Epinastine hydrochloride oral dissolving film composition, preparation method therefor, and use thereof

By preparing an oral dissolving film composition of epinastine hydrochloride containing an active drug, a film-forming material, and a taste masking agent, the problems of bitter taste and low tensile strength of existing formulations are solved, providing a highly efficient, stable, and rapidly dissolving drug solution suitable for children and patients with swallowing difficulties.

WO2025218636A1 Publication Date: 2025-10-23SHANGHAI BOCIMED PHARMA CO LTD +1
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Patent Information

Application Number
PCT/CN2025/088836
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-04-16
Filing Date
2025-04-14
Publication Date
2025-10-23

AI Technical Summary

Technical Problem

Existing epinastine hydrochloride preparations have a bitter taste and low tensile strength, making them particularly unsuitable for children and patients with swallowing difficulties.

Method used

An epinastine hydrochloride orally disintegrating film composition was prepared, comprising an active drug, a film-forming material, and a flavor masking agent. A specific ratio of composition and process was used to ensure that the film is thin, disintegrates rapidly, has a good taste, and dissolves in the oral cavity without the need for drinking water.

Benefits of technology

The resulting epinastine hydrochloride orally disintegrating film composition is thin, disintegrates rapidly, is stable, has a good taste, dissolves instantly without water, and is rapidly absorbed orally, making it suitable for children and patients with swallowing difficulties.

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Abstract

Disclosed are an epinastine hydrochloride oral dissolving film composition, a preparation method therefor, and use thereof. The present invention provides an epinastine hydrochloride oral dissolving film composition comprising an active drug, a film-forming material, and a flavoring agent. The active drug is one or more of 3-amino-9,13-dihydro-1H-dibenzo[c,f]-imidazo[1,5-a]azepine hydrochloride, which is represented by formula I, and a solvate thereof. The epinastine hydrochloride oral dissolving film composition of the present invention has the advantages of a small thickness, rapid disintegration, stable properties, good mechanical properties, a pleasant taste, instant oral dissolution without the need for water, and quick oral absorption. Moreover, the composition is uniform in appearance and good in flexibility, and the process is simple; no sedimentation occurs in the process of preparing a film solution; the content uniformity meets the requirement, and the drug loading capacity is high.
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