Roles of granule size in over-granulation during high shear wet granulation

Limin Shi, Yushi Feng, Changquan Calvin Sun

Research output: Contribution to journalArticlepeer-review

38 Scopus citations

Abstract

A mechanistic understanding of the over-granulation problem during high shear wet granulation (HSWG) process can guide efficient development of robust formulation and manufacturing process. Using microcrystalline cellulose (MCC) as a model compound, we demonstrate that size enlargement is an important mechanism for over-granulation in HSWG. A higher granulation water level results in larger granules and lower tabletability. With increasing water, granules enlarge sharply when water level is higher than 65%. Granule tabletability deteriorates with increasing granule size and becomes over-granulated when more than 70% water is used. For a batch of over-granulated granule that is ground and sieved, tabletability of the sieved fractions decreases with increasing granule size. The tabletability of the finest fraction (45-90 μm) is nearly four times that of the largest fraction (300-425 μm). These results show that size reduction can be an effective strategy to address the problem of over-granulation.

Original languageEnglish (US)
Pages (from-to)3322-3325
Number of pages4
JournalJournal of Pharmaceutical Sciences
Volume99
Issue number8
DOIs
StatePublished - Aug 2010

Keywords

  • Granule size
  • High shear wet granulation
  • Microcrystalline cellulose
  • Over-granulation

Fingerprint Dive into the research topics of 'Roles of granule size in over-granulation during high shear wet granulation'. Together they form a unique fingerprint.

Cite this