WO2008015575A2 - Compositions stimulant la mélanogenèse contenant des extraits de plantes de type nigella - Google Patents
Compositions stimulant la mélanogenèse contenant des extraits de plantes de type nigella Download PDFInfo
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- WO2008015575A2 WO2008015575A2 PCT/IB2007/003240 IB2007003240W WO2008015575A2 WO 2008015575 A2 WO2008015575 A2 WO 2008015575A2 IB 2007003240 W IB2007003240 W IB 2007003240W WO 2008015575 A2 WO2008015575 A2 WO 2008015575A2
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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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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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
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
-
- 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
- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
- A61K8/9783—Angiosperms [Magnoliophyta]
- A61K8/9789—Magnoliopsida [dicotyledons]
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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
- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
- A61K8/9783—Angiosperms [Magnoliophyta]
- A61K8/9794—Liliopsida [monocotyledons]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q5/00—Preparations for care of the hair
- A61Q5/06—Preparations for styling the hair, e.g. by temporary shaping or colouring
- A61Q5/065—Preparations for temporary colouring the hair, e.g. direct dyes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q5/00—Preparations for care of the hair
- A61Q5/10—Preparations for permanently dyeing the hair
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/74—Biological properties of particular ingredients
- A61K2800/78—Enzyme modulators, e.g. Enzyme agonists
- A61K2800/782—Enzyme inhibitors; Enzyme antagonists
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
- A61K2800/91—Injection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
- A61K2800/92—Oral administration
Definitions
- the invention relates generally to a melanogenesis stimulant, and more particularly to a pharmaceutical or cosmetic preparation for stimulating activity to promote melanogenesis.
- the invention also relates to methods for treating and/or preventing conditions related to reduced melanogenesis, particularly in the hair.
- Melanin is produced by melanocytes existing in the epidermis or hair, yielding the pigmentation of hair. Decreased melanin production causes the loss of pigmentation in the hair, leading to white and/or gray hair. This effect can range from a local circumscribed area, to all the hair on a subject. Generally, the condition of reduced melanin production is referred to as leukotrichia, achromotrichia, or hypochromotrichia . Related conditions include grayness or whiteness of the scalp hair associated with aging (canities) or as a result of a pathologic condition (poliosis) .
- Melanin produced by a melanocyte in the epidermis or hair is transported to a keratinocyte, where it is dispersed and provided to tissues.
- the melanin also causes proliferation and differentiation of the keratinocyte.
- the colour of each tissue is determined by the quantitative and qualitative difference of the melanin which is provided to the tissue. Skin spots, freckles, skin-darkening, and pigmentation disorders such as skin-blackening caused by steroids are conditions resulting from an excess accumulation of melanin.
- Melanin is distributed widely in the animal and plant kingdoms. However, it is known that melanin is biosynthesized from tyrosine through complex pathways in a vertebrate, wherein tyrosine is oxidized by tyrosinase in a cytoplasmic granule of melanosome in the melanocyte, biosynthesizing dopa and dopaquinone, which turns into indolquinone through auto-oxidation by ultraviolet light.
- Leukotrichia is mainly caused by a reduction of melanogenesis following a failure of tyrosinase activity of melanocytes in a hair follicle. This condition is considered to detract from beauty and youthfulness in both men and women. However, gradually whitening of the hair with aging is usually considered to be mainly caused by the reduction of melanogenesis .
- Methods to promote melanogenesis by the use of natural extracts include use of extract of Chrysanthemum leaves (US 6,726,940), extract of a rosacea of Sanguisorba officinalis (US 6,187,325), extract of Marrubium vulgare (US 5,653,983), extract of Coleus esquirolii, Coleus scutellarioides, or Coleus xanthantus (US 5,505,934); and Cyperus extract (US 5,476,651) .
- Methods to promote melanogenesis by treatment with other chemical agents or mixtures include use of 2 , 3-R-pinanediol and an alpha-hydroxy acid (US 6,267,948), diols of norbornane derivatives (US 6,214,888), peptone-metal complexes (US 5,888,522), and cyanocarboxylic acid derivatives (US 5, 767, 152) .
- An additional target which has been identified as affecting melanin production is testosterone 5a-reductase . From testosterone, the reductase produces 5a- dihydrotestosterone, an androgenic hormone which depresses the activity of melanocytes through receptor binding.
- the resulting complex synthesizes a protein through expression of mRNA after interacting with a specific DNA.
- the synthesized protein is known to cause irregular hair cycles or hair growth based on the interaction with follicle epidermal cells, induce hair loss due to atrophy of follicle cells, and depress melanocyte activity. Therefore, inhibition of testosterone 5a-reductase will stimulate melanogenesis and promotes hair growth.
- Nigella damascena Nigella sativa, Nigella hispanica, Nigella orientalis
- These grasses have hard upright stems growing in clumps and are found on slopes of the quay, wastelands or fallow in the Mediterranean area, Eurasia and North Africa.
- These grasses usually bloom in the summer season and are utilized as cut flowers, pot plants and/or in flower beds for ornamental purpose.
- the seed of the genus Nigella is commonly known as Black Seed or Black Cumin, and has traditionally been used as a spice in India, Turkey, Greece and Middle East (especially, Egypt and Tunisia) .
