Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Biocides; animal or insect repellents or attractants
Reexamination Certificate
2000-05-31
2002-08-06
Levy, Neil S. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Biocides; animal or insect repellents or attractants
C424S043000, C424S045000, C424S403000, C424S404000, C424S405000, C424S406000, C514S544000
Reexamination Certificate
active
06428801
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to alcohol-based disinfectant compositions containing one or more additional ingredients which form a barrier against dust particles and particularly dust mites and their allergens. More specifically, the invention relates to aerosol spray disinfectants suitable for indoor use which, in addition to having the usual antimicrobial properties, are also effective in preventing people from coming in contact with allergens found in dust, notably dust mite allergens. The invention also provides methods for effectively controlling dust mites and their allergens and for significantly reducing their attendant adverse reactions.
BACKGROUND OF THE INVENTION
Common house dust is an important cause of asthma, rhinitis, atopic dermatitis, eczema and other allergic conditions in sensitive individuals. Household dust generally comprises a variety of particulate matter including pollen, dust mites, dust mite allergens, dirt, skin cells, animal dander, insect parts, pillow feathers, food particles and mould spores. The particular constituents of dust will depend on location within the house, whether pets are present and other obvious factors. One of the principal sources of allergies is dust mites, which inhabit rugs, carpets, and other fabric surfaces, particularly sofas, mattresses, pillows, upholstered chairs and the like. The mite
Dermatophygoides pteronyssinus
has been identified as a major source of house dust allergen. This mite and the related mites
D. farinae, D. microceras
and
Euroglyphus maynei
are the predominant house dust mites in temperate climates in North America, Europe, Australia and other areas.
Dust mites are not insects, but are eight-legged arachnids, relatives to ticks and spiders. They live in close association with humans (or other mammals), their main food source being the shed scales from skin. Adult mites are approximately 300 microns ({fraction (3/10)} mm) in size, having developed over approximately 25 days through egg, larval and nymph stages. Adults live for 2 to 3½ months, during which time each female can produce about 20-40 eggs. Dust mites are photophobic, living deep in pillows, mattresses, carpets, upholstered furniture and other soft materials.
In addition to a food source, the other essential requirement for dust mite growth is adequate humidity. Dust mites are 75% water by weight. They do not drink water, but must absorb water vapor from the air in order to survive. Specialized glands above their pairs of legs produce secretions high in sodium and potassium chloride, which act to absorb water vapor from surrounding air. This can only be accomplished if the surrounding humidity is sufficiently high. Relative humidities of about 65-80% at temperatures ranging from about 20 to 35 C are optimal for dust mite growth. Dust mites will die at humidities of 50% or less. In geographical areas where humidity is high, dust mites are present in nearly all homes and may be as plentiful as 18,000 mites per gram of dust. Literally millions of mites can inhibit a single bed or rug.
A major dust mite allergen is present in mite faecal particles. Each mite produces about 20 faecal particles per day, and more than 100,000 of them may be present in a gram of dust. These particles vary from about 10 to 40 microns in size, comparable to the size of pollen grains, and become airborne during domestic activity such as making beds and vacuuming carpets.
Group I allergens (dermatophagoides farinae I-Der f I and dermatophagoides pteronyssinus I-Der p I) are heat labile, 24,000 molecular weight glycoproteins (hydrolytic enzymes). These allergens appear to be structural homologues and have very similar N-terminal amino acid sequences. These group I allergens are regarded as the most important and are excreted in their highest concentrations by the mite's gastrointestinal tract in the form of mite's faecal particles, suggesting that they are associated with digestion. They elute rapidly (within 2 minutes) from isolated faecal particles, but very slow from mite bodies.
Group II allergens (Der p II and Der f II) are 15,000 molecular weight proteins with almost identical N-terminal amino acid sequences that are also secreted by the mite's gastrointestinal tract in the form of faecal allergens, although not in as high a concentration as the group I allergens. This suggests that they probably derived from a source other than the gut. Their actual function has not been determined.
Most mite-allergic individuals produce antibodies to both the group I and group II allergens.
Allergen
Mol. Weight
pH
Group 1
Der p I
24,000
4.6-7.4
Der f I
24,000
4.6-7.4
Group II
Der p II
15,000
5.0-6.4
Der f II
15,000
7.8-8.3
Acute exposure to mite allergens has been shown to induce wheezing, rhinitis, eustachian tube obstruction or eczema in sensitized patients. Chronic exposure can cause bronchial hyper-reactivity and chronic asthma. There is a correlation between the level of exposure to house dust mite allergen in early childhood and the likelihood of the subsequent development of asthma. Conversely, asthmatics sensitive to dust mites improve in environments without mites, such as at high altitudes or in hospital rooms. Attempts have therefore been made to decrease patients' exposure to dust mites in the home.
Studies of dust avoidance measures in homes have shown that the use of impermeable mattress and pillow encasings and the removal of bedroom carpeting are associated with a decrease in mite counts. These measures have also been shown to be of clinical value, with a decrease in symptoms and medication requirements occurring in children and adults with dust-sensitive asthma when pillows and mattresses are encased and carpets are removed.
Although carpets and upholstered furniture are major sites of dust mite growth, many allergic individuals are unable or unwilling to remove these from their home. Ordinary vacuuming does not remove dust mites or significantly decrease dust mite allergen levels, and in fact, vacuuming of carpets with the usual household appliances actually increases the amount of airborne dust. However, the use of special filters such as HEPA (High Efficiency Particulate Air) filters or two-ply vacuum bags, and/or the employment of central vacuuming systems (where the dust is collected in a receptacle remote from the room being cleaned) have been helpful. Nevertheless, vacuuming seldom removes all of the live mites, mainly because the mites have little suction cups on the tops of their legs which cause them to cling to textile fibres.
Various chemical agents have been used against mites, including: compounds known under the common names as resuethrin, phenothrin, permethrin, allethrins, tetramethrin, furamethrin, cypermethiin, decamethrin, phenvalerate, phenpropathrin, terallethrin, empenthrin and pyrethrin; pyrethroid compounds such as 1-ethynyl-2-methyl-2-pentenyl-2,2-dimethyl-3,3-(2,2-dichlorovinyl)-cyclopropane-1-carboxylate, 1-ethynyl-2-methyl-2-pentenyl-2,2,3,3-tetramethylcyclopropane-1-carboxylate, &agr;-cyano-3-phenoxybenzyl-2,2-dimethyl-3-(2,2,3-tribromomethyl)-cyclopropane-1-carboxylate; organic phosphorus compounds such as sumithion, fenthion, tetrachlorvinphos, diazinon and DDVP; and carbamate compounds such as those sold under the trademarks Baygon and Sevin. However, these conventional miticides are expensive and are often either toxic to human beings or have the potential themselves to cause allergic or other adverse reactions. Therefore, the use of such compounds in a household environment cannot be the solution to controlling the population of dust mites.
A number of less toxic miticidal agents have been proposed for use in controlling dust mites. As noted in U.S. Pat. No. 4,800,196, these include phenyl salicylate, diphenylamine, methyl beta-naphthyl ketone, coumarin, phenethyl benzoate, benzyl salicylate, phenyl benzoate, N-fluorodichloromethylthio-cyclohexene-dicarboxyimide, p-nitrobenzoic acid methyl ester, p-chlorometaxylenol, &agr;-bromocinnamic aldehyde, 2,5-dichloro-4-bromophenol, 2-phe
Bogart Robert
Suh Janette
Vaccaro Laura
Fish & Richardson P.C.
Levy Neil S.
Reckitt Benckiser , Inc.
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