title: An investigation of the influence of process and formulation variables on mechanical properties of high shear granules using design of experiment.
abstract: Being able to predict the properties of granules from the knowledge of the process and formulation variables is what most industries are striving for. This research uses experimental design to investigate the effect of process variables and formulation variables on mechanical properties of pharmaceutical granules manufactured from a classical blend of lactose and starch using hydroxypropyl cellulose (HPC) as the binder. The process parameters investigated were granulation time and impeller speed whilst the formulation variables were starch-to-lactose ratio and HPC concentration. The granule properties investigated include granule packing coefficient and granule strength. The effect of some components of the formulation on mechanical properties would also depend on the process variables used in granulation process. This implies that by subjecting the same formulation to different process conditions results in products with different properties.
authors.affiliation: Particle Products Group, Department of Chemical and Biological Engineering, The University of Sheffield, Mappin Street, Sheffield S1 3JD, UK. c.mangwandi@shef.ac.uk
authors.forename: Chirangano
authors.initials: C
authors.lastname: Mangwandi
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Adams
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Hounslow
authors.forename: Agba D
authors.initials: AD
authors.lastname: Salman
mesh_terms: D000465:Algorithms; D000704:Analysis of Variance; D002110:Caffeine / Q000008:administration & dosage / Q000737:chemistry; D002482:Cellulose / Q000031:analogs & derivatives; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation* / Q000379:methods*; D003890:Desiccation; D004867:Equipment Design / Q000379:methods*; D005079:Excipients; D006244:Hardness; D007785:Lactose; D055595:Mechanical Phenomena; D015233:Models, Statistical; D010316:Particle Size; D011208:Powders; D012044:Regression Analysis; D033081:Shear Strength; D013213:Starch; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D005079:Excipients; D011208:Powders; D002110:Caffeine; D002482:Cellulose; D013213:Starch; C008079:hydroxypropylcellulose; D007785:Lactose