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(12) United States Patent (10) Patent No.: US 9,101,662 B2 Tamarkin Et Al

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(12) United States Patent (10) Patent No.: US 9,101,662 B2 Tamarkin Et Al USOO91 01662B2 (12) United States Patent (10) Patent No.: US 9,101,662 B2 Tamarkin et al. (45) Date of Patent: *Aug. 11, 2015 (54) COMPOSITIONS WITH MODULATING A61K 47/32 (2013.01); A61 K9/0014 (2013.01); AGENTS A61 K9/0031 (2013.01); A61 K9/0034 (2013.01); A61 K9/0043 (2013.01); A61 K (71) Applicant: Foamix Pharmaceuticals Ltd., Rehovot 9/0046 (2013.01); A61 K9/0048 (2013.01); (IL) A61 K9/0056 (2013.01) (72) Inventors: Dov Tamarkin, Macabim (IL); Meir (58) Field of Classification Search Eini, Ness Ziona (IL); Doron Friedman, CPC ........................................................ A61 K9/12 Karmei Yosef (IL); Tal Berman, Rishon See application file for complete search history. le Ziyyon (IL); David Schuz, Gimzu (IL) (56) References Cited (73) Assignee: Foamix Pharmaceuticals Ltd., Rehovot U.S. PATENT DOCUMENTS (IL) 1,159,250 A 11/1915 Moulton (*) Notice: Subject to any disclaimer, the term of this 1,666,684 A 4, 1928 Carstens patent is extended or adjusted under 35 1924,972 A 8, 1933 Beckert 2,085,733. A T. 1937 Bird U.S.C. 154(b) by 0 days. 2,390,921 A 12, 1945 Clark This patent is Subject to a terminal dis 2,524,590 A 10, 1950 Boe claimer. 2,586.287 A 2/1952 Apperson 2,617,754 A 1 1/1952 Neely 2,767,712 A 10, 1956 Waterman (21) Appl. No.: 14/045,528 2.968,628 A 1/1961 Reed 3,004,894 A 10/1961 Johnson et al. (22) Filed: Oct. 3, 2013 3,062,715 A 11/1962 Reese et al. 3,067,784. A 12/1962 Gorman (65) Prior Publication Data 3,092.255. A 6, 1963 Hohman 3,092,555 A 6, 1963 Horn US 2015/OO17103 A1 Jan. 15, 2015 3,141,821 A 7, 1964 Compeau 3,142,420 A 7/1964 Gawthrop Related U.S. Application Data 3,144,386 A 8/1964 Brightenback (Continued) (63) Continuation of application No. 1 1/947,751, filed on Nov. 29, 2007, now Pat. No. 8,795,693, which is a FOREIGN PATENT DOCUMENTS continuation-in-part of application No. 10/835,505, filed on Apr. 28, 2004, now Pat. No. 7,820,145, and a AU 19878O257 9, 1986 continuation-in-part of application No. 1 1/430,599, AU 7825.15 12/2005 AU 2010219295 9, 2012 filed on May 9, 2006, now Pat. No. 7,704,518. CA 21544.38 1, 1996 (60) Provisional application No. 60/530,015, filed on Dec. CA 2422244 9, 2003 16, 2003, provisional application No. 60/492.385, (Continued) filed on Aug. 4, 2003, provisional application No. 60/784,793, filed on Mar. 21, 2006, provisional OTHER PUBLICATIONS application No. 60/679,020, filed on May 9, 2005, U.S. Appl. No. 60/789, 186, filed Apr. 4, 2006, Tamarkin. provisional application No. 60/861,620, filed on Nov. U.S. Appl. No. 60/815,948, filed Jun. 23, 2006, Tamarkin. 29, 2006. U.S. Appl. No. 60/818,634, filed Jul. 5, 2006, Friedman. U.S. Appl. No. 60/843,140, filed Sep. 8, 2006, Tamarkin. (51) Int. Cl. U.S. Appl. No. 61/248,144, filed Oct. 2, 2009, Tamarkin. A6 IK9/00 (2006.01) A6 IK 47/00 (2006.01) (Continued) A6 IK 47/12 (2006.01) A 6LX3/573 (2006.01) Primary Examiner — Robert A Wax A 6LX3/593 (2006.01) Assistant Examiner — Melissa Mercier A6 IK3I/34 (2006.01) (74) Attorney, Agent, or Firm — Fish & Richardson P.C. A6 IK3I/67 (2006.01) A6 IK 47/8 (2006.01) (57) ABSTRACT A6 IK 9/12 (2006.01) The present invention relates to a waterless composition and A 6LX3L/375 (2006.01) foam as a vehicle in which an active pharmaceutical or cos A6 IK 47/26 (2006.01) metic agent, when added is stable or stabilized by or its A6 IK 47/32 (2006.01) destabilization is impeded by the presence of a modulating (52) U.S. Cl. agent. The pharmaceutical or cosmetic composition and CPC ................. A61K 47/12 (2013.01); A61 K9/122 foam, includes: a waterless solvent, a modulating agent and (2013.01); A61 K3I/I67 (2013.01); A61 K one or more