Edge S, Steele D F, Staniforth J N, Chen A, Woodcock P M
Pharmaceutical Technology Research Group, Department of Pharmacy and Pharmacology, University of Bath, Bath BA2 7AY, UK.
Drug Dev Ind Pharm. 2002 Sep;28(8):989-99. doi: 10.1081/ddc-120006430.
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.
在0.17和30毫米/秒的压缩速度下，研究了三种市售的“原样”羟丙基淀粉钠（SSG），即Explotab、Primojel和Vivastar P的压实行为。结果表明，这三种“原样”材料表现出不同的压缩和压实行为。Primojel和Explotab表现出相似的可压性，而Vivastar P制成的压片完整性较差。这种行为在粉末的可压缩性方面并未体现，其中Vivastar P和Explotab表现出相似的性能。使用X射线衍射、扫描电子显微镜、卡尔压缩指数和溶胀体积对这些材料进行了研究。就材料特性而言，所有产品在水中的溶胀情况相似。Primojel和Explotab保留了大部分来自母体马铃薯淀粉的晶体结构顺序，并表现出相当的颗粒表面形貌。Vivastar P的水分含量最低。然而，尚不清楚Vivastar P可压性差是由于水分含量的差异、表面形貌的降低，还是SSG聚合物结构（取代、交联和结晶度）的细微差异。总体而言，尽管这三种市售的羟丙基淀粉钠成功用作崩解剂，但它们在“原样”粉末机械性能方面确实存在差异：Primojel和Explotab表现出相似的可压性，而Vivastar P可压性差，但与Explotab表现出相似的压缩性。在配制可压性差或对水分敏感的药物时，这些观察结果可能具有重要意义。
