Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-06-25
2003-04-08
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S400000, C424S616000, C435S810000, C514S159000, C514S859000
Reexamination Certificate
active
06544562
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to the field of over-the-counter acne treatment compositions.
2. Description of Related Art
Compositions for treatment of acne vulgaris, white heads, black heads and comedones are well known. Generally, such compositions include a keratolytic agent, such as salicylic acid, which dissolves the intracellular matrix of the treated lesion and causes the lesion to slough off the body as dead tissue.
Salicylic acid has been approved by the US Food and Drug Administration for treatment of acne in concentrations of 0.5 to 2% by weight. Such compositions may be in the form of a gel, lotion, cream or solution to be applied with pads.
Salicylic acid is sparingly soluble in water, 1 gram dissolving in about 460 ml of water at room temperature (about 0.2% by weight), to produce a solution with a pH of 2.4. Salicylic acid has a far greater solubility in alcohol, 1 gram dissolving in about 2.7 ml, so most acne treatment compositions are based on a mixture of alcohol and water. The presence of alcohol permits a far greater solubility of salicylic acid than would be possible with water alone.
Benzoyl peroxide is approved by the US Food and Drug Administration for treatment of acne in concentrations of 2.5 to 10% by weight. Benzoyl peroxide is, however, sparingly soluble in both water and alcohol, and is usually provided in the form of creme-type products where it is in suspension form. Benzoyl peroxide increases the epithelial cell growth rate, leading to an increased sloughing rate. This increase results in a larger structure of the follicular plugs, and promotes resolution of comedones. Benzoyl peroxide also has an oxidizing potential which may contribute to bacteriostatic and bacteriocidal activity, suppressing the local population of propiolibacterium acnes.
Benzoyl peroxide is one of the most effective topical nonprescription medications available for acne.
Because the actions of salicylic acid and benzoyl peroxide are slightly different, alternate applications are useful in treatment of acne. However, alternate applications have heretofore required purchase of two different products and following instructions which may not be associated with either product.
SUMMARY OF THE INVENTION
Is therefore an object of the invention to make it possible to provide a dual composition an acne treatment regimen in a single package.
It is another object of the invention to provide in a single package different morning and evening treatments for acne.
It is a further object of the invention to provide in a single package a clear gel morning treatment which can unclog pores and keep pores open due to keratolytic action, and a lotion evening treatment which penetrates, kills bacteria, reduces skin surface fatty acids, helps prevent pimples and prevents them from further spreading.
In order to achieve these and other objects, the invention is directed to a dual regimen acne treatment package comprising an outer container, disposed within the outer container first and second inner containers which are separate from each other, each of said inner containers having an exposed dispensing means, the first said inner container containing a solubilized salicylic acid acne treatment composition, and the second said inner container containing a solubilized benzoyl peroxide acne treatment composition.
Preferably, the dispensing means for the treatment compositions is a pump. However, other dispensing means may also be used, including aerosol and applicator pads. Both dispensing means need not be of the same type.
Preferably, the outer container is fitted with at least one cap covering and protecting the dispensing means.
REFERENCES:
patent: 4355028 (1982-10-01), Kligman et al.
patent: 5470884 (1995-11-01), Corless et al.
patent: 6200964 (2001-03-01), Singleton et al.
patent: WO 99/02133 (1999-01-01), None
Bollinger et al., J Pharm Sci (1977); 66(5): 718-722. Benzoyl peroxide stability in pharmaceutical gel preparations.
Singh Mohinder
Wojcik Michael A.
Arnstein & Lehr
Blistex Inc.
Flood Michele C.
Tate Christopher R.
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