077, 4,278,658, 4,389,418, 4,556,560, 4,569,839, 4,672,074,
4,816,254, 4,911,932, 4,933,330, 5,085,856, 5,208,031, 5,232,691,
5,527,519, 5,543,135, 5,545,673, 5,573,753, 5,603,863, 5,616,331,
5,652,274, 5,662,937, 5,665,426, 5,730,993, 5,733,895, 5,744,146,
5,756,110, 5,762,945, 5,834,290, 5,861,143, 5,861,144, 5,861,146,
5,863,522, 5,869,062, 5,874,094, 5,885,599, 5,914,101, 5,939,053,
5,945,211, 5,961,961, 5,962,441, 5,965,610, 5,968,531, and
5,972,359.
[0011] Some of the compositions containing zinc oxide may be
sprayable (with or without a propellant). See, e.g., U.S. Pat. Nos.
3,770,648, 4,278,658, 4,933,330, 5,652,274, 5,733,895, 5,834,290,
5,861,143, 5,861,144, 5,861,146, 5,863,522, 5,885,599, 5,939,053,
5,945,211, 5,962,441, 5,965,610, and 5,972,359.
[0012] Some of the compositions containing zinc oxide may contain
small zinc oxide particles (e.g., less than 1 micron). See, e.g.,
U.S. Pat. Nos. 5,543,135, 5,527,519, 5,573,753, 5,603,863,
5,616,331, 5,730,993, 5,756,110, 5,861,143, 5,861,144, 5,861,146,
5,914,101, 5,945,211, 5,961,961, and 5,972,359.
[0013] Topical compositions for treating diaper rash containing
zinc oxide include DESITIN.RTM. Ointment and DESITIN.RTM. Creamy
Ointment, both marketed by Pfizer Inc, the assignee of the present
application. DESITIN.RTM. Ointment contains about 40% w zinc oxide
and other ingredients, including white petrolatum, cod liver oil,
lanolin, talc, and about 5% w water. DESITIN.RTM. Creamy Ointment
contains about 10% w zinc oxide and other ingredients, including
mineral oil, mineral wax, dimethicone, cyclomethicone, white
petrolatum, white wax, and over 30% w water.
[0014] Other diaper rash, incontinence/dermatitis, diaper-treating,
and baby treatment compositions include those referred to in U.S.
Pat. Nos. Re. 33,107, 2,843,522, 3,770,648, 3,935,862, 4,034,077,
4,273,786, 4,329,366, 4,556,560, 4,816,254, 4,842,593, 4,911,932,
4,996,238, 4,996,239, 5,362,488, 5,436,007, 5,576,006, 5,558,872,
5,635,191, 5,643,588, 5,652,274, 5,762,945, 5,834,290, 5,869,071,
and 5,945,211.
[0015] Some of those diaper rash, incontinence/dermatitis,
diaper-treating, and baby treatment compositions may form a film
when they are topically applied and may be resistant to wetting by
moisture. See, e.g., U.S. Pat. No. 4,996,238 (column 2, line 20 and
following) and U.S. Pat. No. 4,996,239 (column 2, line 40 and
following).
[0016] Some of those diaper rash, incontinence/dermatitis,
diaper-treating, and baby treatment compositions may contain
film-forming agents. See, e.g., U.S. Pat. No. 4,996,238 (column 2,
line 42 and following), U.S. Pat. No. 4,996,239 (column 2, line 63
and following), U.S. Pat. No. 5,635,191 (column 18, line 34), and
U.S. Pat. No. 5,643,588 (column 18, line 47).
[0017] Some of those diaper rash, incontinence/dermatitis,
diaper-treating, and baby treatment compositions may be sprayable
(with or without a propellant). See, e.g., U.S. Pat. Nos. Re.
33,107, 3,770,648, 3,935,862, 4,273,786, 4,329,366, 4,842,593,
5,436,007, 5,576,006, 5,635,191, 5,643,588, 5,652,274, 5,869,071,
and 5,945,211.
[0018] U.S. Pat. No. Re. 33,107 refers to sprays that may contain
mineral oil for treating skin conditions such as dermatitis.
[0019] U.S. Pat. No. 3,770,648, assigned on its face to
Bristol-Myers Company, refers to substantially non-aqueous
quick-breaking aerosol foaming compositions containing silicone
compounds (e.g., dimethyl silicone fluids), foamable organic
liquids (e.g., mineral oil), and a high vapor pressure propellant
system (e.g., fluorocarbons). Example 2 of the patent refers to
what is called "DESITIN.RTM. baby foam," containing zinc oxide
(about 4.2% w), mineral oil (about 71.7% w), a silicone, and FREON
12 fluorocarbon propellant.
[0020] U.S. Pat. Nos. 3,935,862 and 4,273,786 refer to compositions
containing amino acid compounds to inhibit the formation of ammonia
and therefore treat diaper rash. The compositions may contain solid
diluents such as starch and talc and may also contain silicone-type
fluids such as polysiloxane fluid. Although mineral oil is referred
to in some of the non-sprayable compositions exemplified in the
patents, the only sprayable composition (Example H) contains
micropulverized talc, an amino acid salt, fragrance, anhydrous
ethanol, isopropyl myristate, and two FREON propellants.
[0021] U.S. Pat. No. 4,329,366 refers to compositions containing
acylaminophenols that can be used to treat various conditions,
including diaper rash. Although mineral oil is referred to in some
of the non-sprayable formulations exemplified, the two sprayable
formulations (Formulations F and L) use alcohol and propellants and
at least one of them (Formulation F) contains water.
[0022] U.S. Pat. No. 4,842,593 refers to a pH control system that
can be sprayed onto an article used to prevent or reduce diaper
rash. The fibers of the article may be impregnated with silica.
[0023] U.S. Pat. No. 5,436,007 refers to a diaper rash lotion that
may be sprayed containing dimethicone (e.g., from 1% w to 30% w),
water (e.g., from 50% w to 95% w), and an emulsifier (e.g., from 1%
w to 10% w). The patent also refers to a diaper rash cream that may
contain a linear polydimethylsiloxane (e.g., 20% w), a light
mineral oil (e.g., 4% w), emulsifier (e.g., 8% w), and water (e.g.,
over 40% w). Stearic acid, which is said to function as a
thickener, and aloe may also be used in the lotion and the cream.
See, e.g., column 7, line 6, to column 10, line 26.
[0024] U.S. Pat. No. 5,576,006 refers to antibacterial compositions
that can be used to deodorize footwear and to treat diaper rash.
Although the footwear deodorizing compositions can be sprays, it
appears that the compositions intended for use on infants are "body
preparations and powders," which may contain talc (column 3, lines
47-63, and Example 3). The sprays exemplified contain water.
[0025] U.S. Pat. Nos. 5,635,191 and 5,643,588 refer to a diaper
having a topsheet coated with a composition containing emollients
(such as mineral oil, petrolatum or mineral wax, and polysiloxanes)
and other ingredients (such as viscosity modifiers and film
formers). The composition may be sprayed onto the topsheet.
