US 2011 0008267A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0008267 A1 Arkin et al. (43) Pub. Date: Jan. 13, 2011

(54) PHARMACEUTICAL AND COSMIECEUTICAL A6IP 7/2 (2006.01) WASH-OFF MOUSSE SHAMPOO A6IP 29/00 (2006.01) COMPOSITIONS, PROCESSES FOR A6IP 7/4 (2006.01) PREPARING THE SAME AND USES A6IP 700 (2006.01) THEREOF A6IP3L/04 (2006.01) A6IP 7/02 (2006.01) (75) Inventors: Moshe Arkin, Kfar-Shemaryahu A6IP35/00 (2006.01) (IL); Amira Zeevi, Omer (IL); Nir A6IP3 L/10 (2006.01) Avram, Meitar (IL); Rina Uzan, A6IP 7/06 (2006.01) Beer-Sheva (IL); Hagit Shilo-Volin, A6IP33/10 (2006.01) Meytar (IL); Erez Hollander, Arad A6IP33/00 (2006.01) (IL); Olga Buriakovsky, A6IP3L/00 (2006.01) Beer-Sheva (IL) A6IP 7/08 (2006.01) A6IP3L/2 (2006.01) Correspondence Address: A6IP 9/08 (2006.01) THOMPSON HINE L.L.P. A6IP 7/8 (2006.01) Intellectual Property Group A6IP 7/10 (2006.01) P.O. BOX 8801 A6IP 25/24 (2006.01) DAYTON, OH 45401-8801 (US) A6IP 7/04 (2006.01) (73) Assignee: PERRGO ISRAEL PHARMACEUTICALS LTD., (52) U.S. Cl...... 424/43 Bnei-Brak (IL) (21) Appl. No.: 12/887,021 (57) ABSTRACT A method for treating a disease or disorder of the skin or scalp (22) Filed: Sep. 21, 2010 ofa mammal while simultaneously cleansing the skin or scalp is disclosed. The method includes administering to the skin or Related U.S. Application Data Scalp a mousse formed from a composition that includes a (62) Division of application No. 11/194,582, filed on Aug. therapeutically or cosmeceutically effective amount of at 2, 2005. least one active pharmaceutical ingredient, 10% to 50% by weight of a cleansing agent selected from the group consist (60) Provisional application No. 60/592.405, filed on Aug. ing of anionic Surfactants, nonionic Surfactants and combina 2, 2004. tions thereof, a pharmaceutically acceptable mousse-forming carrier that includes a propellant, the propellant being 3% to Publication Classification 50% by weight of the composition, and water being about (51) Int. C. 40% to about 90% by weight of the composition, waiting a A6 IK 9/12 (2006.01) period of time; and rinsing said skin or scalp with water to A6IP 7/10 (2006.01) remove the mousse. US 2011/0008267 A1 Jan. 13, 2011

PHARMACEUTICAL AND COSMIECEUTICAL 0008 Spray and solution compositions have a number of WASH-OFF MOUSSE SHAMIPOO disadvantages in common. Both often leave unpleasant resi COMPOSITIONS, PROCESSES FOR due on the hands and fingers. Both require rubbing the com PREPARING THE SAME AND USES position into the scalp what may be uncomfortable to a person THEREOF afflicted with a condition. Both are generally suitable only for the delivery of active pharmaceutical ingredients soluble in a RELATED APPLICATIONS single-phase solvent, limiting the type of active pharmaceu tical ingredients that can be applied. Further, active pharma 0001. This application is a divisional of U.S. Ser. No. ceutical ingredients that are alcohol soluble may often not be 11/194,582 filed on Aug. 2, 2005, which claims priority from used as the alcohol solvent often irritates or is harmful to a U.S. Ser. No. 60/592.405 filed on Aug. 2, 2004. The entire scalp afflicted with a condition. contents of the 582 and the 405 applications are incorpo 0009 Ashampoo pharmaceutical composition is an effec rated herein by reference. tive general-purpose vehicle for the delivery of active phar maceutical ingredients. Shampoos allow simultaneous FIELD cleansing of the hair with application of an active pharma 0002 The present invention relates to the field of pharma ceutical ingredient, saving time and improving the quality of cology and more particularly, to a wash-off mousse shampoo life of a person. Shampoos allow delivery of active pharma composition useful for topical delivery of active pharmaceu ceutical ingredients that are soluble in solvents other than tical ingredients to the scalp simultaneously with the cleaning Water. of the hair, processes for the preparation thereof and methods 0010 Shampoos have a number of disadvantages. Sham of treatment using the same. poos are typically and desirably applied on wet hair and thus oftentimes require wetting the hair prior to application. Usu BACKGROUND ally it is necessary to rub a shampoo composition through the 0003. There are many medical conditions that afflict the hair and onto the scalp, something that may be uncomfort scalp. In addition to the discomfort caused by the condition able. Additionally, shampoo compositions have the tendency itself. Scalp conditions often cause an affected person great to drip and run into the eyes of a treated person, something social discomfort. Further, the presence of hair on the scalp that may be dangerous when the shampoo contains an active makes treatment of Scalp conditions difficult, preventing or pharmaceutical ingredient. Further, it is difficult to apply an limiting an applied active pharmaceutical ingredient from accurate dose of a shampoo pharmaceutical composition, making contact with an afflicted area. Additionally, the leading to uneconomical use. curved shape of the scalp and the impossibility of holding the 0011 Mousses are a particularly convenient and pleasant head in a fixed position make application of active pharma to-use product form for hair and scalp treatment formulations. ceutical ingredients to the scalp difficult. Further the proxim The product is generally applied to the user's hand, where it ity of the Scalp to the eyes and mucous membranes often forms a creamy foam which can be easily worked through the makes application difficult, unpleasant and often induces hair and Scalp. Such mousses have found widespread use in dread, especially when the treated person is a child. the context of hair styling products. The conventional hair 0004 Scalp conditions are generally treated with standard styling mousse generally utilizes a water Soluble hair styling topical compositions, most often lotions, creams, pastes, gels, polymer, water, possibly a conditioning agent, an emulsifier, ointments, Salves and milks, delivery forms developed and aesthetic agents and an aerosol propellant. The mousse is optimized for use in treating bare skin. These are generally typically applied to hair dampened with water, spread unsuitable for application to hair as a large proportion of the through the hair and allowed to dry, giving a temporary set composition sticks to the hair and does not contact the scalp. which can be removed by water or by shampooing. 0005 Pharmaceutical compositions specifically formu 0012 Mousse-forming compositions (foamable composi lated for delivering active pharmaceutical ingredients to the tions for application to the scalp) are generally single or Scalp are generally of one of three delivery forms: shampoos, multi-phase liquids provided in a pressurized container. Solutions and sprays. When ejected from the pressurized container, the propellant 0006. A solution pharmaceutical composition for the expands, transforming the composition into a mousse. delivery of an active pharmaceutical ingredient to the scalp is 0013 Mousse shampoo compositions are known for the often used. An amount of solution is poured on the head and delivery of cleansing agents (e.g., U.S. Pat. No. 6,627,585). A quickly rubbed into the scalp with the fingers. It is generally mousse shampoo is applied to the head and spread over the difficult to apply a correct dose of an active pharmaceutical hair. Since cleansing agents are oftentimes irritants if allowed ingredient using a solution. A Solution often drips away from to remain on the scalp for extended periods of time, the the scalp, often to the eyes. composition is Subsequently washed out of the hairby rinsing 0007. A spray pharmaceutical composition for the deliv with water. ery of an active pharmaceutical ingredient to the scalp over 0014 Mousse-forming compositions are also described in comes many of the problems associated with a solution phar U.S. Pat. No. 6,113,881. Such mousse-forming compositions maceutical composition. The amount of composition applied are applied to the head usually after the hair has been cleaned to the hair is more easily regulated, making proper dosing with shampoo and left to dry so that the pharmaceutical or relatively simple. There is reduced run-off and dripping when cosmetic ingredient remains on the scalp. compared to a solution composition. Patient acceptance and 00.15 Mousse-forming compositions have many advan compliance is generally good, especially with children. How tages over other compositions. The rigid yet fluid nature of a ever, a spray pharmaceutical composition can easily enter the mousse allows a mousse-forming composition to be applied eyes. Further, self-application of a spray pharmaceutical in any orientation without run-off as well as allowing conve composition is difficult. nient application of the mousse evenly over a large area. US 2011/0008267 A1 Jan. 13, 2011

Mousses can be used dry, that is applied to hair that has not limited to ammonium laureth Sulfate, ammonium lauryl Sul been wet with water. When applied onto damaged or sensitive fate, ammonium myreth Sulfate, "amphoteric-1', 'amphot skin, the mousse acts as a cushion, allowing spreading with eric-10”, “amphoteric-17”, “amphoteric-18”, “amphoteric out direct physical contact. Mousse-forming compositions 19”, “amphoteric-20, "amphoteric-6”, coconut acid, can be multiphase compositions So, unlike solutions, do not saponified coconut oil, cocoyl sarcosine, DEA-laureth Sul require that a component such as an active pharmaceutical fate, DEA-lauryl sulfate, disodium monolauramido MEA ingredient be soluble in a specific solvent. Further, the fact Sulfo-Succinate, disodium monococamido MIPA sulfoSucc that mousses can be multiphase compositions allows for the formulation of compositions containing various different mate, disodium monococamidosulfo Succinate, disodium beneficial ingredients. Desired or needed amounts of a monolaureth Sulfo-Succinate, disodium monooleamido mousse-forming composition can be accurately dispensed MEA-Sulfo-Succinate, disodium monooleamidosulfo-Succi with ease, allowing for economical and efficient use. Due to nate, disodium monoundecylenamido MEA SulfoSuccinate, these many advantages, mousse-forming compositions gen disodium monooleamido PEG-2 sulfosuccinate, dodecylben erally enjoy greater patient acceptance and compliance with Zene Sulfonic acid, isosteareth-6 carboxylic acid, lauroylsar treatment regimens. cosine, mixed isopropanolamines myristate, oleic acid, 0016. The physical characteristics of a mousse formed by potassium cocoate, potassium coco-hydrolyzed animal pro a mousse-forming composition are dependent upon the tein, potassium cornate, sodium C12-C15 alcohols Sulfate, nature and relative amounts of components such as solvents, sodium C14-C16 olefin sulfonate, sodium C16-C18 olefin propellants and Surface-active agents. Various mousse-form Sulfonate, Sodium cocoglyceryl ether Sulfonate, Sodium ing compositions for the topical delivery of active pharma cocoyl isothionate, Sodium cocoyl sarcosinate, sodium dode ceutical ingredients to the skin are taught, for example, in cylbenzenesulfonate, Sodium lauroyl sarcosinate, sodium U.S. Pat. Nos. 3,856,956, 5,352,437, and 6,126,920. lauryl Sulfate, Sodium myreth Sulfate, Sodium octoxynol-3 0017 Mousse-forming compositions that deliver both an sulfonate, sodium/TEA-lauroyl hydrolyzed animal protein, active pharmaceutical ingredient and contain a cleansing TEA-cocoate, TEA-coco-hydrolyzed animal protein, TEA agent are not known. dodecylbenzenesulfonate, TEA-laurate, TEA-lauryl sulfate, 0018. It would therefore behighly advantageous to have a TEA-oleate, TEA-oleoyl sarcosinate, trideceth-7 carboxylic convenient to use product for the delivery of active pharma acid, potassium Stearate, potassium undecylenoylhydrolyzed ceutical ingredients that also allows simultaneous cleaning of animal protein and Sodium laureth Sulfate. the hair or any other bodily area. 0025. Substances which can also be used as cleansing agents according to the present invention are secondary SUMMARY degergents such as, but not limited to, ammonium nonox 0019. The present invention successfully addresses the ynol4 Sulfate, amphoteric-12, amphoteric-7, benzalkonium above-recited need by providing a pharmaceutical or cosme chloride, benzyl trimethyl ammonium hydrolyzed animal ceutical wash-off mousse shampoo composition containing, protein, capramide DEA, cocamide DEA, cocamide MEA, amongst other ingredients, at least one active pharmaceutical cocamidopropyl betaine, cocamidopropyl Sultaine, cocami ingredient and at least one cleansing agent. For use, the com dopropylamine oxide, cocamine oxide, coco-betaine, DEA position of the present invention is applied to dry or wet hair lauraminopropionate, DEA-linoleate, dihydroxyethyl C12 and rubbed over the scalp. The active pharmaceutical ingre C15 alkoxypropylamine oxide, dihydroxyethyl tallow dient comes in contact with the scalp while the cleansing glycinate, dioctyl sodium sulfoSuccinate, fatty alkylolamide agent cleans the hair. Optionally, the composition of the condensate, isostearamide DEA, lauramide DEA, laurami present invention is similarly applied on any dry or wet skin dopropyl betaine, lauramine oxide, laureth-12, laureth-23, area that is afflicted by a skin disorder or disease, such that the lauryl betaine, linoleamide DEA, myristamide DEA, myris active pharmaceutical ingredient comes in contact with the tamine oxide, myristic acid, myristoyl hydrolyzed animal skin while the cleansing agent cleans the skin. protein, nonoxynol-10, nonoxynol-12, nonoxynol-15, non 0020. According to the teachings of the present invention oxynol-9, octoxynol-13, octoxynol-9, oleamide DEA, olea there is provided a pharmaceutical or cosmeceutical wash-off mide mipa, oleth-20, oleth-3-phosphate, oleyl betaine, olive mousse shampoo composition formulated for topical appli oil, palm kernelamide dea, peg-10 sorbitan laurate, peg-40 cation to the skin and/or scalp of a mammal (human or non lanolin, peg-44 sorbitan laurate, peg-75 lanolin, peg-8 lau human) comprising: (a) a cleansing agent; (b) a cosmeceuti rate, peg-85 lanolin, poloxamer 182, poloxamer 188, poloX cally or pharmaceutically effective amount of at least one amer 238, polysorbate 20, polysorbate 40, polysorbate 80, active pharmaceutical ingredient; and (c) a pharmaceutically potassium ricinoleate, ppg-5-ceteth-10 phosphate, quater acceptable mousse-forming carrier. nium-20, quaternium-6, Sodium cetyl Sulfate, Sodium lau 0021. In one embodiment, the wash-off mousse shampoo raminopropionate, sodium laureth-12 Sulfate, Sodium lauroyl composition is formulated for application to dry hair. Wetting glutamate, Sodium Stearate, Sodium tallow Sulfate, soya acid, the hair, in this embodiment, is effected by the relatively large Stearamide dea, Stearic acid, Sucrose cocoate, Sulfated castor amount of water present in the composition (e.g., 70-80 oil, oleth-10 phosphate, PEG-6 cocamide and sodium lau weight percents). riminodipropionate. 0022. In another embodiment, the wash-off mousse sham 0026 Generally, the wash-off mousse shampoo composi poo composition of the present invention is formulated for tion of the present invention may include irritant ingredients. application to wet hair. Thus, in an embodiment of the present invention the compo 0023 Typical cleansing agents used include but are not sition is formulated so that the composition can be washed out limited to cleansers, detergents and Soaps. of the area to which the composition is applied (e.g., hair) 0024 Specific cleansing agents useful for implementing within 20 minutes, within 10 minutes or even within 5 min the teachings of the present invention include but are not utes of application. In any event, anti-irritants can be added to US 2011/0008267 A1 Jan. 13, 2011 the compositions, so as to minimize or abolish any irritation tional component selected from the group consisting of emul that may be caused while the composition remains on the sifiers, fatty alcohols (e.g., ethoxylated fatty alcohols), hydro treated area. carbon alcohols and water. 0027. According to a feature of the present invention, the 0032. In an embodiment of the present invention, a wash concentration of the at least one active pharmaceutical ingre off mousse shampoo composition of the present invention dient in the composition is high enough so as to allow a includes one or more additional ingredients. Such additional Sufficient amount of the active pharmaceutical ingredient to ingredients include but are not limited to anti perspirants, come in contact with the skin, before being washed off. anti-static agents, buffering agents, bulking agents, chelating Depending on the nature of the active pharmaceutical ingre agents, colorants, conditioners, deodorants, diluents, dyes, emollients, fragrances, hair conditioners, humectants, occlu dient and the other composition components, in some sive agents, oils, penetration enhancers, pearlescent aids, per embodiments the concentration of the at least one active fuming agents, permeation enhancers, pH-adjusting agents, pharmaceutical ingredient is at least about 0.01 weight per preservatives, protectants, skin penetration enhancers, soft centages, at least about 0.1 weight percentages, at least about eners, solubilizers, Sunscreens, Sun blocking agents, Sunless 1 weight percentage and even at least about 3 weight percent tanning agents, viscosity modifiers and vitamins. AS is known ages, of the total weight of the composition. to one skilled in the art, in some instances a specific additional 0028 Preferably, at least one of the at least one active component may have more than one activity, function or pharmaceutical ingredients in the composition is for the treat effect. ment of skin and/or scalp diseases and disorders. Such active 0033. In an embodiment of the present invention, the pharmaceutical ingredients useful in implementing the teach wash-off mousse shampoo composition described herein is ings of the present invention include but are not limited to packaged in a packaging material and identified in print, in or active herbal extracts, acaricides, age spot and keratose on the packaging material, for use for a need selected from the removing agents, analgesics, local anesthetics, antiacne group consisting of curing a condition, treating a condition, agents, antiaging agents, antibacterials, antibiotics, antiburn preventing a condition, treating symptoms of a condition, agents, antidandruff agents, antidepressants, antidermatitis curing symptoms of a condition, ameliorating symptoms of a agents, antiedemics, antihistamines, antihelminths, antihy condition, treating effects of a condition, ameliorating effects perkeratolyte agents, antiinflammatory agents, antiirritants, of a condition, and preventing results of a condition. antilipemics, antimicrobials, antimycotics, antioxidants, 0034. In an embodiment of the present invention, the con antipruritics, antipsoriatic agents, antirosacea agents, antise dition is selected from the group consisting of a medical borrheic agents, antiseptic, antiswelling agents, antiviral condition and a cosmeceutical condition, especially a skin agents, antiyeast agents, astringents, topical cardiovascular and/or scalp disease or disorder. Typical Such skin and/or Scalp disease or disorders include acne rosacea, actinic kera agents, chemotherapeutic agents, corticosteroids, fungicides, toses, actinic porokeratosis, acute inflammatory diseases, age hair growth regulators, hormones, hydroxyacids, insecti spots, allergic contact dermatitis, alopecia, asteatotic eczema, cides, keratolytic agents, lactams, mitocides, non-steroidal atopic dermatitis, atopic eczema, bacterial infection, BCC, anti-inflammatory agents, pediculicides, progestins, sana Bowen's disease, burns, chronic hypertrophic lichen planus, tives, Scabicides, vasodilators and wart removers. chronic Superficial Scaling, contact dermatitis, cradle cap, 0029. In an embodiment of the present invention, the phar cutaneous T-cell lymphoma, cystic acne, dandruff, Darier's maceutically acceptable mousse-forming carrier includes a disease, dermatitis, dermatitis herpetiformis, dermatosis, dis propellant. Suitable propellants include but are not limited to coid eczema, discoid lupus erythematosus, dry skin, eczema, nitrous oxide, carbon dioxide, chloropentafluoroethane, erythrasma, exfoliative keratolysis, folliculitis, fungal infec dichlorodifluoromethane, nitrogen, propane, iso-butane, tion, juvenile plantar dermatosis, granuloma annulare, Grov n-butane, isopentane, n-pentane, dimethyl ether, trichlorof er's disease, hair thinning, ichthyosiform dermatoses, ich luoromethane and mixtures thereof. Generally, a propellant thyosis, impetigo, infantile eczema, infection, intertrigo, makes up from about 3 weight percents to about 50 weight keratosis, keloid scarsmlichen simplex chronicus, lichen pla percents of the total weight of the composition. nus, lichen striatus, lupus erythematosus, neurodermatitis, 0030. In an embodiment of the present invention, the phar palmar hyperkeratosis, palmoplantar psoriasis, papular urti maceutically acceptable mousse-forming carrier further caria, parapsoriasis, pediculosis, pellagra, perifolliculitis, comprises a foam-forming agent, which typically includes pigmented skin, lesions, pityriasis alba, pityriasis one or more surface-active agents. The concentration of the lichenoides, pityriasis rosea, pityriasis rubra pilaris, pityriasis Surface-active agents in a composition of the present inven versicolor, plantar hyperkeratosis, neurodermatitis, pruritis, tion is generally between about 0.1 weight percent and about psoriasis, Reiter's syndrome, rosacea, Seborrhoeic dermatitis, 50 weight percents of the total weight of the composition, Subacute cutaneous lupus erythematosus, tinea capitis, Super and, more preferably is between about 5 weight percents and ficial BCC, warts, wound, wrinkles and yeast infections (es about 50 weight percents of the total weight of the composi pecially of Malassezia ovalis, Malassezia furfur, Pityrospo tion, more preferably is between about 10 weight percents rium orbiculare and Pityrosporium ovale). and about 50 weight percents of the total weight of the com 0035. According to the teachings of the present invention, position, more preferably is between about 15 weight per there is also provided a process for preparing a pharmaceuti cents and about 50 weight percents of the total weight of the cal or cosmeceutical wash-off mousse shampoo composition composition, and even more preferably is between about 20 of the present invention by: (a) obtaining a mixture of a weight percents and about 50 weight percents of the total cleansing agent, at least one active pharmaceutical ingredient weight of the composition. and a pharmaceutically acceptable mousse-forming carrier; 0031. In another embodiment of the present invention, the (b) placing the mixture in a pressure-resistant vessel; and (c) mousse-forming carrier further comprises at least one addi sealing the pressure-resistant vessel. US 2011/0008267 A1 Jan. 13, 2011

