EP2723346A1 - Compositions and methods useful for treating pediculosis - Google Patents
Compositions and methods useful for treating pediculosisInfo
- Publication number
- EP2723346A1 EP2723346A1 EP12802298.5A EP12802298A EP2723346A1 EP 2723346 A1 EP2723346 A1 EP 2723346A1 EP 12802298 A EP12802298 A EP 12802298A EP 2723346 A1 EP2723346 A1 EP 2723346A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- oil
- composition
- group
- pediculosis
- rosemary
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
- A61K8/922—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of vegetable origin
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N65/00—Biocides, pest repellants or attractants, or plant growth regulators containing material from algae, lichens, bryophyta, multi-cellular fungi or plants, or extracts thereof
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N65/00—Biocides, pest repellants or attractants, or plant growth regulators containing material from algae, lichens, bryophyta, multi-cellular fungi or plants, or extracts thereof
- A01N65/08—Magnoliopsida [dicotyledons]
- A01N65/10—Apiaceae or Umbelliferae [Carrot family], e.g. parsley, caraway, dill, lovage, fennel or snakebed
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N65/00—Biocides, pest repellants or attractants, or plant growth regulators containing material from algae, lichens, bryophyta, multi-cellular fungi or plants, or extracts thereof
- A01N65/08—Magnoliopsida [dicotyledons]
- A01N65/22—Lamiaceae or Labiatae [Mint family], e.g. thyme, rosemary, skullcap, selfheal, lavender, perilla, pennyroyal, peppermint or spearmint
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/534—Mentha (mint)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/34—Alcohols
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/37—Esters of carboxylic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
- A61K8/89—Polysiloxanes
- A61K8/891—Polysiloxanes saturated, e.g. dimethicone, phenyl trimethicone, C24-C28 methicone or stearyl dimethicone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/08—Antiseborrheics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P33/00—Antiparasitic agents
- A61P33/14—Ectoparasiticides, e.g. scabicides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
- A61Q17/02—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings containing insect repellants
Definitions
- the invention in some embodiments, relates to the field of pest control, and more specifically, but not exclusively, to methods and compositions for treating infestations by insects, especially infestations by lice (pediculosis).
- Lice belong to the group of external parasites living on warm-blooded animals.
- An infestation of lice is called pediculosis.
- pediculosis In humans there are three different varieties of pediculosis caused by different types of lice: (1) Pediculosis pubis in the pubic area, caused by Pithirus pubis; (2) Pediculosis corporis on the trunk, caused by Pediculus humanus humanus; and (3) Pediculosis capitis on the head, caused by Pediculus humanis capitis.
- Pediculosis affects millions of humans world-wide.
- Essential oils are well known in the art for the treatment of medical problems.
- Essential oils in connection with the present invention are those essential oils embraced by the definition inhackh's Chemical Dictionary, 4 th Edition, page 248.
- essential oils such as rosemary oil
- essential oils have a number of drawbacks.
- the traditional way to use essential oils by direct application of the pure oil to the skin, frequently causes skin irritation accompanied by a burning sensation and erythema.
- Diluting the essential oils in a fixed oil such as olive oil may reduce such side- effects but also reduces the efficacy of the essential oil.
- Dissolving an essential oil in an alcohol, e. g., ethanol often allows preservation of anti-insect properties but generally increases undesirable side-effects, e. g., the burning sensation on the skin and erythema.
- compositions for the pediculosis comprising at least one essential 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.
- An embodiment of the teachings thereof is commercially available in the United States as "Hairclean 1-2-3"® or Scram®, and in Europe as Paranix®.
- the composition is applied to the hair and maintained in contact therewith for at least 15 minutes followed by use of a fine-tooth comb to remove nits and lice.
- Such a composition has a combination of essential oils (rosemary and/or anise oils) and a relatively high concentration of alcohols (ethanol or isopropyl alcohol) which can produce adverse topical reactions, such as contact dermatitis in sensitive subjects.
- essential oils rosemary and/or anise oils
- alcohols ethanol or isopropyl alcohol
- compositions for treating pediculosis includes a combination of silicon oil and isopropyl myristate, for example commercially available as Resultz® (50% cyclomethicone and 50% isopropyl myristate, from Nycomed Canada Inc., Oakville, Ontario, Canada).