According to the patents, the composition on the diaper topsheet is
transferred to the wearer's skin and those topsheets provide "BM
[bowel movement] cleaning, therapeutic or protective lotion coating
benefits" (U.S. Pat. No. 5,635,191, column 2, line 64, to column 3,
line 52; and U.S. Pat. No. 5,643,588, column 2, line 62, to column
3, line 51). The composition is "solid" or "semisolid" at 20
degrees Centigrade (U.S. Pat. No. 5,635,191, column 9, lines 35-67;
and U.S. Pat. No. 5,643,588, column 9, line 39, to column 10, line
4) and is "substantially free of water" (U.S. Pat. No. 5,635,191,
column 10, lines 43-54, and U.S. Pat. No. 5,643,588, column 10,
lines 48-59).
[0026] U.S. Pat. No. 5,652,274 refers to therapeutic wound healing
compositions. Compositions for treating diaper dermatitis are
discussed, for example, at column 11, 5 lines 31-49; column 15,
lines 39-61; column 26, lines 5-26; and column 138, line 52, to
column 145, line 4. Those compositions may contain zinc oxide. At
least some compositions may be sprayed (for example, the
formulations of Embodiment One; see column 42, line 26).
[0027] Some of the compositions may contain petrolatum, mineral
oil, and vitamin E (see, e.g., column 66, lines 35-49).
[0028] U.S. Pat. No. 5,869,071 refers to a spray composition for
incontinent patients that "cleanses, moisturizes and leaves a
protective petrolatum barrier against wetness and irritants in one
step" (column 1, lines 58-63). The composition is said to be an
emulsion of water and petrolatum (or petroleum jelly) and may
contain dimethicone, cyclomethicone, mineral oil, vitamin E, and
aloe.
[0029] U.S. Pat. No. 5,945,211 refers to a composite to which zinc
oxide particles are adhered. The composite may be a diaper and the
zinc oxide may be deposited on the composite from an aqueous medium
(e.g., by spraying an aqueous suspension of zinc oxide).
[0030] Sprayable (with or without a propellant) compositions that
may contact the skin and that may contain dimethicone or other
silicon compounds include those referred to in U.S. Pat. Nos.
3,770,648, 3,935,862, 4,273,786, 4,514,383, 4,847,071, 4,933,330,
5,137,714, 5,266,318, 5,389,204, 5,436,007, 5,635,191, 5,643,588,
5,733,895, 5,776,440, 5,834,290, 5,861,143, 5,861,144, 5,861,146,
5,863,522, 5,869,071, 5,885,599, 5,939,053, 5,962,441, 5,965,610,
and 5,972,359.
[0031] Compositions containing some form of silica (silicon
dioxide) include those referred to in U.S. Pat. Nos. 4,574,082,
4,800,076, 4,996,238, 4,996,239, 5,137,714, 5,208,031, 5,527,519,
5,543,135, 5,573,753, 5,603,863, 5,616,331, 5,733,895, 5,756,082,
5,756,110, 5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522,
5,885,599, 5,914,101, 5,939,053, 5,968,531, and 5,972,359. Some
forms of silica are said to be usefull as thickeners. See, e.g.,
U.S. Pat. Nos. 4,996,238 and 4,996,239. Some of those compositions
containing some form of silica also may contain zinc oxide. See,
e.g., U.S. Pat. Nos. 5,208,031, 5,527,519, 5,543,135, 5,573,753,
5,603,863, 5,616,331, 5,733,895, 5,756,110, 5,834,290, 5,861,143,
5,861,144, 5,861,146, 5,863,522, 5,885,599, 5,914,101, 5,939,053,
5,968,531, and 5,972,359.
[0032] Some of those compositions containing silica (with or
without zinc oxide) may be sprayable. See, e.g., U.S. Pat. Nos.
5,137,714, 5,733,895, 5,834,290, 5,861,143, 5,861,144, 5,861,146,
5,863,522, 5,885,599, 5,939,053, and 5,972,359.
[0033] Some sprayable compositions may contain aloe and/or a form
of vitamin E. See, e.g., U.S. Pat. Nos. 4,847,071, 5,266,318,
5,436,007, 5,861,143, 5,861,144, 5,861,146, 5,869,071, 5,885,599,
5,965,137, 5,965,610, and 5,972,359. Some of the composition
containing aloe and/or a form of vitamin E may be for treating
diaper rash and/or incontinence/dermatitis. See, e.g., U.S. Pat.
Nos. 5,436,007 and 5,869,071.
[0034] Compositions containing (a) mineral oil or petrolatum, (b)
zinc oxide, and (c) dimethicone or other silicone ingredient
include those referred to in U.S. Pat. Nos. 3,770,648, 4,389,418,
4,556,560, 4,569,839, 4,911,932, 4,933,330, 5,085,856, 5,208,031,
5,232,691, 5,543,135, 5,603,863, 5,616,331, 5,665,426, 5,730,993,
5,733,895, 5,744,146, 5,756,110, 5,834,290, 5,861,143, 5,861,144,
5,861,146, 5,863,522, 5,885,599, 5,914,101, 5,939,053, 5,961,961,
5,962,441, 5,965,610, and 5,972,359. Some of those compositions may
be sprayable (with or without a propellant). See, e.g., U.S. Pat.
Nos. 3,770,648, 4,933,330, 5,733,895, 5,834,290, 5,861,143,
5,861,144, 5,861,146, 5,863,522, 5,885,599, 5,939,053, 5,962,441,
5,965,610, and 5,972,359. Some of those compositions may be for
treating diaper rash. See, e.g., U.S. Pat. Nos. 4,556,560 and
4,911,932.
[0035] Some of those compositions containing (a) mineral oil or
petrolatum, (b) zinc oxide, and (c) dimethicone or other silicone
ingredient may also contain silica. See, e.g., U.S. Pat. Nos.
5,208,031, 5,543,135, 5,603,863, 5,616,331, 5,733,895, 5,756,110,
5,834,290, 5,861,143, 5,861,144, 5,861,146, 5,863,522, 5,885,599,
5,914,101, 5,939,053, and 5,972,359. Some of those compositions may
be sprayable (with or without a propellant). See, e.g., U.S. Pat.
Nos. 5,733,895, 5,834,290, 5,861,143, 5,861,144, 5,861,146,
5,863,522, 5,885,599, 5,939,053, and 5,972,359.
[0036] Some of those compositions containing (a) mineral oil or
petrolatum, (b) zinc oxide, and (c) dimethicone or other silicone
ingredient may also contain wax. See, e.g., U.S. Pat. Nos.
4,389,418, 4,556,560, 4,569,839, 4,911,932, 4,933,330, 5,085,856,
5,208,031, 5,232,691, 5,616,331, 5,665,426, 5,730,993, 5,733,895,
5,744,146, 5,834,290, 5,863,522, 5,939,053, and 5,961,961. Some of
those compositions may be sprayable (with or without a propellant).
See, e.g., U.S. Pat. Nos. 4,933,330, 5,733,895, 5,834,290,
5,863,522, and 5,939,053.
