N-n-dimethyltryptamine (DMT) and DMT analog oral transmucosal film compositions, methods of making, and methods of use thereof
The oral transmucosal film compositions of DMT, featuring a polymeric carrier matrix and a backing layer, address the challenges of rapid onset and short duration of action in current DMT delivery methods, achieving a controlled and sustained release of DMT for effective treatment of neurological diseases.
Patent Information
- Application Number
- PCT/US2024/049678
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-05-30
- Filing Date
- 2024-10-02
- Publication Date
- 2025-04-10
AI Technical Summary
Current therapeutic compositions and modes of administration for DMT, such as smoking or intravenous delivery, result in a fast onset and short duration of action, making it challenging to determine an optimal administration regimen for neurological diseases that require sustained therapeutic blood levels of DMT.
Development of oral transmucosal film compositions containing N,N-dimethyltryptamine (DMT) or its pharmaceutically acceptable salts/prodrugs in a polymeric carrier matrix, combined with a backing layer, to enhance transmucosal delivery and stabilize DMT in an amorphous form for extended release.
The oral transmucosal film compositions provide a controlled release of DMT, achieving a Tmax of 0.3 h to 2 h and a Cmax of 5 ng/mL to 80 ng/mL, with an AUCiast of 3 ng h/mL to 70 ng h/mL, thereby potentially offering a more effective and sustained therapeutic effect for neurological diseases.