0036. In a preferred embodiment of this aspect of the pharmaceutical ingredient into the skin or scalp, or to allow present invention, the above described mixture, excluding the the active pharmaceutical ingredient to exert its activity in propellant, is placed in a pressure-resistant vessel and the that period of time. vessel is fitted with a seal-valve. The propellant is then placed 0044. In an embodiment of the present invention, topically in the pressure-resistant vessel, and the seal-valve of the applying simultaneously the active pharmaceutical ingredi pressure-resistant vessel is fitted with an actuator. ent and the cleansing agent is effected while utilizing a wash off mousse shampoo composition that comprises the active 0037 Suitable cleansing agents include but are not limited pharmaceutical ingredient and the cleansing agent. The com to cleansers, detergents and Soaps. position is preferably applied by passing a pharmaceutical or 0038 According to the teachings of the present invention cosmeceutical wash-off mousse shampoo composition there is also provided a method of treating a skin and/or scalp including the at least one active pharmaceutical ingredient, disease or disorder, the method involving (a) topically apply the cleansing agent and a mousse forming-carrier from a first ing to a skin and/or scalp area afflicted by the disease or Volume (e.g. a vessel) having a first pressure through a pas disorder of a mammal (human or non-human) in need thereof sage (e.g. a nozzle) into a second Volume (e.g. the open air) a therapeutically or cosmeceutically effective amount of at having a second pressure, the first pressure being greater than least one active pharmaceutical ingredient simultaneously the second pressure, so as to effect foaming of the composi with a cleansing agent in a mousse form; (b) Subsequent to the tion. A preferred wash-off mousse shampoo composition for applying, waiting a period of time, and (c) Subsequent to implementing the method of the present invention is the waiting, rinsing the skin and/or scalp area. wash-off mousse shampoo composition of the present inven 0039. According to a feature of the present invention, the tion. need for which the method of the present invention is applied 0045. Unless otherwise defined, all technical and scien includes curing a condition, treating a condition, preventing a tific terms used herein have the same meaning as commonly condition, treating symptoms of a condition, curing Symp understood by one of ordinary skill in the art to which this toms of a condition, ameliorating symptoms of a condition, invention belongs. Although methods and materials similar or treating effects of a condition, ameliorating effects of a con equivalent to those described herein can be used in the prac dition, and preventing results of a condition. Conditions tice or testing of the present invention, Suitable methods and include medical conditions and cosmeceutical conditions, materials are described below. All publications, patent appli Such as skin and/or scalp diseases and disorders, as is detailed cations, patents and other references mentioned herein are hereinabove. incorporated by reference in their entirety. In case of conflict, 0040. The specific active pharmaceutical ingredient or the patent specification, including definitions, will control. In ingredients administered is dependent on the need for which addition, the materials, methods, and examples are illustra the method is implemented. Suitable active pharmaceutical tive only and not intended to be limiting. ingredients include but are not limited to active herbal extracts, acaricide, age spots and keratoses removing agents, DETAILED DESCRIPTION analgesics, local anesthetics, antiacne agents, antiaging 0046. The present invention is of a pharmaceutical or cos agents, antibacterials, antibiotics, antiburn agents, antidan meceutical wash-off mousse shampoo composition contain druff agents, antidepressants, antidermatitis agents, anti ing at least one active pharmaceutical ingredient that is useful edemics, antihistamines, antihelminths, antihyperkeratolyte for the topical delivery of the at least one active pharmaceu agents, antiinflammatory agents, antiirritants, antilipemics, tical ingredients to hair or skin of a mammal, whether a antimicrobials, antimycotics, antioxidants, antipruritics, human or non-human mammal, simultaneously with the agents, antipsoriatic agents, antirosacea, antiseborrheic delivery of a cleansing agent to the hair or skin. The present agents, antiseptic, antiswelling agents, antiviral agents, anti invention also includes a process for the preparation of the yeast agents, astringents, topical cardiovascular agents, che wash-off mousse shampoo composition of the present inven motherapeutics, corticosteroids, fungicides, hair growth tion. The present invention also includes methods of treat regulators, hormones, hydroxyacids, insecticides, keratolyt ments of skin, especially of the Scalp, by the simultaneous ics, lactams, mitocides, non-steroidal antiinflammatory delivery of an active pharmaceutical ingredient and a cleans agents, pediculicide, progestins, Sanatives, Scabicide, Vasodi ing agent in a mousse form, followed by rinsing of the area. lators and wart removers. AS is known to one skilled in the art, 0047. As discussed hereinabove, a mousse delivery form in Some instances a specific active pharmaceutical ingredient has many advantages for the topical dispensation of active may have more than one activity, function or effect. pharmaceutical ingredients by providing quick and accurate 0041. In one embodiment of the present invention, the skin dosage, high penetration, convenient application, ease of and/or scalp area is wet before applying the active pharma application, economy in use, and increased safety by avoiding ceutical ingredient and the cleansing agent. In another contact of composition components with mucous membranes embodiment of the present invention, the skin and/or scalp and the eyes to large areas of the scalp Surface. Further, area is not wet before applying the active pharmaceutical mousses for application to the Scalphave greater acceptability ingredient and the cleansing agent. and Subsequently compliance than other delivery forms, 0042. The skin and/or scalp area is preferably a hirsute especially amongst children. area Such as the hair. 0048. The principles, uses and implementations of the 0043. Depending on the embodiment, the period of time present invention are better understood with reference to the waited can be less than 20 minutes, less than 10 minutes or accompanying descriptions and examples. even less than 5 minutes. Consequently, the cosmeceutically 0049. Before explaining at least one embodiment of the or pharmaceutically effective amount of the active pharma invention in detail, it is to be understood that the invention is ceutical ingredient administered must be high enough so as to not limited in its application to the details set forth herein. The allow the absorption of a sufficient amount of the active invention can be implemented with other embodiments and US 2011/0008267 A1 Jan. 13, 2011