[0037] Despite all the work done in this technical area, the need
still exists for a safe and effective liquid skin protectant
composition that is liquid, is water-repellent, substantially
anhydrous, can be applied directly to the skin, quickly, easily,
and without messing one's hands with the composition, and that will
not run after it has been applied to the skin. Moreover, the need
still exists for such a composition that can be applied to the skin
without the need to use high-pressure such as that provided by
propellant gas in an aerosol can. Furthermore, the need still
exists for a composition meeting all those criteria that can be
used for treating diaper rash.
SUMMARY OF THE INVENTION
[0038] A composition that can satisfy some or all of those needs
and provides other benefits that will be apparent to one skilled in
the art has now been developed. Broadly, the composition of this
invention is a skin-protectant composition comprising:
[0039] (a) at least about 0.001% w of at least one active
ingredient for protecting skin;
[0040] (b) at least about 0.001% w of at least one rheology
modifier; and
[0041] (c) carrier;
[0042] wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for protecting the
skin, has suitable adherence to the skin, and resists running.
[0043] Another aspect of the invention concerns a skin-protectant
composition comprising:
[0044] (a) at least about 0.001% w of at least one active
ingredient for protecting skin;
[0045] (b) at least about 0.001% w of a rheology modifier that is
an associative thickener and optionally at least about 0.001% w of
at least one additional rheology modifier; and
[0046] (c) carrier;
[0047] wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for protecting the
skin, has suitable adherence to the skin, and resists running.
[0048] Another aspect of the invention concerns a skin-protectant
composition comprising:
[0049] (a) at least about 0.001% w of at least one active
ingredient for protecting skin;
[0050] (b) at least about 0.001% w of a rheology modifier that is
an associative thickener and optionally at least about 0.001% w of
at least one additional rheology modifier;
[0051] (c) at least about 0.001% w of at least one film-forming
agent; and
[0052] (d) carrier;
[0053] wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for protecting the
skin, has suitable adherence to the skin, and resists running.
[0054] Another aspect of the invention concerns a skin-protectant
composition comprising:
[0055] (a) at least about 0.1% w of at least one active ingredient
for protecting skin;
[0056] (b) at least about 0.1% w of a rheology modifier that is an
associative thickener comprising silica and optionally at least
about 0.1% w of at least one additional rheology modifier;
[0057] (c) at least about 0.1% w of at least one polymeric
film-forming agent; and
[0058] (d) carrier;
[0059] wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for protecting the
skin, has suitable adherence to the skin, and resists running.
[0060] Another aspect of the invention concerns a skin-protectant
composition comprising:
[0061] (a) at least about 0.001% w of at least one active
ingredient for protecting skin;
[0062] (b) at least about 0.001% w of at least one rheology
modifier that is an associative thickener and optionally at least
about 0.001% w of at least one additional rheology modifier that is
a wax;
[0063] (c) at least about 0.001% w of at least one polymeric
film-forming agent selected from the group consisting of
silicon-containing polymers and synthetic waxes; and
[0064] (d) carrier;
[0065] wherein the composition is liquid, water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for protecting the
skin, has suitable adherence to the skin, and resists running.
[0066] Another aspect of the invention concerns a diaper rash
composition comprising:
[0067] (a) at least about 0.1% w of at least one active ingredient
for treating diaper rash;
[0068] (b) at least about 0.1% w of at least one rheology
modifier;
[0069] (c) at least about 0.1% w of at least one film-forming
agent; and
[0070] (d) carrier;
[0071] wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for treating diaper
rash, has suitable adherence to the skin, and resists running.
[0072] Another aspect of the invention concerns a diaper rash
composition comprising:
[0073] (a) at least about 1% w of dimethicone;
[0074] (b) at least about 0.5% w of at least one rheology modifier
selected from the group consisting of associative thickeners and
waxes;
[0075] (c) at least about 0.2% w of at least one polymeric
film-forming agent; and
[0076] (d) carrier;
[0077] wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for treating diaper
rash, has suitable adherence to the skin, and resists running.
[0078] Another aspect of the invention concerns a diaper rash
composition comprising:
[0079] (a) at least about 1% w of dimethicone;
[0080] (b) at least about 1% w of zinc oxide;
[0081] (c) at least about 1% w of wax;
[0082] (d) at least about 1% w of an associative thickener;
[0083] (e) at least about 0.2% w of at least one polymeric
film-forming agent; and
[0084] (f) carrier selected from the group consisting of mineral
oil and mineral oil replacements;
[0085] wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for treating diaper
rash, has suitable adherence to the skin, and resists running.
[0086] Another aspect of the invention concerns a diaper rash
composition comprising:
[0087] (a) at least about 1% w of dimethicone;
[0088] (b) at least about 1% w of mineral wax;
[0089] (c) at least about 0.5% w of silica;
[0090] (d) at least about 0.1% w of a silicon-containing polymeric
film-forming agent;
[0091] (e) at least about 0.1% w of a synthetic wax polymeric
film-forming agent;
[0092] (f) at least about 2% w cyclomethicone;
[0093] (g) at least about 2% w isohexadecane; and
[0094] (h) at least about 50% w mineral oil;
[0095] wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for treating diaper
rash, has suitable adherence to the skin, and resists running.
[0096] Another aspect of the invention concerns a diaper rash
composition comprising:
[0097] (a) from about 0.8% w to about 1.2% w of dimethicone;
[0098] (b) from about 4% w to about 6% w of mineral wax;
[0099] (c) from about 1.8% w to about 2.8% w of silica;
[0100] (d) from about 0.8% w to about 1.2% w of a
silicon-containing polymeric film-forming agent;
[0101] (e) from about 1.6% w to about 2.4% w of a synthetic wax
polymeric film-forming agent;
[0102] (f) from about 7.2% w to about 10.8% w cyclomethicone;
[0103] (g) from about 5.2% w to about 7.8% w isohexadecane; and
[0104] (h) from about 57% w to about 85% w mineral oil;
[0105] wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for treating diaper
rash, has suitable adherence to the skin, and resists running.
[0106] Another aspect of the invention concerns a diaper rash
composition comprising:
[0107] (a) at least about 1% w of dimethicone;
[0108] (b) at least about 1% w of zinc oxide;
[0109] (c) at least about 1% w of mineral wax;
[0110] (d) at least about 0.5% w of silica;
[0111] (e) at least about 0.1% w of a silicon-containing polymeric
film-forming agent;
[0112] (f) at least about 0.1% w of a synthetic wax polymeric
film-forming agent;
[0113] (g) at least about 2% w cyclomethicone;
[0114] (h) at least about 2% w isohexadecane; and
[0115] (i) at least about 50% w mineral oil;
[0116] wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for treating diaper
rash, has suitable adherence to the skin, and resists running.
[0117] Another aspect of the invention concerns a diaper rash
composition comprising:
[0118] (a) from about 0.8% w to about 1.2% w of dimethicone;
[0119] (b) from about 8% w to about 12% w of zinc oxide;
[0120] (c) from about 1.8% w to about 2.7% w of mineral wax;
[0121] (d) from about 1.7% w to about 2.5% w of silica;
[0122] (e) from about 0.4% w to about 0.6% w of a
silicon-containing polymeric film-forming agent;
[0123] (f) from about 1.0% w to about 1.6% w of a synthetic wax
polymeric film-forming agent;
[0124] (g) from about 6.8% w to about 10.2% w cyclomethicone;
[0125] (h) from about 4.5% w to about 6.7% w isohexadecane; and
[0126] (i) from about 53% w to about 80% w mineral oil;
[0127] wherein the composition is liquid, is water-repellent, is
substantially anhydrous, is spray-pumpable, is designed for
spraying onto the skin of a baby or other human for treating diaper
rash, has suitable adherence to the skin, and resists running.
