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True density of microcrystalline cellulose.
1Pfizer Global Research and Development, Portage, Michigan 49001, USA. changquan.sun@pfizer.com
Journal of Pharmaceutical Sciences
|September 2, 2005
Summary
Microcrystalline cellulose (MCC) tableting issues may stem from inaccurate true density measurements. This study determined MCC true density with varying water content, revealing literature values are often overestimated due to helium pycnometry limitations.
Area of Science:
- Materials Science
- Pharmaceutical Sciences
- Physical Chemistry
Background:
- Microcrystalline cellulose (MCC) is a widely used pharmaceutical excipient known for its excellent compressibility.
- However, MCC can exhibit unusual tableting properties that are not fully explained by its known plasticity.
- Inconsistencies in tableting performance can impact drug product quality and manufacturing efficiency.
Purpose of the Study:
- To investigate the influence of water content on the true density of microcrystalline cellulose (MCC).
- To re-evaluate the accuracy of commonly reported MCC true density values.
- To understand how inaccurate true density affects the analysis of MCC tableting data.
Main Methods:
- Determined the true density of MCC as a function of water content using a validated method for hygroscopic solids.
- Employed a technique capable of accurately measuring the true density of solids containing water.
- Compared experimental results with literature values obtained via helium pycnometry.
Main Results:
- True density of MCC is significantly influenced by its water content.
- Literature values for MCC true density are frequently overestimated.
- Limitations in helium pycnometry contribute to the overestimation of MCC true density.
Conclusions:
- Inaccurate true density values, often due to helium pycnometry limitations, can explain some unusual tableting properties of MCC.
- Accurate determination of MCC true density, considering water content, is crucial for reliable tableting data analysis.
- This research highlights the need for careful consideration of material moisture content in solid-state characterization for pharmaceutical applications.