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  • 标题:An Improved Formulation Screening and Optimization Method Applied to the Development of a Self-Microemulsifying Drug Delivery System
  • 本地全文:下载
  • 作者:Ying Liu ; Zhi Qiang Chen ; Xin Zhang
  • 期刊名称:Chemical and Pharmaceutical Bulletin
  • 印刷版ISSN:0009-2363
  • 电子版ISSN:1347-5223
  • 出版年度:2010
  • 卷号:58
  • 期号:1
  • 页码:16-22
  • DOI:10.1248/cpb.58.16
  • 出版社:The Pharmaceutical Society of Japan
  • 摘要:

    This study focused on the development of an improved formulation screening and optimization method for a self-microemulsifying drug delivery system (SMEDDS). Solubility study and construction of a ternary phase diagram were carried out to determine the primary formulation components. Experimental design combined with a desirability study was employed to obtain the optimal formulation composition. The obtained bufalin SMEDDS formulation was Maisine 35-1 and Miglyol 812N (1 : 1, w/w) of 29.5%, Cremophor EL of 39.5%, and Transcutol P of 30.5%. It showed desired properties with droplet size of 33.9 nm; polydispersity index of 0.126; equilibrium solubility of 12.6 mg/ml, and 73.6% of soluble drug post-digestion. A rapid release of up to 21% occurred in the first 10 min. A bufalin SMEDDS was well absorbed at all intestinal segments. The absorption of bufalin from a SMEDDS was 2.38-fold higher than that of bufalin suspension in terms of relative bioavailability. The studies on solubility and ternary phase diagrams combined with experimental design may offer a valuable and efficient strategy for developing and optimizing a SMEDDS to obtain optimal formulations with desired characteristics.

  • 关键词:self-microemulsifying drug delivery system; bufalin; in vitro digestion; in situ intestinal absorption
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