Aqueous Oral Dronabinol Formulation for Stable, Consistent Absorption
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Solution Overview
Problem
Current cannabinoid formulations, particularly dronabinol gelatin capsules, are unstable at room or refrigerated temperatures and exhibit high inter-subject variability in in vivo absorption, lacking a stable and efficient delivery system.
Innovation Solution
An aqueous-based oral cannabinoid solution comprising water, alcohol, and propylene glycol, with added antioxidants and stabilizers, providing improved stability and reduced inter-subject variability, allowing for faster onset and more consistent absorption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gelatin capsule formulations are used, then the cannabinoid formulation is simple to manufacture, but the formulation is unstable at room or refrigerated temperatures and exhibits high inter-subject variability in absorption
Solution Approach 1:
The patent changes the physical and chemical parameters of the formulation by transitioning from gelatin capsules to an aqueous-based liquid solution containing specific concentrations of alcohol (15-65% w/w), propylene glycol (5-21% w/w), and water (33% w/w or less). This parameter change enables the formulation to maintain stability at room or refrigerated temperatures while improving in vivo absorption consistency, as evidenced by reduced inter-subject variability in pharmacokinetic parameters
Solution Approach 2:
The patent employs a composite formulation system combining multiple solvents and co-solvents (alcohol, propylene glycol, water) with cannabinoids. This composite material approach creates a synergistic system where each component contributes to overall stability and absorption: alcohol provides solubility, propylene glycol enhances stability, and water enables aqueous-based formulation. The composite nature of this formulation resolves the contradiction by achieving both reliability and manageable complexity
2Productivity
If conventional oral cannabinoid formulations are used, then the administration is simple, but the in vivo absorption shows high inter-subject variability and slower onset
Solution Approach 1:
The patent modifies the absorption characteristics by changing the formulation from gelatin capsules to an aqueous-based liquid solution with specific solvent compositions. This parameter change results in faster onset of action and more consistent absorption, as demonstrated by improved pharmacokinetic parameters including reduced inter-subject variability and accelerated time to maximum concentration (Tmax), thereby simultaneously improving productivity and reliability of absorption
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 formulation maintains cannabinoid stability for at least 18 months, offers lower inter-subject variability, and achieves faster and more consistent in vivo absorption compared to gelatin capsules.
Implementation Method 1
an aqueous-based oral cannabinoid solution comprising water, alcohol and propylene glycol
Implementation Method 2
an aqueous-based oral cannabinoid solution comprising water, alcohol and propylene glycol that is stable at room or refrigerated temperatures
Data Source
AI summary
Oral cannabinoid formulations, including an aqueous-based oral dronabinol solution, that are stable at room or refrigerated temperatures and may possess improved in vivo absorption profiles with faster onset and lower inter-subject variability.