Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – C-o-group doai
Reexamination Certificate
1999-10-13
2002-01-29
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
C-o-group doai
C514S772100, C514S772500, C514S772600, C514S781000, C514S969000
Reexamination Certificate
active
06342537
ABSTRACT:
This application concerns a matrix-forming and skin-adhesive, anti-evaporant gel for local treatment of skin diseases, skin infections, for both curative and prophylactic treatment of wounds and treatment of insect bites and stings, in both humans and animals. More precisely, the invention relates to a gel characterized by containing lower alkanol in a concentration of more than 90% and by containing a gelling agent, such as ethyl(hydroxyethyl)cellulose, hydroxypropylcellulose or another suitable gelling agent, and possible additives, whereby the gel can be applied to the skin efficiently, easily, and without complications.
BACKGROUND
Infectious skin diseases, viral, microbial and parasitic, are widespread. Some examples of skin diseases are viral skin infections caused by, for example, Herpes simplex virus or Varicellae Zoster virus, bacterial skin infections caused by, for example,
Staphylococcus aureus,
fungal infections caused by, for example,
Trichophyton rubrum,
for eliminating skin parasites, such as
Sarcoptes scabiei
var.
hominis.
The virus infection caused by Herpes simplex, alone occurs with approximately 100 million new cases per year, and in the western world there are 250-400 million eruptions of herpes labialis per year.
Herpes simplex is caused by herpes virus (HSV). Herpes (HSV) simplex virus occurs in two different types, type 1 and type 2. Herpes on the lips and around the mouth (Herpes labialis) is usually caused by type 1; most incidences of Herpes on and around the genitals (Herpes genitalis) are caused by type 2.
The first infection with HSV (primary infection) varies symptomatologically. Usually it occurs during childhood. An this first Infection, HSV-DNA is incorporated as a latent virus into the cells. Intermittently, virus proliferation occurs, resulting in Herpes outbreaks (these outbreaks are called secondary infections). Most Herpes outbreaks in adults are secondary, where the infection flares up due to reduced resistance, febrile diseases (e.g. Pneumonia), traumas, or the effects of cold, heat., or light.
The outbreak starts with flushing, swelling, itching, and pain in the infected area followed by necrosis and a suppurative ulceration which is the most troublesome symptom. A spontaneous healing of the wounds will occur in approximately 10 to 14 days.
The outbreak of Herpes genitalis—mentioned above—is identical to that of Herpes labialis except for the fact that Herpes genitalis is located on and around the genitals.
The number of therapeutics for, for example, HSV skin infections is very limited, and the present antiviral chemotherapy has not convincingly been proved efficient. Furthermore, there exists a few products for advancing the healing of established HSV-wounds and inhibition of further outbreaks. However, none of these products have any convincing effect.
In U.S. Pat. No. 4,628,063 Haines et al disclose the antiviral activity of lidocaine against HSV. This activity is disclosed also by Yanagi, K., et al Arch. Virol. (1989) 10: 151-159. Haines et al is cited in U.S. Pat. No. 5,331,012 by Riddick et al, who use a lidocaine composition as an anaesthetic treatment of skin lesions, some of which may be herpectic in nature. Alcohol is used as a solvent in '012. The results of the examples in '012, at best, confirm the antiviral performance of lidocaine disclosed by '063. The examples do not allow any conclusions to be drawn regarding any antiviral properties of alcohol itself.
Other examples of skin disorders for which there are currently few or no adequate remedies include insect bites and stings.
Other examples of skin disorders for which there are currently few or no adequate remedies include insect bites and stings. The stings of hymenoptera (bees, wasps and ants) contain a variety of components and are biochemically and immunologically distinct between species. Direct toxic effects are mediated by mixtures of low-molecular-weight compounds such as serotonin, histamine, and acetylcholine and several kinins. Polypeptide toxins in honeybee venom include mellitin, which damages cell membranes; mast cell-degranulating protein, which causes histamine release; apamin, a neurotoxin; and adolapin, which has inflammatory action. Enzymes in venom include hyaluronidase, which allows the spread of other venom components, and phospholipases, which may be among the major venom allergens.
Uncomplicated stings cause immediate pain, a wheal-and-flare reaction, and local edema and swelling that subside in a few hours. Multiple stings can lead to vomiting, diarrhea, generalised edema, dyspnea, hypotension, and collapse. Rhabdomyolysis and intravascular hemolysis may cause renal failure. Death from the direct effects of venom has followed 300 to 500 honeybee stings.
Large local reactions that spread ≧10 cm around the sting site over 24 to 48 hours are not uncommon. These reactions may resemble cellulitis but are caused by hypersensitivity rather than secondary infection. Such reactions tend to recur on subsequent exposure but seldom are accompanied by anaphylaxis and are not prevented by venom immunotherapy.
An estimated 0.4 to 4.0 percent of the US population exhibits clinical immediate-type hypersensitivity to insect stings, and 15 percent may have asymptomatic sensitization manifested by positive skin tests. Persons who experience severe allergic reactions are likely to have similar reactions after subsequent stings; occasionally, adults who have had mild reactions later experience serious reactions. Mild anaphylactic reactions from insect stings, as from other causes, consist of nausea, abdominal cramping, generalised urticaria, flushing and angioedema. Serious reactions, including upper airway edema, bronchospasm, hypotension, and shock, may be rapidly fatal. Severe reactions usually begin within 10 minutes of the sting and only rarely develop after 5 hours. Unusual complications, including serum sickness, vasculitis, neuritis, and encephalitis, develop several days or weeks after a sting.
From the literature it is known to use alcohol as disinfectant against, for example, virus including HSV—see, for example, R. Tyler; Journal of Hospital Infection (8: 22-29; 1987). The present inventors have found that when using alcohols as normal liquids (i.e. without taking steps to avoid evaporation) a poor and very brief effect is achieved due to the very rapid evaporation of the alcohols. Also the use of alcohols at concentrations below 90% by weight gives inadequate results.
Furthermore, Moldenhauer, in Zbl. Bakr. Hyg., I Abt. Orig. B 179, 544-554 (1984) compares surface disinfection properties of ethanol, isopropanol, formaldehyde and benzalkonium chloride by suspending virus suspension (including HSV, influenza, cocksackie-B and mumps) in those compounds or solutions. Alcohol concentrations above 90% were not tested. Furthermore in these two references alcohol is being used for surface disinfection properties and not for treatment of infections and the symptoms thereof.
In U.S. Pat. No. 5,145,663, a disinfectant, consisting of 65-75% isopropyl alcohol, 8-12% propylene glycol, and potential inert ingredients or disinfectants or antiseptics, is mentioned. The patent does not mention gels.
In GB-A-2017491 a gel containing alcohol is used as a hand-wash for bacterial disinfection.
In U.S. Pat. No. 5,288,486 viscosified alcohol compositions containing 30 to 90% alcohol are used to disinfect hands and sites of invasine medical procedures. The examples show antimicrobial activity and activity against the yeast
Candida albicans,
but not on skin infected with such microbes.
In the above references describing the use of alcohol, either as such or as a solvent for other active disinfectant agents, in surface disinfection of the skin, the alcohol will remain in contact with the skin for a relatively short period of time. The compositions, if they are washing compositions when they may contain a thickener such as sodium chloride, are generally rinsed off with water. Treatment with no-rinse compositions and alcohol wipes applies a relatively l
Moller Jens C.
Thomsen Aase Brown
Thomsen John Brown
Burns Doane Swecker & Mathis L.L.P.
Jarvis William R. A.
Kim Vickie
Thomsen Aase Brown
Thomsen John Brown
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