Pediculocidal and veterinary compositions

Details Pediculocidal and veterinary compositions Pediculocidal and veterinary compositions

1999-10-13

2001-08-21

Weber, Jon P. (Department: 1651)

Drug, bio-affecting and body treating compositions

Plant material or plant extract of undetermined constitution...

C424S405000, C424S757000, C424S764000

Reexamination Certificate

active

06277415

ABSTRACT:

FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to a pediculocidal composition. More particularly, the present invention is of compositions which contain anise oil as at least one of the active ingredients and which have unexpectedly significant activity against lice.
Volatile oils are well known in the art for the treatment of medical problems. For example, these oils have been used in folk medicine, natural therapy, aromatherapy and even in traditional (Western) medicine. Volatile oils in connection with the present invention are those essential oils embraced by the definition in Hackh's Chemical Dictionary, 4th Edition, page 248.
A number of volatile oils found in plants are known to repel or kill insects. The volatile oils might be part of the mechanisms which plants use to protect themselves from attack by insects and animals. This property to kill or repel insects has also been exploited to produce various medicines. For example, the use of volatile oils in the treatment of parasitic infestations is described in “The Manual of Natural Therapy” by M. Olshevsky, B. Noy and M. Zwang (Published by Facts of Life, New York, 1989). For scabies, the following treatment is suggested (pp 183, 185): “Use the essence of geranium 5% in olive oil base and massage the affected part of the skin once per day until condition improves.” For lice, the following is suggested (P. 185): “Rub the whole body with the following combination in olive oil base: crushed garlic 10%, lavender essence 3%, thyme 2%, rosemary 4%. Do this treatment once per day until condition improves.”
Lice belong to the group of external parasites living on warm blooded animals. In humans, lice are responsible for pediculosis, a parasitic infestation of the skin, trunk or pubic areas. There are three different varieties: (1) Pediculosis pubis caused by
Pithirus pubis;
(2)
Pediculosis corporis,
caused by
Pediculus humanus
humanus; and (3) Pediculosis capits, caused by
Pediculus humanis
capatis.
Scabies is a common type of dermatitis, or irritation of the skin, caused by infestation with the mite
Sarcoptes scabisi.
This skin disease affects humans and is also found in various forms in animals such as dogs, cattle, sheep, camels and birds.
Both scabies and pediculosis are conditions which affect millions of humans world-wide. A variety of treatments are known in the art for scabies or lice infestations but none has succeeded in eradicating these two conditions. Epidemics of scabies and of pediculosis appear to be cyclical in nature.
Although certain volatile oils, such as rosemary oil, have been suggested as treatments, these volatile oils have a number of drawbacks. First, the volatile oils are rather expensive. Moreover, the traditional way to use pure volatile oils, by direct application of the pure oil to the skin, frequently causes skin irritation, accompanied by a burning sensation and erythema, when applied to the skin. Diluting the volatile oils in a fixed oil such as olive oil may reduce these side-effects but also reduces their potency. The resultant treatment is less effective and often requires repeated applications. Fixed oils in connection with the present invention are those embraced by the definition in Hackh's Dictionary (Chemical). 4th Edition, page 269. Dissolving a volatile oil in an alcohol, e.g. ethanol, retains the anti-insect properties but also retains the undesired side-effects, e.g., the burning sensation on the skin and erythema.
Furthermore, the background art neither teaches nor suggests a composition which includes anise as at least one of the active ingredients and which also includes an alcohol and a vegetable oil or other suitable type of fixed oil. Certainly, the background art neither teaches nor suggests such a composition for the treatment of lice. For example, United Kingdom Patent Application No. 2,228,411 teaches a cosmetic composition for application to the skin, which includes ethyl alcohol and vegetable oil, and which may optionally include rosemary essential oil. However, United Kingdom Patent Application No. 2,228,411 neither teaches nor suggests anise oil as a suitable ingredient for this cosmetic composition.
Similarly, U.S. Pat. No. 5,455,055 teaches a composition which includes vegetable oil, ethyl alcohol and an herbal extract, but neither teaches nor suggests anise oil as a suitable type of herbal extract. In any case, the taught composition is a salad dressing spray foodstuff and is not taught to have any type of activity against lice.
United Kingdom Patent Application No. 1,574,609 teaches a pesticidal composition, but neither teaches nor suggests anise oil as a suitable ingredient for this composition.
It has therefore been desirable to find a pharmaceutical or veterinary composition which has the desired anti-insect properties, in which a lower concentration of volatile oils may be used, particularly the volatile oil anise oil, and which has no adverse effect on the skin.
SUMMARY OF THE INVENTION
The compositions and methods of the present invention are directed toward the treatment of lice. The composition includes at least one volatile oil, preferably anise oil; at least one alcohol; and at least one fixed oil and/or one or more emollient ester of fatty acid derived from vegetable oils. The composition according to the present invention is preferably a solution and is prepared by admixing the various ingredients. Suitable volatile oils are, e.g., anise oil, calendula oil, quassia oil, rosemary oil and Sassafras oil. Suitable alcohols are, e.g., ethanol and isopropyl alcohol. Suitable fixed oils are, e.g., almond oil, avocado oil, maize oil, olive oil, peanut oil, soya oil, sunflower oil, sesame seed oil, safflower oil and fractionated coconut oil. Suitable esters include but are not limited to medium chain triglycerides (MCT), caprylic/capric triglyceride; isopropyl myristate; propylene glycol dicaprylate—dicaprate; and isopropyl palmitate. MCT are e.g. those as defined in German Pharmacopea, 8th Edition. Most preferably, such a vegetable oil is olive oil.
According to preferred embodiments of the present invention, the composition includes anise oil at a concentration in a range of from about 5% to about 40%, and more preferably from about 15% to about 30%, volume per volume; isopropyl alcohol present at a concentration in a range of from about 20% to about 60% volume per volume; and at least one ingredient selected from the group consisting of fixed oil and emollient ester of fatty acid derived from vegetable oils, which is most preferably coconut oil. More preferably, the composition also includes rosemary oil, most preferably at a concentration in a range of from about 5% to about 25%. Also more preferably, the composition also includes sassafras oil, most preferably at a concentration in a range of from about 5% to about 25%.
The composition of the present invention is preferably applied topically to the subject, more preferably to the skin and hair of the subject. The subject may be human or lower mammal. According to preferred embodiments of the present invention, the treatment with the composition of the present invention is used to kill eggs of the lice, as well as to kill the lice themselves. Such a treatment may also be used to repel the lice from the head of the subject, as described in greater detail below.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The compositions of the present invention feature a synergistic mixture of anise oil, a fixed oil which is preferably coconut oil and an alcohol which is preferably isopropyl alcohol. Optionally and preferably, the mixture also includes rosemary oil. This mixture has unexpectedly great efficacy against lice, including both lice eggs and the hatched lice form, when topically applied to a subject infested with lice. Furthermore, the composition of the present invention overcomes deficiencies in background art treatments for lice in that the ingredients of this composition are non-toxic and are not irritating to the skin. By contrast, many commercial formulations use highl

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