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Development and evaluation of a miniaturized procedure for determining the bonding index: a novel prototype for solid
Kimberly Lamey1, Joseph Schwartz, Francis Muller
1GlaxoSmithKline (GSK) Pharmaceuticals, King of Prussia, Pennsylvania 19406, USA. Kimberly_A_Lamey@gsk.com
Pharmaceutical Development and Technology
|August 7, 2003
Summary
Miniaturized methods accurately assess tableting performance (ITP) and material properties like tensile strength and hardness. Both miniaturized and University of Minnesota procedures correlate for bonding index, but miniaturized methods better discriminate compaction behaviors.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Mechanical Engineering
Background:
- Accurate determination of tabletability is crucial for direct compression formulations.
- Existing methods for assessing tablet properties can be resource-intensive.
- Miniaturization offers potential for more efficient material characterization.
Purpose of the Study:
- To comparatively evaluate miniaturized versus University of Minnesota (U of Minn.) procedures for determining key tableting performance indices.
- To assess the accuracy and correlation of miniaturized methods for tensile strength, indentation hardness, and bonding index (BI).
- To investigate the ability of miniaturized procedures to differentiate material properties under various compaction conditions.
Main Methods:
- Utilized a compaction simulator and Texture Analyser TA-XT2I for miniaturized procedures.
- Employed the U of Minn. method involving triaxial compression, mechanical stress-strain analysis, and pendulum impact.
- Determined Indices of Tableting Performance (ITP), including bonding index, tensile strength, and indentation hardness.
Main Results:
- Miniaturized and U of Minn. procedures showed good correlation for bonding index (BI).
- Tensile strength and indentation hardness values differed due to variations in compression methods (triaxial vs. standard compaction).
- Miniaturized procedures demonstrated better discrimination of out-of-die compaction properties, correlating precisely with strain rate and material characteristics.
Conclusions:
- Both miniaturized and U of Minn. methods provide similar overall conclusions for direct compression placebo formulations.
- Miniaturized procedures offer enhanced precision in evaluating material properties and particle interactions.
- The study validates miniaturized methods for efficient and accurate assessment of tableting performance.