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WO 2009/032325 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date PCT (10) International Publication Number 12 March 2009 (12.03.2009) WO 2009/032325 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every CUB 9/00 (2006.01) A61Q 13/00 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT,AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, (21) International Application Number: CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, PCT/US2008/010459 EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, (22) International Filing Date: LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, 8 September 2008 (08.09.2008) MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, (25) Filing Language: English RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY,TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (26) Publication Language: English ZW (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 60/967,850 6 September 2007 (06.09.2007) US kind of regional protection available): ARIPO (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, (71) Applicant: FLOW SCIENCE, INC. [US/US]; 76 Brook- ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), side Drive, New Providence, NJ 07974 (US). European (AT,BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, (72) Inventors: BRAGINSKY, Philip; 100-17 67th Dr., For FR, GB, GR, HR, HU, IE, IS, IT, LT,LU, LV,MC, MT, NL, est Hills, NY 11375 (US). MARENBERG, Barry, J.; 76 NO, PL, PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, Brookside Drive, New Providence, NJ 07974 (US). CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). (74) Agent: MARENBERG, Barry, J.; 76 Brookside Drive, Published: New Providence, NJ 07974 (US). — with international search report (54) Title: SHAPED ITEMS CONTAINING A HUMAN PHEROMONE COMPONENT (57) Abstract: Methods are disclosed for preparing shaped articles for application to skin and which may contain active and inactive substances including pheromones comprising skeletal-forming agents that are both protein and non-protein based. These shaped articles should exhibit sufficient cohesion, that is to say, mechanical strength, should dissolve readily in the course of application on the skin, and should result in a pleasant application sensation. Moreover, besides pheromones, these shaped articles should be suitable to receive various active substances, such as, in particular, cosmetic active substances and therapeutic or pharmaceutical active substances, and to act as carriers for such substances. The shaped articles may be applied to the dermis or hair of a subject or internally. SHAPED ITEMS CONTAINING A HUMAN PHEROMONE COMPONENT Related Applications This application claims the benefit of U.S. Provisional Application No. 60/967,850, filed September 6, 2007. Field of the Invention The invention relates to a process for the manufacture porous and/or sponge-like shaped articles containing a human pheromone component, as well as to the shaped articles available thereafter and their use. Background and Summary Pheromones Pheromones are chemicals emitted by living organisms to send messages to individuals of the same species. The classes most widely explored are the sex pheromones produced by female moths which are used to attract conspecif ϊc males for mating. Bombykol, the sex pheromone of the silkmoth, was first synthesized in 1959. Most pheromones consist of blends of two or more chemicals which need to be emitted at exactly the right proportions to be biologically active. The female effluvia or sex gland can contain additional compounds which are related to the pheromone components and whose biological function is often unclear. On the other hand, many attractants of male moths have been discovered simply by field screening, hi several cases it could later be shown that the attractant found with this technique was identical to the natural pheromone produced by the female hi most others, the composition of the true pheromone is still unknown. While it is known that pheromone systems exist in insects, an increasing number of studies have shown that pheromones play a role in many species, including humans. Pheromones in humans are believed to be produced by the apocrine glands. These glands become functional after reaching puberty, which could explain why most people develop an attraction for others at that time. Pheromones could also be the reason why a person can sense "chemistry", or feel an instant attraction or dislike when first meeting someone. Certain compounds believed to have pheromone properties affect a specific behavioral or physiological response in human subjects, e.g., a reduction of negative affect, mood, and character traits. In one particular example, nasal administration provides for contacting neurochemical receptors of a heretofore poorly understood neuroendocrine structure, commonly known as the vomeronasal organ ("VNO); also known as "Jacobson's organ"), with one or more steroid(s) or with compositions containing the steroid(s). This organ is accessed through the nostrils of most higher animals—from snakes to humans, and has been associated, inter alia, with pheromone reception in certain species (see generally Muller-Schwarze & Silverstein, Chemical Signals, Plenum Press, New York (1980)). The axons of the neuroepithelia of the vomeronasal organ, located supra palatinal, form the vomeronasal nerve and have direct synaptic connection to the accessory olfactory bulb and indirect input from there to the cortico-medial amygdaloid basal forebrain and hypothalamic nuclei of the brain. The distal axons of terminalis nerve neurons may also serve as neurochemical receptors in the VNO. Stensaas, L. J., et al., J. Steroid Biochem. and Molec. Biol. (1991) 39:553. This nerve has direct synaptic connection with the hypothalamus. The present invention comprises external application of shaped articles containing active and inactive substances including pheromones comprising skeletal-forming agents that are both protein and non-protein based. These shaped articles should exhibit sufficient cohesion, that is to say, mechanical strength, may dissolve readily in the course of application on the skin, and should result in a pleasant application sensation. Moreover, besides pheromones, these shaped articles should be suitable to receive various active substances, such as, in particular, cosmetic active substances and therapeutic or pharmaceutical active substances, and to act as carriers for such substances. The shaped articles may be applied to the dermis or hair of a subject. The invention consequently provides the use of a shaped article containing at least one skeletal-forming agent, optionally one or more pheromones, optionally one or more active substances and also optionally one or more auxiliary substances for the purpose of external application. A "shaped article" in the sense of the invention is to be understood to mean any shaped body; for example, in particular, polygons, spheres, cuboids, pyramids, stars, but also shaped articles modeled on natural shapes, such as, for example, those in the form of animals such as, for example, marine animals such as starfish, plants and parts of plants, such as leaves etc., as well as shapes to conform to human body parts such as, forehead, lips, nose, chin, cheeks, arms, legs, hands, feet and back. All these shapes and others are available in accordance with the process for producing the shaped articles that are used in accordance with the invention, which is described further below. A plurality of the stated shaped articles in a container is also encompassed in accordance with the invention. It may also be a question of mixtures of shaped articles having various geometries. The shaped articles may be individually packed. However, particularly in the cosmetic application, a plurality of the shaped articles are preferably present in a container, in contact alongside one another. The volumes of the shaped articles that are used are not restricted as such by reason of the process for their production. The volumes expediently amount to at least approximately 0.1 cm , preferably 0.3 cm , more preferably at least approximately 0.5 cm , still more preferably at least approximately 0.8 cm'. The volumes that are used are expediently restricted in the upward direction to up to approximately 6 cm , preferably up to approximately 5 cm , more preferably up to approximately 4 cm . The size of the shaped articles is determined, inter alia, by the site of external application of the shaped articles. For instance, application on relatively large areas of the body or on the hair (for example, direct application of the moistened shaped articles on the back etc., or use as a bath additive) makes the use of relatively large shaped articles possible, whereas smaller shaped articles are preferred in the case of application on smaller parts of the body (for example, the cheek etc.). Alginate Containing Porous Articles It is known that alkali alginates such as sodium alginate are water-soluble, whereas earth- alkaline alginates such as calcium alginates are insoluble in water. Thus, thin water-insoluble layers can be produced, for example, by spraying a thin sodium alginate film with a CaCl2 solution. Also, if manufacture of thicker layers is intended, difficulties arise from the fact that the homogeneous incorporation of free calcium ions into a sodium alginate solution is made difficult by the large increase of the solution's viscosity, so that disjointed calcium alginate agglomerates are the result instead of uniform products. While this is not the preferred method of manufacture, it is a method provided for in the present invention.
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