- Nigella extracts include, herbal compositions comprising an extract of Nigella sativa seed for treatment of viral infections (US 6,841,174), black cumin oil for treatment of psoriasis (US 6,531,164), herbal compositions comprising powdered Nigella sativa seeds for the treatment of diabetes (US 6,042,834), an extract of Nigella sativa for inhibition of cancer cell growth (US 5,653,981), and an extract from Nigella sativa to increase immune function (US 5,482,711).
- herbal compositions comprising an extract of Nigella sativa seed for treatment of viral infections (US 6,841,174), black cumin oil for treatment of psoriasis (US 6,531,164), herbal compositions comprising powdered Nigella sativa seeds for the treatment of diabetes (US 6,042,834), an extract of Nigella sativa for inhibition of cancer cell growth (US 5,653,981), and an extract from Nigella sativa to increase immune function (US 5,48
- the invention provides extracts of a plant of genus Nigella having melanogenesis stimulating activity, where the extracts are prepared by a process comprising
- the invention provides pharmaceutical or personal care preparations having melanogenesis stimulating activity comprising extracts of plants of the genus Nigella.
- hair conditions related to decreased melanin production in patients in need of such treatment.
- Such conditions include, but are not limited to leukotrichia, poliosis, and canities, a general graying and/or whitening of hair as a result of aging.
- extracts of plants of the genus Nigella have melanogenesis stimulating activity in cultured melanoma cells.
- the stimulating activity is based on an indirect mechanism that involves inhibition of testosterone 5a-reductase, and a direct mechanism of acting on melanoma cells.
- these mechanisms have been identified using in vitro assays of melanin production and testosterone 5a-reductase inhibition. Therefore, the extracts and compositions of the invention are useful as a medicine or cosmetic for preventing, improving and/or treating hair conditions or leukotrichia resulting from a failure of melanin-production.
- the invention further provides an extract having melanogenesis stimulating activity comprising an extract or plant of the genus Nigella.
- the plant is Nigella arvensis, Nigella ciliaris, Nigella coerulea, Nigella confuse, Nigella damascena, Nigella divaricata, Nigella gallica, Nigella hispanica, Nigella indica, Nigella integrifolia, Nigella latifolia, Nigella multifida, Nigella nigellastrum, Nigella orientalis, Nigella sativa, Nigella tenuiflora, Nigella truncate, or mixtures thereof.
- the plant is Nigella damascena or Nigella sativa.
- Particularly preferred extracts of the invention are derived from Nigella damascena.
- the extracts of the invention are obtained from one or more plant parts including seeds, leaves, roots, rhizomes, or stems.
- the extract is obtained from the seeds of the Nigella plant.
- Such extracts are readily obtained using well known methods in the art, and preferably by use a solvent .
- the invention provides extracts to stimulate melanogenesis, wherein the extract is obtained with a solvent.
- Solvents include but are not limited to, a lower alcohols, water, or mixtures thereof. Examples of suitable lower alcohols include, but are not limited to methanol, ethanol, n- propanol, i-propanol, n-butanol, s-butanol, and t-butanol, water, or mixtures thereof.
- extracts are obtained with methanol, ethanol, water, or mixtures thereof.
- Preferred solvents are methanol, mixtures of ethanol and water, or water alone. Even more preferably, the invention provides dried extracts, i.e., wherein the solvent has been removed .
- the invention provides personal care compositions useful for stimulating melanogenesis comprising an extract of a plant of genus Nigella and a dermatologically acceptable carrier.
- the extract is obtained from seeds using, as the extraction solvent, methanol, a mixture of ethanol and water, or water alone.
- the extract is obtained from Nigella damascene.
- the dermatological carrier is chosen so that the composition is in the form of a shampoo, hair tonic, conditioner, pomade, ointment, lotion, cream, skin lotion, emulsion, foundation, oil-based cosmetic, or face pack.
- the invention also provides methods for the prevention or treatment of white hair in a patient in need of such treatment, comprising the step of topically applying to the skin, e.g., the scalp, or hair the personal care composition to stimulate melanogenesis comprising an extract of a plant of the genus Nigella, wherein the extract is obtained from the seeds of the plant with methanol, a mixture of ethanol and water, or water alone,- a dermatologically acceptable carrier, and wherein the white hair is a result of canities, aging, poliosis, or leukotrichia .
- the extract is obtained from Nigella damascene.
- such carriers are in the form of a shampoo, hair tonic, conditioner, pomade, ointment, lotion, cream, skin lotion, emulsion, foundation, oil-based cosmetic, or face pack.
- the invention provides pharmaceutical compositions to stimulate melanogenesis comprising an extract of a plant of the genus Nigella, wherein the extract is obtained with methanol, a mixture of ethanol and water, or water alone,- and a pharmaceutically carrier or excipient.
- the extract is obtained from Nigella damascene.
- the pharmaceutical composition as previously described is in the form of a tablet, pill, capsule, syrup or elixir.
- Such compositions are useful for treating or preventing white hair is a result of canities, aging, poliosis, or leukotrichia .
- the invention provides methods for the prevention or treatment of white hair comprising the step of orally administering to a patient in need of such treatment, a pharmaceutical composition to stimulate melanogenesis comprising an extract of a plant of genus Nigella, wherein the extract is obtained from seeds with methanol, a mixture of ethanol and water, or water alone,- and a carrier or excipient.
