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(12) Patent Application Publication (10) Pub. No.: US 2016/0022590 A1 ODID (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2016/0022590 A1 ODID (43) Pub US 2016.0022590A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0022590 A1 ODID (43) Pub. Date: Jan. 28, 2016 (54) COMPOSITIONS AND METHODS FOR A613 L/4439 (2006.01) REDUCING OVERDOSE A619/20 (2006.01) A613 L/485 (2006.01) (71) Applicant: Isa ODIDI, Toronto (CA) A63L/366 (2006.01) (52) U.S. Cl. (72) Inventor: Isa ODIDI, Toronto (CA) CPC ............. A61K 9/2846 (2013.01); A61 K3I/485 (2013.01); A61 K31/192 (2013.01); A61 K (21) Appl. No.: 14/790,101 3I/5513 (2013.01); A61K3I/515 (2013.01); (22) Filed: Jul. 2, 2015 A6 IK3I/167 (2013.01); A61 K3I/366 (2013.01); A61 K3I/4458 (2013.01); A61 K Related U.S. Application Dat 31/135 (2013.01); A6IK3I/197 (2013.01); e pplication Uata A6 IK3I/4439 (2013.01); A61 K9/2813 (63) Continuation of application No. PCT/CA2015/ (2013.01); A61 K9/282 (2013.01); A61 K 050567, filed on Jun. 19, 2015. 9/2013 (2013.01); A61 K9/2018 (2013.01); A6IK9/2054 (2013.01); A61 K9/2059 (60) Pgyal 1 applicationaroplication NoNo. 62/O24,940,94U, filedTlled on Jul.Ju (2013.01); A61 K9/2027 (2013.01);s A61 K 9/2031 (2013.01); A61K 9/4891 (2013.01); Publication Classification A61K 9/4866 (2013.01); A61 K9/4858 (2013.01); A61 K9/485 (2013.01) (51) Int. C. A6 IK 9/28 (2006.01) (57) ABSTRACT A6 IK3I/92 (2006.01) A 6LX3/553 (2006.01) Drug delivery formulations, uses thereof and methods of A6 IK3I/55 (2006.01) making same are provided in order to reduce the potential for A6 IK3I/67 (2006.01) abuse, misuse or improper administration of an addictive A6 IK9/48 (2006.01) Substance or any active Substance and to prevent, reduce, A6 IK3I/4458 (2006.01) inhibit, or delay purposeful or accidental overdose of an A6 IK3I/35 (2006.01) active Substance by ingesting too many dosage forms at once, A 6LX3/97 (2006.01) for example. Patent Application Publication Jan. 28, 2016 Sheet 1 of 35 US 2016/0022590 A1 1000 9.00 –0- 60mg/520ml 8.00 -- 90mg/520ml 7.00 -A - 100mg/320ml 6.00 -- 120mg/520ml -- 60mg/500ml PH 5.00 -o- 100mg/500ml 4.00 -- 120mg/500ml - 180mg/500ml 3.00 - 200mg/500ml 2.00 -e- 240mg/500ml 1.00 0 1 2 3 4 5 6 7 8 9 10 20 30 4050 60 Time (Min) FIG. 1 Patent Application Publication Jan. 28, 2016 Sheet 2 of 35 US 2016/0022590 A1 09070|69/G7£.Z|0 00’0 Patent Application Publication Jan. 28, 2016 Sheet 3 of 35 US 2016/0022590 A1 10.00 900 8.00 700 -0- 20mg/520ml 6.00 pH 5.00 -a- 40mg/520ml 400 5.00 1.00 0.00 0 1 2 3 4 5 6 7 8 9 10 20 30 40 50 60 Time (Min) FIG. 3 Patent Application Publication Jan. 28, 2016 Sheet 4 of 35 US 2016/0022590 A1 h S. s C h Cld s S o OC : X o o ed so ed o o o o o o o Co O Ced Ced Ced C Ced Ced Co Co O O o o ox N o s N can s Co r v Patent Application Publication Jan. 28, 2016 Sheet 5 of 35 US 2016/0022590 A1 (UN)Qu|| G(5)|–| 00"| 00’0 08090,7OZ0 Patent Application Publication Jan. 28, 2016 Sheet 6 of 35 US 2016/0022590 A1 On C. C. N.S N.S CN5 q q. v. r n n C O Co CD CD CD C C C, CD CD C9 O od co o - O S ce CD seF LL O on O S S S S 3 3 S 3 do N. de ned on o Patent Application Publication Jan. 28, 2016 Sheet 7 of 35 US 2016/0022590 A1 (HO)6N6u10OG :fiu-96OO|+ £0000 0 9 09 07 (uN)9uull OZ Patent Application Publication Jan. 28, 2016 Sheet 8 of 35 US 2016/0022590 A1 08 09 00,9 00? 00"| Patent Application Publication Jan. 28, 2016 Sheet 9 of 35 US 2016/0022590 A1 10.00 9.00 8.00 7.00 –0 - 10mg (11.13 actual) 6.00 -H 50mg (50.11 mg actual) pH 5.00 - A - 80mg (81.68mg actual) 4.00 3.00 2.00 1.00 0.00 Time (Min) FIG. 9 Patent Application Publication Jan. 28, 2016 Sheet 10 of 35 US 2016/0022590 A1 0909Off09 (UN)Qu]]| Patent Application Publication Jan. 28, 2016 Sheet 11 of 35 US 2016/0022590 A1 ? C/ O E O s C 2 o CD : s Patent Application Publication Jan. 28, 2016 Sheet 12 of 35 US 2016/0022590 A1 d e d e C - C th d C9 S e t s s c s c E O o .9 C C C9 : Patent Application Publication Jan. 28, 2016 Sheet 13 of 35 US 2016/0022590 A1 -O-1 toblet -- 2 toblets - 3 toblets -0-4 toblets -H 5 toblets - A - 6 toblets 0 1 2 3 4 5 6 7 