Transdermal CBD Delivery Matrix With Supersaturated Mineral Oil
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Solution Overview
Problem
Transdermal delivery of cannabidiol (CBD) is limited by its lipophilic properties, leading to low flux through human skin, which affects dosing and delivery efficiency in existing transdermal delivery systems.
Innovation Solution
A transdermal delivery device (TDD) comprising a backing layer and a matrix of polyisobutylene (PIB) adhesive, mineral oil, and cannabidiol (CBD) with a 'saturated-plus-excess' composition, where the matrix contains at least threefold more CBD than the maximum solubility in the oil, ensuring a constant CBD concentration proximate to the skin for uniform delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If transdermal delivery systems use conventional formulations with CBD dissolved in oil or PIB matrix, then the device structure is simple and easy to manufacture, but the CBD flux through skin is limited to approximately 100-230 μg/cm² over 24 hours
Solution Approach 1:
The patent changes the concentration parameter of CBD in the matrix from conventional saturation levels to supersaturation levels (at least threefold more CBD than maximum solubility in the oil phase). This parameter change enables dramatically increased CBD flux (at least 0.5 mg/cm² over 24 hours, representing a 2-6 fold increase over conventional systems) while maintaining the basic patch structure and manufacturing process.
Solution Approach 2:
The patent employs a composite matrix formulation combining PIB adhesive, mineral oil plasticizer, and supersaturated CBD. This composite material system leverages the adhesive properties of PIB, the solubilizing capacity of mineral oil, and the therapeutic payload of CBD to achieve both high flux and practical device performance including skin adherence and controlled delivery.
2Productivity
If the matrix contains high concentration of CBD (at least threefold more than saturation), then CBD delivery rate increases significantly, but the risk of precipitation and formulation instability increases
Solution Approach 1:
The mineral oil acts as an intermediary substance that solubilizes CBD at supersaturating concentrations. The oil phase serves as a mediator between the hydrophobic CBD and the aqueous environment, preventing precipitation while enabling high CBD content (at least threefold more than saturation) in the matrix, thus maintaining both high delivery rate and formulation stability.
Solution Approach 2:
The patent modifies the physical-chemical parameters of the formulation by using specific ratios of PIB to mineral oil and maintaining CBD at supersaturating but controlled concentrations. This parameter optimization allows the system to achieve high CBD delivery rates while preventing crystallization and maintaining long-term formulation stability during storage and application.
3Reliability
If PIB adhesive with high molecular weight (>100 kDa) is used, then skin adherence and matrix stability improve, but CBD diffusion through the matrix may be restricted
Solution Approach 1:
The patent optimizes the molecular weight parameter of PIB adhesive to be greater than 100 kDa, which provides adequate skin adherence and matrix structural stability. Simultaneously, the supersaturated CBD concentration and mineral oil content are adjusted to maintain high diffusion rates, achieving both reliable adherence and high productivity through coordinated parameter optimization.
Solution Approach 2:
The patent creates a composite matrix system where high molecular weight PIB adhesive provides structural integrity and adhesion, while the mineral oil-CBD complex provides the diffusion pathway. This composite approach allows the system to overcome the potential trade-off between adhesive strength and drug diffusion by using the oil phase as the primary diffusion medium rather than relying solely on PIB chain mobility.
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 TDD achieves a CBD flux of at least 0.5 mg/cm² across human skin in 24 hours, with up to 70% of CBD delivered into the bloodstream over 24 hours, significantly surpassing previous systems, and maintains a consistent delivery rate throughout.
Implementation Method 1
The TDD achieves a CBD flux of at least 0.5 mg/cm² across human skin in 24 hours
Implementation Method 2
the matrix contains at least threefold more CBD than the maximum solubility in the oil, ensuring a constant CBD concentration proximate to the skin for uniform delivery
Data Source
AI summary
Transdermal delivery devices (TDDs) that provide an easy-to-use method of delivering a consistent, steady dose of cannabidiol (CBD) are shown and described herein. The TDDs include a backing layer coated with a mixture of CBD, a polyisobutene adhesive, and plasticizer. Methods of making and using the same are also described.