Transdermal CBD Delivery for DEE Seizures and Behavioral Impairment

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Solution Overview

Problem

Current treatments for developmental and epileptic encephalopathies, such as Lennox-Gastaut and Dravet Syndromes, fail to address behavioral problems and are associated with unwanted side effects like somnolence, lethargy, and sedation, while existing oral CBD formulations face gastrointestinal issues and psychoactive effects.

Innovation Solution

Transdermal administration of cannabidiol (CBD) in the range of 750 mg to 1000 mg daily, formulated as a gel, cream, salve, lotion, or ointment, to treat behavioral problems and seizures in subjects with developmental and epileptic encephalopathy, including SYNGAP1 encephalopathy, reducing adverse events like somnolence and avoiding first-pass liver metabolism.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If oral CBD formulations are used to treat seizures in developmental and epileptic encephalopathy, then seizure frequency is reduced, but gastrointestinal adverse events and psychoactive effects occur

Engineering Contradiction:
Improveseizure treatment efficacyVSAvoidgastrointestinal adverse events and psychoactive effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses transdermal delivery as an intermediary route to administer CBD, avoiding the gastrointestinal tract and first-pass liver metabolism. The gel formulation applied to the skin serves as a mediator that enables CBD to enter systemic circulation through the dermal layer, thereby achieving seizure control without gastrointestinal adverse events or psychoactive effects from THC degradation

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the oral administration route with transdermal delivery. Instead of swallowing CBD capsules or solution that must pass through the digestive system, the CBD is delivered through the skin via gel application, substituting the mechanical process of ingestion and gastrointestinal processing with a transdermal absorption mechanism

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Adaptability or versatility

If oral CBD is administered to treat behavioral problems and seizures, then both conditions are addressed, but somnolence, lethargy, and sedation occur as side effects

Engineering Contradiction:
Improvetreatment coverage for behavioral problems and seizuresVSAvoidsomnolence, lethargy, and sedation
Core Design Contradiction:
Adaptability or versatilityVSObject-generated harmful factors

Solution Approach 1:

The transdermal gel acts as an intermediary delivery system that bypasses the gastrointestinal tract and hepatic first-pass metabolism. This alternative route of administration allows CBD to achieve therapeutic levels for treating both behavioral problems and seizures without metabolizing into compounds that cause somnolence, lethargy, or sedation

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If oral CBD is used to treat epilepsy, then seizure control is achieved, but CBD degrades in gastric acid into THC causing unwanted psychoactive effects

Engineering Contradiction:
Improveseizure controlVSAvoidpsychoactive effects from THC degradation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The transdermal delivery system serves as an intermediary pathway that circumvents the gastrointestinal environment. CBD is absorbed through the skin and enters systemic circulation directly, avoiding exposure to gastric acid that would otherwise degrade CBD into psychoactive THC

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent substitutes the oral ingestion pathway with transdermal absorption. Instead of CBD passing through the gastrointestinal tract where acid degradation occurs, the drug is delivered through the skin, replacing the problematic mechanical and chemical environment of the digestive system with a gentler transdermal absorption process

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

Transdermal CBD effectively reduces seizure frequency by 44% to 58% and improves behavioral deficits, mood, engagement, learning ability, and alertness, while minimizing adverse events like somnolence and gastrointestinal issues.

Implementation Method 1

transdermal administration of cannabidiol (CBD) in the range of 750 mg to 1000 mg daily, formulated as a gel, cream, salve, lotion, or ointment

Methodology Applied
Scientific EffectTransdermal delivery: Permeation

Implementation Method 2

avoiding first-pass liver metabolism

Methodology Applied
Scientific EffectAvoiding first-pass metabolism:

Data Source

PatentEP4031119B1Transdermal treatment of behavioral impairment in developmental and epileptic encephalopathy with cbd
Publication Date: 2025.12.17 HARMONY BIOSCIENCES MANAGEMENT INC
  • EP4031119B1 patent drawingFigure 1

AI summary

The present technology relates to methods of treating behavioral problems and seizures in a subject having developmental and epileptic encephalopathy (DEE) by transdermally administering an effective amount of cannabidiol (CBD) to the subject wherein behavioral problems are treated in the subject.