active pharmaceutical or cosmetic agents. The 31/341 (2013.01); A61 K3I/375 (2013.01); present invention also relates to a method of treatment admin A61 K3I/573 (2013.01); A61 K3I/593 istering the waterless composition and foam. (2013.01); A61 K47/18 (2013.01); A61 K 47/183 (2013.01); A61K 47/26 (2013.01); 46 Claims, No Drawings US 9,101,662 B2 Page 2 (56) References Cited 4,226,344 10, 1980 Booth et al. 4,229.432 10, 1980 Geria U.S. PATENT DOCUMENTS 4,230,701 10, 1980 Holick et al. 4,241,048 12, 1980 Durbak et al. 3,149,543 9, 1964 Naab 4,241,149 12, 1980 Labes et al. 3,154,075 10, 1964 Weckesser 4,252,787 2, 1981 Sherman et al. 3,178,352 4, 1965 Erickson 4,254,104 3, 1981 Suzuki et al. 3,236.457 2, 1966 Kennedy et al. 4,268,499 5, 1981 Keil 3,244,589 4, 1966 Sunnen 4,271,149 6, 1981 Winicov et al. 3,252,859 5, 1966 Silver 4.278,206 T. 1981 Prussin 3,261,695 T. 1966 Sienkiewicz 4,292.250 9, 1981 DeLuca et al. 3,263,867 8, 1966 Lehmann 4,292,326 9, 1981 Nazzaro-Porro et al. 3,263,869 8, 1966 Corsette 4,299,826 11, 1981 Luedders 3,298.919 1, 1967 Bishop et al. 4,305,936 12, 1981 Klein 3,301.444 1, 1967 Wittke 4,309,995 1, 1982 Sacco 3,303,970 2, 1967 Breslau et al. 4,310,510 1, 1982 Sherman et al. 3,330,730 7, 1967 Hernandez 4.323,582 4, 1982 Siegel et al. 3,333,333 8, 1967 Noack 4.323,694 4, 1982 Scala, Jr. 3,334,147 8, 1967 Brunelle et al. 4.325,939 4, 1982 Shah 3,346,451 10, 1967 Collins et al. 4.329,990 5, 1982 Sneider 3,366,494 1, 1968 Bower et al. 4,335,120 6, 1982 Holick et al. 3,369,034 2, 1968 Chalmers 4,352,808 10, 1982 Rane et al. 3,377,004 4, 1968 Wittke 4.385, 161 5, 1983 Caunt et al. 3,384.541 5, 1968 Clark et al. 4,386,104 5, 1983 Nazzaro-Porro 3,395,214 T. 1968 Mummert 4,393,066 T. 1983 Garrett et al. 3,395,215 T. 1968 Schubert 4.427,670 1, 1984 Ofuchi et al. 3,401,849 9, 1968 Weber, III 4,439,416 3, 1984 Cordon et al. 3.419,658 12, 1968 Sanders 4,439,441 3, 1984 Hallesy et al. 3.456,052 T. 1969 Gordon 4,440,320 4, 1984 Wernicke 3,527.559 9, 1970 Sliwinski 4,447,486 5, 1984 Hoppe et al. 3,540,448 11, 1970 Sunnen 4,469,674 9, 1984 Shah et al. 3,559,890 2, 1971 Brooks et al. 4,508,705 4, 1985 Chaudhuri et al. 3,561,262 2, 1971 Borucki 4,522,948 6, 1985 Walker 3,563,098 2, 1971 Weber, III 4,529,601 7, 1985 Broberg et al. 3,574,821 4, 1971 Pfirrmann 4,529,605 7, 1985 Lynch et al. 3,577,518 5, 1971 Shepherd 4.552,872 11, 1985 Cooper et al. 3,667,461 6, 1972 Zamarra 4,574,052 3, 1986 Gupte et al. 3,751,562 8, 1973 Nichols 4,576,961 3, 1986 Lorck et al. 3,770,648 11, 1973 Mackles 4.595,526 6, 1986 Lai 3,787,566 1, 1974 Gauvreau 4,603,812 8, 1986 Stoesser et al. 3,819,524 6, 1974 Schubert et al. 4,627,973 12, 1986 Moran et al. 3,824.303 7, 1974 Lanzet et al. 4,628,063 12, 1986 Haines et al. 3,841,525 10, 1974 Siegel 4,661.524 4, 1987 Thomson et al. 3,849,580 11, 1974 Weinstein et al. 4,672,078 6, 1987 Sakai et al. 3,865,275 2, 1975 De Nunzio 4,673,569 6, 1987 Shernov et al. 3,866,800 2, 1975 Schmitt 4,678.463 7, 1987 Millar 3,878,118 4, 1975 Watson 4,701,320 10, 1987 Hasegawa et al. 3,882,228 5, 1975 Boncey et al. 4,725,609 2, 1988 Kull, Jr. et al. 3,886,084 5, 1975 Vassiliades 4,738,396 4, 1988 Doi et al. 3,890,305 6, 1975 Weber et al. 4,741,855 5, 1988 Grote et al. 3,912,665 10, 1975 Spitzer et al. 4,752.465 6, 1988 Mackles 3,912,667 10, 1975 Spitzer et al. 4,770,634 9, 1988 Pellico 3,923,970 12, 1975 Breuer 4,772.427 9, 1988 Dawson 3,929,985 12, 1975 Webb, Jr. 4,780.309 10, 1988 Geria et al. 3,952,916 4, 1976 Phillips 4,784.842 11, 1988 London et al. 3,959,160 5, 1976 Horsler et al. 4,792,062 12, 1988 Goncalves 3,962,150 6, 1976 Viola 4,798,682 1, 1989 Ansmann 3,963,833 6, 1976 DeSalva et al. 4,804.674 2, 1989 Curtis-Prior et al. 3,966,090 6, 1976 Prussin et al. 4,806,262 2, 1989 Snyder 3,966,632 6, 1976 Colliopoulos et al. 4,808,388 2, 1989 Beutler et al.
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