Drug – bio-affecting and body treating compositions – Dispersion or emulsion
Reexamination Certificate
2000-04-28
2003-01-14
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Dispersion or emulsion
C514S938000
Reexamination Certificate
active
06506803
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to compositions and methods for decreasing the infectivity, morbidity, and rate of mortality associated with a variety of pathogenic organisms. The present invention also relates to methods and compositions for decontaminating areas colonized or otherwise infected by pathogenic organisms. Moreover, the present invention relates to methods and compositions for decreasing the infectivity of pathogenic organisms in foodstuffs. In particular, decreased pathogenic organism infectivity, morbidity, and mortality is accomplished by contacting the pathogenic organism with an oil-in-water nanoemulsion comprising an oil, an organic solvent, and a surfactant dispersed in an aqueous phase.
BACKGROUND OF THE INVENTION
Pathogens such as bacteria, fungi, viruses and bacterial spores are responsible for a plethora of human and animal ills. The first step in microbial infections is generally attachment or colonization of skin or mucus membranes, followed by subsequent invasion and dissemination of the infectious microbe. The portals of entry of pathogenic bacteria are predominantly the skin and mucus membranes.
In particular, bacteria of the Bacillus genus form stable spores that resist harsh conditions and extreme temperatures. Contamination of farmlands with
B. anthracis
leads to a fatal disease in domestic, agricultural, and wild animals (Dragon and Rennie, 1995). Human infection with this organism usually results from contact with infected animals or infected animal products (Welkos et al., 1986). Human clinical syndromes include a pulmonary form that has a rapid onset and is frequently fatal. The gastrointestinal and cutaneous forms of anthrax, although less rapid, can result in fatalities unless treated aggressively (Franz et al., 1997; Pile et al., 1998).
Bacillus anthracis
infection in humans is no longer common due to effective animal controls that include vaccines, antibiotics and appropriate disposal of infected livestock. However, animal anthrax infection still represents a significant problem due to the difficulty in decontamination of land and farms.
While an anthrax vaccine is available (Ivins et al., 1995) and can be used for the prevention of classic anthrax, genetic mixing of different strains can render it ineffective (Mobley, 1995). The potential consequences of the use of Anthrax spores as a biological weapon was demonstrated by the accidental release of
Bacillus anthracis
from a military microbiology laboratory in the former Soviet Union. Seventy-seven cases of human anthrax, including 66 deaths, were attributed to the accident. Some anthrax infections occurred as far as 4 kilometers from the laboratory (Meselson et al., 1994). Genetic analysis of infected victims revealed the presence of either multiple strains or a genetically altered
B. anthracis
(Jackson et al, 1998).
Other members of the Bacillus genus are also reported to be etiological agents for many human diseases.
Bacillus cereus
is a common pathogen. It is involved in food borne diseases due to the ability of the spores to survive cooking procedures. It is also associated with local sepsis, wound and systemic infection (Drobniewski, 1993). Many bacteria readily develop resistance to antibiotics. An organism infected with an antibiotic resistant strain of bacteria faces serious and potentially life-threatening consequences.
Examples of bacteria that develop resistance include staphylococcus which often cause fatal infections, pneumococci that cause pneumonia and meningitis; Salmonella and
E. coli
that cause diarrhea; and enterococci that cause blood-stream, surgical wound and urinary tract infections (Berkelman et. al., 1994).
Although an invaluable advance, antibiotic and antimicrobial therapy suffers from several problems, particularly when strains of various bacteria appear that are resistant to antibiotics. In addition, disinfectants/biocides (e.g., sodium hypochlorite, formaldehyde and phenols) which are highly effective against Bacillus spores, are not well suited for decontamination of the environment, equipment, or casualties. This is due to toxicity that leads to tissue necrosis and severe pulmonary injury following inhalation of volatile fumes. The corrosive nature of these compounds also renders them unsuitable for decontamination of sensitive equipment (Alasfl et al. 1993; Beauchamp et al., 1992; Hess et al., 1991; Lineaweaver et al. 1985; Morgan, 1997; Russell, 1990).
Influenza A virus is a common respirator pathogen that is widely used as a model system to test anti-viral agents in vitro (Karaivanova and Spiro, 1998; Mammen et al., 1995; Huang et al. 1991) and in vivo (Waghorn and Goa, 1998; Mendel et al. 1998; Smith et al. 1998). The envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA), which determine the antigenic specificity of viral subtypes, are able to readily mutate, allowing the virus to evade neutralizing antibodies. Current anti-viral compounds and neuraminidase inhibitors are minimally effective and viral resistance is common (Lamb and Krug, 1996; Schulze, 1997).
Clearly, antipathogenic compositions and methods that decrease the infectivity, morbidity, and mortality associated with pathogenic exposure are needed. Such compositions and methods should preferably not have the undesirable properties of promoting microbial resistance, or of being toxic to the recipient.
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Baker, Jr. James R.
Hamouda Tarek
Myc Andrzej
Shih Amy
Fubara Blessing
Medlen & Carroll LLP
Page Thurman K.
Regents of the University of Michigan
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