Multiparticulate Cannabinoid Formulation for 24-Hour Oral Release
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Solution Overview
Problem
Current cannabinoid-based drugs require multiple daily dosing due to short duration of action, leading to poor patient compliance, fluctuating drug levels, and potential toxicity, with no FDA-approved extended release formulations for THC and CBD combinations.
Innovation Solution
Development of multiparticulate solid oral dosage forms, such as capsules and tablets, containing cannabinoids with controlled release profiles up to 24 hours, utilizing porous beads and specific excipients to achieve uniform distribution and targeted pharmacokinetics.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If multiple daily dosing is used to maintain therapeutic drug levels, then the duration of action is extended, but patient compliance deteriorates and toxicity increases due to fluctuating drug levels
Solution Approach 1:
The invention divides the dosage into multiple small particles or pellets within a single oral administration unit. Each particle contains a small amount of cannabinoid compound, and collectively they provide sustained release over 24 hours. This segmentation allows the drug to be released gradually from multiple particles simultaneously, extending the duration of action while maintaining simple once-daily administration.
Solution Approach 2:
The invention uses pre-formulated particles with controlled release properties that are prepared in advance. The particles are designed with specific release characteristics before administration, allowing them to automatically provide sustained drug release without requiring patient intervention. This preliminary preparation of controlled-release particles enables extended duration of action while maintaining ease of administration.
2Reliability
If multiple daily dosing is administered, then therapeutic drug levels are maintained, but drug level fluctuations increase leading to potential toxicity
Solution Approach 1:
The invention achieves continuous drug release over 24 hours through the simultaneous dissolution and release from multiple particles. The controlled release mechanism ensures a steady, continuous supply of drug to the bloodstream, avoiding the peaks and troughs associated with multiple daily dosing. This continuous action maintains stable therapeutic levels while eliminating harmful fluctuations.
3Speed
If conventional immediate-release formulations are used, then the drug acts quickly, but the duration of action is short requiring frequent dosing
Solution Approach 1:
The invention segments the total drug dose into numerous small particles with different release characteristics. Some particles are designed for faster release to provide quick onset, while others release more slowly to extend duration. This segmentation of release rates within a single administration achieves both rapid onset and prolonged action.
Solution Approach 2:
The invention changes the release parameters of the drug by using particles with varying release profiles. By incorporating particles with different dissolution rates and release characteristics, the formulation achieves a biphasic release pattern that provides both rapid initial effect and sustained prolonged action, resolving the contradiction between speed and duration.
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
Provides a once-daily dosing regimen with uniform drug delivery, improving patient compliance and reducing toxicity by stabilizing drug levels, while offering a safer alternative to opioids for treating chronic conditions.
Implementation Method 1
The composition may release the one or more cannabinoids over a period of at least 6 hours or over a period of about 12-24 hours
Implementation Method 2
multiparticulate solid oral dosage forms comprising one or more cannabinoids
Data Source
AI summary
Compositions for the extended release of one or more cannabinoids, in which the compositions comprise a population of particles. Each particle may comprise the one or more cannabinoids, one or more drug-releasing agents, one or more surfactants, and a core. The core may comprise a porous bead. The one or more cannabinoids may comprise Δ9-tetrahydrocannabinol, cannabidiol, or a combination thereof.