Drug – bio-affecting and body treating compositions – Live hair or scalp treating compositions
Reexamination Certificate
2000-06-30
2003-02-04
Venkat, Jyothsan (Department: 1615)
Drug, bio-affecting and body treating compositions
Live hair or scalp treating compositions
C424S070800, C424S401000, C514S844000, C514S859000, C514S863000, C514S880000
Reexamination Certificate
active
06514489
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates methods of reducing, inhibiting or eliminating malodor in dermatological compositions containing sulfur. The invention also relates to sulfur containing dermatological compositions that produce little or no malodor.
BACKGROUND OF THE INVENTION
Elemental sulfur (in a variety of forms), sulfides, sulfites and/or mercaptans are commonly used ingredients in dermatologic or cosmetic compositions for the treatment of a variety of dermatological conditions. Various forms of sulfur, sulfides, sulfites and mercaptans are believed to have anti-microbial, anti-fungal, anti-parasitic and anti-inflammatory functions. Sulfur, in its various forms, sulfides, sulfites and mercaptans are believed to kill parasites, such as mites, and microorganisms, including but not limited to bacteria, and thereby also suppress their endotoxins and exotoxins, all of which can be irritants that may contribute to the provocation of itching, redness and irritation that are characteristics of rosacea. Further, sulfur causes keratolytic/sloughing activity and may, therefore, remove irritants that are held by the sloughed cells, as well as smoothing and soothing the skin.
Unfortunately, sulfur containing compositions may be, or may become, malodorous over time yielding a characteristic “rotten egg odor.” This malodor is believed to be caused by the formation of volatile sulfur-containing compounds, for example, hydrogen sulfide (H
2
S), sulfur dioxide (SO
2
) and various other volatile sulfides and mercaptans. These odor causing compounds can be generated even by sulfur compounds which are not themselves odor causing. As a result of the unpleasant odor, patients are sometimes reluctant to apply such compositions directed by their physician or pharmacist. Such poor patient compliance can seriously diminish the effectiveness of a treatment regimen.
The prior art has used a variety of techniques to try to deal with the odor associated with sulfur containing compositions. For example, U.S. Pat. No. 4,338,301 describes the use of clays to control the odor of alkaline sulfur containing compositions. Another approach to odor content is to include compounds that react ionically or covalently with odor causing sulfur compounds to reduce or eliminate offensive odors. Examples of agents that can tie-up volatile compounds, such as SO
2
, H
2
S, —SH compound, sulfur include heavy metal oxide and related compounds such as zinc oxide, titanium oxide that can form non-volatile or weakly volatile sulfides such as Zinc sulfide, or telamursulfide and the like. Other approaches include the use of scents or perfume to overpower or mask the offensive odor. Sometimes, formulators forgo the use of particular sulfur compounds that generate strong odors, even though they are otherwise desirable. None of these techniques have been entirely satisfactory.
Accordingly, there is a need for improved methods for reducing, inhibiting or eliminating the production of sulfurous malodor in sulfur containing dermatological or cosmetic compositions.
SUMMARY OF THE INVENTION
The present invention is directed to a composition comprising a sulfur ingredient and a carrier; wherein the composition has a pH of from about 6.5 to about 8.1. Alternatively, the hydrogen ion concentration of the composition should be no more than 3.16×10
−7
and no less than 7.95×10
−9
.
The present invention is also directed to a method for reducing or inhibiting the production of malodor in sulfur containing dermatological compositions comprising the step of adjusting the pH of the composition to between about 6.5 to about 8.1.
The present invention is also directed to a dermatological composition suitable for topical application to human skin, comprising: at least one sulfur ingredient; and a pharmaceutically acceptable carrier, wherein the composition has a pH of about 6.5 to about 8.1 and the composition exhibits substantially reduced sulfur odor, particularly after aging.
DETAILED DESCRIPTION
It has been discovered that the occurrence of sulfur malodor in commercially available sulfur containing dermatological and cosmetic compositions may be reduced, inhibited or eliminated by formulating sulfur containing dermatological compositions to minimize the production of volatile sulfur derivatives, initially and as the composition ages. This may be accomplished by selectively incorporating ingredients that result in the sulfur containing composition having a pH from about 6.0 to 8.5, preferably about 7.0 to about 8.1, or by adding acid or base to the composition to bring the pH of the composition within the desired range. It should be noted that, unlike prior art techniques which call for covalent or ionic bonding with the odor causing sulfur compounds, the present invention does not remove or scavenge odor causing entities, but rather renders them less offensive. It is believed that by avoiding these reactions the effectiveness of the composition is preserved or even enhanced. The present invention is broadly applicable to all types and classes of sulfur containing dermatological and cosmetic compositions, including, for example and without limitation, lotions, masks and cleansers.
The present invention is directed to a composition comprising: at least one sulfur containing ingredient; and a pharmaceutically or cosmetically acceptable carrier, wherein the composition has a pH of from about 6.5 to about 8.1, preferably about 7.0 to about 8.1. The present invention is also directed to a method for reducing or inhibiting initially and over time the production of malodor in sulfur containing dermatological compositions comprising the step of adjusting the pH of the composition to between about 6.5 to about 8.1.
Suitable sulfur ingredients are those that are suitable for use in dermatological compositions, including, without limitation, elemental sulfur, sulfides, sulfites and mercaptans and combinations thereof. A preferred sulfur compound is sodium sulfacetamide. As used herein, the term “sulfur containing dermatological composition” means any composition that contains elemental sulfur, organic or inorganic sulfides, inorganic sulfites, organic or inorganic mercaptans, or any other and that is used by being applied to the skin or hair of a user.
Forms of elemental sulfur suitable for use in the present invention are those forms of elemental sulfur that are known to be useful in dermatological compositions, including, without limitation, colloidal, coated, enrobed, entrapped, fumed, precipitated, and sublimed sulfur. Elemental sulfur, as that term is used herein, will also be understood by one of ordinary skill in the art to include other transformations, fractions and derivatives of sulfur understood by those of ordinary skill in the art to be useful in dermatological compositions. The preferred form of sulfur for use in the present invention is precipitated sulfur.
Inorganic sulfides suitable for use in connection with the present invention are those inorganic sulfides known to be useful in dermatological compositions and include, without limitation, selenium sulfide, sodium thiosulfate as well as those inorganic sulfides having the formula:
RS;
RSH;
R
2
S;
RSSR;
or
RSSH,
wherein
R is an inorganic element that can bind ionically or covalently with sulfur.
Organic sulfides suitable for use in connection with the present invention are those organic sulfides known to be useful in dermatological compositions and include, without limitation, those organic sulfides having the formula:
RS;
R
2
S;
RSH;
R′SSR′,
or
R′SSH,
wherein
R′ is an organic compound and its salts that can bind ionically or covalently with sulfur. Exemplary organic sulfides include, without limitation, sodium thioglycolate (sodium mercaptoacetic acid), gluathione.
Inorganic sulfites suitable for use in the present invention are those inorganic sulfites known to be useful in dermatological compositions, including, without limitation, sulfites and meta bisulfites.
Additional ingredients in these compositions may in
Figureoa Ray
Gans Eugene H.
Shacknai Jonah
Feehery Maryellen
McNichol, Jr. William J.
Medicis Pharmaceutical Corp.
Reed Smith LLP
Venkat Jyothsan
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