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Plasticisation of amylodextrin by moisture. Consequences for compaction behaviour and tablet properties
R Steendam1, H W Frijlink, C F Lerk
1Department of Pharmaceutical Technology and Biopharmacy, Groningen University Institute for Drug Exploration, University of Groningen, Ant. Deusinglaan 1, 9713 AV, Groningen, The Netherlands. steendam@polyganics.com
Summary
Moisture significantly impacts amylodextrin
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Amylodextrin, a starch derivative, is utilized as a controlled-release excipient.
- This excipient is prone to moisture absorption during storage, affecting its physical properties.
Purpose of the Study:
- To investigate the plasticizing effect of moisture on amylodextrin.
- To determine how moisture content influences the compaction behavior and final tablet characteristics of amylodextrin.
Main Methods:
- Differential Scanning Calorimetry (DSC) was used to determine the glass transition temperature (T(g)) of amylodextrin with varying moisture fractions.
- Compressive stress-strain experiments were conducted to measure elastic modulus and yield stress.
- Tablet compaction was simulated at different speeds (3 and 300 mm/s) to assess powder compressibility and compact relaxation.
Main Results:
- The glass transition temperature (T(g)) of amylodextrin decreased with increasing moisture content, reaching room temperature at a moisture fraction of 0.19.
- Elastic modulus showed a sharp decline between moisture fractions of 0.17 and 0.23.
- Moisture initially improved powder compressibility and reduced relaxation, leading to lower tablet porosities around 0.15 moisture fraction. However, higher moisture content (0.23) resulted in reduced compressibility and increased relaxation, ultimately decreasing maximum tablet strength due to weaker particle bonding.
Conclusions:
- Moisture content critically influences the viscoelastic properties and compaction behavior of amylodextrin.
- Precise control over amylodextrin's moisture level is crucial for manufacturing tablets with consistent porosity, strength, and dissolution profiles.