can be practiced or carried out in various ways. It is also midosulfo Succinate, disodium monolaureth Sulfo-Succinate, understood that the phraseology and terminology employed disodium monooleamido MEA-Sulfo-Succinate, disodium herein is for descriptive purpose and should not be regarded as monooleamidosulfo-Succinate, disodium monoundecylena limiting. mido MEA sulfosuccinate, disodium monooleamido PEG-2 0050. As used herein, the term “comprising means that SulfoSuccinate, dodecylbenzene Sulfonic acid, isosteareth-6 other steps and ingredients which do not affect the final result carboxylic acid, lauroyl sarcosine, mixed isopropanolamines can be added. This term encompasses the terms “consisting myristate, oleic acid, potassium cocoate, potassium coco of and “consisting essentially of. hydrolyzed animal protein, potassium comate, sodium C12 0051. The phrase “consisting essentially of means that C15 alcohols sulfate, sodium C14-C16 olefin sulfonate, the composition may include additional ingredients, but only sodium C16-C18 olefin sulfonate, sodium cocoglyceryl ether if the additional ingredients do not materially alter the basic Sulfonate, Sodium cocoyl isothionate, Sodium cocoyl sarco and novel characteristics of the claimed compositions or sinate, Sodium dodecylbenzenesulfonate, Sodium lauroylsar methods. cosinate, sodium lauryl Sulfate, sodium myreth Sulfate, 0.052 The term “method’ refers to manners, means, tech sodium octoxynol-3 sulfonate, sodium/TEA-lauroyl hydro niques and procedures for accomplishing a given task includ lyzed animal protein, TEA-cocoate, TEA-coco-hydrolyzed ing, but not limited to, those manners, means, techniques and animal protein, TEA-dodecylbenzenesulfonate, TEA-lau procedures either known to, or readily developed from known rate, TEA-lauryl sulfate, TEA-oleate, TEA-oleoyl sarcosi manners, means, techniques and procedures by practitioners nate, trideceth-7 carboxylic acid, potassium Stearate, potas of the chemical, pharmacological, biological, biochemical sium undecylenoyl hydrolyzed animal protein and Sodium and medical arts. laureth sulfate. 0053. The term “pharmaceutical composition” refers to 0060 Substances which can also be used as cleansing any composition, which contains at least one active pharma agents according to the present invention are secondary ceutical ingredient and is Suitable for administration to a degergents such as, but not limited to, ammonium nonox patient. ynol-4 Sulfate, amphoteric-12, amphoteric-7, benzalkonium 0054 By “topical administration” or “topical application' chloride, benzyl trimethyl ammonium hydrolyzed animal is meant the application of a therapeutically effective amount protein, capramide DEA, cocamide DEA, cocamide MEA, of a pharmaceutical composition to the external and/or cocamidopropyl betaine, cocamidopropyl Sultaine, cocami exposed Surface of the skin, to access the dermis and/or epi dopropylamine oxide, cocamine oxide, coco-betaine, DEA dermis. lauraminopropionate, DEA-linoleate, dihydroxyethyl C12 0055. By “therapeutically effective amount' is meant an C15 alkoxypropylamine oxide, dihydroxyethyl tallow amount Sufficient to provide Some medical, cosmeceutical or glycinate, dioctyl sodium sulfoSuccinate, fatty alkylolamide cosmetic benefit. condensate, isostearamide DEA, lauramide DEA, laurami 0056. The term “active pharmaceutical ingredient” refers dopropyl betaine, lauramine oxide, laureth-12, laureth-23, to a pharmaceutical or cosmeceutical agent including any lauryl betaine, linoleamide DEA, myristamide DEA, myris natural or synthetic chemical Substance that Subsequent to tamine oxide, myristic acid, myristoyl hydrolyzed animal being applied to a mammal has at least one desired pharma protein, nonoxynol-10, nonoxynol-12, nonoxynol-15, non ceutical effect. oxynol-9, octoxynol-13, octoxynol-9, oleamide DEA, olea 0057 The term “topical active pharmaceutical ingredient’ mide mipa, oleth-20, oleth-3 phosphate, oleyl betaine, olive refers to a pharmaceutical or cosmeceutical agent including oil, palm kernelamide dea, peg-10 sorbitan laurate, peg-40 any natural or synthetic chemical Substance, intended for lanolin, peg-44 sorbitan laurate, peg-75 lanolin, peg-8 lau topical application on a surface of a mammal, especially to rate, peg-85 lanolin, poloxamer 182, poloxamer 188, poloX the skin, and that Subsequent to the topical application has at amer 238, polysorbate 20, polysorbate 40, polysorbate 80, least one desired pharmaceutical effect. potassium ricinoleate, ppg-5-ceteth-10 phosphate, quater 0058. The pharmaceutical or cosmeceutical wash-off nium-20, quaternium-6, Sodium cetyl Sulfate, Sodium lau mousse shampoo composition of the present invention Sub raminopropionate, sodium laureth-12 Sulfate, Sodium lauroyl stantially comprises (a) a cleansing agent, (b) a cosmeceuti glutamate, Sodium Stearate, Sodium tallow Sulfate, soya acid, cally or pharmaceutically effective amount of at least one Stearamide dea, Stearic acid, Sucrose cocoate, Sulfated castor active pharmaceutical ingredient and (c) a pharmaceutically oil, oleth-10phosphate, PEG-6 cocamide and sodium lau acceptable mousse-forming carrier. The wash-off mousse riminodipropionate. composition of the present invention can be formulated to be 0061 Active pharmaceutical ingredients that can be applicable to either or both wet hair or dry hair. When applied advantageously delivered using the teachings of the present on dry hair, wetting the hair is effected by water, which is invention include topical active pharmaceutical ingredient for present in a relatively large amount in the formulation. the treatment of skin and/or scalp diseases and disorders. 0059) Typical cleansing agents used include but are not Such active pharmaceutical ingredients include but are not limited to cleansers, detergents and Soaps. Specific cleansing limited to active herbal extracts, acaricides, age spot and agents useful for implementing the teachings of the present keratose removing agents, analgesics, local anesthetics, anti invention include but are not limited to ammonium laureth acne agents, antiaging agents, antibacterials, antibiotics, anti Sulfate, ammonium lauryl Sulfate, ammonium myreth Sulfate, burn agents, antidandruff agents, antidepressants, antiderma “amphoteric-1”, “amphoteric-10'. “amphoteric-17, titis agents, antiedemics, antihistamines, antihelminths, “amphoteric-18”, “amphoteric-19', 'amphoteric-20, antihyperkeratolyte agents, antiinflammatory agents, antiirri 'amphoteric-6”, coconut acid, Saponified coconut oil, cocoyl tants, antilipemics, antimicrobials, antimycotics, antioxi sarcosine, DEA-laureth sulfate, DEA-lauryl sulfate, diso dants, antipruritics, antipsoriatic agents, antirosacea agents, dium monolauramido MEA-Sulfo-Succinate, disodium antiseborrheic agents, antiseptics, antiswelling agents, anti monococamido MIPA sulfo Succmate, disodium monococa viral agents, antiyeast agents, astringents, topical cardiovas US 2011/0008267 A1 Jan. 13, 2011 cular agents, chemotherapeutic agents, corticosteroids, fun icillin, amplicillin, ansamycins, azelaic acid, bacitracin, beta gicides, hair growth regulators, hormones, hydroxyacids, lactams, candicidin, capreomycin, carbenicillin, cephalexin, insecticides, keratolytic agents, lactams, mitocides, non-ste cephaloridine, cephalothin, cefazolin, cephapirin, cephra roidal anti-inflammatory agents, pediculicides, progestins, dine, cephaloglycin, chloramphenicols, chlorhexidine, chlo Sanatives, Scabicides, vasodilators and wart removers. It is rhexidine gluconate, chlorhexidine hydrochloride, chlorox important to note that in Some cases a specific active pharma ine, chlorquinaldol, chlortetracycline, chlortetracycline ceutical ingredient has one or more types of activities and hydrochloride, ciprofloxacin, circulin, clindamycin, clinda therefore falls within more than one of the types listed above. mycin hydrochloride, clotrimazole, cloxacillin, demeclocy 0062 Suitable active herbal extracts include, but are not cline, dicloSXacillin, diiodohydroxyquin, doxycycline, limited to angelica, anise oil, astragali radix, azalea, benzyl ethambutol, ethambutol hydrochloride, erythromycin, eryth acetate, birch tar oil, bornyl acetate, cacumen biotae, calen romycinestolate, erythromycin Stearate, farnesol, floxacillin, dula, camphor, cantharidin, capsicum, chamomile, cineole, gentamicin, gentamicin Sulfate, gramicidin, griseofulvin, cinnamon bark, cinnamon leaf citronella, citronellol, cit haloprogin, haloquinol, hexachlorophene, iminocylcline, ronellyl acetate, citronellyl formate, eucalyptus, eugenyl iodochlorhydroxyquin, kanamycin, kanamycin Sulfate, lin acetate, fennel, flos carthami, fructus mori, garlic, geraniol, comycin, lineomycin, lineomycin hydrochloride, mac geranium, geranyl acetate, grape, habanera, horsetail, isobu rolides, meclocycline, methacycline, methacycline hydro tyl angelicate, jojoba, lavender, ledum latifolium, ledum chloride, methenamine, methenamine hippurate, palustre, lemongrass, licorice, limonene, linalool, linallyl methenamine mandelate, methicillin, metronidazole, met acetate, methyl anthranilate, methyl cinnamate, meZereum, ronidazole hydrochloride, miconazole, miconazole hydro neem, nerol, neryl acetate, nettle root extract, oleum ricini, chloride, minocycline, minocycline hydrochloride, mupiro oregano, pinenes, alpha.-pinene, beta.-pinene, radix angeli cin, nafcillin, neomycin, neomycin Sulfate, netilmicin, cae sinesis, radix paenoiae rubra, radix polygoni multiflori, netilmicin Sulfate, nitrofuraZone, norfloxacin, nystatin, radix rehmanniae, rhizoma pinelliae, rhizoma Zingiberis octopirox, oleandomycin, orcephalosporins, oxacillin, recens, rosemary, Sabadilla, Sage, Sandalwood oil, saw pal oxytetracycline, oxytetracycline hydrochloride, parachlo metto extract, semen sesami nigrum, shea butter, staphysa rometa Xylenol, paromomycin, paromomycin Sulfate, peni gria, tea tree oil, terpene alcohols, terpene hydrocarbons, cillins, penicillin G, penicillin V, pentamidine, pentamidine terpene esters, terpinene, terpineol, terpinyl acetate, and hydrochloride, phenethicillin, polymyxins, quinolones, derivatives, esters, salts and mixtures thereof. streptomycin Sulfate, tetracycline, tobramycin, tolnaftate, tri 0063 Suitable acaricides include, but are not limited to closan, trifampin, rifamycin, rollitetracycline, spectinomycin, amitraz, flumethrin, fluvalinate, and derivatives, esters, salts spiramycin, streptomycin, Sulfonamide, tetracyclines, tetra and mixtures thereof. cycline, tobramycin, tobramycin Sulfate, triclocarbon, tri 0.064 Suitable age spots and keratoses removing agents closan, trimethoprim-sulfamethoxazole, tylosin, Vancomy include, but are not limited to hydroxyacids, hydroquinone, cin, yrothricin and derivatives, esters, salts and mixtures and derivatives, esters, salts and mixtures thereof. thereof. 0065. As is known to one skilled in the art, many agents 0069 Specifically, suitable antimycotics include, but are have analgesic and/or anesthetic and/or antipruritic activity. not limited to azole compounds, chloroxine, ciclopiroX ola Suitable analgesics include but are not limited to benzocaine, mine, clotrimazole, econazole, fluconazole, griseofulvin, butamben picrate, dibucaine, dimethisoquin, dyclonine, mafenide acetate, nystatin, terbinafine, undecylenic acid, and lidocaine, pramoxine, tetracaine, Salicylates and derivatives, derivatives, esters, salts and mixtures thereof. esters, salts and mixtures thereof. Suitable local anesthetics 0070 Suitable antidandruff agents include, but are not include but are not limited to benzocaine, bupivacaine, limited to aminexil, benzalkonium chloride, benzethonium butamben picrate, chlorprocaine, cocaine, dibucaine, dime chloride, 3-bromo-1-chloro-5,5-dimethyl-hydantoin, thisoquin, dyclonine, etidocaine, hexylcaine, ketamine, chloramine B, chloramine T. chlorhexidine, N-chlorosuccin lidocaine, mepivacaine, pramoxine, procaine, tetracaine, Sali imide.climbazole, 1,3-dibromo-5,5-dimethylhydantoin, 1.3- cylates and derivatives, esters, salts and mixtures thereof. dichloro-5,5-dimethyl-hydantoin, betulinic acid, betulonic Suitable antipruritics include, but are not limited to menthol, acid, celastrol, crataegolic acid, cromakalin, cyproterone methdilazine, trimeprazine, urea and derivatives, esters, salts acetate, dutasteride, finesteride, ibuprofen, ketoconozole, and mixtures thereof. oleanolic acid, phenyloin, picrotone olamine, Salicylic acid, 0066 Suitable antiacne agents include, but are not limited Selenium Sulphides, triclosan, triiodothyronine, ursolic acid, to N-acetylcysteine, adapalene, azelaic acid, benzoyl peroX Zinc gluconate, Zinc omadine, Zinc pyrithione, and deriva ide, cholate, clindamycin, deoxycholate, erythromycin, fla tives, esters, salts and mixtures thereof. Vinoids, glycolic acid, meclocycline, mupirocin, octopirox, 0071 Suitable antidepressants include, but are not limited phenoxy ethanol, phenoxy proponol, pyruvic acid, resorci to norepinephrine-reuptake inhibitors, selective-serotonin nol, retinoic acid, Salicylic acid, Scymnol sulfate, Sulfaceta reuptake inhibitors, monoamine-oxidase inhibitors, seroto mide-sulfur, Sulfur, tazarotene, tetracycline, tretinoin tri nin-and-noradrenaline-reuptake inhibitors, corticotropin-re closan, and derivatives, esters, salts and mixtures thereof. leasing factor antagonists, ..alpha.-adrenoreceptor 0067 Suitable antiaging agents include, but are not lim antagonists, NK1-receptor antagonists, 5-HT. Sub.1A-recep ited to melatonin, and derivatives, esters, salts and mixtures tor agonist, antagonists, amitriptyline, desmethylamitrip thereof. tyline, clomipramine, doxepin, imipramine, imipramine-OX 0068. As is known to one skilled in the art, the term anti ide, trimipramine, adinazolam, amiltriptylinoxide, biotic includes agents with antimicrobial, antibacterial, anti amoxapine, desipramine, maprotiline, nortriptyline, protrip mycotic, antiprotoaZaol activity. Suitable antibiotics include, tyline, amineptine, butriptyline, demexiptiline, dibenzepin, but are not limited to amanfadine hydrochloride, amanfadine dimetacrine, dothiepin, fluacizine, iprindole, lofepramine, Sulfate, amikacin, amikacin Sulfate, aminoglycosides, amox melitracen, metapramine, norclolipramine, noxiptilin, US 2011/0008267 A1 Jan. 13, 2011 opipramol, perlapine, pizotyline, propizepine, quinupramine, paramethasone, prednisolone, prednisone, pregnenolone, reboxetine, tianeptine, binedaline, m-chloropiperzine, citalo progesterone, spironolactone, triamcinolone, triamcinolone pram, dulloxetine, etoperidone, femoxetine, fluoxetine, flu acetonide, and derivatives, esters, salts and mixtures thereof. Voxamine, indalpine, indeloxazine, milnacipran, nefazodone, 0079 Suitable hair growth regulators include, but are not oxaflaZone, paroxetine, prolintane, ritanserin, Sertraline, tan limited to N-acetylgalactosamine, N-acetylglucosamine, dospirone, Venlafaxine and Zimeldine, and derivatives, esters, N-acetylmannosamine, acitretin, aminexil, ascomycin, asi salts and mixtures thereof. atic acid, azelaic acid, benzalkonium chloride, benzethonium 0072 Suitable antihistamines include, but are not limited chloride, benzydamine, benzyl nicotinate, benzoyl peroxide, to chlorcyclizine, diphenhydramine, mepyramine, methapy benzyl peroxide, betulinic acid, betulonic acid, calcium pan rilene, tripelennamine and derivatives, esters, salts and mix tothenate, celastrol, cepharanthine, chlorpheniramine male tures thereof. ate, clinacycin hydrochloride, crataegolic acid, cromakalin, 0073 Suitable antipsoriatic agents include, but are not cyproterone acetate, diaZoxide, diphenhydramine hydrochlo limited to 6-aminonicotinamide, 6-aminonicotinic acid, ride, dutasteride, estradiol, ethyl-2-hydroxypropanoate, fin 2-aminopyrazinamide, anthralin, calcipotriene, 6-carbam asteride, D-fucono-1,5-lactone, furoate, L-galactono-1,4- oylnicotinamide, 6-chloronicotinamide, 2-carbamoylpyrazi lactone, D-galactosamine, D-glucaro-1,4-lactone, namide, corticosteroids, 6-dimethylaminonicotinamide, D-glucosamine-3-sulphate, hinokitiol, hydrocortisone, 2-hy dithranol, 6-formylaminonicotinamide, 6-hydroxy nicotinic droxypropionic acid, isotretinoin, itraconazole, ketocona acid, 6-substituted nicotinamides, 6-substituted nicotinic Zole, latanoprost, 2-methylpropan-2-ol, minocyclin, minoxi acid, 2-substituted pyrazinamide, tazarotene, thionicotina dil, mipirocin, mometaSone, oleanolic acid, panthenol, 1.10 mide, trichothecene mycotoxins, and derivatives, esters, salts phenanthroline, phenyloin, prednisolone, progesterone, and mixtures thereof. propan-2-ol, pseudoterins, resorcinol, selenium sulfide, taZ 0074 Suitable antirosacea agents include, but are not lim arotene, triclocarbon, triclosan, triiodothyronine, ursolic ited to azelaic acid, metronidazole Sulfacetamide, and deriva acid, Zinc pyrithione, and derivatives, esters, salts and mix tives, esters, salts and mixtures thereof. tures thereof. 0075 Suitable antiseborrheic agents include, but are not 0080 Suitable hormones include, but are not limited to limited to glycolic acid, Salicylic acid, selenium sulfide, Zinc methyltestosterone, androsterone, androsterone acetate, pyrithione and derivatives, esters, salts and mixtures thereof. androsterone propionate, androsterone benzoate, androster 0076 Suitable antiviral agents include, but are not limited onediol, androsteronediol-3-acetate, androsteronediol-17 to acyclovir, and derivatives, esters, salts and mixtures acetate, androsteronediol 3-17-diacetate, androsteronediol thereof. 17-benzoate, androsteronedione, androstenedione, 0077 Suitable chemotherapeutic agents include, but are androstenediol, dehydroepiandrosterone, sodium dehydroe not limited to daunorubicin, doxorubicin, lomustine, fote piandrosterone sulfate, dromoStanolone, dromostanolone mustine, idarubicin, amrubicin, pirarubicin, epirubicin, propionate, ethylestrenol, fluoxymesterone, nandrolone mitoxantrone, etoposide, teniposide, vinblastine, Vincristine, phenpropionate, nandrolone decanoate, nandrolone furylpro mitomycin C, 5-FU, paclitaxel, docetaxel, actinomycin D, pionate, nandrolone cyclohexane-propionate, nandrolone colchicine, topotecan, irinotecan, gemcitabine cyclosporin, benzoate, nandrolone cyclohexanecarboxylate, androster Verapamil, Valspodor, probenecid, MK571, GF120918, onediol-3-acetate-1-7-benzoate, Oxandrolone, LY335979, biricodar, terfenadine, quinidine, pervilleine A, oxymetholone, stanozolol, testosterone, testosterone XR9576, and derivatives, esters, salts and mixtures thereof. decanoate, 4-dihydrotestosterone, 5.alpha.-dihydrotestoster 0078 Suitable corticosteroids include, but are not limited one, testolactone, 17.alpha.-methyl-19-nortestosterone, to alclometasone dipropionate, amcinafel, amcinafide, amci desogestrel, dydrogesterone, ethynodiol diacetate, medroX nonide, beclomethasone, beclomethasone dipropionate, yprogesterone, levonorgestrel, medroxyprogesterone betamethsone, betamethasone benzoate, betamethasone dex acetate, hydroxyprogesterone caproate, norethindrone, nore amethasonephosphate, dipropionate, betamethasone Valer thindrone acetate, norethynodrel, allylestrenol, 19-nortest ate, budesonide, chloroprednisone, chlorprednisone acetate, osterone, lynoestrenol, quingestanol acetate, medrogestone, clescinolone, clobetasol, clobetasol propionate, clobetasol norgestrienone, dimethisterone, ethisterone, cyproterone Valerate, clobetaSone, clobetaSone butyrate, clocortelone, acetate, chlormadinone acetate, megestrol acetate, norgesti cortisone, cortodoxone, craposone butyrate, desonide, des mate, norgestrel, desogrestrel, trimegestone, gestodene, oxymethasone, dexamethasone, desoxycorticosterone nomegestrol acetate, progesterone, 5.alpha.-pregnan-3.beta. acetate, dichlorisone, diflorasone diacetate, diflucortolone 20.alpha.-diol sulfate, 5.alpha.-pregnan-3.beta. 20.beta.-diol Valerate, difluorosone diacetate, diflurprednate, fluadre Sulfate, 5.alpha.-pregnan-3.beta.-ol-20-one, 16.5.alpha.- nolone, flucetonide, flucloronide, fluclorolone acetonide, flu pregnen-3.beta.-ol-20-one, 4-pregnen-20.beta.-ol-3-one-20 cortine butylesters, fludroxycortide, fludrocortisone, flu Sulfate, acetoxypregnenolone, anagestone acetate, cyproter methasone, flumethasone pivalate, flumethasone pivalate, one, dihydrogesterone, fluorogestone acetate, gestadene, flunisolide, fluocinolone, fluocinolone acetonide, fluocinon hydroxyprogesterone acetate, hydroxymethylprogesterone, ide, fluocortin butyl, fluocortolone, fluorometholone, fluosi hydroxymethyl progesterone acetate, 3-ketodesogestrel, nolone acetonide, fluperolone, fluprednidene acetate, flu megestrol, melengestrol acetate, norethisterone and deriva prednisolone hydrocortamate, fluradrenolone, tives, esters, salts and mixtures thereof. fluradrenolone acetonide, flurandrenolone, fluticasone, halci I0081 Suitable hydroxyacids include, but are not limited to nonide, hydrocortisone, hydrocortisone acetate, hydrocorti agaricic acid, aleuritic acid, allaric acid, altraric acid, arabi Sone butyrate, hydrocortisone cyclopentylpropionate, hydro raric acid, ascorbic acid, atrolactic acid, benzilic acid, citra cortisone Valerate, hydroxyltriamcinolone, medrysone, malic acid, citric acid, dihydroxytartaric acid, erythraric acid, meprednisone, alpha.-methyl dexamethasone, methylpred galactaric acid, galacturonic acid, glucaric acid, glucuronic nisolone, methylprednisolone acetate, mometaSone furoate, acid, glyceric acid, glycolic acid, gularic acid, gulonic acid, US 2011/0008267 A1 Jan. 13, 2011

