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(12) Patent Application Publication (10) Pub. No.: US 2008/0274168A1 Baker Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2008/0274168A1 Baker Et Al US 20080274168A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0274168A1 Baker et al. (43) Pub. Date: Nov. 6, 2008 (54) TRANSIDERMAL DELIVERY DEVICE Publication Classification DISPOSAL SYSTEM (51) Int. Cl. A 6LX 9/70 (2006.01) (76) Inventors: Carl J. Baker, Middletown, NY (52) U.S. Cl. ........................................................ 424/449 (US); Ihor Shevchuk, Yonkers, NY (57) ABSTRACT (US) The present invention relates to a transdermal delivery device disposal system for disposing of a transdermal delivery Correspondence Address: device containing at least one pharmaceutically active com Duane Morris LLP ponent. The disposal system contains at least one sheet or 1540 Broadway Substrate on which an adhesive is coated; and one or more of New York, NY 10036 (US) the following components: (a) monomer, and optionally comonomer(s), to be polymerized; (b) an initiator, and optionally co-initiator(s), to initiate the polymerization; (c) at (21) Appl. No.: 12/173,451 least one crosslinking agent to crosslink the (co)polymer, and (d) at least one deactivating agent to chemically alter, to (22) Filed: Jul. 15, 2008 degrade, and/or to deactivate the active component(s) con tained in the transdermal delivery device, such as an opioid Related U.S. Application Data antagonist or an opioid agonist deactivating agent so that the euphoric effects of the active component(s) contained in the (62) Division of application No. 10/457.562, filed on Jun. transdermal delivery device are at least temporarily inhibited, 10, 2003. diminished, or halted in vivo, wherein at least one adhesive coated sheet or Substrate adheres to, immobilizes, or isolates, and prevents, inhibits, or diminishes the misuse or abuse of (60) Provisional application No. 60/387,800, filed on Jun. the active component contained in, at least one transdermal 10, 2002. delivery device. Patent Application Publication Nov. 6, 2008 Sheet 1 of 14 US 2008/0274168A1 Patent Application Publication Nov. 6, 2008 Sheet 2 of 14 US 2008/0274168A1 Patent Application Publication Nov. 6, 2008 Sheet 3 of 14 US 2008/0274168A1 24%NNNNNNNNNYNYNNNNNNNNNN 24%.44422. 2 K. Yds 26 6-6 2 SNS ZZZZZZZZYYZZZY 2ZZ%22474%4% 34 gaged % KNNXNSSSSSSSSS. o Patent Application Publication Nov. 6, 2008 Sheet 4 of 14 US 2008/0274168A1 Patent Application Publication Nov. 6, 2008 Sheet 5 of 14 US 2008/0274168A1 ce .9 werSt. o da c .9ext C SS s sa ld p802.1X% Patent Application Publication Nov. 6, 2008 Sheet 6 of 14 US 2008/0274168A1 as cer O res d S Se toSV 2 s N s N SS s papers % Patent Application Publication Nov. 6, 2008 Sheet 7 of 14 US 2008/0274168A1 s pe102.1X% Patent Application Publication Nov. 6, 2008 Sheet 8 of 14 US 2008/0274168A1 l s ge 5 5 eaE SR. S.2 oc Co . co co o o to se Cd co I o co rest Patent Application Publication Nov. 6, 2008 Sheet 9 of 14 US 2008/0274168A1 III s ge --ad5 53 es ill O Od o Co. o. o os o Co o o co o S. to rst cro cin re --- Patent Application Publication Nov. 6, 2008 Sheet 10 of 14 US 2008/0274168A1 con5 O s co seS Seo e-r3 - - a N Ses N cus -E L Patent Application Publication Nov. 6, 2008 Sheet 11 of 14 US 2008/0274168A1 o do fe Ar 7. t A) s S Patent Application Publication Nov. 6, 2008 Sheet 12 of 14 US 2008/0274168A1 Patent Application Publication Nov. 6, 2008 Sheet 14 of 14 US 2008/0274168A1 50 (2ZZZZZZZZZZZZZZZZZZZZZZZZZZZN-1 22 Fig. 14b US 2008/0274168A1 Nov. 6, 2008 TRANSIDERMAL DELVERY DEVICE opioid antagonist is intended to block any euphoric effects DISPOSAL SYSTEM sought through abuse of the dosage form. 0007. The inadvertent and/or intentional misuse and/or FIELD OF THE INVENTION abuse of transdermal delivery devices remains a significant health problem. Thus, there is a need for a transdermal deliv 0001. The present invention relates to a disposal system ery disposal system that is less Susceptible to abuse than is for preventing, inhibiting, and/or diminishing the intentional presently known in the art. and/or inadvertent misuse or abuse of a transdermal delivery device (“TDD) containing an active pharmaceutical agent, SUMMARY OF THE INVENTION Such as an opioid. The present invention also relates to a 0008. One embodiment of the invention relates to a TDD method for disposing of a TDD and/or for preventing the disposal system comprising at least a first Substrate having an misuse or abuse of a TDD or any ingredient of a TDD. adhesive coating on one face thereof, and one or more of the following components present at least in or on the adhesive BACKGROUND OF THE INVENTION coating or in or on the first Substrate, or any combination thereof: 0002 Transdermal dosage forms are convenient dosage 0009 (a) a monomer, and optionally at least one comono forms for delivering