(404d) Measurement Of The Effect Of Total Shear and Compaction Force On Tablet Properties Using Terahertz Pulsed Spectroscopy: Towards The Prediction Of Dissolution Rate
AIChE Annual Meeting
2013
2013 AIChE Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
Application of Quality By Design in Drug Product Process Development II
Wednesday, November 6, 2013 - 9:45am to 10:10am
The purpose of this study was to gain an understanding of the effects of process parameters on tablet properties using terahertz pulsed spectroscopy. This was to determine the feasibility for predicting tablet dissolution rates using parameters obtained by transmission terahertz pulsed spectroscopy. Terahertz Spectroscopy was able to detect the effect of both shear and compaction force on tablet properties.
A pre-blend consisting of microcrystalline cellulose, lactose monohydrate, acetaminophen and magnesium stearate was prepared in a V-blender and subdivided into three fractions. Two of the fractions were subsequently sheared for 160 and 640 minutes, respectively, and the third fraction received no additional shearing. Each of the three blend fractions was compressed into tablets using nominal compression forces of 8, 12 and 16 kN. Tablets from each treatment were analyzed non-destructively using an Advantest TAS7500SP pulsed terahertz spectrometer.
Two important terahertz parameters, refractive index (which is a measure of tablet porosity) and peak absorbance (which is proportional to the blend component concentrations and crystallinity) yielded complementary information. The refractive index of the tablets showed a high degree of correlation with compression force, but no distinct trend with shear time. The intensity of the crystalline lactose monohydrate peak in the terahertz absorbance spectra showed a decreasing trend with shear time and minimal influence due to compaction force.
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