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( 12 ) United States Patent US010182992B2 (12 ) United States Patent ( 10 ) Patent No. : US 10 , 182 , 992 B2 Vamvakas et al. (45 ) Date of Patent: Jan . 22 , 2019 ( 54 ) ABUSE -DETERRENT CONTROLLED A61K 9 /2846 ; A61K 9 / 0004 ; A61K RELEASE FORMULATIONS 9 / 2027 ; A61K 9 /28 ; A61K 31/ 4985 ; A61K 45 / 06 ; A61K 31 / 138 ; A61K (71 ) Applicant : PATHEON SOFTGELS INC . , High 31 / 495 ; A61K 31 /724 ; A61K 31 / 485 ; Point, NC (US ) A61K 9 / 485 ; A61K 9 / 4858 ; A61K 9 / 4866 ; A61K 9 /4875 (72 ) Inventors : George Vamvakas, Greensboro , NC See application file for complete search history . (US ) ; Aqeel A Fatmi, High Point, NC (US ) ( 56 ) References Cited ( 73 ) Assignee : Patheon Softgels Inc ., High Point, NC U . S . PATENT DOCUMENTS (US ) 5 ,146 ,730 A 9 / 1992 Sadek et al. 5 , 459 , 983 A 10 / 1995 Sadek et al . ( * ) Notice : Subject to any disclaimer , the term of this 6 , 482 ,516 B1 11/ 2002 Sadek et al . patent is extended or adjusted under 35 8 ,685 , 445 B2 4 / 2014 Hassan et al. U . S . C . 154 ( b ) by 150 days . 2004 / 0052731 A1 3 /2004 Hirsh et al. 2006 /0115527 A1 6 / 2006 Hassan et al . 2006 / 0165778 A1 7 / 2006 Hassan et al . (21 ) Appl. No. : 14 /679 , 062 2007 /0092560 A1 4 / 2007 Sukuru 2009 /0082466 A1 * 3 / 2009 Babul A61K 9 /4858 (22 ) Filed : Apr . 6 , 2015 514 /646 2009/ 0232887 A1 * 9 / 2009 Odidi . .. .. A61K 9 / 06 (65 ) Prior Publication Data 424 /457 US 2015 /0283087 A1 Oct 8 , 2015 OTHER PUBLICATIONS Related U . S . Application Data International Search Report for PCT / 2015 /024422 , dated Aug. 27 , (60 ) Provisional application No. 61/ 976 ,237 , filed on Apr. 2015. 7 , 2014 , provisional application No . 62/ 101, 431, filed on Jan . 9 , 2015 . * cited by examiner (51 ) Int. Ci. Primary Examiner — Snigdha Maewall A61K 9 / 48 ( 2006 . 01 ) ( 74) Attorney , Agent, or Firm — Brinks Gilson & Lione A61K 31 / 137 ( 2006 .01 ) A61K 31 /485 ( 2006 . 01 ) (57 ) ABSTRACT (52 ) U .S . CI. Described herein are abuse deterrent controlled release oral CPC . .. .. A61K 9 /4866 (2013 . 01 ) ; A61K 9 /485 pharmaceutical compositions comprising and methods for (2013 .01 ) ; A61K 9 /4858 ( 2013 .01 ) ; A61K making the same. In particular , an abuse deterrent controlled 9 /4875 ( 2013 .01 ) ; A61K 31/ 137 (2013 .01 ) ; release oral pharmaceutical composition comprising a soft A61K 31/ 485 (2013 .01 ) capsule and an abuse deterrent controlled release matrix (58 ) Field of Classification Search comprising an active pharmaceutical ingredient are CPC . .. .. .. A61K 2300 /00 ; A61K 31 / 137 ; A61K described . 31/ 135 ; A61K 9 / 2866 ; A61K 9 /2886 ; 4 Claims, 9 Drawing Sheets U . S . Patent Jan . 22, 2019 Sheet 1 of 9 US 10 , 182, 992 B2 FIGURE 1 Physicalmanipulations performed at ambient conditions ( ca . 25 °C ) Tampering Method ????????????????????????????????????Crushing ????????????????????????????????????????????????? ?????????????????????????????Grating ???????????????????????????????? Grinding?????????????????????????? Cutting????????????????????????????????????? The capsule was The capsule was crushed but the grated with a cheese A razor was used to material released was grater . It released a cut the capsule . The thick , waxy , sticky thick , waxy , sticky The capsule could not thick , waxy , sticky fill material that cannot material that cannot be ground in a coffee material cannot be be easily snorted , be easily snorted , grinder . easily snorted , dispersed , dissolved , dispersed , dissolved , dispersed , dissolved , or extracted for or extracted for or extracted for injection . injection . injection . , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , U . S . Patent Jan . 22, 2019 Sheet 2 of 9 US 10 , 182, 992 B2 FIGURE 2 Physical manipulations performed after storage at 40 °C for 2 hours Method of Tampering Crushing Grating Grinding Cutting * * * * * * * 22 The capsule behaved The capsule behaved The capsule behaved The capsule behaved in the samemanner as in the same manner as in the samemanner as in the samemanner as under ambient under ambient under ambient under ambient conditions. conditions. conditions . conditions . U . S . Patent Jan . 22, 2019 Sheet 3 of 9 US 10 , 182, 992 B2 FIGURE 3 Physical manipulationsHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEHEH performed after storage at 0 °C for 2 hours Method of Tampering . : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : ?????????????????????????????????? Crushing Grating Grinding Coro VILLEVILEVILEVILLE VILLA The capsule behaved The capsule behaved The capsule behaved The capsule behaved in the same manner as in the same manner as in the same manner as 1 in the same manner as under ambient under ambient under ambient under ambient conditions. conditions. conditions. conditions. U . S . Patent Jan . 