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(12) Patent Application Publication (10) Pub. No.: US 2012/0187594 A1 Utkhede Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2012/0187594 A1 Utkhede Et Al US 2012O187594A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0187594 A1 Utkhede et al. (43) Pub. Date: Jul. 26, 2012 (54) DRUG CORES FOR SUSTAINED RELEASE 60/970,699, filed on Sep. 7, 2007, provisional applica OF THERAPEUTICAGENTS tion No. 60/970,709, filed on Sep. 7, 2007. (75) Inventors: Deepank Utkhede, Surrey (CA); Publication Classification Robert W. Shimizu, Laguna (51) Int. Cl. Niguel, CA (US); Rachna Jain, Milpitas, CA (US); Stephen Boyd, B2.8B II/2 (2006.01) Murrieta, CA (US); Hanson S. (52) U.S. Cl. ........................................................ 264/157 Gifford, Woodside, CA (US); Eugene de Juan, San Francisco, (57) ABSTRACT CA (US); Cary J. Reich, Los A solid drug core insert can be manufactured by injecting a Gatos, CA (US) liquid mixture comprising a therapeutic agent and a matrix precursor into a sheath body. The injection can be conducted (73) Assignee: QLT INC., Vancouver (CA) at subambient temperatures. The mixture is cured to form a Solid drug-matrix core. The therapeutic agent can be a liquid (21) Appl. No.: 13/367,823 at about room temperature that forms a dispersion of droplets in the matrix material. A Surface of the Solid drug core is (22) Filed: Feb. 7, 2012 exposed, for example by cutting the tube, and the exposed Surface of the Solid drug core releases therapeutic quantities Related U.S. Application Data of the therapeutic agent when implanted into the patient. In (63) Continuation of application No. 12/231,986, filed on SO embodiments, the insert body inhibits release of the Sep. 5, 2008. therapeutic agent, for example with a material Substantially impermeable to the therapeutic agent, such that the therapeu (60) Provisional application No. 61/049.317, filed on Apr. tic quantities are released through the exposed surface, 30, 2008, provisional application No. 60/970,820, thereby avoiding release of the therapeutic agent to non-target filed on Sep. 7, 2007, provisional application No. tissues. -lo 120 110 120 Patent Application Publication Jul. 26, 2012 Sheet 1 of 50 US 2012/0187594 A1 //// Patent Application Publication Jul. 26, 2012 Sheet 2 of 50 US 2012/0187594 A1 Patent Application Publication Jul. 26, 2012 Sheet 3 of 50 US 2012/0187594 A1 Patent Application Publication Jul. 26, 2012 Sheet 4 of 50 US 2012/0187594 A1 188 182A 186 182 Awz// Patent Application Publication Jul. 26, 2012 Sheet 5 of 50 US 2012/0187594 A1 AW2/ 2O2 212A 1. 212 222 /W727 Patent Application Publication Jul. 26, 2012 Sheet 6 of 50 US 2012/0187594 A1 21 4D 214A A- 214 21 OB 21 OB 224A 2. - - - -21 OA 23 2 224 224 214 2 AA 216A 216 226 216 226 Aza' Patent Application Publication Jul. 26, 2012 Sheet 7 of 50 US 2012/0187594 A1 274 264 Patent Application Publication Jul. 26, 2012 Sheet 8 of 50 US 2012/0187594 A1 /W 27 Patent Application Publication Jul. 26, 2012 Sheet 9 of 50 US 2012/0187594 A1 /W.2/ Patent Application Publication Jul. 26, 2012 Sheet 10 of 50 US 2012/0187594 A1 259 269A N 269 Patent Application Publication Jul. 26, 2012 Sheet 11 of 50 US 2012/0187594 A1 232A 242A ZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZ /W74/ Patent Application Publication Jul. 26, 2012 Sheet 12 of 50 US 2012/0187594 A1 CN cro Cro Patent Application Publication Jul. 26, 2012 Sheet 13 of 50 US 2012/0187594 A1 Patent Application Publication Jul. 26, 2012 Sheet 14 of 50 US 2012/0187594 A1 AW.6% Patent Application Publication Jul. 26, 2012 Sheet 15 of 50 US 2012/0187594 A1 422 402 Patent Application Publication Jul. 26, 2012 Sheet 16 of 50 US 2012/0187594 A1 45O 460 N Y 452 456 454 C 404 422 400 Patent Application Publication Jul. 26, 2012 Sheet 17 of 50 US 2012/0187594 A1 470 Y 472 474. NNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNYNNNNNNNNNN 476-> (1 -478 NYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYNYYYYYYYYYZZZZZZZZZZZZZZZZZZZZZZZZZZZ 472 474 480 N 488 as re r - he 2%z"EA --------------4----------------- 486-> -e-486 SNS488 NNN 482 482-3S A / Patent Application Publication Jul. 26, 2012 Sheet 18 of 50 US 2012/0187594 A1 4.96S 494S 496S NNNN2-498 Patent Application Publication Jul. 26, 2012 Sheet 19 of 50 US 2012/0187594 A1 53O Patent Application Publication Jul. 26, 2012 Sheet 20 of 50 US 2012/0187594 A1 810 8O8 840 Patent Application Publication Jul. 26, 2012 Sheet 21 of 50 US 2012/0187594 A1 