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(12) United States Patent (10) Patent No.: US 8,071,075 B2 Reed Et Al

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(12) United States Patent (10) Patent No.: US 8,071,075 B2 Reed Et Al USO08071075B2 (12) United States Patent (10) Patent No.: US 8,071,075 B2 Reed et al. (45) Date of Patent: *Dec. 6, 2011 (54) DERMAL PENETRATION ENHANCERS AND A618/26 (2006.01) DRUG DELIVERY SYSTEMIS INVOLVING A618/02 (2006.01) THE SAME A69/70 (2006.01) (75) Inventors: Barry Leonard Reed, Strathmore (AU); A61N L/30 (2006.01) Timothy Matthias Morgan, Parkville (52) U.S. Cl. .............. 424/47; 424/59: 424/68; 424/401; (AU); Barrie Charles Finnin, Glen Iris 424/449; 604/20 (AU) (58) Field of Classification Search ........................ None See application file for complete search history. (73) Assignee: Acrux DDS Pty Ltd., West Melbourne, Victoria (AU) (56) References Cited (*) Notice: Subject to any disclaimer, the term of this U.S. PATENT DOCUMENTS patent is extended or adjusted under 35 3,989,816 A 11/1976 Rajadhyaksha U.S.C. 154(b) by 758 days. 4,299,826 A 11/1981 Luedders This patent is Subject to a terminal dis (Continued) claimer. FOREIGN PATENT DOCUMENTS (21) Appl. No.: 11/905,926 AU 30258/89 9, 1989 (Continued) (22) Filed: Oct. 5, 2007 OTHER PUBLICATIONS (65) Prior Publication Data “Expert opinion of therapeutic patents' Stella et al., 2004 14(3): US 2008/O152597 A1 Jun. 26, 2008 277-280.* Related U.S. Application Data (Continued) (60) Continuation of application No. 10/759,303, filed on Primary Examiner — Ernst Arnold Jan. 20, 2004, now Pat. No. 7,438,203, which is a continuation-in-part of application No. 09/910,780, Assistant Examiner — Hong Yu filed on Jul. 24, 2001, now Pat. No. 6,818,226, which is (74) Attorney, Agent, or Firm — Foley & Lardner LLP a division of application No. 09/125,436, filed as (57) ABSTRACT application No. PCT/AU97/00091 on Feb. 19, 1997, now Pat. No. 6,299,900. The invention relates to a method for treatment or prophylaxis of a disease or condition in an animal comprising administer (30) Foreign Application Priority Data ing to a mucosal membrane of said animal in need of Such treatment a therapeutically effective amount of a drug deliv Feb. 19, 1996 (AU) ...................................... PN 8144 ery system comprising at least one physiologically active agent or prodrug thereof and at least one penetration enhancer (51) Int. Cl. selected from Safe ester Sunscreens. A6 IK S/37 (2006.01) A6 IK 8/00 (2006.01) 13 Claims, 9 Drawing Sheets US 8,071,075 B2 Page 2 U.S. PATENT DOCUMENTS 2005, 0186141 A1 8, 2005 Gonda et al. 2005, 0196414 A1 9, 2005 Dake et al. 4,310,511 1, 1982 Hollick 2006, O153905 A1 7/2006 Carrara et al. 4,440,777 4, 1984 Zupan 2006/0280783 Al 12/2006 Dipietro et al. 4,557,934 12, 1985 Cooper 2007, 0071803 A1 3, 2007 Reed et al. 4,563,346 1, 1986 Deckner 2007/0077288 A1 4, 2007 Klose et al. 4,663,157 5, 1987 Brock 2007/0275943 Al 1 1/2007 Morgan et al. 4,699,779 10, 1987 Palinczar 2008/O131494 A1* 6/2008 Reed et al. .................... 424/449 4,704,406 11, 1987 Stanisiaus et al. 2010/0322884 A1 12/2010 Di Pietro et al. 4,796,812 1, 1989 Grollier 4,820,724 4, 1989 Nimni FOREIGN PATENT DOCUMENTS 4,824,676 4, 1989 Bodor 4,938.951 7, 1990 Leung et al. AU 49.984, 1990 9, 1989 4,940,586 * 7, 1990 Cheng et al. .................. 424/464 AU A-30258/89 9, 1989 4.946,671 8, 1990 Bissett et al. 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