TAMPER EVIDENT TRANSDERMAL PATCH
Transdermal patch having at least one pharmaceutically active ingredient and a tamper-evidencing element, as well as methods of making and using the same.
1 . A patch comprising:
one or more active pharmaceutical ingredients;
at least one tamper-evidencing element having a first state and a second state, the tamper-evidencing element being configured to change from the first state to the second state upon exposure to at least one type of tampering; and
at least one antenna having one or more electronically readable features, wherein the electronically readable feature is able to provide a first readout associated with the first state of the tamper-evidencing element and at least a second readout associated with the second state of the tamper-evidencing element, wherein the second readout is differentiable from the first readout.
2 . The patch of claim 1 , wherein the patch comprises at least one active pharmaceutical ingredient layer on a substrate having at least one backing layer opposite the active pharmaceutical ingredient layer; wherein
the tamper-evidencing element is disposed between the at least one backing layer and the at least one active pharmaceutical ingredient layer.
3 . The patch of claim 1 , wherein the patch comprises at least one active pharmaceutical ingredient layer comprising at least one active pharmaceutical ingredient and the tamper-evidencing element.
4 . The patch of claim 1 , further comprising a circuit that is electronically connected to the antenna, the circuit comprising a transponder chip for storing and transmitting at least one piece of information.
5 . The patch of claim 4 , wherein at least one piece of information is a first electronically readable feature when the tamper-evidencing element is in the first state and a second piece of information when the tamper-evidencing element is in the second state.
6 . The patch of claim 4 , wherein the at least one piece of information is either (1) associated with the identity of the patch; (2) associated with the identity of a patient to whom the patch is prescribed; or (3) associated with both the identity of the patch and the identity of a patient to whom the patch is prescribed.
7 . The patch of claim 1 , wherein the antenna is a near-field antenna.
8 . The patch of claim 1 , wherein the patch further comprises at least one microneedle protruding from a first major surface of the patch.
9 . The patch of claim 1 , wherein the patch further comprises at least one skin-contact adhesive disposed thereon.
10 . The patch of claim 1 , wherein the tamper-evidencing element is a dissolvable or degradable element.
11 . The patch of claim 1 , wherein the tamper-evidencing element is a swellable element.
12 . The patch of claim 4 , wherein the resistance or impedance of the circuit changes by at least a factor of 5 when the tamper-evidencing element is contacted by a solvent, wherein the solvent is optionally water or a water alcohol mixture.
13 . The patch of claim 4 , wherein the circuit includes at least one analog to digital converter.
14 . The patch of claim 1 , wherein the tamper-evidencing element is a component of the antenna.
15 . The patch of claim 1 , comprising at least two tamper-evidencing elements.
16 . The patch of claim 1 , further comprising a sensing integrated circuit for sensing patient information or patch information.
17 . The patch of claim 1 , wherein the at least one pharmaceutically active ingredient is an opioid pharmaceutical.
18 . The patch of claim 1 , wherein the opioid pharmaceutical is fentanyl.
19 . A method of determining whether a patch was exposed to one or more tampering conditions, comprising:
reading one or more of the at least one electrically readable features of the patch of claim 1 ; and
determining whether the readout provided by the patch is the first readout or the second readout.
20 . The method of claim 19 , wherein the step of reading one or more of the at least one electrically readable features of the patch comprises receiving a near-field electronic signal from the patch.