8 9 10 11 12 131415 1617 1819 2021222324 Time (Hr) FIG. 13A 100 90 80 70 -- 10 tablets - A - 20 toblets is 60 -H 40 toblets -- 60 toblets Ž 50 --80 tablets -- 100 tablets 40 30 20 10 Patent Application Publication Jan. 28, 2016 Sheet 14 of 35 US 2016/0022590 A1 S Š S S Šiš : S S Š O O O O O ŠS Patent Application Publication Jan. 28, 2016 Sheet 15 of 35 US 2016/0022590 A1 100 80 d 60 -E-1 tablet -A-2 tablets a -- 5 toblets - 4 tablets 2 -- 5 tablets -0- 6 tablets s 40 20 O Time (Hr) FIG. 14A -E-10 toblet - A - 20 tablets 2 -e- 40 toblets - 60 toblets Ž s Time (Hr) FIG. 14B Patent Application Publication Jan. 28, 2016 Sheet 16 of 35 US 2016/0022590 A1 FIG. 14C FIG. 14D FIG. 14E F.G. 14F FIG. 14G FIG. 14H Patent Application Publication Jan. 28, 2016 Sheet 17 of 35 US 2016/0022590 A1 100 90 80 70 -E-1 tablet a 60 - A - 2 tablets s -E-5 tablets Ž 50 - 4 tablets S 40 -- 5 tablets 100 80 -- 10 tablet - A - 20 toblets -- 40 toblets - 60 toblets Patent Application Publication Jan. 28, 2016 Sheet 18 of 35 US 2016/0022590 A1 FIG.15D FIG.15F FIG.15H FIG.15 FIG.15K Patent Application Publication Jan. 28, 2016 Sheet 19 of 35 US 2016/0022590 A1 100 SZ 20 Toblets (ENTOSSÍ0% Ø 50 Toblets (Il 40 Toblets Omin §– ?.Š? Time Hr FIG. 15L 10 toblets 20 tablets 50 toblets 40 tablets 50 toblets ZZZZZZZZZZZZZZZZZZZZZ,cº? NBZENZ 100 toblets Patent Application Publication Jan. 28, 2016 Sheet 20 of 35 US 2016/0022590 A1 CENTOSS|(1% N |---- |||zz 201 (100 tob §<!--|loZZZZZZZERË O2 (100 to O3 (100 to FIG. 16A Patent Application Publication Jan. 28, 2016 Sheet 21 of 35 US 2016/0022590 A1 Example 4 Example 2 Rowl Condition of toblet (fter 1 hour in dissolution medic Rowl2 Condition of 2 tablets after 24 hours in dissolution media Row#3 Condition of 3 tablets after 24 hours in dissolution media Row#4 Condition of 4 tablets after 24 hours in dissolution medic Rowi5 Condition of 5 toblets after 24 hours in dissolution medic Condition of 6 toblets after 24 hours in dissolution media FIG. 16B Patent Application Publication Jan. 28, 2016 Sheet 22 of 35 US 2016/0022590 A1 |||…:-**--—09 |||, (SMH)BW|| 01 09 09 —ta--------) OWTOSSIO % Patent Application Publication Jan. 28, 2016 Sheet 23 of 35 US 2016/0022590 A1 Patent Application Publication Jan. 28, 2016 Sheet 24 of 35 US 2016/0022590 A1 FIG. 19 Patent Application Publication Jan. 28, 2016 Sheet 25 of 35 US 2016/0022590 A1 FIG. 20 Patent Application Publication Jan. 28, 2016 Sheet 26 of 35 US 2016/0022590 A1 Patent Application Publication Jan. 28, 2016 Sheet 27 of 35 US 2016/0022590 A1 Patent Application Publication Jan. 28, 2016 Sheet 29 of 35 US 2016/0022590 A1 FIG. 25 Patent Application Publication Jan. 28, 2016 Sheet 30 of 35 US 2016/0022590 A1 FIG. 26 Patent Application Publication Jan. 28, 2016 Sheet 31 of 35 US 2016/0022590 A1 ZZ (?ul/60)2000|0|0)–O– s O 09 Gy 07 9€. (u/5u) UODnu90U00 Patent Application Publication Jan. 28, 2016 Sheet 33 of 35 US 2016/0022590 A1 9 0'09 Patent Application Publication Jan. 28, 2016 Sheet 34 of 35 US 2016/0022590 A1 ||9|GyZ| ||0 6 9 ?.00|| 06 08 01 09 09 Oy 0£ OZ 0|| p09A009. 9UOp00/80 % Patent Application Publication Jan. 28, 2016 Sheet 35 of 35 US 2016/0022590 A1 ÞUE ubiaeuofferg?2?? ?????????????? |woeesubiuuobe..*..* roeesubiuuobelo× US 2016/0022.590 A1 Jan. 28, 2016 COMPOSITIONS AND METHODS FOR emotional, psychological, euphoric, depressive, or generally REDUCING OVERDOSE psychedelic experience are particularly vulnerable to this form of abuse. RELATED APPLICATIONS 0008 Attempts have been made in the past to control abuse or overdose from Swallowing a number of intact solid 0001. This application is a continuation U.S. application dosage forms, but formulations and methods currently taught under 35 U.S.C. S365 of International Patent Application No. have not successfully prevented overdose from Swallowing a PCT/CA2015/050567, filed on Jun. 19, 2015, which claims number of intact tablets or capsules. Some of these priority to U.S. Provisional Patent Application No. 62/024, approaches are sometimes executed after the fact, i.e., 940 filed on Jul.
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