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Ganglionic blocking agents for the treatment of epithelial diseases

A ganglion, skin technology, applied to diseases and mucosal surfaces such as oral or vaginal mucosal diseases, the field of topical application of ganglion blocking drugs, can solve problems such as low level of wart clearance

Inactive Publication Date: 2008-06-18
DOW PHARMA SCI INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, although the positive results were statistically significant, the overall clinical results showed a low level of wart clearance

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1 - Preparation of Test Formulations

[0040] By combining the ingredients shown in Table 1, the following 6 formulations containing 5% TEAC were prepared.

[0041] Table 1

[0042] Preparation 1

[0043] Formulations 1 to 6 are compositions comprising 5% TEAC. Formulation 1 is a prior art occlusive anhydrous hydrophilic ointment (Aquaphor based). Formulation 2 is an occlusive anhydrous hydrophilic ointment containing propylene glycol and urea. Formulations 3 to 6 are aqueous compositions of the invention. Formulations 3, 5 and 6 are hydroalcoholic gel compositions and formulation 4 is a cream composition.

Embodiment 2

[0044] Example 2 - Efficacy of prior art compositions

[0045] The 5% TEAC composition of Example 1 Formulation 1 was tested for its efficacy in treating warts in a double-blind placebo-controlled study. Forty-five (45) patients with warts were evaluated in the study. Thirty patients were the active group treated with Formulation 1 and 15 patients were the vehicle group treated with the same ointment vehicle without TEAC.

[0046] Warts present on day 1 are called baseline warts. These warts are the basis for initial efficacy determinations. Wart clearance was defined as elimination of warts and complete healing of the treated site. Complete response was defined as elimination of all baseline warts. Part of the response is elimination of some, but not all, baseline warts. No response was defined as all baseline warts remained.

[0047] There were 212 warts in the active group and 90 warts in the vehicle group, for a total of 302 warts at baseline. The efficacy (% wart c...

Embodiment 3

[0053] Example 3 - Skin Penetration Study

[0054] with tracer levels (~1 μCi / dose) 14 C-Labeled TEACs All six TEAC-containing compositions in Example 1 (Formulations 1 to 6) were prepared. A single clinically relevant dose (4mg formulation / cm 2 ) were applied to sectioned human skin obtained from elective surgery. Each study used abdominal skin from a single human donor. Five samples were assayed for each formulation. Transdermal absorption was assessed using skin placed on a diffusion cell to assess the amount of TEAC delivered to the epidermis. The receptor solution consisted of phosphate buffered saline containing 0.1% sodium azide and 1.5% Oleth 20. After 24 hours of exposure, the residual formulation remaining on the skin surface was removed by wiping with two dry cotton swabs. Remove the upper layer of the cuticle from the epidermis with single-sided cellophane tape. The remaining epidermis is then physically separated from the dermis. The amount of radioactivit...

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PUM

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Abstract

Compositions, and methods of making and using a composition, containing a ganglionic blocking agent and water provide increased penetration of the ganglionic blocking agent into and through epithelial surfaces, such as skin and mucosal surfaces, provide increased release from formulations containing such ganglionic blocking agents, and provide increased antiviral effectiveness compared with compositions containing a ganglionic blocking agents and lacking water.

Description

technical field [0001] The present invention relates to the field of topical therapies for the treatment of epithelial diseases, such as diseases of the skin and diseases of mucosal surfaces such as the oral or vaginal mucosa. The invention particularly relates to the field of topical administration of ganglion blocking agents for the treatment of, for example, diseases caused by viruses such as febrile herpes, cutaneous warts, and genital warts. Background technique [0002] In humans, warts are skin conditions caused by the human papillomavirus (HPV), of which at least 100 different types have been identified. Warts are benign epithelial growths characterized by greatly thickened and often hyperkeratotic epidermis. Warts typically appear as discrete, skin-colored, raised and rough lesions on the surface of the skin. Warts can also be flat, as is often the case when they are on the soles of the feet, when they are called plantar warts. Estimated prevalence of warts varie...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/14
CPCA61K9/006A61K47/38A61K31/14A61K47/10A61K9/0014A61K31/44A61K9/0034A61P17/12A61P31/20
Inventor G·J·道D·A·巴克斯N·德赛
Owner DOW PHARMA SCI INC