Inter- and Intra-Manufacturer Variability in Pharmaceutical Grades and Lots of Xanthan Gum
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A pharmaceutical formulation typically contains one or more excipients in addition to the active pharmaceutical ingredient(s). Though excipients have been considered inert components of a formulation, variability in their properties has been shown to affect the performance of drug dosage forms and delivery systems. This study investigates the inter- and intra-manufacturer variability among different NF grades and lots of xanthan gum made by two manufacturers. As many formulators rely on compendial standards to monitor and control the variability of excipients, this study focuses on the adequacy of the NF specifications, in particular the viscosity specification, to discern the variability in solution properties of different pharmaceutical grades and lots of xanthan gum. All the grades and lots in this study were NF grade materials. Xanthan gum solutions were prepared in accordance with NF test methodology and were rheologically evaluated using a rotational rheometer. Both steady shear measurements and small amplitude oscillatory measurements were carried out on 1% w/w xanthan gum solutions. Results showed significant inter- and intra-manufacturer variability among the NF grades and lots of xanthan gum that was not reflected in the NF viscosity test specifications.
Key wordsexcipient variability rheology xanthan gum
The authors thank Lynn M. Walker, Professor of Chemical Engineering, Carnegie Mellon University, Pittsburgh, PA for providing access to rheological instrumentation. The authors also thank Dr. Frank D’Amico, Professor of Statistics, Duquesne University, Pittsburgh, PA for his helpful discussions regarding experimental design and data analysis.
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