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Claims for Patent: 5,863,560

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Claims for Patent: 5,863,560

Title: Compositions and methods for topical application of therapeutic agents
Abstract:The present invention generally relates to pharmaceutical compositions that enable control of drug delivery properties and the development of optimal drug delivery strategies customized for particular drugs and particular diseases. The composition includes a dissolved pharmaceutical that has the capacity to permeate the stratum corneum layer of the epidermis and become available systemically, and a pharmaceutical in a microparticulate state that does not readily cross the stratum corneum of the epidermis. The dissolved and microparticulate pharmaceuticals may be the same or different pharmaceuticals. Methods for the preparation and use of the compositions are also provided. In a preferred embodiment, the invention finds particular use in a formulation for the topical application of dapsone for the treatment of acne. In another preferred embodiment, the invention finds particular use for the treatment of herpes lesions.
Inventor(s): Osborne; David W. (The Woodlands, TX)
Assignee: ViroTex Corporation (The Woodlands, TX)
Application Number:08/712,454
Patent Claims: 1. A dermatological gel composition including microparticulate pharmaceutical and dissolved pharmaceutical, which comprises:

about 1% carbomer;

about 83.7 to 86.4% water;

about 10% ethoxydiglycol,

about 0.2% methylparaben;

up to about 3% dapsone in a microparticulate and dissolved state;

and about 2 % sodium hydroxide solution.

2. The dermatological composition of claim 1, wherein the ratio of microparticulate to dissolved dapsone is no greater than 5.

3. A dermatological composition for the treatment of herpes lesions comprising acyclovir and 1-methyl-2-pyrrolidone in a semisolid aqueous gel, wherein said acyclovir is present in dissolved and microparticulate forms.

4. A dermatological composition comprising:

a semisolid aqueous gel;

a pharmaceutical dissolved in said gel, wherein said dissolved pharmaceutical has the capacity to cross the stratum corneum layer of the epidermis and become available systemically; and

a microparticulate pharmaceutical dispersed in said gel, wherein said microparticulate pharmaceutical does not cross the stratum corneum of the epidermis in its microparticulate state and wherein said microparticulate pharmaceutical and dissolved pharmaceutical comprise the same pharmaceutical.

5. A dermatological gel composition for the treatment of herpes lesions comprising:

a semisolid aqueous gel;

a first pharmaceutical in said gel, partially in a microparticulate form and partially in a dissolved form, wherein said first pharmaceutical comprises a nucleoside analogue selected from the group consisting of acylclovir, penciclovir, famciclovir, valacyclovir, and ganciclovir; and

a second pharmaceutical dissolved in said gel, wherein said second pharmaceutical comprises a local anesthetic selected from the group consisting of tetracaine, tetracaine HCl, dyclonine, dyclonine HCl, dibucaine, and dibucaine HCl.

6. The composition of claim 5, wherein said acyclovir comprises about 5% by weight of the composition.

7. The composition of claim 5, wherein said tetracaine HCl comprises about 5% by weight of the composition.

8. The dermatological composition of claim 4, wherein:

the pharmaceutical dissolved in said gel is dapsone; and

the microparticulate pharmaceutical is dapsone.

9. The dermatological composition of claim 4, wherein:

the pharmaceutical dissolved in said gel is dapsone;

the microparticulate pharmaceutical is dapsone; and

the dermatological composition comprises about 0.5 to 10 weight percent dapsone.

10. The dermatological composition of claim 4, wherein:

the pharmaceutical dissolved in said gel is dapsone;

the microparticulate pharmaceutical is dapsone;

the dermatological composition comprises about 0.5 to 10 weight percent dapsone and about 0.5 to 4 weight percent carbomer.
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