many different active therapeutically mer, effective agents, including but not limited to analgesics. Such 0010 (b) an initiator, and optionally at least one co-initia as opioid analgesics. Typical opioid analgesics include, but tor; are not limited to, fentanyl, buprenorphine, etorphines, and 0011 (c) at least one crosslinking agent; and other high potency narcotics. Other therapeutically effective 0012 (d) at least one active agent deactivating agent, e.g., agents which may be delivered by a transdermal delivery an opioidantagonist for use with a TDD comprising an opioid system include, but are not limited to, anti-emetics (Scopola agonist. mine), cardiovascular agents (nitrates and clonidine), hor 0013 Another embodiment of the invention relates to a mones (estrogen and testosterone), nicotine, Vitamins, dietary TDD disposal system further comprising one or more of the Supplements, etc. following components present at least in or on the adhesive 0003. The most common transdermal dosage form is a coating or in or on a second Substrate, or any combination diffusion-driven transdermal system (transdermal patch) thereof: using either a fluid reservoir or a drug-in-adhesive matrix 0.014 (a) a monomer, and optionally at least one system. Other transdermal dosage forms include, but are not comonomer, limited to, topical gels, lotions, ointments, transmucosal sys 0.015 (b) an initiator, an optionally at least one co tems and devices, and iontophoretic (electrical diffusion) initiator, delivery systems. 0016 (c) at least one crosslinking agent; and 0004 Transdermal dosage forms are particularly useful 0017 (d) at least one active agent deactivating agent. for timed-release and Sustained-release of active agents. 0018. An additional embodiment of the invention relates However, many dosage forms, and particularly those for to a kit comprising a transdermal delivery device comprising timed and Sustained release of active agent(s), contain large at least one active agent, and a TDD disposal system; where amounts of active agent(s), often many times the actual the TDD disposal system comprises: absorbed dose. Often, the dosage form contains an excess of 0019 (i) at least a first substrate having an adhesive coat active agent ordelivers less than the entire amount of its active ing on one face thereof, and agent to the Subject being treated. This results in most of the 0020 (ii) one or more of the following components active agent remaining in the dosage form after use. Both the presentat least in or on the adhesive coating or in or on the first unused dosage form and the portion of active agent that Substrate, or any combination thereof: remains in the dosage form after use are Subject to potential 0021 (a) a monomer, and optionally at least one comono illicit abuse, particularly if the active agent is a narcotic or a mer, controlled Substance. For example, used dosage forms con 0022 (b) an initiator, and optionally at least one co-initia taining excess or unused opioids may be tampered with by tor; chewing or extraction by a drug abuser. Even careful disposal 0023 (c) at least one crosslinking agent; and of used dosage forms may not be completely effective in 0024 (d) at least one active agent deactivating agent. preventing abuse, particularly in cases of incomplete or par 0025. In one embodiment, the TDD disposal system com tial compliance. prises at least one non-u-opioid deactivating agent included at 0005 U.S. Pat. No. 5,804.215 to Cubbage et al. relates to least in or on the adhesive coating or in or on the first and/or a disposal system for a transdermal patch containing a medi second Substrate, or any combination thereof. cament, such as nicotine, comprising an adhesive coated flex 0026. Another embodiment of the invention relates to a kit ible tear-resistant substrate. The used transdermal patch is comprising a transdermal delivery device containing at least adhered to the substrate in order to encapsulate and prevent one active agent; and a TDD disposal system comprising at access to the transdermal patch. Rubber based adhesives are least a first rigid, non-planar Substrate having an adhesive preferred by Cubbage coating on at least one face. 0006 U.S. Pat. Nos. 5,149,538 to Grangeretal. and 5,236, 0027. A further embodiment of the invention relates to a 714 to Lee et al. each relate to misuse-resistive dosage forms kit comprising a transdermal delivery device comprising for the transdermal delivery of opioids. In these patents, the buprenorphine or any pharmaceutically acceptable form or respective transdermal patches are provided with an opioid derivative of buprenorphine; and a TDD disposal system antagonist which is intended to be extracted from the patch if comprising at least a first Substrate having an adhesive coat the patch is chewed or Subjected to an extraction process.
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