Powder compaction properties of sodium starch glycolate disintegrants

被引:23
作者
Edge, S [1 ]
Steele, DF
Staniforth, JN
Chen, A
Woodcock, PM
机构
[1] Univ Bath, Dept Pharm & Pharmacol, Pharmaceut Technol Res Grp, Bath BA2 7AY, Avon, England
[2] Univ Bath, Dept Mat Sci & Engn, Bath BA2 7AY, Avon, England
[3] Penwest, Patterson, NY USA
关键词
disintegrant; mechanical properties; sodium starch glycolate;
D O I
10.1081/DDC-120006430
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
The compaction behavior of three "as supplied" commercially, available grades of sodium starch glycolate (SSG), Explotab, Primojel, and Vivastar P, was investigated at compression speeds of 0.17 and 30 mm/sec. The results suggested that the three "as supplied" materials exhibit different compression and compaction behavior. Primojel and Explotab exhibited similar compactibility, whereas Vivastar P produced compacts of poor integrity. This behavior was not mirrored in the compressibility, of the powders, where Vivastar P and Explotab exhibited similar performance. The materials were studied using x-ray diffraction, scanning electron microscopy, Carr's compressibility, index, and swelling volume. In terms of material characteristics, all the products exhibited similar swelling in water. Primojel and Explotab retained most of the crystallographic order from the parent Potato starch and exhibited comparable particle surface topographies. Vivastar P contained the lowest moisture level. However, it is not clear if theferenccs in moisture content, the reduced surface topography, or subtle differences in the SSG polymer structures (substitution, cross-linking, and crystallinity). Overall, even though the three commercial grades of sodium starch glycolate are successfully used as disintegrants, they do exhibit differences in their "as supplied" powder mechanical properties: Primojel and Explotab exhibit similar compactibility, whereas Vivastar P is poorly compactable but exhibits similar compressibility, to Explotab. These observations may have implications own formulating poorly compactable or moisture-sensitive drugs.
引用
收藏
页码:989 / 999
页数:11
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