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(12) United States Patent (10) Patent No.: US 9,549,898 B2 Tamarkin Et Al

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(12) United States Patent (10) Patent No.: US 9,549,898 B2 Tamarkin Et Al 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. A 6, 1963 Hohman 3,092,555 A 6, 1963 Horn 3,141,821 A 7, 1964 Compeau (*) Notice: Subject to any disclaimer, the term of this 3,142,420 A 7/1964 Gawthrop patent is extended or adjusted under 35 3,144,386 A 8/1964 Brightenback U.S.C. 154(b) by 0 days. 3,149,543 A 9, 1964 Naab 3,154,075 A 10, 1964 Weckesser This patent is Subject to a terminal dis 3,178,352 A 4, 1965 Erickson claimer. 3,236,457 A 2, 1966 Kennedy et al. 3,244,589 A 4, 1966 Sunnen (21) Appl. No.: 14/504,942 3,252,859 A 5, 1966 Silver (Continued) (22) Filed: Oct. 2, 2014 FOREIGN PATENT DOCUMENTS (65) Prior Publication Data AU 198780257 9, 1986 US 2015/O118164 A1 Apr. 30, 2015 AU 7825.15 12/2005 (Continued) Related U.S. Application Data OTHER PUBLICATIONS (63) Continuation of application No. 12/795,213, filed on U.S. Appl. No. 60/815.948, filed Jun. 23, 2006, Tamarkin. Jun. 7, 2010, now Pat. No. 8,900,553, which is a Abrams et al., "Ciclopirox gel treatment of scalp Seborrheic der continuation of application No. PCT/IB2008/003939, matitis.” Hydroxy-Piridones as Antifungal Agents with Special filed on Dec. 8, 2008. Emphasis on Onychomycosis, 1999, Chapter 8, 45-50. Adachi. “Storage and Oxidative Stability of O.W. Nano-emul sions.” Foods Food Ingredients, J. Jpn., 2004, 29(11), 1 page. Adisen et al. “Topical tetracycline in the treatment of acne Vulgaris.” (60) Provisional application No. 61/012.414, filed on Dec. J Drugs Dermatol., 2008, 7.953-5. 7, 2007, provisional application No. 61/103,500, filed Alcohol SDA 40B, http://www.pharmco-prod.com/pages/MSDS/ on Oct. 7, 2008. SDS. Sub.--40B. Sub.--200.pdf, accessed Dec. 9, 2008, 2 pages. Alcohol, Wikipedia, the free encyclopedia, retrieved on May 17, (51) Int. Cl. 2014. http://en.wikipedia.org/wiki/Alcohol. 17 pages. 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. See application file for complete search history. 27 Claims, 1 Drawing Sheet US 9,549,898 B2 Page 2 (56) References Cited 4,230,701 10, 1980 Holick et al. 4,241,048 12, 1980 Durbak et al. 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