6OO N Plug Manufacturing 61O Drug Insert Manufacturing 650 Final Assembly: Component Integration 690 Awa/ Hydrogel Rod Assembly 620 40% wt/wt Hydrogel Hydrogel Mixing with organic solvent 624 inject Hydrogel into Silicone Tube 626 "Cure" Hydrogel 628 Cut to Length and Remove 629 AwaZ7 Patent Application Publication Jul. 26, 2012 Sheet 22 of 50 US 2012/0187594 A1 Mold SiliCOne Plug with Coil 630 Wind Polypropylene Place Materials in Mold Coil and Heat Set 634 636 IWW M 632C Patent Application Publication Jul. 26, 2012 Sheet 23 of 50 US 2012/0187594 A1 ////// 079 099 0,29 979 Patent Application Publication Jul. 26, 2012 Sheet 24 of 50 US 2012/0187594 A1 Drug insert Assembly 65O 660 Drug Matrix Syringe Polyimide Tubing Assembly Preparation 662 67O Preparation of Drug Inject Drug Matrix Matrix into Polyimide Tubing 672 Cure Matrix 68O /27.6% Cut to length and apply adhesive 682 Patent Application Publication Jul. 26, 2012 Sheet 25 of 50 US 2012/0187594 A1 Final Assembly 690 insert Drug insert into Punctum Plug 692 Package 694 E Beam Sterilize 696 Product Release 698 /767 Patent Application Publication Jul. 26, 2012 Sheet 26 of 50 US 2012/0187594 A1 Elution study of Latanoprost for Day 1 1600 y = 23.363X + 933.28 2 1400 R = 0,971 12OO A 1000 0 0.006 in tube S. 800 y = 7.4356x + 392.53 .012 in tube C R* = 0.4084 A.025 in tube 600 400 -T y = 11.814x + 84.616 2 200 -- R = 0.8588 percent concentration /W 2/ Patent Application Publication Jul. 26, 2012 Sheet 27 of 50 US 2012/0187594 A1 Elution study of Latanoprost for Day 14 40 y = 2.2495x + 276.33 350 R = 0.0906 A 300 - . A 250 + O.OO6 in tube y = 4.3282x + 59,967 0.012 in tube R= 0,962 A 0.025 tube 150 u y = 3.0192x + 6,0717 50 u R2 = 1 5 10 15 percent concentration Az7 Patent Application Publication Jul. 26, 2012 Sheet 28 of 50 US 2012/0187594 A1 Latanoprost Elution - in Vitro Time (days) Az7 Patent Application Publication Jul. 26, 2012 Sheet 29 of 50 US 2012/0187594 A1 Latanoprost elution (day 1) 16OO 1400 y = 3441.6x + 246.92 2 R^ = 1 y = 3286.1x+202.83 1200 R = 0.97.01 0 latanoprost 5.1% latanoprost 11.2% A latanoprost 17.9% y = 2837.8x + 146.38 R = 0.9925 400 200 O O O.05 O.1 0.15 O2 0.25 O.3 O.35 Area (mm2) Aw ZZ Patent Application Publication Jul. 26, 2012 Sheet 30 of 50 US 2012/0187594 A1 Latanoprost elution (day 14) 400 y = 1060.1x + 21,539 R = 0.9924 350 300 y = 764.35x + 54.036 R = 0.9663 250 200 + latanoprost 5.1% latanoprost 11.2% 1 50 y = 812.19x + 5.7121 A latanoprost 17.9% R = 0.9904 100 50 O O 0.05 O.1 O.15 0.2 0.25 O3 0.35 Area (mm2) A 2A" Patent Application Publication Jul. 26, 2012 Sheet 31 of 50 US 2012/0187594 A1 Elution profile of Non Sterlized (Cyclosporin) 350 300 250 > 200 9 2 150 0 cyclospoln in buffer cyclosporin in buffer + surf 100 50 O O 20 30 40 50 60 Time (days) /24 Patent Application Publication Jul. 26, 2012 Sheet 32 of 50 US 2012/0187594 A1 3 Month bimatoprost elution Bulk deveice, 1% bimatooprost Bimat Elution 100.00 S (5 9 9 10.00 s III 0... form 1 w wa f 2 9 - - - - - - - - TO O) S 1.00 s -A-form 3 CD Y O. 10 O 20 40 60 80 100 120 Time (days) /// Patent Application Publication Jul. 26, 2012 Sheet 33 of 50 US 2012/0187594 A1 3 Week Latanoprost Elution (Non-sterile) Elution Profile for Latanoprost (Non Sterile) OOO 0 Formulation A Formulation B 1OO Formulation C {x Formulation D O 5 10 15 2O 25 Time (days) Az// Patent Application Publication Jul. 26, 2012 Sheet 34 of 50 US 2012/0187594 A1 Punctum Plug Manufacturing Flow Drug Release as a Function of Crosslinking Effect of material and crosslinking in 20% latanoprost 1600 1400 1200 1000 04011 silicon 6385 (2.5% Crosslinking) 800 A 6380 (2.5% Crosslinking) 600 6380 (5% crosslinking) 400 200 5 10 15 20 25 Time (days) A: /// Patent Application Publication Jul. 26, 2012 Sheet 35 of 50 US 2012/0187594 A1 Punctum Plug Manufacturing Flow Drug Release as a Function of Concentration Effect of concentration on release rate (non sterile, buffer) 3000 X 2500 0.5% Lat O 2000 10% Lat g 1500 A A 20% Lat s X 40% Lat 500 H. X O t 5 10 15 20 25 Time (days) /W///7 Patent Application Publication Jul. 26, 2012 Sheet 36 of 50 US 2012/0187594 A1 Drug Release as a Function of Geometry Effect of change of geometry (20% lat in 6385) 1600 1400 1200 0 both ends open 8 O O one end open A both end open/2 2O O i O 5 10 15 Time (days) /W/// Patent Application Publication Jul. 26, 2012 Sheet 37 of 50 US 2012/0187594 A1 Fluorescein Eution Rates Punctal Plug Project o 9% Sufactant, 0.09%.
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