US009101662B2  c12)  United States Patent  Tamarkin et al.  (54)  COMPOSITIONS WITH MODULATING  AGENTS  (IO)  Patent No.:  US 9,101,662 B2  (45)  Date of Patent:  *  Aug. 11, 2015  A61K  47132  (2013.01);  A61K 9/0014  (2013.01);  A61K 9/0031  (2013.01);  A61K 9/0034  (2013.01);  A61K 9/0043  (2013.01);  A61K  9/0046  (2013.01);  A61K 9/0048  (2013.01);  A61K 9/0056  (2013.01)  (71)  Applicant:  Foamix Pharmaceuticals Ltd.,  Rehovot  (IL)  (72)  Inventors:  Dov Tamarkin,  Macabim (IL);  Meir  Eini,  Ness Ziona (IL);  Doron Friedman,  Karmei Yosef (IL);  Tai Berman,  Rishon  le Ziyyon (IL);  David Schuz,  Gimzu (IL)  (73)  Assignee:  Foamix Pharmaceuticals Ltd.,  Rehovot  (IL)  ( *)  Notice:  Subject to any disclaimer, the term ofthis  patent is extended or adjusted under 35  U.S.C. 154(b) by  O  days.  This patent is subject to a terminal dis› claimer.  (21)  Appl. No.:  14/045,528  (22)  Filed:  Oct. 3, 2013  (65)  Prior Publication Data  US 2015/0017103 Al  Jan. 15, 2015  Related U.S. Application Data  (63)  Continuation of application No. 11/947,751, filed on  Nov. 29, 2007, now Pat. No. 8,795,693, which is a  continuation-in-part of application No. 10/835,505,  filed on Apr. 28, 2004, now Pat. No. 7,820,145, and a  continuation-in-part of application No. 11/430,599,  filed on May 9, 2006, now Pat. No. 7,704,518.  (60)  Provisional application No. 60/530,015, filed on Dec.  16, 2003, provisional application No. 60/492,385,  filed on Aug. 4, 2003, provisional application No.  60/784,793, filed on Mar. 21, 2006, provisional  application No. 60/679,020, filed on May 9, 2005,  provisional application No. 60/861,620, filed on Nov.  29, 2006.  (51)  Int. Cl.  A61K9/00  A61K  47100  A61K  47112  A61K  311573  A61K 311593  A61K 31/341  A61K 31/167  A61K  47118  A61K9/12  A61K  311375  A61K  47126  A61K  47132  (2006.01)  (2006.01)  (2006.01)  (2006.01)  (2006.01)  (2006.01)  (2006.01)  (2006.01)  (2006.01)  (2006.01)  (2006.01)  (2006.01)  (52)  U.S. Cl.  CPC .................  A61K  47112  (2013.01);  A61K  91122  (2013.01);  A61K 31/167  (2013.01);  A61K  31/341  (2013.01);  A61K  311375  (2013.01);  A61K  311573  (2013.01);  A61K  311593  (2013.01);  A61K  47118  (2013.01);  A61K  471183  (2013.01);  A61K  47126  (2013.01);  (58)  Field of Classification Search  CPC ........................................................ A61K 9/12  See application file for complete search history.  (56)  References Cited  U.S. PATENT DOCUMENTS  1,159,250 A  11/1915 Moulton  1,666,684  A  4/1928 Carstens  1,924,972 A  8/1933 Beckert  2,085,733  A  7/1937 Bird  2,390,921  A  12/1945 Clark  2,524,590  A  10/1950 Boe  2,586,287  A  2/1952 Apperson  2,617,754 A  11/1952 Neely  2,767,712  A  10/1956 Waterman  2,968,628  A  1/1961 Reed  3,004,894  A  10/1961 Johnson et al.  3,062,715  A  11/1962 Reese et al.  3,067,784  A  12/1962 Gorman  3,092,255  A  6/1963 Hohman  3,092,555  A  6/1963 Horn  3,141,821 A  7/1964 Compeau  3,142,420 A  7/1964 Gawthrop  3,144,386 A  8/1964 Brightenback  (Continued)  FOREIGN PATENT DOCUMENTS  OTHER PUBLICATIONS  (Continued)  AU  198780257  9/1986  AU  782515  12/2005  AU  2010219295  9/2012  CA  2154438  1/1996  CA  2422244  9/2003  U.S. Appl. No. 60/789,186, filed Apr. 4, 2006, Tarnarkin.  U.S. Appl. No. 60/815,948, filed Jun. 23, 2006, Tarnarkin.  U.S. Appl. No. 60/818,634, filed Jul. 5, 2006, Friedman.  U.S. Appl. No. 60/843,140, filed Sep. 8, 2006, Tarnarkin.  U.S. Appl. No. 61/248,144, filed Oct. 2, 2009, Tarnarkin.  (Continued)  Primary Examiner  - Robert A Wax  Assistant Examiner  - Melissa Mercier  (74)  Attorney, Agent, or Firm  - Fish & Richardson P.C.  (57)  ABSTRACT  The present invention relates to a waterless composition and  foam as a vehicle in which an active pharmaceutical or cos› metic agent, when added is stable or stabilized by or its  destabilization is impeded by the presence of a modulating  agent. The pharmaceutical or cosmetic composition and  foam, includes: a waterless solvent, a modulating agent and  one or more active pharmaceutical or cosmetic agents. The  present invention also relates to a method of treatment admin› istering the waterless composition and foam.  46 Claims, No Drawings 