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Novel Thermosensitive and Mucoadhesive Nasal Hydrogel Containing 5-MeO-DMT Optimized Using Box-Behnken Experimental Design.

Pablo Miranda, Analía Castro, Paola Díaz, Lucía Minini, Florencia Ferraro, Erika Paulsen, Ricardo Faccio, Helena Pardo

Polymers July 29, 2024 DOI: 10.3390/polym16152148 (opens in new tab)

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AI-extracted from the abstract
Characteristics Experimental study with 3 × 3 Box-Behnken design Peer reviewed
Intervention 5-methoxy-N
Duration 5 hours in vitro release
Topics 5-MeO-DMT DMT
Keywords Drug delivery systems Nasal drug administration Thermosensitive polymers Pharmaceutical formulations Controlled release technology Hpmc Poloxamer 188 Poloxamer 407 Intranasal formulation Sustained release Tryptamines
Citations 5
Key findings The optimized thermosensitive mucoadhesive hydrogel achieves sustained release of 73.76% of the drug after 5 hours in vitro, with a gelling temperature around 32 °C, viscosity near 100 mPas, and mucoadhesion of about 4.20 N·m.

Abstract

We present the development and characterization of a nasal drug delivery system comprised of a thermosensitive mucoadhesive hydrogel based on a mixture of the polymers Poloxamer 407, Poloxamer 188 and Hydroxypropyl-methylcellulose, and the psychedelic drug 5-methoxy-N,-N-dimethyltryptamine. The development relied on a 3 × 3 Box-Behnken experimental design, focusing on optimizing gelification temperature, viscosity and mucoadhesion. The primary objective of this work was to tailor the formulation for efficient nasal drug delivery. This would increase contact time between the hydrogel and the mucosa while preserving normal ciliary functioning. Following optimization, the final formulation underwent characterization through an examination of the in vitro drug release profile via dialysis under sink conditions. Additionally, homogeneity of its composition was assessed using Raman Confocal Spectroscopy. The results demonstrate complete mixing of drug and polymers within the hydrogel matrix. Furthermore, the formulation exhibits sustained release profile, with 73.76% of the drug being delivered after 5 h in vitro. This will enable future studies to assess the possibility of using this formulation to treat certain mental disorders. We have successfully developed a promising thermosensitive and mucoadhesive hydrogel with a gelling temperature of around 32 °C, a viscosity close to 100 mPas and a mucoadhesion of nearly 4.20 N·m.

Comparable studies

Other experimental studies on 5-MeO-DMT, most cited first.

Study Year Design Participants
Short term changes in the proteome of human cerebral organoids induced by 5-MeO-DMT. Human cerebral organoids 2017 Experimental study
Bufo alvarius: a potent hallucinogen of animal origin. Bufo alvarius toad venom 1994 Experimental study
Prospective examination of synthetic 5-methoxy-N,N-dimethyltryptamine inhalation: effects on salivary IL-6, cortisol levels, affect, and non-judgment Volunteers 2019 Within-subjects experimental study n = 11
Unmasking of a neonatal somatovesical reflex in adult cats by the serotonin autoreceptor agonist 5-methoxy-N,N-dimethyltryptamine. Adult cats 1990 Experimental study n = 10
Studies on the Mechanism of Action of Monoamine Oxidase: Metabolism of N,N-Dimethyltryptamine and N,N-Dimethyltryptamine-N-Oxide 1962 Experimental study

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5-MeO-DMT DMT