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Methods and Compositions for Treatment of Dermal Conditions

a technology of dermal conditions and compositions, applied in the direction of drug compositions, biocides, aerosol delivery, etc., can solve the problems of secondary problems, difficult to treat dermal conditions, and interfere with the function of dermis and dermal structures of host organisms

Inactive Publication Date: 2013-10-17
AVENT INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent is for a device that can be applied to finger and toe nails to help maintain their shape and appearance. The device is made of a special material that can be cut to size and shape. It is secured to the nail using tackiness or adhesive polymer coatings. The device is transparent and can be worn for several days. It helps to maintain a moisture gradient on the nail, which is important for its appearance.

Problems solved by technology

The presence of these organisms in and on dermal structures often cause a range of changes, from merely unsightly to pathological conditions, to the dermis and dermal structures, and can interfere with the functions of the dermis and dermal structures of the host organism.
Additionally, the presence of these organisms can result in immunological responses by the host and cause secondary problems at the site or a general response throughout the entire host organism.
One of the most common and difficult to treat dermal conditions is infection of nail structures.
Nails, like most anatomical structures of the body, are susceptible to disease processes.
Although the condition is not life threatening, infection of these tissues can compromise the appearance and the function of the affected nail.
The incidence of the condition has been difficult to determine largely because it is not life threatening and rarely is reported.
However no studies have confirmed this hypothesis.
This is likely due to the necessity of using heavy protective footwear for prolonged periods to protect the feet from the cold.
One reason for the increase with age is that onychomycosis poorly responds to treatment, hence is seldom treated so there is an accumulation of cases.
Fungal infection of the nails results in characteristic changes in the appearance to the structure.
The reason for this is that nail structure and anatomy are complex and, to some degree, are isolated from systemic circulation.
Moreover, the absence of circulation also restricts the ability of delivering systemic anti-microbial agents effectively to the specific sites where the fungi inhabit.
However, microscopic examination and in vitro culture are time consuming and expensive.
This approach may lead to a misdiagnosis of cases resulting in inappropriate and dangerous treatment modalities.
The current systemic and the topical methods for the management of onychomycosis are expensive, have low success rates and in many cases expose the user to considerable risk of central organ damage.
This often has meant persistent administration of the agent with its concomitant risk of systemic toxicity.
It is effective at removing the nail but it is known to have a fairly high failure rate unless combined with drug treatment.
It is also somewhat controversial as to its effectiveness as there are no studies showing actual incidence of cure.
Drug levels have been recorded by direct assay for the active agents, yet in both topical and oral administration there has been a dismal record of cure rate.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Formation of a Matrix Including Acrylamide

[0082]A mixing tank was charged with 161.4 kg of water and 9.1894 kg of acrylamide, 0.10347 kg of NNNN′-methylenebisacrylamide, and 9.3046 kg of glycerol were added and mixed. Then 1.0213 kg of guar gum non-gellable polysaccharide was dispersed in a mixture containing 0.9770 kg of isopropyl alcohol and 2 kg of water. The solution of guar gum was then added and dispersed into the acrylamide mixture. After suitable mixing, 0.1042 kg of TEMED was added and polymerization was catalyzed with 0.0999 kg ammonium persulphate.

[0083]While the batch was still liquid, it was poured into molds to form sheets. After gelling had occurred, sheets were transferred to a dessicator and dehydrated to form a stable intermediate stock sheet. Prior to cutting to size, the stock material was re-hydrated in a humid atmosphere. After cutting, the material was coated with petrolatum. The resulting composition was then sealed into appropriate packaging and irradiated t...

example 2

[0085]An alternative method for making a polyacrylamide matrix containing citric acid as the active agent was performed. The steps of Example 1 were followed, except the citric acid was not added. Once the matrix was polymerized, it was formed into the desired shape, typically a sheet approximately 25×25×0.5 cm in size. A sheet of hydrophilic matrix was created by dehydration at 45° C. resulting in approximately 3% w / w moisture. The sheet was then reconstituted with the addition of concentrated solutions of citric acid to form sheets so that the moisture content was approximately 50% by weight. The concentration of citric acid in the prototypes was 6%, 8%, 10%, 12% and 16% by weight.

[0086]The polymerized matrices with these concentrations of acid retained the normal properties of plain matrix material and were suitable for application. Sheets made by this procedure were sealed into medical grade polyethylene pouches until used.

example 3

[0087]The application of the sheet to infected nails was carried out by cutting the matrix to the approximate size of the nail. This was then placed onto the nail and secured using a medical grade polyurethane adhesive thin film dressing (OPSITE, Smith & Nephew). The cover dressing was applied so that the matrix parts were completely boardered on all sizes. This prevented slippage of the matrix from the nail but also occluded air contact with the matrix which might lead to dehydration. Matrix applied in this fashion could be worn for up to one week but typically were changed approximately every 2-3 days.

[0088]All prototypes, regardless of the concentration of citric acid were effective at hydrating the nail and particular the portion directly over active fungal invasion (as apparent by the white discoloration of the nail). Several individuals that volunteered to wear samples of the various strengths complained of burning sensation when the 16% sample was worn. This also occurred occ...

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Abstract

The present invention comprises methods and compositions for the treatment of pathological conditions of the dermis and dermal structures of animals and humans. In particular, the present invention comprises the use of topical delivery vehicles, including hydrogels, which incorporate active agents such as organic acids, for the treatment of dermal conditions.

Description

PRIOR RELATED APPLICATIONS[0001]The present application is a continuation-in-part of U.S. patent application Ser. No. 10 / 207,936, filed Jul. 29, 2002, which is incorporated herein in its entirety.FIELD OF THE INVENTION[0002]This invention discloses methods and compositions for the treatment of dermal conditions. Particularly, this invention relates to treatment of pathological dermal conditions using a variety of topical delivery vehicles to provide active agents to the site or sites of pathology.BACKGROUND OF THE INVENTION[0003]The dermal structures of humans and other animals are often the site of infections or attachments by other living organisms. Dermal structures include, but are not limited to, skin, hair, hair follicles, cornea, sclera, organ linings, pleural coverings, dura, toenails, fingernails, hooves, horns, mucous membranes, and other cellular structures made from epithelial cells or keratinized structures. Organisms that live in or on the dermis or dermal structures o...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K47/36A61K47/32A61K9/06A61K9/70A61K31/00A61K31/10A61K31/17A61K31/201A61K31/395A61K31/60
CPCA61K9/0014A61K47/32A61K47/36A61F13/105A61K9/7007A61K31/00A61K31/10A61K31/17A61K31/201A61K31/395A61K31/60A61P17/00A61P31/10
Inventor MALEY, JOSEPH C.GIBBINS, BRUCE L.
Owner AVENT INC
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