- a pharmaceutical composition to stimulate melanogenesis comprising an extract of a plant of genus Nigella, wherein the extract is obtained from seeds with methanol, a mixture of ethanol and water, or water alone,- and a carrier or excipient.
- the extract is obtained from Nigella damascene.
- the pharmaceutical composition as previously described is in the form of a tablet, pill, capsule, syrup or elixir.
- Such methods are useful for treating or preventing white hair is a result of canities, aging, poliosis, or leukotrichia.
- the invention provides an extract of a plant of the Genus Nigella, where the extract is obtained using a solvent selected from lower alcohols, water, and mixtures thereof .
- the invention provides an extract of a plant of the Genus Nigella, where the extract is obtained using a solvent selected from lower alcohols, water, and mixtures thereof; and the plant is Nigella arvensis, Nigella ciliaris, Nigella coerulea, Nigella confuse, Nigella damascena, Nigella divaricata, Nigella gallica, Nigella hispanica, Nigella indica, Nigella integrifolia, Nigella latifolia, Nigella multifida, Nigella nigellastrum, Nigella orientalis, Nigella sativa, Nigella tenuiflora, Nigella truncate, or mixtures thereof.
- the plant is Nigella damascene. More preferably, the extract is obtained from plant parts of Nigella damascene which are seeds, leaves, roots, rhizomes, stems, or mixtures thereof. Even more preferably, the plant is Nigella damascene and the plant parts are seeds.
- the invention provides an extract of a plant of the Genus Nigella, where the extract is obtained using a solvent selected from methanol, ethanol, n- propanol, i-propanol, n-butanol, s-butanol, t-butanol, and mixtures thereof, water, or mixtures thereof; and the plant is Nigella arvensis, Nigella ciliaris, Nigella coerulea, Nigella confuse, Nigella damascena, Nigella divaricata, Nigella gallica, Nigella hispanica, Nigella indica, Nigella integrifolia, Nigella latifolia, Nigella multifida, Nigella nigellastrum, Nigella orientalis, Nigella sativa, Nigella tenuiflora, Nigella truncate, or mixtures thereof.
- a solvent selected from methanol, ethanol, n- propanol, i-prop
- the plant is Nigella damascene. More preferably, the extract is obtained from plant parts of Nigella damascene wherein the plant parts are seeds, leaves, roots, rhizomes, stems, or mixtures thereof. Even more preferably, the plant is Nigella damascene and the plant parts are seeds.
- the invention provides an extract of a plant of the Genus Nigella, where the extract is obtained using a solvent selected from methanol, ethanol, and mixtures thereof water; and the plant is Nigella arvensis, Nigella ciliaris, Nigella coerulea, Nigella confuse, Nigella damascena, Nigella divaricata, Nigella gallica, Nigella hispanica, Nigella indica, Nigella integrifolia, Nigella latifolia, Nigella multifida, Nigella nigellastrum, Nigella orientalis, Nigella sativa, Nigella tenuiflora, Nigella truncate, or mixtures thereof.
- the plant is Nigella arvensis, Nigella ciliaris, Nigella coerulea, Nigella confuse, Nigella damascena, Nigella divaricata, Nigella gallica, Nigella hispanica, Nigella indica,
- the plant is Nigella damascene. More preferably, the extract is obtained from plant parts of Nigella damascene wherein the plant parts are seeds, leaves, roots, rhizomes, stems, or mixtures thereof. Even more preferably, the plant is Nigella damascene and the plant parts are seeds. Even more preferably, the plant is Nigella damascene; the plant parts are seeds,- and the solvent is ethanol and water. Even more preferably, the plant is Nigella damascene; the plant parts are seeds,- and the solvent is water.
- alkyl as used herein, means a straight or branched chain hydrocarbon containing from 1-6, preferably 1-4, and more preferably 1-3, carbon atoms.
- Representative examples of alkyl include, but are not limited to, methyl, ethyl, n- propyl , iso-propyl, n-butyl, sec-butyl, iso-butyl, and tert- butyl .
- lower alcohol means a straight or branched alkyl as defined herein, substituted with a single -OH at any carbon in the alkyl chain.
- lower alcohols include, but are not limited to, methanol, ethanol, n-propanol, i-propanol, n-butanol, and t-butanol.
- Preferred lower alcohols are those having from 1 to 6, preferably 1-4, and more preferably 1-3, carbon atoms. Particularly preferred lower alcohols are methanol and ethanol .
- pharmaceutically acceptable carrier refers to any inactive ingredient added to a drug to dilute it or to give it form or consistency, provide stability, and produce a drug dosage form as are familiar to those skilled in the art.
- carriers or excipients include, but are not limited to, binders, fillers, disintegrants, wetting agents, emulsifying and suspending agents, preservatives, lubricants, coatings, sweeteners, flavorings, or colors.
- white hair refers to any condition affecting melanin production in the hair, resulting in decreased melanin production and therefore, decreased or no pigmentation of the hair. Hair can appear white, grey, silver, and the like, and combinations thereof, as a result of decreased melanin production.
- the condition may be a local or general effect on the hair of a subject. Examples of such conditions include, but are not limited to, greying hair due to aging, leukotrichia, poliosis, and canities.
