Dronabinol Transdermal Delivery for Steady Plasma Levels
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Solution Overview
Problem
Existing oral administration of dronabinol for nausea and vomiting associated with chemotherapy is inconvenient, dose-related, has interpatient variability, causes psychiatric symptoms, undergoes first-pass hepatic metabolism, and is unstable at room temperature, with previous transdermal delivery systems being impractical and inefficient.
Innovation Solution
A transdermal delivery system for dronabinol using synthetic delta-9-THC in forms like co-crystals, amorphous, or coated formulations, with controlled drug release to achieve steady plasma concentrations and reduced dosing frequency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If oral administration of dronabinol is used to treat nausea and vomiting, then the drug can be delivered systemically, but the drug undergoes first-pass hepatic metabolism and only 10%-20% reaches systemic circulation
Solution Approach 1:
The patent extracts dronabinol from the gastrointestinal tract and hepatic metabolism pathway by delivering it directly through the transdermal route, bypassing the first-pass effect and ensuring more drug reaches systemic circulation
Solution Approach 2:
The patent uses the skin as an intermediary delivery route instead of oral administration, allowing dronabinol to enter systemic circulation directly through transdermal absorption without hepatic first-pass metabolism
2Reliability
If high doses of dronabinol are administered to achieve antiemetic effect, then the therapeutic effect is improved, but the likelihood of disturbing psychiatric symptoms increases
Solution Approach 1:
The patent uses transdermal delivery to dynamically control dronabinol release at steady rates, maintaining therapeutic plasma levels while avoiding the peaks associated with oral dosing that cause psychiatric side effects
Solution Approach 2:
The patent changes the delivery parameters from intermittent oral dosing to continuous transdermal release, achieving stable plasma concentrations that provide therapeutic effect without exceeding thresholds for psychiatric symptoms
3Reliability
If oral capsule dosage regimen is used with frequent dosing, then the therapeutic coverage is improved, but the convenience for patients experiencing nausea and vomiting deteriorates
Solution Approach 1:
The patent provides continuous therapeutic action through transdermal delivery, eliminating the need for frequent oral dosing while maintaining consistent plasma levels for nausea and vomiting prevention
Solution Approach 2:
The patent allows pre-application of the transdermal patch before chemotherapy, providing proactive therapeutic coverage without requiring frequent dosing during the treatment period
4Ease of operation
If dronabinol is stored at room temperature, then the storage convenience is improved, but the drug stability deteriorates due to rapid oxidation and degradation
Solution Approach 1:
The patent uses composite transdermal matrix materials that provide a protective environment for dronabinol, stabilizing the drug at room temperature and preventing oxidation and degradation
Solution Approach 2:
The patent creates an inert protective environment within the transdermal system that shields dronabinol from oxygen and environmental factors, allowing stable storage at room temperature without refrigeration
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
Transdermal delivery provides stable, continuous drug delivery with reduced side effects, overcoming hepatic metabolism, and maintaining consistent plasma levels for extended periods, enhancing patient convenience and compliance.
Implementation Method 1
synthetically produced delta-9-THC consists essentially of uncontaminated delta-9-THC that is not adulterated by the presence of other active cannabidiols. Therefore, the synthetic version of delta-9-THC is able to provide improved transdermal permeability
Implementation Method 2
with controlled drug release to achieve steady plasma concentrations and reduced dosing frequency
Implementation Method 3
After oral administration dronabinol undergoes first pass hepatic metabolism and has high lipid solubility; therefore, of the administered dose 10%-20% reaches systemic circulation
Data Source
AI summary
Provided is a transdermal drug delivery system comprising dronabinol. The dronabinol transdermal delivery system provides a drug plasma concentration at predetermined rate for a predetermined period of time, offering a simplified therapeutic regimen by decreasing dosing frequency for the treatment and/or prevention of nausea and/or vomiting associated with, for example, chemotherapy.