TY - JOUR
T1 - Massing in high shear wet granulation can simultaneously improve powder flow and deteriorate powder compaction
T2 - A double-edged sword
AU - Shi, Limin
AU - Feng, Yushi
AU - Sun, Calvin
PY - 2011/5/18
Y1 - 2011/5/18
N2 - The influence of massing during high shear wet granulation (HSWG) process on granule properties and performance was investigated using microcrystalline cellulose (MCC). Massing time varied from 0 to 40 min while other factors were fixed. Granule physical properties, including morphology, size, porosity, and specific surface area (SSA), were characterized. Changes in powder properties were profound in the first 10 min of massing but negligible beyond 10 min. With 10 min of massing, granule tabletability decreased by 75% while flowability increased by 75%. The significantly deteriorated tabletability and improved flowability resulted from dramatic changes in granule morphology, porosity, and SSA. The results confirm that massing time is a key process parameter in HSWG, and it must be carefully evaluated and controlled during process development, scale up, and manufacturing.
AB - The influence of massing during high shear wet granulation (HSWG) process on granule properties and performance was investigated using microcrystalline cellulose (MCC). Massing time varied from 0 to 40 min while other factors were fixed. Granule physical properties, including morphology, size, porosity, and specific surface area (SSA), were characterized. Changes in powder properties were profound in the first 10 min of massing but negligible beyond 10 min. With 10 min of massing, granule tabletability decreased by 75% while flowability increased by 75%. The significantly deteriorated tabletability and improved flowability resulted from dramatic changes in granule morphology, porosity, and SSA. The results confirm that massing time is a key process parameter in HSWG, and it must be carefully evaluated and controlled during process development, scale up, and manufacturing.
KW - Flowability
KW - High shear wet granulation
KW - Massing
KW - Over-granulation
KW - Tabletability
UR - http://www.scopus.com/inward/record.url?scp=79955695532&partnerID=8YFLogxK
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U2 - 10.1016/j.ejps.2011.03.009
DO - 10.1016/j.ejps.2011.03.009
M3 - Article
C2 - 21443948
AN - SCOPUS:79955695532
VL - 43
SP - 50
EP - 56
JO - European Journal of Pharmaceutical Sciences
JF - European Journal of Pharmaceutical Sciences
SN - 0928-0987
IS - 1-2
ER -