Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Biocides; animal or insect repellents or attractants
Reexamination Certificate
2002-04-29
2003-12-16
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
C424S405000, C514S529000, C514S846000, C514S549000, C514S552000, C523S122000
Reexamination Certificate
active
06663876
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to methods and compositions for killing ectoparasites.
BACKGROUND OF THE INVENTION
Head lice infestation is a persistent problem with as many as 6-12 million people worldwide affected each year. The problem is particularly prevalent in children with preschool and elementary-age children aged 3-10 and their families becoming infested most often. Head lice infestation is produced by the common head louse
Pediculus humanus capitis
, and typically causes itching of the scalp. As the lice feed on human blood, they may cause lesions to develop on the scalp, swollen glands on the neck or under arms, or other symptoms. Head lice infestation causes serious problems due to the negative social implications of the infestation. Body lice are also bothersome to humans and carry the additional hazard of being the vectors of certain diseases, such as exanthematic or epidemic typhus and recurrent fever.
Various compositions are available for treating these infestations, which generally take a topical approach to treatment. Most of these treatments involve the use of insecticides that are harsh agents, thus raising toxicity concerns. The lice can also become resistant to the insecticides used and therefore the compositions can lose their effectiveness over time.
SUMMARY OF THE INVENTION
The present invention provides compositions and methods for killing ectoparasites on a subject. In the most preferred embodiments, the subject is a human and the ectoparasites are lice, fleas, and ticks. In one embodiment, the compositions contain a fatty acid ester in an amount sufficient for killing lice, and the fatty acid ester is present as the sole agent effective for such treatment. In one embodiment, the fatty acid ester is an ester of myristate, e.g., isopropyl myristate. In another embodiment, the composition may also contain a siloxane, e.g., deca-cyclomethicone (silicone). And in a most preferred embodiment, the composition contains both isopropyl myristate and decacyclomethicone and does not contain any other agent in an amount sufficient for killing ectoparasites. In other embodiments, the compositions may also contain a mectin (such as ivermectin) and/or a mycin (such as milbemycin). In further embodiments, the compositions also contain sesquiterpenes, such as S-methoprene, which is effective for killing the eggs of ectoparasites, or juvenile hormone analogs (e.g., hydroprene, fenoxycarb and pyriproxyfen).
In a preferred embodiment, the compositions are formulated to be applied to the scalp of a person suffering from a head lice infestation and are left on the treated person for a period of time. The compositions are preferably left on the treated area for about 5-15 minutes, and more preferably for about 10 minutes, with the effect of killing lice and their eggs present within 1 hour or less. In other aspects the compositions, methods, and uses are effective for treating domestic pets for flea infestation or for treating insect infestation of crops.
The term “subject” includes humans, plants, and mammals. The term “mammal” includes humans, and also includes animals that are members of the class Mammalia. This will usually be a human but also includes pets such as dogs, cats, ferrets, rabbits, gerbils, and guinea pigs. Mammals also include domestic animals such as bovines, porcines, ovines, and equines. While most fur-bearing animals can become infested with fleas and ticks, pigs, horses, and cattle can also be infested with lice (e.g., the
Haematopinus suis
, which infests pigs, and other Haematopinus spp. that infest horses and cattle). All of these infestations are treatable with the compositions described herein. By a topical application is meant that the composition is applied to the exterior of the treated subject, e.g. to the exterior skin,.hair, fur, or foliage. This application includes, but is not limited to, manual application or application by various automated means, for example, spraying or painting onto a treated subject, or other means. By “fatty acid ester” is meant an ester composed of an organic molecule bonded to a fatty acid, e.g. isopropyl myristate. Fatty acid refers to any acid derived from fats by hydrolysis and having from 6 to 22 carbon atoms. An ester is a functional derivative of a carboxylic acid, where the —OH group of the carboxylic acid has been replaced by an —OR, R being an alkyl group. By an “agent” is meant any compound, composition, or chemical entity. By “amount sufficient for killing” or “effective” for killing lice or other ectoparasites is meant that at least 75% of lice or ectoparasite present are killed within 24 hours after a 10 minute exposure to the composition. In other embodiments, at least 90% or at least 95% or at least 98% or at least 99% or even 100% of the lice or ectoparasite present on the treated subject are killed within 24 hours after a 10 minute exposure to the composition. In other embodiments, the percentage of lice or other ectoparasites killed can be evaluated after 1 hour following a 10 minute exposure to the composition. In one embodiment, the in vitro test described in the Examples can be used to determine the “amount sufficient” or whether a compound is “effective.” In still further embodiments, the exposure time can be increased to achieve the percentages of lice, fleas, or other ectoparasites killed, e.g. that 95% of the ectoparasites present are killed within 24 hours after a 15 minute exposure, or a 30 minute exposure, or a 45 minute exposure. A siloxane is a compound having the Si—O—Si bond, the main chemical bond found in silica. By “infestation” is meant the presence of lice, fleas, ticks, or other ectoparasites that are the target of the treatment. Ectoparasites or pests include, but are not limited to, head lice, body lice (e.g.,
Pediculus humanus
), crab lice (e.g.,
Phthirus pubis
), mites (scabies), fleas and ticks. The presence of eggs of the target ectoparasite also constitutes infestation.
The methods of the present invention include topically administering a composition of the invention to an area on the mammal where ectoparasites are present. As noted above, the compositions preferably remain in contact with the treated area for a period of time. In various embodiments, no aqueous solution is applied to the treated area for at least 10 minutes or 30 minutes or 1 hour after the topical administration such as, for example, by washing the treated area. In various embodiments the mectin and/or mycin can be replaced with another compound such as pyrethroids, organophosphates such as malathion and diazinon, pyrroles, or more generally azoles, glyphosate, nicotinoids, and triazines.
Methods are also provided of manufacturing a medicament for treating ectoparasite infestation on a fur-bearing mammal. These methods involve providing a medicament containing an above-described composition. New uses of compositions are also provided. The medicaments are useful for killing fleas, lice, ticks, and other pests on a mammal and contain a composition of the present invention. The present invention also provides methods of treating ectoparasite infestation on a mammal by topically administering a composition containing ivermectin to an area on the mammal where lice, fleas, ticks or other ectoparasites are present. The composition can be any of the compositions of the present invention, or can also be ivermectin and any suitable carrier.
The summary of the invention described above is not limiting and other features and advantages of the invention will be apparent from the following detailed description of the preferred embodiments, as well as from the claims.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides compositions that are useful for treating ectoparasites on a mammal. The present inventors discovered unexpectedly that just fatty acid esters alone, preferably isopropyl myristate, have the effect of killing ectoparasites. The present inventors also discovered unexpectedly that silicones (e.g., a cyclomethicone) also have the ability to kill e
Campbell William R.
Palma Kathleen G.
Paulson Neil E.
Levy Neil S.
Piedmont Pharmaceuticals, LLC
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