Liquid pharmaceutical compositions

By using a liquid drug composition with acetate buffer and sugar stabilizer, the composition of adalimumab was optimized, addressing the stability issues of existing formulations and achieving greater drug stability and reduced formulation complexity.

CN106456538BActive Publication Date: 2026-07-10FRESENIUS KABI DEUTSCHLAND GMBH
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
FRESENIUS KABI DEUTSCHLAND GMBH
Filing Date
2015-05-15
Publication Date
2026-07-10

AI Technical Summary

Technical Problem

The existing adalimumab liquid formulation has poor physical and chemical stability, especially under stress conditions, which can lead to molecular changes, resulting in drug instability and affecting clinical efficacy.

Method used

A liquid drug composition containing adalimumab, acetate buffer, and sugar stabilizer was used, avoiding the use of arginine or limiting its content, and the pH, osmotic pressure, and other parameters of the composition were optimized to improve stability.

Benefits of technology

This improves the long-term stability of adalimumab liquid formulations, ensuring the physical and chemical stability of the drug during production, storage, and transportation, while reducing formulation complexity and cost.

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

The present invention relates to a novel liquid pharmaceutical composition of Adalimumab comprising Adalimumab or its biosimilars, an acetate buffer / system such as sodium acetate / acetic acid and a sugar stabilizer such as trehalose. The combination of components results in a formulation with stability (e.g. upon storage and upon contact stress) comparable to those known in the art and with fewer ingredients. This advantage helps the availability of Adalimumab therapy to become more widespread at a minimum cost and extends the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary drug waste.
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