Variable Interval Transdermal Hormone Patch Regimen

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Solution Overview

Problem

Conventional hormone delivery methods for contraception, such as oral administration, often result in inconvenient dosing regimens and side effects like breakthrough bleeding, which can be mitigated by improving the flexibility and efficacy of hormone delivery.

Innovation Solution

A transdermal hormone delivery method involving variable treatment and rest intervals using consecutive applications of progestin and estrogen patches, allowing for flexible duration of treatment and rest periods, with the option to use low-dose hormone patches during rest intervals to minimize side effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If fixed dosing regimens are used for transdermal hormone delivery, then device complexity is reduced and ease of operation is improved, but adaptability to individual user needs deteriorates

Engineering Contradiction:
Improveease of operationVSAvoidadaptability
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The patent implements dynamic dosing regimens where treatment intervals and rest intervals can be varied in length. The system allows users to adjust the duration of treatment periods and rest periods individually, transforming a static fixed-dose system into a flexible dynamic system that adapts to user needs while maintaining operational simplicity through structured guidance.

Inventive Principle:
Principle #15Dynamics

2Reliability

If extended treatment intervals are used, then contraceptive effectiveness is improved, but the duration of continuous hormone exposure increases which may worsen side effects

Engineering Contradiction:
Improvecontraceptive effectivenessVSAvoidside effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs periodic action by implementing defined treatment intervals followed by rest intervals. This creates a cyclical pattern of hormone administration that maintains contraceptive effectiveness during treatment periods while providing regular breaks that reduce cumulative hormone exposure and minimize side effects like breakthrough bleeding.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The system allows parameter changes by enabling variable lengths for both treatment intervals and rest intervals. Users can adjust the duration parameters to optimize between contraceptive reliability and side effect minimization, with the ability to extend treatment intervals for effectiveness while controlling rest interval lengths to manage hormone exposure.

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If complete hormone cessation during rest intervals is implemented, then withdrawal symptoms are reduced, but contraceptive protection may be compromised at interval boundaries

Engineering Contradiction:
Improvewithdrawal symptomsVSAvoidcontraceptive protection
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent applies partial action by implementing rest intervals that provide partial hormone cessation rather than complete interruption. The low-dose hormones administered during rest intervals are sufficient to attenuate withdrawal symptoms and maintain contraceptive protection at interval boundaries, while being low enough to reduce withdrawal effects compared to full-dose continuous administration.

Inventive Principle:
Principle #16Partial or excessive action

4Adaptability or versatility

If variable dosing regimens are implemented, then adaptability and user control are improved, but device complexity and dosing regimen complexity increase

Engineering Contradiction:
ImproveflexibilityVSAvoiddosing regimen complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent applies segmentation by dividing the dosing regimen into distinct treatment intervals and rest intervals. Each interval type has its own characteristics and duration parameters, allowing the complex variable dosing regimen to be broken down into manageable segments that are easier to understand and implement while maintaining overall flexibility.

Inventive Principle:
Principle #1Segmentation

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach provides a flexible and effective contraceptive method that reduces the risk of pregnancy while minimizing side effects by allowing users to adjust treatment and rest intervals and using low-dose hormone patches to attenuate withdrawal symptoms.

Implementation Method 1

transdermally administering an effective amount of a progestin and, of an estrogen

Methodology Applied
Scientific EffectTransdermal delivery: Permeation

Implementation Method 2

a skin permeation enhancer combination for use therein

Methodology Applied
Scientific EffectSkin permeation enhancement: Permeation

Data Source

PatentEP2343979B1Transdermal delivery
Publication Date: 2020.04.08 AGILE THERAPEUTICS INC
  • EP2343979B1 patent drawingFigure 1a~1b
  • EP2343979B1 patent drawingFigure 1c~1d
  • EP2343979B1 patent drawingFigure 2

AI summary

Dosing regimen for transdermal delivery of hormones comprising a variable treatment cycle and a variable rest interval.