Drug – bio-affecting and body treating compositions – Anti-perspirants or perspiration deodorants
Reexamination Certificate
2000-06-14
2003-03-11
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Anti-perspirants or perspiration deodorants
C424S401000
Reexamination Certificate
active
06531119
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to cosmetic compositions such as deodorants and antiperspirants which are based on soap gelled systems and which have reduced irritancy when applied to skin. The composition may be in the form of a gel, stick, soft solid or cream. The present invention is directed to clear, translucent and opaque products, especially clear cosmetic (for example, deodorant) gel compositions and, more especially, a soft gel or stick composition gelled utilizing a soap gelling agent, having reduced skin irritation potential yet having improved clarity.
BACKGROUND OF THE INVENTION
Gel compositions, such as soap-gelled compositions, have proven to be a convenient and efficient vehicle for the application of various active ingredients to the skin. Such active ingredients include (but are not limited to) antiperspirants, deodorants, perfumes, sunscreens, cosmetics, emollients, insect repellents, medicaments and the like. Such gel compositions may be in the form of a gel, soft solid, cream and/or a stick. Rubbing such a product containing an appropriate amount of active ingredient dissolved or dispersed therein against the skin causes transfer of a film of the composition to the skin surface against which the soft gel or stick is rubbed, leaving the active ingredient within the film of the composition on a desired skin surface area.
Conventional soap-gelled base formulations (that is, base gel compositions gelled using a soap gelling agent) for depositing the active ingredient normally include as major components a mixture of from about 3 to about 10% by weight, of the total weight of the composition, of an alkali metal salt of a fatty acid containing primarily 12 to 22 carbon atoms, for example, sodium stearate or sodium palmitate soap, and a suitable solvent in which the soap is soluble, for example, water, organic solvents such as lower monohydric alcohols and/or glycols, or mixtures thereof. The product forms described above (sticks, gels, soft solids, creams) may be formulated as known in the art, depending, for example, on the amount of gelling agent utilized. For example, the stick is formed by pouring a mixture of the various components into a suitably shaped mold and permitting the composition to gel and cool, thereby hardening the composition.
A typical example of a water-based cosmetic stick formulation is disclosed in U.S. Pat. No. 4,322,400 to Yuhas, wherein the composition includes a mixture of water, sodium stearate, a cosmetically active ingredient and up to about 5% by weight, of the total weight of the composition, of sodium chloride, which tends to increase the setting point of the gel. The composition may also optionally contain up to about 10% by weight of one or more glycols, such as propylene glycol or polypropylene glycols having molecular weights of up to 25,000.
Other gel stick formulations, which are essentially free of water, are disclosed, for example, in U.S. Pat. No. 5,284,649 to Juneja. The composition of this patent includes a mixture of about 1-20% by weight, of the total weight of the composition, of a fatty acid soap, a zinc pyridinethione as a deodorant active, and about 7-95% by weight, of the total weight of the composition, of a polar solvent system which solubilizes the soap. Suitable solvents in the polar solvent system include lower monohydric alcohols such as ethanol or propanol, glycols such as ethylene glycol and propylene glycol, and polypropylene glycols such as dipropylene glycol, tripropylene glycol and higher glycols.
In addition, U.S. Pat. No. 4,504,465 to Sampson, et al discloses a water-free stick formulation based on a mixture of about 3-10% by weight soap, from about 6-70% by weight of an aliphatic polyhydric alcohol containing 2 or 3 carbon atoms and from 2 to 3 hydroxy groups, for example, ethylene glycol, propylene glycol, trimethylene glycol or glycerine, and from about 20 to 80% by weight of a condensation product of the formula R(OC
3
H
6
)
a
(OC
2
H
4
)
b
OH, wherein R is either hydrogen or a hydrocarbon chain having from about 2-20 carbon atoms and a and b are each from 0 to 35 and a+b is from 5 to 35. The preferred solvent system disclosed includes a mixture of a lower alkanol such as ethanol, propylene glycol and a major amount of polypropylene glycol, polyethylene glycol or condensates of propylene oxide with C
2
-C
20
alcohols.
European Patent Application (EP) 284765 B1 discloses a soap-based cosmetic stick formulation of improved transparency and of more pleasing aesthetic appearance, wherein the solvent used to formulate the stick is dipropylene glycol or a mixture of dipropylene glycol and propylene glycol.
A non-soap-based stick antiperspirant formulation is disclosed in U.S. Pat. No. 5,200,174 to Gardlik, et al, wherein the solvent system includes a mixture of 2-oxazolidinone and one or more hydroxy solvents inclusive of lower alkanols, glycols such as propylene glycol and polyglycols such as polyethylene and polypropylene glycols. Dipropylene glycol and combinations of dipropylene glycol and propylene glycol are specifically used in the examples.
Gel stick formulations containing both a glycol and water are also known. For example, U.S. Pat. No. 4,702,916 to Geria discloses an analgesic stick composition including a mixture of from about 10-65% by weight of an alcohol, about 6-10% by weight soap and about 10-30% by weight water. The alcohol component preferably is propylene glycol.
One of the problems associated with the use of soap-based products is that they may be harsh to the skin of some consumers, causing skin irritation and leading to the development of erythema. Substitution of the soap with other gelling agents such as dibenzylidene alditol as in U.S. Pat. No. 5,200,174, discussed above, may reduce the irritation problem, but these formulations present stability problems and add to the expense of the product.
Japanese Patent Document No. 63-270614 discloses a soap-free gel base including a mixture of 0.1-5% by weight of a carboxyvinyl polymer used as a gelling agent, 30-80% by weight of a polyhydric alcohol and water. Examples of the disclosed polyhydric alcohols include propylene glycol, 1,3-butylene glycol, dipropylene glycol, tripropylene glycol and hexylene glycol. This composition is described as being safe to the skin.
A stick composition also disclosed as having a reduced tendency to irritate skin, while also being transparent, is disclosed in U.S. Pat. No. 5,128,123 to Brewster. This composition includes, in addition to soap and a polyhydric alcohol solvent such as propylene glycol, up to 40% by weight of an alkoxylate copolymer which is a condensate of ethylene oxide and propylene oxide, or an addition product condensate of ethylene oxide and propylene oxide with ethylene diamine.
A co-pending case now issued as U.S. Pat. 5,730,963 to the same owner as this application describes an approach suitable for use with soap-based and non-soap-based gelling systems which comprises the use of selected higher molecular weight glycols. This case recites lower irritation.
U.S. Pat. 6,036,964, now issued to the same owner as this application, describes a personal care product with an enhanced delivery system comprising a multi-component glycol system with at least three different components (for example, propylene glycol, dipropylene glycol and tripropylene glycol) in selected amounts.
Irritation may, in fact, be a cumulative result of a number of ingredients. The conventional wisdom up to now, for producing cosmetic formulations which are milder to the skin, appears to be (a) elimination of soap totally from the formulation and replacing it with a non-soap gelling agent, (b) reducing the amount of soap present in the formulation and including a different, less irritating co-structurant such as alkylene oxide condensates, or (c) eliminating both the soap and irritating lower alcohols, such as ethanol, from the formulation. Efforts to find additives for reducing irritation have not always proven successful because of stability problems.
The search for improved p
Gale Anne Elisabeth Vickery
Hall-Puzzio Patricia Ann
Colgate-Palmolive Company
Miano Rosemary M.
Page Thurman K.
Tran S.
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