- Resultz® 50% cyclomethicone and 50% isopropyl myristate, from Nycomed Canada Inc., Oakville, Ontario, Canada.
- Such compositions kill adult lice through two modes of action.
- the isopropyl myristate dissolves the waxy coating of the louse exoskeleton, leading to dehydration of the louse, while the silicone oil, acting as a lubricant, makes it difficult for weakened lice to grasp the hair such that the lice are easy to comb out from the hair. Additionally, the silicone oil may have some lice-smothering effect.
- the composition is carefully applied to the scalp and the entire length of the hair shafts, maintained in contact therewith for at least 10 minutes followed by washing, rinsing and combing with a fine-tooth comb to remove dead lice. Even after washing and rinsing, the composition leaves an unpleasant residue that has the advantage of making combing easier.
- the invention in some embodiments thereof, relates to a composition useful for the treatment of pediculosis and, more particularly, but not exclusively, to a composition useful for the treatment of pediculosis comprising a essential oil.
- a composition comprising a essential oil selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil, clove oil, eucalyptus oil, lavender oil, peppermint oil, or combinations thereof; at least one solvent selected from the group consisting of isopropyl alcohol and isopropyl myristate; a silicone oil; and an emollient ester of fatty acid derived from vegetable oils.
- the essential oil is selected from the group consisting of anise oil and rosemary oil.
- a composition comprising a essential oil selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil, clove oil, eucalyptus oil, lavender oil, peppermint oil, or combinations thereof; at least one solvent selected from the group consisting of isopropyl alcohol and isopropyl myristate; a silicone oil; and at least one emollient ester of fatty acid derived from vegetable oils, for use in treating pediculosis.
- a composition comprising a essential oil selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil, clove oil, eucalyptus oil, lavender oil, peppermint oil, or combinations thereof; at least one solvent selected from the group consisting of isopropyl alcohol and isopropyl myristate; a silicone oil; and at least one emollient ester of fatty acid derived from vegetable oils, in the manufacture of a medicament for the treatment of pediculosis.
- a essential oil selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil, clove oil, eucalyptus oil, lavender oil, peppermint oil, or combinations thereof
- at least one solvent selected from the group consisting of isopropyl alcohol and isopropyl myristate
- a method for the treatment of pediculosis comprising topically administering to a subject in need thereof a composition comprising a essential oil selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil, clove oil, eucalyptus oil, lavender oil, peppermint oil, or combinations thereof; at least one solvent selected from the group consisting of isopropyl alcohol and isopropyl myristate; a silicone oil; and at least one emollient ester of fatty acid derived from vegetable oils.
- a essential oil selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil, clove oil, eucalyptus oil, lavender oil, peppermint oil, or combinations thereof
- the composition remains in contact with an area of skin of said subject for a time period of from about 1 to about 15 minutes, such as, for example, about 5 minutes.
- the subject is a human.
- the subject is a non-human animal.
- the pediculosis is selected from the group consisting of pediculosis capitis and pediculosis humanus humanus.
- a method for the preparation of a composition useful in the treatment of pediculosis comprising mixing together a essential oil selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil, clove oil, eucalyptus oil, lavender oil, peppermint oil, or combinations thereof; at least one solvent selected from the group consisting of isopropyl alcohol and isopropyl myristate; a silicone oil; and at least one emollient ester of fatty acid derived from vegetable oils.
- the essential oil is selected from the group consisting of anise oil and rosemary oil.
- the solvent comprises isopropyl alcohol and isopropyl myristate.
- the silicone oil comprises dimethicone. In some embodiments, dimethicone is present at a concentration of from about 5% to about 20% volume per volume.
- the emollient ester of fatty acid comprises caprylic/capric triglyceride. In some embodiments, the caprylic/capric triglyceride is present at a concentration of from about 5% to about 25% volume per volume.
- the composition comprises rosemary oil, isopropyl alcohol, isopropyl myristate, caprylic/capric triglyceride and dimethicone.
- the essential oil is present at a concentration of from about 1% to about 20%) volume per volume.
- the isopropyl alcohol is present at a concentration of from about 10%o to about 30%> volume per volume.
- the isopropyl myristate is present at a concentration of from about 30%) to about 50%> volume per volume.
- the composition comprises one of rosemary oil and anise oil as sole essential oil.
- the composition is formulated for topical administration.
