Medicated Shampoo Composition

The present invention is directed generally to an improved medicated shampoo composition for treating various scalp disorders or conditions. More particularly, the present application is directed to a medicated shampoo composition containing a safe and effective combination of pharmacologically active ingredients, including between approximately 0.1% but less than approximately 0.5% by weight of a hydrocortisone in combination with between approximately 2.5% but less than approximately 5.0% by weight of colloidal sulfur.

Significant proportions of the population are afflicted with various scalp disorder conditions, including but not limited to flaking, scaling, dandruff, psoriasis, eczema, seborrhea and others. In treating such conditions it is desirable to avoid sticky, gooey, gummy, greasy preparations, which may be appropriate for application to other parts of the body which may be concealed either by clothing or a bandage, as such compositions are unattractive in that they would affect the usual or normal appearance of the hair. Also, such compositions would have a tendency to rub off on anything touched by the hair. Accordingly, periodic application of an effective ingredient for treatment of such conditions in the form of a shampoo has been desirable.

In formulating a suitable combination of ingredients for treating such scalp disorder conditions, it has been necessary that such compositions be both safe and effective. Some proposed combinations of ingredients have been safe (i.e., would not cause undesirable side effects in the patient), but have not been effective against the above scalp disorder conditions. Other proposed combinations of ingredients in the prior art have made substantial progress toward treating the above scalp conditions, but have caused various undesirable side effects.

Also various proposed prior art compositions have utilized ingredients which were unstable in combination, and which led to a very short shelf life for the combined mixture. Such short shelf life has led to significant problems and has limited the channels of distribution to those of prescription medications to be produced on an individual basis. This necessary method of production for such prior art compositions has unnecessarily increased the cost to the consumer, and sometimes to prohibitive levels.

It is therefore an object of the medicated shampoo composition of the present invention to alleviate materially these disadvantages and shortcomings of the prior art.

The present invention comprises a medicated shampoo composition for treating scalp disorder conditions including flaking, scaling, dandruff, psoriasis, eczema, seborrhea, and other conditions. The medicated shampoo composition of the present invention includes a safe and effective combination of pharmacologically active ingredients, including between approximately 0.1% but less than approximately 0.5% by weight of a hydrocortisone in combination with between approximately 2.5% but less than approximately 5.0% by weight of colloidal sulfur. These pharmacologically active ingredients are disposed into a shampoo base. In preferred embodiments, the hydrocortisone ingredient comprises approximately 0.3% by weight. Such hydrocortisones may include:

hydrocortisone;

2-methylenehydrocortisone;

.DELTA.1-hydrocortisone;

6-methylhydrocortisone;

6-methyl-.DELTA.1-hydrocortisone;

16-hydroxy-9 fluorohydrocortisone;

16-hydroxy-9-fluoro-.DELTA.1-hydrocortisone;

the substantially water-insoluble 21-esters thereof; and/or the substantially water-insoluble 16, 21-diesters thereof.

In preferred compositions, the colloidal sulfur comprises approximately 4.0% by weight. A catalyst for the colloidal sulfur is also preferably included in the composition. Such catalyst may also act as a local mild semi-irritant. Salicylic acid is suitable for such catalyst and/or local mild semi-irritant, and may be present in amounts of approximately 0.1% to approximately 0.5% by weight.

The shampoo base of the present invention preferably comprises a detergent, with a C14-16 olefin sulfonate being generally preferred. Such detergent may be selected from the group consisting in preferred embodiments of a lauryl sulfate salt, a laureth sulfate salt, an amphoteric, and a betaine. In particular the lauryl sulfate salt may preferably comprise ammonium sulfate, sodium lauryl sulfate and TEA lauryl sulfate. The laureth sulfate salt may preferably comprise ammonium laureth sulfate, sodium laureth sulfate and TEA lauryl sulfate. The betaine may preferably comprise cocamidopopyl betaine.

The medicated shampoo composition of the present invention also preferably comprises at least one each of a foam stabilizer, foam builder, thickener, scalp coolant, shampoo stabilizer, shampoo preservative, and pH adjuster.

The foam stabilizer preferably comprises teadodecylbenzenesulfonate. The foam builder preferably comprises lauramide DEA and/or cocamide DEA. The thickener preferably comprises an inorganic salt, such as sodium chloride, ammonium chloride, potassium chloride or sodium sulfate. The scalp coolant preferably comprises a mild local irritant, such as for example menthol. The shampoo stabilizer preferably comprises PEG-120 methyl glucose dioleate. The shampoo preservative preferably comprises methylparaben and/or imidazolidinyl urea. The pH adjuster may preferably include phosphoric acid. Additionally, various fragrances and/or colorants may be added according to preference.

The following approximate range of ingredients may be utilized in preferred embodiments:

The following ingredients were combined to form the medicated shampoo of the present invention:

the above ingredients were combined according to the following mixing instructions:

A. Dissolve methylparaben in the lauramide DEA and menthol.

B. Dissolve the hydrocortisone in a portion of the sodium C olefin sulfonate and add the salicylic acid with mixing until dissolved.

C. Heat the PEG-120 methyl glucose dioleate with a small portion of the water and teadodecylbenzensulfonate until melted.

D. Dissolve the sodium chloride in a portion of the water.

E. Dissolve the imidazolidinyl urea in a small amount of water.

F. Pump the remainder of water into the mixing tank.

G. Pump the remainder of the sodium C14-16 olefin sulfonate into the tank with the water, and add (A) with controlled speed to prevent excess foaming.

H. Add (B) to the mixture of above. Add the New Sulfur W.

I. Add (C). Continue to stir. Add (E) and then (D).

J. Adjust the pH with the phosphoric acid.

K. When the formula is thoroughly mixed, add the fragrance.

L. Allow the batch to stand until foam has abated and quality control tests are performed. Then fill the bottles.

The basic and novel characteristics of the medicated shampoo compositions of the present invention will be readily understood from the foregoing disclosure by those skilled in the art. It will become readily apparent that various changes and modifications may be made in the ingredients and manner of combining said ingredients of the medicated shampoo compositions of the present invention as set forth hereinabove without departing from the spirit and scope of the invention. Accordingly, the preferred and alternative embodiments of the present invention set forth hereinabove are not intended to limit such spirit and scope in any way.