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  • 标题:Biphasic dissolution method for quality control and assurance of drugs containing active substances in the form of weak acid salts
  • 本地全文:下载
  • 作者:ALEŠ FRANC ; JAN MUSELÍK ; ROMAN GONĚC
  • 期刊名称:Acta Pharmaceutica
  • 电子版ISSN:1846-9558
  • 出版年度:2016
  • 卷号:66
  • 期号:1
  • 页码:139-145
  • DOI:10.1515/acph-2016-0010
  • 语种:English
  • 出版社:Sciendo
  • 摘要:Substances in the form of weak acid salts have been found to be problematic for dissolution testing.Their absorption can start only aft er they are turned into the form of an acid following the gastric passage although they were administered in the form of a salt.Due to poor solubility,they cannot be tested in acidic gastric environment for a biased dissolution profi le.The biphasic dissolution method is promising for overcoming this obstacle.Tablets with warfarin clathrate sodium salt in two concentrations and two diff erent particle size distributions were tested as a suitable model for fi nding the medium and process conditions of dissolution.The dissolution method based on the use of the upper organic layer (1-octanol) and the lower aqueous layer (0.1 mol L–1 HCl) was found suitable and discriminatory for tablets containing active substances in the form of salts of weak acids.The method also refl ects physical diff erences in the quality of used substances.
  • 关键词:weak acid salts;warfarin sodium;dissolution method
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