Process optimization for continuous extrusion wet granulation.
Three granulating binders in high drug-load acetaminophen blends were evaluated using high shear granulation and extrusion granulation. A polymethacrylate binder enhanced tablet tensile strength with rapid disintegration in simulated gastric fluid, whereas polyvinylpyrrolidone and hydroxypropyl cellulose binders produced less desirable tablets. Using the polymethacrylate binder, the extrusion granulation process was studied regarding the effects of granulating liquid, injection rate and screw speed on granule properties. A full factorial experimental design was conducted to allow the statistical analysis of interactions between extrusion process parameters. Response variables considered in the study included extruder power consumption (screw loading), granule bulk/tapped density, particle size distribution, tablet hardness, friability, disintegration time and dissolution.
Tan
Li
L
Pfizer Global R&D, Groton Laboratories, Groton, CT 06340, USA.
Carella
Anthony J
AJ
Ren
Yukun
Y
Lo
Julian B
JB
D000082:Acetaminophen / Q000737:chemistry*; D000704:Analysis of Variance; D002482:Cellulose / Q000031:analogs & derivatives / Q000737:chemistry; D004339:Drug Compounding / Q000379:methods*; D005079:Excipients / Q000737:chemistry*; D010316:Particle Size; D011109:Polymethacrylic Acids / Q000737:chemistry*; D011205:Povidone / Q000737:chemistry; D011208:Powders / Q000737:chemistry; D033081:Shear Strength; D012995:Solubility; D013607:Tablets; D013718:Tensile Strength
D005079:Excipients; D011109:Polymethacrylic Acids; D011208:Powders; D013607:Tablets; C030613:polymethacrylic acid; D000082:Acetaminophen; D002482:Cellulose; C008079:hydroxypropylcellulose; D011205:Povidone