FGFR4 inhibitor compositions, methods for producing the same, and pharmaceutical uses

The FGFR4 inhibitor composition, using specific fillers and carriers, enhances the fluidity and dissolution of the compound, addressing industrial production issues and meeting clinical research needs.

JP2026520585APending Publication Date: 2026-06-23ABBISKO THERAPEUTICS CO LTD
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
ABBISKO THERAPEUTICS CO LTD
Filing Date
2024-06-07
Publication Date
2026-06-23

AI Technical Summary

Technical Problem

The dissolution characteristics and fluidity of the FGFR4 inhibitor compound p-toluenesulfonate are unsatisfactory, making industrial production difficult and hindering clinical formulation development.

Method used

A pharmaceutical composition comprising a compound of formula (I) as the active ingredient, combined with pharmaceutically acceptable fillers and carriers such as calcium hydrogen phosphate, mannitol, lactose, and microcrystalline cellulose, optimized through processes like wet granulation to improve fluidity and dissolution, ensuring uniformity and stability.

Benefits of technology

The composition achieves improved drug dissolution rates, uniformity, and physicochemical stability, suitable for industrial production and clinical research, addressing the challenges of formulation development.

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Abstract

The present invention relates to an FGFR4 inhibitor composition, a method for producing the same, and a pharmaceutical use thereof, wherein the FGFR4 inhibitor composition contains a compound free base or an acidic salt thereof represented by formula (I) having the following structure as an active ingredient, employs appropriate fillers and other pharmaceutically acceptable carriers, and develops a formulation process suitable for industrial production, thereby enabling the creation of a drug formulation that satisfies clinical needs in terms of drug fluidity, dissolution rate, uniformity of content, content of related substances, and physicochemical stability. This is expected to meet the needs of clinical research and drug market introduction, solve the problem of drug access, and accelerate the development of a new generation of FGFR4 inhibitors. [Case 1] TIFF2026520585000049.tif60169
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