Subcutaneous Cannabinoid Composition for Steady Bioavailability
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Solution Overview
Problem
Cannabinoid-based medications, such as CBD, face challenges with low oral bioavailability, short half-life, and liver toxicity, necessitating alternative administration methods to improve bioavailability and reduce toxicity.
Innovation Solution
A pharmaceutical composition for subcutaneous administration comprising cannabinoids with a concentration of at least 25 grams per liter and viscosity less than 420 centipoise, administered via continuous infusion and optional bolus administration using an ambulatory fluid delivery device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If oral administration is used for cannabinoid-based medications, then the medication can be easily taken, but the bioavailability is low (13-19%) and liver toxicity occurs
Solution Approach 1:
The patent introduces a subcutaneous infusion pump as an intermediary device that delivers cannabinoids directly into the subcutaneous tissue, bypassing the gastrointestinal tract and first-pass liver metabolism. This mediator approach resolves the contradiction by maintaining ease of administration through automated delivery while achieving reliable bioavailability through direct tissue injection.
Solution Approach 2:
The patent replaces the mechanical swallowing process with a subcutaneous injection system. Instead of relying on gastrointestinal absorption mechanisms that result in low bioavailability, the system uses direct tissue penetration and lymphatic absorption, substituting the biological absorption mechanism with a more efficient physical delivery method.
2Ease of operation
If oral administration is used for cannabinoid-based medications, then the medication can be easily taken, but the half-life is short resulting in inconsistent bioavailability
Solution Approach 1:
The patent implements continuous subcutaneous infusion through a pump system that delivers cannabinoids continuously over extended periods. This continuous delivery mechanism eliminates the short half-life problem by maintaining steady plasma concentrations, while the automated system preserves ease of administration by eliminating the need for frequent manual dosing.
3Ease of operation
If oral administration is used for cannabinoid-based medications, then the medication can be easily taken, but liver toxicity is induced under certain dosing regimens
Solution Approach 1:
The patent extracts the cannabinoid delivery from the gastrointestinal tract and directs it straight to the subcutaneous tissue. By taking out the first-pass liver metabolism step entirely from the delivery pathway, the system eliminates liver toxicity while maintaining ease of administration through automated subcutaneous infusion.
4Reliability
If subcutaneous administration is used to improve bioavailability, then bioavailability increases and toxicity reduces, but the composition must maintain specific concentration (≥25 g/L) and viscosity (<420 cP) requirements
Solution Approach 1:
The patent applies parameter changes by formulating cannabinoids with specific concentration (≥25 g/L) and viscosity (<420 cP) characteristics optimized for subcutaneous infusion. These parameter adjustments enable reliable bioavailability while ensuring the formulation can be delivered through standard infusion pumps, balancing manufacturing complexity with clinical effectiveness.
Data Source
AI summary
This application concerns pharmaceutical compositions comprising cannabinoids which are suitable for subcutaneous administration in human subjects. Thus, this application concerns pharmaceutical compositions for subcutaneous administration. The pharmaceutical compositions according to the invention are particularly suitable for subcutaneous administration, which is advantageous for improving bioavailability and reducing toxicity.