- compositions of any of the embodiments described herein for killing of nits.
- the term “treating” includes curing a condition, treating a condition, preventing a condition, treating symptoms of a condition, curing symptoms of a condition, ameliorating symptoms of a condition, treating effects of a condition, ameliorating effects of a condition, and preventing results of a condition.
- the terms “comprising”, “including”, “having” and grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. These terms encompass the terms “consisting of and “consisting essentially o .
- the term "pharmaceutically acceptable” means approved by a regulatory agency of the US Federal or a US state government or listed in the U.S. Pharmacopeia or other generally recognized pharmacopeia for use in animals, and more particularly in humans.
- pharmaceutically acceptable carrier refers to an approved carrier or a diluent that does not cause significant irritation to an organism and does not abrogate the biological activity and properties of the administered conjugate.
- carrier refers to a diluent, adjuvant, excipient, or vehicle with which the therapeutic is administered.
- excipient refers to an inert substance added to a pharmaceutical composition to further facilitate processes and administration of the active pharmaceutical ingredients.
- the invention in some embodiments thereof, relates to a composition useful for the treatment of pediculosis and, more particularly, but not exclusively, to a composition useful for the treatment of pediculosis comprising an essential oil.
- the essential oil is selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil (including oil of leaf, bark, fruit, or twig of the cinnamon plant, or combinations thereof), clove oil (including oil of the flower, bud or leaf, or combinations thereof), eucalyptus oil (including citriodora, radiata, smithii, staigeriana and globulus, or combinations thereof), lavender oil (including angustifolia and latifolia), peppermint oil, or combinations thereof.
- the essential oil is selected from the group consisting of anise oil and rosemary oil.
- compositions for the treatment of pediculosis which are applied to the scalp of a subject and are generally kept in contact with the hair and scalp for a period of at least 15 minutes for maximal efficacy. Such a time period can be seen as inconveniently long, especially when treating young children who may have limited patience and must be continually prevented from touching the head once the composition is applied. Use of such compositions has resulted in 100% mortality of adult lice but insufficient nit mortality. As a result, repeated application is required after 7-10 days when a new batch of lice nymphs hatch from surviving nits.
- compositions described in the PCT application either comprise a combination of rosemary oil and anise oil (both which are expensive) and/or use a relatively high concentrations of ethanol and/or isopropyl alcohol, which can cause contact dermatitis and other adverse topical reactions in particularly sensitive subjects.
- the present invention provides a composition for the treatment of lice infestation.
- Some embodiments of the composition comprises a single essential oil and not a combination of essential oils. Some embodiments of the composition have a comparatively low alcohol content, reducing potential undesirable side-effects. Some embodiments of the composition are fast-acting, in some embodiments requiring even less than 15 minutes contact with the hair and scalp for maximal efficacy. Some embodiments of the composition are unexpectedly effective in killing nits, even close to 100% nit mortality 10 days after application. Accordingly, some embodiments of a composition as described herein have been experimentally proven to be at least as effective and/or to have advantages in the treatment of lice infestation compared to the compositions disclosed in WO 01/26471.
- the minimal recommended application time for maximal efficacy is equal or shorter than that required with prior art compositions.
- the composition disclosed herein is effective against nits and hatched lice (nymphs and adults) when topically applied to a subject infested with lice, such that, all things being equal, hatching of nits and recurrence of the infestation is less likely to occur.
- compositions and preparation of composition are compositions and preparation of composition
- a composition comprising a essential oil selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil, clove oil, eucalyptus oil, lavender oil, peppermint oil, or combinations thereof; at least one solvent selected from the group consisting of isopropyl alcohol and isopropyl myristate; a silicone oil; and at least one emollient ester of fatty acid derived from vegetable oils.
- a composition is useful in the treatment of pediculosis.
- such a composition is useful in the manufacture of a medicament for the treatment of pediculosis.
- a method for the treatment of pediculosis comprising topically administering to a subject in need thereof a composition comprising a essential oil selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil, clove oil, eucalyptus oil, lavender oil, peppermint oil, or combinations thereof; at least one solvent selected from the group consisting of isopropyl alcohol and isopropyl myristate; a silicone oil; and at least one emollient ester of fatty acid derived from vegetable oils.
