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Powder compaction properties of sodium starch glycolate disintegrants.
S Edge1, D F Steele, J N Staniforth
1Pharmaceutical Technology Research Group, Department of Pharmacy and Pharmacology, University of Bath, Bath BA2 7AY, UK. prssje@bath.ac.uk
Drug Development and Industrial Pharmacy
|October 16, 2002
Summary
Sodium starch glycolate (SSG) grades show varied mechanical properties. Primojel and Explotab offer good compactibility, while Vivastar P has poor compactibility but similar compressibility, impacting drug formulation.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Sodium starch glycolate (SSG) is a common pharmaceutical excipient used as a disintegrant.
- Commercial SSG grades may exhibit variations in physical and mechanical properties.
- Understanding these variations is crucial for effective drug formulation.
Purpose of the Study:
- To investigate and compare the compaction and compressibility behavior of three commercially available sodium starch glycolate (SSG) grades: Explotab, Primojel, and Vivastar P.
- To identify potential reasons for differences in mechanical properties among SSG grades.
- To assess the implications of these differences for pharmaceutical formulation.
Main Methods:
- Powder mechanical properties were evaluated at different compression speeds (0.17 and 30 mm/sec).
- Techniques included x-ray diffraction, scanning electron microscopy, Carr's compressibility index, and swelling volume measurements.
- Material characteristics such as moisture content, crystallographic order, particle surface topography, and swelling were analyzed.
Main Results:
- Significant differences in compaction behavior were observed among the three SSG grades.
- Primojel and Explotab demonstrated similar compactibility, producing robust compacts.
- Vivastar P exhibited poor compact integrity despite comparable compressibility to Explotab; its low moisture content and reduced surface topography were noted but not definitively linked to poor compactibility.
Conclusions:
- Commercial SSG grades possess distinct "as supplied" powder mechanical properties, impacting their performance in compaction.
- Primojel and Explotab show similar, favorable compactibility, whereas Vivastar P is poorly compactable.
- These mechanical property variations have implications for selecting SSG grades when formulating drugs, particularly those that are poorly compactable or moisture-sensitive.