HME Cleaner Plus (GMP)

Easy cleaning of hot melt extrusion? Why not!

More than half of New Chemical Entities (NCEs), which have been developed recently, tend to show high crystallinity and poor solubility in water. Solid dispersion is a technique to improve the solubility and bioavailability of these NCEs. Hot-melt extrusion (HME) is one of the main methods to prepare solid dispersions.

Enteric Polymers (e.g. AQOAT®, EUDRAGIT®, Kollicoat® etc.), which are widely used as an enteric coating agent, are useful carriers for solid dispersions and applicable for HME. However, these polymers are insoluble in water and users often have difficulties cleaning their extruder after processing.

HME Cleaner Plus (GMP) is an almost water-soluble purge compound with a micro-cleansing effect which solves this cleaning difficulty for the HME process.HME Cleaner Plus (GMP) provides effective clean-up because of its high detergency and low residual properties. Shin-Etsu developed the HME Cleaner in 2012 as technical material. Based on Shin-Etsu’s formulation, BIOGRUND now offers this cleaner, produced in accordance with IPEC GMP guidelines and meeting all requirements of USP/NF, Ph.Eur. and JP. All ingredients have been used as pharmaceutical excipients including water-soluble cellulose ethers.