Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
1998-07-24
2001-05-01
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S445000, C424S446000, C424S449000, C424S195110, C424S641000, C424S642000
Reexamination Certificate
active
06224896
ABSTRACT:
FIELD OF INVENTION
This invention relates to a novel composition useful for the treatment of epidermal traumas. Furthermore, the invention also relates to the novel method of treatment of these epidermal traumas using the composition of the instant invention.
BACKGROUND OF THE INVENTION
Epidermal traumas include, for example, but not limited to, maladies such as pressure sores, burns, cuts, abrasions, wounds, rashes, lesions, skin conditions, skin infections and decubitus ulcers. Generally, these epidermal traumas are treated with ointments or preparations, sometimes with little or no success.
Pressure sores and decubitus ulcers are particularly painful for the patients and difficult to treat. Pressure on a area of skin for an extended time period may cause pressure sores. Generally, pressure sores occur at weight bearing sites. Patients eventually develop necrosis at these pressure sores since the pressure at the weight bearing sites can exceed local perfusion pressure. As the skin sloughs, bacteria tends to colonize at these sites. Abetted by further pressure induced necrosis, the infection tends to get deeper and deeper, possibly resulting in decubitus ulcers. Other factors which contribute to pressure sores include skin over bony prominence, anemia, malnutrition and immobilization. Pressure sores are especially prevalent among individuals incapable of moving, such as patients who are bedridden due to various infirmities such as strokes, quadriplegia, paraplegia or those who are in a coma. These patients suffer greatly from the pain caused by these wounds.
Generally, patients with pressure sores or decubitus ulcers are treated with topical antiseptics or relief of pressure by frequent turning. Sometimes topical debriding enzymes such as sutilains available under the trademark “Travase”, manufactured by the Boots Company, collagenase available under the trademark “Santyl”, manufactured by Knoll Pharmaceuticals, and fibrinolysin with desoxyribonuclease available under the trademark “Elase”, manufactured by Fujisawa[Parke Davis] are used in the treatment of pressure sores and decubital ulcers. Various drug therapies may be prescribed dependent upon the type of infections that occur. Additionally, specialized beds that distribute the pressure more evenly may be used. As a final measure, surgical treatment may be necessary to remove the pressure sore itself.
U.S. Pat. No. 5,407,670 to Shinault discloses a topical ointment for the treatment of epidermal trauma. The topical ointment includes a mixture of polymyxin, bacitracin, neomycin, iodine and sugar. This ointment is applied daily until healing of the wound occurs. Numerous other ointments also exist for these traumas.
U.S. Pat. No. 5,503,847 discloses a hydrocolloid wound gel composition useful for cleansing and debriding wounds. The composition includes sodium carboxymethyl cellulose, pectin, propylene glycol and water. In addition, if desired, the hydrocolloid wound gel composition can contain a small amount of an antibiotic such as metronidazole, or a skin protective agent such as zinc oxide. This hydrocolloid gel is applied directly to the wound itself. Usually, the wound cavity is partially filled with the gel and sealed with an occlusive dressing.
Similarly, U.S. Pat. No. 5,662,924 discloses a wound dressing. The wound dressing contains a water insoluble, water swellable cross-linked cellulose derivative, water and a polyol component, wherein the dressing comprises a gel and the cellulose derivative which comprises less than 10% by weight of gel. The wound dressing may also include the antimicrobial agent metronidazole. The dressing is placed into the wound itself; the patent states a minimum depth of 5 mm should be achieved. The gel is then covered with additional absorbent material.
Nonetheless, despite these dressings, there exists a need for effective treatment and relief of epidermal traumas. In particular, there exists a great need for treatment and relief of pressure sores and decubitus ulcers, which is easy to use yet still effective on the wound.
SUMMARY OF THE INVENTION
The present invention is directed to a composition which can be used in the treatment of epidermal traumas. The composition comprises a nitroimadazole, an occlusive skin barrier composition and a occlusive synthetic dressing. Furthermore, the invention also comprises the method of treatment using this novel composition.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention provides for a novel composition that comprises a nitroimadazole compound, a occlusive skin barrier composition and an occlusive synthetic dressing. In addition, the present invention provides for the novel method of application of this composition for the treatment of epidermal traumas, such as decubitus ulcers.
The nitroimadazole compound used in the instant invention is metronidazole. Metronidazole has the following chemical structure:
These compounds are available from numerous manufacturers including Searle under the trademark “Flagyl”, Ortho under the trademark “Protostat”, Fielding under the trademark “Metric 21”, Lemmon under the trademark “Methyl” and McGaw under the trademark “Metro I.V.” Additionally, metronidazole is also available from Zenith. It is believed that metronidazole hydrochloride as well as other analogues of metronidazole and other synthetic nitroimadazole compounds could be used in the instant invention in place of the metronidazole. The physical form of the nitroimadazole can be either powder or liquid. Further, the nitroimadazole can be placed in other carriers (i.e., for example, but not limited to other polymers, gels, liquids) provided that the efficiency of the nitroimadazole is not altered. The decision of which exact physical form of the nitroimadazole to use is well within the skill of one of ordinary skill in the art. For example, the nitroimadazole in tablet form can be dissolved in water or any other liquid that does not destroy the efficacy of the nitroimadazole for ease of application or incorporation with the other ingredients. Alternatively, the nitroimadazole if obtained in tablet form can be crushed into a powder, for effective delivery. This powder can be used alone or combined with other material(s) to form a paste.
The composition of the instant invention also includes an occlusive skin barrier composition. Any occlusive skin barrier composition can be used provided that the composition has occlusive properties. Preferably, the occlusive skin barrier composition also has antimicrobial properties. Preferably, the occlusive skin barrier composition comprises zinc oxide. Most preferably, the occlusive skin barrier comprises zinc oxide and benzethonium chloride. An example of a commercially available occlusive skin barrier comprising zinc oxide and benzethonium chloride is Critic-Aid® Antimicrobial Skin Paste, NDC 11701-030-32, manufactured by Sween.
The composition of the instant invention also includes a occlusive synthetic dressing. A variety of occlusive synthetic dressings are commercially available and used for promoting topical drug absorption and for wound healing. Generally, these dressings prevent the loss of the topical drug from the skin, promote skin hydration and increase the skin temperature. It is believed that these actions enhance penetration of certain medications. Examples of occlusive synthetic dressings include polyurethane transparent occlusive semipermeable dressings, hydrogels, dimethylpolysiloxanes and hydrocolloids. Preferably, hydrogel occlusive synthetic dressings are used. An example of a commercially available hydrogel is Carrasyn® Hydrogel Wound Dressing (NDC 053303-010-30) manufactured by Carrington Laboratories. It is believed that the Carrasyn® Hydrogel Wound Dressing is manufactured from aloe extracts as set forth in U.S. Pat. Nos. 4,917,890, 4,735,935, and 4,957,907. Therefore, alternatively, in place of the occlusive synthetic dressing, it is believed any ointment or lotion mixture containing aloe vera can be use. Examples of other aloe vera lotions or ointments that
Abrams Hugh A.
Channavajjala Lakshmi
Curlor Healthcare Technologies, LLC
Page Thurman K.
Sidley & Austin
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