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.