USOO8480637B2 (12) United States Patent (10) 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 379.83- w A SE us 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 1 1/1999 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 W W 38E. d38 past list: listed under 35 W. Wooyo 12/2009 M YW- y to 12 dayaWS. OTHER PUBLICATIONS (21) Appl. No.: 12/618,233 “Under the Counter: The Diversion and Abuse of Controlled Pre 1-1. 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. (65) Prior Publication Data CASA, Jul. 2005. US 2010/0152699 A1 Jun. 17, 2010 (Continued) Primary Examiner — Manuel Mendez Related U.S. Application Data Assistant Examiner — Gerald Landry, II (60) Provisional application No. 61/114,687, filed on Nov. (74) Attorney, Agent, or Firm — Parker Highlander PLLC 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, A. iM 25/00 (2006.01) an outlet, and a nanochannel. The nanochannel may be ori (52) U.S. Cl ented parallel to the primary plane of the nanochannel deliv USPG 604/264: 604/43 ery device. The inlet and outlet may be in direct fluid com (58) Field of- -Classification - - - - - - - - - - - - - - - - - - - - - - - Search- - - - - - - - - - - - - - - - - - - - s U1Ca1OW1icati ith th aOClaeh 1. CPC ....................................................... B82Y 4O/OO 15 Claims, 35 Drawing Sheets US 8,480,637 B2 Page 2 U.S. PATENT DOCUMENTS Nath et al., “Buprenorphine pharmacokinetics: relative bioavail 6,044,981 4, 2000 Chu et al. ...................... 210,490 ability of Sublingual tablet and liquid formulations.” J. Clin. 7,025,871 4, 2006 Broadley et al. 205,793 Pharmacol. 39:619-623, 1999. 7,135,144 11, 2006 Christel et al. ..... 422,527 Report Stakeholder Workshop on a National Buprenorphine Program 7,326,561 2, 2008 Goodman et al. 435/286.5 Health Canada Nov. 18, 2004. 2004.0011647 1, 2004 Broadley et al. ... ... 204,435 Samhsa, "Overview of Findings from the 2002 National Survey on 2004/O116905 6, 2004 Pedersen et al. 604/890.1 Drug Use and Health.” Rockville, MD, DHHS publication, SMA 2004/0260418 12, 2004 Staats ......... 7OO/97 O3-3774. 2006, O180469 8, 2006 Han et al. .... ... 204f601 Samhsa, “Results from the 2003 National Survey on Drug Use and 2007/0066138 3, 2007 Ferrari et al. ... 439,607.01 Health: National Findings.” Rockeville, MD, DHHS publication, 2007/OO77273 4, 2007 Martin et al. ... 424/423 S.MA 04-3964. 2008.OO73506 3, 2008 Lazar ............. 250/288 Samhsa, “The DAWN Report: Oxycodaone, hydrocodone, and 2009/0214392 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 U.S. Patent Jul. 9, 2013 Sheet 3 Of 35 US 8,480,637 B2 FIG. 20 FIG. 2D U.S. Patent Jul. 9, 2013 Sheet 5 Of 35 US 8,480,637 B2 Ø FIG. 3B // .//…***~~~~).... U.S. Patent Jul. 9, 2013 Sheet 6 of 35 US 8,480,637 B2 FIG. 3D U.S. Patent Jul. 9, 2013 Sheet 7 Of 35 US 8,480,637 B2 FIG. 3E S /// (/. 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 U.S. Patent Jul. 9, 2013 Sheet 10 Of 35 US 8,480,637 B2 N N SN • ---x^^ 3- ------- ------- --/-)-2-// 2 ii if 11161, 1% ^ % 1, -----: 1444 u-220 2.3 3. 3--------- a. --- 2. 