Paraben-free fexofenadine formulation

JP2026501487A5Pending Publication Date: 2026-06-19オペラ ヘルスケア グループ ソシエテ パル アクシオン サンプリフィエ
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
オペラ ヘルスケア グループ ソシエテ パル アクシオン サンプリフィエ
Filing Date
2023-06-19
Publication Date
2026-06-19

AI Technical Summary

Technical Problem

Existing fexofenadine formulations contain parabens, which raise safety concerns, and there is a need for a bioequivalent, paraben-free formulation that maintains stability and solubility while masking the bitter taste.

Method used

A paraben-free fexofenadine formulation with a pH range of 5.8 to 7.0, using fexofenadine zwitterionic dihydrate Form I, a wetting agent, suspending agent, sweetener system, preservative system, and buffer system, including potassium sorbate, domiphen bromide, cetylpyridinium chloride, or sodium benzoate, and a flavoring agent, to maintain stability and solubility.

Benefits of technology

The formulation achieves bioequivalence to current fexofenadine suspensions without parabens, ensuring stability and solubility, while masking the bitter taste and maintaining safety.

✦ Generated by Eureka AI based on patent content.

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Abstract

Fexofenadine zwitterionic dihydrate form I of formula (I) Paraben-free aqueous pharmaceutical suspension formulations and uses thereof are provided, including JPEG2026501487000031.jpg4390. In certain embodiments, the formulations include polypropylene glycol, edetate disodium, potassium sorbate, xanthan gum, poloxamer 407, titanium dioxide, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, artificial raspberry cream flavor, sucrose, xylitol, and purified water. The disclosure also includes methods of making such formulations.
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