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

[0009]In one aspect, the invention provides an abuse deterrent or misuse deterrent transdermal patch system comprising a patch hacking layer, wherein one or more aversive agents is incorporated into or irreversibly adhered onto the distal side of the patch backing layer, and wherein the one or more aversive agents exhibits a biphasic or sustained release profile when immersed in a dissolution medium.
[0010]In another aspect, the invention provides an abuse deterrent or misuse deterrent transdermal drug delivery system comprising a patch...

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 transde...

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

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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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