Multiple particles

JP2025524357A5Pending Publication Date: 2026-06-15ARTELO BIOSCIENCES LTD
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Patent Information

Application Number
JP2024572176
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-06-07
Filing Date
2023-06-07
Publication Date
2026-06-15

AI Technical Summary

Technical Problem

Developing a pharmaceutical composition of N-(2-(tert-butyl)-1-((4,4-difluorocyclohexyl)methyl)-1H-benzimidazol-5-yl)ethanesulfonamide (Compound I) that requires very low therapeutic doses poses challenges due to its poor flowability and cohesion, leading to segregation and uniformity issues, along with instability in solution, making it difficult to achieve uniform distribution and stability during manufacturing.

Method used

The composition involves forming granules using a wet granulation process with pharmaceutically acceptable excipients like diluents, binders, and disintegrants, ensuring uniform distribution and stability of Compound I, which are then formulated into immediate-release oral dosage forms.

Benefits of technology

The granulation process ensures consistent and stable delivery of Compound I, maintaining content uniformity and physical/chemical stability, facilitating optimal absorption and patient safety.

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Abstract

The present disclosure relates to a plurality of granules containing N-(2-(tert-butyl)-1-((4,4-difluorocyclohexyl)methyl)-1H-benzimidazol-5-yl)ethanesulfonamide or a pharmaceutically acceptable salt thereof as an active substance. The plurality of granules are suitable for use in a pharmaceutical composition. The pharmaceutical composition is suitable for use in the treatment of medical conditions in which treatment with an agonist of the CB1 / CB2 receptor is beneficial.
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