Pharmaceutical composition comprising 5-methoxy-n,n-dimethyltryptamine
Inventors
FEILDING-MELLEN, Cosmo • Mason, Timothy
Assignees
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Publication Number
US-11680044-B2
Publication Date
2023-06-20
Expiration Date
Abstract
An intranasal composition comprising a dosage amount of 50-150 mg/ml 5-methoxy-N,N-dimethyltryptamine (5MeODMT) in a liquid medium, wherein the 5MeODMT is formulated as the chloride salt of 5MeODMT (5MeODMT hydrochloride) and wherein the 5MeODMT hydrochloride is crystalline and characterised by one or more of: peaks in an XRPD diffractogram; an endothermic event in a DSC thermograph; an onset of decomposition in a TGA thermograph; and a DVS isotherm profile.
Core Innovation
The disclosure provides a method of treatment of a patient by administering crystalline 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) hydrochloride. The crystalline 5-MeO-DMT hydrochloride is defined by peaks in an X-ray powder diffraction (XRPD) diffractogram at specific 2θ values as measured using an X-ray wavelength of 1.5406 Å. The patient has depression, an eating disorder, a substance use disorder, an addictive disorder, an obsessive-compulsive disorder, a body dysmorphic disorder, a post-traumatic stress disorder, or anxiety.
The disclosure also describes intranasal pharmaceutical compositions of crystalline 5-methoxy-N,N-dimethyltryptamine (5MeODMT) as the hydrochloride salt in a liquid medium. The crystalline solid-state form is characterized using XRPD peak positions together with DSC/TGA and Dynamic Vapour Sorption (DVS) profiles.
In addition, the disclosure supports salt and solid-form characterization of crystalline lots using XRPD/DSC/TGA/DVS and microscopy. The described pharmaceutical options include pharmaceutically acceptable salts and polymorphs, including “Polymorph A,” and liquid-medium formulation examples for intranasal administration.
Claims Coverage
The independent claim is directed to a method of treatment in which crystalline 5-MeO-DMT hydrochloride is administered for specified psychiatric disorders, where the crystalline material is defined by XRPD diffractogram peak positions at particular 2θ values measured at an X-ray wavelength of 1.5406 Å.
Treatment with XRPD-defined crystalline 5-MeO-DMT hydrochloride
Administering crystalline 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) hydrochloride to a patient, where the crystalline 5-MeO-DMT hydrochloride is characterized by XRPD diffractogram peaks at 2θ values of 9.2°±0.1°, 12.2°±0.1°, 14.1°±0.1°, 15.0°±0.1°, 18.5°±0.1°, and 19.5°±0.1°, as measured using an X-ray wavelength of 1.5406 Å, for a patient having depression, an eating disorder, a substance use disorder, an addictive disorder, an obsessive-compulsive disorder, a body dysmorphic disorder, a post-traumatic stress disorder, or anxiety.
The claim coverage centers on administering XRPD-defined crystalline 5-MeO-DMT hydrochloride to treat specified psychiatric conditions, with refinement in dependent claims by narrowing indications, adding administration-route options, and specifying certain dosing and combination therapy elements.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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