[0128] Another aspect of this invention concerns a hand-held spray
pump dispenser containing and for spraying the composition of this
invention.
[0129] Another aspect of this invention concerns a method of
protecting human skin comprising applying the composition of this
invention to human skin.
[0130] Another aspect of this invention concerns a method of
treating diaper rash in a human comprising applying the composition
of this invention to human skin.
[0131] The composition of this invention is safe, effective, and
can be applied directly to the skin (i.e., by spraying). Spraying
obviates the need to first put the composition on one's hands or on
an application device and then rub it onto the skin of a baby or
other human being. Such rubbing on skin already affected with, for
example, diaper rash would likely cause discomfort. The composition
of this invention is storage-stable, even though it can contain a
significant concentration of solids, such as zinc oxide particles.
The composition can be sprayed using a hand-held pump sprayer (a
hand-held spray pump dispenser), that is, without the need to use a
pressurized (e.g., propellant-containing) device. Hand-held spray
pump dispensers are easier to use, more environmentally friendly,
and their use avoids having a pressurized container used near, for
example, an infant. The composition of this invention tends to
resist running after it has been applied to the skin, and it has a
reduced greasy feel.
[0132] Further aspects, features, and advantages of this invention
will become apparent to those skilled in the art from the
description of the invention herein.
DETAILED DESCRIPTION OF THE INVENTION
[0133] The composition of this invention is a liquid,
water-repellent, substantially anhydrous, spray-pumpable
composition that is designed for spraying onto the skin of a baby
or other human being for protecting skin (e.g., for treating diaper
rash). It is believed that this composition is the first skin
protectant spray composition that, among other things, is liquid,
is designed for direct application to the skin of a human being
(including to the tender skin of a baby), is efficacious in
protecting the skin to which it is applied, has suitable adherence
to the skin, can contain particles (e.g., of silica), is
storage-stable, water-repellent, substantially anhydrous, and
spray-pumpable, and resists running. It is also believed that the
diaper rash spray embodiment is the first diaper rash spray
composition of its type that, among other things, is liquid, is
designed for direct application to the tender skin of a baby,
provides efficacious treatment of diaper rash, has suitable
adherence to the skin, can contain zinc oxide particles, is
storage-stable, water-repellent, substantially anhydrous, and
spray-pumpable, and resists running.
[0134] By "liquid" is meant that at 20 degrees Centigrade under
atmospheric pressure the substance in question hag a continuous
liquid phase and otherwise meets the definition of a liquid. For
example, the composition of this invention is liquid before being
sprayed because it has a continuous liquid phase at 20 degrees
Centigrade under atmospheric pressure. Thus, for example, the
presence of solid particles (e.g., of zinc oxide and/or silica) in
the composition does not prevent it from being considered to be a
"liquid" composition.
[0135] By "water-repellent" is meant that the composition when on
the skin substantially impedes the passage of liquid water through
the composition for a sufficiently long period of time. Thus, for
example, in the case of a diaper rash composition of this
invention, the composition is water-repellent because it impedes
the passage of water for at least what is a typical period of time
between diaper changes (e.g., three hours, five hours, seven hours,
or in some cases even longer).
[0136] By "substantially anhydrous" is meant that the water content
of the composition will be less than about 5% w by weight,
typically less than about 3% w, desirably less than about 2% w,
more desirably less than about 1% w, most desirably less than about
0.5% w, preferably less than about 0.3% w, more preferably less
than about 0.1% w, and most preferably less than about 0.05% w.
Although no water preferably is intentionally added as a separate
ingredient when making the composition, it is possible that some of
the ingredients used to formulate the composition may contain trace
quantities of water. If any water is present in the composition of
this invention, there desirably is no "free" (i.e., non-emulsified)
water and, therefore, there desirably is no separate water phase.
Thus, preferably, at least as may be observed using normal human
vision (i.e., 20/20) without the aid of any magnifying or detection
equipment, no separate aqueous layer forms when the composition of
this invention stands for 24 hours at 20 degrees Centigrade in a
closed container padded with inert gas.
[0137] The presence of free water in the composition tends to
adversely affect the physical and other properties of the
composition. More free water could create a discrete water layer
and/or increase the surface tension of the composition (reducing
the ability of the composition to "wet" the working parts of the
spray pump dispenser and thereby be easily sprayed) and/or decrease
the composition's adherence to the skin (tackiness) and/or increase
its "runnyness" (i.e., the tendency of the composition to run off
the skin to which it has been applied because of gravity or other
force). Thus, free (i.e., non-emulsified) water in a layer of
composition on skin being protected (which includes being treated)
is believed to reduce the efficacy of the composition for its
intended purpose of protecting skin (e.g., treating diaper rash) by
reducing the sprayability of the composition, by reducing the
barrier properties of the composition (including making the
composition less water-repellent), and by making it easier for the
composition to prematurely leave the skin being treated (e.g., to
prematurely rub off or prematurely flow off under the force of
gravity). If the composition were formulated to contain water, it
would be necessary to add an emulsifier; however, it is a feature
of this invention that the composition can be "emulsifier-free."
Preferably the composition is emulsifier-free. Including an
emulsifier in the composition (so that any water present is not
"free") would tend to make the composition less spray-pumpable and
less water-repellent, and it is a feature of this invention that
the composition is spray-pumpable and water-repellent.
[0138] By "spray-pumpable" is meant that a hand-held spray pump
dispenser can be used to dispense the composition, which is liquid
at 20 degrees Centigrade under normal atmospheric pressure, by
spraying using normal finger pressure on the portion of the spray
pump assembly designed to be activated by finger pressure. By
"spray" is meant a jet of finely divided liquid composition. (See,
e.g., U.S. Pat. Nos. 3,159,316, 4,034,900, and 4,050,860, which
show different spray pump dispensers.) The hand-held spray pump
dispenser used to dispense (spray) a composition of this invention
typically contains the composition at atmospheric pressure and it
is only when finger pressure is applied that the spray pump
mechanism temporarily pressurizes the composition to cause a
portion of it to leave the dispenser as a spray. The pressure in
the mechanism soon returns to atmospheric after the small portion
of composition has been dispensed. Such a hand-held spray pump
dispenser is considered to be a non-pressurized dispenser. In other
words, a feature of this invention is that a hand-held spray pump
dispenser (i.e., a non-pressurized dispenser) can be used in its
normal manner to dispense the composition of this invention.
[0139] "Spray cans" or "aerosol cans," which use propellants (e.g.,
a FREON or other fluid having a vapor pressure at 20 degrees
Centigrade significantly higher than atmospheric pressure), are
well-known types of pressurized dispensers. Another type of
pressurized dispenser is one having a resilient deformable bladder
that has been force-filled with enough mass to cause it to expand.