- a essential oil selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil, clove oil, eucalyptus oil, lavender oil, peppermint oil, or combinations thereof
- a method for the preparation of a composition useful in the treatment of pediculosis comprising combining a essential oil selected from the group consisting of anise oil, rosemary oil, calendula oil, tea tree oil, sassafras oil, quassia oil, cinnamon oil, clove oil, eucalyptus oil, lavender oil, peppermint oil, or combinations thereof; at least one solvent selected from the group consisting of isopropyl alcohol and isopropyl myristate; a silicone oil; and at least one emollient ester of fatty acid derived from vegetable oils.
- the essential oil comprises a combination of anise oil and rosemary oil. That said, in preferred embodiments, either anise oil or rosemary oil comprises the sole essential oil.
- the at least one solvent comprises a mixture of isopropyl alcohol and isopropyl myristate.
- the silicone oil is selected from the group consisting of a polyalkyl siloxane, a polyaryl siloxane, a polyalkylaryl siloxane or a polyether siloxane copolymer, and combinations thereof.
- the polyalkyl siloxane comprises polymethyl siloxane (dimethicone).
- the emollient ester of fatty acid is selected from the group consisting of medium chain triglycerides (MCT), caprylic/capric triglyceride; propylene glycol dicaprylate-dicaprate; and isopropyl palmitate.
- MCT medium chain triglycerides
- the ester comprises caprylic/capric triglyceride.
- composition described herein may be manufactured using processes well known in the art, e.g., by means of conventional mixing, dissolving, emulsifying etc. Further techniques for formulation and administration of active ingredients may be found in "Remington's Pharmaceutical Sciences,” Mack Publishing Co., Easton, PA, latest edition, which is incorporated by reference as if fully set forth herein.
- composition as described herein further comprises a suitable carrier to facilitate administration.
- a composition as described herein further comprises additional excipients and auxiliaries, known to those skilled in the art, to facilitate processing of the active ingredients into preparations which, can be used pharmaceutically.
- excipients include anti-oxidants, gelling agents, thickening agents, stabilizers, and the like.
- a composition as described herein may be used for treating any subject suffering from pediculosis, either a human or a non-human animal.
- a composition as described herein may be used in any suitable manner, but is preferably applied topically to the subject, most preferably to the skin and/or hair and/or pelt and/or fur of the subject. In some embodiments, the composition is used in a manner analogous to the use of "Hairclean 1-2-3"® or Resultz®.
- a composition as described herein is provided in any suitable form which enables the composition to remain in contact with the skin and/or hair for a desired time period.
- suitable forms include a liquid, a gel, a cream, an ointment, a paste, a lotion, a milk, a suspension, an aerosol, a spray, a foam, or a serum.
- a composition as described herein is applied (e.g., by massaging into the hair) topically for a period of time up to about 15 minutes, up to about 10 minutes, and even up to about 5 minutes. In some embodiments, the composition is applied for about 5 minutes.
- the hair is combed with a fine-tooth comb to remove lice and/or nits.
- the composition is removed either by rinsing with water or by washing with normal shampoo followed by rinsing.
- Rosemary oil (CAS Nr. 8000-25-7 ⁇
- compositions as described herein comprise rosemary oil as an essential oil.
- Some preferred embodiments comprise rosemary oil as a sole essential oil.
- Some embodiments comprise rosemary oil together with at least one additional essential oil.
- Rosemary is a woody, perennial herb with fragrant, evergreen, needle-like leaves, which is native to the Meditteranean region.
- Rosemary essential oil which is extracted mainly from the leaves of the plant by steam distillation, is considered to stimulate hair growth, boost mental activity, relieve respiratory problems, reduce pain, and treat indigestion, flatulence and stomach cramps.
- Rosemary oil is used extensively for hair care in shampoos and lotions. Regular use of rosemary oil helps in stimulating follicles, as a result of which, hair grow longer and stronger. It is also believed that rosemary oil slows down premature hair loss and graying of hair.
- Rosemary essential oil is also beneficial for dry and flaky scalps. Regular massage of scalp with rosemary oil nourishes the scalp and removes dandruff. Further, it is often mixed with tea tree oil and basil oil to treat scalp problems.
- an antilice composition is disclosed having between about 3% and 70% rosemary oil.
- the composition comprises between about 1% and about 20%, in some embodiments between about 1% and about 15%, and in some embodiments even between about 5% and about 15% rosemary oil (v/v).