hydroxypyruvic acid, idaric acid, isocitric acid, lactic acid, within 2 minutes of application. As a result, the active phar lyXaric acid, malic acid, mandelic acid, mannaric acid, meth maceutical ingredient is washed out along with the dirt and yllactic acid, mucic acid, phenyllacetic acid, pyruvic acid, cleansing agent during rinsing. quinic acid, ribaric acid, ribonic acid, Saccharic acid, talaric 0091. Accordingly, the concentration of the at least one acid, tartaric acid, tartronic acid, threaric acid, tropic acid, active pharmaceutical ingredient in the composition of the uronic acids, Xylaric acid, and derivatives, esters, salts and present embodiments is high enough so as to allow a sufficient mixtures thereof. amount of the active pharmaceutical ingredient to be 0082 Suitable keratolytic agents include, but are not lim absorbed in the skin and/or to exert a substantial activity, ited to N-acetylcysteine, glycolic acid, pyruvic acid, resorci before being washed off. nol, Sufur, Salicyclic acid, retinoic acids and derivatives, 0092. Depending on the nature of the active pharmaceuti esters, salts and mixtures thereof. cal ingredient and the other composition components, in 0083) Suitable lactams include, but are not limited to L-ga Some embodiments the concentration of the at least one active lactono-1,4-lactam, L-arabino-1,5-lactam, D-fucono-1,5- pharmaceutical ingredient is at least about 0.01 weight per lactam, D-glucaro-1,4-lactam, D-glucurono-6.3-lactam, 2.5- centages, at least about 0.05 weight percentages, at least tri-O-acetyl-D-glucurono-6.3-lactam, 2-acetamido-2- about 0.1 weight percentages, at least about 0.5 weight per deoxyglucono-1,5-lactam, 2-acetamido-2-deoxygalactono centages, at least about 1 weight percentage, at least about 2 1.5-lactam, D-glucaro-1,4:6.3-dilactam, L-idaro-1,5-lactam, weight percentages, and even at least about 3 weight percent 2,3,5, tri-O-acetyl-D-glucaro-1,4-lactam, 2.5-di-O-acetyl-D- ages, of the total weight of the wash-off mousse shampoo glucaro-1,4:6.3-dilactam, D-glucaro-1,5-lactam methyl composition. ester, 2-propionoamide-2-deoxyglucaro-1,5-lactam and 0093. As used herein throughout, the phrase “weight per derivatives, esters, salts and mixtures thereof. centage(s) describes the weight percentage(s) of an ingredi 0084 Suitable non-steroidal anti-inflammatory agents ent of the total weight of a composition containing the ingre include, but are not limited to oxicams, piroXicam, isoxicam, dient. As used herein the term “about” refers to ..+-.10%. tenoxicam, Sudoxicam, CP-14.304, Salicylates, aspirin, dis 0094 Since the wash-offmousse shampoo composition of alcid, benorylate, trilisate, Safapryn, Solprin, diflunisal, fen the present embodiments may include irritant ingredients and dosal, acetic acid derivatives, diclofenac, fenclofenac, further since it may be applied Such that it is maintained on the indomethacin, Sulindac, tolmetin, isoxepac, furofenac, tiopi treated area for a certain period of time, as described herein nac, Zidometacin, acematacin, fentiazac, Zomepirac, clin above, the composition preferably further includes agents danac, oxepinac, felbinac, ketorolac, fenamates, mefenamic, that can reduce or substantially abolish such an irritation. meclofenamic, flufenamic, niflumic, tolfenamic acids, propi 0.095 As used herein, the phrase “acceptable carrier' onic acid derivatives, ibuprofen, naproxen, benoxaprofen, describes a carrier that does not cause significant irritation to flurbiprofen, ketoprofen, fenoprofen, fenbufen, indopropfen, an organism and does not abrogate the biological activity and pirprofen, carprofen, oxaprozin, pranoprofen, miroprofen, properties of the applied active ingredient. tioxaprofen, Suprofen, alminoprofen, tiaprofen, pyrazoles, 0096. As used herein, the phrase “mousse-forming car phenylbutaZone, oxyphenbutaZone, feprazone, azapropa rier describes a carrier that is designed to form a mousse, Zone, trimethaZone and derivatives, esters, salts and mixtures typically as a result of its dispension. thereof. 0097. One skilled in the artis well acquainted with various 0085 Suitable pediculicides include, but are not limited to carriers useful for mousse formulations, see for example U.S. DDT, lindane, malathion, permethrin and derivatives, esters, Pat. Nos. 6,627,585, 6,589,509, 6,589,518, 6.368,575, 6,395, salts and mixtures thereof. 258, 6,383,472, 6,080,392, 6,045,779, 5,830,438, 5,690,921, 0.086 Suitable vasodilators include, but are not limited 5,681,546, 5,066,481, 4,834,968, 4,900,326, 4,673,569, and ethyl nicotinate, capsicum extract and derivatives, esters, especially the U.S. patent application by the same assignee salts and mixtures thereof. identified by Attorney Docket Number 27246, and references 0087 Suitable wart removers include, but are not limited cited therein. A number of preferred formulations of a phar to imiquimod, podophyllotoxin and derivatives, esters, salts maceutical or cosmeceutical wash-offmousse shampoo com and mixtures thereof. position of the present invention are discussed hereinfurther. 0088. The exact amount of a given active pharmaceutical 0098. The mousse-forming carrier used in the context of ingredient in a pharmaceutical or cosmeceutical wash-off the present invention typically comprises a propellant. Tradi mousse shampoo composition of the present invention is tional mousse compositions for application on hair are dis dependent on the need for which the wash-off mousse sham pensed from an aerosol container onto damp hair or onto dry poo composition is intended to be used or the condition the hair or can be dispensed from a nonaerosol pump spray hav wash-offmousse shampoo composition is formulated to treat, ing a foam actuator. When dispensed from an aerosol con the exact mode of use and the active pharmaceutical ingredi tainer, the dissolved propellant expands and generates a ent itself. dense, finely-bubbled foam. The foam is stable when left 0089 Generally, the wash-off mousse shampoo composi undisturbed, and may gradually or partially collapse into a tion of the present invention is formulated so as to be in liquid when rubbed into the hair. The introduction of air under contact with the skin or scalp for sufficient time so as to allow pressure forms foam when the mousse is applied from a pump the absorption of a Sufficient amount of the active pharma Spray. ceutical ingredient therein and/or to allow the active pharma (0099 Suitable propellants for use in the context of the ceutical ingredient to exert its activity. present invention include, without limitation, chlorofluoro 0090 Thus, the composition is preferably formulated so carbons, hydrofluorocarbons, hydrochlorocarbons, hydrocar that the composition is washed out of the hair or skin area to bons, dialkylether, alkanes, compressed propellants and the which the composition is applied within 20 minutes, within like. Representative examples include but are not limited to 15 minutes, within 10 minutes, within 5 minutes or even nitrous oxide, carbon dioxide, chloropentafluoroethane, US 2011/0008267 A1 Jan. 13, 2011