The memory of the resilient bladder material causes it to try to
return to its original, non-deformed size and shape, which thereby
pressurizes the mass inside the bladder. Another type of
pressurized dispenser is a motor-driven pump (e.g., a centrifugal
pump, a positive displacement pump).
[0140] The higher pressures that are provided by pressurized
dispensers are not needed to dispense (spray) the composition of
this invention, although in some cases they may be used. The fact
that a spray-pumpable composition of this invention is also able to
be dispensed using a pressurized dispenser (e.g., a dispenser
containing a propellant, a dispenser containing a resilient
expanded bladder, a motor-driven pump) does not mean that the
composition is not spray-pumpable; however, hand-held spray pump
dispensers (i.e., non-pressurized dispensers) are preferred for use
in spraying the composition of this invention onto the skin to be
treated. Broadly speaking, hand-held spray pump dispensers are less
expensive, more economical, and more environmentally friendly than
pressurized dispensers.
[0141] It is not believed that any special design for the hand-held
spray pump dispenser is needed, although some adjustment of
specific dimensions and/or materials of construction may be needed
because of the physical and chemical properties of the particular
composition to be dispensed. As will be understood by those skilled
in the art, the particular design of the spray pump dispenser is
not critical and any hand-held spray pump dispenser that allows
appropriate dispensing of the composition of this invention, in
which the composition is sufficiently storage-stable, and which
itself is not adversely affected by the composition (e.g., by
prolonged storage) can be used. Broadly speaking, spray pump
dispensers are affected to some degree by the compositions they
contain and dispense. For example, storage of the composition in
the spray pump dispenser in warm weather over an extended period
may cause swelling of the different parts of the spray pump
dispenser to differing degrees. That in turn may adversely affect
operation of the spray pump and dispensing (spraying) of the
composition. Selection of a hand-held spray pump dispenser design
and of suitable materials of construction are well within the skill
of the art.
[0142] The terms "protecting skin," "protecting the skin," and
"protecting human skin" are synonymous, have been defined above,
and each include protecting and/or treating skin in connection with
various indications involving the skin, including diaper rash;
minor burns; cuts; scrapes; sunburn; chaffed, chapped, cracked, or
windburned skin or lips; skin irritation; and oozing and/or weeping
of skin caused by poison ivy, poison oak, and/or poison sumac.
[0143] The term "diaper rash" has been defined above as an
inflammatory skin condition in the diaper area (perineum, buttocks,
lower abdomen, and inner thighs) caused by one or more of the
following factors: moisture, occlusion, chaffing, continued contact
with urine or feces or both, or mechanical or chemical irritation.
Thus, "diaper rash" is the well-known condition often suffered by
babies and older incontinent people as a result of their wearing
diapers or the like (e.g., incontinence pads). Diaper rash may also
be referred to as "diaper dermatitis" or "incontinence
dermatitis."
[0144] The term "treating diaper rash" has been defined above and
includes treating an existing diaper rash condition or preventing a
diaper rash condition or both.
[0145] A composition that is "designed for spraying onto the skin
of a baby or other human" is a sprayable composition that will not
harm the skin of any human being, not even the more delicate
(tender) skin of a baby, will not be toxic, will not cause
irritation, will not be malodorous, will not decompose to cause any
harmful reactions, will not adversely affect any diaper or other
substrate that may be in contact with the composition, etc.
Compositions "designed for spraying onto the skin of a baby or
other human" include compositions designed to be sprayed onto the
skin of babies or other human beings for any indication for which a
skin protectant is used.
[0146] A composition that is "designed for spraying onto the skin
of a baby or other human for protecting the skin" is a composition
that is "designed for spraying onto the skin of a baby or other
human" and is efficacious for the purpose of protecting the
skin.
[0147] A composition that is "designed for spraying onto the skin
of a baby or other human for treating diaper rash" is a composition
that is "designed for spraying onto the skin of a baby or other
human" and is efficacious for the purpose of treating diaper
rash.
[0148] A composition of this invention that has "suitable adherence
to the skin" will after being applied to the skin remain adhered to
the skin long enough under normal conditions of use to have an
efficacious effect (for example, for treating diaper rash). A layer
of composition on the skin may be thought of as a stack of parallel
thin layers, each layer being at least one molecule thick. With a
composition that has suitable adherence to the skin, the
composition's molecular layer closest to the skin (the bottom
molecular layer) will temporarily bond physically and/or chemically
to the skin on a molecular level, the composition's molecular layer
above the bottom molecular layer will temporarily bond physically
and/or chemically to that bottom molecular layer, and so on. The
bonds between the skin and the bottom molecular layer and between
the successive molecular layers cannot be permanent or else it
would be difficult to remove the composition from the skin.
[0149] If a composition "resists running," the composition will
not, for example, under the force of gravity, easily or quickly
flow from the skin to which it has been applied. The ability to
"resist running" in any particular case depends not only on the
physical and chemical properties of the composition itself, but
also on variables such as the thickness of the layer of composition
applied to the skin and the condition (e.g., oiliness, cleanliness)
of the skin to which the composition was applied. The rheology
modifiers, optional film-forming agents, and optional volatile
carrier ingredients used in the composition help it resist
running.
[0150] The ability of a composition of this invention to resist
running was compared to the ability of two compositions outside the
scope of invention to resist running. All of the test runs were
performed at room temperature (about 20 degrees Centigrade). The
preferred zinc oxide-containing composition of this invention
(described in detail below) was placed in a dispenser that
dispenses as a spray nominally 0.13 milliliters of composition per
pump. The spray nozzle was held 2 inches (about 5.1 centimeters)
above a piece of FORMICA plastic laminate lying flat on a
horizontal work surface so that the centerline of the dispensing
aperture in the nozzle was perpendicular to the surface of the
laminate, and three "pumps" of composition were dispensed (a total
of nominally 0.39 milliliters of composition). The resulting circle
formed on the laminate surface by the sprayed composition was 1.5
inches (about 3.8 centimeters) in diameter. The piece of plastic
laminate was rotated to a vertical position so that the plane of
the circle was perpendicular to the horizontal work surface, and a
line 4 inches (about 10.2 centimeters) below the bottom of the
circle and parallel to the horizontal work surface was established.
The preferred zinc oxide-containing composition of this invention
did not run down from its 1.5-inch circle, much less traverse the 4
inches (about 10.2 centimeters), even after 2 hours.
[0151] The test was also performed on two compositions outside the
scope of the invention: (1) a liquid consisting of only the mineral
oil used in the preferred zinc oxide-containing composition and (2)
a liquid consisting of 99% w of that mineral oil and 1% w of the
dimethicone used in the preferred zinc oxide-containing
composition. The 100% w mineral oil flowed down the surface of the
plastic laminate and traversed the distance of 4 inches (about 10.2
centimeters) in less than a second. The liquid consisting of 99% w
mineral oil and 10% w dimethicone flowed down the surface of the
plastic laminate and traversed the distance of 4 inches (about 10.2
centimeters) in about 4 seconds.