- Anise oil (CAS Nr. 8007-70-3 ⁇
- compositions as described herein comprise anise oil as an essential oil. Some preferred embodiments comprise anise oil as a sole essential oil. Some embodiments comprise anise oil together with at least one additional essential oil.
- Anise (Pimeinella anisum) is a herbaceous, annual flowering plant in the family Apiaceae, native to the eastern Mediterranean region and Southwest Asia.
- the essential oil obtained by steam distillation of the seeds, mainly comprises anethole, a phytoestrogen.
- Anise oil is used in aromatherapy for bronchitis, colds and flu, for treatment of flautulence, impotence, menstrual pains, migraines and colic.
- an antilice composition is disclosed having between about 5% and 34% anise oil.
- the composition comprises between about 1% and about 20%, in some embodiments between about 1% and about 15%, and in some embodiments even between about 5% and about 15% anise oil (v/v).
- Cinnamon leaf oil (CAS 8007-80-051 cinnamon oil (CAS 8015-91-6 ⁇
- compositions as described herein comprise cinnamon leaf oil and/or cinnamon oil (comprising oil from the bark, fruit, leaf and/or twig).
- Cinnamon is a spice obtained from the inner bark of several trees from the genus Cinnamomum.
- Species of cinnamon include Cinnamomum verum, C. burmannii, C. loureiroi, and C. aromaticum.
- Cinnamon is considered to boost cognitive function, and memory, treat rheumatism, aid in digestion and relief of menstrual disorders. It is also considered as a cure for colds and fever, treatment for diarrhea, flatulence and other problems of the digestive system, treatment of toothache, bad breath, cough, headache, and heart disease, and has been suggested as a treatment for Alzheimer's disease and Type 2 diabetes. Cinnamon also serves as a natural food preservative, inhibiting bacterial growth and food spoilage.
- Cloves are the aromatic dried flower buds of a tree in the family Myrtaceae. Cloves are used in cooking, either in whole or in ground form, and as incense. Cloves are considered to be useful in relieving dental pain, and have been suggested as reducing blood sugar levels.
- Active compounds in cloves include eugenol, acetyl eugenol, beta- caryophyllene and vanillin; crategolic acid; tannins, gallotannic acid, methyl salicylate (painkiller); the flavonoids eugenin, kaempferol, rhamnetin, and eugenitin; triterpenoids like oleanolic acid, stigmasterol and campesterol; and several sesquiterpenes.
- Eucalyptus is a diverse genus of flowering trees and shrubs in the myrtle family, Myrtaceae.
- Essential eucalyptus oils include citriodora (CAS No. 129828-24-6), radiata
- Eucalyptus oil is used externally as an antiseptic; for treatment of burns, sores, ulcers, scrapes, boils and wounds. Eucalyptus oil is applied topically for relief of rheumatic pain, aches, stiffness and neuralgia. Inhalation of the vapor of boiled eucalyptus leaves is useful for relief of congestion, asthma and respiratory problems. Eucalyptus rubbed into the skin acts as an insect repellant, especially for mosquitoes and fleas. Rubbed into the chest, it relieves congestion and cough. Lavender oil (angustifolia CAS No. 8000-28-0; latifolia CAS No. 8016-78-2)
- Lavender is a genus of 39 species of flowering plants in the mint family, including Lavandula angustifolia, Lavandula latifolia, and Lavandula lanata.
- Essential oil of lavender is used in balms, salves, perfumes, cosmetics, and topical applications, and is considered to have antiseptic and anti-inflammatory properties. Infusion of lavender is considered to soothe and heal insect bites and burns. Bunches of lavender repel insects. If applied to the temples, lavender oil soothes headaches. In pillows, lavender seeds and flowers aid sleep and relaxation.
- Peppermint oil (mentha piperita. CAS No. 8006-90-4)
- Peppermint is a hybrid mint, a cross between the watermint (Mentha aquatic) and spearmint (Mentha spicata).
- Medicinal uses of peppermint oil include uses in aiding digestion, reduction of motion sickness and upset stomach; as an antiseptic and breath freshener in dental care; relief of respiratory problems, including nasal congestion, sinusitis, asthma, bronchitis, cold and cough; relief of nausea and headache; relief of stress, depression and mental exhaustion; relief of irritable bowel syndrome; and pain relief.