- Extract from the plants of the genus Nigella in the invention are prepared by known extraction methods. It is possible to use fresh plants or dried plants in the compositions of the invention, but dry powder, or an extract obtained with a solvent or pressure extract is preferable from the aspect of formulation and/or usability.
- the extract may be obtained from seeds, leaves, roots, rhizomes, stems of the plants with water or organic solvents using well known methods in the art for extraction. Also powders are available from these extracts by removing the extraction such as by lyophilization, spray drying, or evaporation under reduced pressure.
- Suitable organic solvents include Ci-C 6 alcohols, preferably Ci-C 4 alcohols such as methanol, ethanol, propanol and butanol ; C 2 - C 4 ethers such as ethyl ether and methyl ether; and C 3 -C 4 ketones such as acetone and methyl ethyl ketone.
- the most preferred solvent is ethanol.
- Each solvent may be used alone or in combination with one or more other solvents.
- mixed solvents containing water and organic solvent e.g., ethanol, methanol, or propanol, are useful.
- Suitable extraction solvents include aqueous alcohol, and aqueous ethanol is most preferred.
- the ethanol content is preferably about at least 20% on a volume basis (v/v) , more preferably from 40% to 60 %, and most preferably about 50%.
- the most preferred extraction solvent is 50% (v/v) aqueous ethanol (50% EtOH) .
- the amount of the solvent used in the extraction is not critical.
- the specified method for extraction includes cold infusion, hot infusion and percolation etc., which are used to prepare extracts and tinctures, for example.
- the resulting extracts may be used without further modification, or after being condensed, diluted or purified.
- the extract of the invention may be used in the invention.
- the content of the plants and/or its extract described above is usually from 0.0001 to 20 weight%, preferably 0.01 to 10 weight%, of the total weight in terms of dry weight of the plant (in a case of extraction, the dry weight of the solid plant used for extraction) .
- the content of the plants and/or extracts described above of these external preparations is usually from 0.0001 to 20 weight%, preferably 0.01 to 10 weight%, of the total weight in terms of dry weight of the plant (in a case of extraction, the dry weight of the solid plant used for extraction) , and the said preparations can be produced by a conventional method. It may include components such as oils, surfactants, moisturizers, medical components, alcohols, preservatives, thickeners, coloring agent and flavor etc., which are commonly used in medicinal external preparations or hair cosmetics, as well as the plants and/or extracts described above.
- the extract of the invention prepared by the methods described above may be used orally or topically, and an external preparation is convenient and preferable, which is directly applied for the scalp or hair.
- compositions especially compositions for topical application to the hair and/or skin, can be formulated into a wide variety of product types, including hair sprays, mousses, gels, lotions, creams, ointments, tonics, sprays, shampoos, conditioners, rinses, hand and body lotions, facial moisturisers, sunscreens, anti-acne preparations, topical analgesics, pomades, emulsions, foundations, oil-based cosmetics, face packs, and the like.
- Personal care compositions of the invention comprise a dermatologically acceptable diluent or carrier.
- compositions of the invention preferably contain the melanogenesis stimulant extract in an amount of from 0.0001% to 30%, more preferably from 0.01 to 20%, even more preferably from 0.1 to 10% by weight.
- Compositions of the invention may, optionally, comprise a fragrance or perfume and/or one or more of the optional additional components described hereinafter, but are not limited to the following .
- the carriers and additional components required to formulate such products vary with product type and can be routinely chosen by one skilled in the art. The following is a description of some of these carriers and additional components .
- Extracts of the invention can comprise a dermatologically acceptable carrier, or a mixture of such carriers, which are suitable for application to the hair and/or skin.
- the carriers are at from about 0.5% to about 99.5%, preferably from about 5.0% to about 99.5%, more preferably from about 50.0% to about 99.0%, of the composition.
- the choice of appropriate carrier will also depend on whether the product formulated is meant to be left on the surface to which it is applied (e.g., hair spray, mousse, tonic, or gel) or rinsed off after use (e.g., shampoo, conditioner, rinse) .
- the product formulated is meant to be left on the surface to which it is applied (e.g., hair spray, mousse, tonic, or gel) or rinsed off after use (e.g., shampoo, conditioner, rinse) .
- the carriers used herein can include a wide range of components conventionally used in hair care compositions.
- the carriers can contain a solvent to dissolve or disperse the particular extract being used, with water, the Ci-C 6 alcohols, lower alkyl acetate and mixtures thereof being preferred.
- the carriers can also contain a wide variety of additional materials such as acetone, hydrocarbons (such as isobutane, hexane, decene) , halogenated hydrocarbons (such as Freons) and volatile silicones such as cyclomethicone .
- the preferred solvents include water, ethanol, volatile silicone derivatives, and mixtures thereof.
- Suitable propellants for use are volatile hydrocarbon propellants which can include liquefied lower hydrocarbons of 3 to 4 carbon atoms such as propane, butane and isobutane.
- Other suitable propellants are hydrofluorocarbons such as 1 , 2-difluoroethane (Hydrofluorocarbon 152A) supplied as Dymel 152A by DuPont .
- propellants are dimethylether, N-butane, isobutane, propanes, nitrogen, carbon dioxide, nitrous oxide and atmospheric gas and mixtures thereof.
- a tonic or hair spray product having a low viscosity may also utilise an emulsifying agent.
