Conference Contribution Details
Mandatory Fields
Peddapatla R.V.G.1,2, Rizwan Ahmed M.3, Blackshields C.A., Fitzpatrick D., Crean A.M.
EuPAT8
Broadband acoustic resonance dissolution spectroscopy: a novel at-line process analytical technology tool for the analysis of lubricated blends/tablets
Cork, Ireland
Oral Presentation
2016
()
0
Optional Fields
03-OCT-16
04-OCT-16
Objectives: To evaluate the continuous feeding behavior of lubricated blends and assess the use of BARDS as an at-line PAT tool enabling the monitoring of blends and tablets. Methods: Blend-1 (microcrystalline cellulose 90%w/w + metoclopramide 10%w/w and Blend 2 (microcrystalline cellulose 89.5%w/w + metoclopramide 10%w/w + magnesium stearate 0.5%w/w) were prepared using a double cone blender and fed using a K-Tron MT12 continuous feeder at 3 feed rates. Feeder performance was evaluated using a KSampler Test System. Variability (%RSD) was determined from data collected at 30sec intervals over 30mins. Blend compaction profiles following feeding were generated on a Riva tablet press. Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS) recorded the steady state resonance of the system for 30 s1. Changes in the pitch of the resonance of system upon material addition was recorded for 800-1200 seconds. Results: Reduced %RSD at 3 different set points was observed for Blend 2. More variability was observed at lower set points for both blends. BARDS revealed different acoustic profiles for Blend 1 and 2 due to the presence of lubricant. BARDS detected differences in lubricated blends fed at different set points demonstrating increased lubrication. Increased feed rate negatively effected tablet tensile strength indicating increased lubrication for Blend 2. BARDS detected differences in tablets of same composition but different lubricant distribution and tensile strength. BARDS distinguished between tablets compressed at different forces and between tablets prepared from Blend 1 and 2 at similar compression forces. Conclusions: A deeper understanding of the impact of processing parameters in the feeding stage and inclusion of lubricant in fed blends on compression was obtained. The potential of BARDS as novel at-line PAT tool in pharmaceutical processing to detect differences in blends and the effect of processing parameters was demonstrated. Key References: 1. Fitzpatrick, D. et al. (2012). Analytical chemistry, 84(5), 2202-2210.
EI/IDA Pharmaceutical Manufacturing Technology Centre