Technical Report

Hot melt extrusion (HME) is the method to obtain the solid dispersion through amorphousization of powder mixture of API (Active Pharmaceutical Ingredient) and Polymer (as API filler) that goes under the heating, kneading and cooling process. It enables continuous process with no solvent used. It is expected as a new solution to improve the solubility of poorly water-soluble drugs.

It is twin extruder that performs this HME method. Twin extruder is consisted of two screws driven by motor, separable barrels and discharge unit. The material is fed into the temperature-controlled barrel constantly. It receive screw rotation force and barrel heat. As the polymer is softened by heating, API is mixed, dispersed and kneaded rapidly, making solid dispersion in polymer. The kneaded material is pushed out from the discharge port (“die”).



This method is often applied for high active drugs, and containment of equipment is required from an industrial hygiene perspective. It is possible to put Extruder in GloveBox with negative pressure control to handle it safety.

Raw material feeder is installed on the top of GloveBox.,
Extruder and Belt Conveyor to cool down the product are installed inside of GloveBox.

【Material Feed】
ChargePoint, the containment valve, is used to supply the material powder into Screw Feeder under the containment atmosphere.

【Intake and Exhaust Air of Glove Box】
Gas intake and exhausting is done through HEPA filter, and the air passes only one way. Inner pressure is always kept negative to prevent the exposure to highly active powders. In addition, the air flow in the box prevents inner temperature from going up.
HEPA filter for both intake and exhaust air can be replaced safely after being wet down inside of GloveBox via bag-out method.

【Extruder】
The barrels of Extruder are situated in GloveBox. The barrel cover has special design, equipped with spray ball. It can be disassembled after being wet down by using gloves or by opening the barrel cover.

【Material Cooling Belt and Product Collection】
Cooling of the extruded product, disintegration, product collection can be maneuvered inside of GloveBox. The product is packaged in the box and taken out from the bag-out port. The extruder screws can be also replaced inside of GloveBox.

We can provide various containment solution from our longtime experience that fits to your equipment and process.