dichlorodifluoromethane, diethyl ether, dimethyl ether, nitro mide, alkyldimethyl hydroxyethylammonium chloride, gen, propane, iso-butane, n-butane, isopentane, n-pentane, alkyldimethyl hydroxyethyl ammonium bromide, dialky dimethyl ether, trichlorofluoromethane and mixtures thereof. ldimethylammonium chloride, dialkyldimethylammonium Generally, the propellant makes up between about 3 weight bromide, alkylpyridinium salts, lauryl pyridinium chloride, percentages and about 50 weight percentages of the total cetyl pyridinium chloride, alkylamidoethyltrimethylammo weight of the wash-off mousse shampoo composition. nium ether Sulfates, amine oxides, alkylmethylaminoxide, 0100. A preferred pharmaceutically acceptable mousse alkylaminoethyldimethylaminoxide and derivatives, esters, forming carrier useful in formulating a wash-off mousse salts and mixtures thereof. shampoo composition of the present invention further 0103) The concentration of surface-active agents in a com includes at least one foam-forming agent in addition to the position of the present invention can range between about 0.1 propellant. weight percetange and about 50 weight percentages of the 0101. As used herein, the phrase “foam-forming agent' total weight of the wash-off mousse shampoo composition describes an agent that further plays a part in the formation of and preferably ranges between about 5 weight percentages a mousse form. Such agents are also referred to in the art as and 50 weight percentages of the total weight of the compo “foam boosters' and typically include one or more surface sition, more preferably between about 10 weight percentages active agents. and 50 weight percentages of the total weight of the compo 0102. As used herein, the phrase “surface-active agent' sition, more preferably between about 15 weight percentages describes a chemical Substance that has a lipophilic group and and 50 weight percentages of the total weight of the compo a hydrophilic group and therefore has the property of modi sition, and even more preferably between about 20 weight fying the interfacial tension of the liquid in which it is dis percentages and 50 weight percentages of the total weight of Solved. This phrase typically includes Soaps, detergents, the composition. emulsifiers, dispersing agents and wetting agents. Surface 0104 Emulsifiers suitable for use in formulating a active agents Suitable for use in formulating a mousse-form mousse-forming carrier of the present invention include but ing carrier of the present invention include anionic, nonionic, are not limited to Sorbitan isostearate, Sorbitan oleate, Sorbi amphoteric, cationic and Zwitterionic Surface-active agents. tan sesquioleate, Sorbitan trioleate, polyglyceryl-3-diisos Specific Suitable Surface-active agents include but are not tearate, polyglycerol esters of oleic/isostearic acid, polyglyc limited to acyl glutamates, acyl taurates, N-alkoyl sarcosi eryl-6 hexaricinolate, polyglyceryl-4-oleate, polygylceryl-4 nates, alkylalkoxy Sulfates, alkylamidopropyl betaines, alkyl oleate/PEG-8 propylene glycol cocoate, oleamide DEA, arylsulfonates, alkyl amine oxides, alkyl betaines, alkyl car sodium glyceryl oleate phosphate, hydrogenated vegetable bonates, alkyl carboxyglycinates, alkyl ether carboxylates, glycerides phosphate, glyceryl monostearate, diethylamino alkyl ether phosphates, alkyl ether sulfates, alkyl ether sul ethylalkylamide phosphate, glyceryl, glycol esters of Stearic fonates, alkyl glyceryl ether Sulfates, alkyl glycinates, alkyl acid, eicosene copolymer, Sorbitan oleate, and derivatives, phosphates, alkyl Succinates, alkyl Sulfates, alkyl Sulphosuc esters, salts and mixtures thereof. cinates, ammonium alkyl Sulphates, ammonium lauryl Sul 0105. The concentration of emulsifiers in a wash-off phate, ammonium lauryl Sulphosuccinate, ammonium Sul mousse shampoo composition of the present invention is fonate, aryl Sulfonates, cocamidopropyl betaine, generally between about 0.01 weight percentage and about 10 cocodimethyl Sulphopropyl betaine, cocomethyl tauride, weight percenatges of the total weight of the wash-offmousse cocomonoethanolamide, cocodiethanolamide, coco dimethyl shampoo composition. carboxymethyl betaine, cocomonoisopropanolamide, diso dium laureth Sulfo Succinate, dodecylbenzenesulfonate, 0106 The phrase “wetting agent” as used herein refers to ethoxylated sorbitan palmitate, ethoxylated sorbitan oleate, a chemical Substance that increases the spreading and pen ethoxylated Sorbitan Stearate, fatty acid alkanolamides, fatty etrating properties of a liquid by lowering its surface tension, acid amino polyoxyethylene Sulfates, fatty acids, fatty alco i.e., the tendency of its molecules to adhere to each other hol ethoxylates, fatty taurides, isothienates, lauryl amine and/or to other Substances such as the Solid Surfaces they wet. oxide, lauryl betaine, lauryl dimethyl carboxymethyl betaine, Examples of wetting agent in the context of the present inven lauryl ether carboxylate, lauryl ether Sulfate, lauryl glucoside, tion include, without limitation Such Substances as ammo lauryl sarcosinate, lauryl Sulfate, lauryl SulfoSuccinate, non nium Sulphate, 1,3-butylene glycol, glycerin, propylene gly Oxynol phosphates, nonyl phenol ethoxylates, olefin Sul col, pyroglutamic acid salts, triethanolamine Sulphate, fonates, octoxynol phosphates, polyethylene glycols, sodium lauryl sulphate, polysorbate 60, polysorbate 20, polysorbate 60, Sarcosinates, sodium alkyl Sulphates, sodium polysorbate 40, polysorbate 80, benzalkonium chloride, benzene Sulfonate, sodium cocamphopropionate, sodium docosate Sodium, poaxamer, polyoxyethylene alkyl ethers, cocoylisethionate, Sodium cumene Sulfonate, sodium dode polyoxyethylene castor oil derivatives, polyoxyethylene cylbenzene Sulphonate, Sodium lauroyl isethionate, sodium Stearate, Sodium lauryl Sulfate, and Sorbitan esters. N-lauryl sarcosinate, sodium laureth Sulphate, Sodium lauryl 0107 The mousse-forming carrier may further comprise Sulphate, Sodium oleyl Succinate, sodium Xylene Sulfonate, at least one component selected from the group consisting of Sulfated monoglycerides, Sulfobetaines, SulfoSuccinates, Sul fatty alcohols, hydrocarbon alcohols and water. taines, taurates, triethanolamine dodecylbenzene Sulphonate, 0108. As used herein, the phrase “fatty alcohol describes triethanolamine lauryl Sulphate, triethanolamine monolauryl a non-aromatic hydrocarbon alcohol having at least ten car phosphate, alkyldimethylbenzyl chloride ammonium salts, bonatoms and no more than one alcohol group. Fatty alcohols alkyldimethylbenzyl bromide ammonium salts, alkyltrimeth Suitable for use in formulating a mousse-forming carrier of ylbenzyl chloride ammonium salts, alkyltrimethylbenzyl the present invention include but are not limited to ethoxy bromide ammonium salts, cetyltrimethylammonium chlo lated fatty alcohols having between 10 and 22 carbon atoms. ride, cetyltrimethylammonium bromide, tetradecyltrimethy When present, the concentration of fatty alcohols in a com lammonium chloride, tetradecyltrimethylammonium bro position of the present invention is generally between about US 2011/0008267 A1 Jan. 13, 2011

0.01 weight percentage and about 20 weight percenatges of 0114 Suitable buffering agents include, but are not lim the total weight of the wash-off mousse shampoo composi ited to citrate buffers, acetic acid/sodium acetate buffers and tion. phosphoric acid/sodium phosphate buffers. 0109 As used herein, the phrase “hydrocarbon alcohol 0115 Suitable conditioners include, but are not limited to describes a hydrocarbon that is substituted by one or more cationic Surface-active agents such as quaternary ammonium hydroxyl groups. Hydrocarbon alcohols suitable for use in hydroxides, tetramethylammonium hydroxide, alkyltrim formulating a mousse-forming carrier of the present inven ethylammonium hydroxides, octyltrimethylammonium tion include but are not limited to alcohols having between 1 hydroxide, dodecyltrimethyl ammonium hydroxide, hexade and 10 carbon atoms and more preferably between 1 and 6 cyltrimethylammonium hydroxide, cetyltrimethylammo carbonatoms, especially aliphatic hydrocarbon alcohols. The nium hydroxide, octyldimethylbenzylammonium hydroxide, aliphatic chain is branched or un-branched, saturated or decyldimethyl-benzylammonium hydroxide, stearyldimeth unsaturated, preferably saturated. Example of suitable hydro ylbenzylammonium hydroxide, didodecyldimethylammo carbon alcohols include but are not limited to methanol, etha nium hydroxide, dioctadecyldimethylammonium hydroxide, nol, n-propanol, isopropanol, n-butanol, Sec-butanol, isobu tallow trimethylammonium hydroxide, cocotrimethylammo tanol and t-butanol and mixtures thereof. When present, the nium hydroxide, cetylpyridinium hydroxide, polyalkylaryl concentration of hydrocarbon alcohols in a composition of siloxanes, polyalkyl siloxanes, polydimethyl siloxanes, poly the present invention is generally between about 0.01 weight diethyl siloxanes, polydimethylsiloxane polymers, polydim percentage and about 15 weight percenatges of the total ethyl siloxane/diphenyl/methylvinylsiloxane copolymers, weight of the wash-off mousse shampoo composition. polydimethylsiloxane/methylvinylsiloxane copolymers and 0110. The concentration of water in a composition of the derivatives and mixtures thereof. present invention is can range between about 0.5 weight 0116 Suitable emollients include, but are not limited to percentage and about 95 weight percenatges of the total mineral oil, lanolin oil, coconut oil, cocoa butter, olive oil, weight of the wash-off mousse shampoo composition and aloe Vera extract, jojoba oil, castor oil, fatty acids, fatty alco preferably ranges between about 40 weight percentages and hols, diisopropyl adipate, hydroxybenzoate esters, benzoic about 90 weight percentages and more preferably between acid esters of C. Sub.9 to C. Sub.15 alcohols, isononyl iso about 70 weight percentages and about 80 weight percentages nonanoate, silicone oils, polyethers, C. Sub. 12 to C.Sub.15 of the total weight of the composition. alkylbenzoates, oleic acid, Stearic fatty acid, cetyl alcohols, 0111. In some embodiments, a wash-off mousse shampoo hexadecyl alcohol, dimethyl polysiloxane, polyoxypropylene composition presented herein includes, in addition to a cetyl ether, polyoxypropylene butyl ether, and derivatives, mousse-forming carrier, a cleansing agent and an active phar esters, salts and mixtures thereof. maceutical ingredient, one or more additional ingredients. 0117 Suitable foam stabilizers include, but not limited to Such additional ingredients may serve to provide an added capramide DEA, cellulose gum, cocamide DEA, cocamide value to the composition, to increase acceptance, stability, MEA, cocamidopropyl betaine, cocamidopropylamine and the like, to provide aesthetic characteristics, to perform oxide, cocamine oxide, coco-betaine, dihydroxyethyl C12-15 additional pharmaceutical, cosmeceutical, or cosmetic func alkoxypropylamine oxide, dimethicone copolyol, fatty alky tions, or to add other functionalities. lolamide condensate, hydrolyzed animal protein, hydroxy 0112 One skilled in the artis well acquainted with the use ethyl methylcellulose, hydroxyethylcellulose, hydroxypro and combination of various additional ingredients in mousse pyl methylcellulose, hydroxypropylcellulose, isostearamide formulations see, for example, the references cited above. It is DEA, lauramide DEA, lauramidopropyl betaine, lauramine important to note that in Some cases a specific additional oxide, laureth-3, lauryl alcohol, lauryl betaine, lecithin, ingredient also serves as a component of the carrier or serves linoleamide DEA, methylcellulose, myristamide DEA, two or more additional functions. For example, in a specific myristamine oxide, myristoyl hydrolyzed animal protein, composition ethanol can serve as a preservative, as a viscosity oleamide MIPA, oleyl betaine, palm kernelamide dea, peg-6 modifier and as a solubilizer. Suitable additional ingredients cocamide, PVP quaternium-41, sodium methyl cocoyl tau include antimicrobial agents, antioxidants, antiperspirants, rate, Stearamide DEA, Stearamine oxide, tallow amidopropy anti-static agents, astringents, buffering agents, bulking lamine oxide, oleamide DEA, and derivatives, esters, salts agents, chelating agents, colorants, conditioners, deodorants, and mixtures thereof. detoxifiers, diluents, dyes, emollients, fragrances, foam sta 0118 Suitable fragrances include, but are not limited to bilizers, hair conditioners, humectants, occlusive agents, oils, menthol, eugenol, phenoxyethanol, isopropyl palmitate, iso opacifiers and pearling agents (pearlescent aids), penetration propyl myristate, benzyl salicylate, phenylethyl salicylate, enhancers, perfuming agents, permeation enhancers, pH-ad thymol, isoamyl salicylate, phenylethyl salicylate, benzoic justing agents, preservatives, protectants, skin penetration acid, benzyl benzoate, methyl salicylate, phenol, oleic acid, enhancers, softeners, Solubilizers, Sun blocking agents, Sun caproic acid, carbaryl, balm mint extract, carrot oil, chamo less tanning agents, Sunscreens, ultraviolet light absorbers, mile extract, dipentene, eucalyptus oil, fennel extract, gera Viscosity modifiers and vitamins. In some instances a specific nium oil, juniper tar, lemon extract, matricaria extract, men additional ingredient may have more than one activity, func tol, oil of Italian mandarine, pine tar, rosemary extract, Sage tion or effect. extract, sandalwood, thym extract, FRAGRANCE 3949-5, 0113 Suitable anti-static agents include but are not lim FRAGRANCE520AFRAGRANCE 91-122, FRAGRANCE ited to synthetic quaternized polymers (e.g., polyduaternium HERBAL 10396, FRAGRANCE UNGERER HONEY 7), quaternized protein or protein-Silicon copolymer, quater SUCKLE K2771, and derivatives, esters, salts and mixtures nized protein hydrolizate (e.g., croquet L), cationic cellulose thereof. derivative (e.g., polyduaternium 10), poly(diallyldimethy 0119 Suitable humectants include, but are not limited to lammonium chloride), tricetyl methyl ammonium chloride acetamide monoethanolamine, alkoxylated glucose, allan and any derivatives and mixtures thereof. toin, allantoin acetyl methionine, aloe, aloe Vera, aloe Vera US 2011/0008267 A1 Jan. 13, 2011 gel, ammonium glycolate, ammonium lactate, butylene gly sodium lauroyl sarcosinate, sodium/TEA-lauroyl hydrolyzed col, calcium chloride, glycerin, glycine, glycolate salts, gly animal protein, Stearamine oxide, TEA-coco-hydrolyzed ani colic acid, hexanetriol, hexylene glycol, a hexylene glycol mal protein, TEA-oleoyl sarcosinate, cocamidopropyl Sul derivative, honey, hyaluronic acid, hydrolyzed animal pro taine, cocamine oxide, cocoyl sarcosine and disodium mono tein, hydrolyzed milk protein, inositol, keratin amino acids, cocamidosulfo Succinate. keratin polypeptides, lactamide monoethanolamine, lactate 0.125 Suitable astringents include, but are not limited to salts, lactic acid, lactose, polyethylene glycol, polyhydroxy apple juice, birch leaf extract, birch sap, calcium chloride, alcohol, propylene glycol, quaternary alkyl ammonium gly cucumber juice, cucumber oil, cupric acetate, fennel extract, colate, quaternary alkyl ammonium lactate, Sorbitol, a starch, horsetail extract, isopropyl alcohol, lemon extract, lemon a starch derivative, a Sugar, a Sugar derivative, urazole, urea, juice, nettle extract, rosemary extract, witch hazel, witch and derivatives, esters, salts and mixtures thereof. hazel distillate, witch hazel extract, yarrow extract, Zinc 0120 Suitable pH-adjusting agents include, but are not acetate, Zinc oxide, Zinc phenolsulfonate and Sage extract. limited to adipic acid, calcium hydroxide, citric acid, glycine, 0.126 Suitable skin penetration enhancers include but are hydrochloric acid, lactic acid, magnesium aluminometasili not limited to acetone, acyl lactylates, acyl peptides, acylsar cates, phosphoric acid, sodium carbonate, Sodium citrate, cosinates, alkanolamine salts of fatty acids, alkyl benzene Sodium hydroxide, Sorbic acid, Succinic acid, tartaric acid, Sulphonates, alkyl ether Sulphates, alkyl Sulphates, anionic and derivatives, salts and mixtures thereof. Surface-active agents, benzyl benzoate, benzyl salicylate, 0121 Suitable preservatives include but are not limited to butan-1,4-diol, butylbenzoate, butyl laurate, butyl myristate, C12 to C15 alkylbenzoates, alkyl p-hydroxybenzoates, aloe butyl Stearate, cationic Surface-active agents, citric acid, Vera extract, ascorbic acid, benzalkonium chloride, benzoic cocoamidopropylbetaine, decyl methyl Sulfoxide, decyl ole acid, benzoic acid esters of C9 to C15 alcohols, butylated ate, dibutyl azelate, dibutyl phthalate, dibenzyl sebacate, hydroxytoluene, diazolidinyl urea, DMDM hydantoin, etha dibutyl sebacate, dibutyl suberate, dibutyl succinate, dicapryl nol, hydroxybenzoate esters, iodopropynyl butylcarbamate, adipate, didecyl phthalate, diethylene glycol, diethyl seba methylparaben, polyoxypropylene butyl ether, polyoxypro cate, diethyl-m-toluamide, di(2-hydroxypropyl)ether, diiso pylene cetyl ether, potassium Sorbate, sodium benzoate, propyl adipate, diisopropyl sebacate, N,N-dimethyl aceta Sodium bisulfite, Sorbic acid, esters, salts and mixtures mide, dimethyl azelate, N,N-dimethyl formamide, 1.5- thereof. dimethyl-2pyrrolidone, dimethyl sebacate, dimethyl 0122 Suitable antioxidants include, but are not limited to Sulphoxide, dioctyladipate, dioctyl azelate, dioctyl sebacate, butylated hydroxyanisole (BHA), butylated hydroxytoluene 1.4 dioxane, 1-dodecylazacyloheptan-2-one, dodecyl dim (BHT), lecithin, potassium Sorbate, propylene glycol, Sodium ethylamine oxides, ethyl caprate, ethyl caproate, ethyl capry bisulfate, sodium Sulfite, Sorbic acid, tocopherol, wheat germ late, 2-ethyl-hexyl pelargonate, ethyl-2-hydroxypropanoate, and wheat germ oil. ethyl alcohol, ethyl laurate, ethyl myristate, 1-ethyl-2-pyr 0123 Suitable antimicrobial agents include, but are not rolidone, ethyl salicylate, hexyl laurate, 2-hydroxyoctanoic limited to benzalkonium chloride, benzoic acid, benzyl alco acid, 2-hydroxypropanoic acid, 2-hydroxypropionic acid, hol, boric acid, 2-bromo-2-nitropropane-1,3-diol, butylene isethionates, isopropyl isostearate, isopropyl palmitate, guar glycol, captan, chloromethyl isothiazolinone, chloroxylenol, hydroxypropyltrimonium chloride, hexan-2,5-diol, khellin, dehydroacetic acid, dimethoxane, disodium monoundecyle lamepons, lauryl alcohol, maypons, metal salts offatty acids, namido MEA sulfosuccinate, DMDM hydantoin, eucalyptus methyl nicotinate, 2-methylpropan-2-ol. 1-methyl-2-pyrroli oil, formaldehyde, glutaral, isopropyl alcohol, isopropyl done, 5-methyl-2-pyrrolidone, methyltaurides, miranol, non cresols, imidazolidinyl urea, MDM hydantoin, methyl ionic Surface-active agents, octyl alcohol, octylphenoxy Isothiazolinone, methylparaben, myristalkonium chloride, polyethoxyethanol, oleic acid, oleic ethanolamide, pleyl phenoxyethanol, potassium Sorbate, propylene glycol, propy alcohol, pentan-2,4-diol, phenoxyethanol, phosphatidylcho lparaben, quaternium-14, quaternium-15, resorcinol, low line, phosphine oxides, polyalkoxylated ether glycolates, alcohols, SD alcohol 23-A, SD alcohol 38-B, SD alcohol 3-A, poly(diallylpiperidinium chloride), poly(dipropyldiallylam SD alcohol 40, SD alcohol 40-B, sodium dehydroacetate, monium chloride), polyglycerol esters, polyoxyethylene lau Sodium benzoate, Sodium bisulfate, Sodium salicylate, ryl ether, polyoxy:polyoxyethylene Stearate, polyoxypropy Sodium sulfite, Sorbic acid, Zinc phenolsulfonate, Zinc lene 15 stearyl ether, poly(vinyl pyridinium chloride), pyrithione, potassium undecylenoyl hydrolyzed animal pro propan-1-ol, propan-2-ol, propylene glycol dipelargonate, tein and salicylic acid. pyroglutamic acids, 2-pyrrolidone, pyruvic acids, Quater 0124 Suitable detoxifiers include, but are not limited to nium 5, Quaternium 18, Quaternium 19, Quaternium 23, acetamide MEA, allantoin, aloe, cholesterol, cocamidopro Quaternium 31, Quaternium 40, Quaternium 57, quartenary pyl betaine, cocamidopropylamine oxide, coco-betaine, diso amine salts, quaternised poly(dimethylaminoethylmethacry dium hlouolauramido MEA SulfoSuccinate, disodium mono late), quaternised poly(vinyl alcohol), Sapamin hydrochlo cocamido MIPA sulfosuccmate, disodium monolaureth ride, Sodium cocaminopropionate, Sodium dioctyl Sulphon SulfoSuccinate, disodium monooleamido MEA Sulfo Succi Succinate, Sodium laurate, Sodium lauryl ether Sulphate, nate, disodium monooleamido PEG-2 SulfoSuccinate, diso Sodium lauryl Sulphate, Sugar esters, Sulphosuccinate, tet dium monooleamido Sulfo Succinate, laneth-16, laneth-10 rahydrofuran, tetrahydrofurfural alcohol, transcutol, trietha acetate, laneth-9 acetate, lauramidopropyl betaine, lauramine nolamine dodecyl benzene Sulphonate, triethanolamine ole oxide, lauroyl sarcosine, lauryl betaine, myristamine oxide, ate, urea, water esters, salts and mixtures thereof. oleyl betaine, PEG-10 sorbitan laurate, PEG-40 lanolin, peg 0127 Suitable solubilizers include, but are not limited to, 44 sorbitan laurate, PEG-75 lanolin, PEG-85 lanolin, propylene glycol. 1,3-propylene diol, polyethylene glycol, polysorbate 20, polysorbate 40, polysorbate 80, potassium ethanol, propanol, glycerine, dimethyl Sulphoxide, dimethyl coco-hydrolyzed animal protein, PPG-12-PEG-50-lanolin, acetamide, dimethyl formamide, hexylene glycol, propylene PVP, sodium cocoyl sarcosinate, sodium laureth-12 sulfate, carbonate, and derivatives, salts and mixtures thereof. US 2011/0008267 A1 Jan. 13, 2011