- suitable emulsifying agents include nonionic, cationic, anionic surfactants, or mixtures thereof. If such an emulsifying agent is used, it is preferably at a level of from about 0.01% to about 7.5% by weight based on total weight of the composition.
- the level of propellant can be adjusted as desired but is generally from about 3% to about 30% by weight based on total weight for mousse compositions and from about 15% to about 50% by weight based on total weight for aerosol hair spray compositions.
- Suitable spray containers are well known in the art and include conventional, non-aerosol pump sprays i.e., "atomisers", aerosol containers or cans having propellant, as described above, and also pump aerosol containers utilising compressed air as the propellant.
- the carrier can include a wide variety of conditioning materials.
- the carrier can include, for example, surfactants, suspending agents, and thickeners.
- Hair styling creams or gels also typically contain a structurant or thickener, typically in an amount of from 0.01% to 10% by weight.
- the carrier can be in a wide variety of forms .
- emulsion carriers including oil-in-water, water-in- oil, water-in-oil-in-water, and oil-in-water-in-silicone emulsions, are useful herein. These emulsions can cover a broad range of viscosities, e.g., from about 100 cps to about 200,000 cps. These emulsions can also be delivered in the form of sprays using either mechanical pump containers or pressurised aerosol containers using conventional propellants. These carriers can also be delivered in the form of a mousse.
- suitable topical carriers include anhydrous liquid solvents such as oils, alcohols, and silicones (e.g., mineral oil, ethanol, isopropanol, dimethicone, cyclomethicone, and the like) ; aqueous-based single phase liquid solvents (e.g., hydro-alcoholic solvent systems) ; and thickened versions of these anhydrous and aqueous-based single phase solvents (e.g., where the viscosity of the solvent has been increased to form a solid or semi -solid by the addition of appropriate gums, resins, waxes, polymers, salts, and the like) .
- anhydrous liquid solvents such as oils, alcohols, and silicones (e.g., mineral oil, ethanol, isopropanol, dimethicone, cyclomethicone, and the like)
- aqueous-based single phase liquid solvents e.g., hydro-alcoholic solvent systems
- Cream bases are, for example, beeswax, cetyl alcohol, stearic acid, glycerine, propylene glycol, propylene glycol monostearate, polyoxyethylene cetyl ether and the like.
- Lotion bases include, for example, oleyl alcohol, ethanol, propylene glycol, glycerine, lauryl ether, sorbitan monolaurate and the like.
- Solutions typically include an aqueous solvent (e.g., from about 50% to about 99.99%, such as from about 90% to about 99%, by weight of a pharmaceutically acceptable aqueous solvent) .
- aqueous solvent e.g., from about 50% to about 99.99%, such as from about 90% to about 99%, by weight of a pharmaceutically acceptable aqueous solvent
- Topical compositions useful in the subject invention may be formulated as a solution comprising an emollient.
- Such compositions preferably contain from about 2% to about 50% of an emollient (s) .
- emollients refer to materials used for the prevention or relief of dryness, as well as for the protection of the skin.
- suitable emollients are known and may be used herein. See the International Cosmetic Ingredient Dictionary and Handbook, eds . Wenninger and McEwen, pp. 1656-61, 1626, and 1654-55 (The Cosmetic, Toiletry, and Fragrance Assoc., Washington, D. C, 7 th Edition, 1997) (hereinafter "ICI Handbook”) contains numerous examples of suitable materials.
- a lotion can be made from such a solution.
- Lotions typically comprise from about 1% to about 20% (e.g., from about 5% to about 10%) of an emollient (s) and from about 50% to about 90% (e.g., from about 60% to about 80%) of water.
- a cream typically comprises from about 5% to about 50% (e.g., from about 10% to about 20%) of an emollient (s) and from about 45% to about 85% (e.g., from about 50% to about 75%) of water.
- An ointment may comprise a simple base of animal or vegetable oils or semi-solid hydrocarbons.
- An ointment may comprise from about 2% to about 10% of an emollient (s) plus from about 0.1% to about 2% of a thickening agent (s).
- s an emollient
- s a thickening agent
- a more complete disclosure of thickening agents or viscosity increasing agents useful herein can be found in the ICI Handbook pp. 1693-1697.
- the topical compositions useful in the invention can also be formulated as emulsions.
- the carrier is an emulsion, from about 1% to about 10% (e.g., from about 2% to about 5%) of the carrier comprises an emulsifier (s) .
- Emulsifiers may be nonionic, anionic or cationic. Suitable emulsifiers are disclosed in the ICI Handbook, pp.1673-1686.
- Lotions and creams can be formulated as emulsions. Typically, such lotions comprise from 0.5% to about 5% of an emulsifier (s) .
- Such creams would typically comprise from about 1% to about 20% (e.g., from about 5% to about 10%) of an emollient (s) ; from about 20% to about 80% (e.g., from 30% to about 70%) of water; and from about 1% to about 10% (e.g., from about 2% to about 5%) of an emulsifier (s) .
- Single emulsion skin care preparations such as lotions and creams, of the oil-in-water type and water- in-oil type are well-known in the cosmetic art and are useful in the subject invention.
- Multiphase emulsion compositions such as the water-in-oil-in-water type are also useful in the subject invention.
- such single or multiphase emulsions contain water, emollients, and emulsifiers as essential ingredients .
