Oral CBD Composition Using BCP for Stability and Precise Dosing

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Solution Overview

Problem

Existing oral cannabinoid therapies, particularly those containing cannabidiol (CBD), face challenges such as variable potency, instability during storage, and imprecise dosing due to the presence of impurities like THC, which complicates their use as pharmaceutical products.

Innovation Solution

A stable cannabidiol composition is developed, comprising synthetic CBD with high purity, beta-caryophyllene (BCP) as a solvent, and alpha tocopherol as an antioxidant, along with a mixture of C8 and C10 triglycerides, to maintain stability and reduce THC impurities below 1 ppm, ensuring consistent dosing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If CBD is administered orally in existing formulations, then ease of administration is improved, but stability and dosing precision deteriorate due to degradation and impurities

Engineering Contradiction:
Improveease of administrationVSAvoidstability and dosing precision
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent extracts and removes degradation products (THC, CBN, quinone, CBDO) and impurities from the CBD composition through purification processes, achieving THC levels below 1000 ppm and preferably below 100 ppm. This extraction of harmful components resolves the contradiction by maintaining oral ease of administration while eliminating stability and dosing precision issues caused by degradation products.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the chemical and physical parameters of the CBD composition by establishing specific concentration ranges for CBD (1-35% w/w), antioxidants (0.1-5% w/w), and solvents, along with controlling storage conditions (temperature, light exposure, humidity). These parameter changes maintain formulation stability during storage while preserving oral administrability, thus resolving the contradiction between ease of administration and reliability.

Inventive Principle:
Principle #35Parameter changes

2Duration of action of stationary object

If CBD compositions are stored over time, then duration of action is extended, but potency and effectiveness deteriorate due to conversion to degradation products

Engineering Contradiction:
Improvestorage durationVSAvoidpotency and effectiveness
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The patent applies preliminary action by adding antioxidants (such as vitamin E, vitamin C, or BHT) to the CBD composition before storage, and by purifying the CBD to remove precursors of degradation products. This preliminary protection prevents degradation during storage, allowing extended storage duration while maintaining potency and effectiveness.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent controls storage parameters including temperature (refrigerated or frozen conditions), light exposure (protected from light), and humidity to prevent degradation. By optimizing these parameters, the composition maintains stability over extended storage periods, resolving the contradiction between storage duration and potency retention.

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If THC levels are reduced to below 1000 ppm, then safety and dosing precision are improved, but manufacturing complexity increases

Engineering Contradiction:
Improvesafety and dosing precisionVSAvoidmanufacturing complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent employs extraction and purification techniques such as chromatography, filtration, or crystallization to remove THC and other degradation products from the CBD composition. By systematically extracting harmful impurities to achieve THC levels below 1000 ppm (preferably below 100 ppm), the patent improves safety and dosing precision while managing manufacturing complexity through established purification protocols.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent controls manufacturing parameters including synthesis conditions, purification thresholds, and final formulation specifications to ensure THC levels remain below 1000 ppm. By establishing clear parameter targets and using standardized purification processes, the patent achieves high safety standards without excessive manufacturing complexity.

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 composition provides a stable, safe, and consistent oral delivery of CBD, maintaining potency over time and ensuring minimal THC levels, suitable for pharmaceutical applications.

Implementation Method 1

beta-caryophyllene (BCP) as a solvent

Methodology Applied
Scientific EffectSolvation: Solvation

Implementation Method 2

alpha tocopherol as an antioxidant

Methodology Applied
Scientific EffectAntioxidation: Oxidation

Data Source

PatentEP4028059B1Stable medicinal cannabidiol compositions
Publication Date: 2025.12.24 CARDIOL THERAPEUTICS INC
  • EP4028059B1 patent drawing
  • EP4028059B1 patent drawing
  • EP4028059B1 patent drawing

AI summary

A stable medicinal cannabidiol composition for use in oral delivery, the composition comprising synthetic cannabidiol (CBD) having a purity of at least 99.8 %, preferably at least 99.9 %, together with beta-caryophyllene (BCP) which functions as both a solvent and antioxidant in the present compositions. The compositions further contain at least one additional lipophilic solvent (e.g. medium chain triglycerides (MCT) and coconut oil) and at least one additional antioxidant (e.g. alpha tocopherol (vitamin E)). The composition is substantially free of other cannabinoids, terpenes, solvents, and pharmaceutically active ingredients. Also disclosed are methods of making and stabilizing CBD in an oral composition.