0128 Suitable sunscreens and ultraviolet light absorbers cupric acetate, dna, egg, egg powder, ergocalciferol, eucalyp include, but are not limited to benzophenone-2, benzophe tus oil, fennel extract, geranium oil, glycerin, henna, henna none-3, benzophenone-4, benzophenone-6, benzophenone extract, herbal extract, honey, horsetail extract, hybrid saf 8, benzophenone-9, benzophenone-11, benzophenone-12, flower oil, hydrolyzed animal protein, hydrolyzed milk pro drometrizole, homosalate, methyl anthranilate, octocrylene, tein, inositol, jojoba extract, jojoba oil, juniper tar, keratin octyl methoxycinnamate, octyl salicylate, uric acid and amino acids, keratin polypeptides, lactic acid, lactose, laneth derivatives, esters, salts and mixtures thereof. 16, laneth-9 acetate, lanolin, lemon extract, lemon juice, liq 0129 Suitable viscosity modifiers include, but are not lim uid silk complex, malt extract, matricaria extract, matricaria ited to carbomer, polyethylene glycol, polypropylene glycol, oil, menthol, milk protein, mink oil, myristoyl hydrolyzed Sodium Xylene Sulphonate, sodium toluene Sulphonate, urea, animal protein, nettle extract, niacinamide, nonfat dry milk, acacia, alcohol, ammonium laureth Sulfate, ammonium nucleic acid, olive oil, panthenol, peach kernel oil, pectin, myreth Sulfate, ammonium pareth-25 Sulfate, amphoteric-12, pine tar, placental extract, potassium cocoate, pyridoxine amphoteric-7, bentonite, butylene glycol, carbomer-934, car HCl, resorcinol, ribonucleic acid, rosemary extract, safflower bomer-941, cationic polymers, cellulose gum, hydroxyethyl oil, sage extract, sandalwood, sandalwood oil, Sesame oil, cellulose, methylcellulose, hydroxyethyl methylcellulose, Soya acid, soybean oil. Sucrose, Sulfated castor oil, Sweet hydroxypropyl methylcellulose, cetyl alcohol, cocamide almond oil, thiamine HCl, thyme extract, tocopherol, toco DEA, cocamide MEA, cocamidopropyl betaine, cocami pheryl acetate, vegetable oil, wheat germ, wheat germ oil, dopropyl Sultaine, cocamidopropylamine oxide, cocamine witch hazel, witch hazel distillate, witch hazel extract, yarrow oxide, coco-betaine, DEA-laureth sulfate, dihydroxyethyl extract, yogurt, Zinc acetate and any combination thereof. C12-C15 alkoxypropylamine oxide, dimethyl octynediol, I0131 The choice of a propellant or combination of pro emulsifying wax, ethoxydiglycol, ethyl hexanediol, fatty pellants, the exact composition of a mousse-forming carrier, alkylolamide condensate, glyceryl Stearate, guarhydroxypro the choice of cleansing agent and which additional compo pyltrimonium chloride, hexylene glycol, hydroxyethyl meth nents are added to a specific formulation of a pharmaceutical ylcellulose, hydroxyethyl Stearamide-mtpa, hydroxypropyl or cosmeceutical mousse of the present invention is depen methylcellulose, hydroxypropylcellulose, isopropyl alcohol, dent on Such factors as the nature of the active pharmaceutical isostearamide DEA, laneth-16, lanolin, lauramide DEA, lau ingredient, the desired mode of use of the mousse and other ramidopropyl betaine, lauramine oxide, laureth-3, lauroyl factors. sarcosine, lauryl betaine, lecithin, linoleamide DEA, magne I0132 Guidance for formulating preferred mousse-form sium aluminum silicate, methylcellulose, montmorillonite, ing carriers useful in implementing a pharmaceutical or cos myristamide DEA, myristamine oxide, oleamide MIPA, oleic meceutical mousse of the present invention include the acid, oleth-10 phosphate, oleyl betaine, palm kernelamide mousse-forming carriers of the wash-off mousse shampoo dea, PEG-14M, PEG-150 distearate, PEG-150 stearate, PEG compositions taught in U.S. Pat. Nos. 6,627,585, 6,589,509, 16 hydrogenated castor oil, PEG-5M, PEG-8 dilaurate, 6,589,518, 6.368,575, 6,395,258, 6,383,472, 6,080,392, PEG-8 distearate, PEG-8 laurate, petrolatum, poloxamer 101, 6,045,779, 5,830,438, 5,690,921, 5,681,546, 5,066,481, poloxamer 182, poloxamer 188, poloxamer 238, potassium 4,834,968, 4,900,326, 4,673,569, and especially the U.S. Stearate, propylene glycol, PVP quaternium-19, quaternium patent application by the same assignee identified by Attor 41, SD alcohol 23-A, SD alcohol 38-B, SD alcohol 3-A, SD ney Docket Number 27246, and references cited therein. alcohol 40, SD alcohol 40-B, sodium cetyl sulfate, sodium Further preferred formulations of wash-off mousse shampoo laureth Sulfate, sodium myreth Sulfate, sodium Stearate, compositions of the present invention are described in the Sodium Xylene Sulfonate, Sorbitan laurate, Stearamide DEA, Examples below. Stearamide MEA-stearate, Stearamine oxide, Stearic acid, I0133. The wash-off mousse shampoo composition of the stearyl alcohol, tallow amidopropylamine oxide, TEA-oleoyl present invention is formulated to deliver an active pharma sarcosinate and mixtures thereof. Suitable opacifiers and ceutical ingredient to a skin area of the body and particularly pearling agents include, but are not limited to bentonite, cetyl the scalp, so as to treat a medical condition that affects Such alcohol, glyceryl Stearate, glycol distearate, glycol Stearate, skin areas. hydroxyethyl Stearamide-mtpa, lanolin, latex opacifier, mag I0134. The wash-off mousse shampoo composition of the nesium aluminum silicate, magnesium carbonate, mica, present invention is advantageously formulated to deliver an montmorillonite, myristic acid, PEG-8 distearate, sodium active pharmaceutical ingredient to hirsute skin areas. cetyl sulfate, Sodium octoxynol-3 Sulfonate, Sodium Stearate, 0.135 Such hirsute areas include, for example, the scalp, Sodium styrenefacrylates/divinylbenzene copolymer, sodium the armpit, the loins, the genital areas and in some cases also styrene? peg-10 maleate/nonoxynol-10 maleate/acrylate the arms, the back, the legs and others. copolymer, Sodium tallow Sulfate, Stearamide DEA, Steara 0.136. It is therefore preferred that a wash-off mousse mide MEA-stearate, Stearic acid, Stearyl alcohol, styrene? shampoo composition of the present invention be packaged in acrylate copolymer, talc, tocopherol and Zinc oxide. a packaging material and identified in print, in or on the 0130. Other ingredients, selected for their folkloric value, packaging material, for use for a need selected from the group may be added to the formulation of the wash-off mousse consisting of curing a condition, treating a condition, prevent shampoo composition of the present inventions such as but ing a condition, treating symptoms of a condition, curing not limited to acacia, allantoin biotin, allantoin calcium pan symptoms of a condition, ameliorating symptoms of a con tothenate, applejuice, apricot juice, autolyzed yeast, avocado dition, treating effects of a condition, ameliorating effects of oil, balm mint extract, balsam, balsam canada, balsam a condition, and preventing results of a condition. A specific oregon, balsam tolu, beer, birch leaf extract, birch sap, caro condition and specific use is dependent on the exact formu tene, carrot juice, carrot oil, chamomile extract, cholecalcif lation of a specific wash-off mousse shampoo composition, erol, cholesterol, clover blossom extract, coconut acid, coco especially the nature and amount of the one or more active nut oil, collagen, corn oil, cucumber juice, cucumber oil, pharmaceutical ingredients therein. US 2011/0008267 A1 Jan. 13, 2011

