Powder compaction properties of sodium starch glycolate disintegrants.
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 the poor compactibility of Vivastar P is due to differences 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 when formulating poorly compactable or moisture-sensitive drugs.
Edge
S
S
Pharmaceutical Technology Research Group, Department of Pharmacy and Pharmacology, University of Bath, Bath BA2 7AY, UK. prssje@bath.ac.uk
Steele
D F
DF
Staniforth
J N
JN
Chen
A
A
Woodcock
P M
PM
D002626:Chemistry, Pharmaceutical; D005079:Excipients / Q000737:chemistry*; D006244:Hardness; D008855:Microscopy, Electron, Scanning; D011208:Powders; D011312:Pressure; D013213:Starch / Q000031:analogs & derivatives* / Q000737:chemistry*; D013499:Surface Properties; D013607:Tablets; D013718:Tensile Strength; D014961:X-Ray Diffraction
D005079:Excipients; D011208:Powders; D013607:Tablets; D013213:Starch; C048390:sodium starch glycolate