Composition for treating and/or ameliorating the diseases of...

Drug – bio-affecting and body treating compositions – Live hair or scalp treating compositions – Amphoteric or zwitterionic surfactant containing

Reexamination Certificate

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C424S070220, C424S070100, C424S070110, C514S881000, C514S880000

Reexamination Certificate

active

06333027

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a composition that is useful for treating and/or ameliorating the disease of dandruff, seborrheic dermatitis, psoriasis And eczema and/or the symptoms associated therewith and has a low degree of ocular and skin irritation. More specifically, this invention is related to such compositions comprised of undecylenamidopropylbetaine and mixtures thereof with undecylenic acid which are suitable for such uses.
2. Description of the Prior Art
It is well known that many surfactants used in shampoos are irritating to the eyes, which is of particular concern in shampoos used on infants and children. As a result, several less irritating surfactants have been developed.
However, as children approach the age of puberty, hormonal changes associated with the development of scalp conditions normally associated with dandruff, such as scalp irritation and scaling, often occur. Unfortunately the active ingredients that are effective in treating such conditions are irritating to the eyes. For example, Undecylenic Acid, which is commercially available from Elf Atochem of France, and its betaine derivative, Undecylenamidopropylbetaine, which is commercially available from CECA-ATO of France under the tradename, “Amphoram U,” are known as being useful for antidandruff properties in shampoos, but not without the disadvantage of eye irritancy. Therefore, there is a need for a shampoo formulation, which is not only suitable for use by children to effectively treat the skin conditions cited above, but also possesses a low degree of ocular and skin irritation.
SUMMARY OF THE INVENTION
The present invention provides a composition that is useful for treating the diseases of dandruff, seborrheic dermatitis, eczema, and psoriasis and/or the symptoms associated therewith and is non-stinging to the eyes comprising, consisting essentially of, and/or consisting of, based upon the total weight of the composition,
a) from about 0.5 percent to about 16 percent of at least one amphoteric surfactant;
b) from about 1 percent to about 10 percent of at least one anionic surfactant;
c) from about 0.1 percent to about 10 percent of at least one non-ionic surfactant; and
d) from about 0.1 weight percent to about 15 weight percent active ingredient.
In a second embodiment, the present invention provides a method for treating and/or ameliorating the diseases of dandruff, seborrheic dermatitis, eczema, and psoriasis and/or the symptoms associated therewith comprising, consisting essentially of, and/or consisting of: topically applying an effective amount of the detergent composition described above to an area desired.
In a third embodiment, the present invention provides a method for treating and/or ameliorating the diseases of dandruff, seborrheic dermatitis, eczema, and psoriasis and/or the symptoms associated therewith comprising, consisting essentially of, and/or consisting of: topically applying an effective amount of a detergent composition including a) from about 1 percent to about 11 percent of at least one amphoteric surfactant; b) from about 1 percent to about 8 percent of at least one anionic surfactant; c) from about 1 percent to about 10 percent of at least one non-ionic surfactant; and d) from about 3.5 percent to about 9 percent active ingredient comprised of, based upon the total weight of detergent composition, 1) from about 3 percent to about 7 percent of Undecylenamidopropylbetaine; and 2) from about 0.5 percent to about 2 percent of undecylenic acid, to an area desired.
In a fourth embodiment, the present invention provides a method for treating and/or ameliorating the diseases of dandruff, seborrheic dermatitis, eczema, and psoriasis and/or the symptoms associated therewith comprising, consisting essentially of, and/or consisting of: topically applying an effective amount of a detergent composition including a) from about 2 percent to about 10 percent of at least one amphoteric surfactant; b) from about 1 percent to about 6 percent of at least one anionic surfactant; c) from about 4 percent to about 8 percent of at least one non-ionic surfactant; and d) from about 0.8 percent to about 7 percent active ingredient comprised of, based upon the total weight of detergent composition, 1) from about 5 percent to about 6 percent of Undecylenamidopropylbetaine; and 2) from about 0.8 percent to about 1 percent of Undecylenic Acid, to an area desired.
We have unexpectedly found that the detergent composition of the present invention is not only effective in treating and/or ameliorating the diseases of dandruff, seborrheic dermatitis, eczema, and psoriasis and/or the symptoms associated therewith, but it does so with a low degree of skin and ocular irritation.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
The first embodiment of the present invention is directed to a detergent composition comprised of, based upon the total weight of the detergent composition, from about 0.5 percent to about 16 percent, preferably from about 1 percent to about 11 percent, and more preferably from about 2 percent to about 10 percent of at least one amphoteric surfactant; from about 1.0 percent to about 10 percent, preferably from about 1 percent to about 8 percent, and more preferably from about 1 percent to about 6 percent of at least one anionic surfactant; from about 0.1 percent to about 10 percent, preferably from about 1 percent to about 10 percent, and more preferably from about 4 percent to about 8 percent of at least one non-ionic surfactant; and from about 0.1 weight percent to about 15 weight percent, preferably from about 3.5 weight percent to about 9 weight percent, and more preferably from about 5 weight percent to about 7 weight percent of an active ingredient.
As used herein, the term “amphoteric” shall mean: 1) molecules that contain both acidic and basic sites such as, for example, an amino acid containing both amino (basic) and acid (e.g., carboxylic acid, acidic) functional groups; or 2) zwitterionic molecules which possess both positive and negative charges within the same molecule. The charges of the latter may be either dependent on or independent of the pH of the composition. Examples of zwitterionic materials include, but are not limited to, alkyl betaines and amidoalkyl betaines. The amphoteric surfactants are disclosed herein without a counter ion. One skilled in the art would readily recognize that under the pH conditions of the compositions of the present invention, the amphoteric surfactants are either electrically neutral by virtue of having balancing positive and negative charges, or they have counter ions such as alkali metal, alkaline earth, or ammonium counter ions.
Commercially available amphoteric surfactants suitable for use in the present invention include, but are not limited to amphocarboxylates, alkyl betaines, amidoalkyl betaines, amidoalkyl sultaines, amphophosphates, phosphobetaines, pyrophosphobetaines, carboxyalkyl alkyl polyamines, and mixtures thereof. Cocamidopropylbetaine and Lauroamphodiacetate are preferred.
Suitable anionic surfactants include, but are not limited to alkyl sulfates; alkyl ether sulfates; alkyl monoglyceryl ether sulfates; alkyl monoglyceride sulfates; alkyl monoglyceride sulfonates; alkyl sulfonates; alkylaryl sulfonates; alkyl sulfosuccinates; alkyl ether sulfosuccinates; alkyl sulfosuccinamates; alkyl amidosulfosuccinates; alkyl carboxylates; alkyl amidoethercarboxylates; alkyl succinates; fatty acyl sarcosinates; fatty acyl amino acids; fatty acyl taurates; fatty alkyl sulfoacetates; alkyl phosphates; and mixtures thereof, wherein the alkyl group has from about 10 to about 16 carbon atoms. Preferred anionic surfactants include Sodium Laureth Sulfate 3 EO.
One class of nonionic surfactants useful in the present invention are polyoxyethylene derivatives of polyol esters, wherein the polyoxyethylene derivative of polyol ester (1) is derived from (a) a fatty acid containing from about 8 to about 22, and preferably from about 10 to about 14 carbon atoms, and (b) a polyol selected fr

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