[0152] As used herein, the term "resists running" means that when a
composition is tested in this manner, if it is going to flow at
all, it requires at least about 10 seconds to traverse (flow down)
the 4 inches (in other words, it "resists running for at least
about 10 seconds"), usually at least about 15 seconds to traverse
the 4 inches (it "resists running for at least about 15 seconds"),
typically at least about 20 seconds to traverse the 4 inches (it
"resists running for at least about 20 seconds"), desirably at
least about 30 seconds to traverse the 4 inches (it "resists
running for at least about 30 seconds"), more desirably at least
about 45 seconds to traverse the 4 inches (it "resists running for
at least about 45 seconds"), most desirably at least about 1 minute
to traverse the 4 inches (it "resists running for at least about 1
minute"), preferably at least about 2 minutes to traverse the 4
inches (it "resists running for at least about 2 minutes"), more
preferably at least about 5 minutes to traverse the 4 inches (it
"resists running for at least about 5 minutes"), most preferably at
least about 10 minutes to traverse the 4 inches (it "resists
running for at least about 10 minutes"), and in some cases, it
requires at least about 30 minutes to traverse the 4 inches (it
"resists running for at least about 30 minutes"). The most
preferred compositions do not traverse the 4 inches even after an
hour or more and therefore may be said to "resist running" (they
"resist running for at least about 1 hour").
[0153] These tests demonstrate that the preferred zinc
oxide-containing composition of this invention "resists running"
and that neither of the other two compositions that were tested
"resists running." The latter two compositions are outside the
scope of the invention because, for example, neither contains a
rheology modifier and neither resists running. The test performed
with the preferred zinc oxide-containing composition also
demonstrates that it has suitable adherence to the skin.
[0154] The composition of this invention has the appropriate
rheology to be spray-pumpable (i.e., to have a low enough viscosity
under shear) as well as to resist running after it has been applied
to skin (i.e., to have a high enough viscosity when not under
shear). That arises in part from the fact that one or more rheology
modifiers are used to make the viscosity of the composition
generally decrease as the shear on it increases (i.e., the
composition may be pseudoplastic or thixotropic). Thus, as the
composition that had been at rest (i.e., not flowing) in the spray
pump dispenser starts to move, for example, up a tube inside the
spray pump dispenser, the shear increases and the viscosity of the
composition decreases. As the composition continues to move, for
example, in a narrowing passage towards the small aperture in the
nozzle of the spray pump dispenser, the shear continues to increase
and the viscosity continues to decrease. The shear may be at a
maximum, and the viscosity at a minimum, as the composition passes
through the aperture in the nozzle and leaves the spray pump
dispenser.
[0155] After the composition comes to rest on the skin, the force
being applied to the composition is substantially less than when
the composition was being forced to move inside the spray pump
dispenser and through the aperture. Accordingly, the viscosity of
the composition on the skin may become essentially the same as the
viscosity of the composition when it was at rest inside the spray
pump dispenser (and may become even higher if volatile carrier
ingredients evaporate, which is what desirably happens with the
compositions of this invention). This return to higher viscosity as
the shear decreases plus the optional use of one or more
film-forming agents help the composition resist running on the
skin. In short, a "rheology modifier" is a substance otherwise
suitable for incorporation into a composition of this invention
that helps impart to the composition the needed transport
properties and make it, for example, pseudoplastic or
thixotropic.
[0156] Broadly, the composition of this invention contains at least
one active ingredient for protecting skin, at least one rheology
modifier, and a carrier. A preferred embodiment of this invention
contains at least one active ingredient for treating diaper rash,
at least one rheology modifier, and a carrier. The composition of
this invention desirably also contains at least one film-forming
agent. Various optional ingredients include colorants, fragrances,
anti-microbials, preservatives, emollients, conditioners,
adherence-promoting agents, water-resistance agents, and
water-proofing agents.
[0157] The term "active ingredients for protecting skin" includes
mineral oil, dimethicone, zinc oxide, allantoin, calamine, kaolin,
petrolatum, white petrolatum, cod liver oil, lanolin, talc, topical
starch, aluminum hydroxide gel, cocoa butter, glycerine, shark
liver oil, zinc acetate, and zinc carbonate. The term "active
ingredients for protecting skin" also includes other substances
that are now or may in the future be efficacious for protecting
skin, provided they can be successfully used alone or in
combination with other active ingredients to form a composition of
this invention.
[0158] The term "active ingredients for treating diaper rash"
includes mineral oil, dimethicone, zinc oxide, allantoin, calamine,
kaolin, petrolatum, white petrolatum, cod liver oil, lanolin, talc,
and topical starch. The term "active ingredients for treating
diaper rash" also includes other substances that are now or may in
the future be efficacious for treating diaper rash, provided they
can be successfully used alone or in combination with other active
ingredients to form a composition of this invention. Of the active
ingredients listed above, dimethicone is preferred and a
combination of dimethicone and zinc oxide is most preferred.
[0159] The concentration of the one or more active ingredients for
protecting skin should be at least about 0.001% w, usually at least
about 0.01% w, desirably at least about 0.1% w, and preferably at
least about 1% w. In some cases, the concentration will be at least
about 5% w, at least about 10% w, or even at least about 50% w. The
FDA allows a claim to be made that dimethicone is present in a
composition as an active ingredient for treating diaper rash if its
concentration in the composition in question is from 1% w to 30% w
(and providing other FDA requirements are met). The corresponding
range for zinc oxide under current FDA regulations is from 1% w to
40% w. The corresponding range for mineral oil is from 50% w to
100% w.
[0160] The limitation "at least about 0.001% w of at least one
active ingredient for protecting skin" is satisfied or met (a) if
any active ingredient for protecting skin is present in a
concentration of at least about 0.001% w or (b) if two or more
active ingredients for protecting skin are present in a total
concentration of at least about 0.001% w even if none of the active
ingredients for protecting skin is individually present in a
concentration of at least about 0.001% w. Similarly, the limitation
"at least about 0.1% w of at least one active ingredient for
treating diaper rash" is satisfied or met (a) if any active
ingredient for treating diaper rash is present in a concentration
of at least about 0.1% w or (b) if two or more active ingredients
for treating diaper rash are present in a total concentration of at
least about 0.1% w even if none of the active ingredients for
treating diaper rash is individually present in a concentration of
at least about 0.1% w. In the same way, the limitation "at least
about 0.001% w of at least one rheology modifier" is satisfied or
met (a) if any rheology modifier is present in a concentration of
at least about 0.001% w or (b) if two or more rheology modifiers
are present in a total concentration of at least about 0.001% w
even if none of the rheology modifiers is individually present in a
concentration of at least about 0.001% w.
[0161] Other limitations specifying at least a certain weight
percent of at least one of a certain type of ingredient should be
understood that same way (making allowances, of course, for
different numerical limits and types of ingredients). For example,
the limitation "at least about 0.1% w of at least one film-forming
agent" is satisfied or met (a) if any film-forming agent is present
in a concentration of at least about 0.1% w or (b) if two or more
film-forming agents are present in a total concentration of at
least about 0.1% w even if none of the film-forming agents is
individually present in a concentration of at least about 0.1%
w.
