Salt, crystalline form, and method for producing the same

JP2026076262A5Pending Publication Date: 2026-05-25SUMITOMO PHARMA AMERICA INC
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
SUMITOMO PHARMA AMERICA INC
Filing Date
2026-01-23
Publication Date
2026-05-25

AI Technical Summary

Technical Problem

Existing methods for preparing (S)-(4,5-dihydro-7H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine fail to provide a stable and bioavailable pharmaceutical dosage form with reproducible properties, particularly in solid oral formulations, due to challenges in achieving desired polymorphism, crystal size, and morphology.

Method used

The development of (S)-(4,5-dihydro-7H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine hydrochloride crystalline form A, characterized by specific X-ray diffraction peaks and high enantiomeric and chemical purity, is produced through solvent systems involving alkyl alcohols and HCl addition, enabling stable and bioavailable formulations.

Benefits of technology

The crystalline form A ensures high stability, reproducibility, and enhanced bioavailability, facilitating effective treatment of neurological disorders through solid oral dosage forms.

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Abstract

The present invention provides a pharmaceutical formulation for (S)-(4,5-dihydro-7H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine that has high storage stability and is easily bioavailable. [Solution] Salts of (S)-(4,5-dihydro-7H-thieno[2,3-c]pyran-7-yl)-N-methylmethaneamine and various crystalline forms thereof, as well as compositions thereof, pharmaceuticals, pharmaceutically acceptable formulations, and methods for producing the same. Furthermore, compounds containing a specific particle size distribution of crystalline (S)-(4,5-dihydro-7H-thieno[2,3-c]pyran-7-yl)-N-methylmethaneamine HCl and methods for creating and adjusting such particle size distributions are provided.
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