Salts and solid forms of (R)-1-(5-methoxy-1H-indol-1-yl)-N,N-dimethylpropan-2-amine

Inventors

Duncton, Matthew • Clark, Samuel

Assignees

Terran Biosciences Inc

Abstract

The present disclosure is directed to salt and solid forms of (R)-1-(5-METHOXY-1H-INDOL-1-YL)-N,N-DIMETHYLPROPAN-2-AMINE and methods of treating neurological disorder and/or a psychiatric disorder in a subject in need thereof.

Core Innovation

The disclosure relates to salts and solid forms of (R)-1-(5-methoxy-1H-indol-1-yl)-N,N-dimethylpropan-2-amine, referred to as compound 1, with emphasis on fumarate, including monofumarate and hemifumarate, and on crystalline polymorphic forms of the compound 1 monofumarate salt. The crystalline polymorphic form is characterized by XRPD/PXRD signals at selected 2θ values measured with Cu Kα radiation within stated tolerances, and the identification is supported by extensive XRPD tables, alternative signal combinations, and figure-referenced profiles. The disclosure further distinguishes crystalline polymorphic forms from amorphous forms and uses solvate/hydrate distinctions in solid-state characterization.

The invention further characterizes the crystalline polymorphic salt by orthogonal solid-state metrics including DSC melting signals and TGA onset features. It also describes alternative salt forms of compound 1, including sulfate, ascorbate, mesylate, esylate, phosphate, edisylate, adipate, and tartrate salt, with amorphous/crystalline designation and pattern similarity to specific figures. Example solid-form identifiers are provided for compound 1 monofumarate Form A using XRPD/DSC/TGA characterization and referenced figure/table information.

The disclosure places these solid forms in a pharmaceutical context, including pharmaceutical compositions comprising the disclosed solid forms with pharmaceutically acceptable carrier and/or excipients. It also describes use for brain, neurological, and/or psychiatric disorders, including methods of treatment by administering the disclosed compound 1 solid form to a subject in need.

Claims Coverage

The independent claims cover crystalline polymorphic forms of the compound 1 monofumarate salt defined by XRPD signal sets measured with Cu Kα radiation and stated 2θ tolerances. Across the independent claims, the inventive features center on XRPD-defined polymorph criteria, with dependent claims adding expanded or table-referenced XRPD signal sets, DSC/TGA characterization, pharmaceutical compositions, and treatment methods for brain, neurological, and/or psychiatric disorders.

Overall, claim coverage centers on defining specific crystalline polymorphic forms of compound 1 monofumarate by XRPD signal position criteria under Cu Kα radiation with stated tolerances, with dependent claim refinements that broaden or specify acceptable XRPD signal combinations and add DSC/TGA characterization. The claim set additionally covers pharmaceutical compositions containing the defined salt and therapeutic methods for treating brain, neurological, and/or psychiatric disorders by administration.

Stated Advantages

Documented Applications