Polyurethane Stabilized Amphetamine Transdermal Compositions

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Solution Overview

Problem

Transdermal drug delivery compositions for amphetamine face challenges in stability against degradation products, such as phenyl acetone, which reduces the effective amphetamine content and impairs efficacy.

Innovation Solution

Incorporating polyurethane in the polymer matrix or adjacent layers of transdermal drug delivery compositions for amphetamine, formulated with specific isocyanates and polyols, effectively controls the formation of phenyl acetone, maintaining stability and efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If transdermal drug delivery compositions are formulated with amphetamine, then therapeutic efficacy for CNS stimulation is achieved, but degradation products such as phenyl acetone form reducing stability

Engineering Contradiction:
Improvestability against degradation productsVSAvoidformation of phenyl acetone
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent introduces polyurethane as an intermediary substance in the transdermal delivery composition. The polyurethane acts as a protective mediator that interferes with the degradation pathway of amphetamine, preventing the formation of phenyl acetone without interfering with the therapeutic action of amphetamine. This resolves the contradiction by adding a third component that protects the active ingredient from degradation.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent creates a composite transdermal delivery system combining amphetamine with polyurethane materials. This composite formulation integrates the active drug with a stabilizing polymer matrix, where the polyurethane components work synergistically to maintain amphetamine stability while enabling transdermal delivery. The composite structure prevents degradation while preserving therapeutic efficacy.

Inventive Principle:
Principle #40Composite materials

2Reliability

If polyurethane is added to control phenyl acetone formation, then stability is improved, but composition complexity increases

Engineering Contradiction:
Improvestability against degradation productsVSAvoidcomposition complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The polyurethane component serves multiple functions simultaneously: it acts as a structural matrix for the transdermal delivery system, provides stabilization against amphetamine degradation, and controls the release profile of the drug. By making the polyurethane multi-functional, the patent avoids adding separate components for each function, thereby limiting the increase in composition complexity while achieving stability enhancement.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent merges the stabilizing function with the existing polyurethane structural components of the transdermal system. Rather than adding a separate stabilizing agent, the polyurethane material is formulated to perform both structural and protective roles. This consolidation reduces the number of discrete components needed, minimizing complexity increases while maintaining stability benefits.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentEP3086783B1Compositions and methods for transdermal delivery of amphetamine
Publication Date: 2018.08.29 NOVEN PHARMACEUTICALS INC
  • EP3086783B1 patent drawing

AI summary

Described are transdermal drug delivery compositions comprising amphetamine, methods of manufacturing transdermal drug delivery compositions comprising amphetamine, and therapeutic methods using transdermal drug delivery compositions comprising amphetamine, such as may be desired for achieving central nervous system stimulation, such as for the treatment of attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), or for the treatment of narcolepsy. In some embodiments, the compositions comprise an amount of polyurethane effective to control the presence of and/or prevent the formation of phenyl acetone in the compositions. The polyurethane may be present in a drug-containing polymer matrix or in a backing adjacent the drug-containing polymer matrix.