title: Insights into the functionality of pelletization aid in pelletization by extrusion-spheronization.
abstract: This study investigated the particle sizes of pelletization aids from the different wet processing steps of extrusion-spheronization, and their influence on rheological and pellet properties. Three commercial microcrystalline cellulose (MCC) grades, three commercial cross-linked polyvinyl pyrrolidone (X-PVP) grades and two agglomerated X-PVP grades (prepared using roller compaction from two commercial fine particle size X-PVP grades) were used as pelletization aid. The pelletization aids were analyzed for their dry state particle size, individual particle size (sonicated powder dispersion in water) and in-process particle sizes (dispersions of processed materials from the different processing steps). No remarkable particle size changes were observed with the commercial X-PVP grades under the different conditions. The two fine X-PVP grades, but not the coarse grade, produced good quality pellets. MCC and agglomerated X-PVP grades exhibited spectacularly lower individual and in-process particle sizes, and produced good quality pellets although some of them had dry state particle sizes comparable to that of the commercial coarse X-PVP grade. In-process particle sizes of pelletization aids correlated strongly with the rheological and pellet properties of the pelletization aid:lactose (1:3) binary mixtures. These results demonstrated that small in-process particle size of pelletization aid is a critical requirement for successful pelletization by extrusion-spheronization.
authors: GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, Singapore.
authors: Srimanta
authors: S
authors: Sarkar
authors: Paul W S
authors: PW
authors: Heng
authors: Celine V
authors: CV
authors: Liew
mesh_terms: D002482:Cellulose / Q000737:chemistry*; D003432:Cross-Linking Reagents / Q000737:chemistry; D004304:Dosage Forms; D004339:Drug Compounding / Q000379:methods*; D005079:Excipients / Q000737:chemistry*; D010316:Particle Size; D011205:Povidone / Q000737:chemistry*; D012212:Rheology
chemical_list: D003432:Cross-Linking Reagents; D004304:Dosage Forms; D005079:Excipients; D002482:Cellulose; D011205:Povidone; C109691:microcrystalline cellulose