Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 50-56 |
| Number of pages | 7 |
| Journal | European Journal of Pharmaceutical Sciences |
| Volume | 43 |
| Issue number | 1-2 |
| DOIs | |
| State | Published - May 18 2011 |
Bibliographical note
Funding Information:This work is supported by the Dane O. Kildsig Center for Pharmaceutical Processing Research (CPPR) and University of Minnesota (Grant-in-aid). We thank Drs. Chetan Pujara of Allergan and Francisco Alvarez of Amgen for helpful suggestions.
Copyright:
Copyright 2011 Elsevier B.V., All rights reserved.
Keywords
- Flowability
- High shear wet granulation
- Massing
- Over-granulation
- Tabletability