Transdermal CBD Gel for Sleep Apnea Treatment

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Solution Overview

Problem

Current treatments for refractory seizures and sleep disturbances in patients with developmental and epileptic encephalopathies (DEE) and Autism Spectrum Disorder (ASD) are inadequate, often causing side effects like somnolence, sedation, and are not effective in reducing seizure frequency or improving sleep quality.

Innovation Solution

Transdermal administration of cannabidiol (CBD) in the form of ZYN002, a synthetic CBD gel formulation, which is administered in effective amounts ranging from 250 mg to 1000 mg daily, to treat refractory seizures and improve sleep-related impairments, including sleep quality and sleep breathing disorders.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If oral CBD is administered to treat refractory seizures, then seizure frequency is reduced, but gastrointestinal adverse events and somnolence occur

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

Solution Approach 1:

The patent introduces a transdermal delivery system as an intermediary between the CBD and the body's internal systems. This mediator allows CBD to enter the bloodstream through the skin, bypassing the gastrointestinal tract entirely and avoiding first-pass metabolism, thereby eliminating GI adverse events and reducing somnolence while maintaining antiseizure efficacy

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the oral administration route (mechanical ingestion and gastrointestinal processing) with a transdermal delivery system. This substitution eliminates the need for the CBD to pass through the digestive system, thereby avoiding gastrointestinal side effects and hepatic first-pass metabolism that cause somnolence

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

2Reliability

If oral CBD is administered to treat sleep disturbances, then sleep quality may improve, but degradation into THC occurs causing psychoactive effects

Engineering Contradiction:
Improvesleep disturbance treatmentVSAvoidpsychoactive effects from THC degradation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The transdermal delivery system acts as an intermediary that protects CBD from gastric acid degradation. By delivering CBD directly through the skin into the bloodstream, the system prevents the chemical transformation of CBD into THC that occurs in the acidic gastric environment, thereby eliminating unwanted psychoactive effects while preserving sleep benefit

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If multiple antiseizure medications are administered to treat refractory epilepsy, then seizure control may improve, but quality of life declines due to side effects

Engineering Contradiction:
Improveseizure controlVSAvoidside effects reducing quality of life
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the therapeutic CBD component from the problematic oral administration route and delivers it through the transdermal system. This isolation of the active ingredient from the gastrointestinal pathway eliminates the side effects associated with oral CBD and multiple medication regimens while maintaining seizure control efficacy

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the delivery parameter from oral to transdermal, which fundamentally alters the pharmacokinetic profile of CBD. This parameter change results in different blood concentration patterns that achieve seizure control without the cumulative side effects of multiple oral antiseizure medications

Inventive Principle:
Principle #35Parameter changes

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

The transdermal CBD administration significantly reduces seizure frequency, improves sleep quality, and decreases the occurrence of sleep breathing disorders, such as sleep apnea, without causing excessive somnolence or addiction, thereby enhancing the quality of life for patients with DEE and ASD.

Implementation Method 1

transdermally administering an effective amount of cannabidiol (CBD) to a subject in need thereof

Methodology Applied
Scientific EffectTransdermal delivery: Permeation

Data Source

PatentUS20240307418A1Treatment of sleep apnea with cbd
Publication Date: 2024.09.19 ZYNERBA PHARMACEUTICALS INC
  • US20240307418A1 patent drawing
  • US20240307418A1 patent drawing
  • US20240307418A1 patent drawing

AI summary

Provided are methods of treating sleep disorders in patients by transdermally administering an effective amount of cannabidiol (CBD) to a subject in need thereof.