- the topical compositions of this invention can also be formulated as a gel (e.g., an aqueous gel using a suitable gelling agent (s) ) .
- Suitable gelling agents for aqueous gels include, but are not limited to, natural gums, acrylic acid and acrylate polymers and copolymers, and cellulose derivatives (e.g., hydroxymethyl cellulose and hydroxypropyl cellulose) .
- Suitable gelling agents for oils include, but are not limited to, hydrogenated butylene/ethylene/styrene copolymer and hydrogenated ethylene/propylene/styrene copolymer. Such gels typically comprises between about 0.1% and 5%, by weight, of such gelling agents.
- the personal care compositions of the invention can contain one or more humectant or moisturizing materials.
- humectant or moisturizing materials can be employed and each can be at a level of from about 0.1% to about 20%, more preferably from about 1% to about 10% and most preferably from about 2% to about 5%.
- These materials include urea,- guanidine,- glycolic acid and glycol ate salts (e.g. ammonium and quaternary alkyl ammonium); lactic acid and lactate salts (e.g.
- aloe vera in any of its variety of forms (e.g., aloe vera gel); polyhydroxy alcohols such as sorbitol, glycerol, hexanetriol, propylene glycol, butylene glycol, hexylene glycol and the like,- polyethylene glycols,- sugars and starches,- sugar and starch derivatives (e.g., alkoxylated glucose) ,- hyaluronic acid; lactamide monoethanolamine,- acetamide monoethanolamine,- and mixtures thereof
- Preferred humectants and moisturizers are glycerol, butylene glycol, hexylene glycol, and mixtures thereof.
- topical compositions of the invention can also be formulated into a solid formulation (e.g., a wax-based stick, soap bar composition, powder, or a wipe containing powder) .
- a solid formulation e.g., a wax-based stick, soap bar composition, powder, or a wipe containing powder
- Micelle formulations are also useful compositions of the subject invention. Such compositions can be prepared using single chain surfactants and lipids. Micelles typically have size from about 1 nm to about 100 nm, such as from about 10 nm to about 50 nm. The micelle preparation may then incorporated into one of the above carriers (e.g., a gel or a solution) in order to produce the micelle formulation.
- a gel or a solution e.g., a gel or a solution
- compositions useful in the subject invention may contain, in addition to the aforementioned components, a wide variety of additional oil-soluble materials and/or water-soluble materials conventionally used in compositions for use on hair and/or skin.
- the extracts of the invention may be administered orally, parenterally, by inhalation or spray or rectally in dosage unit formulations containing conventional non-toxic pharmaceutically acceptable carriers, adjuvants and vehicles.
- parenteral as used herein includes percutaneous, subcutaneous, intravascular (e.g., intravenous), intramuscular, or intrathecal injection or infusion techniques and the like.
- a pharmaceutical formulation comprising an extract of the inventions and a pharmaceutically acceptable carrier.
- One or more extracts of the invention may be present in association with one or more non-toxic pharmaceutically acceptable carriers and/or diluents and/or adjuvants, and if desired other active ingredients.
- compositions containing extracts of the invention may be in a form suitable for oral use, for example, as tablets, troches, lozenges, aqueous or oily suspensions, dispersible powders or granules, emulsion, hard or soft capsules, or syrups or elixirs .
- Compositions intended for oral use may be prepared according to any method known to the art for the manufacture of pharmaceutical compositions and such compositions may contain one or more agents selected from the group consisting of sweetening agents, flavoring agents, coloring agents and preservative agents in order to provide pharmaceutically elegant and palatable preparations. Tablets contain the active ingredient in admixture with non-toxic pharmaceutically acceptable excipients that are suitable for the manufacture of tablets.
- excipients may be for example, inert diluents, such as calcium carbonate, sodium carbonate, lactose, calcium phosphate or sodium phosphate,- granulating and disintegrating agents, for example, corn starch, or alginic acid; binding agents, for example starch, gelatin or acacia, and lubricating agents, for example magnesium stearate, stearic acid or talc.
- the tablets may be uncoated or they may be coated by known techniques . In some cases such coatings may be prepared by known techniques to delay disintegration and absorption in the gastrointestinal tract and thereby provide a sustained action over a longer period.
- a time delay material such as glyceryl monosterate or glyceryl distearate may be employed.
- Formulations for oral use may also be presented as hard gelatin capsules, wherein the active ingredient is mixed with an inert solid diluent, for example, calcium carbonate, calcium phosphate or kaolin, or as soft gelatin capsules wherein the active ingredient is mixed with water or an oil medium, for example peanut oil, liquid paraffin or olive oil.
- Formulations for oral use may also be presented as lozenges .
- Aqueous suspensions contain the active materials in admixture with excipients suitable for the manufacture of aqueous suspensions.
- excipients are suspending agents, for example sodium carboxymethylcellulose, methylcellulose, hydropropyl-methylcellulose, sodium alginate, polyvinylpyrrolidone, gum tragacanth and gum acacia
- - dispersing or wetting agents may be a naturally-occurring phosphatide, for example, lecithin, or condensation products of an alkylene oxide with fatty acids, for example polyoxyethylene stearate, or condensation products of ethylene oxide with long chain aliphatic alcohols, for example heptadecaethyleneoxycetanol, or condensation products of ethylene oxide with partial esters derived from fatty acids and a hexitol such as polyoxyethylene sorbitol monooleate, or condensation products of ethylene oxide with partial esters derived from fatty acids and hexitol anhydrides, for example polyethylene sorbitan mono
- the aqueous suspensions may also contain one or more preservatives, for example ethyl, or n-propyl p- hydroxybenzoate, one or more coloring agents, one or more flavoring agents, and one or more sweetening agents, such as sucrose or saccharin.