[0162] If dimethicone is used, it will typically be present in the
composition in a concentration range of about 0.01% w to about 30%
w, desirably in a range of about 0.1% w to about 10% w, and
preferably in a range of about 0.2% w to about 3% w. If zinc oxide
is used, it will typically be present in a concentration range of
about 0.01% w to about 40% w, desirably in a range of about 0.1% w
to about 20% w, and preferably in a range of about 00.2% w to about
15% w. If mineral oil is used, it will typically be present in the
composition in a concentration range of about 10% w to about 99% w,
desirably in a range of about 50% w to about 85% w, and preferably
in a range of about 55% w to about 80% w.
[0163] The dimethicone used will desirably be a crystal clear
viscous liquid, free from suspended matter, and with very little
odor. Any dimethicone can be used. One dimethicone found suitable
has a viscosity in the range of about 333 to about 368 centistokes
when measured using a Ubbelhode Size 3 viscometer at 25 degrees
Centigrade and a specific gravity of about 0.96 to about 0.98 (25
degrees Centigrade/25 degrees Centigrade).
[0164] The zinc oxide used will desirably be a high purity USP
(United States Pharmacopoeia) zinc oxide with a typical particle
size of about 0.11 microns, a maximum particle size of about 0.14
microns, a minimum surface area (BET) of about 8 square meters per
gram, a typical surface area (BET) of about 9 square meters per
gram, a bulk density of about 50 pounds per cubic foot (0.80 grams
per cubic centimeter), an apparent density of about 16 pounds per
cubic foot (0.26 grams per cubic centimeter), and with about 99.99%
of the particles passing through a 325 mesh screen. Thus, the zinc
oxide used herein will typically have an average particle size of
less than about 1 micron (desirably less than about 0.75 microns,
more desirably less than about 0.50 microns, most desirably less
than about 0.25 microns, preferably less than about 0.20 microns,
and more preferably less than about 0.15 microns) and a BET surface
area of at least about 5 square meters per gram. The zinc oxide
particle size (and the size of any other particulates in the
composition) should not be so large as to prevent the composition
from being spray-pumpable.
[0165] The mineral oil is desirably light mineral oil NF (National
Formulary) and is a colorless, odorless, transparent oil liquid.
Its viscosity will desirably be in the range of about 7 to about 10
centistokes when measured using a Ubbelhode Size 2 viscometer at 40
degrees Centigrade, with a specific gravity of about 0.83 to about
0.84 (25 degrees Centigrade/25 degrees Centigrade).
[0166] The concentration of the one or more rheology modifiers
should be at least about 0.001% w, usually at least about 0.01% w,
desirably at least about 0.1% w, and preferably at least about 1%
w. In some cases, the concentration will be at least about 5% w, at
least about 110% w, or even at least about 20% w.
[0167] The term "rheology modifier" includes waxes and associative
thickeners. The term "rheology modifier" also includes other
substances that are now or may in the future be useful as rheology
modifiers, provided they can be successfully used alone or in
combination with other rheology modifiers to form a composition of
this invention. The one or more rheology modifiers help impart the
desired transport properties to the composition, that is, they help
make the composition for example, pseudoplastic or thixotropic, so
that it is spray-pumpable but able to resist running after it has
been applied to the skin.
[0168] The wax, if used, is desirably a mineral wax. If mineral wax
is used, it will typically be present in the composition in a
concentration range of about 0.01% w to about 20% w, desirably in a
range of about 0.1% w to about 15% w, and preferably in a range of
about 0.2% w to about 6% w. The mineral wax will typically be a
white to yellowish odorless waxy solid, desirably having a melting
range of from about 65 degrees Centigrade to about 71 degrees
Centigrade.
[0169] The associative thickener, if used, desirably comprises a
silica and preferably colloidal silicon dioxide NF (National
Formulary). Its particle size cannot be so large as to prevent the
composition from being spray-pumpable.
[0170] Desirably the mineral wax and colloidal silicon dioxide are
both used. The wax helps give the composition some body, provides
internal cohesiveness (internal tack) to the layer of composition
on the skin (which facilitates removal from the skin), and provides
water repellency, in addition to acting as a rheology modifier. The
colloidal silicon dioxide acts as a rheology modifier and if zinc
oxide is present in the composition, the silicon dioxide helps to
suspend the zinc oxide particles. As between these two types of
rheology modifiers (waxes and associative thickeners), the
associative thickeners are believed to play a larger role in giving
the composition of this invention the desired transport properties
to make it, for example, pseudoplastic or thixotropic.
[0171] The carrier can comprise more than one ingredient. The
concentration of the carrier in the composition should be at least
about 10% w, usually at least about 20% w, desirably at least about
30% w, preferably at least about 40% w, more preferably at least
about 50% w, and most preferably at least about 60% w.
[0172] The term "carrier" includes mineral oil and mineral oil
replacements. The term "carrier" also includes other substances
that are now or may in the future be useful as carriers, provided
they can be successfully used alone or in combination with other
carrier ingredients to form a composition of this invention.
[0173] Mineral oil replacements include alkanes having at least 10
carbon atoms (e.g., isohexadecane), benzoate esters, aliphatic
esters, noncomodogenic esters, volatile silicone compounds (e.g.,
cyclomethicone), and volatile silicone substitutes. Examples of
benzoate esters include Cl.sub.2-C.sub.15 alkyl benzoate,
isostearyl benzoate, 2-ethyl hexyl benzoate, dipropylene glycol
benzoate, octyldodecyl benzoate, stearyl benzoate, and behenyl
benzoate.
[0174] Examples of aliphatic esters include C.sub.12-C.sub.15 alkyl
octonoate and dioctyl maleate. Examples of noncomodogenic esters
include isononyl isononanoate, isodecyl isononanoate, diisostearyl
dimer dilinoleate, arachidyl propionate, and isotridecyl
isononanoate. Examples of volatile silicone substitutes include
isohexyl decanoate, octyl isononanoate, isononyl octanoate, and
diethylene glycol dioctanoate.
[0175] If mineral oil is used, it will typically be present in the
composition in a concentration range of about 10% w to about 99% w,
desirably in a range of about 50% w to about 85% w, and preferably
in a range of about 55% w to about 80% w.
[0176] If isohexadecane is used, it will typically be present in
the composition in a concentration range of about 0.01% w to about
50% w, desirably in a range of about 0.1% w to about 15% w, and
preferably in a range of about 0.2% w to about 10% w. The
isohexadecane helps reduce the greasiness of the composition that
might be felt if it were not present. Isohexadecane by itself tends
to feel "dry" and not greasy.
[0177] If cyclomethicone is used, it will typically be present in
the composition in a concentration range of about 0.01% w to about
99% w, desirably in a range of about 0.1% w to about 20% w, and
preferably in a range of about 0.2% w to about 15% w.
Cyclomethicone is an evaporative silicone and it helps make the
composition spray-pumpable. Furthermore, after the composition is
dispensed and contacts the skin, the cyclomethicone tends to
evaporate, thereby helping to the composition to resist running and
thereby fix the composition on the skin on which it was
sprayed.
[0178] Preferably the carrier comprises a combination of mineral
oil, isohexadecane, and cyclomethicone.
