Lactose-free solid oral dosage form of itopride

A mannitol-based itopride formulation addresses lactose intolerance by ensuring rapid drug absorption and bioequivalence, overcoming manufacturing challenges and patient discomfort.

WO2026114514A1PCT designated stage Publication Date: 2026-06-04PRO MED CS PRAHA A S
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-12-01
Publication Date
2026-06-04

AI Technical Summary

Technical Problem

Existing itopride formulations contain lactose, which are unsuitable for patients with lactose intolerance, leading to gastrointestinal discomfort and exacerbating conditions like functional dyspepsia and gastroparesis, and replacing lactose with conventional excipients like microcrystalline cellulose, pregelatinized starch, or fructose results in poor bioavailability and manufacturing issues.

Method used

A lactose-free formulation using mannitol as a filler, combined with povidone as a binder and crospovidone as a disintegrant, achieves rapid dissolution and bioequivalence through high-shear granulation, ensuring compliance and comfort for lactose-intolerant patients.

Benefits of technology

The mannitol-based formulation ensures rapid drug absorption, meets bioequivalence criteria, and is suitable for industrial-scale manufacturing, providing a lactose-free alternative with comparable efficacy to lactose-containing products.

✦ Generated by Eureka AI based on patent content.

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Abstract

An orally swallowable, immediate release tablet, comprising itopride or a pharmaceutically acceptable salt thereof as an active ingredient, characterized in that the tablet comprises granules containing the active ingredient, mannitol and optionally at least one additional pharmaceutically acceptable excipient, wherein the tablet does not contain lactose. Said tablet for use in prevention or treatment of gastrointestinal motility disorders. A method for manufacturing the orally swallowable, immediate release tablet according to any of the preceding claims, comprising: a) granulating itopride or a pharmaceutically acceptable salt thereof with mannitol and optionally at least one additional pharmaceutically acceptable excipient, b) optionally blending the granules obtained in step a) with at least one extra-granular pharmaceutically acceptable excipient, and c) compressing the granules from step a) or the blend from step b) into tablets.
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Citation Information

Patent Citations

  • Itopride hydrochloride orally disintegrating tablets and preparation method thereof

    CN107789331A

  • Itopride hydrochloride pharmaceutical composition

    CN116763749A

  • Stable pharmaceutical composition comprising trimebutine and prokinetic agent

    KR101132977B1

  • Immediate-release and sustained-release pharmaceutical preparation including itopride hydrochloride

    WO2018151580A1