0.137 Typical conditions for which a wash-off mousse 0.143 A prophylactically, therapeutically, pharmaceuti shampoo composition of the present invention is formulated cally or cosmeceutically effective amount, as used herein, are medical conditions and cosmeceutical conditions, espe means an amount of an active pharmaceutical ingredient cially skin and/or scalp diseases or disorders. needed to achieve the desired outcome, which is generally to 0.138. Such skin and/or scalp diseases or disorders include, prevent, alleviate orameliorate the condition or symptoms of but are not limited to, acne rosacea, actinic keratoses, actinic the condition described hereinabove. Determination of the porokeratosis, acute inflammatory diseases, age spots, aller effective amount, and consequently the dose and dose fre gic contact dermatitis, alopecia, asteatotic eczema, atopic quency, is within the capability of one skilled in the art, dermatitis, atopic eczema, bacterial infection, BCC, Bowen's especially in light of the detailed disclosure provided herein. disease, burns, chronic hypertrophic lichen planus, chronic Factors in determining the effective amount vary with sever Superficial Scaling, contact dermatitis, cradle cap, cutaneous ity of the condition as well as Such factors as the Subject being T-cell lymphoma, cystic acne, dandruff, Darier's disease, der treated, the severity of the condition, the age, body weight and matitis, dermatitis herpetiformis, dermatosis, discoid response of an individual patient and the judgment of the eczema, discoid lupus erythematosus, dry skin, eczema, prescribing physician. erythrasma, exfoliative keratolysis, folliculitis, fungal infec 0144. In a preferred embodiment of this aspect of the tion, juvenile plantar dermatosis, granuloma annulare, Grov present invention, the active pharmaceutical ingredient and er's disease, hair thinning, ichthyosiform dermatoses, ich the cleansing agent form a part of a pharmaceutical or cos thyosis, impetigo, infantile eczema, infection, intertrigo, meceutical wash-off mousse shampoo composition contain keratosis, keloid scarsmlichen simplex chronicus, lichen pla ing same. Such that topically applying these agents simulta nus, lichen striatus, lupus erythematosus, neurodermatitis, neously is effected by topically applying Such a composition. palmar hyperkeratosis, palmoplantar psoriasis, papular urti caria, parapsoriasis, pediculosis, pellagra, perifolliculitis, 0145 The pharmaceutical or cosmeceutical wash-off pigmented skin, lesions, pityriasis alba, pityriasis mousse shampoo composition preferably further comprises a lichenoides, pityriasis rosea, pityriasis rubra pilaris, pityriasis mousse-forming carrier and more preferably it is the pharma versicolor, plantar hyperkeratosis, neurodermatitis, pruritis, ceutical or cosmeceutical wash-off mousse shampoo compo psoriasis, Reiter's syndrome, rosacea, Seborrhoeic dermatitis, sition described in detail hereinabove. Subacute cutaneous lupus erythematosus, tinea capitis, Super 0146 According to this embodiment, the at least one ficial BCC, warts, wound, wrinkles and yeast infections (es active pharmaceutical ingredient is administered by passing a pecially of Malassezia ovalis, Malassezia furfur, Pityrospo pharmaceutical or cosmeceutical wash-off mousse shampoo rium orbiculare and Pityrosporium ovale). composition containing the at least one active pharmaceutical 0.139. The teachings of the present invention also provide ingredient, the cleansing agent and a mousse-forming carrier a method of treatment, the method being substantially from a first volume (e.g. a vessel) having a first pressure effected by (a) administering (e.g., by topically applying) to a through a passage (e.g. a noZZle) into a second Volume (e.g. skin and/or scalp area (wet or dry, depending on the embodi the open air) having a second pressure, the first pressure being ment) of a mammal (non-human or human) in need thereof, a greater than the second pressure, so as to effect foaming of the therapeutically or cosmeceutically effective amount of at composition. least one active pharmaceutical ingredient simultaneously 0147 When implementing the method of the present with the administration of a cleansing agent in amousse form; invention, it is often desired to apply to the treated area (b) Subsequent to the administering, waiting a period of time; additional ingredients in addition to the active pharmaceutical and (c) Subsequent to the waiting, rinsing the area. During the ingredient and the cleansing agent. Thus, the pharmaceutical waiting period the skin area is cleaned and the active phar or cosmeceutical wash-off mousse shampoo composition maceutical ingredient acts or is absorbed into the skin and/or used in implementing the method of the present invention is Scalp. The time can be short (e.g. the usual time for applying often formulated with additional components. a shampoo, spreading and rinsing) or may be longer. Gener 0.148. The teachings of the present invention also provide ally, due to the irritating nature of cleansing agents, the hair a process for preparing a pharmaceutical or cosmeceutical must typically be rinsed within 20 minutes, within 5 minutes wash-off mousse shampoo composition as described above or even within 5 minutes of application of the cleansing agent and which is useful in implementing the method of the present and the active pharmaceutical ingredient. invention by (a) obtaining a mixture of a cleansing agent, at 0140. By need is meant a need selected from the group least one active pharmaceutical ingredient and a pharmaceu consisting of curing a condition, treating a condition, prevent tically acceptable mousse-forming carrier, (b) placing the ing a condition, treating symptoms of a condition, curing mixture in a pressure-resistant vessel, and (c) sealing the symptoms of a condition, ameliorating symptoms of a con pressure-resistant vessel. dition, treating effects of a condition, ameliorating effects of 0149. In cases where the mousse-forming carrier com a condition, and preventing the results of a condition. Condi prises a propellant, the propellant is added to the mixture tions include medical conditions and cosmeceutical condi separately and Subsequent to its placing in the vessel. tions, such as skin and/or scalp diseases and disorders, as is 0150. Thus, in an embodiment of the process according detailed hereinabove. this aspect of the present invention, the mousse-forming car 0141. The specific active pharmaceutical ingredient or rier comprises a propellant and placing the mixture in the ingredients administered is dependent on the need for which vessel is effected by placing Such a mixture while not adding the method is implemented and can be selected from the list of the propellant thereto; placing the mixture in a pressure active pharmaceutical ingredients delineated hereinabove. resistant vessel and fitting the vessel with a seal-valve, (c) 0142. The cleansing agent administered is preferably placing an amount of at least one propellant in the pressure selected from the group consisting cleansers, detergents and resistant vessel, and (d) fitting the seal-valve of the pressure Soaps, as is detailed hereinabove. resistant vessel with an actuator. US 2011/0008267 A1 Jan. 13, 2011

0151. The types and specific examples of suitable active grance (0.01-5%), and mixing the solution at room tempera pharmaceutical ingredients, cleansing agents, Suitable ture until the clobetasol propionate is fully dissolved. mousse-forming carriers and Suitable propellants have been 0160 The aqueous phase was prepared by mixing purified discussed hereinabove. water (70-80% by weight) as a base vehicle, trisodium citrate 0152) Obtaining a mixture as described above generally (0.2-0.9% by weight) and citric acid (0.01-2.0% by weight) as involves making a first Solution, a second solution, and, if a buffer, coconut fatty acid diethanolamide (cocamide DEA, desired, a third and a forth solution and then combining the 1-5% by weight) serving as a nonionic Surfactant, foam Solutions, so as to achieve the desired mixture. The various boosting and Stabilization agent, Viscosity control agent, con Solutions are typically prepared under different conditions ditioning agent and a solubilization agent, polysorbate 20 and/or in different solvents or carriers. Thus, in one exem (1-5% by weight) serving as a mild foaming agent, a cleans plary embodiment, a first solution is prepared by dissolving ing agent, an anti-irritant and a solubilizer, polyduaternium water-soluble components in water at room temperature, 10 (0.1-1.0% by weight) serving as a cationic polymer, con whereby the second solution is prepared by dissolving other ditioner and a viscosity control agent, and Sodium lauryl ether components in water while heating. In another exemplary Sulfate (5-15-96 by weight) serving as an anionic Surfactant, a embodiment, a first Solution is prepared by dissolving water foaming agent and a cleansing agent. soluble components in water, optionally while heating and a 0.161 The alcoholic phase was dissolved in the aqueous second Solution is prepared by dissolving water-insoluble phase and the mixture was allowed to stirat room temperature components in a water-miscible organic solvent, optionally until clear. by heating. In still another exemplary embodiment, a first 0162 The mixture was poured into an aluminum aerosol Solution is prepared by dissolving water-soluble components spraying canister, a valve was attached to the canister, in water at room temperature, a second solution is prepared by vacuum was applied to the canister and the valve was there dissolving other components in water while heating, and a after crimpled, thereby sealing the canister. A hydrocarbon third solution is prepared by dissolving water-insoluble com propellant mixture was then added and an actuator was ponents in a water-miscible organic solvent, optionally by assembled on the valve. heating. 0163 Table 1 below presents the list of ingredients in 0153 Combining the solutions can be effected either at Composition 1. room temperature or while heating. 0154 Additional objects, advantages, and novel features TABLE 1 of the present invention will become apparent to one ordi Percent by narily skilled in the art upon examination of the following Weight of examples, which are not intended to be limiting. Additionally, Ingredient Assumed Purpose Composition each of the various embodiments and aspects of the present invention as delineated hereinabove and as claimed in the Clobetasol active pharmaceutical O.OS propionate ingredient claims section below finds experimental Support in the fol Ethanol Solvent and a preservative 5-15 lowing examples. Fragrance fragrance O.O1-5 Water base vehicle 70-80 EXAMPLES Trisodium citrate buffer O.2-0.9 Citric acid buffer O.O1-2.O Coconut fatty acid nonionic Surfactant, foam 1-5 0155 Reference is now made to the following examples, diethanol amide boosting stabilization agent, which together with the above description illustrate the inven (cocamide DEA) viscosity control agent, tion in a non-limiting fashion. conditioning agent and a Solubilization agent 0156 Generally, the nomenclature used herein and the Polysurbate 20 mild foaming agent, a 1-5 laboratory procedures utilized in the present invention cleansing agent, an anti include chemical and analytical techniques with which on irritant and a solubilizer skilled in the art is familiar. Unless otherwise defined, tech Polyguaternium 10 cationic polymer, 0.1-1.0 conditioner and viscosity nical and Scientific terms used herein have the same meaning control agent as commonly understood by one of ordinary skill in the art to Sodium lauryl ether anionic Surfactant, a foaming 5-15 which this invention belongs. Although methods and materi sulfate agent and a cleansing agent als similar or equivalent to those described herein can be used Hydrocarbon propellant 3-7 in the practice or testing of the present invention, Suitable propellant methods and materials are described below. 0157 AWash-Off Mousse Shampoo Containing Clobeta 0164. A Wash-Off Mousse Shampoo Containing Clobeta Sol Propionate—Composition 1: Sol Propionate—Composition 2: 0158 Clobetasol propionate is a corticosteroid topically 0.165. The alcoholic phase was prepared by dissolving the used for the treatment of skin conditions including severe clobetasol propionate (0.05% weigh percentage of the total cases of psoriasis and eczematous dermatitis, which takes weight of the composition) in the ethyl alcohol (5-15% by effect by reducing Swelling, redness and itching associated weight) serving as a solvent and a preservative, and a fragrant with the skin condition. In the example that follows, clobeta (0.01-5%), and mixing the solution at room temperature until Sol propionate is used in a composition directed at treating the clobetasol propionate is fully dissolved. skin conditions of the scalp. 0166 The aqueous phase was prepared by mixing purified 0159. The alcoholic phase was prepared by dissolving the water (70-80% by weight) as a base vehicle, trisodium citrate clobetasol propionate (0.05% weigh percentage of the total as a buffer (0.2-0.9% by weight), polysorbate 60 (1-10% by weight of the composition) in the ethyl alcohol (5-15% by Weight) serving as a mild foaming agent, a cleansing agent, an weight) serving as a solvent and a preservative, and a fra anti-irritant and a solubilizer, polyduaternium 10 (0.2-1% by US 2011/0008267 A1 Jan. 13, 2011

weight) serving as a cationic polymer, conditioner and a 0.174. The mixture was poured into an aluminum aerosol Viscosity control agent, and sodium lauryl ether Sulfate spraying canister, a valve was attached to the canister, (5-15% by weight) serving as an anionic Surfactant, a foam vacuum was applied to the canister and the valve was there ing agent and a cleansing agent, and adjusting the pH to 5-7 by after crimpled, thereby sealing the canister. A hydrocarbon the addition while stirring of solid citric acid (0.01-2% by propellant mixture was then added and an actuator was weight). assembled on the valve. 0167. The alcoholic phase was dissolved in the aqueous phase and the mixture was allowed to stir at room temperature (0175 Table 3 below presents the list of ingredients in until clear. Composition 3. 0168 The mixture was poured into an aluminum aerosol spraying canister, a valve was attached to the canister, TABLE 3 vacuum was applied to the canister and the valve was there Percent by after crimpled, thereby sealing the canister. A hydrocarbon Weight of propellant mixture was then added and an actuator was Ingredient Assumed Purpose Composition assembled on the valve. Clobetasol active pharmaceutical O.OS 0169 Table 2 below presents the list of ingredients in propionate ingredient Composition 2. Ethanol Solvent and a preservative 5-15 Fragrance fragrance O.O1-5 Water base vehicle 70-80 TABLE 2 Trisodium citrate buffer O.2-0.9 Lauramide DEA nonionic Surfactant, foam 1-10 Percent by boosting and stabilization Weight of agent, viscosity control Ingredient Assumed Purpose Composition agent, conditioning agent and a solubilization agent Clobetasol active pharmaceutical O.OS Polysorbate 20 mild foaming agent, a 2-5 propionate ingredient cleansing agent, an anti Ethanol Solvent and a preservative 5-15 irritant and a solubilizer Fragrance fragrance O.O1-5 Polyguaternium 10 cationic polymer, 0.2-1 Water base vehicle 70-80 conditioner and viscosity Trisodium citrate buffer O.2-0.9 control agent Polysorbate 60 mild foaming agent, a 1-10 Sodium lauryl ether anionic Surfactant, a foaming 5-15 cleansing agent, an anti sulfate agent and a cleansing agent irritant and a solubilizer Citric acid buffer O.O1-2.0 Polyguaternium 10 cationic polymer, 0.2-1 Hydrocarbon propellant 3-7 conditioner and viscosity propellant control agent Sodium lauryl ether anionic Surfactant, a foaming 5-15 sulfate agent and a cleansing agent Citric acid buffer O.O1-2.O 0176 A Wash-Off Mousse Shampoo Containing Clobeta Hydrocarbon propellant 3-7 Sol Propionate—Composition 4: propellant 0177. The alcoholic phase was prepared by dissolving the clobetasol propionate (0.05% weigh percentage of the total 0170 A Wash-Off Mousse Shampoo Containing Clobeta weight of the composition) in the ethyl alcohol (8-10% by sol Propionate Composition 3: weight) serving as a solvent and a preservative, and a fra 0171 The alcoholic phase was prepared by dissolving the grance (0.01-5%), and mixing the solution at room tempera clobetasol propionate (0.05% weigh percentage of the total ture until the clobetasol propionate is fully dissolved. weight of the composition) in the ethyl alcohol (5-15% by 0.178 The aqueous phase was prepared by mixing purified weight) serving as a solvent and a preservative, and a fragrant water (70-80% by weight) as a base vehicle, trisodium citrate (0.01-4%), and mixing the solution at room temperature until (0.3-0.9% by weight) serving as a buffer, polysorbate 60 the clobetasol propionate is fully dissolved. (2-10% by weight) serving as a mild foaming agent, a cleans 0172. The aqueous phase was prepared by mixing purified ing agent, an anti-irritant and a solubilizer, polyduaternium water (70-80% by weight) as a base vehicle, trisodium citrate 10 (0.2-5% by weight) serving as a cationic polymer, condi (0.2-0.9% by weight) serving as a buffer, lauramide DEA (1-10% by weight) serving as a nonionic Surfactant, foam tioner and a viscosity control agent, and sodium lauryl ether boosting and Stabilization agent, viscosity control agent, con Sulfate (8-10% by weight) serving as an anionic Surfactant, a ditioning agent and a solubilization agent, polysorbate 20 foaming agent and a cleansing agent, and adjusting the pH to (2-5% by weight) serving as a mild foaming agent, a cleans 5-7 by the addition while stirring of solid citric acid (0.01-2% ing agent, an anti-irritant and a solubilizer, polyduaternium by weight). The resulting mixture was heated to 60.degree. C. 10 (0.2-1% by weight) serving as a cationic polymer, condi and stirred until clear. tioner and a viscosity control agent, and sodium lauryl ether 0179 The alcoholic phase was dissolved in the cooled Sulfate (5-15% by weight) serving as an anionic Surfactant, a aqueous phase and the mixture was allowed to stir at room foaming agent and a cleansing agent, and adjusting the pH to temperature until clear. 5-7 by the addition while stirring of solid citric acid (0.01-2% 0180. The mixture was poured into an aluminum aerosol by weight). The resulting mixture was heated to 60.degree. C. spraying canister, a valve was attached to the canister, and stirred until clear. vacuum was applied to the canister and the valve was there 0173 The alcoholic phase was dissolved in the cooled after crimpled, thereby sealing the canister. A hydrocarbon aqueous phase and the mixture was allowed to stir at room propellant mixture was then added and an actuator was temperature until clear. assembled on the valve. US 2011/0008267 A1 Jan. 13, 2011

