Non-aqueous formulations for ram and screen extrusion-spheronisation

Publication date: Available online 11 February 2019Source: International Journal of PharmaceuticsAuthor(s): M. Zhang, S.L. Rough, R. Ward, C. Seiler, D.I. WilsonAbstractThe use of non-aqueous cellulose-based formulations for extrusion-spheronisation (E-S) is investigated. A 10 wt% hydroxypropyl cellulose/isopropyl alcohol solution (HPC/IPA) was identified as a suitable sticky liquid binder for preparing non-aqueous pastes. Preliminary tests were performed on a series of pastes using a ram as well as a laboratory roller screen extruder, since the former is commonly used in batch testing and the latter replicates the shear range in a manufacturing screen extruder. Pellets with acceptable size and shape distributions were obtained with AvicelĀ® HFE-102 NF/HPC/IPA for ram E-S, and with AvicelĀ® RC-591/HPC/IPA for screen E-S. Further investigation was performed with calcium carbonate added as a model active pharmaceutical ingredient. Both formulations were able to generate pellets with acceptable size and shape characteristics at up to 50 wt% carbonate loading: further work is required to optimise yields.Graphical abstract
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research