- Peppermint oil is also considered to boost the immune system and improve blood circulation. Peppermint oil is used in hair care to remove dandruff and lice, and in skin care to nourish dull skin and improve oily skin.
- compositions as described herein comprise isopropyl alcohol as a solvent. Some embodiments comprise isopropyl alcohol together with at least one additional solvent. Some embodiments comprise isopropyl alcohol as a sole solvent.
- the isopropyl alcohol helps wet the hair, assisting in providing a more even distribution of the composition over the hair and scalp, thereby assisting in ensuring that all lice are exposed to the composition.
- Isopropyl alcohol also known as rubbing alcohol, is considered relatively non-toxic and evaporates quickly. Long-term application to the skin can cause defatting. Isopropyl alcohol causes irritation of mucous membrane and eyes, and may cause dryness, irritation and dermatitis of the skin at high concentrations.
- PCT patent publication WO 01/26471 is disclosed that isopropyl alcohol has an anti-lice effect and compositions disclosed thereon typically comprise between about 5% and 70% isopropyl alcohol.
- a composition comprises between about 10% and about 30%>, in some embodiments between about 15% and about 25%, and in some embodiments even between about 15% and about 20% isopropyl alcohol (v/v). In some preferred embodiments, the composition comprises 20%> (v/v) isopropyl alcohol. Isopropyl myristate
- compositions as described herein comprise isopropyl myristate as a solvent. Some embodiments comprise isopropyl myristate together with at least one additional solvent. Some embodiments comprise isopropyl myristate as a sole solvent.
- Isopropyl myristate is the ester of isopropyl alcohol and myristic acid. Isopropyl myristate is known as having an anti-lice effect, which works by dissolving the wax that covers the exoskeleton of the lice, leading to water evaporation and death by dehydration.
- Resultz® is a commercially-available composition for treating lice infestation including a combination of 50% isopropyl myristate and 50% silicon oil (cyclomethicone).
- a composition comprises between about 30% and about 50%>, in some embodiments between about 30% and about 45%, and in some embodiments even between about 35% and about 45% isopropyl myristate (v/v). In some preferred embodiments, the composition comprises 40% (v/v) isopropyl myristate.
- compositions as described herein comprise a silicone oil.
- Silicone oils are known for use in the treatment of head lice (Burgess, Ian F (2009) BMC Pharmacology 9(3):3, the commercially-available Resultz®), apparently acting as a lubricant, making it difficult for hatched lice to grasp hair and therefore easier to comb out.
- silicone oils such as dimethicone have some (minor) a pediculicidal effect, blocking the breathing apparatus of lice, leading to suffocation.
- the silicone oil component of a composition as described herein acts as a lubricant, making it difficult for lice to grasp the hair, and additionally, making combing the hair simpler and less painful.
- suitable silicone oils include a polyalkyl siloxane, a polyaryl siloxane, a polyalkylaryl siloxane or a polyether siloxane copolymer, and combinations thereof.
- the polyalkyl siloxane comprises polymethyl siloxane (dimethicone).
- compositions as described herein comprise dimethicone as a silicone oil. Some embodiments comprise dimethicone together with at least one additional silicone oil. Some embodiments comprise dimethicone as a sole silicone oil.
- a composition comprises between about 5% and about 20%, in some embodiments between about 5% and about 15%, and in some embodiments even between about 5% and about 10% silicone oil (e.g., dimethicone) (v/v). In some preferred embodiments, the composition comprises 10% (v/v) silicone oil (e.g., dimethicone).
- Embodiments of the composition comprise an emollient ester of fatty acid derived from vegetable oils as an emollient and a diluent (helping reduce the chance of undesirable side effects).
- the emollient ester of fatty acid derived from vegetable oils as a lubricant making it difficult for lice to grasp the hair, and additionally, making combing the hair simpler and less painful.
- compositions as described herein comprise caprylic/capric triglyceride as an emollient ester of fatty acid derived from vegetable oils. Some embodiments comprise caprylic/capric triglyceride together with at least one additional emollient ester of fatty acid derived from vegetable oils. Some embodiments comprise caprylic/capric triglyceride as a sole emollient ester of fatty acid derived from vegetable oils.
- Caprylic/capric triglyceride also known as fractionated coconut oil, is commonly used as an emollient for calming and smoothing the skin.
