Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 559, Issue -, Pages 37-47Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ijpharm.2019.01.014
Keywords
Twin-screw melt granulation; Gabapentin; Hydroxypropyl cellulose; Continuous manufacturing; Tabletability
Categories
Funding
- Foster Delivery Science (Putnam, CT, USA)
Ask authors/readers for more resources
The effect of thermal binders on the physicochemical properties of gabapentin, a thermally labile drug, in granules prepared using twin-screw melt granulation was investigated in this study. Hydroxypropyl cellulose (HPC), a thermoplastic high molecular-weight binder, was compared against conventional low molecular-weight semi-crystalline thermal binders PEG 8000 and Compritol. Both the chemical degradation and polymorph form change of gabapentin were analyzed. The effects of particle size and molecular weight of HPC on the properties of granules were also studied. To overcome the high melt viscosity of HPC, higher barrel temperatures and higher specific mechanical energy were required to attain suitable granules. As a result, higher levels of gabapentin degradant were observed in HPC-based formulations. However, gabapentin form change was not observed in all formulations. Smaller particle size and lower molecular weight of HPC led to faster granule growth. The tabletability of granules was insensitive to the variations in particle size and molecular weight of HPC. Gabapentin crystal size reduction, HPC size reduction, and HPC enrichment on granule surface were observed for HPC-based granules.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available