2. - If I i 3333222222222222222232 -: --. 1. 2. 33.a--- - 3 3.^x. 2. 262. % 32 23,22. 3 2--- 32. 23 s%3. -3 3 2 3 32. 3.33 2. 22- 2. 32 3 2. - × - × 32 23 23. 3 3 333 3 2. 332. 3 2. 222222222222223. 2 33.33 3.a. 2 22. --------------- --- M 32222222 3- ---. ----- . - 2 3 W. 23 3 36. 2 23-dz2. 2 T 3.3223.3 22 2. 3. % 2. 3 --> 33X a. - 3.>32 a. 32.--- 222 %32.- - ^^^- 3^ 2,it initial33 3 3 - 250 23233 22 33 22 3 3 2 2. 3 322. × 33223222222222 2. --> 2. 3 3, 33. - 2 33.3 23 U.S. Patent Jul. 9, 2013 Sheet 13 Of 35 US 8,480,637 B2 FIG. 5H U.S. Patent Jul. 9, 2013 Sheet 14 of 35 US 8,480,637 B2 U.S. Patent Jul. 9, 2013 Sheet 15 Of 35 US 8,480,637 B2 430 3 - 420 3 3 2 3 3 & s3 %3 2. 33 TITIATIII, III, III ITT.III. T.I.T.3 - 450 Z 32. 3 3 3 410 3 - - - - - 2 3 2 323 32. 3 FIG. 8A U.S. Patent Jul. 9, 2013 Sheet 16 of 35 US 8,480,637 B2 SS é2. & SSSSSSSSSSSSSS SSS3 3Se 22. : s illili 3- -. - - 2. ^^^X. XX ^ --- 23 3. 2 3- ---XX.22.2,2. 3.2. 2 3-2. d 32 23 3 3.------- 2. ----- - -> 2.3 3s 3in x. 2. 2. xxx^ 3. ^s 22 2. 2 2. &-- a MX^ 2 2.3 3 2. 2. %s 32, 3 32 2 3 3 22 % 3 3.3 ^.3. &2. 2,222. 3 2 3 33. 33 3. 2. 2.32 3/410 3 ------------ 2. W. 2.2.3 2,2. 33 -----> 3 X 3% 2 3 22:32:3- - 3s322 2. a. × 22. 32. 3 2 > 3 --- 2 % % 3 3% 3 3 - 2.3 32. FIG. 8B SNS <sS S S SxYSSYS SSSSSSS NN M - X ^^^^ 223 2.%3 3 M 3 %23. 2 ::::::: ---------> Ll l ill Hill ill &: Lil --- x. ^ -- ^. t 2 2.. 32 333 3 2 .. 22. ^^^X^^. -- 232 ..a - ---- 8. ^^^ ^ M 22. 2. 2. 333.22.22%. 3. 32, 3 - ---. - 3-. - M - 6 - M - 3 %^. 3 2. 22 32 3 3 233 3 3. % 3 2 32 32 3 -. 23 3% 32222222223 23 U.S. Patent Jul. 9, 2013 Sheet 17 Of 35 US 8,480,637 B2 41 1-1 441 441 421 SSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSS SSSSSS NXXX SSS SS Sy y SS SS NY. S. SSS SS SS SS y^N SS NX SS SSSSSS Ny S SS SNSS - N- - SS Š SSX N NN N N N 411 N NSy NS. S SSSSSSSSSN S S SS S S NSSSSSSSSSSSSSSSSSSSSS N N NN N N r SSN SSN NSSSSS SS SSSN S&S SSSSSSSSN NSNSX-N SS S \ N N& S. SSSSSN N SX N S S N N N ySN N SSN NNS w N SS. NNN. ŠSSS N N SSSSSSSSSSSSSSSSS y - s s S. S. S. N NS. S N N S SS S NS S S SS N S N SN NNSS SSNS N&YYXX^XXX S. SSSS N NxYxxx N - TTT T S ------------- ------ 3 3 %3^ & 3 8 j i ; É.i.i. i. lili 323-y 3. & 450 2 232. 333 %32 2% ---. a------> - s 3. % 3 % 2. M 2 & ^^ M 2. 3 2. 3 33 - --- 3.32. 2.222222.6% % 3 32 W. 3 2. 2 2. 3 2. 2. 3 33 23 3 % 3 2. 3. 3 s22. 3% U.S. Patent Jul. 9, 2013 Sheet 18 Of 35 US 8,480,637 B2 421 441 430 3 L 2. 420 22--> : . - - -3. - - 1--------1-------1------------->3 & 3 32222222 3. --- 33-4402. % 2. 2 222222222222.222222,3 3. 3. a 3 450 21. a %--- ---> 3 - 3.3 3--- 22222222222 3 3.a.3 2. 2 2 22.22, 3322 3.3 2. 23 %2. ----------------- 3 -1- 3 22 3 32 3. 32 % 3 2.----> 33 FIG. 8F 421 441 430 420 3 440 2% 32 y 3 450 2 3.3. 3 --- 233 - 22. 3 %23. 22323 2. 3 6 3 3 3 3 3 3N410a- 2.-------> 2.:------- 2222222222, 2 -a- W 3 3. 2. 2. 22 3. 3. 2. -3 2322222222 3 322222222222 3.- - 3 - U.S. Patent Jul. 9, 2013 Sheet 19 Of 35 US 8,480,637 B2 445 N T nitri I E. FIG. 8H 450 410 FIG. 8 U.S. Patent Jul. 9, 2013 Sheet 21 Of 35 US 8,480,637 B2 550 FIG.