- Caprylic/capric triglyceride is present in the commercially available anti-lice composition "Hairclean 1-2-3"® described in the introduction.
- an anti-lice composition is disclosed having between about 25% and 100% caprylic/capric triglyceride (Estasan GT 8- 60).
- a composition comprises between about 5% and about 25%, in some embodiments between about 5% and about 20%, and in some embodiments even between about 10% and about 20% caprylic/capric triglyceride (v/v). In some preferred embodiments, the composition comprises 15% (v/v) caprylic/capric triglyceride.
- Example 1 Exemplary compositions
- compositions were prepared in accordance with the teachings herein using commercially-available ingredients .
- the exemplary compositions prepared consisted of anise oil or rosemary oil as an essential oil; a combination of isopropyl myristate and isopropyl alcohol as solvent; and caprylic/capric triglyceride as emollient ester of fatty acid derived from vegetable oils, and dimethicone as a lubricant, in the concentrations shown in Table 1 below.
- Isopropyl myristate and caprylic/capric triglyceride (Myritol 318) were purchased from Cognis (Monheim, Germany, a subsidiary of BASF SE, Ludwigshafen, Germany); isopropyl alcohol was purchased from Gadot Lab Supplies (Or Akiva, Israel); dimethicone was either DC 1501 from Dow Corning Corporation (Midland, Michigan, USA) and/or Belsil 1000 from Wacker Chemie AG (Munich, Germany).
- the components were added at room temperature to a mixer equipped with an agitating planetary propeller and a high-shear homogenizer or dispersing disc and mixed until a clear solution was achieved, after about 5 minutes.
- Example 3 Pediculicidal activity of the exemplary compositions
- Body lice Pediculus humanus humanus
- Cole M.M. Body lice. In: Insect colonization and mass production. Smith, C.N. (ed.), Academic Press, New York, New York, USA, p. 15-24 (1966)].
- Example 4 Ovicidal activity of the exemplary compositions
Abstract
Description
Claims
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US201161499450P | 2011-06-21 | 2011-06-21 | |
PCT/IB2012/053109 WO2012176131A1 (en) | 2011-06-21 | 2012-06-20 | Compositions and methods useful for treating pediculosis |
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EP2723346A4 EP2723346A4 (en) | 2015-03-18 |
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EP12802298.5A Withdrawn EP2723346A4 (en) | 2011-06-21 | 2012-06-20 | Compositions and methods useful for treating pediculosis |
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WO (1) | WO2012176131A1 (en) |
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GB201404505D0 (en) * | 2013-09-06 | 2014-04-30 | Mars Inc | Oral anti-parasitic composition |
ITRM20130647A1 (en) * | 2013-11-22 | 2015-05-23 | Rsi S A | COMPOSITION FOR HAIRCARE INCLUDING CAFFEINE AND EUCALYPTUS EXTRACT |
ITRM20130643A1 (en) * | 2013-11-22 | 2015-05-23 | Rsi S A | COMPOSITION FOR HAIRCARE INCLUDING CAFFEINE AND EXTRACT OF ROSEMARY LEAVES AND CALENDULA FLOWERS |
US11654128B2 (en) * | 2021-05-13 | 2023-05-23 | Nuvo Pharmaceuticals (Ireland) Designated Activity Company | Methods and compositions for treating ectoparasite infestations |
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Publication number | Priority date | Publication date | Assignee | Title |
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US4147800A (en) * | 1977-01-17 | 1979-04-03 | Block Drug Company, Inc. | Pediculicidal toxicants |
IL98828A (en) * | 1991-07-15 | 1996-10-16 | Trima | Pharmaceutical or veterinary composition for combating insects |
US6277415B1 (en) * | 1996-03-29 | 2001-08-21 | Orna Levin | Pediculocidal and veterinary compositions |
US9955695B2 (en) * | 2005-11-18 | 2018-05-01 | Wild Child | Pediculicide/ovicide composition |
US20080193387A1 (en) * | 2007-02-14 | 2008-08-14 | Ricki De Wolff | Essential oil compositions for killing or repelling ectoparasites and pests and methods for use thereof |
IL191743A (en) * | 2008-05-27 | 2012-10-31 | Fischer Pharma Ltd | Pediculicide compositions |
-
2012
- 2012-06-20 EP EP12802298.5A patent/EP2723346A4/en not_active Withdrawn
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