Systematic Screening of Compressed ODT Excipients: Cellulosic Versus Non-Cellulosic
Ali Al-Khattawi, Affiong Iyire, Tom Dennison, Eman Dahmash, Clifford J. Bailey, Julian Smith, Peter Rue and Afzal R. Mohammed
Pages 486-500 (15)
The successful development of compressed ODTs utilises low compression forces to create a porous structure
whereby excipients are added to enhance wicking/swelling action or provide strength to the fragile tablet framework. In
this work, a systematic investigation comparing materials from two different categories was employed to understand their
functionality in binary mixture tablets of the most commonly used diluent mannitol. Cellulose based excipients such as
HPC (SSL-SFP), L-HPC (NBD-022) and MCC (Avicel PH-102) were compared with non-cellulosic materials such as
PEO (POLYOX WSR N-10) and Crospovidone (XL-10). Pure excipient properties were studied using Heckel Plot, compressibility
profile, SEM and XRPD, whereas the prepared binary mixture compacts were studied for hardness, disintegration
time and friability. Results from our investigation provide insight into differences encountered in product performance
of ODT upon inclusion of additional materials. For example, non-cellulosic excipients Polyox and Crospovidone
showed higher plasticity (Py values 588 and 450MPa) in pure form but not in binary mixtures of mannitol. Cellulosic
excipients, nonetheless, offer faster disintegration (<30 sec) specifically L-HPC and MCC tablets. Disintegration time for
tablets with fully substituted-HPC was prolonged (200-500 sec) upon increasing concentration between 1-10% due to gelation/
matrix formation. It can be concluded that despite the reasonably good plasticity of both cellulosic and noncellulosic
excipients in pure form, the mechanical strength in binary mixtures is negatively impacted by the fragmentation/
fracture effect of mannitol.
Cellulose, Compaction, Crospovidone, Excipients, MCC, Mannitol, ODT, POLYOX.
Aston Pharmacy School, Aston University, Birmingham, B4 7ET, UK.