Anti-infective compositions, methods and systems for treating pathogen-induced disordered tissues

Abstract

Compositions, methods and systems for treating disordered epithelial tissues, such as is caused by pathogens and / or by toxins produced thereby. The invention relates to the use of an anti-infective and / or antimicrobial active agent in a carrier, with vigorous agitation of the disordered epithelial tissue for topical treatment thereof under such conditions sufficient to achieve clinically discernable improvement of the disordered epithelial tissue. The preferred anti-infective and / or antimicrobial active agent comprises a nucleoside, such as acyclovir, valcyclovir, penciclovir, famciclovir, ganciclovir, cidofovir, adefovir, and tenofovir, and derivatives, analogs, or metabolites thereof, or a mixture thereof, or 1-docosanol, optionally in combination with an organohalide. The inventive compositions and methods may employ the use of an applicator adapted for use in promoting the penetration of the treatment composition and / or the vigorous agitation of the disordered tissue.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of copending U.S. application Ser. No. 10 / 816,571, filed Apr. 1, 2004, which is a continuation-in-part of copending U.S. application Ser. No. 10 / 200,897, filed Jul. 22, 2002, now U.S. Pat. No. 6,759,434, which is a continuation-in-part of U.S. application Ser. No. 09 / 668,953, filed on Sep. 22, 2000, now U.S. Pat. No. 6,423,750, which is a continuation-in-part of U.S. application Ser. No. 09 / 401,076, filed Sep. 22, 1999, now U.S. Pat. No. 6,211,243. For purposes of disclosure, the foregoing patents and applications are incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] 1. The Field of the Invention [0003] The present invention relates to the treatment of disordered tissue with anti-viral compositions. Such treatment compositions include a tissue-penetrating substance and at least one anti-viral agent, such as a nucleoside, docosanol, and / or a quaternary amine compound having at ...

AI Technical Summary

Benefits of technology

[0023] It has been found that the therapeutic irritation of disordered tissue with a preferred treatment composition and the optional use of an applicator, stimulates rapid immunological attack and makes the composition and therapeutic irritation synergistically more effective. After the therapeutic irritation of the disordered tissue through vigorous rubbing and / or pressure, the treatment composition penetrates into the disordered tissue to enable the anti-infective active agent or agents to become chemically active much more deeply within the disordered tissue as compared to conventional application techniques.

[0024] In addition to the anti-infective active agent or agents, the composition also includes a carrier such as an alcohol. Oil and fatty carrier substances are preferably not added to the composition to the extent they inhibit penetration of the treatment composition into the skin. Although various compositions have been applied to disordered tissue, the inventive methods and systems of vigorous agitation of the disordered tissue in connection with a preferred composition has an extraordinary therapeutic effect. Consequently, the inventive compositions as well as the methods of application with vigorous agitation of disordered tissue provide effective methods of treatment.

[0025] The inventive systems utilize an applicator to deliver the treatment composition and most of the applicators can also be utilized to vigorously agitation disordered tissue to convey the inventive composition into the disordered tissue. The applicators allow the patient or a health professional to vigorously agitate the disordered tissue without cross-contamination from a dirty finger or the like. A finger may be used, of course; however, it lacks the advantages of a sterile applicator, the absorbability of an applicator tip, and the ability to agitate or massage the skin surface in the same manner as an applicator tip. The applicator has the added advantage of directing focused pressure into the disordered tissue while the active compounds are expressed from the applicator into the disordered tissue. The combined effect of vigorous agitation of the disordered tissue and the administration of the inventive treatment compositions has the remarkable result of surprising therapeutic effects.

Problems solved by technology

Tissue disorders, particularly those which impact epithelial tissue caused by all types of Herpes, such as Herpes Simplex types I and II and Herpes Zoster (shingles), candida albicans, chicken pox, acne, psoriasis, eczema, seborrhea, dermatitis, and pink eye are common but often difficult to treat.

Some individuals with oral herpes that impacts the trigeminal nerve have excruciating facial pain, difficulty swallowing, eating and facial swelling.

Individuals with the herpes that impacts the sacral nerve have pain in the genital area, upper leg pain, swelling, and on occasion great difficulty walking.

Herpes infections pose very serious health threats, often causing blindness, increased cancer risk of the cervix, aseptic meningitis and encephalitis, neonatal deaths, viremia, the spread of the human immunodeficiency virus (HIV), etc.

The devastating effects of this disease go well beyond the medical scope of human suffering; HSV is responsible for serious psychological and emotional distress as well as substantial economic loss.

Most prior treatments have proven disappointing.

However, acyclovir is only successful in interrupting the replication of the virus and is currently only used to treat infectious outbreak systemically.

Individuals with Auto Immune Deficiency Syndrome (AIDS) are seriously immune-compromised and can suffer especially debilitating outbreaks of HSV.

Additionally, AIDS individuals may carry acyclovir resistant strains of HSV, which can make acyclovir ineffective for these individuals.

In fact, such compositions are generally absorbed into clothing more than into the skin due to a relatively slow epidermal penetration rate.

Even when sufficient time is allowed for the compositions to penetrate, they are often not sufficiently effective in treating the disordered tissue.

Many compositions of the prior art contain ingredients that may provide symptomatic relief of pain and itching, but are not claimed to be effective against Herpes infection except the drugs based on acyclovir technology, which are purported to have some topical efficacy.

Additionally, most compositions intended to treat such disorders do not effectively treat the discomfort and the disease symptoms, let alone cure the disorder or put it into a significant remission.

A portion of such compositions may eventually penetrate beyond the surface of the disordered tissue such as the outer surface of skin or a lip; however, the viscosity of the composition, combined with the application technique, prevents such compositions from achieving effective penetration.

Some of the formulation may be absorbed into the skin; however, a significant portion is likely rapidly evaporated due to the high content of water and acetone.

While these compounds are useful, particularly as antifungal agents, it is doubtful that they assist in penetrating the afflicted tissue and may in fact retard penetration or enhance the skin's natural resistance to penetration.

The FDA does not consider these compounds as useful in the treatment of herpes, rather they are used for their softening effects.

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