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pps proceeding
Symposium: Polymer Processing in Pharmacy
Oral Presentation
 
 

Micro Pelletizing of Pharmaceutical HME Formulations Using a Die Face Pelletizer

Witschnigg Andreas (1), Koscher Gerold (1), Treffer Daniel (2), Mürb Reinhardt (3), Laske Stephan (1), Khinast Johannes (1)*

(1) Research Center Pharmaceutical Engineering - Styria - Austria, (2) Technical University Graz, Institute for Process and Particle Engineering - Graz - Austria, (3) Automatik Plastics Machinery GmbH - Bayern - Germany

Hot melt extrusion (HME) is increasingly used in the pharmaceutical industry as it has significant potential for overcoming challenges associated with poorly soluble drug molecules via amorphous solid dispersion (ASD) formation. Due to the increased solubility ASDs show significant higher bioavailability which is an important benefit for the patients. Beside this strong argument, HME as inherent continuous process provides also improved efficiency and reduced operational costs compared with standard pharmaceutical batch processes. After HME the material is often pelletized for further application. Such pellets, which are intermediates for tablet compaction, capsule filling or injection molding can be produced either by die face pelletizing or strand pelletizing. Die face pelletizing is executed with a rotating knife pressed on the extrusion die plate. Here, the material is in a viscous state during cutting and can deform due to surface tension into rounded pellets. These spherical pellets have a better flowability and enhance dosing accuracy in subsequent handling steps. The dosing accuracy can be further improved if micro pellets are used. Usually pellets are conveyed with a cooling air stream to the product container. Air-cooled die face pelletizing is however limited to few formulations due to stickiness. The problem of melt stickiness becomes even more serious if micro pellets are used due to the higher surface to volume ratio. Further studies showed that a thermally decoupling of the die face from the melt flow channel avoids agglomeration due to a lower surface temperature. The novel designed die face pelletizer (Automatik Plastics Machinery GmbH, Sphero®-THA) was incorporated into a HME line to produce spherical micro pellets from sticky pharmaceutical polymers. The present study shows different cases of application where micro pellets could successfully be produced using the described technology.