[0179] Desirably at least one film-forming agent is used in the
composition. The concentration of the one or more film-forming
agents should be at least about 0.001% w, usually at least about
0.01% w, desirably at least about 0.1% w, more desirably at least
about 0.2% w, preferably at least about 1% w, and more preferably
at least about 2% w. In some cases, the concentration will be at
least about 5% w, at least about 10% w, or even at least about 20%
w.
[0180] The term "film-forming agent" includes polymers such as
silicone-containing polymers and synthetic waxes. The term
"film-forming agent" also includes other substances that are now or
may in the future be useful as film-forming agents, provided they
can be successfully used alone or in combination with other
film-forming agents to form a composition of this invention.
[0181] The silicone-containing polymers that are useful herein will
typically have silicone-seeking groups and hydrophobic groups. An
example of a silicone-containing polymer that may be used as a
film-forming agent is a polydimethylsiloxane-polypropylene glycol
ether/isopropyldiisocyanat- e copolymer, which is a silicone
polyurethane and is described as a semi-clear faint yellow viscous
liquid. Such a material is marketed under the name Polyderm
PPI-SI-WI by Alzo Inc., located in Matawan, N.J., United States. If
that silicone-containing polymer is used, it will typically be
present in the composition in a concentration range of about 0.01%
w to about 15% w, desirably in a range of about 0.1% w to about 10%
w, and preferably in a range of about 0.2% w to about 3% w. This
polymer functions not only as a film-forming agent but also is a
conditioner and emollient, helps impart water-resistance, and helps
provide adherence of the composition to the skin. This polymer also
helps couple the silicone-containing components present (e.g.,
dimethicone and cyclomethicone) to the non-silicone-containing
ingredients present (e.g., mineral oil).
[0182] An example of a synthetic wax that may be used as a
film-forming agent is described as a highly branched hydrocarbon
manufactured from olefins. A suitable synthetic wax may have a
polydispersity of about 2.4, a number average molecular weight of
about 900, and a weight average molecular weight of about 2,200.
One such suitable material is marketed under the name Performa V
825 Polymer by New Phase Technologies located in Piscataway, N.J.,
United States. The company's "NPT Technical Bulletin 6825-1"
(revision dated 3/99) describes the material as "an excellent film
former and conditioner," which "provides gloss to lipsticks and
improves the rheology of sunscreen formulations." If that synthetic
wax is used, it will typically be present in the composition in a
concentration range of about 0.01% w to about 30% w, desirably in a
range of about 0.1% w to about 10% w, and preferably in a range of
about 0.2% w to about 6% w. This synthetic wax functions not only
as a film-forming agent but also helps impart water-resistance.
[0183] Many different optional ingredients may be included in the
composition, including colorants, fragrances, anti-microbials,
preservatives, emollients, conditioners, adherence-promoting
agents, water-resistance agents, and water-proofing agents. For
example, an aloe barbadensis product may be included as may
vitamins such as vitamin E. An aloe product, if used in the
composition, will typically be present in the composition in a
concentration range of about 0.01% w to about 15% w, desirably in a
range of about 0.1% w to about 10% w, and preferably in a range of
about 0.2% w to about 6% w. Vitamin E, if used in the composition,
will typically be present in the composition in a concentration
range of about 0.01% w to about 5% w, desirably in a range of about
0.1% w to about 3% w, and preferably in a range of about 0.2% w to
about 1% w, and may be added in its acetate ester form.
[0184] A preferred composition without zinc oxide and a preferred
composition with zinc oxide are shown below (numerical values are
weight percentages).
1 Preferred Composition Preferred Composition Ingredient Without
Zinc Oxide With Zinc Oxide Mineral Oil 70.95 66.50 Polyderm
PPI-SI-WI 1.00 0.50 Dimethicone 1.00 1.00 Mineral Wax 5.00 2.25
Performa V 825 Polymer 2.00 1.30 Colloidal Silicon Dioxide 2.30
2.10 Cyclomethicone 9.00 8.50 Isohexadecane 6.50 5.60 Aloe
Barbadensis Extract 2.00 2.00 Vitamin E Acetate 0.25 0.25 Zinc
Oxide 0.00 10.00 Total 100.00 100.00
[0185] A typical process for manufacturing the preferred
composition with zinc oxide is as follows. The first five
ingredients (mineral oil, Polyderm PPI-SI-WI, dimethicone, mineral
wax, and Performa V 825 Polymer) are placed in a suitable stainless
steel container and heated to about 80 degrees Centigrade while
mixing at slow speed. After the mineral wax melts, heating is
halted and the zinc oxide is added while mixing at about 500 RPM
(revolutions per minute) for at least 10 minutes. When the batch
cools to about 50 degrees Centigrade (while still mixing), the
colloidal silicon dioxide is added and the mixing speed is
increased to about 2,000 RPM and held at that speed for at least 20
minutes. The remaining ingredients (cyclomethicone, isohexadecane,
aloe barbadensis extract, and vitamin E acetate) are then added and
mixing is continued for about 15 minutes. At the end of this time,
the material is milled to further homogenize it and the manufacture
is then complete. To make the preferred composition that does not
contain the zinc oxide, the process is essentially the same, the
major difference being that the step in which the zinc oxide is
added is omitted. The processes for making other compositions of
the invention are well within the skill of the art.
[0186] When the composition contains solid suspended particles
(e.g., the zinc oxide and/or colloidal silica), it might be seem to
be more appropriate to refer to the composition as a dispersion or
suspension rather than as a liquid. However, even though solid
particles may be present, the composition of this invention will
still be referred to as a "liquid" because (a) the continuous phase
of the composition is liquid and typically will account for the
majority of the composition (and preferably about 90% w of it) and
(b) the user will likely perceive such a composition as being
"liquid."
[0187] For a variety of reasons, such a dispersion or suspension is
desirably storage-stable, that is, the particles desirably do not
settle out, even after prolonged standing. When zinc oxide
particles are present, the silica (e.g., colloidal silicon dioxide)
helps prevent their settling. If particles do settle out, they
should be readily and easily redispersable and resuspendable,
preferably merely by shaking the composition a few times.
[0188] As will be apparent, a single ingredient can perform more
than a single function in a composition of this invention. Thus, it
should be understood in applying the claims to a given composition
that because an ingredient of the composition may perform more than
one function, that one ingredient may thereby satisfy (or meet)
more than one limitation of a claim. For example, mineral oil,
which can act as an active ingredient, is also a preferred carrier.
If mineral oil is present in a composition in at least the minimum
concentration for an active ingredient for protecting skin
specified by the limitation of a given claim, then the mineral oil
of that composition meets that claim limitation. If the mineral oil
is also present in that composition in at least the minimum
concentration specified for the carrier by another limitation of
the same claim, then the mineral oil of that composition also meets
that limitation of the claim. Thus, the same ingredient and amount
of ingredient can satisfy more than a single limitation of a claim.
(If no numerical minimum is specified in a claim limitation that
requires the presence of an ingredient, for example, a limitation
that just requires "carrier," that limitation is satisfied (or met)
if at least some of the ingredient is present.)
[0189] Variations and modifications will be apparent to those
skilled in the art and the claims are intended to cover all
modifications and variations that fall within the true spirit and
scope of the invention.
* * * * *