Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai
Reexamination Certificate
2001-11-07
2003-05-06
Reamer, James H (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ester doai
C427S099300
Reexamination Certificate
active
06559182
ABSTRACT:
The present invention relates to a method for treating and preventing infections caused by enveloped viruses. More particularly, jojoba oil esters are used to treat and prevent envelope virus infections.
BACKGROUND
Enveloped virus infections occur in a very large segment of the population and are one of the commonest infections of mankind throughout the world. The class of enveloped virus includes herpes virus, e.g., herpes simplex 1 and 2; myxovirus, e.g., influenza virus; paramyxovirus, e.g., virus responsible for measles and mumps, and respiratory syncitial virus responsible for croup; corona virus, which is also implicated in the common cold; and toga virus, e.g., rubella virus and virus responsible for encephalitis and hemorrhagic fever, Varicella Zoster Virus, Human Herpesvirus-6, cytomegaolovirus, and HIV-1.
There are two main types of herpes simplex virus (HSV). HSV1 is mainly associated with lip, mouth, nose and eye facial infections and HSV2 is mainly genital. Both type 1 and type 2 herpes simplex viruses reside in a clinically latent state in the ganglion of sensory nerves going from the skin toward the central nervous system. With each attack of herpes simplex the virus grows down the nerves and out into the skin or mucous membranes where it multiplies, causing a clinical lesion. After each attack it travels back up the nerve fiber to the ganglion. Herpes simplex, a permanent resident in the nerve tissue of infected humans, causes recurrent acute outbreaks in the skin that are self-limiting and cause pain and embarrassment due to the unsightly redness, swelling and ulceration around the prominently visible lips and nose. When the central part of the cornea of the eye is infected (herpes keratitis) scarring and loss of vision can result if the infection penetrates through the epithelium into the corneal stromal tissue.
HSV can be shed and spread to others in the saliva and genital secretions from individuals without symptoms, especially in the days and weeks following a clinical attack. Following the initial infection, immunity develops but it does not fully protect against further attacks. However where immunity is deficient, both initial and recurrent infections tend to occur more frequently and are more pronounced.
Recurrences of HSV infections can be triggered by minor trauma, other infections including minor upper respiratory tract infections, colds, fevers, chapped lips, ultraviolet radiation (sunlight or artificial tanning devices), conditions affecting the nerves of the face, operations on the face nerves, dental surgery, dermabrasion or laser resurfacing, menstrual cycle (flare-ups may occur before the monthly period), emotional stress and general fatigue, and in many cases no reason for the eruption is evident. Recurrent infections differ from first infections in the smaller size of the vesicles and their close grouping. Recurrent attacks do not usually affect the inside of the mouth. Generally the affected person feels quite well. Tingling, itching or burning precedes by minutes up to a few hours the development of small, closely grouped vesicles in an inflamed area. They normally heal in 7-10 days without scarring. They occur most frequently around the mouth and nose, but can be situated anywhere on the body, particularly where dry skin meets mucosa (wet skin). Recurrences tend to be in the same region, but are not always at the identical site. The vesicles often form in repeated irregular clusters. Fever, pain and enlarged lymph nodes may also be associated with herpes of the hand and forearm or other areas.
As to genital herpes, recurrences are fairly common with clusters of small vesicles which produce shallow ulcers on the glans or shaft of the penis. Similar lesions may occur on the labia, vagina or cervix and can cause distressingly painful symptoms. In other individuals the lesions can be unnoticed.
Stages of recurrent Herpes simplex infection can be summarized as follows: (1) prodromal (tingling, buring and itching.), 99.5% of patients experience this (J. Der. Aug. 2001); (2) papule (redness and slight elevation); (3) vesicle (blister or usually a series of blisters); (4) ulcer/soft crust (loss of skin with soft grey crust); (5) hard crust (dark red scab formation); and (6) healing (diminishing redness until completely healed).
Viral infections have in the past been largely resistant to antibiotic therapy. In particular, herpes infections have proven to be especially refractory. Recent research has shown that certain lipophilic compounds inhibit replication of some enveloped viruses in vitro (U.S. Pat. No. 5,534,554). Sands (Antimicrobial Agents and Chemotherapy, 12, 523-528 (1977)), describes various fatty acids that can inhibit viral replication in bacteriophage, and that at least two modes of fatty acid inhibition can be involved. The first mode involves inactivation of the virus, i.e., virucidal activity. Oleic acid, a monounsaturated C18 fatty acid, was the most effective fatty acid tested for this property, but a C18 acid having two double bonds was essentially inactive. The second method is inhibition of replication, without killing the virus, i.e., anti-viral or virustatic activity. This phenomenon is related to the stage in the infectious cycle in which the fatty acid is added.
Reinhardt et al. (J. Virology, 25, 479-485 (1978)), described unsaturated fatty acids that can inhibit the viral replication of PR4 bacteriophage in vitro. The most effective acids were oleic acid and palmitoleic acid. Arachidonic acid (C20 tetraene) was moderately effective, but less effective than linolenic acid (C18 triene).
Sands et al. (Antimicrobial Agents and Chemotherapy, 15, 67-73 (1979)) describes antiviral activity in vitro of C14-20 unsaturated alcohols having 1-4 double bonds, the most active being gamma-linolenyl alcohol (6,9,12-octadecatrien-1-ol), while C20 tetraenyl alcohol had the least activity. Lower antiviral activity in vitro was described for saturated alcohols by Snipes et al. (Ibid., 11, 98-104 (1977), and Snipes et al. (Symp. Pharm. Effects Lipids (AOCS Monograph No. 5), 63-74 (1978)). Further, U.S. Pat. No. 5,534,554 describes the use of creams containing 20 to 28 carbon aliphatic alcohols for the treatment of viral and inflammatory disease.
In practice, the clinical treatment of enveloped virus infection may include a number of different treatment options. For example, the use of high SPF sunscreens and stress management are important to prevent recurrent facial herpes simplex. Further, herpes simplex infections have been treated using treatments such as ABREVA OTC with 10% docosanol as the active ingredient and with antiviral drugs that include acyclovir, valacyclovir, famciclovir. These drugs will stop the herpes simplex virus from multiplying once it reaches the skin or mucous membranes but cannot eradicate the virus from its resting stage within the nerve cells. They can therefore shorten and prevent attacks while the drug is being taken, but a single course cannot prevent future attacks.
Topical acyclovir, in the form of a cream, can shorten an attack of recurrent herpes simplex, provided it is started early enough. Antiviral drugs are indicated for severe frequently recurring herpes simplex infections. Patients with significant recurring herpes simplex, particularly of the genital type, may require repeated courses or continuous prophylactic therapy for several months or more at a time.
One deficiency with docosanol, which is a saturated solid material containing particles averaging 0.1 microns in size, and with acyclovir for treatment of viral infections, is that they have limited ability to be adsorbed into the skin. It is necessary to add surfactants and emollients to improve penetration (U.S. Pat. No. 5,534,554). Because n-Docosanol is a solid, it was a challenge to add the optimal proportions of emollients and surfactants to attain adequate percutaneous adsorption. The same was true for other long chain compounds tested (PCT W098/11887; U.S. Pat. No. 5,952,392; Parry et al., J. Invest. Dermatol., 98(6): 856-863 (1992); Sprua
Fitch Even Tabin & Flannery
Purcell Jojoba International, LLC
Reamer James H
LandOfFree
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