Ipsen Pharma's Montmorillonite Oral Suspension Approved in China for Gastrointestinal Disorders

On February 24, the latest announcement on the official website of China's National Medical Products Administration (NMPA) revealed that the marketing application for Ipsen Pharma's Category 5.1 new drug, Montmorillonite Suspension, has been approved. According to literature reports, montmorillonite is an excellent gastrointestinal mucosal protective agent, commonly used to treat gastrointestinal conditions such as acute and chronic diarrhea in adults and children.

Screenshot source: NMPA official website

Public data shows that montmorillonite, a layered mineral composed of extremely fine particles of hydrated aluminum silicate, is widely used in the pharmaceutical field for diarrhea relief. Many cases of chronic diarrhea, despite having various causes, are all associated with damage to the intestinal mucosal barrier. The gastrointestinal mucosa forms a crucial barrier where numerous microorganisms and environmental antigens come into close contact with the host immune system, and damage to this barrier is linked to various diseases.

According to publicly available data from Ipsen, montmorillonite has a certain protective and reparative effect on the four major barriers of the intestinal mucosa (i.e., biological barrier, chemical barrier, mechanical barrier, and immune barrier). For example, within the biological barrier, montmorillonite facilitates the colonization of beneficial bacteria and can bind with harmful bacterial toxins as well as inhibit their colonization. Within the chemical barrier, after diarrhea leads to the loss of the mucus layer, montmorillonite acts as a substitute for the chemical barrier while also promoting tight junctions between epithelial cells.

Currently, the more mature products of montmorillonite in clinical applications mainly include montmorillonite powder. There are also various formulations such as dispersible tablets, granules, and suspensions. Among them, suspension-type preparations generally refer to liquid preparations forming a non-uniform dispersion system with insoluble drug particles dispersed in a liquid medium, where the particle size is relatively larger compared to solutions. This type of formulation can address the challenges faced when poorly soluble drugs need to be made into liquid preparations for clinical use.

The product recently approved for Ipsen in China is a montmorillonite suspension. According to publicly available information, it is a natural montmorillonite microparticle powder with a layered structure and non-uniform charge distribution. It not only immobilizes and suppresses viruses, bacteria, and the toxins and gases they produce in the digestive tract but also has the effect of balancing normal flora and providing local pain relief.

We hope that the approval of Ipsen's montmorillonite suspension will bring more treatment options and clinical benefits to patients.

References:

[1] Information on Pending Drug Approval Documents Released on February 24, 2022. Retrieved Feb 24, 2022, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20220224084133178.html

[2] All About Infectious Diarrhea. Retrieved Jun 5, 2019, from https://mp.weixin.qq.com/s/nvUNXqeZpxOF4FxTO10jew

▽Follow 【WuXi AppTec】Germany】WeChat Official Account