USO09549898B2 (12) United States Patent (10) Patent No.: US 9,549,898 B2 Tamarkin et al. (45) Date of Patent: *Jan. 24, 2017 (54) OIL AND LIQUID SILICONE FOAMABLE (56) References Cited CARRIERS AND FORMULATIONS U.S. PATENT DOCUMENTS (71) Applicant: Foamix Pharmaceuticals Ltd., 1,159,250 A 11/1915 Moulton Rehovot (IL) 1,666,684 A 4, 1928 Carstens 1924,972 A 8, 1933 Beckert (72) Inventors: Dov Tamarkin, Macabim (IL); Helena 2,085,733. A T. 1937 Bird 2,390,921 A 12, 1945 Clark Shifrin, Rehovot (IL); Rita Keynan, 2,524,590 A 10, 1950 Boe Rehovot (IL); Enbal Ziv, Gedera (IL); 2,586.287 A 2/1952 Apperson Tal Berman, Rishon le Ziyyon (IL); 2,617,754 A 11/1952 Neely 2,767,712 A 10, 1956 Waterman David Schuz, Gimzu (IL); Elana 2.968,628 A 1/1961 Reed Gazal, Rehovot (IL) 3,004,894 A 10/1961 Johnson et al. 3,062,715 A 11/1962 Reese et al. (73) Assignee: Foamix Pharmaceuticals Ltd., 3,067,784. A 12/1962 Gorman Rehovot (IL) 3,092.255. 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A6 IK 9/12 (2006.01) (Continued) A6 IK 45/06 (2006.01) A6 IK 47/24 (2006.01) Primary Examiner — Mina Haghighatian A6 IK3I/65 (2006.01) (74) Attorney, Agent, or Firm — Fish & Richardson P.C. A6 IK 9/00 (2006.01) (57) ABSTRACT A6 IK 47/06 (2006.01) A waterless foamable pharmaceutical composition Suitable A6 IK 47/4 (2006.01) for external administration is disclosed. The composition A6 IK 8/04 (2006.01) includes a foamable carrier least one liquefied or com (52) U.S. Cl. pressed gas propellant. The foamable carrier includes at least CPC ................. A61K 9/12 (2013.01); A61K 8/046 one liquid oil; at least one silicone and at least one least one (2013.01); A61K 9/0014 (2013.01); A61 K stabilizing agent; wherein the stabilizing agent selected from 9/122 (2013.01); A61K 3 1/65 (2013.01); A61 K the group consisting of about 0.01% to about 25% by weight 45/06 (2013.01); A61K 47/06 (2013.01); A61 K of at least one Surface-active agent alone or on combination 47/14 (2013.01); A61K 47/24 (2013.01); YIOS with a foam adjuvant; and about 0% to about 5% by weight 514/871 (2013.01); YIOS 514/945 (2013.01) of at least one polymeric agent alone or on combination with (58) Field of Classification Search a foam adjuvant; and mixtures thereof. Pharmaceutical com CPC ........ A61K 9/12: A61K 9/0014: A61 K 9/122; positions comprising active agents, methods for their prepa A61K 31/65; A61K 47/06; A61K 47/24: ration, propellants suitable for use with the carriers and uses A61K 45/06 thereof are further described. 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