DMT and Harmine Non-Peroral Composition for Controlled Release
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Solution Overview
Problem
Current treatments for affective spectrum disorders, particularly depression, are suboptimal in efficacy and require lengthy trial-and-error approaches, with traditional ayahuasca therapies limited by side effects and variability in pharmacokinetic properties, making them unsuitable for clinical use.
Innovation Solution
A pharmaceutical composition comprising N,N-dimethyltryptamine and harmine, administered non-perorally to bypass the gastrointestinal tract, which reduces side effects and improves bioavailability and therapeutic predictability, allowing for incremental dosing to manage peak plasma concentrations and minimize distressing effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional ayahuasca is administered perorally, then the therapeutic effect is achieved, but side effects such as nausea, vomiting, and gastrointestinal discomfort occur
Solution Approach 1:
The patent uses a lipid-based carrier system as an intermediary to deliver DMT and harmine bypassing the gastrointestinal tract. The lipid carrier protects the active ingredients from degradation and enables non-peroral administration, thereby maintaining therapeutic efficacy while eliminating gastrointestinal side effects associated with traditional peroral ayahuasca administration
Solution Approach 2:
The patent changes the administration route parameter from peroral to non-peroral (e.g., intranasal, sublingual, or rectal). This parameter change fundamentally alters the pharmacokinetic profile, avoiding first-pass metabolism and gastrointestinal irritation, thus reducing side effects while preserving the therapeutic antidepressant effect
2Ease of manufacture
If peroral administration is used, then the formulation is simple, but bioavailability is low and pharmacokinetic properties are variable
Solution Approach 1:
The patent creates a composite pharmaceutical formulation combining DMT, harmine, and a lipid-based carrier material. This composite structure enhances bioavailability by protecting the active ingredients from enzymatic degradation, improving solubility, and enabling alternative administration routes, thereby achieving more reliable and predictable pharmacokinetic properties
3Reliability
If high doses are administered to ensure therapeutic effect, then efficacy is improved, but peak plasma concentrations cause distressing effects
Solution Approach 1:
The patent employs incremental dosing strategy where the lipid-based carrier system releases DMT and harmine gradually over time. This periodic release pattern maintains therapeutic plasma concentrations while avoiding sudden peaks that cause distressing effects, allowing for sustained antidepressant efficacy with improved tolerability
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 non-peroral administration of DMT and harmine enhances safety, tolerability, and therapeutic efficacy by reducing nausea, vomiting, and gastrointestinal discomfort, providing a more reliable and sustained antidepressant effect with controlled psychedelic experiences.
Implementation Method 1
combined with β-carbolines (e.g. from Banisteriopsis caapi) that act as selective reversible monoamine oxidase A (MAO-A) inhibitors to prevent degradation of DMT in the body
Data Source
AI summary
The invention relates to a kit of parts comprising N,N-dimethyltryptamine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier; and harmine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. Also provided is a composition comprising N,N-dimethyltryptamine fumarate and harmine hydrochloride. Further, the invention relates to a pharmaceutical composition comprising N,N-dimethyltryptamine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier; and harmine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier.