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Abuse and misuse deterrent transdermal systems

a technology of abuse and misuse, which is applied in the direction of bandages, dressings, drug compositions, etc., can solve the problems of patch misuse, accidental misuse, severe adverse reactions,

Inactive Publication Date: 2017-01-12
4P THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention is about a transdermal patch system that is designed to prevent abuse or misuse. The system includes a patch hacking layer that has a layer of aversive agent incorporated on its surface. The aversive agent has a biphasic or sustained release profile when exposed to a dissolution medium. The system also includes an adhesive drug-containing layer that has the aversive agent incorporated on its surface. This layer is adhered to the patch backing layer, and a permeable release liner is adhered to the adhesive drug-containing layer. The technical effect of this invention is to make the transdermal patch system difficult or unappealing to abuse or misuse.

Problems solved by technology

In addition, many of these drugs are highly potent and are prone to deliberate abuse or accidental misuse that can cause severe adverse reactions if ingested by children or animals.
Accidental misuse can occur when children or animals access fresh patches, patches that fall off the skin of the wearer during treatment, and discarded used patches.
Additionally, if the child or animal is being treated with the transdermal patch, they could misuse the patch via removing and chewing and / or swallowing the patch and receiving the drug in a dangerous bolus dose.
While these technologies may be effective, they have significant drawbacks.
Therefore, much of the art discloses incorporation of the aversive agent in a location in the patch where it is not deliverable transdermally, but can manifest its deterrent effect when the patch is abused.

Method used

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  • Abuse and misuse deterrent transdermal systems
  • Abuse and misuse deterrent transdermal systems
  • Abuse and misuse deterrent transdermal systems

Examples

Experimental program
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Effect test

example 1

[0040] An abuse deterrent system backing for a transdermal patch is prepared using a commercial backing comprising a 50 micrometer polyethylene terephthalate film bound to an ethylene / vinyl acetate film containing dissolved and dispersed aversive agents and aversive agents in dispersed poly(DL-lactide-co-glycolide) microparticles. A mixture of denatonium benzoate (1 weight percent), capsaicin (3 weight percent), and polyvinyl pyrrolidone (3 weight percent; K value 30) are added to ethylene / vinyl acetate copolymer (40 percent VA), The mixture is heated and agitated in the mixing chamber of a kneader extruder until uniform. A 1:3 blend of denatonium benzoate and capsaicin totaling 10 weight percent on a dry basis is dissolved in a 10 weight percent solution of poly(DL-lactide-co-glycolide) in methylene chloride. Microparticles of the aversive agents and PLGA are manufactured via spray drying or oil-in-water emulsion / evaporation and the particles are added at a 20 weight percent loadin...

example 3

[0044] An abuse deterrent system backing for a transdermal patch is prepared using a commercial backing comprising a layer of non-woven polyester adhesively laminated to a layer of dense polyethylene terephthalate film. 2 weight percent denatonium benzoate and 5 weight percent capsaicin and 5 weight percent polyvinyl pyrrolidone (K value 30) are added (on a solids basis) to a 40 weight percent solution of ethylene / vinyl acetate copolymer (40 percent VA) dissolved in methylene chloride. The mixture is agitated until uniform and then cast into a film on the non-woven side of the commercial hacking material and allowed to dry.

[0045]A standard formulation of fentanyl in acrylic adhesive solution used in common subsaturated fentanyl transdermal patches is cast on the dense polyethylene terephthalate film side of the backing and allowed to dry. A 2 mil thick film of hydratable cellulose coated with a silicone release coating is laminated to the dried adhesive fentanyl containing layer. Fi...

example 5

[0047] A misuse deterrent system backing for a transdermal patch is prepared using a commercial backing comprising a 50 micrometer polyethylene terephthalate film bound to an ethylene / vinyl acetate film containing dissolved and dispersed aversive agents and aversive agents in dispersed poly(DL-lactide-co-glycolide) microparticles. A mixture of denatonium benzoate (1 weight percent). capsaicin (3 weight percent), and polyvinyl pyrrolidone (3 weight percent; K value 30) are added to ethylene / vinyl acetate copolymer (40 percent VA). The mixture is heated and agitated in the mixing chamber of a kneader extruder until uniform. A 1:3 blend of denatonium benzoate and capsaicin totaling 10 weight percent on a dry basis is dissolved in a 10 weight percent solution of a starch in water at a temperature above 80° C. Microparticles of the aversive agents and starch are manufactured via spray drying and the particles are added at a 20 weight percent loading to the heated blend of aversive agents...

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Abstract

An abuse deterrent and Misuse deterrent transdermal patch comprising aversive agents incorporated in the backing layer of the patch. The aversive agents can exhibit biphasic or sustained kinetics of release with an immediate portion released rapidly and an extended portion released in a prolonged manner when exposed to a dissolution medium. The prolonged aversive agent release provides deterrence against extraction of drug from fresh and used patches and serves to prevent accidental misuse of used patches by children. The abuse deterrent and misuse deterrent patch systems can be used for transdermal delivery of therapeutically active agents and particularly those drugs that are highly prone to abuse such as opiate and opioid analgesics and stimulants.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of priority from U.S. Provisional Application No. 61 / 930,090 filed Jan. 21, 2014; U.S. Provisional Application No. 61 / 930,104 filed Jan. 21, 2014; U.S. Provisional Application No. 62 / 014,721 filed Jun. 19, 2014; U.S. Provisional Application No. 62 / 014,723 filed Jun. 19, 2014; and U.S. Provisional Application No. 62 / 083,620 filed Nov. 24, 2014, the entirety of all of which are incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention is in the field of transdermal drug delivery, and more particularly transdermal systems that limit the potential for intentional abuse or accidental misuse of the system.BACKGROUND OF THE INVENTION[0003]Transdermal drug delivery systems for single day and multi-day delivery of therapeutic agents have been developed and marketed. Many of these systems are transdermal patches. The patches often contain a significant excess of the therapeutic agent to e...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4468A61K31/167A61K47/18
CPCA61K9/7084A61K31/167A61K31/4468A61K47/18A61K31/4458A61K31/4535A61K31/485A61P25/04A61P25/30A61K9/70C08F214/26C08F214/18A61F13/02A61L15/44
Inventor ENSCORE, DAVID JAMESTAGLIAFERRI, FRANKDAMON, STEVEN PAULSMITHGAULDING, JEFFREY C.
Owner 4P THERAPEUTICS
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