Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
1999-12-13
2002-09-24
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S560000, C514S763000
Reexamination Certificate
active
06455586
ABSTRACT:
BACKGROUND OF THE INVENTION
Contact sensitizers such as dinitrochlorobenzene (DNCB) have been reported to raise CD4+ helper T cell counts and reduce viral load in HIV positive patients (1,2). The DNCB was applied to the skin in 10% concentration dissolved in the volatile solvent acetone which resulted in unreliable and unpredictable contact sensitization reactions. Biologically, increases in CD+ helper T cell counts are accompanied by variable decreases in HIV retroviral replication as measured by human immunovirus ribonucleic acid (RNA) levels in dendritic cells that are the primary antigen presenting cells of the human immune system. It is the dendritic cells and microphages that are infected during the initial phases of human immunovirus growth in AIDS patients. Optimally formulated contact sensitizers when topically applied, can induce TH-1 type immunity by releasing cytokines including Interleukin 2,valuable in treating hepatitis B&C, and forms of cancer as well as AIDS. On the other hand, the medical use of the preferred contact sensitizer diphenylcyclopropenone has been limited primarily to the treatment of alopecia areata as disclosed in referenced U.S. Pat. No. 4,985,464 wherein the volatile solvent acetone with unreliable absorption properties was used as the formulation vehicle. Other contact sensitizers referenced in the literature (3) are, but not limited to, squaric acid dibutylester, urishiol, oxazolone, dinitrofluorobenzene, and paraphenylenediamine. In all referenced cases, the volatile solvent acetone with unreliable absorption characteristics was used as the drug delivery system for the contact sensitizers. Accordingly, there is a need for a more reliable stabilized composition in which the contact sensitizers are soluble and will be reliably and predictably absorbed through the skin to reach the aforementioned dendritic cells of the dermis.
SUMMARY OF THE INVENTION
This invention provides compositions for the topical application of contact sensitizers in a unique topical pharmaceutical emulsion drug delivery system to reliably penetrate the epidermis of immunocompromised human patients in order to stimulate the release of CD4+ helper T cells and induce TH-1 type immunity by releasing cytokines including Interleukin 2, valuable in treating AIDS, Hepatitis B&C, other viral infectious diseases, and Cancer. The compositions contain controlled amounts of diphenyl-cyclopropenone, dinitrochlorobenzene, dinitrofluorobenzene, squaric acid dibutylester, urishiol, oxazolone, paraphenylene-diamine or other medically useful contact sensitizers emulfified in a non-toxic drug delivery system formula consisting of pharmaceutically acceptable non-volatile, non-ionic surfactants and pharmaceutically acceptable emollients at optimized levels wherein the contact sensitizer(s) are reliably absorbed through the epidermis to reach the dendritic cells in the dermis during the early stages of viral infections in immunocompromised patients. A preferred embodiment of the invention includes diphenylcyclopropenone as the contact sensitizer uniquely formulated in a microemulsified drug delivery sytem consisting of the non-ionic surfactant polyoxyethylene 20 sorbitan momooleate and the emollients isopropyl myristate and/or isopropyl palmitate.
REFERENCES:
patent: 4020183 (1977-04-01), Asculai et al.
patent: 4997851 (1991-03-01), Isaacs et al.
patent: 96/32142 (1996-10-01), None
129CA:130918, Loftsson et al. 1998.*
99CA:181485, Keith, 1982.*
Merck Index, 10th edition, Windholz et al ED., Merck, Dohm & Sharp, Rahway, NJ, abstract #7455. 1984.
Kaplan Leonard L.
Levis William R.
Nissim Stuart H.
Travers Russell
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