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Evaluation of Lactose-Based Direct Tableting Agents' Compressibility Behavior Using a Compaction Simulator
Yıldız Özalp1, Motunrayo M Onayo1, Nailla Jiwa1
1Near East University Faculty of Pharmacy, Department of Pharmaceutical Technology, Nicosia, Cyprus.
Turkish Journal of Pharmaceutical Sciences
|September 17, 2020
Summary
StarLac® and FlowLac®100, two direct tableting agents (DTAs), were compared for compressibility using a compaction simulator. StarLac® demonstrated less brittle behavior and lower sensitivity to compression force, indicating better plasticity for tablet formulation.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Chemical Engineering
Background:
- Direct tableting agents (DTAs) are crucial for efficient tablet manufacturing.
- Lactose-based DTAs are widely used due to their good compressibility and flowability.
- Evaluating DTA behavior under compaction is essential for successful tablet formulation, especially for poorly soluble drugs like paracetamol.
Purpose of the Study:
- To evaluate the compaction behavior of two lactose-based direct tableting agents (DTAs): StarLac® and FlowLac®100.
- To compare the compressibility and plasticity of StarLac® and FlowLac®100 using a compaction simulator (CS).
- To assess their suitability for formulating tablets containing poorly flowable paracetamol.
Main Methods:
- Physical characterization of powders including densities and scanning electron microscopy.
- Flowability assessment using angle of repose, Hausner ratio, and Carr's compressibility index.
- In-die compression analysis using a compaction simulator (CS) to capture force, thickness, and displacement data.
- Compressibility evaluation via Heckel equation analysis.
Main Results:
- No significant differences in physical characteristics were observed between StarLac® and FlowLac®100.
- Tablet formulations with FlowLac® showed higher sensitivity to increased compression force compared to StarLac®.
- Heckel analysis yielded yield pressure (Py) values of 85.2 MPa for StarLac® and 87.5 MPa for FlowLac®100 at 5 kN, indicating brittle behavior for both.
Conclusions:
- StarLac® exhibits less brittle behavior and lower sensitivity to compression force, suggesting superior plasticity.
- Yield pressure (Py) values derived from the Heckel equation provide real-time insights into the compressibility and plasticity of DTAs during compaction.
- The compaction simulator effectively differentiates the compaction behaviors of lactose-based DTAs, aiding in formulation development.
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