Instant FaSSIF and FeSSIF—Biorelevance Meets Practicality

Abstract

The objective of this study was to prepare an “instant” form of FaSSIF and FeSSIF that could be implemented easily and reproducibly in the laboratory setting. Concentrated solutions containing bile salts and lecithin were freeze-dried and further processed into bulk packs, blisters, or tablets, or sealed in powder form under nitrogen in vials. Physical properties as well as solubility and dissolution data for two poorly soluble compounds, danazol and a Boehringer-Ingelheim development compound (BIXX), were compared with data for freshly prepared FaSSIF and FeSSIF and a commercially available “instant” product. After the freeze-dried FaSSIF and FeSSIF media were reconstituted with appropriate buffers, their properties were close to those of freshly prepared media and a commercially available product for reconstitution, SIF Powder. Additionally, the solubility and dissolution profiles of danazol and BIXX in media prepared by all three methods were similar. Reconstitution of freeze-dried “instant” FaSSIF and FeSSIF appears to be an accurate, reproducible, and efficient way of preparing biorelevant dissolution media.