- preservatives for example ethyl, or n-propyl p- hydroxybenzoate
- coloring agents for example ethyl, or n-propyl p- hydroxybenzoate
- flavoring agents for example ethyl, or n-propyl p- hydroxybenzoate
- sweetening agents such as sucrose or saccharin.
- Oily suspensions may be formulated by suspending the active ingredients in a vegetable oil, for example arachis oil, olive oil, sesame oil or coconut oil, or in a mineral oil such as liquid paraffin.
- the oily suspensions may contain a thickening agent, for example beeswax, hard paraffin or cetyl alcohol .
- Sweetening agents and flavoring agents may be added to provide palatable oral preparations. These compositions may be preserved by the addition of an anti -oxidant such as ascorbic acid.
- Dispersible powders and granules suitable for preparation of an aqueous suspension by the addition of water provide the active ingredient in admixture with a dispersing or wetting agent, suspending agent and one or more preservatives. Suitable dispersing or wetting agents or suspending agents are exemplified by those already mentioned above. Additional excipients, for example sweetening, flavoring and coloring agents, may also be present.
- compositions of the invention may also be in the form of oil-in-water emulsions.
- the oily phase may be a vegetable oil or a mineral oil or mixtures of these.
- Suitable emulsifying agents may be naturally-occurring gums, for example gum acacia or gum tragacanth, naturally-occurring phosphatides, for example soy bean, lecithin, and esters or partial esters derived from fatty acids and hexitol, anhydrides, for example sorbitan monooleate, and condensation products of the said partial esters with ethylene oxide, for example polyoxyethylene sorbitan monooleate.
- the emulsions may also contain sweetening and flavoring agents.
- Syrups and elixirs may be formulated with sweetening agents, for example glycerol, propylene glycol, sorbitol, glucose or sucrose. Such formulations may also contain a demulcent, a preservative, flavoring, and coloring agents.
- the pharmaceutical compositions may be in the form of a sterile injectable aqueous or oleaginous suspension. This suspension may be formulated according to the known art using those suitable dispersing or wetting agents and suspending agents that have been mentioned above.
- the sterile injectable preparation may also be a sterile injectable solution or suspension in a non-toxic parentally acceptable diluent or solvent, for example as a solution in 1,3- butanediol .
- Suitable vehicles and solvents that may be employed are water, Ringer's solution and isotonic sodium chloride solution.
- sterile, fixed oils are conventionally employed as a solvent or suspending medium.
- any bland fixed oil may be employed including synthetic mono-or diglycerides .
- fatty acids such as oleic acid find use in the preparation of injectables.
- the compounds of the present invention may also be administered in the form of suppositories, e.g., for rectal administration of the drug.
- suppositories e.g., for rectal administration of the drug.
- These compositions can be prepared by mixing the drug with a suitable non- irritating excipient that is solid at ordinary temperatures but liquid at the rectal temperature and will therefore melt in the rectum to release the drug.
- a suitable non- irritating excipient that is solid at ordinary temperatures but liquid at the rectal temperature and will therefore melt in the rectum to release the drug.
- Such materials include cocoa butter and polyethylene glycols.
- Compounds of the present invention may be administered parenterally in a sterile medium.
- the drug depending on the vehicle and concentration used, can either be suspended or dissolved in the vehicle.
- adjuvants such as local anesthetics, preservatives and buffering agents can be dissolved in the vehicle.
- Dosage levels of the order of from about 0.1 mg to about 140 mg per kilogram of body weight per day are useful in the treatment of the above- indicated conditions (about 0.5 mg to about 7 g per patient per day) .
- the amount of active ingredient that may be combined with the carrier materials to produce a single dosage form will vary depending upon the host treated and the particular mode of administration. Dosage unit forms will generally contain between from about 1 mg to about 500 mg of an active ingredient.
- the daily dose can be administered in one to four doses per day. In the case of skin conditions, it may be preferable to apply a topical preparation of compounds of this invention to the affected area two to four times a day.
- the specific dose level for any particular patient will depend upon a variety of factors including the activity of the specific compound employed, the age, body weight, general health, sex, diet, time of administration, route of administration, and rate of excretion, drug combination and the severity of the particular disease undergoing therapy.
- the composition may also be added to the animal feed or drinking water. It may be convenient to formulate the animal feed and drinking water compositions so that the animal takes in a therapeutically appropriate quantity of the composition along with its diet. It may also be convenient to present the composition as a premix for addition to the feed or drinking water.
- Preferred non-human animals include domesticated animals .
- Exemplary Extract-A was obtained according to the following steps:
- Exemplary Extract-B was obtained in a similar manner to that described in Example 1 by extracting with methanol, followed by filteration and evaporation of the methanol in vacuo (11.8% yield).
- Example 3
- Cell culture B16 (cultured melanoma mouse cell line) was adjusted to a concentration of 2 x 10 4 cells/well (in a 6- well plate) /1.9 mL using a D-MEM medium (Invitrogen Corp.) containing 10% fetal bovine serum (FBS, Invitrogen Corp.)
- D-MEM medium (hereinafter "D-MEM medium"), and subjected to preliminary culture for 24h at 37 0 C in a CO 2 incubator (5% CO 2 ) .
- Nigella Damascena extract was dissolved in a 1:1 solvent mixture of dimethylsulfoxide (DMSO) -phosphate buffer saline
- pBS pBS to concentrations of 10 ⁇ g/tnl and 50 ⁇ g/ml .
- the 1:1 mixture of DMSO and PBS was used as the control .
- 4 ⁇ L of each of these solutions was diluted using 96 ⁇ L of D-MEM medium and the 100 ⁇ L of the solution thus obtained was added to the culturing plate.
- the final concentration of DMSO was adjusted to 0.1%. After culturing the cells for 3 more days, the melanin content inside and outside was determined as described below.
- Intracellular Cells collected by trypsin treatment were washed with Ca- and Mg-free PBS. 400 ⁇ L of IN NaOH was added to the washed cells and the cells disrupted by keeping at 8O 0 C for 30 min. The intracellular melanin content was then determined by measuring the absorbance of this solution at 475 nm.
- Table 1 shows the melanogenesis promoting effect of 50% Ethanol Extract of Nigella damascena in a B16 melanoma cell culture system:
- the melanin content is given in terms of mean absorbance ⁇ standard error. Significant differences (p ⁇ 0.01) are marked with a "*" .
- the liver of a 5 week-old Slc/SD male rat fasted for 24h was perfused with ice-cooled Kreps-Ringer solution. To this was added 5 times the amount of ice-cooled tris-HCl buffer (10 ttiM, pH 7.2), stirred and centrifuged at 900 x g for 10 min. The supernatant obtained was then centrifuged at 5000 x g for 10 min, and the supernatant obtained in this step was further centrifuged at 9000 x g for 10 min. The supernatant obtained here was used as the 5a-reductase-containing crude enzyme solution (S-9) . After adjusting the protein content of S-9 to 14 mg/ml , it was cryopreserved at -8O 0 C.
- the measurement conditions were, YMC-pack ODS-AM for the column, a 65/35 mixture of methanol -water for the mobile phase solvent, a flow rate of 1 ml/min, UV absorption beam of 254 nm, and a column temperature of 4O 0 C.
- the internal standard method was used for the measurement, and the conversion (%) and the inhibition (%) were calculated using the following formulas;
- Inhibition (%) [(Testosterone content of 0 min. control) - (Testosterone content after adding test solution)] x 100 / [(Testosterone content of 0 min. control) - (Testosterone content of 30 min. control)]
- Testosterone content of 0 min. control The testosterone content after mixing the tris-HCl buffer, testosterone, test solution and the enzyme solution when dichloromethane is added to prevent the reaction, before adding the NADPH.
- Testosterone content of 30 min. control The testosterone content after the reaction using 50% EtOH in place of the test solution.
- teststerone 5a-reductase In vitro inhibition of teststerone 5a-reductase by the two extracts prepared in Examples 1 and 2 were assayed according to Example 6. The results of the experiment are given in Table 2 below. It shows that aqueous ethanol and aqueous methanol extracts of the seeds of Nigella Damascena have inhibitory activity on testosterone 5 ⁇ -reductase . For comparison, activity of a known teststerone 5a-reductase inhibitor, ethinyl estradiol, was included.
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Abstract
L'invention concerne des extraits et des compositions contenant des extraits stimulant la mélanogenèse et obtenus à partir de plantes de type Nigella (Ranunculaceae). Les extraits et les compositions sont utiles dans des compositions de soins personnels et pharmaceutiques pour prévenir, améliorer ou traiter des conditions capillaires et/ou une leucotrichie résultant d'une sous-production ou d'une absence de production de mélanine. De telles compositions peuvent être appliquées topiquement ou absorbées oralement. Les compositions stimulent la production de mélanine de même qu'elles inhibent la testostérone 5a-réductase, procédé indirect stimulant la production de mélanine.
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WO2016176485A1 (fr) * | 2015-04-29 | 2016-11-03 | Petkoska Anka T | Compositions antioxydantes et procédés de protection de la peau, des cheveux et des ongles contre la lumière bleue-violette fortement énergétique |
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NGUYEN DUC ET AL: "Isolation of dioctyl phthalate with high depigmenting effect from Chinese herb Nigella glandulifera Freyn" JOURNAL OF BIOTECHNOLOGY, vol. 131, no. 2, Suppl. S, September 2007 (2007-09), page S43, XP002481534 & 13TH EUROPEAN CONGRESS ON BIOTECHNOLOGY (ECB 13); BARCELONA, SPAIN; SEPTEMBER 16 -19, 2007 ISSN: 0168-1656 * |
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WO2016176485A1 (fr) * | 2015-04-29 | 2016-11-03 | Petkoska Anka T | Compositions antioxydantes et procédés de protection de la peau, des cheveux et des ongles contre la lumière bleue-violette fortement énergétique |
US11576853B2 (en) | 2015-04-29 | 2023-02-14 | CSI: Create.Solve. Innovate. LLC | Antioxidant compositions and methods of protecting skin, hair and nails against high energy blue-violet light |
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