111111111111111111111111111111111111111111111111111111111111111111111111 (12) United States Patent (lo) Patent No.: US 8,480,637 B2 Ferrari et al. (45) Date of Patent : Jul. 9, 2013 (54) NANOCHANNELED DEVICE AND RELATED USPC .................. 604/264; 907/700, 902, 904, 906 METHODS See application file for complete search history. (75) Inventors: Mauro Ferrari, Houston, TX (US); (56) References Cited Xuewu Liu, Sugar Land, TX (US); Alessandro Grattoni, Houston, TX U.S. PATENT DOCUMENTS (US); Daniel Fine, Austin, TX (US); 5,651,900 A 7/1997 Keller et al . .................... 216/56 Randy Goodall, Austin, TX (US); 5,728,396 A 3/1998 Peery et al . ................... 424/422 Sharath Hosali, Austin, TX (US); Ryan 5,770,076 A 6/1998 Chu et al ....................... 210/490 5,798,042 A 8/1998 Chu et al ....................... 210/490 Medema, Pflugerville, TX (US); Lee 5,893,974 A 4/1999 Keller et al . .................. 510/483 Hudson, Elgin, TX (US) 5,938,923 A 8/1999 Tu et al . ........................ 210/490 5,948,255 A * 9/1999 Keller et al . ............. 210/321.84 (73) Assignees: The Board of Regents of the University 5,985,164 A 11/1999 Chu et al ......................... 516/41 of Texas System, Austin, TX (US); The 5,985,328 A 11/1999 Chu et al ....................... 424/489 Ohio State University Research (Continued) Foundation, Columbus, OH (US) FOREIGN PATENT DOCUMENTS (*) Notice: Subject to any disclaimer, the term of this WO WO 2004/036623 4/2004 WO WO 2006/113860 10/2006 patent is extended or adjusted under 35 WO WO 2009/149362 12/2009 U.S.C. 154(b) by 612 days. OTHER PUBLICATIONS (21) Appl. No.: 12/618,233 "Under the Counter: The Diversion and Abuse of Controlled Pre- scription Drugs in the US," The National Center on Addiction and (22) Filed: Nov. 13, 2009 Substance Abuse (CASA) at Columbia University, New York, NY, CASA, Jul. 2005. (65) Prior Publication Data (Continued) US 2010/0152699 Al Jun. 17, 2010 Primary Examiner Manuel Mendez Related U.S. Application Data Assistant Examiner Gerald Landry, II (74) Attorney, Agent, or Firm Parker Highlander PLLC (60) Provisional application No. 61/114,687, filed on Nov. 14, 2008, provisional application No. 61/168,844, (57) ABSTRACT filed on Apr. 13, 2009. A nanochannel delivery device and method of manufacturing (51) Int. Cl. and use. The nanochannel delivery device comprises an inlet, an outlet, and a nanochannel. The nanochannel may be ori- A61M25100 (2006.01) ented parallel to the primary plane of the nanochannel deliv- (52) U.S. Cl. ery device. The inlet and outlet may be in direct fluid com- USPC ............................................. 604/264; 604/43 munication with the nanochannel. (58) Field of Classification Search CPC ....................................................... B82Y 40/00 15 Claims, 35 Drawing Sheets 280 /~ 270 210 US 8,480,637 B2 Page 2 U.S. PATENT DOCUMENTS Nath et al., `Buprenorphine pharmacokinetics: relative bioavail- ability of sublingual tablet and liquid formulations," J. Clin. 6,044,981 A 4/2000 Chu et al ....................... 210/490 Pharmacol., 39:619-623, 1999. 7,025,871 132 4/2006 Broadley et al ............... 205/793 Report Stakeholder Workshop on a National Buprenorphine Program 7,135,144 132 * 11/2006 Christel et al ................. 422/527 Health Canada Nov. 18, 2004. 7,326,561 132 2/2008 Goodman et al. ......... 435/286.5 Samhsa, "Overview of Findings from the 2002 National Survey on 2004/0011647 Al * 1/2004 Broadley et al ............... 204/435 2004/0116905 Al 6/2004 Pedersen et al............ 604/890.1 Drug Use and Health," Rockville, MD, DHHS publication, SMA 2004/0260418 Al * 12/2004 Staats ............................. 700/97 03-3774. 2006/0180469 Al* 8/2006 Han et al ....................... 204/601 Samhsa, "Results from the 2003 National Survey on Drug Use and 2007/0066138 Al 3/2007 Ferrari et al . ............ 439/607.01 Health: National Findings," Rockeville, MD, DHHS publication, 2007/0077273 Al* 4/2007 Martin et al . ................. 424/423 S.MA 04-3964. 2008/0073506 Al* 3/2008 Lazar ............................ 250/288 Samhsa, "The DAWN Report: oxycodaone, hydrocodone, and 2 009/02 143 92 Al* 8/2009 Kameoka et al . ............. 422/102 polydrug use," 2002. Jul. 2004 http://oas.samhsa.gov/2k4/ oxycodone/oxycodone.cfm. OTHER PUBLICATIONS Extended European Search Report issued in European Application No. 09826831, mailed Jul. 12, 2012. "The Economic Costs of Drug Abuse in the United States," www. whitehousedrugpolicy.gov, Sep. 2001. * cited by examiner U.S. Patent Jul. 9, 2013 Sheet 1 of 35 US 8,480,637 B2 hi' lli t o p Q1 j 11i 11 _ j 'r';1 1 I i l am p l f Ali all CQ cs CQ cz iz TZ r ll '"! W I ~ illrl l' ~ 'lil A'~ i1I~1~1~~j fir I,i ~ ,llrli Pi l l 11,11ii 1i 1~ il i i cm lri + i r li lr I ' i(r ,11'iir' I ~ ~~l i iii I II ccs t 'illli` ~11 ZZ rirr if'rrr ~~( iz I~~ r1 i iii rii i ~ 1 W t'rriM ~ ~ r i III O i i7 ~Y1'~~ ' ' i r'''iii lil Ii l+ ~ 'i I ~~1 1 l'I ri WN, ' i 'IT 11 11 1~ 1I ~ l4 N 1 I i i l~ l, L, 1, H'I IN! 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U.S. Patent Jul. 9, 2013 Sheet 6 of 35 US 8,480,637 B2 AE 26 *"-40 FIG. 3D U.S. Patent Jul. 9, 2013 Sheet 7 of 35 US 8,480,637 B2 20 "`- 40 FIG. 3E 20 FIG. 3F U.S. Patent Jul. 9, 2013 Sheet 8 of 35 US 8,480,637 B2 FIG. 3G U.S. Patent Jul. 9, 2013 Sheet 9 of 35 US 8,480,637 B2 i 11.'I llil'I r ±ri i 1iI Il I I i Il i I~ 111„ i i l ~ lll !I 'Iilllli'!i u lir ' II i l i it 'i; II VIII ~ illll i~ Iri 1 ~l'III 'il illi'r 1' ~ !iil, ~"!fi l l rii ri , ~ I i r r l+ril, Iri I r!I I r 'II ty, Ilh1I0lil'Ili ~ ' ril ~+i r r Ir i"I ii r r r ,rl!Irl r r Iii ~ ! 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