5-MeO-DMT Dry Powder Formulation for Intranasal Delivery
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Solution Overview
Problem
Existing formulations of 5-MeO-DMT, particularly intranasal formulations, face challenges such as stability issues, discolouration, and reduced pharmacokinetic properties, making them difficult to develop and administer effectively.
Innovation Solution
A dry blended, free-flowing dry powder formulation comprising 5-MeO-DMT or its pharmaceutically acceptable salt and silicon dioxide, combined with an active nasal delivery device, which provides a desirable nasal deposition profile and improved stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If liquid intranasal formulations of 5-MeO-DMT hydrochloride salt are used, then systemic drug delivery across the blood brain barrier is achieved, but stability issues, discolouration and reduced pharmacokinetic properties occur
Solution Approach 1:
The patent transforms the formulation from liquid to dry powder form, fundamentally changing the physical state parameter. This parameter change eliminates the stability and discolouration issues associated with liquid formulations while maintaining the ability to deliver 5-MeO-DMT across the blood brain barrier through intranasal administration
Solution Approach 2:
The patent creates a composite dry powder formulation combining 5-MeO-DMT hydrochloride salt with specific excipients including silicon dioxide and cellulose derivatives. This composite material approach improves formulation stability and prevents discolouration while maintaining pharmacokinetic properties
2Stability of the object's composition
If dry powder formulations are used to improve stability, then formulation stability is enhanced, but free-flowing properties and nasal deposition profile may be compromised
Solution Approach 1:
The patent introduces silicon dioxide as an intermediary excipient that mediates between the drug substance and the environment. This intermediary prevents direct interaction causing degradation while also providing free-flowing properties essential for dry powder formulation performance and nasal delivery
Solution Approach 2:
The patent optimizes particle size parameters of the dry powder formulation to achieve both stability and free-flowing properties. By controlling particle size distribution and morphology, the formulation maintains stability while ensuring good flow characteristics for nasal administration
3Device complexity
If passive nasal delivery device is used, then device simplicity is maintained, but undesirable nasal deposition profile is produced
Solution Approach 1:
The patent transitions from a passive to an active nasal delivery device, introducing dynamic control capabilities. The active device uses powered mechanisms to control powder release and delivery, achieving the desired nasal deposition profile that cannot be obtained with passive devices while maintaining reasonable complexity
Data Source
AI summary
The present invention provides a dry powder formulation of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable carriers or excipients. The formulations described herein may be used to treat a disease or condition, such as depression or alcohol use disorder in a subject in need thereof.