0181 Table 4 below presents the list of ingredients in 0190. The mixture was poured into an aluminum aerosol Composition 4. spraying canister, a valve was attached to the canister, vacuum was applied to the canister and the valve was there TABLE 4 after crimpled, thereby sealing the canister. A hydrocarbon propellant mixture was then added and an actuator was Percent by assembled on the valve. Weight of Ingredient Assumed Purpose Composition (0191) Table 5 below presents the list of ingredients in Composition 5. Clobetasol active pharmaceutical O.OS propionate ingredient Ethanol Solvent and a preservative 8-10 TABLE 5 Fragrance fragrance O.O1-5 Water base vehicle 70-80 Percent by Trisodium citrate buffer O.3-0.9 Weight of Polysorbate 60 mild foaming agent, a 2-10 Ingredient Assumed Purpose Composition cleansing agent, an anti irritant and a solubilizer Citric acid buffer 1-4 Polyguaternium 10 cationic polymer, O.2-5 Water base vehicle 70-90 conditioner and viscosity Ketoconazole active pharmaceutical 2.1 control agent ingredient Sodium lauryl ether anionic Surfactant, a foaming 8-10 Sodium lauryl ether anionic Surfactant, a foaming S-10 sulfate agent and a cleansing agent Sulfate (Standapol agent and a cleansing agent Citric acid buffer O.O1-2.O ES-2) Hydrocarbon propellant 3-7 Disodium laureth mild foaming agent, a 1-7 propellant SulfoSuccinate cleansing agent and (Stepan mild SL3) detoxifying agent Sodium hydroxide buffer O.S.-1.5 Germall 115 preservative O-O.7 0182. A Wash-Off Mousse Shampoo Containing Keto (imidurea) conazole Composition 5: Edetate disodium chelating agent O-1 0183 Ketoconazole is a broad-spectrum synthetic anti Sodium antioxidant O-1 fungal agent typically administered either orally or topically metabisulfite Tween 20 mild foaming agent, O-5 to treat a variety of systemic and topical fungal infections (polysorbate 20) or cleansing agent, anti-irritant such as candida, blastomycosis, histoplasmosis, coccidiomy Tween 60 and solubilizer cosis and others and as an anti-dandruff agent. (polysorbate 60) 0184 The entire process of preparation of the wash-off Fragrance fragrance O.O1-5 Coconut fatty acid nonionic Surfactant, foam 16-5 mousse shampoo composition containing ketoconazole was diethanol amide boosting and stabilizing carried out at room temperature either at ambient atmosphere (cocamide DEA) agent, viscosity control or under nitrogen. agent, conditioner and solubilizer 0185. Citric acid (1-4% by weight of the total weight of the Crocoate L conditioner and foam 0.1-2 finished composition) was dissolved in purified water (70 (Lauradimonium stabilizer 90% by weight) serving as a base vehicle, and ketoconazole hydroxypropyl (2.1% by weight) was added thereto and stirred until all the hydrolyzed collagen) Hydrocarbon propellant 3-7 ketoconazole was dissolved. propellant 0186 Sodium lauryl ether sulfate (Standapol ES-2) (5-10% by weight) serving as an anionic Surfactant, a foam ing agent and a cleansing agent, and disodium laureth Sulfo 0.192 A Wash-Off Mousse Shampoo Containing Keto succinate (Stepan mild SL3) (1-7% by weight) serving as a conazole Composition 6: mild foaming agent, a cleansing agent and a detoxifying agent (0193 Sodium lauryl ether sulfate (Standapol ES-2) were added to the acidic aqueous Solution and stirred until the (6-15% by weight of the total weight of the finished compo resulting mixture was clear. sition) and disodium laureth Sulfo Succinate (Stepan mild 0187 Sodium hydroxide (0.5-1.5% by weight) was added SL3) (2-7% by weight) were added to half of the total amount to adjust the pH to 5-7, and thereafter Germall 115 (imidurea) of purified water (40-42% by weight), and the resulting mix (0-0.7% by weight) serving as a preservative, edetate di ture was stirred until clear. Sodium (0-1% by weight) serving as a chelating agent and (0194 Sodium hydroxide (0.5-1.5% by weight) was added Sodium metabisulfite (0-1% by weight), serving as an anti to the mixture so as to adjust the pH to 5-7. oxidant, were added and the mixture was stirred until clear. (0195 Citric acid (1-3% by weight) was dissolved in the 0188 Tween 20 (polysorbate 20) or Tween 60 (polysor remaining amount of the purified water (39-42% by weight), bate 60) (0-5% by weight) serving as a mild foaming agent, a and ketoconazole (2.1% by weight) was added thereto and cleansing agent, an anti-irritant and a solubilizer, and a fra stirred until all the ketoconazole was dissolved. The resulting grance (0-4% by weight) were added thereafter to the mixture solution was thereafter added to the pH adjusted mixture and stirred until the mixture was clear. containing the Sodium lauryl ether Sulfate and the disodium 0189 Coconut fatty acid diethanol amide (cocamide laureth SulfoSuccinate, and the combined solutions were DEA) (1.6-5% by weight) serving as a nonionic surfactant, stirred until clear. foam boosting and stabilizing agent, Viscosity control agent, (0196) Germall 115 (imidurea) (0-0.5% by weight), edetate conditioner and solubilizer, and crocoate L (Lauradimonium di Sodium (0-1% by weight) serving as a chelating agent and hydroxypropyl hydrolyzed collagen) (0.1-2% by weight) sodium metabisulfite (0-1% by weight) serving as an antioxi serving as a conditioner and a foam stabilizer, were added to dant, were added thereafter and the mixture was stirred until the mixture and the mixture was stirred until clear. clear. US 2011/0008267 A1 Jan. 13, 2011

0.197 Coconut fatty acid diethanol amide (cocamide construed as an admission that Such reference is available as DEA) (1.6-2% by weight) and crocoate L (Lauradimonium prior art to the present invention. hydroxypropyl hydrolyzed collagen) (0.5-2% by weight) What is claimed is: were added thereafter to the mixture and the mixture was 1. A method for treating a disease or disorder of a skin or stirred until clear. Scalp of a mammal while simultaneously cleansing the skin or 0198 The mixture was poured into an aluminum aerosol Scalp, said method comprising the steps of spraying canister, a valve was attached to the canister, (a) administering to said skin or scalp a mousse formed vacuum was applied to the canister and the valve was there from a composition comprising: after crimpled, thereby sealing the canister. A hydrocarbon (i)atherapeutically or cosmeceutically effective amount propellant mixture was then added and an actuator was of at least one active pharmaceutical ingredient; assembled on the valve. (ii) 10 to 50 percent by weight of a cleansing agent; (0199 Table 6 below presents the list of ingredients in (iii) a pharmaceutically acceptable mousse-forming car Composition 6. rier comprising a propellant, said propellant compris ing 3 to 50 percent by weight of said composition; and TABLE 6 (iv) water comprising about 40 to about 90 percent by weight of said composition; Percent by Weight of (b) waiting a period of time for the active pharmaceutical Ingredient Assumed Purpose Composition ingredient to treat said skin or scalp; and (c) rinsing said skin or scalp with water to remove the Sodium lauryl ether anionic Surfactant, a foaming 6-15 Sulfate (Standapol agent and a cleansing agent OUISS. ES-2) 2. The method of claim 1 wherein said skin or scalp Disodium laureth mild foaming agent, a 2-7 includes a hirsute area. SulfoSuccinate cleansing agent and 3. The method of claim 1 further comprising moistening (Stepan mild SL3) detoxifying agent Water base vehicle 79-84 said skin or scalp with water prior to administering said Sodium hydroxide buffer O.S.-1.5 OUISS. Citric acid buffer 1-3 4. The method of claim 1 wherein said skin or scalp is dry Ketoconazole active pharmaceutical 2.1 prior to said administering step. ingredient Germall 115 preservative O-O.S 5. The method of claim 1 wherein administering said (imidurea) mousse includes spreading said mousse over a portion of said Edetate disodium chelating agent O-1 skin or scalp to be cleansed and treated. Sodium antioxidant O-1 metabisulfite 6. The method of claim 1 wherein said period of time is less Coconut fatty acid nonionic Surfactant, foam 1.6-2 than about 20 minutes. diethanol amide boosting and stabilizing 7. The method of claim 1 wherein said period of time is less (cocamide DEA) agent, viscosity control than about 5 minutes. agent, conditioner and solubilizer 8. The method of claim 1 wherein said disease or disorder Crocoate L conditioner and foam O.5-2 is selected from the group consisting of acne, acne rosacea, (Lauradimonium stabilizer actinic keratoses, actinic porokeratosis, acute inflammatory hydroxypropyl hydrolyzed collagen) diseases, age spots, allergic contact dermatitis, alopecia, Hydrocarbon propellant 3-7 asteatotic eczema, atopic dermatitis, atopic eczema, bacterial propellant infection, BCC, Bowen's disease, burns, chronic hyper trophic lichen planus, chronic Superficial scaling, contact der matitis, cradle cap, cutaneous T-cell lymphoma, cystic acne, 0200. It is appreciated that certain features of the inven dandruff, Darier's disease, dermatitis, dermatitis herpetifor tion, which are, for clarity, described in the context of separate mis, dermatosis, discoid eczema, discoid lupus erythemato embodiments, may also be provided in combination in a Sus, dry skin, eczema, erythrasma, exfoliative keratolysis, single embodiment. Conversely, various features of the folliculitis, fungal infection, juvenile plantar dermatosis, invention, which are, for brevity, described in the context of a granuloma annulare, Grover's disease, hair thinning, ichthy single embodiment, may also be provided separately or in any osiform dermatoses, ichthyosis, impetigo, infantile eczema, suitable subcombination. infection, intertrigo, keratosis, keloid scarsmlichen simplex 0201 Although the invention has been described with ref chronicus, lichen planus, lichen striatus, lupus erythemato erence to specific embodiments thereof, many alternatives, Sus, neurodermatitis, palmar hyperkeratosis, palmoplantar modifications and variations will be apparent to those skilled psoriasis, papularurticaria, parapsoriasis, pediculosis, pella in the art. Accordingly, it is intended that the present invention gra, perifolliculitis, pigmented skin, lesions, pityriasis alba, embrace all Such alternatives, modifications and variations pityriasis lichenoides, pityriasis rosea, pityriasis rubra pilaris, that fall within the spirit and broad scope of the appended pityriasis versicolor, plantar hyperkeratosis, neurodermatitis, claims. pruritis, psoriasis, Reiter's syndrome, rosacea, Seborrhoeic 0202 All publications, patents and patent applications dermatitis, Subacute cutaneous lupus erythematosus, tinea mentioned in this specification are herein incorporated in capitis, Superficial BCC, warts, wound, wrinkles and yeast their entirety by reference into the specification, to the same infections, Malassezia ovalis infections, Malassezia furfur extent as if each individual publication, patent and patent infections, Pityrosporium orbiculare infections and Pity application was specifically and individually indicated to be rosporium ovale infections. incorporated herein by reference. In addition, citation oriden 9. The method of claim 1 wherein said active pharmaceu tification of any reference in this application shall not be tical ingredient is a topical active pharmaceutical ingredient. US 2011/0008267 A1 Jan. 13, 2011

10. The method of claim 1 wherein said active pharmaceu (a) administering to said skin or scalp a mousse formed tical ingredient is selected from the group consisting of active from a composition comprising: herbal extracts, acaricide, age spots and keratoses removing (i)atherapeutically or cosmeceutically effective amount agents, analgesics, local anesthetics, antiacne agents, antiag of corticosteroid; ing agents, antibacterials, antibiotics, antiburn agents, anti (ii) 10 to 50 percent by weight of a cleansing agent; dandruff agents, antidepressants, antidermatitis agents, anti (iii) a pharmaceutically acceptable mousse-forming car edemics, antihistamines, antihelminths, antihyperkeratolyte rier comprising a propellant, said propellant compris agents, anti-inflammatory agents, antiirritants, antilipemics, ing 3 to 7 percent by weight of said composition; and (iv) water comprising about 40 to about 90 percent by antimicrobials, antimycotics, antioxidants, antipruritics, weight of said composition; and agents, antipsoriatic agents, antirosacea, antiseborrheic (b) waiting a period of time for said corticosteroid to treat agents, antiseptic, antiswelling agents, antiviral agents, anti said skin or scalp; and yeast agents, astringents, topical cardiovascular agents, che (c) rinsing said skin or scalp with water to remove the motherapeutics, corticosteroids, fungicides, hair growth mousse; regulators, hormones, hydroxyacids, insecticides, keratolyt wherein said administering step includes passing said com ics, lactams, mitocides, non-steroidal anti-inflammatory position from a first volume having a first pressure agents, pediculicide, progestins, Sanatives, Scabicide, Vasodi through a passage into a second Volume having a second lators and wart removers. pressure, said first pressure being greater than said sec 11. The method of claim 1 wherein said administering step ond pressure, so as to effect foaming of said composition includes passing said composition from a first volume having into the mousse. a first pressure through a passage into a second Volume having 17. The method of claim 16 wherein said corticosteroid a second pressure, said first pressure being greater than said includes clobetasol propionate. second pressure, so as to effect foaming of said composition 18. The method of claim 17 wherein said clobetasol pro to form said mousse. pionate comprises about 0.05 percent by weight of said com 12. The method of claim 1 wherein said cleansing agent position. comprises an anionic Surfactant. 19. The method of claim 16 further comprising moistening 13. The method of claim 12 wherein said cleansing agent said skin or scalp with water prior to administering said OUISS. further comprises a nonionic Surfactant. 20. The method of claim 16 wherein administering said 14. The method of claim 1 wherein said scalp includes hair mousse includes spreading said mousse over a portion of said and said administering of said mousse includes spreading skin or scalp to be cleansed and treated. said mousse through said hair and Scalp. 21. The method of claim 16 wherein said period of time is 15. The method of claim 1 wherein said pharmaceutically less than about 20 minutes. acceptable mousse-forming carrier further comprises an 22. The method of claim 16 wherein said disease or disor emulsifier. deris selected from the group consisting of psoriasis, eczema 16. A method for treating a disease or disorder of a skin or tous dermatitis, and combinations thereof. Scalp of a mammal while simultaneously cleansing the skin or Scalp, said method comprising the steps of c c c c c