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Compressibility of binary powder formulations: investigation and evaluation with compaction equations
Nicolaos D Gentis1, Gabriele Betz
1Department of Pharmaceutical Sciences, Industrial Pharmacy Research Group, University of Basel, 4056 Basel, Switzerland.
Journal of Pharmaceutical Sciences
|November 15, 2011
Summary
This study evaluated powder compressibility in drug-excipient mixtures. Mathematical models revealed nonlinear relationships between drug load and compressibility, crucial for predicting formulation behavior.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Understanding powder compressibility is vital for successful tablet formulation.
- Binary mixtures of excipients and active pharmaceutical ingredients (APIs) present unique compaction challenges.
Purpose of the Study:
- To investigate and evaluate the powder compressibility of binary mixtures containing microcrystalline cellulose and brittle APIs (paracetamol, mefenamic acid).
- To assess the progression of compressibility with increasing drug load (0%-100% m/m).
- To analyze the applicability of mathematical models in predicting compaction behavior.
Main Methods:
- Compacted powder formulations to various relative densities using a Zwick material tester.
- Applied mathematical models (Heckel, modified Heckel, Leuenberger) to compaction force and tensile strength data.
- Analyzed factors k, C, and susceptibility values in relation to drug load.
Main Results:
- Factors k and C (Heckel equations) exhibited nonlinear correlations with drug load, with significant drops at higher drug concentrations.
- The observed changes in compressibility factors suggest potential percolation thresholds in binary mixtures.
- Susceptibility values (Leuenberger equation) varied without a clear trend related to drug load.
Conclusions:
- Mathematical modeling of powder compaction is essential for scientific evaluation and prediction.
- Drug load significantly impacts powder compressibility, posing challenges for formulation design.
- Identifying percolation thresholds through compressibility analysis is critical for robust tablet development.
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