Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from camellia
Reexamination Certificate
2002-09-03
2004-03-30
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from camellia
C424S725000, C424S765000, C424S777000
Reexamination Certificate
active
06713094
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method of using an herbal extract-based composition to inhibit pathogenesis induced by inhalation of particles. More particularly, provided is a method of therapy for (to treat and/or prevent) pulmonary disease (acute and/or chronic) in an individual, wherein administered to the individual is a composition in an amount effective to reduce inflammation; and wherein the composition comprises an extract of
Gynostemma pentaphyllum
, an extract of
Crataegus pinnatifida
, and an extract of
Camellia sinensis.
BACKGROUND OF THE INVENTION
Inhalation of inorganic (e.g., mineral) dust is known to induce pathological changes in lung tissue leading to pulmonary disease. Inorganic dust may include, but is not limited to silica, asbestos, cristobalite, man-made vitreous fibers, and the like. For example, inhalation of silica (e.g., silcon dioxide, quartz) can cause inflammation, pulmonary fibrosis, and lead to respiratory impairment. Inhalation of crystalline silica is known to be associated with both acute and chronic pulmonary disease. Injury to the lung comprising pulmonary disease may result from one or more of the following mechanisms: (a) silica-induced release of lysosomal enzymes from alveolar macrophages; (b) silica-induced activation and release of reactive oxygen intermediates (e.g., one or more of superoxide anion radical, hydrogen peroxide, hydroxyl radical, nitric oxide, and the like) from alveolar macrophages which may result in oxidant-induced damage to lung tissue (e.g., parenchyma); and (c) silica-induced release of mediators from alveolar macrophages which enhance the proliferation of fibroblasts and other processes which can promote fibrosis.
Various forms of asbestos, such as chrysotile, crocidolite and amosite, have been found to be toxic to mammals, particularly when inhaled. Inhalation of asbestos can induce one or more of inflammation and pulmonary fibrosis, either or both of which can lead to pulmonary disease such as respiratory impairment, as well as promote development of malignant pleural mesotheliomas. It is believed that inhalation of asbestos can induce pulmonary disease utilizing similar or same mechanisms as inhalation of silica. For example, inhaled asbestos (e.g., crystalline particles and/or fibers) typically contacts pulmonary macrophages which induces an inflammatory response characterized by production and release of toxic, reactive oxygen intermediates in the lung. Additionally, in vivo and in vitro studies show that alveolar macrophages, following exposure to asbestos, can release neutrophil chemotaxins such as interleukin-8 which can further contribute to inflammation in the respiratory tract.
Additional concerns for inhalation exposure to harmful inorganic dust have been raised by the collapse of the World Trade Center and the smoke from the associated fires. The steel columns of the World Trade Center were coated with sprayed asbestos as a fire retardant. Upon the collapse of the buildings, a fine white dust could be seen, the dust including pulverized concrete, tons of fine particles of asbestos and other inorganic dust such as particles containing one or more of silicon, sulfur, titanium, vanadium, and nickel. Some reports estimate that, as a result of the collapse, nearly 5,000 tons of asbestos were released in Manhattan. Those people in the vicinity of the collapsed buildings (including, but not limited, to firefighters, other rescue workers, public safety workers, construction workers, office workers, students, residents, and the like) have been and may continue to be exposed to such inorganic dusts. Not only is dust released during the ongoing clean-up of Ground Zero, but homes and offices contain dust in the carpets, drapery, and other furnishings. Pulmonary diseases, likely both acute and chronic, have been attributed to the inhalation of dusts such as pulverized concrete, fiberglass, asbestos, and other particulates that filled the air following the collapse of the towers, as well as the fires that burned thereafter. Symptoms include chest tightness, bloody noses, sinus infections, and other respiratory ailments, including what is now termed as the “World Trade Center cough” (a persistent cough resulting from pulmonary inflammation). Nearly 1 in 4 firefighters who have been working at the Ground Zero site complain of having the World Trade Center cough, and a heaviness in their chest that is “like a bad cold that doesn't clear up”. Of these firefighters, at least 10% have positive CAT scans showing pulmonary inflammation as a result of their exposure. Evaluations of the area by leading asbestos researchers show the increased risk to people who live, work, or study in the area could be as high as one additional cancer death for every 10 people exposed. It has been reported (e.g., by EPA experts, and CDC physicians) that even a one time dose of asbestos, if large enough, can raise the risk of mesothelioma. In addition to the acute respiratory illnesses that people are experiencing, it is now clear, as time progresses, that some individuals are experiencing chronic pulmonary disease as a result of the World Trade Center collapse. The chronic pulmonary disease may include, but is not limited to, one or more of chronic infectious sinus conditions, chronic coughing, wheezing, asthma, and a disorder known as “reactive airways dysfunction syndrome”. Of those with chronic symptoms, more than 15% of the individuals tested have the presence of nodules and granulomas in their lungs—classic signs of disease caused by inhalation of inorganic dusts.
Additionally, pulmonary disease comprising bronchiolitis obliterans is a disease initiated by inhalation of particles (inorganic dust, organic dust, and a combination thereof) in the small conducting airways of the respiratory tract, and which leads to inflammation of these airways that can ultimately result in irreversible airway obstruction. Examples of occupations that can develop such bronchiolitis through the inhalation of particles includes silo workers, textile workers, and workers in the food industry (food-flavoring, microwave popcorn packaging, and the like).
Hence, there is a need for a method for inhibiting pathogenesis induced by inhalation of particles (inorganic dust, organic dust, or a combination thereof) by an individual. More particularly, there is a need for a method of therapy to treat or prevent pulmonary disease (including respiratory ailments) in an individual, wherein administered to the individual is a composition in an amount effective to reduce inflammation induced by inhalation of inorganic dust in the respiratory tract, particularly in the lungs. By inhibiting such inflammation, inherently reduced is any subsequent sequelae such as fibrosis, granulomata, and/or other pathological changes that may lead to development and/or progression of pleural mesothelioma.
SUMMARY OF THE INVENTION
The invention relates to a method for inhibiting pulmonary disease in, by inhibiting inflammation in the respiratory tract of, an individual. In one embodiment, administered to an individual whom has inhaled particles (comprising inorganic dust, organic dust, or a combination thereof) is a composition in an amount effective to reduce inflammation induced in the respiratory tract of the individual as a result of the inhaled particles.
In another embodiment of the present invention, the method for inhibiting pulmonary disease comprises administering, to an individual at risk for inhaling particles (e.g., due to occupation or environmental exposure), the composition in an amount to be effective prophylactically; i.e., so that the active ingredients of the composition are already present in the respiratory tract of the individual so as to reduce inflammation upon the inhalation of the particles.
The composition, and methods of making the composition are disclosed in U.S. Pat. No. 5,910,308; and methods for using the composition in anticancer therapy are disclosed in U.S. Pat. No. 6,168,795 (the disclosures of which are herein incorpora
Lilling Herbert J.
Nelson M. Bud
Sante International Inc.
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