Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – C-o-group doai
Reexamination Certificate
2001-06-29
2002-10-22
Pryor, Alton (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
C-o-group doai
C514S731000
Reexamination Certificate
active
06469068
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to compositions for controlling germs, such as bacteria, viruses, and mold. More specifically, the present invention relates to compositions for controlling germs that grow on instruments used to clean inside the oral cavity.
2. Description of the Prior Art
Recently, the news media have focused on the microbial dangers one confronts on a daily basis. Food-borne illnesses have received particular attention. In fact, the Centers for Disease Control are beginning a major effort to quantify and limit the increase in food-borne illness. In addition, the role of mold spores as a cause of allergy has been well documented. Recently,
Stachybotrys atra
has received close attention as a potentially dangerous household fungus. Furthermore, advertisements for products for disinfecting or sanitizing surfaces in the home and advertisements for hand sanitizing soaps and lotions can be seen on television during prime time.
Yet, while millions of toothbrushes are sold each year, the average American buys less than one toothbrush per year. Also, there is little public awareness that, with use, toothbrush bristles become heavily contaminated by germs. A toothbrush used in the morning may not be used again until twelve to fourteen hours later, which affords ample opportunity for germ growth. This is of particular concern for the increasing population of elderly and immuno-impaired patients, as well as young children, because oral contaminants constitute an important cause of opportunistic infections. Even in otherwise healthy people, inadequate oral hygiene and dental maintenance has been increasingly linked to disease ideology.
A germ is generally defined herein as any microorganism from which growth and development are expected. This includes viruses, bacteria, mold, fungus, pollen, protozoan, yeast, and algae. Specifically in reference to toothbrushes and other oral cavity cleaning and periodontal instruments, normal microbiota include viridans group streptocci, which are the most common group of microorganisms in the oral cavity and Moraxella catarrhalis. Potential pathogens include
Staphylococcus aureus, Streptococcus pneumoniae, Streptococccus pyogenes, E. coli, Pseudomonas aeruginosa, Neisseria meningitidis, Haemophilus influenzae
, and
Candida albicans
(a fungus), and
Moraxella cararrhalis
. Primary infections, such as scarlet fever, and streptococcal toxic shock syndrome, as well as several dangerous late sequelae, such as rheumatic fever and hemorrhagic glomerulonephritis are caused by
S. pyogenes.
Millions of germs inhabit the human oral cavity, and many have the capacity to cause sickness and infections. Germs are capable of growing on the minuscule food particles that remain trapped within the bristles of a toothbrush after use. Furthermore, many families store their toothbrushes in a common container in a moist, humid bathroom that facilitates germ growth and cross-contamination. In fact, studies have shown that the bathroom may be the most contaminated room in the home. Pointedly, when individuals brush their teeth with used toothbrushes, they put an implement teeming with dangerous germs into their mouths. It is also likely that the bristles of contaminated toothbrushes play a role in the transmission of contaminating germs by abrading the gums being brushed. Clearly, controlling germs on toothbrushes deserves serious attention.
Germs can be controlled through sterilization. Sterilization refers to the complete destruction of all forms of life including bacterial endospores. Destruction of bacterial endospores is most readily achieved by the use of physical methods, most often moist heat, at temperatures well above the boiling point of water, i.e., autoclaving. Yet, autoclaving is too time, labor, and money intensive for practical domestic use. Additionally, many contaminated items are heat sensitive and, therefore, chemical methods must be used. Chemical sterilization is time consuming and uses agents, such as glutaraldehyde, which are relatively toxic. Therefore, chemical sterilization should not be considered for practical domestic use.
Germs can also be controlled by disinfection. Disinfection refers to the destruction of only those organisms that are either primary causes of infectious disease or act as secondary invaders. The destruction of the most commonly encountered organisms of clinical interest is within the capability of a variety of chemical agents. These organisms include bacteria that are relatively resistant, such as
Mycobacterium tuberculosis
and viruses, such as HIV, herpes, respiratory syncytial, influenza A and B, parainfluenza, coxsackie, rotavirus, and caliciviruses (agent of acute infectious non-bacterial gastroenteritis), as well as the vegetative cells of endospore forming species of both Bacillus species and Clostridium species. Disinfection is clearly more appropriate for toothbrushes and other oral cavity cleaning instruments compared to sterilization.
Chemical disinfection is affected by the nature and concentration of the chemical, and the amount of time the germ is exposed to the chemical. For instance, merely dipping a toothbrush into a small container of a disinfectant will obviously be less effective than soaking the toothbrush over-night. Other factors affecting chemical disinfection include the presence or absence of organic or inorganic material as well as pH and temperature. The presence of protein on the surface of the item to be disinfected may inactivate the disinfectant and protect the microorganisms. The surface of the item to be disinfected must also be taken into account. For example, hard smooth surfaces are more readily disinfected than soft porous surfaces.
There are several tried and true classes of disinfectants, each with their own advantages and disadvantages.
Phenolics, such as phenol, have been used as anti-germ ingredients. Yet, phenol is less frequently used today. Phenolics have a chemically altered phenol molecule, which reduces toxicity and enhances antibacterial activity. The most well known phenolics are cresols, known by the names Lysol, O-Syl, and Amphyl, which are used as environmental disinfectants. The bis-phenols, such as hexachlorophene, enjoyed popularity for many years, but now require a prescription. Phenolics coagulate protein and, when combined with surfactants, are also virucidal, fungicidal and tuberculocidal, but are not sporicidal agents.
Alcohols, in a concentration of 50 percent to 80 percent of the total weight of the composition, are lethal for
M. tuberculosis
and the vegetative forms of other bacteria as well as enveloped viruses. Alcohols have a broad spectrum of virucidal activity, demonstrating effectiveness against lipophilic viruses (adenovirus, herpes, and influenza) as well as hydrophilic viruses (poliovirus 1, echovirus 6, coxsackie B1). Yet, alcohol cannot combat non-enveloped viruses. High proof alcohols also have a distinctive, and often unpleasantly strong, taste and aroma. Such an obnoxious taste and aroma is clearly undesirable in a composition for disinfecting toothbrushes.
Surface active agents, such as detergents, exert their antimicrobial action by wetting the surface of the microbe. In other words, surface active agents form a bridge between the interior contents of the cell and the external environment. This often causes the cell to become denatured, which results in cell injury or death. Cationic detergents, a subclass of surface active agents, form positively charged ions causing adherence to microorganisms. This group includes the quaternary ammonium compounds. These compounds are limited by their affinity for many proteins and for soaps. They are readily bound and inactivated by plant fibers. Although effective against some gram-positive organisms, they are relatively ineffective against gram negative organisms.
Pseudomonas aeruginosa
has been found to utilize some quaternary ammonium compounds as a substrate for growth.
Oxidizing agents, such as iodine, chlorine, bromine, and fl
Ohlandt Greeley Ruggiero & Perle L.L.P.
Pryor Alton
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