Pediculicidal compositions, a kit, and methods of use

Details Pediculicidal compositions, a kit, and methods of use Pediculicidal compositions, a kit, and methods of use

2001-03-26

2003-08-19

Venkat, Jyothsna (Department: 1615)

Drug, bio-affecting and body treating compositions

Live hair or scalp treating compositions

C424S070110, C424S070220, C424S070240, C424S070310, C424S642000, C424S670000, C424S671000, C424S679000, C424S680000, C424S681000, C424S678000

Reexamination Certificate

active

06607716

ABSTRACT:

BACKGROUND OF THE INVENTION
Definitions Used in the Invention
Often times in this invention the term ‘pediculicide’ will be used to characterize the present invention, even though the pest that is targeted may be other than lice. The compositions are effective against lice, nits, and other ecto-parasites such as bed bugs, fleas, aquatic leeches, scabies, mites, and the like.
In this invention the term ‘nits’ will mean both louse eggs, which are viable and alive, as well as egg casings without a live louse fetus inside. Live lice, eggs, and fetuses are all included as the pesticidal entities of this invention.
In this invention, ‘natural’ will mean that the pediculicidal compositions that are non-toxic. The product requires no label or other warning against its use by persons with certain allergies or medical conditions. Natural therapies are generally thought to require more time to achieve the therapeutic outcome than chemical cures. The examples and comparative examples recited herein indicate the treatment time difference between chemical (prior art) and natural (instant invention) therapies for pediculosis.
In this invention, ‘Pharmaceutically acceptable gelling agent’ will mean a material that thickens the composition sufficiently to remain on the hair of a scalp for an extended period of time. The material is thick enough not to drip; run or leak out from under the plastic cap provided as part of the instant kit which provides the tools necessary for at least one application to treat lice-infested scalp hair. The viscosity of the gel is an important feature of this invention. The gel composition is thick enough to immobilize the ecto-parasite so that the active ingredients can kill them. A range of thickness required may be expressed as a viscosity ranging from about 3,000 to about 15,000 centipoise (cps). A more preferred viscosity range for the gel composition of the instant invention is from about 6,000 to about 14,000 cps. A still more preferred range is from about 10,000 to about 12,000 cps. It should be noted that the terms ‘viscosity increasing agent’ and ‘thickener’ are synonymous and are used interchangeably in this patent application.
In this invention, ‘stable’ will mean that the composition will not decompose either chemically or physically. This is especially important for the gel compositions of this invention that are part of a kit sold to consumers for treating lice-infested scalp hair. The shelf life of the gel in said kit is at least three years.
In this invention, there are two different categories of fragrance components optionally included in the pediculicidal compositions . One category will impart a soothing fragrance to the composition. This category of fragrance may be from any source. A preferred category of fragrance used in the compositions of this invention will be derived from a plant, and called a plant essence. Another, more preferred category of fragrance will be a plant essence that has pediculicidal activity as well as a pleasant aroma.
Another important definition of this invention is what is meant by ‘areas without hair’. In this invention, ‘areas without hair’ will mean body parts such as limbs which may have body hair but do not have the concentration of hair as does the scalp or the pubic area. It is on these body parts that the active composition of the invention will be formulated as an ointment or a lotion.
Background Discussion
Infestation of lice (pediculosis), fleas and similar ecto-parasites is a common problem. Infestation is often spread from shared hats, combs, lockers, closets, and other unavoidable contacts in school. Infestation can easily spread to other children, or family members by touching or via shared clothing or hair accessories. According to the National Pediculosis Association, there are reportedly 10-12 million cases of pediculosis reported annually.
Head lice (
pediculus humanus capitis
) are small parasitic insects that have adapted to living on the scalp and neck of a host organism. Long associated with human hosts, lice are usually acquired by children in school settings, as has been described previously. Head lice derive nutrients by bloodfeeding several times per day. They cannot survive for more than a day at room temperature without ready access to, the host's blood. A nymphal louse hatches from its egg after about eight days of development, and begins to feed, grow and develop until it attains the adult stage 2-3 weeks after hatching
Body lice are closely related to head lice, but are less frequently encountered in the United States. Body lice generally infest body hair but may migrate to the scalp and facial hair. They usually remain on clothing near the skin and deposit their eggs near the seams of garments. Body lice are usually acquired through direct contact with an infested person or their clothing.
Pubic or crab lice are found in the pubic hair and are usually not associated with children. Public lice are generally transmitted through sexual contact. They may also spread through sharing a bed with an infested person.
Once present on the head, the average female louse has a lifespan of about 25 days and lays up to 10 eggs (nits) each day. The nits attach to the hair shaft by a strong adhesive. The nits hatch within 7-9 days producing more adult lice which continue the cycle. As the lice feed, they cause intense skin irritation. Scratching may lead to secondary infections of the scalp.
In the past, various chemical agents and insecticides have been used to treat pediculosis. These compounds include DDT, hexachlorocyclohexane (HCH), malathion, lindane, cholinesterase inhibitors, pyrethrins, permethrin, and the like. Many of these chemical insecticides have toxic and other unpleasant side effects.
Besides toxicity, another problem with using chemical insecticides to control ecto-parasites such as head lice is that the pests may develop resistance to the insecticides. According to Busvine in his work
Insects and Hygiene
, recent years have seen the emergence of lice which are resistant to DDT and HCH in Britain, Denmark, France, Hungary, Canada, and the United States.
In the past, attempts have been made to eradicate this pest. For example, in U.S. Pat. No. 4,927,813, Bernstein uses a therapeutically effective amount of formic acid in a pharmaceutically acceptable carrier. The procedure recited therein requires application of a formic acid-based material that will dissolve the cement that hold nits in the hair, maintaining the solution on the hair for certain time periods, and washing with shampoo following the treatment. This method may be unduly long, laborious, and difficult to follow, especially if the lice-infested person is young and uncomfortable. Another danger of this art is that formic acid is believed to be toxic. Its absorption through the skin may effect the liver.
Another example of an insecticidal shampoo composition used to treat pediculosis is cited by Juvin et al in U.S. Pat. No. 4,518,593. Juvin et al disclose a shampoo comprising a non-ionic wetting agent, acetic acid, and a plant extract. Examples recited therein use multiple washings. The remedy proposed by Juvin et al is in the form of shampoo.
Plant extracts are mentioned in U.S. Pat. No. 5,676,958 to Emerson et al. This art discloses the use of aromatic aldehydes to kill undesirable parasites. The active insecticidal moiety in Emerson is also formulated into a shampoo.
U.S. Pat. No. 5,696,158 to Oliver discloses a composition that uses piperonal dissolved in water and various alcohol solvents that repel lice and have a pleasant fragrance. U.S. Pat. No. 5,496,852 also to Oliver discloses a method of repelling lice using piperonal-based formulations.
Fragrance is also noted in U.S. Pat. Nos. 5,227,163 and 5,411,992 to Eini et al. These documents disclose the use of various terpenes as lice repellents. Pleasant fragrance is a concern of both these patents. Both Oliver and Eini comment about unpleasant smells associated with many pesticidal louse repellents.
An attempt was made in the past to utilize salt compositions f

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