22, 2019 Sheet 4 of 9 US 10 , 182, 992 B2 FIGURE 4 PercentRelease . 0 100 200 300 400 500 600 700 800 Time (min ) U . S . Patent Jan . 22, 2019 Sheet 5 of 9 US 10 ,182 ,992 B2 FIGURE 5 ??????? ????????? / / / / / / / / / / / / / / / P A / PercentRelease / ??????????????????? ??? ?????? ???????????? 0 T uusuvussanomaan 0 20 40 60 80 100 120 140 Time (min ) U . S . Patent Jan . 22, 2019 Sheet 6 of 9 US 10 , 182, 992 B2 FIGURE 6 PercentRelease 3 months + 2 months + 1 month 10months 0 100 200 300 400 500 600 700 800 Time (min ) atent Jan . 22 , 2019 Sheet 7 of 9 US 10 , 182, 992 B2 FIGURE 7 PercentRelease 0 months + - 1 month + 2 months - 3 months 0 20 40 60 80 100 120 140 Time (min ) U . S . Patent Jan . 22, 2019 Sheet 8 of 9 US 10 , 182, 992 B2 FIGURE 8 H PercentRelease 20 + RD1147 _ 171 INITIAL + RD1147 _ 171 2wk 30 /65 + RD1147 _ 171 2wk 40 /75 0 100 200 300 400 500 600 700 Time (min ) U . S . Patent Jan . 22, 2019 Sheet 9 of 9 US 10 , 182, 992 B2 FIGURE 9 PercentRelease + RD1163 _ 141_ F2 + RD1163 _ 141_ F2 _ ETOH 0 100 200 300 400 500 600 700 Time (min ) US 10 , 182 , 992 B2 ABUSE -DETERRENT CONTROLLED changed into the active form of the drug in the gastrointes RELEASE FORMULATIONS tinal tract . The pharmaceutical industry is utilizing these strategies to develop abuse - deterrent pharmaceutical com CROSS REFERENCE TO RELATED positions in order to reduce the potential for misuse of APPLICATIONS prescription pharmaceutical compositions . Accordingly , there is a need for abuse deterrent pharma This application claimspriority to U . S . Provisional Patent ceutical compositions that have controlled release proper Application Nos . U . S . 61 /976 ,237 , filed on Apr. 7 , 2014 and ties . The matrix formulations described herein minimize the U . S . 62 / 101, 431 , filed on Jan . 9 , 2015, both of which are likelihood of tampering , " dose dumping, ” or the extraction incorporated by reference herein in their entirety . This 10 of active pharmaceutical ingredients from the composition . application is related to International Patent Application No . PCT/ US2015 /24422 filed on Apr. 6 , 2015 , which is incor SUMMARY porated by reference herein in its entirety . This application is also related to U . S . patent application Ser . No . 14 /679 ,233 Described herein are pharmaceutical compositions com and International Patent Application No . PCT/ US2015 / 15 prising abuse deterrent controlled release matrices compris 24464 , both filed on Apr. 6 , 2015 , both of which are ing active pharmaceutical ingredients . The matrix is struc incorporated by reference herein in their entirety . tured to prevent extraction of the active pharmaceutical ingredients . TECHNICAL FIELD One embodiment described herein is an abuse deterrent 20 oral pharmaceutical composition comprising a tamper resis Described herein are abuse deterrent controlled release tant controlled release matrix comprising: ( a ) at least one oral pharmaceutical compositions comprising and methods lipid or lipophilic vehicle; ( b ) at least one hydrophilic for making the same. In particular, an abuse deterrent polymer ; ( c ) at least one hygroscopic polymer; and ( d ) at controlled release oral pharmaceutical composition compris least one active pharmaceutical ingredient; wherein the ing a soft capsule and an abuse deterrent controlled release 25 matrix is resistant to tampering and is encapsulated in a soft matrix comprising an active pharmaceutical ingredient are capsule shell . described . In one embodiment, the abuse deterrent oral pharmaceu tical compositions described herein further comprises at BACKGROUND least one suspension agent. In one aspect , the suspension 30 agent comprises fumed silica , fumed alumina, or mixtures Increased attention has been drawn to the recreational use thereof. and abuse of prescription pharmaceutical compositions . The I n one aspect , the lipid or lipophilic vehicle comprises abuse , or non -medicinal use , of prescription pharmaceutical about 25 % to about 90 % of the total matrix mass . In another compositions is an increasing problem . Accordingly , pre - aspect , the at least one hygroscopic polymer comprises from venting the abuse of prescription pharmaceuticals through 35 about 1 % to about 10 % of the total matrix mass . In another the development of abuse deterrent pharmaceutical compo - aspect , the at least one hydrophilic polymer comprises about sitions has become a high public health priority for the U . S . 5 % to about 17 % of the total matrix mass . In another aspect , Food and Drug Administration (FDA ) . Prescription phar- the at least one active pharmaceutical ingredient comprises maceutical compositions
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