Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2001-04-25
2004-04-27
Levy, Neil S. (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C424S070110, C424S078020, C424S405000, C424S406000
Reexamination Certificate
active
06727228
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to compositions and methods for controlling and treating adult lice and nits (or ova) of species of the order of Anoplura, including but not limited to pediculus capitis, pediculus humanus and pthiris pubic, by applying a composition of pediculicides and ovacides in solution to skin and hair, including but not limited to human skin and hair. The compositions comprise effective pediculicidal agents and ovacidal agents which are solubilized to promote penetration of the ova. More particularly, the effective pediculicidal agents and ovacidal agents are spinosad, Spinosyn A, Spinosyn D, or combinations thereof.
BACKGROUND OF THE INVENTION
Lice present a source of serious health problems worldwide for man and animals. Not only do lice carry a variety of bacteria on their outer surfaces, but in their fecal matter as well. Lice transmit the bacteria to their hosts through puncture wounds which are inflicted during feeding, since lice must feed from their host's blood. Ailments ranging from skin infections to typhus can be traced back to lice infestation.
Lice belong to the order Anoplura. Specific species that affect human beings include pediculus capitis (head lice), pediculus humanus (body lice) and pthiris pubic (pubic lice). Lice are capable of spreading rapidly. A fertilized female lays about six to eight eggs, or nits, every twenty-four hours. It has been estimated that a single female louse and her daughters could have 112,778 offspring in a period of forty-eight days.
Pediculus capitis clings to the hair shaft when feeding, mating, and laying eggs. Removal of nits is particularly difficult, as each nit is cemented to a shaft of hair by a glycoprotein glue, acting as a binding cement. Lice eggs themselves are covered by a chitinous sheath which surrounds both the nit and the attached hair shaft.
Various methods and compositions have been used to remove lice, for example mechanical removal with combs and chemical removal with insecticides (known as pediculicides). Pediculicides, such as lindane and various permethrins, have been used in conjunction with shampoos for killing and rinsing out lice. However, as noted in the prior art, the use of these methods and compositions is not entirely effective in controlling head lice, as some lice often survive the treatment. Indeed, the National Pediculosis Association has reported that twenty to eighty percent of nits survive initial pediculicide treatment, resulting in reinfestation.
In the prior art, pyrethrum, permethrin, and lindane pesticides, all work as central nervous system toxins on lice. Their effectiveness depends on their ability to reach the functioning central nervous system on lice. Unfortunately, nits do not develop a functioning central nervous system until they are between three and four days old, during an average incubation period of approximately ten days. As a result, only sixty to seventy percent of nits treated can be killed upon application of one of these pediculicides.
Moreover, recently, lice may have begun to develop resistance to current pediculicides. For example, resistance has already been documented in Europe, United States and Israel. Thus, a new active to kill lice and their eggs is desirable.
It has been discovered that Spinosyn A and Spinosyn D, compounds that have been used as insecticides for turf building and ornamental plants may be used for killing lice. Spinosyn A and Spinosyn D are components of a fermentation product derived from the bacterium species Saccharopolyspora spinosa. The bacteria decomposes much of the organic matter in soil and the most active metabolites from this fermentation were identified as Spinosyn A and D.
The chemical structure of spinosad contains two sugar molecules, one located at each end. A tetracyclic ring structure joins the two sugars. This structure is one of a class of compounds called macrolides. The chemical structure of spinosyns has the general formula of:
R is defined as any chemical group which provides pediculicidal and ovacidal properties, most preferably H and CH3.
It is known that Spinosyn A and Spinosyn D are useful as insecticides against Lepidoptera and Diptera species. Spinosyns have been used in a pediculicidal shampoo. The prior art does not teach the use of spinosyns in solution.
Known pediculicides have been noted to be ineffective on killing ova. Thus, the use of these pediculicides results in a reinfestation of the hair or skin as soon as the ova hatch, since the treatment was ineffective in controlling and killing the ova. A need has arisen to develop an effective treatment for both adult lice and their ova in a cosmetically elegant form.
SUMMARY OF THE INVENTION
The present invention includes a composition comprising an effective amount of one or more agents having pediculicidal and ovacidal properties for adult lice and nits of a specie of order Anoplura in solution.
Another embodiment of the invention comprises pediculicidal agents and ovacidal agents in solution for adult lice and nits which comprise the chemical structure of:
In another embodiment, the present invention includes a composition comprising a mixture of spinosyn A and spinosyn D in an approximate weight ratio of 85:15, water, methyl vinyl ether/maleic anhydride crosslinked with 1,9 decadiene, propylene glycol, a mixture of cetyl and stearyl alcohols, ceteareth-20, stearalkonium chloride, benzyl alcohol, pentylene glycol, isopropyl alcohol, BHT and sodium hydroxide.
The present invention includes a method of controlling adults and ova of the species of order Anoplura by topically applying to one or more of skin and hair a composition comprising an effective amount of one or more agents having pediculicidal and ovacidal properties for adult lice and nits of a specie of order Anoplura in solution. The pediculicidal and ovacidal properties include the abilities to control adult lice and lice ova (or nits).
The present invention includes a method of controlling adults and ova of the species of order Anoplura by topically applying to one or more of skin and hair a composition comprising an effective amount of one or more agents having pediculicidal and ovacidal properties for adult lice and nits of a specie of order Anoplura in solution, which agents comprise the chemical structure of:
The present invention includes a method of controlling adults and ova of the species of order Anoplura by topically applying to one or more of skin and hair a composition comprising a mixture of spinosyn A and spinosyn D in an approximate weight ratio of 80:20, water, methyl vinyl ether/maleic anhydride crosslinked with 1,9 decadiene, propylene glycol, a mixture of cetyl and stearyl alcohols, ceteareth-20, stearalkonium chloride, benzyl alcohol, pentylene glycol, isopropyl alcohol, BHT and sodium hydroxide.
Another embodiment of the present invention includes a method of controlling adults and ova of the species of order Anoplura by topically applying to one or more of skin and hair a composition comprising about 1 to about 2.2% of Spinosyn A & D in an approximate weight ratio of 85:15, about 44% deionized water, about 1.1 Stabileze QM, about 3% propylene glycol, about 3% cetostearyl alcohol NF, about 0.9% Ceteareth-20, about 4.17% stearalkonium chloride (or Ammonyx 4 (18%)), about 10% benzyl alcohol, about 6% hexylene glycol, about 4% pentylene glycol, about 20% isoproyl alcohol, about 0.1% BHT and about 1.2 to about 1.9% sodium hydroxide (10% solution).
A further separate embodiment of the present invention is a method for solubilizing agents having pediculicidal and ovacidal properties comprising combining one or more solvents and an effective amount of one or more agents having pediculicidal and ovacidal properties; wherein the agents comprise a chemical structure of:
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to a composition comprising an effective amount of agents with pediculicidal and ovacidal properties in a cosmetically elegant solution or emulsion, including but not limited to imidacloprid, spinosad
Ho Kie
Janssen Herwig
Lamb C. Scott
Nystrand Glenn
Williams Dexter
Feehery Maryellen
Johnson & Johnson Consumer Companies Inc.
Levy Neil S.
Reed Smith LLP
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